Page Range | 62429-63070 | |
FR Document |
Page and Subject | |
---|---|
80 FR 62435 - Presidential Determination With Respect to Foreign Governments' Efforts Regarding Trafficking in Persons | |
80 FR 62433 - Presidential Determination on Refugee Admissions for Fiscal Year 2016 | |
80 FR 62431 - Determination With Respect to the Child Soldiers Prevention Act of 2008 | |
80 FR 62429 - Delegation of Authority Under Section 404(c) of the Child Soldiers Prevention Act of 2008 | |
80 FR 62576 - Sunshine Act Meeting Notice | |
80 FR 62530 - Sunshine Act Meeting | |
80 FR 62542 - National Institute of Neurological Disorders and Stroke, Interagency Pain Research Coordinating Committee Call for Committee Membership Nominations | |
80 FR 62526 - Proposed Information Collection Request; Comment Request; Hazardous Chemical Reporting: The Emergency and Hazardous Chemical Inventory Forms (Tier I and Tier II) | |
80 FR 62563 - Eastern States: Filing of Plats of Survey | |
80 FR 62595 - Culturally Significant Objects Imported for Exhibition Determinations: “Woven Gold: Tapestries of Louis XIV” Exhibition | |
80 FR 62594 - Culturally Significant Objects Imported for Exhibition Determinations: “Picturing the Americas: Landscape Painting From Tierra del Fuego to the Artic” Exhibition | |
80 FR 62488 - International Affairs; High Seas Fishing Compliance Act; Permitting and Monitoring of U.S. High Seas Fishing Vessels | |
80 FR 62501 - Fisheries of the Caribbean, Gulf of Mexico, and South Atlantic; Snapper-Grouper Resources of the South Atlantic; Trip Limit Reduction for Gag Grouper | |
80 FR 62527 - Receipt of Test Data Under the Toxic Substances Control Act | |
80 FR 62528 - Pesticide Product Registration; Receipt of Applications for New Uses | |
80 FR 62443 - Nondiscrimination on the Basis of Disability Minority and Women Outreach Program Contracting | |
80 FR 62534 - Agency Information Collection Activities: Proposed Collection; Comment Request | |
80 FR 62541 - Proposed Collection; 60-day Comment Request; Media-Smart Youth Leaders Program (NICHD) | |
80 FR 62543 - Proposed Action Under the NIH Guidelines for Research Involving Recombinant or Synthetic Nucleic Acid Molecules (NIH Guidelines) | |
80 FR 62513 - Public Quarterly Meeting of the Board of Directors | |
80 FR 62526 - Northern Indiana Public Service Company, Notice of Availability of Draft Environmental Assessment | |
80 FR 62598 - Soo Line Railroad Company-Abandonment Exemption-in Cook County, Ill. | |
80 FR 62595 - Culturally Significant Objects Imported for Exhibition Determinations: “The Greeks-Agamemnon to Alexander the Great” Exhibition | |
80 FR 62574 - Meetings of Humanities Panel; Correction | |
80 FR 62574 - Meetings of Humanities Panel | |
80 FR 62510 - Federal Housing Administration (FHA): Single Family Mortgage Insurance Maximum Time Period for Filing Insurance Claims, Curtailment of Interest and Disallowance of Operating Expenses Incurred Beyond Certain Established Timeframes; Partial Withdrawal | |
80 FR 62506 - Raisins Produced From Grapes Grown in California; Proposed Amendments to Marketing Order | |
80 FR 62513 - Plant Variety Protection Board; Open Meeting | |
80 FR 62524 - Sunshine Act Notice | |
80 FR 62554 - Changes in Flood Hazard Determinations | |
80 FR 62556 - Changes in Flood Hazard Determinations | |
80 FR 62572 - Comment Request for Information Collection for the Self-Employment Training (SET) Demonstration Evaluation (SET Evaluation); Extension Request Without Change to an Existing Collection | |
80 FR 62502 - Fisheries of the Exclusive Economic Zone Off Alaska; Reapportionment of the 2015 Gulf of Alaska Pacific Halibut Prohibited Species Catch Limits for the Trawl Deep-Water and Shallow-Water Fishery Categories; Correction | |
80 FR 62562 - Notice of Intent To Amend the Resource Management Plan for the White River Field Office and Prepare an Associated Environmental Assessment for Travel and Transportation Management, Colorado | |
80 FR 62502 - Fisheries of the Exclusive Economic Zone Off Alaska; Exchange of Flatfish in the Bering Sea and Aleutian Islands Management Area; Correction | |
80 FR 62564 - Initial Classification of Public Lands and Minerals for State Indemnity Selection, Colorado | |
80 FR 62560 - Application for Withdrawal and Opportunity for Public Meeting, Deep Creek Canyon and Corridor, Colorado | |
80 FR 62551 - Sewage Treatment Technology-Type Approval of Marine Sanitation Devices | |
80 FR 62530 - Agency Information Collection Activities; Proposed Collection; Comment Request | |
80 FR 62537 - Draft Recommendations for the Permitted Daily Exposures for Two Solvents, Triethylamine and Methylisobutylketone, According to the Maintenance Procedures for the Guidance Q3C Impurities: Residual Solvents; International Conference on Harmonisation; Availability | |
80 FR 62519 - U.S. Integrated Ocean Observing System (IOOS®) Advisory Committee | |
80 FR 62457 - Drawbridge Operation Regulations; Atlantic Intracoastal Waterway, South Branch of the Elizabeth River, Portsmouth and Chesapeake, VA | |
80 FR 62456 - Drawbridge Operation Regulations; James River, Isle of Wight and Newport News, VA | |
80 FR 62570 - Agency Information Collection Activities: Proposed eCollection, eComments Requested; Revision of a Currently Approved Collection; National Incident-Based Reporting System (NIBRS) | |
80 FR 62572 - Agency Information Collection Activities; Proposed eCollection, eComments Requested; Extension of a Currently Approved Collection Cargo Theft Incident Report | |
80 FR 62518 - North Pacific Fishery Management Council; Public Meeting | |
80 FR 62520 - Pacific Fishery Management Council; Public Meeting (Webinar) | |
80 FR 62517 - Pacific Fishery Management Council; Public Meeting | |
80 FR 62520 - Pacific Fishery Management Council; Public Meeting | |
80 FR 62519 - Fisheries of the South Atlantic; South Atlantic Fishery Management Council; Public Meeting | |
80 FR 62518 - Pacific Fishery Management Council; Public Meeting | |
80 FR 62526 - Environmental Impact Statements; Notice of Availability | |
80 FR 62525 - Agency Information Collection Activities; Comment Request; Educational Quality Through Innovative Partnerships (EQUIP) Experimental Sites Initiative | |
80 FR 62524 - Agency Information Collection Activities; Comment Request; Student Assistance General Provisions-Non-Title IV Revenue Requirements (90/10) | |
80 FR 62521 - Procurement List; Addition | |
80 FR 62550 - National Institute of Environmental Health Sciences; Notice of Meeting | |
80 FR 62523 - Proposed Collection; Comment Request | |
80 FR 62523 - Membership of the Performance Review Board | |
80 FR 62584 - Self-Regulatory Organizations; New York Stock Exchange LLC; Order Approving Proposed Rule Change, Amending Section 907.00 of the Listed Company Manual (the “Manual”) To (i) Amend the Suite of Complimentary Products and Services That Are Offered to Certain Current and Newly Listed Companies, (ii) Update the Value of Complimentary Products and Services Offered to Listed Companies, and (iii) Provide That Complimentary Products and Services Would Also Be Offered to Companies That Transfer Their Listing to the Exchange From Another National Securities Exchange | |
80 FR 62522 - Agency Information Collection Activities; Submission for OMB Review; Comment Request-Testing and Recordkeeping Requirements for Carpets and Rugs | |
80 FR 62521 - Agency Information Collection Activities; Submission for OMB Review; Comment Request-Notification Requirements for Coal and Wood Burning Appliances | |
80 FR 62566 - Notice of Inventory Completion: U.S. Department of the Interior, National Park Service, Natchez Trace Parkway, Tupelo, MS | |
80 FR 62592 - Self-Regulatory Organizations; Notice of Filing of Proposed Rule Change Amending Several Rules To Address Certain Order Handling Obligations on the Part of Its Floor Brokers | |
80 FR 62576 - Order Granting Limited Exemptions From Exchange Act Rule 10b-17 and Rules 101 and 102 of Regulation M to PowerShares DWA Tactical Sector Rotation Portfolio Pursuant to Exchange Act Rule 10b-17(b)(2) and Rules 101(d) and 102(e) of Regulation M | |
80 FR 62588 - Self-Regulatory Organizations; BATS Exchange, Inc.; Notice of Filing and Immediate Effectiveness of a Proposed Rule Change Related to Fees for Use of BATS Exchange, Inc. | |
80 FR 62591 - Self-Regulatory Organizations; The NASDAQ Stock Market LLC; Order Approving Proposed Rule Change To Adopt a Kill Switch for NOM | |
80 FR 62578 - Self-Regulatory Organizations; Financial Industry Regulatory Authority, Inc.; Notice of Filing and Immediate Effectiveness of a Proposed Rule Change To Extend the TRACE Pilot Program in FINRA Rule 6730(e)(4) | |
80 FR 62593 - Self-Regulatory Organizations; ICE Clear Credit LLC; Notice of Filing of Proposed Rule Change Related to the ICC Rule Enforcement Process for Missed Submissions | |
80 FR 62590 - Self-Regulatory Organizations; NYSE Arca, Inc.; Notice of Filing and Immediate Effectiveness of Proposed Rule Change, as Modified by Amendment No. 1, Amending the Exchange's Fee Schedule To Eliminate the Sponsor Fee In Connection With Listing a New Derivative Securities Product on the Exchange | |
80 FR 62580 - Self-Regulatory Organizations; The NASDAQ Stock Market LLC; Order Granting Approval of Proposed Rule Change Relating to the Listing and Trading of the Shares of the AltShares Long/Short High Yield Fund of ETFis Series Trust I | |
80 FR 62533 - Availability of Draft Toxicological Profile; Set 27 Toxicological Profiles | |
80 FR 62536 - Submission for OMB Review; Comment Request | |
80 FR 62533 - Meeting of the National Advisory Council for Healthcare Research and Quality | |
80 FR 62599 - Lone Star Railroad, Inc. and Southern Switching Company-Track Construction and Operation Exemption-in Howard County, Tex | |
80 FR 62538 - Clarifying Current Roles and Responsibilities Described in the Coordinated Framework for the Regulation of Biotechnology and Developing a Long-Term Strategy for the Regulation of the Products of Biotechnology; Public Meeting | |
80 FR 62439 - NRCS Procedures for Granting Equitable Relief | |
80 FR 62513 - Proposed Information Collection; Comment Request; Current Population Survey (CPS) Fertility Supplement | |
80 FR 62570 - Certain Automated Teller Machines and Point of Sale Devices and Associated Software Thereof; Notice of Commission Determination Not To Review an Initial Determination Granting Complainant's Motion To Amend the Complaint and the Notice of Investigation | |
80 FR 62512 - Petitions for Reconsideration of Action in Rulemaking Proceeding; Correction | |
80 FR 62529 - Information Collection Being Reviewed by the Federal Communications Commission | |
80 FR 62462 - 2-Propen-1-Aminium, N,N-Dimethyl-N-Propenyl-, Chloride, Homopolymer; Exemption From the Requirement of a Tolerance | |
80 FR 62569 - Certain Recombinant Factor VIII Products; Commission Determination Not To Review an Initial Determination Granting an Unopposed Motion To Amend the Complaint and Notice of Investigation | |
80 FR 62487 - Federal Motor Vehicle Safety Standard; Automatic Emergency Braking | |
80 FR 62552 - Coast Guard Acceptance of Sewage Treatment Plants for Type-Approval to International Maritime Organization Resolution MEPC.227(64) | |
80 FR 62957 - Temporary Agricultural Employment of H-2A Foreign Workers in the Herding or Production of Livestock on the Range in the United States | |
80 FR 62595 - Requested Administrative Waiver of the Coastwise Trade Laws: Vessel PAESANA; Invitation for Public Comments | |
80 FR 62504 - Chemical Facility Anti-Terrorism Standards (CFATS) Appendix A | |
80 FR 62466 - Shipping; Technical, Organizational, and Conforming Amendments | |
80 FR 62509 - Proposed Establishment of Class E Airspace; Los Angeles, CA | |
80 FR 62451 - Establishment of Class E Airspace; Marshall, AR | |
80 FR 62511 - Approval of Implementation Plans; Arizona, Phoenix-Mesa; 2008 Ozone Standard Requirements | |
80 FR 62457 - Approval of Implementation Plans; Arizona, Phoenix-Mesa; 2008 Ozone Standard Requirements | |
80 FR 62558 - Federal Property Suitable as Facilities To Assist the Homeless | |
80 FR 62514 - Healthcare Technology & Hospital Information Services Trade Mission to the Kingdom of Saudi Arabia and Kuwait | |
80 FR 62450 - Establishment of Class E Airspace, Cottonwood, AZ | |
80 FR 62447 - Amendment of Class D and Class E Airspace, Revocation of Class E Airspace; Mountain Home, ID | |
80 FR 62516 - Small Diameter Graphite Electrodes From the People's Republic of China: Final Rescission of Antidumping Duty New Shipper Review; 2014 | |
80 FR 62567 - Information Collection: Atlantic Offshore Wind Energy Development-Public Attitudes, Values, and Implications for Tourism and Recreation; Submitted for OMB Review; Comment Request | |
80 FR 62441 - Energy Conservation Program for Consumer Products: Test Procedures for Clothes Washers; Correcting Amendments | |
80 FR 62445 - Amendment of Class E Airspace; Ashland, VA | |
80 FR 62446 - Establishment of Class E Airspace; Newport, NH | |
80 FR 62449 - Amendment of Class E Airspace; Ponce, PR | |
80 FR 62596 - Deepwater Port License Application: Liberty Natural Gas LLC, Port Ambrose Deepwater Port; Final Application Public Hearing and Final Environmental Impact Statement | |
80 FR 62601 - 2015 Edition Health Information Technology (Health IT) Certification Criteria, 2015 Edition Base Electronic Health Record (EHR) Definition, and ONC Health IT Certification Program Modifications | |
80 FR 62761 - Medicare and Medicaid Programs; Electronic Health Record Incentive Program-Stage 3 and Modifications to Meaningful Use in 2015 Through 2017 | |
80 FR 62455 - Standard Instrument Approach Procedures, and Takeoff Minimums and Obstacle Departure Procedures; Miscellaneous Amendments | |
80 FR 62452 - Standard Instrument Approach Procedures, and Takeoff Minimums and Obstacle Departure Procedures; Miscellaneous Amendments | |
80 FR 62470 - Ensuring Continuity of 911 Communications |
Agricultural Marketing Service
Natural Resources Conservation Service
Census Bureau
International Trade Administration
National Oceanic and Atmospheric Administration
Federal Energy Regulatory Commission
Agency for Healthcare Research and Quality
Agency for Toxic Substances and Disease Registry
Centers for Medicare & Medicaid Services
Children and Families Administration
Food and Drug Administration
National Institutes of Health
Coast Guard
Federal Emergency Management Agency
Land Management Bureau
National Park Service
Ocean Energy Management Bureau
Employment and Training Administration
National Endowment for the Humanities
Federal Aviation Administration
Maritime Administration
National Highway Traffic Safety Administration
Surface Transportation Board
Consult the Reader Aids section at the end of this issue for phone numbers, online resources, finding aids, and notice of recently enacted public laws.
To subscribe to the Federal Register Table of Contents LISTSERV electronic mailing list, go to http://listserv.access.thefederalregister.org and select Online mailing list archives, FEDREGTOC-L, Join or leave the list (or change settings); then follow the instructions.
Natural Resources Conservation Service, USDA.
Final rule.
The Natural Resources Conservation Service (NRCS) issues its final rule implementing the equitable relief authority, and the procedures set forth in section 1613 of the Farm Security and Rural Investment Act of 2002 (the 2002 Act), relating to relief for participants for covered programs administered by NRCS. The relief applies to cases where the program participant took action to his or her detriment based on action or advice from an NRCS employee, and situations where the participant acted in good faith, but failed to fully comply with program requirements.
This rule is effective October 16, 2015.
Paulette Craig, National Equitable Relief Specialist, at (301) 504-1650.
The Office of Management and Budget (OMB) designated this rule as not significant under Executive Order 12866 as supplemented by Executive Order 13563. Therefore, OMB will not review this final rule.
The Regulatory Flexibility Act (5 U.S.C. 601-612) generally requires an agency to prepare a regulatory flexibility analysis of any rule subject to notice and comment rulemaking requirements under the Administrative Procedure Act or any other statute. However, this regulation implements section 1613 of the 2002 Act, which is part of Title I of the 2002 Act. Section 1601(c) of the 2002 Act requires NRCS to promulgate regulations or administer Title I without regard to 5 U.S.C. 553. Therefore, NRCS did not prepare a regulatory flexibility analysis for this final rule.
Title II of the Unfunded Mandates Reform Act of 1995 (UMRA) (2 U.S.C. 1531-1538) requires Federal agencies to assess the effects of their regulatory actions on State, local, and Tribal governments, or the private sector of $100 million or more in any one year.
This rule contains no Federal mandates, as defined under Title II of UMRA, for State, local, and Tribal governments, or the private sector. Therefore, a statement under section 202 of UMRA is not required.
This rule is not a major rule under the Small Business Regulatory Enforcement Fairness Act of 1996, (Pub. L. 104-121). Therefore, NRCS is not required to delay the effective date for 60 days from the date of publication to allow for congressional review. Accordingly, this rule is effective upon publication in the
Section 1601(c)(2) of the 2002 Act requires that the implementation of this provision be carried out without regard to the Paperwork Reduction Act, Chapter 35 of Title 44, United States Code. Therefore, NRCS is not reporting recordkeeping or estimated paperwork burden associated with this final rule.
NRCS is committed to compliance with the Government Paperwork Elimination Act as well as continued pursuit of providing all services electronically when practicable. This rule requires that a program participant make a written request for equitable relief for a program administered by NRCS. In part, this rule lends itself to electronic requests as submitted by State Conservationists or participants.
NRCS has determined that changes made by this rule fall within a category of actions that are excluded from the requirement to prepare either an environmental assessment or an environmental impact statement. Administrative changes made in this rule fall within a categorical exclusion for policy development relating to routine activities and similar administrative functions (7 CFR 1b.3(a)(1)) and NRCS has identified no extraordinary circumstances that would otherwise require preparation of either.
NRCS has determined through a Civil Rights Impact Analysis (CRIA) that the final rule discloses no disproportionately adverse impacts for minorities, women, or persons with disabilities. The CRIA provides responses to the Final rule amendments.
The data presented indicates producers who are members of the protected groups have participated in NRCS conservation programs at parity with other producers. Extrapolating from historical participation data, it is reasonable to conclude that NRCS programs, including procedures for granting equitable relief for ineligibility for these programs, will continue to be administered in a non-discriminatory manner. Outreach and communication strategies are in place to ensure all producers will be provided the same information to allow them to make informed compliance decisions regarding the use of their lands that will affect their participation in U.S. Department of Agriculture (USDA) programs.
The equitable relief procedures apply to all persons equally regardless of their race, color, national origin, gender, sex, or disability status. Therefore, the final rule portends no adverse civil rights implications for women, minorities, or persons with disabilities.
This section amends, adds, or removes a number of defined terms in the rule. Specifically, it adds definitions for “appeal rights,” “equitable relief,” “participant,” and “State.” “Appeal rights” is defined to clarify that a
The amended rule clarifies the application of subsection (a), and strikes subsections (b) and (c) which are no longer needed.
The amended rule makes changes to this section to more closely conform to the language of the statute by enumerating the specific requirements to qualify for relief under this section. These changes do not substantively change the scope of this authority.
Section 635.4 of the amended rule makes changes to this section to more closely conform to the language of the statute by enumerating the specific requirements to qualify for relief under this section. These changes provide more flexibility for State Conservationists and participants to request equitable relief, and do not substantively change the scope of this authority.
The amended rule makes technical and grammatical changes to this section, and removes references to “loans” since NRCS does not have authority to make loans.
The amended rule restructures and clarifies the existing language of § 635.6. In particular, the revised section explains the limitations on a State Conservationist's authority in a separate subsection, and amends the description of the State Conservationist's authority to more closely reflect the statutory language.
The amended rule strikes the list of covered programs in paragraph (a). The definition of “covered programs” sufficiently identifies these programs.
The amended rule allows the Chief, State Conservationist, or participant to initiate a request for equitable relief. Under the current rule, only the participant can initiate a request for equitable relief. The State Conservationist cannot initiate a request even if he or she believes the participant qualifies for such relief. For example, an NRCS employee's misaction or misinformation may impact several different participants, resulting in a number of them being determined ineligible for program benefits. Under the current rule, the participants must request equitable relief from NRCS in order to obtain equitable relief. The State Conservationist cannot initiate an equitable relief request, even if he or she knows that other participants would likely also qualify for equitable relief. Given the potential for treating participants differently, NRCS is amending this procedure to allow the Chief or a State Conservationist to initiate a request for equitable relief for a participant meeting the requirements of this part.
Section 635.7 is also amended to add § 635.7(e) and (f). Paragraph 635.7(e) provides that requests for equitable relief must include any information necessary to determine eligibility under this authority and such other information as required by NRCS to determine whether granting equitable relief is appropriate. This revision reflects that the information needed by the agency to assess equitable relief requests will be provided and updated by applicable policy and procedure at Title 440 of the Conservation Program Manual, Part 509.
Paragraph 635.7(f) provides the participant with appeal rights to the National Appeals Division, pursuant to § 614.9(e) of this chapter, if equitable relief is denied.
Administrative practice and procedure, Agriculture, Conservation programs, Equitable Relief.
Accordingly, for the reasons set forth in the preamble, 7 CFR part 635 is revised to read as follows:
7 U.S.C. 7996.
The following terms apply to this part:
This part applies to all covered programs administered by the Natural Resources Conservation Service, except for the Highly Erodible Land and Wetland Conservation provisions of Title XII, subtitles B and C of the Food Security Act of 1985, as amended, (16 U.S.C. 3811
The Chief may grant equitable relief to any participant that NRCS determines is not in compliance with the requirements, terms and conditions of a
(a) Acting in good faith, relied on action and advice from an NRCS employee or representative of USDA to their detriment;
(b) Did not know or have sufficient reason to know that the action or advice upon which they relied would be detrimental; and
(c) Did not act in reliance on their own misunderstanding or misinterpretation of the program provisions, notices, or information.
The Chief may grant equitable relief to any participant that NRCS determines is not in full compliance with the requirements, terms and conditions of a covered program, and therefore ineligible for a payment, or other benefit, if the participant—
(a) Made a good faith effort to comply fully with the requirements; and
(b) Rendered substantial performance.
(a) The Chief may authorize a participant in a covered program to:
(1) Retain payments or other benefits received under the covered program;
(2) Continue to receive payments and other benefits under the covered program;
(3) Continue to participate, in whole or in part, under any contract executed under the covered program;
(4) Re-enroll all or part of the land covered by the program; and
(5) Receive such other equitable relief as determined to be appropriate.
(b) As a condition of receiving relief under this part, the participant may be required to remedy their failure to meet the program requirement or mitigate its effects.
(a)
(1) The program matter with respect to which the relief is sought is a program matter in a covered program operated within the authorized jurisdiction of the State Conservationist;
(2) The total amount of relief (including payments and other benefits) that will be provided to the participant under this section during the fiscal year is less than $20,000;
(3) The total amount of such relief that has been previously provided to the participant using this section in the fiscal year, as calculated in paragraph (a)(2) of this section, is not more than $5,000;
(4) The total amount of payments and benefits of any kind for which relief is provided to similarly situated participants by a State Conservationist in a fiscal year, is not more than $1,000,000.
(b)
(1) Payment limitations under part 1400 of this title;
(2) Payment limitations under a conservation program administered by the Secretary; or
(3) The highly erodible land and wetland conservation requirements under subtitles B or C of Title XII of the Food Security Act of 1985 (16 U.S.C. 3811
(c)
(d)
(e)
(a) The Chief or State Conservationist may initiate a request for equitable relief for a participant that meets the requirement of this part.
(b) Participants may request equitable relief from the Chief or the State Conservationist as provided in §§ 635.3 and 635.4 of this part.
(c) Only a participant directly affected by the non-compliance with the covered program requirements is eligible for equitable relief under this part.
(d) Requests by a participant for equitable relief must be made in writing, no later than 30 calendar days from the date of receipt of the notification of non-compliance with the requirements of the covered conservation program.
(e) Requests for equitable relief must include any information necessary to determine eligibility under this part and such other information as required by NRCS to determine whether granting equitable relief is appropriate. Information needed by the agency to assess equitable relief requests will be provided and updated by applicable policy and procedure.
(f) If equitable relief is denied by the Chief or the State Conservationist, the participant will be provided with written notice of appeal rights to the National Appeals Division, pursuant to 7 CFR part 614.
Office of Energy Efficiency and Renewable Energy, Department of Energy.
Final rule; correcting amendments.
On August 5, 2015, the U.S. Department of Energy (DOE) published a final rule amending the test procedures for clothes washers. This correction addresses several cross-reference numbering errors, in which the cross-references were inadvertently not updated to reflect the revised section numbering resulting from the final rule amendments. In addition, this correction republishes several amendments from the final rule that could not be incorporated into the Code of Federal Regulations (CFR) due to inaccurate amendatory instructions, and clarifies several of the amendatory instructions in the final rule to remove certain sections of the test procedures. Furthermore, this correction reinstates three sections of the clothes washer test procedure that were inadvertently removed from the CFR starting with the 2013 annual edition. Neither the errors nor the corrections in this document affect the substance of the rulemaking or any of the conclusions reached in support of either of these final rules.
Mr. Bryan Berringer, U.S. Department of Energy, Office of Energy Efficiency and Renewable Energy, Building Technologies Office, Mailstop EE-5B, 1000 Independence Avenue SW., Washington, DC 20585-0121. Telephone: (202) 586-0371. Email:
Mr. Eric Stas, U.S. Department of Energy, Office of the General Counsel,
DOE published a final rule in the
In addition, this final rule republishes the amendments to sections 2.6.5.1 and 2.6.5.2. It also clarifies that sections 2.6.5.3 (including its subsections), 2.6.5.4, 2.6.6.1, 2.6.6.2, 2.6.7.1, and 2.6.7.2 of Appendix J1 are to be removed.
Finally, in a test procedure final rule published on March 7, 2012 (the “March 2012 final rule”), DOE amended section 3.6 of Appendix J1 and intended for sections 3.6.1 through 3.6.3 to remain unchanged. 77 FR 13888. In the January 1, 2013 version of the CFR, sections 3.6.1 through 3.6.3 of Appendix J1 were inadvertently removed. Section 3.6 requires measuring water and electrical energy consumption for the Cold Wash temperature selection using the water fill levels and test load sizes specified in sections 3.6.1 through 3.6.3. As was the case prior to the inadvertent deletion and as reinstated, sections 3.6.1 through 3.6.3 provide these specifications and also define the variables associated with each measurement. This final rule correction reinstates these sections as they appeared in the January 1, 2012 version of the CFR, except that the word “adaptive” in section 3.6.3 is changed to “automatic,” as described in the August 2015 final rule.
The regulatory reviews conducted for this rulemaking are those set forth in the March 2012 final rule and August 2015 final rule that originally codified the respective amendments to DOE's test procedures for clothes washers. The amendments in the March 2012 final rule became effective April 6, 2012, and the amendments in the August 2015 final rule became effective September 4, 2015.
Pursuant to the Administrative Procedure Act, 5 U.S.C. 553(b), DOE has determined that notice and prior opportunity for comment on this rule are unnecessary and contrary to the public interest. Neither the errors nor the corrections in this document affect the substance of the rulemakings or any of the conclusions reached in support of either of these final rules. For these reasons, DOE has also determined that there is good cause to waive the 30-day delay in effective date.
Administrative practice and procedure, Confidential business information, Energy conservation, Household appliances, Imports, Intergovernmental relations, Small businesses.
For the reasons stated in the preamble, part 430 of title 10 of the Code of Federal Regulations is corrected by making the following correcting amendments:
42 U.S.C. 6291-6309; 28 U.S.C. 2461 note.
The revisions and additions read as follows:
2.6.5.1 Using the coefficients A and B calculated in Appendix J3 to 10 CFR part 430, subpart B:
2.6.5.2 Substitute RMC
2.7
3.6
3.6.1
3.6.2
3.6.3
3.7.1 For the rinse only, measure the amount of hot water consumed by the clothes washer including all deep and spray rinses, for the maximum (R
3.7.2 Measure the amount of electrical energy consumed by the clothes washer to heat the rinse water only, including all deep and spray rinses, for the maximum (ER
4.2.3
4.4
3.8.2.6 Apply the RMC correction curve described in section 7 of appendix J3 to this subpart to calculate the corrected remaining moisture content, RMC
3.8.3.2 Apply the RMC correction curve described in section 7 of appendix J3 to this subpart to calculate the corrected remaining moisture content for Cold Wash/Cold Rinse, RMC
3.8.3.4 Apply the RMC correction curve described in section 7 of appendix J3 to this subpart to calculate the corrected remaining moisture content for Warm Wash/Warm Rinse, RMC
4.2.4
4.2.5
4.2.12
4.2.13
4.5
4.6
Federal Deposit Insurance Corporation (FDIC).
Final rule.
The FDIC is updating its regulations, Nondiscrimination on the Basis of Disability, and Minority and Women Outreach Program Contracting, to reflect a name change from the Agency's Office of Diversity and Economic Opportunity (ODEO) to the Office of Minority and Women Inclusion (OMWI).
This final rule will become effective on October 16, 2015.
Melodee Brooks, Senior Deputy Director, Office of Minority and Women Inclusion, (703) 562-6090; or Robert Lee, Counsel, Legal Division, (703) 562-2020, Federal Deposit Insurance Corporation, 550 17th Street, NW., Washington, DC 20429-0002.
Following a recent review, the FDIC is updating 12 CFR parts 352 and 361 to reflect a name change from the FDIC Office of Diversity and Economic Opportunity to the FDIC Office of Minority and Women Inclusion.
Part 352 is the FDIC's regulation on nondiscrimination on the basis of disability and is intended to implement sections 504 and 508 of the Rehabilitation Act of 1973, as amended. Section 504 prohibits discrimination on the basis of disability in programs and activities conducted by a federal executive agency. Section 508 requires federal agencies to utilize electronic and information technology that is designed to allow individuals with disabilities access that is comparable to the access of those who are not disabled, unless such agency would incur an undue burden. Subsections 352.9(b) and 352.10 set forth information that is no longer accurate, as the Office of Diversity and Economic Opportunity's responsibilities and employees were transferred to the Office of Minority and Women Inclusion, a new office established by the FDIC Board of Directors pursuant to Section 342 of the Dodd-Frank Wall Street Reform and Consumer Protection Act (Act). Section 342 of the Act is codified at 12 U.S.C. 5452. The remaining contact information for OMWI remains the same as that of the predecessor office—3501 N. Fairfax Drive, Arlington, VA 22226; (877) 275-3342 or (703) 562-2473 (TTY).
Part 361 established in regulatory form the FDIC's Minority and Woman Outreach Program (MWOP) to ensure that minority- and women-owned businesses (MWOBs) are given the opportunity to participate fully in all contracts entered into by the FDIC as it is the FDIC's policy that minorities and women, and businesses owned by them have the maximum practicable opportunity to participate in contracts awarded by the FDIC. Subsections 361.5 and 361.6(a) set forth information that is no longer accurate, as the Office of Diversity and Economic Opportunity's responsibilities and employees have been transferred to the Office of Minority and Women Inclusion.
The final rule for parts 352 and 361 updates the name of the FDIC Office of Diversity and Economic Opportunity (ODEO) to the FDIC Office of Minority and Women Inclusion (OMWI). The amendments are procedural and non-substantive in nature, and would update the regulations to be consistent with the FDIC's practices and procedures. The revisions to each of the sections cited below in the List of Subjects simply reflect the change in office name.
Section 553 of the Administrative Procedure Act (APA)(5 U.S.C. 553) sets forth requirements for providing the general public notice of, and the opportunity to comment on, proposed agency rules. However, unless notice or hearing is required by statute, those requirements do not apply:
(A) To interpretive rules, general statements of policy, or rules of agency organization, procedure, or practice; or
(B) When the agency for good cause finds (and incorporates the findings and a brief statement of reasons therefor in the rules issued) that notice and public procedure thereon are impracticable, unnecessary, or contrary to the public interest. 5 U.S.C. 553(b).
The FDIC is updating parts 352 and 361 to reflect a name change from the FDIC Office of Diversity and Economic Opportunity to the FDIC Office of Minority and Women Inclusion. Since the changes relate to agency organization, procedure, or practice, and because the FDIC has determined for good cause that public notice and comment are unnecessary, the rules are being published in final form without public notice and comment.
Section 553 of the APA provides that a regulation shall not be made effective less than 30 days after its publication in the
The Regulatory Flexibility Act (RFA) (5 U.S.C. 601-612) does not apply to a rulemaking where a general notice of proposed rulemaking is not required. (5 U.S.C. 603 and 604). As noted previously, the FDIC has determined that it is unnecessary to publish a notice of proposed rulemaking for the final rule amending part 352. Accordingly, the RFA's requirements relating to an initial and final regulatory flexibility analysis do not apply to this rulemaking for parts 352 and 361.
The final rule for parts 352 and 361 does not contain any requirements for the collection of information pursuant to the Paperwork Reduction Act (44 U.S.C. 3501,
The FDIC has determined that the final rule for parts 352 and 361 will not affect family well-being within the meaning of section 654 of the Treasury and General Government Appropriations Act, 1999, enacted as part of the Omnibus Consolidated and Emergency Supplemental Appropriations Act, 1999 (Pub. L. 105-277, 112 Stat. 2681).
The Office of Management and Budget has determined that the final rule for parts 352 and 361 is not a “major rule” within the meaning of the Small Business Regulatory Enforcement Fairness Act of 1996 (SBREFA)(Title II, Pub. L. 104-121). As required by SBREFA, the FDIC will file appropriate reports with Congress and the Government Accountability Office so that the final rule for parts 352 or 361 may be reviewed.
Nondiscrimination on the basis of disability, Access to electronic and information technology, Employment, Communications.
Minority and Women Outreach Program Contracting.
For the reason set forth in the preamble, parts 352 and 361 of Chapter III of title 12 of the Code of Federal Regulations are amended as follows:
12 U.S.C. 1819(a), 29 U.S.C. 794d.
12 U.S.C. 1833e.
Federal Aviation Administration (FAA), DOT.
Final rule.
This action amends Class E Airspace at Ashland, VA as new Standard Instrument Approach Procedures have been developed at Hanover County Municipal Airport. This action enhances the safety and airspace management of Instrument Flight Rules (IFR) operations at the airport. This action also updates the geographic coordinates of the airport.
Effective 0901 UTC, December 10, 2015. The Director of the Federal Register approves this incorporation by reference action under title 1, Code of Federal Regulations, part 51, subject to the annual revision of FAA Order 7400.9 and publication of conforming amendments.
FAA Order 7400.9Z, Airspace Designations and Reporting Points, and subsequent amendments can be viewed on line at
FAA Order 7400.9, Airspace Designations and Reporting Points, is published yearly and effective on September 15.
John Fornito, Operations Support Group, Eastern Service Center, Federal Aviation Administration, P.O. Box 20636, Atlanta, Georgia 30320; telephone (404) 305-6364.
The FAA's authority to issue rules regarding aviation safety is found in Title 49 of the United States Code. Subtitle I, Section 106 describes the authority of the FAA Administrator. Subtitle VII, Aviation Programs, describes in more detail the scope of the agency's authority. This rulemaking is promulgated under the authority described in Subtitle VII, Part, A, Subpart I, Section 40103. Under that section, the FAA is charged with prescribing regulations to assign the use of airspace necessary to ensure the safety of aircraft and the efficient use of airspace. This regulation is within the scope of that authority as it amends Class E airspace at Hanover County Municipal Airport, Ashland, VA.
On March 9, 2015, the FAA published in the
Class E airspace designations are published in paragraph 6005 of FAA Order 7400.9Z dated August 6, 2015, and effective September 15, 2015, which is incorporated by reference in 14 CFR part 71.1. The Class E airspace designations listed in this document will be published subsequently in the Order.
This document amends FAA Order 7400.9Z, Airspace Designations and Reporting Points, dated August 6, 2015, and effective September 15, 2015. FAA Order 7400.9Z is publicly available as listed in the
This amendment to Title 14, Code of Federal Regulations (14 CFR) part 71 amends Class E airspace extending upward from 700 feet above the surface within a 7-mile radius of Hanover County Municipal Airport, Ashland, VA, providing the controlled airspace required to support the new standard instrument approach procedures for IFR operations at the airport. The geographic coordinates of the airport are adjusted to be in concert with the FAAs aeronautical database.
Class E airspace designations are published in Paragraph 6005 of FAA
The FAA has determined that this regulation only involves an established body of technical regulations for which frequent and routine amendments are necessary to keep them operationally current, is non-controversial and unlikely to result in adverse or negative comments. It, therefore, (1) is not a “significant regulatory action” under Executive Order 12866; (2) is not a “significant rule” under DOT Regulatory Policies and Procedures (44 FR 11034; February 26, 1979); and (3) does not warrant preparation of a Regulatory Evaluation as the anticipated impact is so minimal. Since this is a routine matter that only affects air traffic procedures and air navigation, it is certified that this rule, when promulgated, does not have a significant economic impact on a substantial number of small entities under the criteria of the Regulatory Flexibility Act.
The FAA has determined that this action qualifies for categorical exclusion under the National Environmental Policy Act in accordance with FAA Order 1050.1E, “Environmental Impacts: Policies and Procedures,” paragraph 311a. This airspace action is not expected to cause any potentially significant environmental impacts, and no extraordinary circumstances exist that warrant preparation of an environmental assessment.
Airspace, Incorporation by reference, Navigation (air).
In consideration of the foregoing, the Federal Aviation Administration amends 14 CFR part 71 as follows:
49 U.S.C. 106(f), 106(g); 40103, 40113, 40120; E.O. 10854, 24 FR 9565, 3 CFR, 1959-1963 Comp., p. 389.
That airspace extending upward from 700 feet above the surface within a 7-mile radius of Hanover County Municipal Airport.
Federal Aviation Administration (FAA), DOT.
Final rule.
This action establishes Class E Airspace at Newport, NH, to accommodate new Area Navigation (RNAV) Global Positioning System (GPS) Standard Instrument Approach Procedures (SIAPs) serving Parlin Field Airport. Controlled airspace is necessary for the safety and management of instrument flight rules (IFR) operations at the airport.
Effective 0901 UTC, December 10, 2015. The Director of the Federal Register approves this incorporation by reference action under title 1, Code of Federal Regulations, part 51, subject to the annual revision of FAA Order 7400.9 and publication of conforming amendments.
FAA Order 7400.9Z, Airspace Designations and Reporting Points, and subsequent amendments can be viewed on line at
FAA Order 7400.9, Airspace Designations and Reporting Points, is published yearly and effective on September 15.
John Fornito, Operations Support Group, Eastern Service Center, Federal Aviation Administration, P.O. Box 20636, Atlanta, Georgia 30320; telephone (404) 305-6364.
The FAA's authority to issue rules regarding aviation safety is found in Title 49 of the United States Code. Subtitle I, Section 106 describes the authority of the FAA Administrator. Subtitle VII, Aviation Programs, describes in more detail the scope of the agency's authority. This rulemaking is promulgated under the authority described in Subtitle VII, Part, A, Subpart I, Section 40103. Under that section, the FAA is charged with prescribing regulations to assign the use of airspace necessary to ensure the safety of aircraft and the efficient use of airspace. This regulation is within the scope of that authority as it establishes Class E airspace at Parlin Field Airport, Newport, NH.
On August 14, 2015, the FAA published in the
Class E airspace designations are published in paragraph 6005 of FAA Order 7400.9Z dated August 6, 2015, and effective September 15, 2015, which is incorporated by reference in 14 CFR part 71.1. The Class E airspace designations listed in this document will be published subsequently in the Order.
This document amends FAA Order 7400.9Z, Airspace Designations and
This amendment to Title 14, Code of Federal Regulations (14 CFR) part 71 establishes Class E airspace extending upward from 700 feet above the surface within a 12.1-mile radius of Parlin Field Airport, Newport, NH, providing the controlled airspace required to support the new RNAV (GPS) standard instrument approach procedures for Parlin Field Airport.
Class E airspace designations are published in Paragraph 6005 of FAA Order 7400.9Z, dated August 6, 2015, and effective September 15, 2015, which is incorporated by reference in 14 CFR 71.1. The Class E airspace designation listed in this document will be published subsequently in the Order.
The FAA has determined that this regulation only involves an established body of technical regulations for which frequent and routine amendments are necessary to keep them operationally current, is non-controversial and unlikely to result in adverse or negative comments. It, therefore, (1) is not a “significant regulatory action” under Executive Order 12866; (2) is not a “significant rule” under DOT Regulatory Policies and Procedures (44 FR 11034; February 26, 1979); and (3) does not warrant preparation of a Regulatory Evaluation as the anticipated impact is so minimal. Since this is a routine matter that only affects air traffic procedures and air navigation, it is certified that this rule, when promulgated, does not have a significant economic impact on a substantial number of small entities under the criteria of the Regulatory Flexibility Act.
The FAA has determined that this action qualifies for categorical exclusion under the National Environmental Policy Act in accordance with FAA Order 1050.1E, “Environmental Impacts: Policies and Procedures,” paragraph 311a. This airspace action is not expected to cause any potentially significant environmental impacts, and no extraordinary circumstances exist that warrant preparation of an environmental assessment.
Airspace, Incorporation by reference, Navigation (air).
In consideration of the foregoing, the Federal Aviation Administration amends 14 CFR part 71 as follows:
49 U.S.C. 106(f), 106(g); 40103, 40113, 40120; E.O. 10854, 24 FR 9565, 3 CFR, 1959-1963 Comp., p. 389.
That airspace extending upward from 700 feet above the surface within a 12.1-mile radius of Parlin Field Airport.
Federal Aviation Administration (FAA), DOT.
Final rule.
This action modifies Class D airspace, Class E surface area airspace, Class E airspace extending upward from 700 feet above the surface, and removes Class E surface area airspace designated as an extension at Mountain Home AFB, Mountain Home, ID. The FAA found it necessary to amend the airspace area by increasing the Class D airspace and reducing the Class E airspace extending upward from 700 feet above the surface for the safety and management of Instrument Flight Rules (IFR) operations for arriving and departing aircraft at the airport and to change from navigation aids to geographic coordinate references in the legal description. This action updates the geographic coordinates of Mountain Home Municipal Airport, Mountain Home, ID.
Effective 0901 UTC, December 10, 2015. The Director of the Federal Register approves this incorporation by reference action under title 1, Code of Federal Regulations, part 51, subject to the annual revision of FAA Order 7400.9 and publication of conforming amendments.
FAA Order 7400.9Z, Airspace Designations and Reporting Points, and subsequent amendments can be viewed online at
FAA Order 7400.9, Airspace Designations and Reporting Points, is published yearly and effective on September 15.
Steve Haga, Federal Aviation Administration, Operations Support Group, Western Service Center, 1601 Lind Avenue SW., Renton, WA, 98057; telephone (425) 203-4500.
The FAA's authority to issue rules regarding aviation safety is found in Title 49 of the United States Code. Subtitle I, Section 106 describes the authority of the FAA Administrator. Subtitle VII, Aviation Programs, describes in more detail the scope of the agency's authority. This rulemaking is promulgated under the authority described in Subtitle VII, Part A, Subpart I, Section 40103. Under that section, the FAA is charged with prescribing regulations to assign the use
On July 28, 2015, the FAA published in the
Class D and Class E airspace designations are published in paragraph 5000, 6002, 6004, and 6005, respectively, of FAA Order 7400.9Z, dated August 6, 2015, and effective September 15, 2015, which is incorporated by reference in 14 CFR part 71.1. The Class E airspace designation listed in this document will be published subsequently in the Order.
This document amends FAA Order 7400.9Z, airspace Designations and Reporting Points, dated August 6, 2015, and effective September 15, 2015. FAA Order 7400.9Z is publicly available as listed in the
This amendment to Title 14, Code of Federal Regulations (14 CFR) part 71 modifies Class D airspace, Class E surface area airspace, Class E airspace extending upward from 700 feet above the surface, and removes Class E surface area airspace as an extension at Mountain Home AFB, Mountain Home, ID. After a review, the FAA found an increase of the Class D airspace necessary to protect instrument arrival procedures at the airport. Class D airspace is extended upward from the surface to and including 5,500 feet within a 5-mile radius of Mountain Home AFB, extending to 6.5 miles to the southeast and northwest of the airport. Class E surface area airspace extends upward from the surface within a 5-mile radius of Mountain Home AFB, extending to 6.5 miles to the southeast and northwest of the airport. Class E airspace extending upward from 700 feet above the surface is modified to within a 7.7-mile radius northeast of Mountain Home AFB, extending to 12.4 miles to the northeast, and 17.7 miles to the east. The lateral boundary for that Class E airspace extending from 1,200 feet above the surface is defined utilizing latitude and longitude reference points instead of Federal airway reference, and does not change the lateral boundaries or operating requirements of the 1,200 foot airspace. This action also updates the geographic coordinates of Mountain Home Municipal Airport, Mountain Home, ID.
The FAA has determined that this regulation only involves an established body of technical regulations for which frequent and routine amendments are necessary to keep them operationally current, is non-controversial and unlikely to result in adverse or negative comments. It, therefore, (1) is not a “significant regulatory action” under Executive Order 12866; (2) is not a “significant rule” under DOT Regulatory Policies and Procedures (44 FR 11034; February 26, 1979); and (3) does not warrant preparation of a Regulatory Evaluation as the anticipated impact is so minimal. Since this is a routine matter that only affects air traffic procedures and air navigation, it is certified that this rule, when promulgated, does not have a significant economic impact on a substantial number of small entities under the criteria of the Regulatory Flexibility Act.
The FAA has determined that this action qualifies for categorical exclusion under the National Environmental Policy Act in accordance with FAA Order 1050.1E, “Environmental Impacts: Policies and Procedures,” paragraph 311a. This airspace action is not expected to cause any potentially significant environmental impacts, and no extraordinary circumstances exist that warrant preparation of an environmental assessment.
Airspace, Incorporation by reference, Navigation (air).
In consideration of the foregoing, the Federal Aviation Administration amends 14 CFR part 71 as follows:
49 U.S.C. 106(f), 106(g); 40103, 40113, 40120; E.O. 10854, 24 FR 9565, 3 CFR, 1959-1963 Comp., p. 389.
That airspace extending upward from the surface to and including 5,500 feet MSL within a 5-mile radius of the Mountain Home AFB and within 2 miles each side of the 135° bearing from the airport extending from the 5-mile radius to 6.5 miles southeast of the airport, and within 2 miles each side of the 315° bearing from the airport extending from the 5-mile radius to 6.5 miles northwest of the airport. This Class D airspace area is effective during the specific dates and times established in advance by a Notice to Airmen. The effective date and time will thereafter be continuously published in the Airport/Facility Directory.
That airspace extending upward from the surface within a 5-mile radius of the Mountain Home AFB, and within 2 miles each side of the 135° bearing from the airport extending from the 5-mile radius to 6.5 miles southeast of the airport, and within 2 miles each side of the 315° bearing from the airport extending from the 5-mile radius to 6.5 miles northwest of the airport.
That airspace extending upward from 700 feet above the surface bounded by a line beginning at lat. 43°06′48″ N., long. 115°28′39″ W.; to lat. 43°02′06″ N., long. 115°31′12″ W.; to lat. 43°03′25″ N., long. 115°36′21″ W.; to lat. 42°54′24″ N., long. 115°48′41″ W.; to lat. 42°54′24″ N., long. 115°56′47″ W.; to lat. 43°00′12″ N., long. 116°04′42″ W.; to lat. 43°06′51″ N., long. 116°01′24″ W.; to lat. 43°09′22″ N., long. 115°57′57″ W.; to lat. 43°12′54″ N., long. 115°42′51″ W., thence to point of beginning, that airspace extending upward from 1,200 feet above the surface bounded by a line beginning at lat. 43°33′06″ N., long. 116°11′32″ W.; to lat. 42°48′43″ N., long. 115°00′21″ W.; to lat. 42°23′58″ N., long. 115°00′21″ W.; to lat. 42°23′58″ N., long. 115°18′28″ W.; thence clockwise along the 46.0-mile radius of Mountain Home AFB to lat. 43°09′17″ N., long. 116°54′28″ W.; thence to point of beginning.
Federal Aviation Administration (FAA), DOT.
Final rule.
This action amends Class E Airspace at Ponce, PR, as the PONCE VHF Omni-Directional Radio Range Tactical Air Navigation Aid, (VORTAC) has been decommissioned, requiring airspace redesign at Mercedita Airport. This action enhances the safety and management of Instrument Flight Rules (IFR) operations at the airport.
Effective 0901 UTC, December 10, 2015. The Director of the Federal Register approves this incorporation by reference action under title 1, Code of Federal Regulations, part 51, subject to the annual revision of FAA Order 7400.9 and publication of conforming amendments.
FAA Order 7400.9Z, Airspace Designations and Reporting Points, and subsequent amendments can be viewed on line at
FAA Order 7400.9, Airspace Designations and Reporting Points, is published yearly and effective on September 15.
John Fornito, Operations Support Group, Eastern Service Center, Federal Aviation Administration, P.O. Box 20636, Atlanta, Georgia 30320; telephone (404) 305-6364.
The FAA's authority to issue rules regarding aviation safety is found in Title 49 of the United States Code. Subtitle I, Section 106 describes the authority of the FAA Administrator. Subtitle VII, Aviation Programs, describes in more detail the scope of the agency's authority. This rulemaking is promulgated under the authority described in Subtitle VII, Part, A, Subpart I, Section 40103. Under that section, the FAA is charged with prescribing regulations to assign the use of airspace necessary to ensure the safety of aircraft and the efficient use of airspace. This regulation is within the scope of that authority as it amends Class E airspace at Mercedita Airport, Ponce, PR.
On July 16, 2015, the FAA published in the
Class E airspace designations are published in paragraph 6002 of FAA Order 7400.9Z dated August 6, 2015, and effective September 15, 2015, which is incorporated by reference in 14 CFR part 71.1. The Class E airspace designations listed in this document will be published subsequently in the Order.
This document amends FAA Order 7400.9Z, airspace Designations and Reporting Points, dated August 6, 2015, and effective September 15, 2015. FAA Order 7400.9Z is publicly available as listed in the
This amendment to Title 14, Code of Federal Regulations (14 CFR) part 71 amends Class E surface area airspace at Mercedita Airport, Ponce, PR.
Airspace reconfiguration to within a 4.1-mile radius of the airport is necessary due to the decommissioning of the Ponce VORTAC and cancellation of the VOR approach, and for continued safety and management of IFR operations at the airport.
The FAA has determined that this regulation only involves an established body of technical regulations for which frequent and routine amendments are necessary to keep them operationally current, is non-controversial and unlikely to result in adverse or negative comments. It, therefore, (1) is not a “significant regulatory action” under Executive Order 12866; (2) is not a “significant rule” under DOT Regulatory Policies and Procedures (44 FR 11034; February 26, 1979); and (3) does not warrant preparation of a Regulatory Evaluation as the anticipated impact is so minimal. Since this is a routine matter that only affects air traffic procedures and air navigation, it is certified that this rule, when promulgated, does not have a significant economic impact on a substantial number of small entities under the criteria of the Regulatory Flexibility Act.
The FAA has determined that this action qualifies for categorical exclusion
Airspace, Incorporation by reference, Navigation (air).
In consideration of the foregoing, the Federal Aviation Administration amends 14 CFR part 71 as follows:
49 U.S.C. 106(f), 106(g); 40103, 40113, 40120, E.O. 10854, 24 FR 9565, 3 CFR, 1959-1963 Comp., p. 389.
Within a 4.1-mile radius of Mercedita Airport. This Class E airspace is effective during the specific dates and times established in advance by a Notice to Airmen. The effective date and time will thereafter be continuously published in the Airport/Facility Directory.
Federal Aviation Administration (FAA), DOT.
Final rule.
This action establishes Class E airspace at Cottonwood Airport, Cottonwood, AZ, to accommodate new Standard Instrument Approach Procedures (SIAP) at the airport. The FAA found establishment of controlled airspace necessary for the safety and management of Instrument Flight Rules (IFR) operations.
Effective 0901 UTC, December 10, 2015. The Director of the Federal Register approves this incorporation by reference action under title 1, Code of Federal Regulations, part 51, subject to the annual revision of FAA Order 7400.9 and publication of conforming amendments.
FAA Order 7400.9Z, Airspace Designations and Reporting Points, and subsequent amendments can be viewed online at
FAA Order 7400.9, Airspace Designations and Reporting Points, is published yearly and effective on September 15.
Steve Haga, Federal Aviation Administration, Operations Support Group, Western Service Center, 1601 Lind Avenue SW., Renton, WA, 98057; telephone (425) 203-4500.
The FAA's authority to issue rules regarding aviation safety is found in Title 49 of the United States Code. Subtitle I, Section 106 describes the authority of the FAA Administrator. Subtitle VII, Aviation Programs, describes in more detail the scope of the agency's authority. This rulemaking is promulgated under the authority described in Subtitle VII, Part A, Subpart I, Section 40103. Under that section, the FAA is charged with prescribing regulations to assign the use of airspace necessary to ensure the safety of aircraft and the efficient use of airspace. This regulation is within the scope of that authority as it establishes controlled airspace at Cottonwood, AZ.
On August 5, 2015, the FAA published in the
Class E airspace designation is published in paragraph 6005, of FAA Order 7400.9Z, dated August 6, 2015, and effective September 15, 2015, which is incorporated by reference in 14 CFR part 71.1. The Class E airspace designation listed in this document will be published subsequently in the Order.
This document amends FAA Order 7400.9Z, airspace Designations and Reporting Points, dated August 6, 2015, and effective September 15, 2015. FAA Order 7400.9Z is publicly available as listed in the
This amendment to Title 14, Code of Federal Regulations (14 CFR) part 71 establishes Class E airspace extending upward from 700 feet above the surface at Cottonwood Airport, Cottonwood, AZ. New standard instrument approach procedures have been developed for IFR operations at the airport. The Class E airspace is established to within a 4-mile radius of Cottonwood Airport, with a segment extending from the 4-mile radius to 15 miles southeast of the airport.
The FAA has determined that this regulation only involves an established body of technical regulations for which
The FAA has determined that this action qualifies for categorical exclusion under the National Environmental Policy Act in accordance with FAA Order 1050.1E, “Environmental Impacts: Policies and Procedures,” paragraph 311a. This airspace action is not expected to cause any potentially significant environmental impacts, and no extraordinary circumstances exist that warrant preparation of an environmental assessment.
Airspace, Incorporation by reference, Navigation (air).
In consideration of the foregoing, the Federal Aviation Administration amends 14 CFR part 71 as follows:
49 U.S.C. 106(f), 106(g); 40103, 40113, 40120; E.O. 10854, 24 FR 9565, 3 CFR, 1959-1963 Comp., p. 389.
That airspace extending upward from 700 feet above the surface within a 4-mile radius of Cottonwood Airport excluding that airspace southwest of a line beginning where the 299° bearing from the airport intersects the 4-mile radius to a point where the 181° bearing from the airport intersects the 4-mile radius; and that airspace 1.8 miles southwest and 1.2 miles northeast of the 150° bearing from the 4-mile radius to 15 miles southeast of the airport.
Federal Aviation Administration (FAA), DOT.
Final rule.
This action s establishes Class E airspace at Marshall, AR. Controlled airspace is necessary to accommodate new Standard Instrument Approach Procedures at Searcy County Airport. This action enhances the safety and management of Instrument Flight Rules (IFR) operations at the airport.
Effective 0901 UTC, December 10, 2015. The Director of the Federal Register approves this incorporation by reference action under title 1, Code of Federal Regulations, part 51, subject to the annual revision of FAA Order 7400.9 and publication of conforming amendments.
FAA Order 7400.9Z, Airspace Designations and Reporting Points, and subsequent amendments can be viewed on line at
FAA Order 7400.9, Airspace Designations and Reporting Points is published yearly and effective on September 15.
Rebecca Shelby, Central Service Center, Operations Support Group, Federal Aviation Administration, Southwest Region, 10101 Hillwood Parkway, Fort Worth, TX 76177; telephone: 817-222-5857.
The FAA's authority to issue rules regarding aviation safety is found in Title 49 of the United States Code. Subtitle I, Section 106 describes the authority of the FAA Administrator. Subtitle VII, Aviation Programs, describes in more detail the scope of the agency's authority. This rulemaking is promulgated under the authority described in Subtitle VII, Part, A, Subpart I, Section 40103. Under that section, the FAA is charged with prescribing regulations to assign the use of airspace necessary to ensure the safety of aircraft and the efficient use of airspace. This regulation is within the scope of that authority as it establishes Class E airspace at Searcy County Airport, Marshall, AR
On August 13, 2015, the FAA published in the
Class E airspace designations are published in paragraph 6005 of FAA Order 7400.9Z, dated August 6, 2015, and effective September 15, 2015, which is incorporated by reference in 14 CFR part 71.1. The Class E airspace designations listed in this document will be published subsequently in the Order.
This document amends FAA Order 7400.9Z, airspace Designations and Reporting Points, dated August 6, 2015, and effective September 15, 2015. FAA Order 7400.9Z is publicly available as listed in the
This action amends Title 14, Code of Federal Regulations (14 CFR), Part 71 by establishing Class E airspace extending upward from 700 feet above the surface within an 11.2-mile radius of Searcy County Airport, Marshall, AR, to accommodate new Standard Instrument Approach Procedures for IFR operations at the airport.
The FAA has determined that this regulation only involves an established body of technical regulations for which frequent and routine amendments are necessary to keep them operationally current. It, therefore, (1) is not a “significant regulatory action” under Executive Order 12866; (2) is not a “significant rule” under DOT Regulatory Policies and Procedures (44 FR 11034; February 26, 1979); and (3) does not warrant preparation of a regulatory evaluation as the anticipated impact is so minimal. Since this is a routine matter that only affect air traffic procedures and air navigation, it is certified that this rule, when promulgated, will not have a significant economic impact on a substantial number of small entities under the criteria of the Regulatory Flexibility Act.
The FAA has determined that this action qualifies for categorical exclusion under the National Environmental Policy Act in accordance with FAA Order 1050.1F, “Environmental Impacts: Policies and Procedures” paragraph 311a. This airspace action is not expected to cause any potentially significant environmental impacts, and no extraordinary circumstances exist that warrant preparation of an environmental assessment.
Airspace, Incorporation by reference, Navigation (air).
In consideration of the foregoing, the Federal Aviation Administration amends 14 CFR part 71 as follows:
49 U.S.C. 106(f), 106(g); 40103, 40113, 40120; E.O. 10854, 24 FR 9565, 3 CFR, 1959-1963 Comp., p. 389.
That airspace extending upward from 700 feet above the surface within a 11.2-mile radius of Searcy County Airport.
Federal Aviation Administration (FAA), DOT.
Final rule.
This rule amends, suspends, or removes Standard Instrument Approach Procedures (SIAPs) and associated Takeoff Minimums and Obstacle Departure Procedures for operations at certain airports. These regulatory actions are needed because of the adoption of new or revised criteria, or because of changes occurring in the National Airspace System, such as the commissioning of new navigational facilities, adding new obstacles, or changing air traffic requirements. These changes are designed to provide for the safe and efficient use of the navigable airspace and to promote safe flight operations under instrument flight rules at the affected airports.
This rule is effective October 16, 2015. The compliance date for each SIAP, associated Takeoff Minimums, and ODP is specified in the amendatory provisions.
The incorporation by reference of certain publications listed in the regulations is approved by the Director of the Federal Register as of October 16, 2015.
Availability of matter incorporated by reference in the amendment is as follows:
1. U.S. Department of Transportation, Docket Ops-M30, 1200 New Jersey Avenue SE., West Bldg., Ground Floor, Washington, DC 20590-0001;
2. The FAA Air Traffic Organization Service Area in which the affected airport is located;
3. The office of Aeronautical Navigation Products, 6500 South MacArthur Blvd., Oklahoma City, OK 73169 or,
4. The National Archives and Records Administration (NARA). For information on the availability of this material at NARA, call 202-741-6030, or go to:
All SIAPs and Takeoff Minimums and ODPs are available online free of charge. Visit the National Flight Data Center online at
Richard A. Dunham III, Flight Procedure Standards Branch (AFS-420) Flight Technologies and Procedures Division, Flight Standards Service, Federal Aviation Administration, Mike Monroney Aeronautical Center, 6500 South MacArthur Blvd., Oklahoma City, OK 73169 (Mail Address: P.O. Box 25082 Oklahoma City, OK 73125) telephone: (405) 954-4164.
This rule amends Title 14, Code of Federal Regulations, Part 97 (14 CFR part 97) by amending the referenced SIAPs. The complete regulatory description of each SIAP is listed on the appropriate FAA Form 8260, as modified by the National Flight Data Center (NFDC)/Permanent Notice to Airmen (P-NOTAM), and is incorporated by reference under 5 U.S.C. 552(a), 1 CFR part 51, and 14 CFR 97.20. The large number of SIAPs, their complex nature, and the need for a special format make their verbatim publication in the
The material incorporated by reference is publicly available as listed in the
The material incorporated by reference describes SIAPs, Takeoff Minimums and/or ODPs as identified in the amendatory language for part 97 of this final rule.
This amendment to 14 CFR part 97 is effective upon publication of each separate SIAP and Takeoff Minimums and ODP as amended in the transmittal. For safety and timeliness of change considerations, this amendment incorporates only specific changes contained for each SIAP and Takeoff Minimums and ODP as modified by FDC permanent NOTAMs.
The SIAPs and Takeoff Minimums and ODPs, as modified by FDC permanent NOTAM, and contained in this amendment are based on the criteria contained in the U.S. Standard for Terminal Instrument Procedures (TERPS). In developing these changes to SIAPs and Takeoff Minimums and ODPs, the TERPS criteria were applied only to specific conditions existing at the affected airports. All SIAP amendments in this rule have been previously issued by the FAA in a FDC NOTAM as an emergency action of immediate flight safety relating directly to published aeronautical charts.
The circumstances that created the need for these SIAP and Takeoff Minimums and ODP amendments require making them effective in less than 30 days.
Because of the close and immediate relationship between these SIAPs, Takeoff Minimums and ODPs, and safety in air commerce, I find that notice and public procedure under 5 U.S.C. 553(b) are impracticable and contrary to the public interest and, where applicable, under 5 U.S.C. 553(d), good cause exists for making these SIAPs effective in less than 30 days.
The FAA has determined that this regulation only involves an established body of technical regulations for which frequent and routine amendments are necessary to keep them operationally current. It, therefore— (1) is not a “significant regulatory action” under Executive Order 12866; (2) is not a “significant rule” under DOT regulatory Policies and Procedures (44 FR 11034; February 26, 1979); and (3) does not warrant preparation of a regulatory evaluation as the anticipated impact is so minimal. For the same reason, the FAA certifies that this amendment will not have a significant economic impact on a substantial number of small entities under the criteria of the Regulatory Flexibility Act.
Air Traffic Control, Airports, Incorporation by reference, Navigation (air).
Accordingly, pursuant to the authority delegated to me, Title 14, Code of Federal regulations, Part 97, (14 CFR part 97), is amended by amending Standard Instrument Approach Procedures and Takeoff Minimums and ODPs, effective at 0901 UTC on the dates specified, as follows:
49 U.S.C. 106(g), 40103, 40106, 40113, 40114, 40120, 44502, 44514, 44701, 44719, 44721-44722.
By amending: § 97.23 VOR, VOR/DME, VOR or TACAN, and VOR/DME or TACAN; § 97.25 LOC, LOC/DME, LDA, LDA/DME, SDF, SDF/DME; § 97.27 NDB, NDB/DME; § 97.29 ILS, ILS/DME, MLS, MLS/DME, MLS/RNAV; § 97.31 RADAR SIAPs; § 97.33 RNAV SIAPs; and § 97.35 COPTER SIAPs, Identified as follows:
Federal Aviation Administration (FAA), DOT.
Final rule.
This rule establishes, amends, suspends, or removes Standard Instrument Approach Procedures (SIAPs) and associated Takeoff Minimums and Obstacle Departure Procedures (ODPs) for operations at certain airports. These regulatory actions are needed because of the adoption of new or revised criteria, or because of changes occurring in the National Airspace System, such as the commissioning of new navigational facilities, adding new obstacles, or changing air traffic requirements. These changes are designed to provide safe and efficient use of the navigable airspace and to promote safe flight operations under instrument flight rules at the affected airports.
This rule is effective October 16, 2015. The compliance date for each SIAP, associated Takeoff Minimums, and ODP is specified in the amendatory provisions.
The incorporation by reference of certain publications listed in the regulations is approved by the Director of the Federal Register as of October 16, 2015.
Availability of matters incorporated by reference in the amendment is as follows:
1. U.S. Department of Transportation, Docket Ops-M30, 1200 New Jersey Avenue SE., West Bldg., Ground Floor, Washington, DC 20590-0001.
2. The FAA Air Traffic Organization Service Area in which the affected airport is located;
3. The office of Aeronautical Navigation Products, 6500 South MacArthur Blvd., Oklahoma City, OK 73169 or,
4. The National Archives and Records Administration (NARA). For information on the availability of this material at NARA, call 202-741-6030, or go to:
All SIAPs and Takeoff Minimums and ODPs are available online free of charge. Visit the National Flight Data Center at
Richard A. Dunham III, Flight Procedure Standards Branch (AFS-420), Flight Technologies and Programs Divisions, Flight Standards Service, Federal Aviation Administration, Mike Monroney Aeronautical Center, 6500 South MacArthur Blvd. Oklahoma City, OK. 73169 (Mail Address: P.O. Box 25082, Oklahoma City, OK 73125) Telephone: (405) 954-4164.
This rule amends Title 14 of the Code of Federal Regulations, Part 97 (14 CFR part 97), by establishing, amending, suspending, or removes SIAPS, Takeoff Minimums and/or ODPS. The complete regulatory description of each SIAP and its associated Takeoff Minimums or ODP for an identified airport is listed on FAA form documents which are incorporated by reference in this amendment under 5 U.S.C. 552(a), 1 CFR part 51, and 14 CFR part § 97.20. The applicable FAA forms are FAA Forms 8260-3, 8260-4, 8260-5, 8260-15A, and 8260-15B when required by an entry on 8260-15A.
The large number of SIAPs, Takeoff Minimums and ODPs, their complex nature, and the need for a special format make publication in the
The material incorporated by reference is publicly available as listed in the
The material incorporated by reference describes SIAPS, Takeoff Minimums and/or ODPS as identified in the amendatory language for part 97 of this final rule.
This amendment to 14 CFR part 97 is effective upon publication of each separate SIAP, Takeoff Minimums and ODP as Amended in the transmittal. Some SIAP and Takeoff Minimums and textual ODP amendments may have been issued previously by the FAA in a Flight Data Center (FDC) Notice to Airmen (NOTAM) as an emergency action of immediate flight safety relating directly to published aeronautical charts.
The circumstances that created the need for some SIAP and Takeoff Minimums and ODP amendments may require making them effective in less than 30 days. For the remaining SIAPs and Takeoff Minimums and ODPs, an effective date at least 30 days after publication is provided.
Further, the SIAPs and Takeoff Minimums and ODPs contained in this amendment are based on the criteria contained in the U.S. Standard for Terminal Instrument Procedures (TERPS). In developing these SIAPs and Takeoff Minimums and ODPs, the TERPS criteria were applied to the conditions existing or anticipated at the
The FAA has determined that this regulation only involves an established body of technical regulations for which frequent and routine amendments are necessary to keep them operationally current. It, therefore—(1) is not a “significant regulatory action” under Executive Order 12866; (2) is not a “significant rule” under DOT Regulatory Policies and Procedures (44 FR 11034; February 26,1979); and (3) does not warrant preparation of a regulatory evaluation as the anticipated impact is so minimal. For the same reason, the FAA certifies that this amendment will not have a significant economic impact on a substantial number of small entities under the criteria of the Regulatory Flexibility Act.
Air Traffic Control, Airports, Incorporation by reference, Navigation (air).
Accordingly, pursuant to the authority delegated to me, Title 14, Code of Federal Regulations, Part 97 (14 CFR part 97) is amended by establishing, amending, suspending, or removing Standard Instrument Approach Procedures and/or Takeoff Minimums and Obstacle Departure Procedures effective at 0901 UTC on the dates specified, as follows:
49 U.S.C. 106(g), 40103, 40106, 40113, 40114, 40120, 44502, 44514, 44701, 44719, 44721-44722.
Coast Guard, DHS.
Notice of deviation from drawbridge regulations.
The Coast Guard has issued a temporary deviation from the operating schedule that governs the James River Bridge (US 17 and VA 258) across the James River, mile 5.0, between Isle of Wight and Newport News, VA. This deviation allows the bridge to remain in the closed-to-navigation position to facilitate work on electrical control and power wiring systems on the bridge.
This deviation is effective from 8 a.m. on October 16, 2015, until 8 p.m. on October 19, 2015.
The docket for this deviation, [USCG-2015-0948], is available at
If you have questions on this temporary deviation, call or email Mr. Hal R. Pitts, Bridge Administration Branch Fifth District, Coast Guard; telephone (757) 398-6222, email
The Virginia Department of Transportation, who owns and operates the James River Bridge (US 17 and VA 258), has requested a temporary deviation from the current operating regulations to facilitate work on electrical control and power wiring systems on the bridge. The bridge is a vertical lift draw bridge and has a vertical clearance in the closed position of 60 feet above mean high water.
The current operating schedule is set out in 33 CFR 117.5. Under this temporary deviation, the bridge will remain in the closed-to-navigation position from 8 a.m. on October 16, 2015 until 8 p.m. on October 19, 2015.
Vessels able to pass through the bridge in the closed position may do so at anytime. The bridge will not be able to open for emergencies and there is no alternate route for vessels unable to pass through the bridge in the closed position. The Coast Guard will also inform the users of the waterways through our Local and Broadcast Notice to Mariners of the change in operating schedule for the bridge so that vessels can arrange their transits to minimize any impacts caused by this temporary deviation.
In accordance with 33 CFR 117.35(e), the drawbridge must return to its regular operating schedule immediately at the end of the effective period of this temporary deviation. This deviation from the operating regulations is authorized under 33 CFR 117.35.
Coast Guard, DHS.
Notice of deviation from drawbridge regulations.
The Coast Guard has issued a temporary deviation from the operating schedule that governs the Belt Line Railroad Bridge across the South Branch of the Elizabeth River, mile 2.6, between Portsmouth and Chesapeake, VA. This deviation allows the bridge to remain in the closed-to-navigation position to facilitate a tie replacement project.
This deviation is effective without actual notice from October 16, 2015 until 6 p.m. on October 23, 2015. For the purposes of enforcement, actual notice will be used from 7 a.m. on October 16, 2015, until October 16, 2015.
The docket for this deviation, [USCG-2015-0944], is available at
If you have questions on this temporary deviation, call or email Mr. Hal R. Pitts, Bridge Administration Branch Fifth District, Coast Guard; telephone (757) 398-6222, email
The Norfolk and Portsmouth Belt Line Railroad Company, who owns and operates the Belt Line Railroad Bridge, has requested a temporary deviation from the current operating regulations to facilitate a tie replacement project on the bridge. The bridge is a vertical lift draw bridge and has a vertical clearance in the closed position of 6 feet above mean high water.
The current operating schedule is set out in 33 CFR 117.997(a). Under this temporary deviation, the bridge will remain in the closed-to-navigation position from 7 a.m. to 6 p.m., except for scheduled daily openings at 9 a.m., 12 noon, and 3 p.m., from October 16, 2015 through October 23, 2015. During this temporary deviation, the bridge will operate per 33 CFR 117.997(a) from 6 p.m. to 7 a.m. The South Branch of the Elizabeth River is used by a variety of vessels including deep draft ocean-going vessels, U.S. government vessels, small commercial vessels, recreational vessels and tug and barge traffic. The Coast Guard has carefully coordinated the restrictions with commercial and recreational waterway users.
Vessels able to pass through the bridge in the closed position may do so at any time. The bridge will be able to open for emergencies and there is no alternate route for vessels unable to pass through the bridge in the closed position. The Coast Guard will also inform the users of the waterways through our Local and Broadcast Notice to Mariners of the change in operating schedule for the bridge so that vessels can arrange their transits to minimize any impacts caused by this temporary deviation.
In accordance with 33 CFR 117.35(e), the drawbridge must return to its regular operating schedule immediately at the end of the effective period of this temporary deviation. This deviation from the operating regulations is authorized under 33 CFR 117.35.
Environmental Protection Agency (EPA).
Direct final rule.
The Environmental Protection Agency (EPA) is taking direct final action to approve revisions to the Arizona State Implementation Plan (SIP) concerning the emission inventory, emission statements, reasonably available control technology corrections and the vehicle inspection and maintenance requirements for the Phoenix-Mesa 2008 eight-Hour Ozone National Ambient Air Quality Standard (NAAQS) Marginal nonattainment area. We are approving these revisions under the Clean Air Act (CAA or the Act).
This rule is effective on December 15, 2015 without further notice, unless the EPA receives adverse comments by November 16, 2015. If we receive such comments, we will publish a timely withdrawal in the
Submit comments, identified by docket number [EPA-R09-OAR-2015-0240 by one of the following methods:
1.
2.
3.
Nancy Levin, EPA Region IX, (415) 972-3848,
Throughout this document, “we,” “us,” and “our” refer to the EPA.
On March 12, 2008, the EPA strengthened the primary and secondary eight-hour ozone NAAQS to 0.075 ppm (annual fourth-highest daily maximum eight-hour concentration, averaged over three years) (73 FR 16436).
The EPA proposed the 2008 ozone NAAQS SIP Requirements Rule (SRR) on June 6, 2013 (78 FR 34178) and finalized the SRR on March 6, 2015 (80 FR 12264, codified at 40 CFR part 51, subpart AA), effective April 6, 2015. The SRR both promulgated implementation requirements for the 2008 ozone NAAQS and revoked the 1997 ozone NAAQS.
On August 27, 2015, the EPA proposed to reclassify the Maricopa NAA as Moderate for the 2008 ozone NAAQs because the Maricopa NAA failed to attain the 2008 ozone NAAQS by the Marginal area attainment deadline of July 20, 2015 (80 FR 51992). Should this action be finalized, the Maricopa NAA would be subject to additional requirements, including (1) an attainment demonstration; (2) provisions for reasonably available control technology (RACT) and reasonably available control measures (RACM); (3) reasonable further progress (RFP) reductions in volatile organic compounds (VOC) and/or nitrogen oxide (NO
CAA section 110(a)(1) and 110(l) require states to provide reasonable notice and public hearing prior to adoption of SIP revisions. Section 110(k)(1)(B) requires the EPA to determine whether a SIP submittal is complete within 60 days of receipt. Any plan that we have not affirmatively determined to be complete or incomplete will become complete six months after the day of submittal by operation of law. A finding of completeness does not approve the submittal as part of the SIP nor does it indicate that the submittal is approvable. It does start a 12-month clock for the EPA to act on the SIP submittal (see CAA section 110(k)(2)).
ADEQ's Submittal documents the public review process followed by MAG and ADEQ in adopting the “MAG 2014 Eight-Hour Ozone Plan—Submittal of Marginal Area Requirements for the Maricopa Nonattainment Area” prior to submittal to the EPA as a revision to the SIP (See Appendix B.1). In addition, ADEQ's Submittal documents the adoption of the MAG 2014 Eight-Hour Ozone Plan by the MAG Regional Council and includes a letter dated June 27, 2014 from MAG to ADEQ, requesting that ADEQ submit the MAG 2014 Eight-Hour Ozone Plan to the EPA for approval.
Based on the documentation included in ADEQ's Submittal, we find that the submittal of the MAG 2014 Eight-Hour Ozone Plan, as a SIP revision, satisfies the procedural requirements of sections 110(a)(1) and 110(l) of the Act requiring states to provide reasonable notice and public hearing prior to adoption of SIP revisions. The MAG 2014 Eight-Hour Ozone Plan became complete by operation of law on January 2, 2015 pursuant to section 110(k)(1)(B). The technical support document (TSD) for our action has more information on our evaluation.
For Marginal nonattainment areas, states are required to comply with sections 172(c) and 182(a) of the Act. Marginal areas have up to three years from the effective date of designation to attain the NAAQS (40 CFR 51.1103(a)). Unlike areas classified as Moderate and above, Marginal areas are not required to submit an attainment demonstration or RFP provisions (see CAA section 182(a) and 80 FR 12268). Below we summarize the CAA and SRR requirements, how they are addressed in the Submittal, and our recommended action. Please refer to the TSD in the docket for this action for additional information.
CAA section 182(a)(1) and 40 CFR 51.1115(a) require states to submit a “base year inventory” for each 2008 ozone nonattainment area within two years of the effective date of designation. This inventory must be “a comprehensive, accurate, current inventory of actual emissions from sources of VOC and NO
The Maricopa County Air Quality Department (MCAQD) prepared a base year emissions inventory, with the assistance of MAG, and MAG submitted the base year inventory as part of the MAG 2014 Eight-hour Ozone Plan.
The following is a summary of the 2011 Maricopa NAA Emissions Inventory.
The TSD for this action contains more information about how MCAQD developed the emission inventory (EI) data for each category of sources.
The EPA has reviewed the 2011 ozone season day base year inventory including emission estimates for point source, area source, nonroad and onroad sources. We find that MCAQD's selection of 2011 as the base year is appropriate because 2011 was the most recent calendar year for which a complete triennial inventory was required to be submitted to the EPA under the AERR (see 40 CFR 51.30(b)). We also find that the data elements in the base year inventory are “consistent with the detail” required by the AERR. Generally, MCAQD used published emission factors from EPA's National Emissions Inventory,
However, we believe that MCAQD's initial selection of July-September as the basis for calculating the “ozone season day emissions” was not appropriate because it was based on 1981-1991 exceedance data for a previous ozone NAAQS.
We agree with MCAQD that using June-August to calculate ozone season day emissions for the base year inventory is appropriate for the Maricopa NAA, given that it was the three-month period with the highest average Air Quality Index value and the greatest number of exceedances of the 2008 ozone standard in the NAA in 2011. However, in light of the relatively small differences in total anthropogenic emissions between the June-August 2011 and July-September 2011 periods, we do not believe it is necessary for MCAQD, MAG and ADEQ to submit a formal SIP revision reflecting the June-August period at this time. Accordingly, we find that the base year emission estimates approaches and methodologies are acceptable and that the state has met the requirements of the Act and the SRR with respect to base year inventories. We recommend that a revised 2011 season-day EI based on June-August data be included as part of a subsequent SIP revision to meet the CAA's Moderate ozone nonattainment area requirements, as described above.
Section 182(a)(3)(B)(i) of the Act requires States to submit a SIP revision requiring owners or operators of stationary sources of VOC or NO
ADEQ references three SIP-approved rules as meeting the requirements of CAA section 182(a)(3)(B): Maricopa County Rule 100, Section 500—Monitoring and Records, ADEQ Rule 18-2-327—Annual Emissions Inventory Questionnaire and Pinal County rule PG3-1-103—Annual EI questionnaire.
Maricopa County Rule 100 (Section 500, Subsection 503) (approved into the Arizona SIP on November 5, 2012 (77 FR 66405)) requires owners/operators of sources that emit NO
ADEQ Rule 18-2-327, Annual Emissions Inventory Questionnaire (approved into the Arizona SIP on November 5, 2012 (77 FR 66405)), requires every source subject to air permit requirements to complete and submit an annual emissions inventory questionnaire including facility contact information, process and control device descriptions, and a quantification of actual emissions of regulated air pollutants
Pinal County Rule PG3-1-103 (approved into the Arizona SIP on December 20, 2000 (65 FR 79742)) requires every source that is subject to a permit or obtains an authorization to operate, to complete and submit to the Control Officer an annual emissions inventory questionnaire. The questionnaire must include the source's name, address, contact information, address, and process information (
Based on the contents of these rules, we find that Arizona has met the requirements of CAA section 182(a)(3)(B) for emission statements.
Section 182(a)(2)(A) of the CAA requires the State to submit, within six months of classification under section 181(a), all rules and corrections to existing RACT rules that were required under section 172(b) of the old (pre-1990 Amendments) CAA. Newly designated nonattainment areas are not subject to the RACT “fix-ups” required by section 182(a)(2)(A) because they were not subject to section 172(b) of the old law (see 57 FR 13498, 13503).
The Submittal lists the SIP-approved Rules that apply to source categories subject to CAA section 182(a)(2)(A) and notes that the EPA approved Arizona's RACT demonstration for the Maricopa County 1-hour Serious Area Ozone NAA on June 14, 2005 (70 FR 34362).
As noted in the Submittal, the EPA previously determined that Arizona had met the VOC RACT requirements under section 182(a)(2)(A) for the Maricopa one-hour ozone NAA (see 70 FR 13435 and 70 FR 34363). Although the NAA for the 2008 eight-hour ozone standard is larger than that the one-hour NAA, only the original one-hour area is subject to the RACT correction requirement of 182(a)(2)(A). Therefore, we find that Arizona has met the requirements of CAA section 182(a)(2)(A) with respect to the Maricopa 2008 eight-hour ozone NAA.
Section 182(a)(2)(B)(i) of the Act requires the State to submit a revision, immediately after November 15, 1990, to correct any pre-1990 schedules for vehicle emission control inspection and
The Submittal notes that the EPA approved ADEQ's Basic and Enhanced Vehicle Emissions Inspection and Maintenance Programs on January 22, 2003, and approved a statutory provision extending the State's vehicle emissions inspection program on December 21, 2009 (74 FR 67819).
As noted in the Submittal, the EPA previously approved an “enhanced” I/M program that exceeds the requirements of section 182(a)(2)(B) for the Phoenix-Mesa nonattainment area (69 FR 2912 (January 22, 2003)). Therefore, we find that Arizona has met the requirements of CAA section 182(a)(2)(B) with respect to the Maricopa 2008 eight-hour ozone NAA.
Section 182(a)(2)(C) of the Act, requires states to submit a SIP revision within two years after November 15, 1990 to require pre-construction permits for new or modified major stationary sources in the NAA, and to correct requirements regarding pre-1990 permit programs. However, as explained in the preambles to the EPA's final Phase 2 implementation rule for the 1997 eight-hour standard and the final SRR, the EPA considers the submission of new source review (NSR) SIPs due on November 15, 1992 to have fulfilled this CAA requirement (See 75 FR 71683, n. 110, and 80 FR 12267). Therefore, the EPA has concluded that the two-year deadline contained in CAA section 182(a)(2)(C)(i) does not apply to subsequent NSR SIPs for revised ozone standards, including the nonattainment NSR SIPs for implementing the eight-hour ozone NAAQS. (Id.) Accordingly, the SRR at 40 CFR 51.1114 sets a deadline of three years from the date of designation for states to submit their nonattainment NSR program SIPs for the 2008 ozone NAAQS.
The Submittal describes the roles of ADEQ, MCAQD and PCAQCD in implementing the preconstruction permit program in the Maricopa NAA. In particular, the Submittal explains that ADEQ has permitting jurisdiction for the following stationary source categories: smelting of metal ores, coal-fired electric generating stations, petroleum refineries, Portland cement plants, and portable sources. ADEQ also has permitting jurisdiction over other major sources in Pinal County, but has delegated implementation of the major source program to PCAQCD, which implements ADEQ's major NSR rules. MCAQD has jurisdiction over other sources in Maricopa County. The Submittal also described various SIP revisions submitted by ADEQ to meet nonattainment NSR requirements.
The EPA recently finalized a limited approval and limited disapproval of various rules that comprise ADEQ's NSR program.
CAA Section 173 requires new and modified major sources in nonattainment areas to secure emissions reductions (
The Submittal lists “Meet Transportation Conformity Requirements—CAA Section 176(c)” as a marginal area requirement. We note that motor vehicle emission budgets, used in transportation conformity determinations, are not required for marginal areas because such areas are not required to submit a “control strategy implementation plan revision.”
The EPA is taking direct final action to approve the MAG 2014 Eight-Hour Ozone Plan with respect to the requirements of CAA section 182(a)(1), (2)(A) and (B), and (3)(B) and is deferring action with respect to the requirements of CAA sections 176(c) and 182(a)(2)(C) and (4). We do not think anyone will object to this approval, so we are finalizing it without proposing it in advance. However, in the Proposed Rules section of this
Under the CAA, the Administrator is required to approve a SIP submission that complies with the provisions of the Act and applicable Federal regulations. 42 U.S.C. 7410(k); 40 CFR 52.02(a). Thus, in reviewing SIP submissions, the EPA's role is to approve state choices, provided that they meet the criteria of the Clean Air Act. Accordingly, this action merely approves state law as meeting Federal requirements and does not impose additional requirements beyond those imposed by state law. For that reason, this action:
• Is not a significant regulatory action subject to review by the Office of Management and Budget under Executive Orders 12866 (58 FR 51735, October 4, 1993) and 13563 (76 FR 3821, January 21, 2011);
• does not impose an information collection burden under the provisions of the Paperwork Reduction Act (44 U.S.C. 3501
• is certified as not having a significant economic impact on a substantial number of small entities under the Regulatory Flexibility Act (5 U.S.C. 601
• does not contain any unfunded mandate or significantly or uniquely affect small governments, as described in the Unfunded Mandates Reform Act of 1995 (Pub. L. 104-4);
• does not have Federalism implications as specified in Executive Order 13132 (64 FR 43255, August 10, 1999);
• is not an economically significant regulatory action based on health or safety risks subject to Executive Order 13045 (62 FR 19885, April 23, 1997);
• is not a significant regulatory action subject to Executive Order 13211 (66 FR 28355, May 22, 2001);
• is not subject to requirements of Section 12(d) of the National Technology Transfer and Advancement Act of 1995 (15 U.S.C. 272 note) because application of those requirements would be inconsistent with the Clean Air Act; and
• does not provide the EPA with the discretionary authority to address, as appropriate, disproportionate human health or environmental effects, using practicable and legally permissible methods, under Executive Order 12898 (59 FR 7629, February 16, 1994).
In addition, the SIP is not approved to apply on any Indian reservation land or in any other area where the EPA or an Indian tribe has demonstrated that a tribe has jurisdiction. In those areas of Indian country, the rule does not have tribal implications and will not impose substantial direct costs on tribal governments or preempt tribal law as specified by Executive Order 13175 (65 FR 67249, November 9, 2000).
The Congressional Review Act, 5 U.S.C. 801
Under section 307(b)(1) of the Clean Air Act, petitions for judicial review of this action must be filed in the United States Court of Appeals for the appropriate circuit by December 15, 2015. Filing a petition for reconsideration by the Administrator of this final rule does not affect the finality of this action for the purposes of judicial review nor does it extend the time within which a petition for judicial review may be filed, and shall not postpone the effectiveness of such rule or action. Parties with objections to this direct final rule are encouraged to file a comment in response to the parallel notice of proposed rulemaking for this action published in the Proposed Rules section of today's
Environmental protection, Air pollution control, Incorporation by reference, Intergovernmental relations, Ozone, Reporting and recordkeeping requirements, Volatile organic compounds.
Part 52, Chapter I, Title 40 of the Code of Federal Regulations is amended as follows:
42 U.S.C. 7401
(c) * * *
(172) The following plan was submitted July 2, 2014, by the Governor's designee.
(i) [Reserved]
(ii)
(A) Arizona Department of Environmental Quality (ADEQ).
(
(
(
Environmental Protection Agency (EPA).
Final rule.
This regulation establishes an exemption from the requirement of a
This regulation is effective October 16, 2015. Objections and requests for hearings must be received on or before December 15, 2015, and must be filed in accordance with the instructions provided in 40 CFR part 178 (see also Unit I.C. of the
The docket for this action, identified by docket identification (ID) number EPA-HQ-OPP-2015-0363, is available at
Susan Lewis, Registration Division (7505P), Office of Pesticide Programs, Environmental Protection Agency, 1200 Pennsylvania Ave. NW., Washington, DC 20460-0001; main telephone number: (703) 305-7090; email address:
You may be potentially affected by this action if you are an agricultural producer, food manufacturer, or pesticide manufacturer. The following list of North American Industrial Classification System (NAICS) codes is not intended to be exhaustive, but rather provides a guide to help readers determine whether this document applies to them. Potentially affected entities may include:
• Crop production (NAICS code 111).
• Animal production (NAICS code 112).
• Food manufacturing (NAICS code 311).
• Pesticide manufacturing (NAICS code 32532).
You may access a frequently updated electronic version of 40 CFR part 180 through the Government Printing Office's e-CFR site at
Under FFDCA section 408(g), 21 U.S.C. 346a, any person may file an objection to any aspect of this regulation and may also request a hearing on those objections. You must file your objection or request a hearing on this regulation in accordance with the instructions provided in 40 CFR part 178. To ensure proper receipt by EPA, you must identify docket ID number EPA-HQ-OPP-2015-0363 in the subject line on the first page of your submission. All objections and requests for a hearing must be in writing, and must be received by the Hearing Clerk on or before December 15, 2015. Addresses for mail and hand delivery of objections and hearing requests are provided in 40 CFR 178.25(b).
In addition to filing an objection or hearing request with the Hearing Clerk as described in 40 CFR part 178, please submit a copy of the filing (excluding any Confidential Business Information (CBI)) for inclusion in the public docket. Information not marked confidential pursuant to 40 CFR part 2 may be disclosed publicly by EPA without prior notice. Submit the non-CBI copy of your objection or hearing request, identified by docket ID number EPA-HQ-OPP-2015-0363, by one of the following methods:
•
•
•
Additional instructions on commenting or visiting the docket, along with more information about dockets generally, is available at
In the
Inert ingredients are all ingredients that are not active ingredients as defined in 40 CFR 153.125 and include, but are not limited to, the following types of ingredients (except when they have a pesticidal efficacy of their own): Solvents such as alcohols and hydrocarbons; surfactants such as polyoxyethylene polymers and fatty acids; carriers such as clay and diatomaceous earth; thickeners such as carrageenan and modified cellulose; wetting, spreading, and dispersing agents; propellants in aerosol dispensers; microencapsulating agents; and emulsifiers. The term “inert” is not intended to imply nontoxicity; the ingredient may or may not be chemically active. Generally, EPA has exempted inert ingredients from the requirement of a tolerance based on the low toxicity of the individual inert ingredients.
Section 408(c)(2)(A)(i) of FFDCA allows EPA to establish an exemption from the requirement for a tolerance (the legal limit for a pesticide chemical residue in or on a food) only if EPA determines that the exemption is “safe.”
EPA establishes exemptions from the requirement of a tolerance only in those cases where it can be clearly demonstrated that aggregate exposure to pesticide chemical residues under reasonably foreseeable circumstances will pose no appreciable risks to human health. In order to determine the risks from aggregate exposure to pesticide inert ingredients, the Agency considers the toxicity of the inert in conjunction with possible exposure to residues of the inert ingredient through food, drinking water, and through other exposures that occur as a result of pesticide use in residential settings. If EPA is able to determine that a finite tolerance is not necessary to ensure that there is a reasonable certainty that no harm will result from aggregate exposure to the inert ingredient, an exemption from the requirement of a tolerance may be established.
Consistent with FFDCA section 408(c)(2)(A), and the factors specified in FFDCA section 408(c)(2)(B), EPA has reviewed the available scientific data and other relevant information in support of this action. EPA has sufficient data to assess the hazards of and to make a determination on aggregate exposure for PolyDADMAC including exposure resulting from the exemption established by this action. EPA's assessment of exposures and risks associated with PolyDADMAC follows.
EPA has evaluated the available toxicity data and considered their validity, completeness, and reliability as well as the relationship of the results of the studies to human risk. EPA has also considered available information concerning the variability of the sensitivities of major identifiable subgroups of consumers, including infants and children. Specific information on the studies received and the nature of the adverse effects caused by PolyDADMAC as well as the no-observed-adverse-effect-level (NOAEL) and the lowest-observed-adverse-effect-level (LOAEL) from the toxicity studies are discussed in this unit.
A single dose feeding study with rats classified PolyDADMAC as “slightly toxic” at a dose level of 5 milliliter/kilogram (mL/kg) (approx. 2,000 milligram/kilogram (mg/kg)). The results of two skin irritation studies performed with rabbits indicate that PolyDADMAC is not a skin irritant. In two eye irritation studies performed with PolyDADMAC on rabbits, the results indicate that the product was slightly irritating to the eyes and that the effects were totally reversed within 72 hours following exposure. In an eye study performed with PolyDADMAC on cultured fibroblasts, the results indicate that PolyDADMAC is slightly irritating. In a teratology study performed with Sprague-Dawley rats, the administration of 600 milligram/kilogram/day (mg/kg/day) of PolyDADMAC, and to a lesser extent, at the 450 and 150 mg/kg/day test groups, elicited a significant reduction in maternal food consumption during the first half of the dosing period. The NOAEL for PolyDADMAC on embryonic development is 600 mg/kg/day. A multi-generational study performed with PolyDADMAC using Sprague-Dawley rats dosed with 0.375, 12.5, and 125 mg/kg/day (oral gavage) showed no increase in reproductive failure, nor were there any effects upon the fertility index or any other F1 or F2 generation parameters. The inferred NOAEL from the study was 125 mg/kg/day. The two genotoxicity studies performed with PolyDADMAC were negative in both an Ames test and in a mouse micronucleus assay. There are no carcinogenicity studies available for PolyDADMAC. However, no significant systemic toxicity was observed in the teratology, multi-generational and mutagenicity toxicity studies. In the absence of significant systemic toxicity, and lack of mutagenicity concerns, PolyDADMAC is not likely to be carcinogenic.
Once a pesticide's toxicological profile is determined, EPA identifies toxicological points of departure (POD) and levels of concern to use in evaluating the risk posed by human exposure to the pesticide. For hazards that have a threshold below which there is no appreciable risk, the toxicological POD is used as the basis for derivation of reference values for risk assessment. PODs are developed based on a careful analysis of the doses in each toxicological study to determine the dose at which the NOAEL and the LOAEL are identified. Uncertainty/safety factors are used in conjunction with the POD to calculate a safe exposure level—generally referred to as a population-adjusted dose (PAD) or a reference dose (RfD)—and a safe margin of exposure (MOE). For non-threshold risks, the Agency assumes that any amount of exposure will lead to some degree of risk. Thus, the Agency estimates risk in terms of the probability of an occurrence of the adverse effect expected in a lifetime. For more information on the general principles EPA uses in risk characterization and a complete description of the risk assessment process, see
PolyDADMAC is a large molecular weight chemical which satisfies all of the TSCA Polymer Exemption Rule except for its cationic properties. Generally, high molecular weight polymers are unlikely to be absorbed significantly through any route of exposure. In the case of PolyDADMAC, this is evidenced by: No systemic toxicity up to 600 mg/kg/day in the teratology study, no systemic toxicity in the multi-generational reproduction study up to 125 mg/kg/day, and low acute toxicity. Therefore, no adverse effect level endpoints have been selected for PolyDADMAC, and EPA concludes that it is not necessary to assess quantitative dietary risk or risk from exposure via dermal or inhalation.
1.
2.
3.
While there are no current or proposed residential uses for PolyDADMAC, it is possible that PolyDADMAC may be used as an inert ingredient in pesticide products for which residential exposures may result. However, in the case of PolyDADMAC no applicable endpoints of concern for residential exposures have been identified and a quantitative exposure assessment from residential exposures was not performed.
4.
EPA has not found PolyDADMAC to share a common mechanism of toxicity with any other substances, and PolyDADMAC does not appear to produce a toxic metabolite produced by other substances. For the purposes of this tolerance action, therefore, EPA has assumed that PolyDADMAC does not have a common mechanism of toxicity with other substances. For information regarding EPA's efforts to determine which chemicals have a common mechanism of toxicity and to evaluate the cumulative effects of such chemicals, see EPA's Web site at
1.
2.
3.
Based on the lack of any endpoints of concern, EPA concludes that there is a reasonable certainty that no harm will result to the general population or to infants and children from aggregate exposure to PolyDADMAC residues.
An analytical method is not required for enforcement purposes since the Agency is establishing an exemption from the requirement of a tolerance without any numerical limitation.
In making its tolerance decisions, EPA seeks to harmonize U.S. tolerances with international standards whenever possible, consistent with U.S. food safety standards and agricultural practices. EPA considers the international maximum residue limits (MRLs) established by the Codex Alimentarius Commission (Codex), as required by FFDCA section 408(b)(4). The Codex Alimentarius is a joint United Nation Food and Agriculture Organization/World Health Organization food standards program, and it is recognized as an international food safety standards-setting organization in trade agreements to which the United States is a party. EPA may establish a tolerance that is different from a Codex MRL; however, FFDCA section 408(b)(4) requires that EPA explain the reasons for departing from the Codex level.
The Codex has not established a MRL for PolyDADMAC.
Therefore, an exemption from the requirement of a tolerance is established under 40 CFR 180.940(a) for PolyDADMAC (CAS No. 26062-79-3) when used as an inert ingredient as a dispersing aid in food contact surface sanitizing solutions at less than 0.6% by weight in the final product.
This action establishes a tolerance under FFDCA section 408(d) in response to a petition submitted to the Agency. The Office of Management and Budget (OMB) has exempted these types of actions from review under Executive Order 12866, entitled “Regulatory Planning and Review” (58 FR 51735, October 4, 1993). Because this action has been exempted from review under Executive Order 12866, this action is not subject to Executive Order 13211, entitled “Actions Concerning Regulations That Significantly Affect Energy Supply, Distribution, or Use” (66 FR 28355, May 22, 2001) or Executive Order 13045, entitled “Protection of Children from Environmental Health Risks and Safety Risks” (62 FR 19885, April 23, 1997). This action does not contain any information collections
Since tolerances and exemptions that are established on the basis of a petition under FFDCA section 408(d), such as the tolerance in this final rule, do not require the issuance of a proposed rule, the requirements of the Regulatory Flexibility Act (RFA) (5 U.S.C. 601
This action directly regulates growers, food processors, food handlers, and food retailers, not States or tribes, nor does this action alter the relationships or distribution of power and responsibilities established by Congress in the preemption provisions of FFDCA section 408(n)(4). As such, the Agency has determined that this action will not have a substantial direct effect on States or tribal governments, on the relationship between the national government and the States or tribal governments, or on the distribution of power and responsibilities among the various levels of government or between the Federal Government and Indian tribes. Thus, the Agency has determined that Executive Order 13132, entitled “Federalism” (64 FR 43255, August 10, 1999) and Executive Order 13175, entitled “Consultation and Coordination with Indian Tribal Governments” (65 FR 67249, November 9, 2000) do not apply to this action. In addition, this action does not impose any enforceable duty or contain any unfunded mandate as described under Title II of the Unfunded Mandates Reform Act (UMRA) (2 U.S.C. 1501
This action does not involve any technical standards that would require Agency consideration of voluntary consensus standards pursuant to section 12(d) of the National Technology Transfer and Advancement Act (NTTAA) (15 U.S.C. 272 note).
Pursuant to the Congressional Review Act (5 U.S.C. 801
Environmental protection, Administrative practice and procedure, Agricultural commodities, Pesticides and pests, Reporting and recordkeeping requirements.
Therefore, 40 CFR chapter I is amended as follows:
21 U.S.C. 321(q), 346a and 371.
(a) * * *
Coast Guard, DHS.
Final rule.
This final rule makes non-substantive technical, organizational, and conforming amendments to existing regulations throughout Title 46 of the Code of Federal Regulations. This rule will have no substantive effect on the regulated public.
This final rule is effective October 16, 2015.
Documents mentioned in this preamble as being available in the docket are part of docket USCG-2015-0867, which is available at
If you have questions on this final rule, call or email Mr. Paul Crissy, Coast Guard; telephone 202-372-1093, email
We did not publish a notice of proposed rulemaking for this rule. Under 5 U.S.C. 553(b)(A), the Coast Guard finds that this rule is exempt from notice and comment rulemaking requirements, because these changes involve rules of agency organization, procedure, or practice. In addition, the Coast Guard finds that notice and comment procedures are unnecessary under 5 U.S.C. 553(b)(B), as this rule consists only of corrections and editorial, organizational, and conforming amendments, and that these changes will have no substantive effect on the public. Under 5 U.S.C. 553(d)(3), the Coast Guard finds that, for the same reasons, good cause exists for making this final rule effective upon publication in the
On the 1st of October each year, the printed editions of Titles 46 and 49 of the Code of Federal Regulations (CFR) are re-codified. This rule, which becomes effective October 16, 2015, makes technical and editorial corrections throughout Title 46. There are no technical or editorial corrections for Title 49 this year. This rule does not create or change any substantive requirements.
Each year, the Coast Guard issues technical, organizational, and conforming amendments to existing regulations in Titles 46 and 49 of the CFR. These annual “technical amendments” provide the public with more accurate and current regulatory information, but do not change the impact on the public of any Coast Guard regulations. This rule makes no changes to Title 49.
This rule makes changes in the following sections of Title 46 in the CFR:
We developed this rule after considering numerous statutes and executive orders (E.O.s) related to rulemaking. Below we summarize our analyses based on these statutes or E.O.s.
Executive Orders 13563 and 12866 direct agencies to assess the costs and benefits of available regulatory alternatives and, if regulation is necessary, to select regulatory approaches that maximize net benefits (including potential economic, environmental, public health and safety effects, distributive impacts, and equity). Executive Order 13563 emphasizes the importance of quantifying both costs and benefits, of reducing costs, of harmonizing rules, and of promoting flexibility. This rule has not been designated a “significant regulatory action,” under section 3(f) of Executive Order 12866. Accordingly, the rule has not been reviewed by the Office of Management and Budget. Because this rule involves non-substantive changes and internal agency practices and procedures, it will not impose any additional costs on the public. The benefit of the non-substantive changes is increased clarity of regulations.
Under the Regulatory Flexibility Act (5 U.S.C. 601-612), rules exempt from the notice and comment requirements of the Administrative Procedure Act are not required to examine the impact of the rule on small entities. Nevertheless, we have considered whether this rule would have a significant economic impact on a substantial number of small entities. The term “small entities” comprises small businesses, not-for-profit organizations that are independently owned and operated and are not dominant in their fields, and governmental jurisdictions with populations of less than 50,000.
There is no cost to this final rule, and we do not expect it will have an impact on small entities because the provisions of this rule are technical and non-substantive. It will have no substantive effect on the public and will impose no additional costs. Therefore, the Coast Guard certifies under 5 U.S.C. 605(b) that this final rule will not have a significant economic impact on a substantial number of small entities.
Under section 213(a) of the Small Business Regulatory Enforcement Fairness Act of 1996 (Pub. L. 104-121), we want to assist small entities in understanding this rule so that they can better evaluate its effects on them and participate in the rulemaking. If the rule would affect your small business, organization, or governmental jurisdiction and you have questions concerning its provisions or options for compliance, please consult Mr. Paul Crissy by phone at 202-372-1093 or via email at
Small businesses may send comments on the actions of Federal employees who enforce, or otherwise determine compliance with, Federal regulations to the Small Business and Agriculture Regulatory Enforcement Ombudsman and the Regional Small Business Regulatory Fairness Boards. The Ombudsman evaluates these actions annually and rates each agency's responsiveness to small business. If you wish to comment on actions by employees of the Coast Guard, call 1-888-REG-FAIR (1-888-734-3247).
This rule calls for no new collection of information under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3520).
A rule has implications for federalism under E.O. 13132 (“Federalism”) if it has a substantial direct effect on the States, on the relationship between the national government and the States, or on the distribution of power and responsibilities among the various levels of government. We have analyzed this rule under that order and have determined that it is consistent with the fundamental federalism principles and preemption requirements described in E.O. 13132.
The Unfunded Mandates Reform Act of 1995 (2 U.S.C. 1531-1538) requires Federal agencies to assess the effects of their discretionary regulatory actions. In particular, the Act addresses actions that may result in the expenditure by a State, local, or tribal government, in the aggregate, or by the private sector of $100,000,000 (adjusted for inflation) or more in any 1 year. Though this final rule will not result in such an expenditure, we do discuss the effects of this rule elsewhere in this preamble.
This final rule will not cause a taking of private property or otherwise have taking implications under E.O. 12630 (“Governmental Actions and Interference with Constitutionally Protected Property Rights”).
This final rule meets applicable standards in sections 3(a) and 3(b)(2) of E.O. 12988 (“Civil Justice Reform”), to minimize litigation, eliminate ambiguity, and reduce burden.
We have analyzed this final rule under E.O. 13045 (“Protection of Children from Environmental Health Risks and Safety Risks”). This final rule is not an economically significant rule and would not create an environmental risk to health or risk to safety that might disproportionately affect children.
This final rule does not have tribal implications under E.O. 13175 (“Consultation and Coordination with Indian Tribal Governments”), because it does not have a substantial direct effect on one or more Indian tribes, on the relationship between the Federal Government and Indian tribes, or on the distribution of power and responsibilities between the Federal Government and Indian tribes.
We have analyzed this final rule under E.O. 13211 (“Actions Concerning Regulations That Significantly Affect Energy Supply, Distribution, or Use”). We have determined that it is not a “significant energy action” under that order because it is not a “significant regulatory action” under E.O. 12866 and is not likely to have a significant adverse effect on the supply, distribution, or use of energy. The Administrator of OMB's Office of Information and Regulatory Affairs has not designated it as a significant energy action. Therefore, it does not require a Statement of Energy Effects under E.O. 13211.
The National Technology Transfer and Advancement Act (15 U.S.C. 272 note) directs agencies to use voluntary consensus standards in their regulatory activities unless the agency provides Congress, through the OMB, with an explanation of why using these standards would be inconsistent with applicable law or otherwise impractical. Voluntary consensus standards are technical standards (
This final rule does not use technical standards. Therefore, we did not consider the use of voluntary consensus standards.
We have analyzed this rule under Department of Homeland Security Management Directive 023-01 and Commandant Instruction M16475.lD, which guide the Coast Guard in complying with the National Environmental Policy Act of 1969 (42 U.S.C. 4321-4370f), and have concluded that this action is one of a category of actions that do not individually or cumulatively have a significant effect on the human environment. This rule is categorically excluded under section 2.B.2 and figure 2-1, paragraph (34)(a) of the Instruction. This final rule involves amendments to regulations that are editorial or procedural. An environmental analysis checklist and a categorical exclusion determination are available in the docket for this final rule where indicated under
Marine safety, Reporting and recordkeeping requirements, Vessels.
Administrative practice and procedure, Alcohol abuse, Drug abuse, Investigations, Seamen.
Penalties, Reporting and recordkeeping requirements, Schools, Seamen.
Marine safety, Oil and gas exploration, Reporting and recordkeeping requirements, Vessels.
Communications equipment, Fire prevention, Vessels.
Marine safety, Passenger vessels, Reporting and recordkeeping requirements.
Marine safety, Passenger vessels.
Administrative practice and procedure, Cargo vessels, Hazardous materials transportation, Marine safety, Seamen.
Business and industry, Laboratories, Marine safety, Reporting and recordkeeping requirements.
Fire prevention, Marine safety, Oil pollution, Reporting and recordkeeping requirements.
Marine safety, Passenger vessels, Reporting and recordkeeping requirements.
For the reasons discussed in the preamble, the Coast Guard amends 46 CFR parts 2, 5, 11, 107, 113, 114, 117, 125, 159, 162, 175, and 180 to read as follows:
Sec. 622, Pub. L. 111-281; 33 U.S.C. 1903; 43 U.S.C. 1333; 46 U.S.C. 2103, 2110, 3306, 3703; E.O. 12234, 45 FR 58801, 3 CFR, 1980 Comp., p. 277, sec. 1-105; Department of Homeland Security Delegation No. 0170.1(II)(77), (90), (92)(a), (92)(b).
46 U.S.C. 2103, 7101, 7301, 7701; Department of Homeland Security Delegation No. 0170.1.
(b) The completed application and letter must be addressed to the U.S. Coast Guard Office of Investigations and Analysis, Commandant (CG-INV-1), U.S. Coast Guard Stop 7501, 2703 Martin Luther King Jr. Avenue SE., Washington, DC 20593-7501, and must be delivered in person to the nearest Officer in Charge, Marine Inspection.
14 U.S.C. 633; 31 U.S.C. 9701; 46 U.S.C. 2101, 2103, and 2110; 46 U.S.C. chapter 71; 46 U.S.C. 7502, 7505, 7701, 8906, and 70105; E.O. 10173; Department of Homeland Security Delegation No. 0170.1. Section 11.107 is also issued under the authority of 44 U.S.C. 3507.
43 U.S.C. 1333; 46 U.S.C. 3306, 3307; 46 U.S.C. 3316; Department of Homeland Security Delegation No. 0170.1; § 107.05 also issued under the authority of 44 U.S.C. 3507.
46 U.S.C. 3306, 3703; Department of Homeland Security Delegation No. 0170.1.
46 U.S.C. 2103, 3306, 3703; Pub. L. 103-206, 107 Stat. 2439; 49 U.S.C. App. 1804; Department of Homeland Security Delegation No. 0170.1; § 114.900 also issued under 44 U.S.C. 3507.
46 U.S.C. 2103, 3306; E.O. 12234, 45 FR 58801, 3 CFR, 1980 Comp., p. 277; Department of Homeland Security Delegation No. 0170.1.
46 U.S.C. 2103, 3306, 3307; 49 U.S.C. App. 1804; sec. 617, Pub. L. 111-281, 124 Stat. 2905; Department of Homeland Security Delegation No. 0170.1.
46 U.S.C. 3306, 3703; 49 CFR 1.45, 1.46; Section 159.001-9 also issued under the authority of 44 U.S.C. 3507.
(a) * * *
(4) Publishes a record of the approval in the Coast Guard Maritime Information Exchange (CGMIX). A listing of current and formerly approved equipment and materials may be found on the Internet at:
33 U.S.C. 1321(j), 1903; 46 U.S.C. 3306, 3703, 4104, 4302; E.O. 12234, 45 FR 58801, 3 CFR, 1980 Comp., p. 277; E.O. 12777, 56 FR 54757, 3 CFR, 1991 Comp., p. 351; Department of Homeland Security Delegation No. 0170.1.
46 U.S.C. 2103, 3205, 3306, 3703; Pub. L. 103-206, 107 Stat. 2439; 49 U.S.C. App. 1804; Department of Homeland Security Delegation No. 0170.1; § 175.900 also issued under 44 U.S.C. 3507.
46 U.S.C. 2104, 3306; E.O. 12234, 45 FR 58801, 3 CFR, 1980 Comp., p. 277; Department of Homeland Security Delegation No. 0170.1.
Federal Communications Commission.
Final rule.
In this document the Federal Communications Commission (FCC or Commission) adopts rules to promote continued access to 911 during commercial power outages by requiring providers of facilities-based, fixed residential voice services, which are not line powered, to offer subscribers the option to purchase a backup solution capable of 8 hours of standby power, and within three years, an additional solution capable of 24 hours of standby power. The item also promotes consumer education and choice by requiring providers of covered services to disclose to subscribers the following information: availability of backup power sources; service limitations with and without backup power during a power outage; purchase and replacement options; expected backup power duration;) proper usage and storage conditions for the backup power source; subscriber backup power self-testing and monitoring instructions; and backup power warranty details, if any.
Public Safety and Homeland Security Bureau, Linda M. Pintro, at (202) 418-7490 or
This is a summary of the Commission's
1. In this
2. For over one hundred years, consumers have trusted that they will hear a dial tone in an emergency even when the power is out. Now, as networks transition away from copper-based, line-powered technology, many are aware of the innovation this transition has spurred in emergency services, but many consumers, remain unaware that they must take action to ensure that dial tone's availability in the event of a commercial power outage. The Commission's own consumer complaints portal reveals frustration over the failure of service providers to adequately inform subscribers about how to self-provision backup power in order to access 911 services in a power outage. This period of transition has the potential to create a widespread public safety issue if unaddressed.
3. Accordingly, we create new section 12.5 of our rules to place limited backup power obligations on providers of facilities-based fixed, residential voice services that are not line-powered to ensure that such service providers meet their obligation to provide access to 911 service during a power outage, and to provide clarity for the role of consumers and their communities should they elect not to purchase backup power. To be sure, many providers of residential voice communications already offer some level of backup power to consumers. However, the vital importance of the continuity of 911 communications, and the Commission's duty to promote “safety of life and property through the use of wire and radio communication,” favor action to ensure that all consumers understand the risks associated with non-line-powered 911 service, know how to protect themselves from such risks, and have a meaningful opportunity to do so. Specifically, we require all providers of facilities-based, fixed, voice residential service that is not line powered—including those fixed applications of wireless service offered as a “plain old telephone service” (POTS) replacement—to offer new subscribers the option to purchase a backup solution that provides consumers with at least 8 hours of standby power during a commercial power outage, which will enable calls to 911. In addition, we require these providers to offer, within three years of the effective date of the eight hour obligation, at least one option that provides a minimum of 24 hours of 911 service.
4. Additionally, we require all providers of facilities-based, fixed, voice residential service that is not line-powered to notify subscribers, at the point of sale and annually thereafter until September 1, 2025, of the availability of backup power purchasing options, use conditions and effect on power source effectiveness, power source duration and service limitations, testing and monitoring, and replacement details. Additionally, we direct the PSHSB to work with CGB to develop, prior to the implementation date of these rules for smaller providers, as herein defined, non-binding guidance with respect to the required notifications to subscribers. We limit these obligations to ten years as that should be enough time to ensure that overall consumer expectations regarding residential voice communications are aligned with ongoing technology transitions.
5. Finally, we encourage covered providers to conduct tailored outreach to state and local disaster preparedness entities to ensure that consumables and rechargeable elements associated with backup power technical solutions deployed in their area are well understood so that communities may prioritize restocking and/or recharging in response to extended power outages.
6. Our Nation's communications infrastructure and the services available to consumers are undergoing technology transitions. The Commission has recognized that these transitions will bring enormous benefits to consumers, but also that they raise important questions about how to appropriately carry out our obligations set forth in the Communications Act, including promoting public safety and national security, and protecting consumers.
7. To further these statutory objectives, in November 2014, the Commission adopted a
8. Communications services play an essential role in the delivery of public safety services, particularly 911, and that role is especially prominent during emergencies that lead to power outages. In the NPRM in this proceeding, we sought comment on the means to ensure that consumers have access to minimally essential communications, including 911 calls and telephone-based alerts and warnings, during a loss of commercial power. In this
9. As discussed in greater detail below, we require that providers of non-line-powered facilities-based, fixed, voice residential service, including fixed wireless service intended as POTS replacement, offer, at the subscriber's option and expense, a backup power solution that provides 911 access for 8 hours in the event of commercial power loss. Within three years, providers must also offer a 24-hour backup power solution. We also require covered providers to explain at point of sale how the subscriber may extend the provision of backup power during longer, multi-day outages through devices such as solar chargers, car chargers or mobile charging stations and to direct customers to sources of such equipment. No provider will be required to install backup power unless requested by, and at the expense of, the subscriber, and no subscriber will be forced to purchase unwanted equipment. Rather, our rules will ensure that subscribers who so elect can obtain backup power simply and conveniently when activating a covered
10. In the
11. During a power outage, many subscribers must rely on a battery back-up, or an uninterruptible power supply (UPS), to ensure that their service will continue to operate. That is, many subscribers cannot rely on the availability of continuous power that is sufficient to provide basic telephony indefinitely in their homes. Specifically, modern fiber and cable networks do not provide power to operate necessary equipment at the subscriber location, including network devices (
12. Given that consumers are increasingly relying on new types of service for residential voice communications, and that in many areas traditional line-powered 911 service is now, or is soon likely to be, no longer be available, the
13. We adopt the rules that follow because we believe that it is essential for all consumers to be able to access 911 emergency services during commercial power outages, especially those outages caused by catastrophic storms or other unpredictable events, and to understand how to do so. Ensuring the ability to maintain such service is a vital part of our statutory mandate to preserve reliable 911 service, and more generally, our statutory goal to promote “safety of life and property through the use of wire and radio communication.” We agree with the National Association of State Utility Consumer Advocates (NASUCA) that it is unlikely that our concerns would be adequately addressed without the adoption of regulatory requirements. We are supported in our conclusion by commenters such as the Pennsylvania Public Utility Commission (PA PUC), which urges the Commission to adopt baseline requirements for ensuring continuity of power during commercial power outages applicable to providers of interconnected VoIP-based services that do not provide line power at their central office, but rather rely on backup power.
14. Specifically, we find that public safety officers, first responders and other public officials have a need to communicate with citizens through whatever means possible, and 911 service plays an important role in this regard. Indeed, consumer advocates and 911 providers emphasize the need to adopt robust backup power requirements to ensure public safety. For example, Public Knowledge notes that right now consumers of traditional landline service are “guaranteed backup power during power outages” and “many consumers keep their landline service specifically to retain this feature.” Public Knowledge further states that, “[w]ith the advent of cordless phones the only time the consumer worried about backup batteries was for their cordless phone or they simply retained a traditional phone to use during emergencies.”
15. NASUCA and many other commenters agree that Commission action will help preserve consumers' ability to access 911 service. Specifically, NASUCA “fully supports the Commission's determination to ensure reliable backup power for consumers of IP-based voice and data services across networks that provide residential, fixed service that substitutes for and improves upon the kind of traditional telephony used by people to dial 911.” According to NASUCA, “[b]ackup power requirements will help ensure that service will continue in a power outage.” The National Association of State 911 Administrators (NASNA) similarly observes that “[t]he transition from legacy copper loops to other network technologies means that an important safety net—Central Office provisioning of line power to the subscriber premises—will disappear unless the Commission takes action to mitigate it.” The Communications Workers of America (CWA) asserts that CWA, consumer organizations, state regulatory commissions, and public safety associations “support Commission proposals to facilitate the
16. We agree that this period of transition gives rise to the need for “upgrading Commission rules.” We observe that the consumers most at risk of losing continuity of 911 communications during commercial power outages are those in the midst of transitioning from legacy copper, or that are new to non-copper media, because they may currently assume they will be able to reach 911 during a power outage. For example, Public Knowledge asserts that “the new technologies with which AT&T and Verizon propose to replace traditional POTS are not self-powered, do not work with vital devices on which consumers rely, and are not available in every community.” Public Knowledge further argues that, “[w]hile technology transitions hold tremendous promise for a state-of-the-art communications network, the loss of guaranteed backup power or shifting backup power responsibility to the consumer are serious changes that could end up creating a network that serves some and not others.”
17. We agree with the commenters who assert that transitions to new technology should not result in 911 service being more vulnerable than when consumers used the legacy network. As we stated in the
18. We reiterate our observation in the
19. We recognize that, as noted by some commenters, many users of interconnected VoIP service may well be unconcerned about backup power, choosing instead to rely on their mobile phones or alternative backup sources. Nonetheless, because of the critical nature of 911 communications, we are not persuaded by the argument that there is no need for action to ensure the continuity of 911 communications to homes across the country. Nor are we convinced that we should abandon this effort because of claims that consumer expectations, which have developed over decades, are already reset such that they no longer expect their home phone to work during power outages. Consumers who have yet to abandon (or who have only recently abandoned) line-powered service may not have had their expectations “reset.” At this time of transition, it is these consumers who are more likely to mistakenly believe that they can access emergency services during a power outage when the line power option had already been eliminated.
20. We find merit in NASUCA's argument that the public interest requires the industry to be responsible for ensuring that its subscribers at least have some option to purchase backup power, either from the service provider or a third party. Therefore, as more fully discussed below, we conclude that the public interest would be best served by ensuring the option for continued access to backup power to maintain continuity of 911 communications during a loss of commercial power.
21. We have previously recognized that the benefits associated with reliable 911 service are substantial. The provision of backup power for network equipment at the subscriber premises promotes the “safety of life and property through the use of wire and radio communication,” by enabling 911 calls for subscribers of the covered services, when the power is out. Specifically, the rules we adopt today will preserve safety of life by enabling the use of VoIP and other non-line powered services to contact 911 in a commercial power outage, which is what millions of Americans have come to expect from their “home phone.” We expect that providing the option for at least 8 hours of backup power would ensure the ability to make many life-saving 911 calls during commercial power outages. Therefore, we find, as we have before, that “[r]eliable 911 service provides public safety benefits that, while sometimes difficult to quantify, are enormously valuable to individual callers and to the nation as a whole.”
22. We have also previously found that greater access to 911 enables other public safety-related benefits as well. The Commission's “Text-to-911” proceeding concluded that increasing access to 911 “could yield other benefits, such as reduced property losses and increased probability of apprehending criminal suspects. Also, the increased ability to place 911 calls necessarily means that there is an increased ability to receive calls in an emergency, including calls from public entities attempting to disseminate important information during widespread emergencies (such as evacuation notices). Many communities have installed such a function that “has proven to be effective in other counties and cities, such as San Diego during the fires of 2007.”
23. In the
24. We also noted that voice services historically have been the primary means of contacting 911 for emergency help. Moreover, we observed that line-powered service can operate continuously and indefinitely during a commercial power failure, and does not require a backup power source to maintain continuity of communications for access to 911. Thus, we proposed that any rules apply “to facilities-based, fixed voice services, such as interconnected VoIP, that are not line-powered by the provider.”
25. Consistent with this proposal, we conclude that it would be in the best interest of the public to apply our rules
26. Although the rule we adopt today would allow for calls other than to or from 911, we find there is not currently a means to prioritize the provision of power for only some voice calls (such as 911 calls) over other communications (such as calls to friends and family). Many commenters generally agree that there is no practical way to maintain power for only some calls. For example, according to Verizon, calibrating a provider's battery backup obligations and capabilities based upon essential versus non-essential calls would be inconsistent with consumer's expectations, and unnecessarily complex. ITTA, the Alarm Industry Communications Committee (AICC), NASUCA, and others argue that it would be technically difficult, if not impossible, to distinguish among certain types of calls or functions in a way that would allow rapid load-shedding of non-essential communications to conserve backup power, if minimally essential communications were defined as only 911 or emergency communications.
27. Some commenters argue for an even broader definition of covered services, citing various examples. Although we recognize that limiting the definition as we have done omits some services on which consumers currently rely in emergencies, we expect that both the consumer backup power needs and our rules will evolve. More importantly, we do not more broadly define covered services because we find that at this time it would be in the best interests of the public to limit application of our rules to discharge our statutory duty to ensure the continued viability of 911. Imposing specific obligations on providers to support other communications could introduce confusion and impose costs on providers that may well exceed the incremental benefits. This is particularly true given the many backup power solutions on the market today that are capable of supporting both essential and non-essential communications.
28. We reject the argument of NCTA and others that adopting backup power rules exclusively for fixed services unduly favors competing mobile services. The rules we adopt herein are intended to clarify the obligations of providers and the expectations of consumers in the provision of services that a customer would perceive as replacing line-powered telephone service. Mobile wireless services increasingly compete with fixed services, but they function differently in multiple respects. Perhaps most significantly, mobile wireless devices are battery-powered in their normal mode of operation. Thus, we do not believe that consumers would reasonably expect such devices to draw line power during a commercial power failure. Moreover, the battery that powers a mobile device provides an inherent source of “backup power” that is often capable of providing far more than 8 hours of service per charge, and often may be charged through additional means, such as a car charger.
29. Therefore, we conclude that, at this time, the appropriate services that should be subject to backup power requirements for effective 911 service during power outages are facilities-based, fixed voice service that is not line-powered by the providers, and is offered as a residential service.
30. To promote clear expectations and customer choice, we adopt a combination of performance and disclosure requirements to empower consumers to understand the backup power options available to maintain continuity of 911 service and to obtain the equipment necessary to provide such service, if they wish, at the point of sale. Providers of covered services must offer at least one technical solution capable of supporting at least 8 hours of uninterrupted 911 service and install such equipment, at the subscriber's option and expense, as part its installation of service. Within three years, providers of covered services also must offer new subscribers at the point of sale and install, at the subscriber's option and expense, a 24-hour backup power solution if a subscriber desires additional protection. We also adopt a disclosure requirement designed to ensure that both current and new subscribers understand their options with respect to backup power and are aware of the consequences of their decisions whether, and to what extent, to purchase backup power. Finally, we encourage providers of covered services to engage in targeted outreach to the communities they serve to ensure that local emergency managers are aware of the limitations inherent in various fixed, residential voice service technologies commonly used in their areas, as well as backup power options for individuals and communities more broadly to maintain continuity of communications in an emergency.
31. We adopt backup power requirements that offer consumers meaningful alternatives to address their individualized needs, recognizing that consumers may have different preferences for backup power. Comments in response to the
32. In the
33. While we believe that 8 hours of backup power would address the need for continuity of communications immediately after a power outage, we recognize that, in some cases, 8 hours of backup power may not be enough for subscribers to reach critical emergency services during an extended loss of power. AARP urges the Commission to require providers to be “responsible for the deployment and maintenance of voice-enabling CPE that delivers at least 12 hours of standby time.” NASUCA and the Communications Workers of America (CWA) also suggest that a longer time period, such as 12 or 24 hours, would be more useful for subscribers who need a longer duration to attend to other time sensitive matters that arise during the course of a natural disaster or other emergency. While industry commenters oppose a mandate to provide more than 8 hours of backup power to every subscriber, service providers note existing solutions, as well as innovative new solutions, that are capable of supporting longer standby times. Along similar lines, NASUCA urges the Commission to monitor advances in battery technology, and as soon as such technology is available at a reasonable cost, to require providers to furnish backup batteries with 7-day standby time and 24-hour talk time.
34. In light of the critical need for maintaining 911 service during more severe and long-lasting power failures, we will require providers to offer subscribers a 24-hour backup power solution within three years. The record indicates that the provision of 24 hours of backup power is at least technically feasible today. ACA has “determined that batteries with 24 hour stand by capability can be ordered from at least one vendor but are not immediately available because they are not widely used.” As explained below, we do not require providers to offer technologically distinct 8-hour and 24-hour solutions, so a 24-hour solution could consist simply of three 8-hour batteries. Many providers that offer an 8-hour solution are therefore likely to be capable of offering a 24-hour solution with minimal additional difficulty. That said, we want to encourage continued innovation in the development of 24-hour and longer term backup power solutions and avoid locking in solutions that are minimally compliant but that may not provide the best value to consumers. We will therefore phase-in the 24-hour requirement over three years, during which time we expect providers to work diligently to implement innovative solutions for providing at least 24 hours of backup power that improve upon current offerings in terms of cost, reliability and ease of use. This is consistent with ACA's recommendation for a phase-in of the 24-hour battery requirement for smaller providers; however, we find that given the overall market conditions for 24-hour battery supplies, including questions about immediate availability, it is appropriate to phase in the requirements for all providers, regardless of size. While NASUCA recommends that the Commission monitor battery backup power developments and phase in the requirements as soon as the market will allow, we find that providing a date certain both allows the market sufficient time to develop, and places a backstop for development, thereby spurring innovation in a reasonable timeframe. In the meantime, we encourage but do not require providers to offer a 24-hour solution using available technologies.
35. As commenters note, the need for continued access to 911 during an extended power outage does not end after 8, or even 24, hours. For example, Public Knowledge argues that “a minimum time of seven days backup power is a reasonable requirement that will keep consumers safe before, during, and after a natural disaster, and allow them to rebuild their communities.” Based on a study by the Environmental and Energy Study Institute, Public Knowledge observes that restoring power after Hurricane Sandy and Hurricane Katrina took 12 and 15 days respectively, and on average takes 7 to 23 days. To address such extended losses of commercial power Public Knowledge asserts that “carriers must prioritize the adoption of devices that use batteries that can last days and are not proprietary.” Other commenters argue that “Americans have come to trust and expect basic telephone service to work indefinitely, particularly during power outages caused by natural disasters and public safety emergencies” and urge us to adopt even longer backup power requirements, ranging from seven days to two weeks.
36. We are not persuaded that a requirement for providers of covered services to offer or install more than 24 hours of backup power is necessary at
37. In adopting these requirements, we acknowledge observations that “[n]otwithstanding the availability of backup batteries, many customers today choose not to obtain a battery, given the growing reliance on wireless or the customers' use of handsets or other devices that themselves require commercial power to operate.” We also agree with commenters such as Verizon that “[c]ustomers should be free to decline [a backup] battery, depending on their personal preference.” We further acknowledge that comments in the record indicate that, when it is offered, consumers often may not choose to avail themselves of options to purchase backup power. Commenters note, for example, that many subscribers of fixed, residential VoIP service also purchase mobile voice service that provides an alternate means of reaching 911 in an emergency, and that others prefer cordless phones that require backup power beyond that supplied by service provider networks. Nevertheless, some consumers—particularly the elderly and other populations that are at the greatest risk during an emergency—may not subscribe to mobile wireless service and may rely solely on the continued functionality of their residential voice service to reach 911. Furthermore, mobile networks are not designed in the same manner as wireline networks and may become overloaded in times of extreme use in an emergency situation, and thus be unavailable for use to reach 911. We emphasize that nothing in our rules forces consumers to purchase backup power they do not want. We require only that consumers who want service that will work during power outages and have not otherwise provided for such uninterrupted service have the option of obtaining that capability, and that they have sufficient information to make an informed decision.
38. In the
39. We agree with commenters who advocate flexibility in how providers achieve continuity of 911 access for the time periods discussed above. The record reflects that providers currently employ a variety of backup power technologies and that a range of backup power options are also available direct-to-consumer from third-party sources. CSRIC, for example, identifies nine “use cases” for residential VoIP deployment, with a range of equipment functioning as an analog telephone adaptor (ATA) with varying levels of battery backup. CSRIC observes that “[t]he most commonly deployed model for VoIP services in the United States is to locate the ATA function in a network device, installed inside the living unit.” In addition, as NCTA states, uninterruptible power supplies (UPS) that can power multiple devices during a power outage are already widely available at national retailers. Bright House also describes “numerous retail options available to subscribers like UPS, portable power packs, solar, and
40. We do not require use of a specific technical solution or combination of solutions. Providers, which are not providing line-powered service, have flexibility to develop and offer their own backup power solutions, as long as those solutions comply with the rules we adopt today. In addition, we expect that installers should be able to answer questions about backup power. For example, a provider could offer a solution with a single, internal battery delivering 8 hours of backup power. With respect to the 24-hour option required within three years, providers may choose to offer consumers a single 24-hour battery (or battery tray as offered by Verizon), three 8-hour batteries, or some other combination of installed and spare batteries, UPS systems or other technologies to provide 24 hours total. If the solution requires a proprietary battery or other equipment that is not widely available in retail stores, the equipment should be provided as part of the installation of service. If, however, the solution accepts commonly available equipment such as D-Cell batteries, providers need not supply such equipment themselves, as long as they notify subscribers at the point of sale that it is not included and must be supplied by the subscriber for the solution to function properly. In cases involving spare batteries that are not widely available at retail stores, the solution offered to subscribers should also include a charger or some other method of ensuring that such batteries are stored in a charged state.
41. In the
42. We do not believe it would serve the public interest to require providers of covered services to remotely monitor backup power status at this time. Similarly, we decline to adopt any requirement that providers inspect or test backup power equipment after fulfilling their initial responsibility under our rules to offer subscribers the option, at the point of sale, for backup power to be installed as part of the initiation of service. This is consistent with CSRIC's observations that “[i]ncreasingly, battery backup is being offered as an optional accessory to the consumer, which they can control and manage themselves.” While we believe service providers are in the best position to identify and make available backup power solutions compatible with and appropriately sized for specific covered services, we agree with commenters who believe subscribers are in the best position to monitor backup power once installed, and in light of the disclosure requirements we are implementing designed to ensure they are adequately informed on how to do so. With respect to batteries, we are not persuaded that battery monitoring technology has evolved to the point of allowing service providers to conduct useful remote monitoring of battery status without raising costs to consumers or diverting resources away from more important network reliability issues through an increase in false failure alarms. We observe, however, that our allocation of monitoring responsibility to consumers is based on the expectation that service providers offer adequate information for subscribers to understand when their equipment is functioning properly and when it may require maintenance or replacement. Service providers should also inform subscribers of the potential for batteries to degrade over time and either make replacement batteries available for self-installation at the subscriber's expense or provide sufficient information for subscribers to obtain replacement batteries from third parties.
43. Some service providers express concerns about the cost and complexity of any obligation to retrofit currently installed equipment to comply with any backup power requirements the Commission adopts. AT&T, for example, states that “[i]f service providers were required to provide CPE backup power, the Commission should require only prospective implementation in order to avoid the technological pitfalls of retrofitting prior deployments.” ITTA argues that “[r]etrofitting existing service deployments for customers who are not interested in battery backup power would divert resources from new deployments, thus slowing the expansion of services to customers who desire advanced broadband capabilities.” We agree and decline to adopt any obligation that providers of covered services retrofit currently-deployed equipment to accommodate the amount of backup power specified in our rules for new installations. The record reflects that some covered services are currently deployed without backup power and that consumers may prefer to continue using their existing equipment. Accordingly, we require only that backup power options be offered at the point of sale. Providers may continue offering retrofit options for backup power upgrades to existing customers or those who decline the option at the point of sale, but they are under no obligation to do so. We note, however, that even service providers that do not currently offer backup power acknowledge that third-party UPS units may allow subscribers to maintain communications capabilities without the need to retrofit existing equipment. Therefore, we conclude that providers' obligations to current subscribers
44. In the
45. Accordingly, we conclude that providers of covered services may charge subscribers for the backup power capabilities provided under our rules, if subscribers wish to purchase such capabilities. We emphasize that we do not specify the rates at which providers of covered services may offer backup power or related accessories, we expect market forces to ensure that backup power is offered at competitive prices. A service provider can receive compensation for all aspects of implementing the rules we adopt today, including the backup power installation, and costs of equipment and labor, from the consumer that elects to have backup power installed. And we do not preclude service providers from including backup power capabilities without separate charge, if they choose to do so for competitive or other reasons.
46. By requiring only that service providers provision backup power upon subscriber request at point of sale, and at the requesting subscriber's expense, we have effectively negated the argument that these rules will substantially increase costs to providers. The majority of commenters who raise issues related to costs base their arguments on the assumption that the Commission would mandate a universal backup power solution across all subscribers, including retrofitting existing subscribers. The action we take today will substantially limit the providers' costs by requiring backup power installations only for customers that request backup power at the point of sale, and at those customers' expense. Fiber to the Home Council Americas states that “while the industry has generally supplied backup batteries to all subscribers, it would make a material difference to the cost of a build, enabling expansion into less dense areas, if it could supply battery backup only to those subscribers that expressly want it—a number all-fiber service providers has determined is not great.” Similarly, NCTA stated that in their experience only a small number of customers have purchased backup power. We also find concerns about the environmental effects of requiring all consumers to obtain backup power are inapplicable because we do not make such a requirement.
47. There are additional factors that minimize the costs associated with compliance for the covered providers. First, as noted previously, the record indicates that numerous entities comprising a significant share of the IP voice services market are already offering their customers 8 hours of backup power; for those entities no additional costs are necessary. To the extent that a service provider is not currently offering the requisite 8 hours of backup power, the fact that numerous providers are currently offering such a solution indicates that solutions exist and are widely available. Accordingly, there is little need to custom-design a solution when many of the solutions can be used universally. Indeed, providers may avoid the costs of supplying or installing a proprietary solution. This also saves providers the costs of supplying batteries directly. The same cost-mitigating principles apply to the discussion of 24-hour and extended duration backup power; the commercial market for this solution already exists and even the smaller providers are confident in their ability to provide this level of backup power if provided ample transition. The record also indicates that many providers already offer some form of backup power, even if it is not an 8-hour solution, and therefore would be familiar with the practice of installing backup power solutions for their customers. Because the cost to providers of complying with this rule should be minimal both at the outset as well as when the 24-hour requirement takes effect, and the particular benefit to the public of enhanced continuity of communications to reach help through 911 during power outages is substantial, we conclude that our action today produces a net public benefit.
48. In the
49. Commenters representing government stakeholders and consumers support such a requirement. For example, PA PUC states that, if providers require their customers to be responsible for purchasing or replacing backup power batteries, providers “must develop and implement outreach and education programs to ensure customers are aware that [customers] are responsible for providing their own backup power.” The New York Public Service Commission indicates that it is “critical that information about the consumer's role in maintaining continuity of power is transmitted to the customer by the service provider,” and that providers need to develop programs to “ensure consumers are aware that [they] are responsible for providing their own backup power.” The Attorneys General for the Peoples of the States of Illinois and New York state that, because of the reluctance to advertise a diminished service, “carriers may not emphasize the need for backup power disclosures.” The FCC's Intergovernmental Advisory Committee asserts that “providers should be required to communicate effectively and accurately the services that may no
50. Industry stakeholders, on the other hand, oppose such a requirement. The Independent Telephone & Telecommunications Alliance (ITTA) states that there is “no evidence that additional consumer education would be helpful or necessary, and argues that a requirement is “unwarranted and a waste of resources.” AT&T recommends that the Commission refrain from imposing a consumer education requirement, and instead work with providers to review backup power best practices for consumer education. Others, such as CenturyLink, Hawaiian Telcom, NCTA, and Verizon, suggest that the Commission support the implementation of CSRIC recommendations regarding consumer notification. They argue that this would give providers the flexibility to implement consumer education measures as their networks and business models warrant.
51. Others argue that a requirement is unnecessary because providers already give consumers information related to backup power. For example, NCTA argues that the Commission's existing rules already “ensure that consumers are made aware of the backup power ramifications of choosing a VoIP service,” and require providers at the initiation of interconnected VoIP service to “inform consumers of the `circumstances under which E911 service may not be available,' . . . includ[ing] `loss of electrical power.' ” ITTA notes that it is “standard industry practice for interconnected VoIP providers to notify consumers regarding the potential limitations of IP-enabled voice services and equipment during a power outage.” Fiber to the Home Council Americas (FTTH Council) also asserts that industry efforts to notify consumers about battery backup availability are effective based on assumptions regarding consumer adoption of wireless and VoIP services.
52. AT&T states that providers of IP-based voice service already educate consumers on the necessity of a backup battery during a power outage and provide information about the backup battery, including practices for prolonging battery life, where to purchase battery replacement, and replacement instructions. CenturyLink indicates that it plans to provide information regarding “sample batteries that would work with [CenturyLink] equipment as well as suppliers of such equipment for those customers wishing to provide their own backup power.” Charter and Cablevision state that they are making “significant efforts to educate their customers about the VoIP services they offer, including that such service will not work during a power outage without a backup battery.”
53. We find that the lack of uniformity in providers' backup power information, and as commenters present, lack of consumer awareness at a time of technological transition, may lead to consumer confusion about consumer expectations and responsibilities in the access of 911 service during power outages. While some providers already offer or plan to make available information to consumers in the near future, it appears from comments submitted and providers' Web sites that the information provided to consumers is not consistent across the industry. This lack of uniformity may lead to consumer confusion at a time of technological transition from services provided over copper networks to services provided over IP-based networks, and agree with commenters that there are consumers who “may not be aware that VoIP and wireless service operate differently from traditional landline telephony in a commercial power outage.” We acknowledge the concerns of commenters representing unique populations, such as AARP, which states that “[g]iven the diversity of service provider practices . . . the level of consumer understanding of CPE battery backup issues is certainly not uniform.” Further, subscriber complaints reveal that current disclosure practices are likely insufficient. For example, the Commission's consumer complaints portal reveals that some subscribers are frustrated by VoIP service providers' failure to inform subscribers about the need to self-provision a battery to operate backup power in order to access 911 services. Based on the record, while we acknowledge that there are some disclosures already mandated and some additional information provided voluntarily, we are not convinced disclosures currently required only for interconnected VoIP providers, are of sufficient scope or uniformity across all covered providers, to satisfy the Commission's obligation to promote the safety of life and property and ensure consistent 911 services. Although not all subscribers may receive backup power information from more than one provider in a given year, we acknowledge that backup power information may be confusing especially for unique populations struggling during the technology transition, or those who may need to switch providers often, such as military families needing to relocate. We find that it is in the public interest for the Commission to establish a uniform requirement to provide minimum information as described below in order to ensure that all subscribers of covered services are equipped with necessary information to access 911 services during power outages regardless of provider or technology used.
54. Adoption of best practices established by CSRIC, as recommended by some industry commenters, may help, and we do not intend to discourage adoption of these practices. However, we are not convinced that the voluntary adoption of these practices without a standard, mandatory baseline will eliminate consumer confusion. We therefore address these concerns by requiring minimum subscriber disclosure obligations, while at the same time encouraging providers to voluntarily follow additional CSRIC best practices regarding backup power.
55. As NCTA discussed, current Commission rules require a limited customer notification for interconnected VoIP service providers. This requirement, however, is only for a subset of covered providers considered in this
56. We conclude that requiring providers to develop and implement subscriber disclosures regarding backup power with minimum baseline disclosures serves the public interest and will promote access to 911 while being of minimal cost to the providers. As CenturyLink notes, there is a clear public benefit in promoting consumers' awareness of the need for affirmative action to acquire and maintain backup power. According to the Communications Workers of America (CWA), “Commission oversight is essential to encourage . . . consumer education about the time limits and capabilities of battery-provided backup power.” Attorneys General state that “enabling consumers to prepare
57. The disclosure requirements adopted today are intended to equip subscribers with necessary information to purchase and maintain a source of backup power to enhance their ability to maintain access to reliable 911 service from their homes. Several parties commented on what information should be included in the disclosures. For example, some commenters strongly support including information about battery life spans, procedures for ordering, installing, replacing, and extending battery life during a power outage. The City of New York recommends that we require providers to furnish information to assist in extending the “useful life of battery backup” such as powering off the system or closing applications. APCO suggests that a public education requirement include information on “any impact to 9-1-1 services.” The respective Attorneys General for the State of Illinois and the State of New York strongly support consumer education addressing the many factors that can affect the amount of “stand-by time” a backup power solution provides. The California PUC urges the Commission “to mandate that service providers give customers educational materials consistent with California's existing requirements,” which include, for example, requiring providers to tell their customers that their services require backup power on the customer's premises, limitations of service, and potential service failure during power outages. The California PUC also requires providers to tell consumers about how to best “maximize the ability to make or receive necessary phone calls during an outage.”
58. In addition to commenting on the appropriate level of disclosure in any Commission requirements, some commented on the opportunity for states to require more extensive disclosure. For example, the California PUC requests that the Commission allow the states to “adopt more extensive backup power requirements.” Similarly, NARUC suggested that the Commission establish “a floor” that does not impact more protective state-level measures.
59. Several industry commenters identified information that is currently included in some backup power notifications to subscribers. For example, ACA asserts that providers inform potential and current subscribers that their voice service is not powered by the network, and during a power outage, without battery backup, the subscriber may lose access to 911. ACA explains that this notice also alerts customers about specific backup power capabilities of the equipment.
60. We agree with the commenters who suggest that the Commission adopt minimal requirements for the types of information that service providers must give subscribers, regarding backup power. This will decrease the likelihood of consumer confusion, and ensure that all subscribers have access to basic information about the need for, and how to acquire and conserve, backup power. In this respect, we observe that several providers already give relevant information to their customers; however, the amount and type of information given varies greatly from one provider to another, and thus gives rise to the potential for consumer confusion. This confusion may lead the consumer to fail to take proper precautions to acquire and maintain backup power, and ultimately result in the inability to access 911 at a critical moment during a power outage. Thus, we find it in the public interest to identify minimum information that must be communicated to consumers regarding backup power. In this respect, we require providers to disclose to subscribers the following information: (1) Availability of backup power sources; (2) service limitations with and without backup power during a power outage; (3) purchase and replacement options; (4) expected backup power duration; (5) proper usage and storage conditions for the backup power source; (6) subscriber backup power self-testing and monitoring instructions; and (7) backup power warranty details, if any. In order to minimize the burden on smaller providers, we direct the PSHSB to work with CGB to develop such forms or other documents, prior to the implementation date of these rules for smaller providers, as herein defined, for the use of smaller providers in disclosing the required notifications to their subscribers, including subscribers with disabilities.
61.
62.
63. At this time, we decline to require providers of a Covered Service to disclose the limitations of cordless handsets during power outages. Commenters such as US Telecom and California PUC note that cordless
64.
65.
66. We strongly encourage providers to assist subscribers in developing a plan for extended backup power by notifying them of options to extend backup power beyond the life of the battery. For example, providers could inform subscribers that they could purchase several backup power units for use during prolonged outages, and provide directions for rotating these as required to keep the units charged. We also strongly encourage providers to inform subscribers of any available accessories such as solar or car chargers, which may be able to recharge a depleted backup power unit. And, when applicable, providers should inform subscribers of the availability of deployed mobile charging stations. This information will arm subscribers with the knowledge necessary to be prepared for extended power outages and to take steps to mitigate disruption to their 911 communications.
67.
68.
69. Each element of the information described above must be given to subscribers both at the point of sale and annually thereafter, as described below. This information will help subscribers plan in advance to extend the effectiveness of their backup power and ultimately, as we stated in the
70. We sought comment in the
71. Commenters support disclosure of backup power information to subscribers at various points in time. For example, the Attorneys General argue that the Commission should inform subscribers “when new service requires additional equipment to access emergency services in a power outage.” The CPUC supports providing information upon “service initiation and annually thereafter regarding backup power,” as well as sending “an annual reminder to customers to check the status of their battery.” On the other hand, providers such as CenturyLink see value in asking “at the point-of-sale” if their customers want backup power, at which time consumers will be assessed a “one-time, non-recurring charge.”
72. We are persuaded by comments supporting an initial disclosure at the point of sale for the new service and an annual disclosure for all subscribers, both new and existing. We agree with AT&T that subscribers should have the information they need to “shop among
73. We also sought comment on how providers should make backup power information available to consumers. Commenters suggest that providers should offer information on Web sites, and in individual electronic and paper billing materials. ACA, for example, states that its members use a variety of approaches, such as posting information on the operator's Web site, to inform subscribers about backup power supplies for CPE. CenturyLink states that “service providers are increasingly communicating with customers about the issue of backup power,” and supplementing brochures provided to customers with information on the company Web site. ESA raises concerns that there may be scenarios, for example with the elderly, requiring “personal interaction with consumers to assist with upgrading or changing a battery.” NTCA, GVNW, and Vantage Point Solutions suggest that consumers that “utilize an assistive device in connection with a disability” should be part of the consumer education process.
74. We seek to provide flexibility regarding the manner in which providers inform their subscribers, while also honoring any preferences expressed by customers. We thus permit providers to convey both the initial and annual disclosures and information described above by any means reasonably calculated to reach the individual subscriber. For example, a provider may meet this obligation through a combination of disclosures via email, an online billing statement, or other digital or electronic means for subscribers that communicate with the provider through these means. For a subscriber that does not communicate with the provider through email and/or online billing statements—such as someone who ordered service on the phone or in a physical store and receives a paper bill by regular mail—email would not be a means reasonably calculated to reach that subscriber.
75. We observe that many providers use a variety of methods to offer backup power source information on their Web sites as well as in welcome kits, including charts, pictorial explanations, and links to backup power source manufacturers. We encourage providers to continue to do this, as long as required disclosures are reasonably calculated to reach each subscriber. Posting information on a Web site may be helpful but, by itself, would not satisfy our requirement that notifications be reasonably calculated to reach individual subscribers, even for those subscribers that communicate with the provider via online means. Further, we are persuaded by commenters that there are populations, such as the elderly or individuals with disabilities, who have no or a very limited online relationship with the provider or otherwise may need more targeted consumer education outreach beyond posting online information.
76. We believe that the cost of these backup power disclosure requirements will be minimal and, thus, will be exceeded by the significant benefits we expect to result from this subscriber disclosure, such as enhanced subscriber access to 911 services. Among other things, we note that the vast majority of providers already furnish subscribers with some backup power information. As a result of current disclosure practices, we expect that only a small share of the providers will need to take additional steps to comply with these rules beyond modifications to existing disclosures. Similarly, providers already furnish subscribers with information upon initiation of service, and are free to include the information we require herein with the other materials, removing the need for a special cost of distribution. Also, in order to limit costs to providers, we make clear above that a service provider may fulfill its disclosure obligation via any means reasonably calculated to reach the consumer, while also honoring any preference expressed by the customer. Such methods may include electronic outreach, including email notification and paperless billing statements; paper copies are not required for subscribers who access and receive information through those means. The annual notification associated with this requirement gives service providers ample time to plan, for example including the appropriate notifications in normally-distributed billing statements in a manner that does not serve to increase the number of printed pages distributed. As noted above, the Commission will further reduce compliance costs by providing guidance as to the required notifications to subscribers. Accordingly, the costs of satisfying the notification requirement should be minimal for service providers, and the benefits of informing consumers of backup power solutions in order to reach 911 service from the subscriber premises during power outages, far outweighs any such minimal costs.
77. As with the rules obligating providers to offer backup power solutions, there are numerous benefits associated with the disclosure requirements on how commercial power outages affects VoIP service. Millions of Americans have come to rely on their TDM voice service working during a commercial power outage to call 911. With this backdrop, educating consumers that their phones will not work in a commercial power outage absent backup power is essential even if the consumer opts not to purchase backup power. At a minimum, an educated consumer will not have the expectation of relying on a VoIP service only to have it fail to operate when the consumer tries to make a 911 call, wasting valuable time in the process. In this way the consumer notifications not only promote the availability of 911 service in power outages, pursuant to our statutory mandate governing IP transitions, but also promote the “safety of life and property through the use of wire and radio communication,” the Commission's statutory charge, by enabling customers to know the limitations of their service in an power outage situation and to make alternate arrangements—either via a backup power solution or alternate means of communication—to ensure the 911 call can go through. This is consistent with our findings with respect to requiring minimum wireless location accuracy where we found that the rules “will improve emergency response times, which, in turn, will improve patient outcomes, and save lives.” We find, therefore, that it is reasonable to expect that the rules we adopt today will save lives and result in numerous other benefits that are less quantifiable but still advance important public interest objectives. Given that the notification requirements contained herein have minimal associated costs, we find that the benefits of these rules far exceed the costs.
78. In the
79. We agree with MDTC that to provide for flexibility in the delivery of technology transition information, while ensuring its accuracy and effectiveness, providers should develop outreach and education plans in coordination with state, local, and tribal agencies and community organizations. Our Intergovernmental Advisory Committee (IAC) notes that “education efforts must include all levels of governments that interact with consumers. In this manner, state, local and tribal governments will be able to assist consumers in making informed choices that satisfy their communications needs.” However, the IAC further believes that providers instead of the FCC, state, local or tribal governments should have the primary responsibility to do consumer outreach on technology transitions. Thus, the IAC asserts that the FCC should “require [ ] providers to inform consumers of their options well before actual transition occurs.” For example, the IAC recommends that “providers should have dedicated phone, Web site and email contacts for consumers to report issues, and to obtain information. The objective of such outreach should be to provide information and answer questions, rather than market new services to consumers.”
80. We recognize that many providers already offer consumer education beyond providing mere written notice, and they already engage in community outreach as well. We see great value in providers forging closer relationships with communities, so that local officials can know and understand the likelihood that their residents will be able to summon help, or communicate the status of their welfare in an extended power outage. Community outreach can also help ensure the best possible outcome before disaster strikes (for example, by encouraging communities to maintain sufficient supplies of batteries and other UPS equipment).
81. We also note that many communities have a robust telephone-based alert capability to warn residents of emergencies in their area. For this reason, and for the great value in being able to receive incoming calls from emergency services personnel, providers of covered services should organize their outreach to subscribers pursuant to this
82. In order to minimize cost and provide maximum flexibility, at this time, we encourage, but do not require, all providers to engage in the type of community outreach that would be required for a consumer education plan to truly be considered comprehensive.
83. Today we adopt rules to educate and empower consumers to take necessary steps to ensure that their “home phone” is capable of making 911 calls during a power outage. These rules are well-grounded in the “broad public safety and 911 authority Congress has granted the FCC.” Congress created the Commission, in part, “for the purpose of promoting safety of life and property through the use of wire and radio communications.” Congress specifically directed the Commission to “designate 911 as the universal emergency telephone number within the United States for reporting an emergency to appropriate authorities and requesting assistance,” in legislation the purpose of which was to “encourage and facilitate the prompt deployment through the United States of a seamless, ubiquitous, and reliable end-to-end infrastructure for communications . . . to meet the Nation's public safety and other communications needs.” The DC Circuit has also specifically upheld the Commission's extension to interconnected VoIP providers of the obligation “already required of providers of traditional telephone service [to] transmit 911 calls to a local emergency authority.” In 2008, Congress expressly confirmed that authority to adopt rules that “promote and enhance public safety by facilitating the rapid deployment of IP-enabled 911 and E-911 services.” Congress has also charged the Commission with promulgating “regulations, technical standards, protocols, and procedures as are necessary to achieve reliable, interoperable communication that ensures access by individuals with disabilities to an Internet protocol-enabled emergency network, where achievable and technically feasible.”
84. In this
85. Many commenters agree that our adoption of requirements to promote continuity of access to 911 during power outages is an appropriate—and necessary—exercise of our statutory public safety authority. Communications Workers of America states that “[t]he Commission has the statutory obligation to promote public safety through our nation's communications networks” and affirms our view that “protecting public safety is one of the core principles that must guide [the Commission's] policies during the technology transition.” The Alarm Industry Communications Committee (AICC) also contends that “[b]ackup power requirements should be adopted to protect consumers and to meet the Commission's mandate to promote the national defense and the safety of life and property” under Title I. Similarly, the PA PUC “believes that
86. Commenters also cite the importance of safeguarding 911 service in particular as a basis for our adoption of rules proposed in the
87. We disagree with Corning's suggestion that the rules we adopt today contravene the holding of
88. For similar reasons, we find unavailing AT&T's comment that “[b]ecause the Commission has deregulated CPE, it has disclaimed any authority to impose CPE backup power requirements.” The rules we adopt today do not apply to CPE or regulate CPE. Rather, those rules govern the obligations of service providers to provide access to 911 service during a commercial power outage in the absence of line powering. While solutions offered under our flexible performance rule may encompass—solely at such providers' option—the backup of some devices or equipment that might be classified as deregulated CPE, that does not mean that our rules cannot encompass such equipment when powering such equipment (which is located on a customer's premises) is part of the solution chosen by the service provider. As discussed above, there is no general requirement to provide backup power for all equipment that might be located at the customer's premises. Rather, the requirement is that, in lieu of line powering provided as a part of traditional POTS service, a covered service provider must offer a backup power solution that provides the customer with 911 access during a commercial power outage.
89.
90. Moreover, under the standard set forth in
91. The rules we adopt today ensure that consumers are adequately informed
92. Pursuant to the Regulatory Flexibility Act of 1980, as amended (RFA), an Initial Regulatory Flexibility Analysis (IRFA) was included in the NPRM in PS Docket No. 14-174. The Commission sought written comment on the proposals in this docket, including comment on the IRFA. This Final Regulatory Flexibility Analysis conforms to the RFA.
93. This document contains new information collection requirements subject to the Paperwork Reduction Act of 1995 (PRA), Public Law 104-13. It will be submitted to the Office of Management and Budget (OMB) for review under Section 3507(d) of the PRA. OMB, the general public, and other Federal agencies are invited to comment on the new or modified information collection requirements adopted in this
94. In addition, we note that pursuant to the Small Business Paperwork Relief Act of 2002, Public Law 107-198, see 44 U.S.C. 3506(c)(4), we previously sought comment on how the Commission might further reduce the information collection burden for small business concerns with fewer than 25 employees, in the FRFA in Appendix B of the full
95. The Commission will send a copy of this
96. In this
97. We delay the effective date of two of the rules we adopt herein for providers that have fewer than 100,000 domestic retail subscriber lines for an additional 180 days to afford ample time to modify their current practices as necessary to come into compliance with our rules. The obligation of these providers to offer 8 hours of backup power will become effective 300 days after publication of this
98. Such an accommodation addresses the concerns of some commenters that adopting mandatory backup power obligations for all customers will be particularly burdensome for providers with a small number of lines, and is in line with Commission precedent. While we do not think that the more limited backup power obligations that we adopt herein will be overly burdensome for any provider, we agree with ACA's suggestion that providers with a small number of lines are more resource-constrained and would benefit from additional time to obtain any necessary equipment and prepare materials and processes for disclosure, and prepare materials and processes for disclosure. We note that ACA asserts that smaller operators should be defined as those with fewer than 100,000 voice service customers, and cites the
99. For this purpose, we rely on the standard adopted in the 2013 Rural Call Completion proceeding. In the
100. Accordingly,
101.
102.
103.
104.
Communications equipment, Security measures.
Federal Communications Commission.
For the reasons set forth in the preamble, the Federal Communications Commission amends 47 CFR part 12 as follows:
47 U.S.C. 151, 154(i), 154(j), 154(o), 155(c), 218, 219, 251(e)(3), 301, 303(g), 303(j), 303(r), 332, 403, 621(b)(3), 621(d); 47 U.S.C. 615a-1; and 47 U.S.C. 615c, unless otherwise noted.
(a)
(b)
(1)
(2)
(3) At the provider's discretion, the options in paragraphs (b)(1) and (2) of this section may be either:
(i) A complete solution including battery or other power source; or
(ii) Installation by the provider of a component that accepts or enables the use of a battery or other backup power source that the subscriber obtains separately. If the provider does not offer a complete solution, the provider shall install a compatible battery or other power source if the subscriber makes it available at the time of installation and so requests.
(c)
(d)
(i) Capability of the service to accept backup power, and if so, the availability of at least one backup power solution available directly from the provider, or after the initiation of service, available from either the provider or a third party. After the obligation to offer for purchase a solution for twenty-four hours of standby backup power becomes effective, providers must disclose this information also for the twenty-four-hour solution;
(ii) Service limitations with and without backup power;
(iii) Purchase and replacement information, including cost;
(iv) Expected backup power duration;
(v) Proper usage and storage conditions, including the impact on duration of failing to adhere to proper usage and storage;
(vi) Subscriber backup power self-testing and -monitoring instructions; and
(vii) Backup power warranty details, if any.
(2)
(3) The disclosures required under this paragraph are in addition to, but may be combined with, any disclosures required under § 9.5(e) of this chapter.
(e)
(f)
(2) For a provider of a Covered Service that (together with any entities under common control with such provider) has fewer than 100,000 domestic retail subscriber lines, the obligations in paragraph (b)(1) of this section are effective August 11, 2016, the obligations in paragraph (b)(2) of this section are effective as prescribed therein, and the obligations under paragraph (d) of this section are effective 300 days after the Commission announces approval from the Office of Management and Budget.
(g)
National Highway Traffic Safety Administration (NHTSA), Department of Transportation (DOT).
Grant of petition for rulemaking.
This document grants the petition for rulemaking submitted by the Truck Safety Coalition, the Center for Auto Safety, Advocates for Highway and Auto Safety, and Road Safe America on February 19, 2015, to establish a safety standard to require automatic forward collision avoidance and mitigation systems on certain heavy vehicles. For several years, NHTSA has researched forward collision avoidance and mitigation technology on heavy vehicles, including forward collision warning and automatic emergency braking systems. The agency will continue to conduct research and to evaluate real-world performance of these systems through track testing and field operational testing. NHTSA will determine whether to issue a rule in the course of the rulemaking proceeding, in accordance with statutory criteria.
October 16, 2015.
For technical issues, you may call Dr. Abigail Morgan in the Office of Crash Avoidance Standards at (202) 366-1810. For legal issues, you may call Mr. David Jasinski or Ms. Analiese Marchesseault in the Office of Chief Counsel at (202) 366-2992. You may send mail to these officials at: National Highway Traffic Safety Administration, 1200 New Jersey Avenue SE., Washington, DC 20590.
On February 19, 2015, the Truck Safety Coalition, the Center for Auto Safety, Advocates for Highway and Auto Safety, and Road Safe America (hereon referred to collectively as the “petitioners”) submitted a petition to NHTSA. Their petition requested that the agency initiate rulemaking to establish a new Federal motor vehicle safety standard to require vehicle manufacturers to install forward collision avoidance and mitigation (FCAM) systems on all vehicles with a gross vehicle weight rating (GVWR) of 10,000 pounds or more. The petitioners claimed that FCAM systems have the potential to provide significant safety, economic, and societal benefits.
On May 4, 2015, the Commercial Vehicle Safety Alliance (CVSA) submitted a letter supporting the petition for rulemaking. However, CVSA recommended that the mandate for FCAM systems apply to vehicles with a GVWR of 10,001 pounds or more (rather than 10,000 pounds or more) to better conform to existing commercial motor vehicle safety classes.
There are a number of terms being used by industry and regulators for FCAM technology, including forward collision warning (FCW), crash imminent braking (CIB), dynamic brake support (DBS), automatic emergency braking (AEB), and collision mitigation braking (CMB). Consistent with the terminology used in the petitioners' request, in this notice, the FCAM technologies of focus are the systems that combine FCW alert signals with CMB automatic braking capability.
FCAM systems use forward-looking sensors, typically radars and/or cameras, to detect vehicles in the roadway. When a rear-end crash is imminent, the FCW system warns the driver of the threat. If the driver takes no action, such as braking or steering, or if the driver does brake but not enough to avoid the crash, a CMB or AEB system may automatically apply or supplement the brakes to avoid or mitigate the rear-end crash.
In their petition for rulemaking, the petitioners cited estimated safety benefits from a 2012 research study
For several years, NHTSA has been conducting research on heavy vehicle FCAM technologies. This research includes test track evaluations of first generation systems, evaluation of driver-warning interface effectiveness, and an ongoing field operational test of production systems. Based on this research, the agency agrees with the petitioners that FCAM systems have the potential to save lives by preventing or reducing the severity of rear-end crashes.
The industry has indicated that next generation automatic emergency braking systems for truck tractors will be commercially available later this year and will have improved performance that enables the vehicle to warn the driver and automatically brake in response to stationary lead vehicles. In addition to the increased performance from the next generation systems, industry is also expected to begin production of automatic emergency braking systems on air-braked single unit trucks with a GVWR of more than 26,000 pounds in the near future.
The agency's test experience has been limited to first generation production systems on truck tractors and a prototype system on a motorcoach, and the agency is aware of a few vehicles with a GVWR greater than 10,000 pounds and less than or equal to 26,000 pounds sold in the U.S. currently equipped with AEB systems. The agency plans to test the next generation systems as they become available, including AEB systems that are installed on vehicles with a GVWR greater than 10,000 pounds and less than or equal to 26,000 pounds. If available, NHTSA would consider this additional information in the rulemaking.
The European Union (EU) Commission Regulation No. 347/2012 requires an advanced emergency braking system (AEBS) with forward collision warning on most new heavy vehicles, with some exceptions.
Considering the information before the agency, including the information referenced in the petition, NHTSA grants the February 19, 2015 petition in accordance with 49 CFR part 552 and initiates a rulemaking proceeding with respect to forward collision avoidance and mitigation systems on vehicles with a GVWR greater than 10,000 pounds. The granting of the petition from Truck Safety Coalition, the Center for Auto Safety, Advocates for Highway and Auto Safety, and Road Safe America does not mean that the agency will issue a final rule. The determination of whether to issue a rule is made after study of the requested action and the various alternatives in the course of the rulemaking proceeding, in accordance with statutory criteria.
49 U.S.C. 322, 30111, 30115, 30117, 30162, 30166, and 49 CFR part 552; delegation of authority at 49 CFR 1.95.
National Marine Fisheries Service (NMFS), National Oceanic and Atmospheric Administration (NOAA), Commerce.
Final rule.
This final action sets forth regulatory changes to improve the administration of the High Seas Fishing Compliance Act program and the monitoring of U.S. fishing vessels operating on the high seas. This final rule includes, for all U.S. fishing vessels operating on the high seas, adjustments to permitting and reporting procedures. It also includes requirements for the installation and operation of enhanced mobile transceiver units (EMTUs) for vessel monitoring, carrying observers on vessels, reporting of transshipments taking place on the high seas, and protection of vulnerable marine ecosystems. This final rule has been prepared to minimize duplication and to be consistent with other established requirements.
This rule is effective January 14, 2016.
Mark Wildman, Trade and Marine Stewardship Division, Office for International Affairs and Seafood Inspection, NMFS (phone 301-427-8386 or email
The purposes of the High Seas Fishing Compliance Act (HSFCA; 16 U.S.C. 5501
The HSFCA authorizes a system of permitting U.S. fishing vessels that operate on the high seas to satisfy the obligation of Parties to the Compliance Agreement (Parties) to require that fishing vessels flying their flags obtain specific authorization to operate on the high seas. The HSFCA requires the Secretary of Commerce (Secretary) to establish conditions and restrictions on each permit issued under HSFCA as necessary and appropriate to carry out the obligations of the United States under the Compliance Agreement. 16 U.S.C. 5503 (d). At a minimum, such conditions and restrictions must include the marking of the permitted vessel in accordance with the FAO Standard Specifications for the Marking and Identification of Fishing Vessels, and reporting of fishing activities. Parties are also responsible for ensuring that their authorized vessels do not undermine conservation and management measures, including those adopted by international fisheries management organizations, or by treaties or other international agreements. Accordingly, the HSFCA prohibits the use of fishing vessels on the high seas in contravention of international conservation and management measures recognized by the United States. 16 U.S.C. 5505(1). A list of the international conservation and management measures recognized by the United States is published by NMFS in the
Finally, the HSFCA authorizes NMFS to promulgate regulations “as may be necessary to carry out the purposes of the Agreement and [the Act],” including its permitting authorities. 16 U.S.C. 5504(d). In promulgating such regulations, NMFS shall ensure that “[t]o the extent practicable, such regulations shall also be consistent with regulations implementing fishery management plans under the Magnuson-Stevens Fishery Conservation and Management Act,” 16 U.S.C. 1801
Regulations implementing the HSFCA were first promulgated in 1996 (61 FR 11751, March 22, 1996). The initial regulations included application and issuance procedures for high seas fishing permits. Subsequent regulations promulgated in 1999 (64 FR 13, January 4, 1999) specified how high seas fishing vessels must be marked for identification purposes and required vessel owners and operators to report catch and fishing effort when fishing on the high seas.
On April 13, 2015, NMFS published a notice of proposed rulemaking for this action (80 FR 19611) to codify NMFS' procedures for reviewing its high seas fishing authorizations under environmental laws, particularly the
Responses to public comments received on the proposed rule are set forth below.
NMFS has made one change to the final rule in light of comments received on the proposed rule. Section 300.333(i) in the proposed rule, which addressed provisions for permit modification and revocation, has been modified to clarify that modification, suspension, or revocation of a high seas permit will be carried out consistent with the Administrative Procedure Act and other applicable law. Additional detail is provided in Responses to Public Comments section below.
NMFS received 18 public comments on the proposed rule. Comments were received from the Western Fish Boat Owners Association, the American Albacore Fishing Association, the Hawaii Longline Association, and individual west coast albacore fishers potentially affected by new requirements in this rule.
NMFS received numerous comments from west coast albacore fishers who voiced their view that the proposed rule, if finalized, would impose considerable and unnecessary burdens. These fishers noted that the additional burden on the fleet resulting from the requirements contained in this rule would have adverse impacts on vessels, families, onshore support businesses, local communities, and consumers. Commenters noted the rule could reduce access to high seas fisheries by U.S. vessels and ensure that an increasing portion of catch would be taken by foreign vessels that are not subject to similar requirements. Commenters also noted that the U.S. albacore fishery already has mandatory logbook requirements that would not change under this new rule, and the information in these logbooks provides all the information necessary to monitor this fishery.
These new requirements are deemed necessary to improve U.S. capacity to monitor its vessels' compliance with domestic laws, including those used to implement RFMO requirements (both for those RFMOs to which we are a party as well as those recognized by the United States for purposes of the Compliance Act). This will enhance the United States' ability to comply with its international obligations, including the obligation to report high seas fishery data to the U.N. Food and Agriculture Organization. NMFS believes the cost of complying with these new requirements is justified in light of the benefits that will be gained from a uniform level of real-time monitoring of all high seas activities conducted by U.S. fishers.
High seas vessel owners that do not currently possess VMS/EMTU units type-approved for use on the high seas may apply for reimbursement by contacting the VMS reimbursement program at the Pacific States Marine Fisheries Commission (
Vessel owners are reimbursed on a first-come, first-served basis until funds for the reimbursement program are exhausted. The standard processing time is within 30 days of a completed application. Since funding for these reimbursements in only available until the end of 2015, NOAA recommends VMS installations/activations be made no later than November 15, 2015, and all applications for reimbursement be submitted to the Pacific States Marine Fisheries Commission no later than 5 p.m./PST on November 30, 2015.
This final rule is published under the authority of the High Seas Fishing Compliance Act (16 U.S.C. 5501
The Office of Management and Budget has determined that this rule is not significant for purposes of Executive Order 12866.
A Final Regulatory Flexibility Analysis (FRFA) was prepared, as required by section 603 of the Regulatory Flexibility Act (RFA). The FRFA describes the economic impact this final rule will have on small entities. This FRFA incorporates the Initial Regulatory Flexibility Analysis (IRFA) published in the
The final rule will apply to owners and operators of U.S. fishing vessels operating on the high seas, including harvesting vessels, refrigerated cargo vessels, and other vessels used to support fishing. There are approximately 600 U.S. vessels permitted under the HSFCA to fish on the high seas. The majority of these
In this RFA analysis, an individual vessel is the proxy for each business entity. Although a single business entity may own multiple vessels, NMFS does not have a reliable means at this time to track ownership of multiple vessels to a single business entity. Based on limited financial information about the affected fishing vessels, NMFS believes that all the affected fish harvesting businesses, except for the Pacific tuna purse seine vessels, are small entities as defined by the RFA; that is, they are independently owned and operated and not dominant in their fields of operation, and have annual receipts of no more than $20.5 million.
For each element of the final rule, the analysis of impacts to small entities is described below.
The final rule is explicit about the requirement that vessels harvesting or participating in operations on the high seas in support of harvesting, such as transshipment and provision of supplies or fuel, have on board a valid high seas fishing permit. NMFS expects this aspect of the final rule to result in few additional applications for high seas permits, if any, because transshipment of fish on the high seas is prohibited in some fisheries and, where it is not prohibited, records show few instances of transshipment. NMFS is not aware of any U.S. vessels that provide supplies or fuel to harvesting vessels on the high seas.
The rule will require a photograph of the high seas fishing vessel to be submitted with the permit application. The time necessary to photograph the vessel, print or scan the photograph, and attach it to the application is estimated to take 30 minutes per application.
The final rule will allow a person, which could include an organization or a group of persons, to request that NMFS add a fishery to the list of fisheries authorized on the high seas. A request will need to include the following information:
(a) The species (target and incidental) expected to be harvested and the anticipated amounts of harvest and bycatch.
(b) The approximate times and places fishing will take place, approximate number of vessels participating, and the type, size, and amount of gear to be used.
(c) A description of the specific area that may be affected by the fishing activities.
(d) A description of any anticipated impacts on the environment, including impacts on fish stocks, marine mammals, species listed as threatened or endangered under the ESA or their critical habitat.
(e) If requested by NMFS, any additional information necessary for NMFS to conduct analyses under ESA, MMPA and NEPA.
Making the request to add an authorized fishery is expected to take approximately 110 hours. This time would be spent gathering and compiling the required information. NMFS does not expect such requests on a regular basis. For the purposes of this FRFA, NMFS estimates that one request might be submitted every 5 years. The impact from this aspect of the final rule is not expected to be significant because this is not a requirement, but an option for the public, and such requests are expected to be made infrequently.
Under the final rule, approximately 200 of the currently permitted high seas fishing vessels will need to install an EMTU. The remaining 400 or so vessels currently holding high seas fishing permits are already subject to EMTU requirements and will not bear any additional compliance costs as a result of this final rule.
The majority of the approximately 200 affected vessels are albacore trollers or pole and line vessels operating in the Pacific Ocean. These vessels have generally not been subject to VMS requirements contained in other regulations. The cost of compliance with this requirement includes the cost of purchase, installation, maintenance, and operation of the EMTU. The costs of purchase and installation are treated as one-time costs because this analysis shows costs just in the near-term future. Table 1 summarizes the costs associated with the EMTU requirement. A description of the estimates and calculations used in Table 1 is provided below the table.
Units must be installed by a qualified marine electrician. Based on experience in other fisheries with EMTU requirements, NMFS believes that installation cost can range from $50 to $400, depending on the vessel, proximity to the installer, and the difficulty of the installation. For estimation purposes, $400 was used to calculate the costs of compliance with this final rule.
The cost of transmitting data through the EMTU depends on the type of
The EMTU may be powered down if the vessel will be at the dock or mooring for more than 72 consecutive hours or if the vessel, for 30 or more consecutive days, will not be operating on the high seas or participating in a fishery that requires EMTU operation. A message notifying NMFS of the power-down must be sent to NMFS prior to powering down the unit and again when the EMTU will be powered back up. If an EMTU is powered down for portions of the year, the actual annual cost of transmitting position data will be less. Thus the annual costs of EMTU operation will vary among individual vessels depending on the number of days an EMTU may be powered down.
The cost of compliance for vessel owners is estimated to be $4025 per vessel in the first year (Table 1). This is the cost of compliance prior to receiving reimbursement for the cost of the EMTU. Reimbursement funds of up to $3,100 per VMS unit will reduce the cost to $925 per vessel, on average, for reimbursement-eligible vessels. The cost of operating the EMTU in year two and beyond will include the cost of sending position reports and maintenance and is estimated to be $625.
Aside from the costs of purchase, installation, and operation of EMTUs, vessel owners or operators will need to spend time purchasing a unit, having it installed, and submitting an installation and activation report form. These steps are estimated to take an average of 4 hours. The notices prior to power-down and powering back up the EMTU are estimated to take 10 minutes each.
The compliance cost of obtaining, carrying on board, and monitoring communication devices required to be used in the event of an EMTU failure is expected to be zero, as NMFS believes all affected small entities already carry and monitor such devices.
In high seas fisheries where only a portion of the high seas fishing vessels are selected for observer coverage, the possibility of being selected to carry an observer may increase under this final rule. However, as noted in response to Comment 8 above, NMFS would carefully take into consideration both the scientific need for observer coverage as well as the characteristics of the fishery when designating high seas vessels for observer coverage. Vessels that are not already subject to any other observer requirements may be selected to carry observers. This includes, but is not limited to, South Pacific albacore trollers, purse seine vessels of Class 5 or smaller participating in the Eastern Pacific tuna fisheries, and some longline vessels in Western Pacific pelagic fisheries.
When a vessel is selected for observer coverage under this rule, the vessel owner or operator will be required to provide NMFS a notice of their next fishing trip. This notification is estimated to take 5 minutes and cost $1 in communication costs.
For trips on which an observer is deployed under this new requirement, the affected entity will at least be responsible for the costs associated with providing the observer with food, accommodations, and medical facilities. These costs are expected to be $20 to $50 per day. Assuming a high seas fishing trip averages 20 days in duration, the estimated cost of compliance for accommodating an observer on a vessel would be between $400 and $1,000.
Transshipment is also regulated under other applicable law. For example, in the Atlantic Ocean, transshipments (the offloading, unloading, or transferring of fish or fish products from one vessel to another) are generally prohibited, with some exceptions. In the Pacific Ocean, purse seine vessels are prohibited from transshipping in some instances. NMFS is aware that during 2006 to 2009, four to eight vessels offloaded longline-caught fish each year and four to eight vessels received longline-caught fish each year. It is likely that most of these transshipments took place at sea by the Hawaii-based longline fleet, but it is unknown how many of these transshipments took place on the high seas. NMFS also has data on past transshipments on the high seas involving a few U.S. albacore troll vessels.
Each transshipment notice is estimated to take about 15 minutes and no more than $1 in communication costs to prepare and submit to NMFS.
Each transshipment report is estimated to take about 60 minutes and $1 in communication costs to prepare and submit to NMFS. Thus, for each transshipment event on the high seas, the time burden is estimated to be 1 hour and 15 minutes and cost $2 for each U.S. flagged vessel involved in the transshipment.
NMFS attempted to identify alternatives that would accomplish the objectives of the rulemaking and minimize any significant economic impact of the final rule on small entities.
The alternative of taking no action was rejected because it would fail to achieve the objectives of the rulemaking.
NMFS evaluated an option to rely on existing permit programs, other than the HSFCA permit program, to authorize high seas fishing activities. However, by continuing to require the separate HSFCA permit, NMFS is able to maintain a separate record of vessels
With respect to the EMTU requirement, one alternative would be to require EMTU operation at all times, which would provide NMFS the ability to monitor a vessel's location at any time. However, NMFS is aware that some vessels holding high seas fishing permits may remain in the EEZ for extended periods and are not currently subject to EMTU operation requirements while in the EEZ. Some of these vessels may also dock their vessels and not engage in fishing for portions of the year. This alternative is not preferred because the regulatory burden could be minimized by providing some exemptions to the EMTU operation requirement, such as exemptions to address the two circumstances described above. The preferred alternative would maintain the ability to monitor high seas fishing vessels yet minimize the regulatory burden.
Another alternative would be to require EMTU operation only on the high seas. However, allowing units to be powered down while a vessel is in the EEZ of the U.S. for less than the allotted exemption time or in the EEZ of another country would weaken the effectiveness of using EMTU position information to monitor the locations of high seas fishing vessels. For vessels that are highly mobile and could operate at any time of the year, such as many high seas fishing vessels, EMTUs are more effective if they remain in operation at all times. Allowing power-downs whenever in the EEZ, in addition to the in-port and long-term exemptions provided in the proposed rule, could also encourage non-compliance and result in large gaps in NMFS' ability to monitor high seas fishing vessels. Thus, this alternative is not preferred.
With respect to the requirement for prior notice of high seas transshipments, one alternative would be to allow affected entities to provide the notice of high seas transshipment to NMFS at least one business day in advance of the transshipment, rather than 36 hours as proposed. However, a shorter advance notice would reduce opportunities for NMFS or the U.S. Coast Guard to observe transshipments in the event they are able to meet the transshipping vessels at sea. For this reason, this alternative is not preferred.
With respect to the transshipment reporting requirements, one alternative would be to impose a different timeframe for submission of the report. The report could be submitted more than 15 days after completion of the transshipment. However, NMFS believes 15 days is a reasonable timeframe, and that extending it further could lead to NMFS not receiving transshipment reports in a timely manner and would not support collection of complete information regarding authorized fisheries.
Section 212 of the Small Business Regulatory Enforcement Fairness Act of 1996 states that, for each rule or group of related rules for which an agency is required to prepare a FRFA, the agency shall publish one or more guides to assist small entities in complying with the rule, and shall designate such publications as “small entity compliance guides.” The agency shall explain the actions a small entity is required to take to comply with a rule or group of rules. As part of this rulemaking process, a letter to permit holders that also serves as small entity compliance guide (the guide) was prepared. Copies of this final rule are available from the NMFS Office for International Affairs and Seafood Inspection, and the guide,
The provisions of this rule are administrative in nature and facilitate monitoring of all high seas fishing vessels. The requirements for the installation of VMS EMTUs on vessels, the carrying of observers, and the prior notice and reporting of transshipments on the high seas will facilitate monitoring of vessels and will not have any impacts on the human environment. Moreover, the final rule also includes procedures that incorporate reviews under ESA and NEPA prior to any authorization of activities on the high seas. Therefore, this action is categorically excluded from further environmental review under NEPA pursuant to section 6.03.c.3(i) of NOAA Administrative Order 216-6.
This final rule contains a collection-of-information requirement approved by OMB under the Paperwork Reduction Act (PRA). This collection of information, under OMB Control No. 0648-0304, includes a permit application, vessel marking requirements, and high seas fishing effort and catch reporting. In addition to this collection of information, the final rule includes new requirements listed below.
The public reporting burden for each requirement has been estimated, including the time for reviewing instructions, searching existing data sources, gathering and maintaining the data needed, and completing and reviewing the collection of information per response. The estimates are as follows:
• Inclusion of a vessel photograph in the permit application: 30 minutes.
• Request for a fishery to be authorized on the high seas (optional): 110 hours.
• EMTU purchase and installation: 4 hours for purchase, installation, and activation of the EMTU and submittal of the installation and activation report.
• Position reports: Automatically sent by the EMTU.
• Notices of EMTU power-down and power-up: 10 minutes each.
• Prior notice for high seas transshipments: 15 minutes.
• Transshipment reporting: 1 hour.
Notwithstanding any other provision of the law, no person is required to respond to, and no person shall be subject to penalty for failure to comply with, a collection of information subject to the requirements of the PRA, unless that collection of information displays a currently valid OMB control number.
The reporting requirements described above amend an existing collection of information, (OMB Control No. 0648-0304) which has been approved by the Office of Management and Budget (OMB) under the Paperwork Reduction Act.
Administrative practice and procedure, Confidential business information, Fisheries, Fishing, Fishing vessels, Foreign relations, Intergovernmental relations, Penalties, Reporting and recordkeeping requirements, Statistics.
Administrative practice and procedure, Confidential business information, Fisheries, Fishing, Fishing
Administrative practice and procedure, American Samoa, Fisheries, Fishing, Guam, Hawaiian Natives, Indians, Northern Mariana Islands, Reporting and recordkeeping requirements.
Accountability measures, Annual catch limits, Fisheries, Fishing, Western and central Pacific.
For the reasons set out in the preamble, 50 CFR parts 300, 600, 660 and 665 are amended as follows:
16 U.S.C. 951
16 U.S.C. 5501
This subpart implements the High Seas Fishing Compliance Act of 1995 (Act), which requires the Secretary to license U.S. vessels fishing on the high seas and to ensure that such vessels do not operate in contravention of international conservation and management measures recognized by the United States.
In addition to the terms defined in section 300.2 and those in the Act and the Agreement to Promote Compliance with International Conservation and Management Measures by Fishing Vessels on the High Seas, adopted by the Conference of the Food and Agriculture Organization of the United Nations on November 24, 1993 (Agreement), the terms used in this subpart have the following meanings. If a term is defined differently in section 300.2, the Act, or the Agreement, the definition in this section shall apply.
Any Regional Administrator or the Office Director may issue permits required under this subpart. While applicants for permits may submit an application to any Regional Administrator or the Office Director, applicants are encouraged to submit their applications (with envelopes marked “Attn: HSFCA Permits”) to the Regional Administrator or the Office Director with whom they normally interact on fisheries matters.
(a)
(i) The foreign nation suspended such authorization, because the vessel undermined the effectiveness of international conservation and management measures, and the suspension has not expired; or
(ii) The foreign nation, within the 3 years preceding application for a permit under this section, withdrew such authorization, because the vessel undermined the effectiveness of international conservation and management measures.
(2) The restrictions in paragraphs (a)(1)(i) and (ii) of this section do not apply if ownership of the vessel has changed since the vessel undermined the effectiveness of international conservation and management measures, and the new owner has provided sufficient evidence to the Regional Administrator or Office Director demonstrating that the owner and operator at the time the vessel
(3) The restrictions in paragraphs (a)(1)(i) and (ii) of this section do not apply if it is determined by the Regional Administrator or Office Director that issuing a permit would not subvert the purposes of the Agreement.
(b)
(c)
(1) A complete, accurate application form signed by the vessel owner or operator.
(2) Information required under this section and § 300.334(a).
(3) A color photograph showing an entire bow-to-stern side-view of the vessel in its current form and appearance. The photograph must clearly and legibly display the vessel name and identification markings. If the vessel's form or appearance materially changes (such as the vessel is painted another color, the vessel's identification markings change, or the vessel undergoes a structural modification) the vessel owner and operator must submit a new photograph of the vessel within 15 days of the change.
(4) For vessels with state registration instead of U.S. Coast Guard documentation, the applicant must supply additional vessel information that NMFS may request.
(5) The fee specified in the application form. Payment by a commercial instrument later determined to be insufficiently funded will invalidate any permit. NMFS charges this fee to recover the administrative expenses of permit issuance, and the amount of the fee is determined in accordance with the procedures of the NOAA Finance Handbook.
(d)
(2) The Regional Administrator or Office Director will not issue a permit unless an EMTU has been installed and activated on the vessel in accordance with § 300.337(c)(2).
(3) The Regional Administrator or Office Director will not issue a permit unless the applicant holds a valid permit for the subject vessel for any U.S. domestic fisheries related to the authorized high seas fishery.
(4) Except as otherwise provided, permits issued under this subpart are valid for 5 years from the date of issuance. For a permit to remain valid to its expiration date, the vessel's U.S. Coast Guard documentation or state registration must be kept current. A permit issued under this subpart is void when the vessel owner or the name of the vessel changes, or in the event the vessel is no longer eligible for U.S. documentation, such documentation is revoked or denied, or the vessel is removed from such documentation.
(5) A permit issued under this subpart is not transferable or assignable to another vessel or owner; it is valid only for the vessel and owner to which it is issued.
(e)
(f)
(g)
(h)
(i)
(a)
(1) 50 CFR part 300, subpart C—Eastern Pacific Tuna Fisheries.
(2) 50 CFR part 300, subpart D—South Pacific Tuna Fisheries.
(3) 50 CFR part 300, subpart G—Antarctic Marine Living Resources.
(4) 50 CFR part 635—Atlantic Highly Migratory Species Fisheries.
(5) 50 CFR part 660, subpart K—U.S. West Coast Fisheries for Highly Migratory Species.
(6) 50 CFR part 665, subpart F—Western Pacific Pelagic Fisheries.
(7) South Pacific Albacore Troll Fishery.
(8) Northwest Atlantic Fishery.
(b)
(1) Abide by the regulations, set forth in other parts of this chapter and Chapter VI, governing those authorized fisheries while operating on the high seas;
(2) Obtain and renew any appropriate permits or authorizations; and
(3) Notify the Regional Administrator or Office Director who issued the permit immediately in the event that a species listed as threatened or endangered under the ESA is taken incidental to the fishing activities without authorization under a relevant incidental take statement.
(c)
(d)
(1) The proposed fishing activities would detrimentally affect the well-being of the stock of any regulated species of fish, marine mammal, or species listed as threatened or endangered under the Endangered Species Act;
(2) The proposed fishing activities would be inconsistent with relevant fishery management plans and their implementing regulations or other applicable law;
(3) Insufficient mechanisms exist to effectively monitor the activities of vessels engaged in the proposed fishing activities; or
(4) The proposed fishing activities would contravene international conservation and management measures recognized by the United States.
(e)
(1) The species (target and incidental) expected to be harvested and the anticipated amounts of such harvest and bycatch;
(2) The approximate times and places when fishing is expected to take place, the number and type of vessels expected to participate, and the type, size, and amount of gear expected to be used;
(3) A description of the specific area that may be affected by the fishing activities;
(4) A description of any anticipated impacts on the environment, including impacts on fisheries, marine mammals, and species listed as threatened or endangered under the ESA or their critical habitat;
(5) Other information that addresses considerations under paragraph (d) of this section; and
(6) If requested by NMFS, any additional information necessary for NMFS to conduct analyses required under applicable laws.
(7) Once all required information is received to proceed with consideration of a request, NMFS will publish in the
(f)
(a) Bottom fishing may be permitted on the high seas when authorized by international conservation and management measures recognized by the United States. For bottom fishing activity not subject to international conservation measures recognized by the United States, a person who seeks to engage in such fishing must request authorization of a new high seas fishery as described in § 300.334(e) and then, if the fishery is authorized, must obtain all applicable permits including a high seas fishing permit issued under § 300.333. NMFS may specify conditions and restrictions in the permit to mitigate adverse impacts on VMEs, which may include the types of conditions that have been adopted in relevant RFMO measures recognized by the United States.
(b)
(a)
(b)
(1) In accordance with vessel identification requirements specified in Federal fishery regulations issued under the Magnuson-Stevens Act or under other Federal fishery management statutes; or
(2) In accordance with the following identification requirements:
(i) A vessel must be marked with its international radio call sign (IRCS) or, if not assigned an IRCS, must be marked (in order of priority) with its Federal, state, or other documentation number appearing on its high seas fishing permit and, if a WCPFC Area Endorsement has been issued for the vessel under § 300.212, that documentation number must be preceded by the characters “USA” and a hyphen (that is, “USA-”);
(ii) The markings must be displayed at all times on the vessel's side or
(iii) The markings must be placed so that they do not extend below the waterline, are not obscured by fishing gear, whether stowed or in use, and are clear of flow from scuppers or overboard discharges that might damage or discolor the markings;
(iv) Block lettering and numbering must be used;
(v) The height of the letters and numbers must be in proportion to the size of the vessel as follows: for vessels 25 meters (m) and over in length overall, the height of letters and numbers must be no less than 1.0 m; for vessels 20 m but less than 25 m in length overall, the height of letters and numbers must be no less than 0.8 m; for vessels 15 m but less than 20 m in length overall, the height of letters and numbers must be no less than 0.6 m; for vessels 12 m but less than 15 m in length overall, the height of letters and numbers must be no less than 0.4 m; for vessels 5 m but less than 12 m in length overall, the height of letters and numbers must be no less than 0.3 m; and for vessels under 5 m in length overall, the height of letters and numbers must be no less than 0.1 m;
(vi) The height of the letters and numbers to be placed on decks must be no less than 0.3 m;
(vii) The length of the hyphen(s), if any, must be half the height (h) of the letters and numbers;
(viii) The width of the stroke for all letters, numbers, and hyphens must be h/6;
(ix) The space between letters and/or numbers must not exceed h/4 nor be less than h/6;
(x) The space between adjacent letters having sloping sides must not exceed h/8 nor be less than h/10;
(xi) The marks must be white on a black background, or black on a white background;
(xii) The background must extend to provide a border around the mark of no less than h/6; and
(xiii) The marks and the background must be maintained in good condition at all times.
(a)
(b)
(c)
(2)
(i) Turn on the EMTU to make it operational;
(ii) Submit a VMS Installation and Activation Certification form, or an activation report as directed by OLE, to the OLE divisional office within or nearest to the region issuing the permit under this subpart; and
(iii) Receive confirmation from OLE that transmissions are being received properly from the EMTU.
(d)
(1) In-port exemption: The EMTU may be powered down when the vessel will remain at a dock or permanent mooring for more than 72 consecutive hours and after the notice required in paragraph (d)(3) of this section is submitted to OLE. When powering up the EMTU after the in-port exemption, the vessel owner or operator must submit the report required in paragraph (d)(4) of this section at least 2 hours before leaving port or mooring.
(2) Long-term exemption: The EMTU may be powered down if the vessel will not operate on the high seas, or in any fishery that requires EMTU operation, for more than 30 consecutive days and after the notice required in paragraph (d)(3) of this section is submitted. When powering up the EMTU from the long-term exemption, the vessel owner or operator must submit the report required in paragraph (d)(4) of this section.
(3) Prior to each power-down of the EMTU, under paragraph (d)(1) or (2) of this section, the vessel owner or operator must report to the OLE divisional office in, or nearest, the Region issuing the permit under this subpart during business hours, via email or other means as directed by OLE: the vessel's name; the vessel's official number; the intent to power down the EMTU; the reason for power-down; the port where the vessel is docked or area where it will be operating; and the full name, telephone, and email contact information for the vessel owner or operator.
(4) When powering up the EMTU, the vessel owner or operator must report to the OLE divisional office in, or nearest, the Region issuing the permit under this subpart during business hours, via email or other means as directed by OLE: The fact that the EMTU has been powered up; the vessel's name; the vessel's official number; port name; intended fishery; and full name, telephone, and email contact information for the vessel owner or operator.
(5) If the EMTU is powered up after a long-term or in-port exemption, the vessel owner must receive confirmation from the OLE divisional office in, or nearest, the Region issuing the permit under this subpart that EMTU transmissions are being received properly before leaving port, entering the high seas, or entering a fishery that requires EMTU operation.
(e)
(1) If the vessel is in port, the vessel owner or operator shall repair or replace the EMTU and comply with the requirements in paragraph (c)(2) of this section before the vessel leaves port.
(2) If the vessel is at sea, the vessel owner, operator, or designee shall contact the OLE divisional office in, or nearest, the Region issuing the permit under this subpart by telephone or email at the earliest opportunity during business hours and identify the caller, vessel name, vessel location, and the type of fishing permit(s). The vessel operator shall follow the instructions provided by the OLE divisional office, which could include: Ceasing fishing, stowing fishing gear, returning to port, or submitting periodic position reports at specified intervals by other means. The vessel owner or operator must repair or replace the EMTU and comply with the requirements in paragraph (c)(2) of this section within 30 days or before the vessel leaves port, whichever is sooner.
(f)
(1) On the high seas, the EMTU is operated continuously and position information is automatically transmitted a minimum of once every hour;
(2) The EMTU is type-approved by NMFS;
(3) OLE is authorized to receive and relay transmissions from the EMTU; and
(4) The requirements of paragraph (d) of this section are complied with. If the EMTU is owned by NMFS, the requirement under paragraph (e) of this section to repair or replace the EMTU will be the responsibility of NMFS, but the vessel owner and operator shall be responsible for ensuring that the EMTU complies with the requirements specified in paragraph (c)(2) of this section before the vessel leaves port.
(g)
(h)
(i)
(j)
(k)
(a) Where observer coverage is not otherwise required by other regulations or relevant RFMO conservation and management measures, NMFS may select for at-sea observer coverage any vessel that has been issued a high seas fishing permit. A vessel so selected by NMFS must carry an observer when directed to do so.
(b) NMFS will contact a vessel owner, in writing, when his or her vessel is selected for observer coverage under this section.
(c) A vessel shall not fish on the high seas without taking an observer if NMFS contacted the vessel owner under paragraph (b) of this section, or if so required as a condition of a permit issued under this subpart or pursuant to other legal authorities, unless the requirement to carry an observer has been waived under paragraph (d) of this section.
(d) The vessel owner that NMFS contacts under paragraph (b) of this section must notify NMFS of his or her next fishing trip that may take place on the high seas before commencing the fishing trip. NMFS will specify the notification procedures and information requirements, such as expected gear deployment, trip duration and fishing area, in its selection letter. Once notified of a trip by the vessel owner, NMFS will assign an observer for that trip or notify the vessel owner that coverage pursuant to this subpart is not required, given the existing requirement for observer coverage under other legal authorities.
(e) The owner, operator, and crew of a vessel on which a NMFS-approved observer is assigned must comply with safety regulations at §§ 600.725 and 600.746 of this title and—
(1) Facilitate the safe embarkation and debarkation of the observer.
(2) Provide the observer with accommodations, food, and amenities that are equivalent of those provided to vessel officers.
(3) Allow the observer access to all areas of the vessel necessary to conduct observer duties.
(4) Allow the observer free and unobstructed access to the vessel's bridge, working decks, holding bins, weight scales, holds, and any other space used to hold, process, weigh, or store fish.
(5) Allow the observer access to EMTUs, communications equipment, and navigation equipment to verify operation, obtain data, and use the communication capabilities of the units for official purposes.
(6) Allow the observer to inspect and copy the vessel's log, communications logs, and any records associated with the catch and disposition of fish for that trip.
(7) Provide accurate vessel locations by latitude and longitude upon request by the observer.
(8) Provide access to sea turtle, marine mammal, sea bird, or other specimens as requested by the observer.
(9) Notify the observer in a timely fashion when commercial fishing activity is to begin and end.
(f) The permit holder, vessel operator, and crew must cooperate with the observer in the performance of the observer's duties.
(g) The permit holder, vessel operator, and crew must comply with other terms and conditions to ensure the effective deployment and use of observers that the Regional Administrator or Office Director imposes by written notice.
(a) In addition to any other applicable restrictions on transshipment, including those under parts 300 and 635 of this title, the following requirements apply to transshipments, when authorized, taking place on the high seas:
(1) The owner or operator of a U.S. vessel receiving or offloading fish on the high seas shall provide a notice by fax or email to the Regional Administrator or the Office Director at least 36 hours prior to any intended transshipment on the high seas with the following information: the vessels offloading and receiving the transshipment (names, official numbers, and vessel types); the location (latitude and longitude to the nearest tenth of a degree) of transshipment; date and time that transshipment is expected to occur; and species, processed state, and quantities (in metric tons) expected to be transshipped. If another requirement for prior notice applies, the more restrictive requirement (
(2) U.S. high seas fishing vessels shall report transshipments on the high seas to the Regional Administrator or Office Director within 15 calendar days after the vessel first enters into port, using the form obtained from the Regional Administrator or Office Director. If there are applicable transshipment reporting requirements in other parts of this title, the more restrictive requirement (
(b) [Reserved]
In addition to the prohibitions in § 300.4, it is unlawful for any person to:
(a) Use a high seas fishing vessel on the high seas in contravention of international conservation and management measures.
(b) Fish on the high seas unless the vessel has been issued, and has on board, a valid permit issued under § 300.333(d).
(c) Fish on the high seas unless the vessel has been issued, and has on board, valid permits related to the authorized fisheries noted on the high seas fishing permit, as required under § 300.334(b).
(d) Operate a high seas fishing vessel on the high seas that is not marked in accordance with § 300.336.
(e) With respect to the EMTU,
(1) Fail to install, activate, or continuously operate a properly functioning and type-approved EMTU as required in § 300.337;
(2) Power-down or power-up the EMTU without following the procedures required in § 300.337;
(3) In the event of EMTU failure or interruption, fail to repair or replace an EMTU, fail to notify the appropriate OLE divisional office and follow the instructions provided, or otherwise fail to act as required in § 300.337;
(4) Disable, destroy, damage or operate improperly an EMTU installed under § 300.337, attempt to do any of the same, or fail to ensure that its operation is not impeded or interfered with, as provided in § 300.337;
(5) Fail to make an EMTU installed under § 300.337 or the position data obtained from it available for inspection, as provided in § 300.337; or
(6) Fail to carry on board and monitor communication devices as required in § 300.337(l);
(f) With respect to observers,
(1) Fail to provide to an observer, a NMFS employee, or a designated observer provider, information that has been requested pursuant to § 300.338 or § 600.746 of this title, or fail to allow an observer, a NMFS employee, or a designated observer provider to inspect any item described at § 300.338 or § 600.746 of this title;
(2) Fish without an observer when the vessel is required to carry an observer pursuant to § 300.338(c);
(3) Assault, oppose, harass, impede, intimidate, or interfere with an observer;
(4) Prohibit or bar by command, impediment, threat, coercion, interference, or refusal of reasonable assistance, an observer from conducting his or her duties as an observer; or
(5) Tamper with or destroy samples or equipment.
(g) Fail to submit a prior notice or a report of a transshipment as provided in § 300.339(b) of this title.
(h) Fail to comply with reporting requirements as provided in § 300.341.
(a)
(1) The vessel owner and operator are responsible for obtaining and completing the reporting forms from the Regional Administrator or Office Director who issued the permit holder's high seas fishing permit. The completed forms must be submitted to the same Regional Administrator or Office Director or, if directed by NMFS, to a Science Center.
(2) Reports must be submitted within the deadline provided for in the authorized fishery or within 15 days following the end of a fishing trip, whichever is sooner. Contact information for the Regional Administrators and Science Center Directors can be found on the NMFS Web site.
(b) [Reserved]
5 U.S.C. 561 and 16 U.S.C. 1801
(g)
(a)
16 U.S.C. 1801
(c) Fishing activities on the high seas are governed by regulations of the High Seas Fishing Compliance Act set forth in 50 CFR part 300, subparts A and Q.
16 U.S.C. 1801
(b) General regulations governing fishing by all vessels of the United States and by fishing vessels other than vessels of the United States are contained in 50 CFR parts 300 and 600.
National Marine Fisheries Service (NMFS), National Oceanic and Atmospheric Administration (NOAA), Commerce.
Temporary rule; trip limit reduction.
NMFS reduces the commercial trip limit for gag grouper (gag) in or from the exclusive economic zone (EEZ) of the South Atlantic to 500 lb (227 kg), gutted weight. This trip limit reduction is necessary to protect the South Atlantic gag resource.
This rule is effective 12:01 a.m., local time, October 18, 2015, until 12:01 a.m., local time, January 1, 2016.
Mary Vara, NMFS Southeast Regional Office, telephone: 727-824-5305, email:
The snapper-grouper fishery in the South Atlantic includes gag and is managed under the Fishery Management Plan for the Snapper-Grouper Fishery of the South Atlantic Region (FMP). The FMP was prepared by the South Atlantic Fishery Management Council and is implemented by NMFS under the authority of the Magnuson-Stevens Fishery Conservation and Management Act (Magnuson-Stevens Act) by regulations at 50 CFR part 622.
The commercial ACL (commercial quota) for gag in the South Atlantic during the 2015 fishing year is 295,459 lb (134,018 kg), gutted weight, 348,642 lb (158,141 kg), round weight, as specified in 50 CFR 622.190(a)(7)(i).
Under 50 CFR 622.191(a)(7)(ii), NMFS is required to reduce the commercial trip limit for gag from 1,000 lb (454 kg), gutted weight, 1,180 lb (535 kg), round weight, to 500 lb (227 kg), gutted weight, 590 lb (268 kg), round weight, when 75 percent of the quota is reached or is projected to be reached, by filing a notification to that effect with the Office of the Federal Register, as implemented by the final rule for Regulatory Amendment 14 to the FMP (79 FR 66316, November 7, 2014). Based on current data, NMFS has determined that 75 percent of the available gag commercial quota will be reached by October 18, 2015. Accordingly, NMFS is reducing the commercial trip limit for gag to 500 lb (227 kg), gutted weight, 590 lb (268 kg), round weight, in or from the South Atlantic EEZ at 12:01 a.m., local time, on October 18, 2015. This 500-lb (227-kg), gutted weight, 590-lb (268-kg), round weight, trip limit will remain in effect until either the commercial sector reaches its quota and the sector closes, or through the end of the current fishing year on December 31, 2015, whichever occurs first.
The Regional Administrator, Southeast Region, NMFS, has determined this temporary rule is necessary for the conservation and management of South Atlantic gag and is consistent with the Magnuson-Stevens Act and other applicable laws.
This action is taken under 50 CFR 622.191(a)(7) and is exempt from review under Executive Order 12866.
These measures are exempt from the procedures of the Regulatory Flexibility Act because the temporary rule is issued without opportunity for prior notice and comment.
This action responds to the best scientific information available. The Assistant Administrator for Fisheries, NOAA (AA), finds that the need to immediately implement this commercial trip limit reduction constitutes good cause to waive the requirements to provide prior notice and opportunity for public comment pursuant to the authority set forth in 5 U.S.C. 553(b)(B), because prior notice and opportunity for public comment on this temporary rule is unnecessary and contrary to the public interest. Such procedures are unnecessary, because the rule establishing the trip limit reduction has already been subject to notice and comment, and all that remains is to notify the public of the reduced trip limit. The procedures are contrary to the public interest, because there is a need to immediately implement this action to protect the gag resource since the capacity of the fishing fleet allows for rapid harvest of the quota. Prior notice and opportunity for public comment on this action would require time and would increase the probability that the commercial sector could exceed the quota.
For the aforementioned reasons, the AA also finds good cause to waive the 30-day delay in the effectiveness of this action under 5 U.S.C. 553(d)(3).
16 U.S.C. 1801
National Marine Fisheries Service (NMFS), National Oceanic and Atmospheric Administration (NOAA), Commerce.
Temporary rule; correction.
The National Marine Fisheries Service (NMFS) is correcting a temporary rule that exchanged unused Community Development Quota (CDQ) for CDQ acceptable biological catch (ABC) reserves that published on October 5, 2015. The CDQ group that initiated this transfer was incorrect.
Effective October 16, 2015.
Josh Keaton, 907-586-7228.
NMFS published the exchange of unused CDQ for CDQ ABC reserves on October 5, 2015. The document contained errors by incorrectly stating which CDQ group initiated the transfer. This correction will not affect the fishing operations. These corrections are necessary to provide the correct information on which CDQ group initiated the transfer in order to avoid confusion by fishery participants.
1. In the
“The Norton Sound Economic Development Corporation has requested that NMFS exchange 568 mt of flathead sole and 210 mt of rock sole CDQ reserves for 778 mt of yellowfin sole CDQ ABC reserves under § 679.31(d).”
2. In the
“This requirement is impracticable and contrary to the public interest as it would prevent NMFS from responding to the most recent fisheries data in a timely fashion and would delay the flatfish exchange by the Norton Sound Economic Development Corporation in the BSAI.”
The Assistant Administrator for Fisheries, NOAA (AA), finds good cause to waive the requirement to provide prior notice and opportunity for public comment pursuant to the authority set forth at 5 U.S.C. 553(b)(B) as such requirement is impracticable and contrary to the public interest. This correction amendment corrects an error identifying the CDQ group that initiated the transfer and does not change operating practices in the fisheries. Corrections should be made as soon as possible to avoid confusion for participants in the fisheries.
The AA also finds good cause to waive the 30-day delay in the effective date of this action under 5 U.S.C. 553(d)(3). This finding is based upon the reasons provided above for waiver of prior notice and opportunity for public comment.
16 U.S.C. 1801
National Marine Fisheries Service (NMFS), National Oceanic and Atmospheric Administration (NOAA), Commerce.
Temporary rule; correction.
The National Marine Fisheries Service (NMFS) is correcting a temporary rule that reapportioned halibut prohibited species catch limits in the Gulf of Alaska (GOA) that published on September 11, 2015. The table in the document contained errors.
Effective October 16, 2015.
Josh Keaton, 907-586-7228.
NMFS published the reapportionment of the 2015 Gulf of Alaska Pacific halibut prohibited species catch limits for the trawl deep-water and shallow-water fishery categories on September 11, 2015. The table in the document contained errors in the July 1-September 1 row and the Subtotal January 20-October 1 row. This correction will not affect the fishing operations. These corrections are necessary to provide the correct 2015 halibut PSC apportionments and eliminate potential confusion for participants in the fisheries.
In the
The Assistant Administrator for Fisheries, NOAA (AA), finds good cause to waive the requirement to provide prior notice and opportunity for public comment pursuant to the authority set forth at 5 U.S.C. 553(b)(B) as such requirement is impracticable and contrary to the public interest. This correction amendment corrects the unintentional transposition of the 3rd season halibut apportionments between deep-water and shallow water fishery categories in Table 16 and does not change operating practices in the fisheries. Corrections should be made as soon as possible to avoid confusion for participants in the fisheries.
The AA also finds good cause to waive the 30-day delay in the effective date of this action under 5 U.S.C. 553(d)(3). This finding is based upon the reasons provided above for waiver of prior notice and opportunity for public comment.
16 U.S.C. 1801
National Protection and Programs Directorate, Department of Homeland Security.
Notice of public meeting.
The Department of Homeland Security (DHS or the Department) invites public comment on the Appendix A Chemicals of Interest (COI) list. These comments may be used for potential revisions to the Chemical Facility Anti-Terrorism Standards (CFATS) regulations.
A roundtable discussion will be held from 8:30 a.m. to 12:00 p.m. followed by a listening session from 1:00 p.m. to 4:00 p.m. on Tuesday, October 27, 2015. Written comments must be submitted on or before Monday, November 30, 2015.
The roundtable discussion and public listening session will be held at:
• The National Training Center, 1310 North Courthouse Road, Suite 600, Arlington, VA 22201.
You may submit comments, identified by docket number DHS-2014-0016. To avoid duplication, please use only one of the following methods:
•
•
•
Jon MacLaren, Rulemaking Section Chief, Office of Infrastructure Protection, Infrastructure Security Compliance Division, 245 Murray Lane, Mail Stop 0610, Washington, DC 20528-0610, Telephone 703-235-5263. For additional information on the Appendix A meeting, please email
Section 550 of the Department of Homeland Security Appropriations Act of 2007 (Pub. L. 109-295) authorized the Department to regulate the security of chemical facilities that, in the discretion of the Secretary, may present high levels of security risk. Under the Section 550 authority, on April 9, 2007, DHS issued the CFATS interim final rule, 6 CFR part 27.
On December 18, 2014, the President signed into law the Protecting and Securing Chemical Facilities from Terrorist Attacks Act of 2014, (“the Act”) (Pub. L. 113-254 (6 U.S.C. 621
DHS is interested in obtaining information and recommendations from the public on Appendix A. Comments and recommendations are welcomed on all aspects of CFATS Appendix A;
• The possible addition of chemicals to, and/or the deletion or modification of COI currently listed in Appendix A;
• The applicability and/or modification of any Screening Threshold Quantities (STQ) or minimum concentrations;
• Concentration and mixtures rules associated with Appendix A, which are described in 6 CFR 27.204;
• Isotopic variants to include comments on Chemical Abstract Service (CAS) Registry Numbers and nomenclature;
• The classification of COI within different security issues, to include the potential for re-designating certain chemicals now listed solely as release flammable so they are listed solely as toxic or as toxic and flammable; and
• Criteria for “counting rules” for screening threshold quantities to include clarification on how to determine if a COI is in transportation.
All interested persons, even those who are unable to attend the roundtable discussion and/or public listening session in-person, may submit written comments, data, or views on how Appendix A of the current CFATS regulations, 6 CFR part 27, might be improved. Please explain the reason for any comments and include other information or authority that supports such comments. Feedback that simply states that a stakeholder feels strongly that DHS should modify the Appendix A COI list will not enable the Department to adequately evaluate the commenter's concern, nor could DHS propose possible changes to address the commenter's feedback. Therefore the Department requests that commenters provide actionable data, including how the proposed change would impact the costs and benefits of CFATS, to allow the Department to fully consider the commenter's comment and recommendation.
Written comments may be submitted electronically or by mail, as explained previously in the
Except as provided below, all comments received, as well as pertinent background documents, will be posted without change to
Interested parties are encouraged to submit comments in a manner that avoids discussion of trade secrets, confidential commercial or financial information, Chemical-terrorism Vulnerability Information (CVI), or any other category of sensitive information that should not be disclosed to the general public. If it is not possible to avoid such discussion, however, please specifically identify any confidential or sensitive information contained in the comments with appropriate warning language (
DHS will not place any identifiable confidential or sensitive comments in the public docket; rather, DHS will handle them in accordance with applicable safeguards and restrictions on access.
The Department will hold a public roundtable discussion and listening session to solicit the public's views and recommendations on how the current Appendix A COI list might be improved.
This meeting is open to the public. DHS will use sign-in sheets to voluntarily collect contact information from the attending public and to properly log oral comments received during the two sessions. Providing contact information will be voluntary, and members of the public also may make anonymous oral comments. Seating may be limited, but session organizers will make every effort to accommodate all participants. Please note that members of the public who participate through the listen-only webinar may log in as a guest on the Homeland Security Information Network. This log in does not require your full name or a password. As previously stated, comments will not be accepted through the webinar. If you wish to submit a written comment please submit through the methods identified in the
DHS will place a transcript of the public meeting in the docket for this rulemaking.
In addressing these topics, DHS encourages interested parties to provide specific data that documents the costs, burdens, and benefits of the current regulatory approach. Commenters also might address how DHS can best obtain and consider accurate, objective information and data about the costs, burdens, and benefits of Appendix A, and whether there are lower cost alternatives that would to allow the
Agricultural Marketing Service, USDA.
Proposed rule.
This proposed rule invites public comments on proposed amendments to Marketing Order No. 989, which regulates the handling of raisins produced from grapes grown in California. The Raisin Administrative Committee (Committee), which is responsible for the local administration of the order and is comprised of producers and handlers of raisins operating within the production area, recommended the amendments that would authorize the Committee to borrow from a commercial lending institution and authorize the establishment of a monetary reserve equal to up to one year's budgeted expenses. Allowing the Committee to utilize these customary business practices would help to improve administration of the order.
Comments must be received by December 15, 2015.
Interested persons are invited to submit written comments concerning this rule. Comments must be sent to the Docket Clerk, Marketing Order and Agreement Division, Fruit and Vegetable Program, AMS, USDA, 1400 Independence Avenue SW., STOP 0237, Washington, DC 20250-0237; Fax: (202) 720-8938; or Internet:
Geronimo Quinones, Marketing Specialist, or Michelle P. Sharrow, Rulemaking Branch Chief, Marketing Order and Agreement Division, Fruit and Vegetable Program, AMS, USDA; 1400 Independence Avenue SW., Stop 0237, Washington, DC 20250-0237; Telephone: (202) 720-2491, Fax: (202) 720-8938, or Email:
Small businesses may request information on complying with this regulation by contacting Jeffrey Smutny, Marketing Order and Agreement Division, Fruit and Vegetable Program, AMS, USDA, 1400 Independence Avenue SW., STOP 0237, Washington, DC 20250-0237; Telephone: (202) 720-2491, Fax: (202) 720-8938, or Email:
This proposal is issued under Marketing Order No. 989, as amended (7 CFR part 989), regulating the handling of raisins produced from grapes grown in California, hereinafter referred to as the “order.” The order is effective under the Agricultural Marketing Agreement Act of 1937, as amended (7 U.S.C. 601-674), hereinafter referred to as the “Act.”
The Department of Agriculture (USDA) is issuing this rule in conformance with Executive Orders 12866, 13563, and 13175.
This proposal has been reviewed under Executive Order 12988, Civil Justice Reform. This rule is not intended to have retroactive effect.
The Act provides that administrative proceedings must be exhausted before parties may file suit in court. Under section 608c(15)(A) of the Act, any handler subject to an order may file with USDA a petition stating that the order, any provision of the order, or any obligation imposed in connection with the order is not in accordance with law and request a modification of the order or to be exempted therefrom. Such handler is afforded the opportunity for a hearing on the petition. After the hearing, USDA would rule on the petition. The Act provides that the district court of the United States in any district in which the handler is an inhabitant, or has his or her principal place of business, has jurisdiction to review USDA's ruling on the petition, provided an action is filed not later than 20 days after the date of the entry of the ruling.
Section 1504 of the Food, Conservation, and Energy Act of 2008 (2008 Farm Bill) (Pub. L. 110-246) amended section 18c(17) of the Act, which in turn required the addition of supplemental rules of practice to 7 CFR part 900 (73 FR 49307; August 21, 2008). The additional supplemental rules of practice authorize the use of informal rulemaking (5 U.S.C. 553) to amend Federal fruit, vegetable, and nut marketing agreements and orders. USDA may use informal rulemaking to amend marketing orders based on the nature and complexity of the proposed amendments, the potential regulatory and economic impacts on affected entities, and any other relevant matters.
AMS has considered these factors and has determined that the amendment proposals are not unduly complex and the nature of the proposed amendments is appropriate for utilizing the informal rulemaking process to amend the order. A discussion of the potential regulatory and economic impacts on affected entities is discussed later in the “Initial Regulatory Flexibility Analysis” section of this rule.
The proposed amendments were unanimously recommended by the Committee following deliberations at a public meeting held on October 2, 2014. Currently, the order does not allow the Committee to borrow funds from a commercial lending institution or retain unspent handler assessments past the close of a fiscal year. Allowing the Committee to utilize these customary business practices would help to improve administration of the order by providing it with the means for ensuring continuity of operations when its cash flow needs are greater than available handler assessment income.
Section 989.80 of the order, Assessments, authorizes the Committee to collect assessments from handlers to administer the program.
This proposal would provide the Committee with authority to borrow from a commercial lending institution during times of cash shortages. Since inception of the marketing order, the Committee sometimes has used the order's volume regulation provisions to pool a portion of the annual raisin crop to assure orderly marketing. These pooled raisins, designated by the Committee as reserve raisins, were sold and released to handlers throughout the crop year. In managing the pooled raisins for the best return to growers, the Committee pooled the cash received
Volume regulation has not been in effect under the marketing order since 2010, and the Committee has been returning equity payments to the growers who contributed raisins to the 2009 reserve raisin pool. Therefore, funds from the reserve raisin pool are no longer available for the Committee to use during times of cash shortages. The Committee's proposed amendment to the order would allow it to borrow from a commercial lending institution when no other funding is available. This would assist the Committee in bridging finances from the end of one fiscal year through the first quarter of the new fiscal year before assessments on the new crop are received.
Additionally, the Committee has received grants from the Foreign Agricultural Service's (FAS) Market Access Program (MAP) since 1995 to conduct market expansion and development activities in various international markets. Under MAP, participants must first use their own resources for activities and request reimbursement from FAS. Sometimes there is a time-lag between submission of reimbursement requests and receipt of payments, which causes budgeting issues. Having authority to borrow from a commercial lending institution would help to ensure continuity of operations when this occurs.
Therefore, for the reasons stated above, it is proposed that § 989.80, Assessments, be amended by adding a sentence in paragraph (c) that would provide the Committee with authority to borrow from a commercial lending institution when no other funding is available.
Section 989.81 of the order, Accounting, authorizes the Committee to credit or refund unexpended assessment funds from the crop year back to the handlers from whom it was collected. Currently, the order doesn't allow the Committee to retain handler assessments from prior crop years.
This proposal would allow the Committee to establish a monetary reserve equal to one year's operational expenses as averaged over the past six years. Reserve funds could be used for specific administrative and overhead expenses such as staff wages, salaries and related benefits, office rent, utilities, postage, insurance, legal expenses, and audit costs; to cover deficits incurred during any period when assessment income is less than expenses; to defray expenses incurred during any period when any or all provisions of the order are suspended; liquidation of the order; and other expenses recommended by the Committee and approved by the Secretary. Reserve funds could not be used for promotional expenses during any crop year prior to the time that assessment income is sufficient to cover such expenses.
As previously stated in Proposal #1, the Committee borrowed cash from the reserve raisin pool and repaid it with interest when handler assessment cash shortages occurred in the past. This practice helped the Committee to bridge finances from one fiscal crop year to the next until assessment income for the new crop year was received. This option is no longer available.
For the reasons stated above, it is proposed that § 989.81, Accounting, be amended to allow the Committee to retain excess assessment funds for the purpose of establishing a monetary reserve equal to one year's budgeted expenses as averaged over the past six years. Such excess funds could only be used for specific administrative and operational expenses.
Pursuant to the requirements set forth in the Regulatory Flexibility Act (RFA) (5 U.S.C. 601-612), the Agricultural Marketing Service (AMS) has considered the economic impact of this action on small entities. Accordingly, AMS has prepared this initial regulatory flexibility analysis.
The purpose of the RFA is to fit regulatory actions to the scale of businesses subject to such actions in order that small businesses will not be unduly or disproportionately burdened. Marketing orders issued pursuant to the Act, and rules issued thereunder, are unique in that they are brought about through group action of essentially small entities acting on their own behalf.
There are approximately 3,000 producers of California raisins and approximately 28 handlers subject to regulation under the marketing order. The Small Business Administration defines small agricultural producers as those having annual receipts of less than $750,000 and defines small agricultural service firms as those whose annual receipts are less than $7,000,000 (13 CFR 121.201).
Based upon information provided by the Committee, it may be concluded that a majority of producers and approximately 18 handlers of California raisins may be classified as small entities.
The proposed rule would authorize the Committee to borrow from commercial lending institutions and to establish a monetary reserve fund equal to one year's budgeted expenses. This would help to ensure proper management and funding of the program.
The Committee reviewed and identified a yearly budget that would be necessary to continue program operations in the absence of a reserve pool. Based on this budget, the Committee believes a monetary reserve of approximately $2 million would be sufficient to continue operations. The anticipated $2 million to be accumulated in a monetary reserve would not be accrued in one crop year. It would be spread over several years, depending on expenses, assessment revenue, and excess handler assessments accrued in each crop year. For example: If excess annual handler assessments amount to $400,000, it would take five years to accrue $2 million. Currently, the average excess handler assessments paid yearly over the last six years has been $861,622. During the time in which the monetary reserve fund would be accumulated, the Committee would seek funding from a commercial lending institution as previously explained in Proposal #1.
While this action would result in a temporary increase in handler costs, these costs would be uniform on all handlers and proportional to the size of their businesses. However, these costs are expected to be offset by the benefits derived from operation of the order. Additionally, these costs would help to ensure that the Committee has sufficient funds to meet its financial obligations. Such stability is expected to allow the Committee to conduct programs that would benefit all entities, regardless of size. California raisin producers should see an improved business environment and a more sustainable business model because of the improved business efficiency.
Alternatives were considered to these proposals, including making no changes at this time. However, the Committee believes it would be beneficial to have the means and funds necessary to effectively administer the program.
In accordance with the Paperwork Reduction Act of 1995 (44 U.S.C. Chapter 35), the order's information
This proposed rule would impose no additional reporting or recordkeeping requirements on either small or large California raisin handlers. As with all Federal marketing order programs, reports and forms are periodically reviewed to reduce information requirements and duplication by industry and public sector agencies.
The Committee's meeting was widely publicized throughout the California raisin production area. All interested persons were invited to attend the meeting and encouraged to participate in Committee deliberations on all issues. Like all Committee meetings, the October 2, 2014, meeting was public, and all entities, both large and small, were encouraged to express their views on these proposals. Finally, interested persons are invited to submit comments on the proposed amendments to the order, including comments on the regulatory and informational impacts of this action on small businesses.
Following analysis of any comments received on the amendments proposed in this rule, AMS will evaluate all available information and determine whether to proceed. If appropriate, a proposed rule and referendum order would be issued, and producers would be provided the opportunity to vote for or against the proposed amendments. Information about the referendum, including dates and voter eligibility requirements, would be published in a future issue of the
AMS is committed to complying with the E-Government Act to promote the use of the Internet and other information technologies, to provide increased opportunities for citizen access to Government information and services, and for other purposes.
USDA has not identified any relevant Federal rules that duplicate, overlap, or conflict with this action. A small business guide on complying with fruit, vegetable, and specialty crop marketing agreements and orders may be viewed at:
The findings hereinafter set forth are supplementary to the findings and determinations which were previously made in connection with the issuance of the marketing order; and all said previous findings and determinations are hereby ratified and affirmed, except insofar as such findings and determinations may be in conflict with the findings and determinations set forth herein.
1. The marketing order as hereby proposed to be amended, and all of the terms and conditions thereof, would tend to effectuate the declared policy of the Act;
2. The marketing order as hereby proposed to be amended regulates the handling of raisins produced by grapes grown in California and is applicable only to persons in the respective classes of commercial and industrial activity specified in the marketing order;
3. The marketing order as hereby proposed to be amended is limited in application to the smallest regional production area which is practicable, consistent with carrying out the declared policy of the Act, and the issuance of several orders applicable to subdivisions of the production area would not effectively carry out the declared policy of the Act;
4. The marketing order as hereby proposed to be amended prescribes, insofar as practicable, such different terms applicable to different parts of the production area as are necessary to give due recognition to the differences in the production and marketing of raisins produced or packed in the production area; and
5. All handling of raisins produced or packed in the production area as defined in the marketing order is in the current of interstate or foreign commerce or directly burdens, obstructs, or affects such commerce.
A 60-day comment period is provided to allow interested persons to respond to these proposals. Any comments received on the amendments proposed in this rule will be analyzed, and if AMS determines to proceed based on all the information presented, a producer referendum would be conducted to determine producer support for the proposed amendments. If appropriate, a final rule would then be issued to effectuate the amendments favored by producers participating in the referendum.
Raisins, Marketing agreements, Reporting and recordkeeping requirements.
For the reasons set forth in the preamble, 7 CFR part 989 is proposed to be amended as follows:
7 U.S.C. 601-674.
(c) During any crop year or any portion of a crop year for which volume percentages are not effective for a varietal type, all standard raisins of that varietal type acquired by handlers during such period shall be free tonnage for purposes of levying assessments pursuant to this section. The Secretary shall fix the rate of assessment to be paid by all handlers on the basis of a specified rate per ton. At any time during or after a crop year, the Secretary may increase the rate of assessment to obtain sufficient funds to cover any later finding by the Secretary relative to the expenses of the committee. Each handler shall pay such additional assessment to the committee upon demand. In order to provide funds to carry out the functions of the committee, the committee may accept advance payments from any handler to be credited toward such assessments as may be levied pursuant to this section against such handler during the crop year. In the event cash flow needs of the committee are above cash available generated by handler assessments, the committee may borrow from a commercial lending institution. The payment of assessments for the maintenance and functioning of the committee, and for such purposes as the Secretary may pursuant to this subpart determine to be appropriate, may be required under this part throughout the period it is in effect, irrespective of whether particular provisions thereof are suspended or become inoperative.
(a) If, at the end of the crop year, the assessments collected are in excess of expenses incurred, such excess shall be accounted for in accordance with one of the following:
(1) If such excess is not retained in a reserve, as provided in paragraph (a)(2) of this section, it shall be refunded proportionately to the persons from whom collected in accordance with § 989.80;
(2) The committee may carry over such excess funds into subsequent crop years as a reserve;
(i) To defray essential administrative expenses (
(ii) To cover deficits incurred during any period when assessment income is less than expenses;
(iii) To defray expenses incurred during any period when any or all provisions of this part are suspended;
(iv) To meet any other such expenses recommended by the committee and approved by the Secretary; and
(v) To cover the necessary expenses of liquidation in the event of termination of this part. Upon such termination, any funds not required to defray the necessary expenses of liquidation shall be disposed of in such manner as the Secretary may determine to be appropriate;
Federal Aviation Administration (FAA), DOT.
Notice of proposed rulemaking (NPRM).
This action proposes to establish Class E surface area airspace designated as an extension to the Class D airspace at Whiteman Airport, Los Angeles, CA. After reviewing the airspace, the FAA found it necessary to establish Class E surface area for the safety and management of Instrument Flight Rules (IFR) operations for at the airport.
Comments must be received on or before November 30, 2015.
Send comments on this proposal to the U.S. Department of Transportation, Docket Operations, M-30, West Building Ground Floor, Room W12-140, 1200 New Jersey Avenue SE., Washington, DC 20590; telephone (202) 366-9826. You must identify FAA Docket No. FAA-2015-1139; Airspace Docket No. 15-AWP-4, at the beginning of your comments. You may also submit comments through the Internet at
FAA Order 7400.9Z, Airspace Designations and Reporting Points, and subsequent amendments can be viewed online at
FAA Order 7400.9, Airspace Designations and Reporting Points, is published yearly and effective on September 15.
Steve Haga, Federal Aviation Administration, Operations Support Group, Western Service Center, 1601 Lind Avenue SW., Renton, WA 98057; telephone (425) 203-4500.
The FAA's authority to issue rules regarding aviation safety is found in Title 49 of the United States Code. Subtitle I, Section 106 describes the authority of the FAA Administrator. Subtitle VII, Aviation Programs, describes in more detail the scope of the agency's authority. This rulemaking is promulgated under the authority described in Subtitle VII, Part, A, Subpart I, Section 40103. Under that section, the FAA is charged with prescribing regulations to assign the use of airspace necessary to ensure the safety of aircraft and the efficient use of airspace. This regulation is within the scope of that authority as it would establish Class E airspace at Whiteman Airport, Los Angeles, CA.
Interested parties are invited to participate in this proposed rulemaking by submitting such written data, views, or arguments, as they may desire. Comments that provide the factual basis supporting the views and suggestions presented are particularly helpful in developing reasoned regulatory decisions on the proposal. Comments are specifically invited on the overall regulatory, aeronautical, economic, environmental, and energy-related aspects of the proposal. Communications should identify both docket numbers and be submitted in triplicate to the address listed above. Commenters wishing the FAA to acknowledge receipt of their comments on this notice must submit with those comments a self-addressed, stamped postcard on which the following statement is made: “Comments to Docket No. FAA-2015-1139; Airspace Docket No. 15-AWP-4.” The postcard will be date/time stamped and returned to the commenter.
An electronic copy of this document may be downloaded through the Internet at
You may review the public docket containing the proposal, any comments received, and any final disposition in person in the Dockets Office (see the
Persons interested in being placed on a mailing list for future NPRMs should contact the FAA's Office of Rulemaking, (202) 267-9677, for a copy of Advisory Circular No. 11-2A, Notice of Proposed Rulemaking Distribution System, which describes the application procedure.
This document proposes to amend FAA Order 7400.9Z, Airspace Designations and Reporting Points, dated August 6, 2015, and effective September 15, 2015. FAA Order 7400.9Z is publicly available as listed in the
The FAA is proposing an amendment to Title 14 Code of Federal Regulations (14 CFR) Part 71 by establishing Class E surface area airspace designated as an extension to the Class D airspace at Whiteman Airport, Los Angeles, CA. The Class E surface area airspace would extend from the 3-mile radius of Whiteman Airport to 6.6 miles northwest of the airport for the safety and management of IFR operations.
Class E airspace designations are published in paragraph 6004, of FAA Order 7400.9Z, dated August 6, 2015, and effective September 15, 2015, which is incorporated by reference in 14 CFR 71.1. The Class E airspace designations listed in this document will be published subsequently in the Order.
The FAA has determined this proposed regulation only involves an established body of technical regulations for which frequent and routine amendments are necessary to keep them operationally current. It, therefore; (1) is not a “significant regulatory action” under Executive Order 12866; (2) is not a “significant rule” under DOT Regulatory Policies and Procedures (44 FR 11034; February 26, 1979); and (3) does not warrant preparation of a regulatory evaluation as the anticipated impact is so minimal. Since this is a routine matter that will only affect air traffic procedures and air navigation, it is certified this proposed rule, when promulgated, would not have a significant economic impact on a substantial number of small entities under the criteria of the Regulatory Flexibility Act.
This proposal will be subject to an environmental analysis in accordance with FAA Order 1050.1E, “Environmental Impacts: Policies and Procedures” prior to any FAA final regulatory action.
Airspace, Incorporation by reference, Navigation (air).
Accordingly, pursuant to the authority delegated to me, the Federal Aviation Administration proposes to amend 14 CFR part 71 as follows:
49 U.S.C. 106(f), 106(g), 40103, 40113, 40120; E.O. 10854, 24 FR 9565, 3 CFR, 1959-1963 Comp., p. 389.
Office of the Assistant Secretary for Housing—Federal Housing Commissioner, HUD.
Partial withdrawal of proposed rule.
This document withdraws part of a proposed rule, published in the
As of October 16, 2015, HUD withdraws the proposed additions of §§ 203.317a and 203.372, and proposed revision to § 203.318, published Monday, July 6, 2015 (80 FR 38410).
Ivery Himes, Director, Office of Single
On July 6, 2015, HUD published in the
In response to public comments expressing concern over the implementation of the proposed provisions regarding the maximum time period within which an FHA-approved mortgagee must file a claim with FHA for insurance benefits, HUD is withdrawing the proposed additions of §§ 203.317a and 203.372, and proposed revision to § 203.318. HUD will publish in the
Hawaiian Natives, Home improvement, Indians-lands, Loan programs-housing and community development, Mortgage insurance, Reporting and recordkeeping requirements, Solar energy.
Environmental Protection Agency (EPA).
Proposed rule.
The Environmental Protection Agency (EPA) is proposing to approve revisions to the Arizona State Implementation Plan (SIP) concerning the emission inventory, emission statements, reasonably available control technology corrections and the vehicle inspection and maintenance requirements for the Phoenix-Mesa 2008 eight-Hour Ozone National Ambient Air Quality Standard (NAAQS) Marginal nonattainment area. We are approving these revisions under the Clean Air Act.
Any comments on this proposal must arrive by November 16, 2015.
Submit comments, identified by docket number EPA-R09-OAR-2015-0240, by one of the following methods:
1.
2.
3.
Nancy Levin, EPA Region IX, (415) 972-3848,
Throughout this document, “we,” “us” and “our” refer to the EPA. This proposal addresses revisions to the Arizona SIP concerning the emission inventory, emission statements, reasonably available control technology corrections and the vehicle inspection and maintenance requirements for the Phoenix-Mesa 2008 eight-Hour Ozone NAAQS Marginal nonattainment area. In the Rules and Regulations section of this
We do not plan to open a second comment period, so anyone interested in commenting should do so at this time. If we do not receive adverse comments, no further activity is planned. For further information, please see the direct final action.
Environmental protection, Air pollution control, Incorporation by reference, Intergovernmental relations, Ozone, Reporting and recordkeeping requirements, Volatile organic compounds.
Federal Communications Commission.
Petitions for reconsideration; correction.
The Federal Communications Commission published in the
Replies to opposition are due on October 29, 2015.
Paul Powell, 202-418-1613; Email:
The FCC published a document in the
In proposed rule 2015-25001 published at 80 FR 59705, October 2, 2015, make the following correction. On page 59705, in the first column, in the
United States African Development Foundation.
Notice of meeting.
The U.S. African Development Foundation (USADF) will hold its quarterly meeting of the Board of Directors to discuss the agency's programs and administration.
The meeting date is Tuesday, October 27, 2015, 9:00 a.m. to 11:30 a.m.
The meeting location is 1400 I Street Northwest, Suite #1000 (Main Conference Room), Washington, DC 2005-2246.
Julia Lingham, 202-233-8811.
Pub. L. 96-533 (22 U.S.C. § 290h).
Agricultural Marketing Service, USDA.
Notice of meeting.
Pursuant to the Federal Advisory Committee Act (FACA), the Agricultural Marketing Service (AMS) is announcing a meeting of the Plant Variety Protection Board (Board). The meeting is being held to discuss a variety of topics including, but not limited to, work and outreach plans, subcommittee activities, and proposals for procedure changes. The meeting is open to the public. This notice sets forth the schedule and location for the meeting.
Monday, December 7, 2015, from 1:00 p.m. to 5:00 p.m. and Tuesday, December 8, 2015, from 8:00 a.m. to 5:00 p.m.
The meeting will be held at the Hyatt Regency Chicago Hotel at the Ogden Room, at 151 East Wacker Drive, Chicago, IL 60601.
Maria Pratt, Program Analyst, U.S. Department of Agriculture (USDA), AMS, Science and Technology Programs, 1400 Independence Avenue SW., Washington, DC 20250. Telephone number (202) 720-1104, fax (202) 260-8976, or email:
Pursuant to the provisions of section 10(a) of the FACA (5 U.S.C. Appendix 2), this notice informs the public that the Plant Variety Protection Office (PVPO) is having a Board meeting within the 15 day requirement of the FACA. The Plant Variety Protection Act (PVPA) (7 U.S.C. 2321
The purpose of the meeting will be to discuss the PVPO 2015 achievements, the electronic application system, reports of the outreach and molecular techniques subcommittees, PVP cooperation with other countries, and PVPO 2016 business plan.
Agenda Items: The agenda will include, welcome and introductions, discussions on program activities that encourage the development of new plant varieties and also address appeals to the Secretary. There will be presentations on 2015 accomplishments, the electronic PVP application system, PVP outreach activities, the use of molecular markers for PVP applications, PVP cooperation with other countries, and the 2016 business plan. The meeting will be open to the public. Those wishing to participate are encouraged to pre-register by November 30, 2015 by contacting Maria Pratt, Program Analyst; Telephone: (202) 720-1104; Email:
Meeting Accommodation: The meeting hotel is ADA compliant, and the USDA provides reasonable accommodations to individuals with disabilities where appropriate. If you need a reasonable accommodation to participate in this public meeting, please notify Maria Pratt at: Email:
U.S. Census Bureau, Commerce.
Notice.
The Department of Commerce, as part of its continuing effort to reduce paperwork and respondent burden, invites the general public and other Federal agencies to take this opportunity to comment on proposed and/or continuing information collections, as required by the Paperwork Reduction Act of 1995, Public Law 104-13 (44 U.S.C. 3506(c)(2)(A)).
To ensure consideration, written comments must be submitted on or before December 15, 2015.
Direct all written comments to Jennifer Jessup, Departmental Paperwork Clearance Officer, Department of Commerce, Room 6616, 14th and Constitution Avenue NW., Washington, DC 20230 (or via the Internet at
Requests for additional information or copies of the information collection instrument(s) and instructions should be directed to Karen Woods, U.S. Census Bureau, 7H110F, Washington, DC 20233-8400 at (301) 763-3806.
The U.S. Census Bureau plans to request clearance for the collection of data concerning the Fertility Supplement to be conducted in conjunction with the June 2016 CPS. The Census Bureau sponsors the supplement questions, which were previously collected in June 2014, and have been asked periodically since 1971. Title 13 U.S.C. Sections 141 and 182 authorize the collection of this information on individuals and households. This year, the 2016 Fertility Supplement will include questions on marital status and cohabitation of women at the time of their first birth.
This survey provides information used mainly by government and private analysts to project future population growth, to analyze child spacing, and to aid policymakers in their decisions affected by changes in family size and composition. Past studies have discovered noticeable changes in the patterns of fertility rates and the timing of the first birth. Potential needs for government assistance, such as aid to families with dependent children, child care, and maternal health care for single parent households, can be estimated using CPS characteristics matched with fertility data.
The fertility information will be collected by both personal visit and telephone interviews in conjunction with the regular June CPS interviewing. All interviews are conducted using computer-assisted interviewing.
Comments are invited on: (a) Whether the proposed collection of information is necessary for the proper performance of the functions of the agency, including whether the information shall have practical utility; (b) the accuracy of the agency's estimate of the burden (including hours and cost) of the proposed collection of information; (c) ways to enhance the quality, utility, and clarity of the information to be collected; and (d) ways to minimize the burden of the collection of information on respondents, including through the use of automated collection techniques or other forms of information technology.
Comments submitted in response to this notice will be summarized and/or included in the request for OMB approval of this information collection; they also will become a matter of public record.
International Trade Administration, Department of Commerce.
Notice.
The United States Department of Commerce, International Trade Administration (ITA), with support from the U.S. Chamber of Commerce and organizers of the Saudi-American Healthcare Forum (SAHF) is organizing a Healthcare Technology & Hospital Information Services Trade Mission to the Kingdom of Saudi Arabia and Kuwait from April 23-28, 2016. The purpose of the mission is to introduce U.S. firms to the rapidly expanding healthcare sectors in these two countries and to assist U.S. companies in pursuing opportunities in this sector.
The mission is designed for U.S. companies and international hospital groups providing hospital operation and management services, hospital information systems, and eHealth solutions. The mission also will assist U.S. companies already doing business in Saudi Arabia and Kuwait to expand their footprint. Target sectors holding high potential for U.S companies include:
• Hospital operation and management,
• healthcare training and staffing services,
• healthcare education, and
• health information systems and informatics (
The mission is timed to take place during the Saudi-American Healthcare Forum (SAHF) on April 25-27, 2016. The SAHF is an exclusive event dedicated to building new relationships, fostering existing partnerships, and exchanging best practices between the United States and the Middle East. The 2015 forum attracted over 1,000 attendees intent on promoting healthcare diplomacy through bilateral and international research, technology development, and education and training. Approximately 50 U.S. companies and organizations attended the event. Additional information about the SAHF can be found here:
Supported by American industry participants and the U.S. Embassy, the
The mission will help participating U.S. firms and associations/organizations gain market insights, make industry and government contacts, solidify business strategies and advance specific projects with the goal of increasing U.S. healthcare services exports. The trade mission will start in Riyadh, Saudi Arabia, where participants will receive market briefings from U.S. Commercial Service and industry experts, hold one-on-one business meetings, meet with Saudi government officials and organizations, and participate in networking events. Delegates will be invited to participate in the SAHF. Following the SAHF, trade mission participants will travel to Jeddah, Saudi Arabia and then to Kuwait, where they will have additional opportunities to meet with key contacts and decision makers. Participating firms may also wish to remain in Riyadh, or if the firm decides to send two participants on the mission, one representative can remain in Riyadh, rather than continue to Jeddah, to participate in SAHF seminars. Participating in an official U.S. industry delegation, rather than traveling on their own, will enhance the companies' abilities to identify opportunities in Saudi Arabia and Kuwait.
All parties interested in participating in the trade mission must complete and submit an application package for consideration by the U.S. Department of Commerce. All applicants will be evaluated on their ability to meet certain conditions and best satisfy the selection criteria as Outlined below and will be notified whether they are chosen to participate in the mission. A minimum of 12 and maximum of 15 companies and/or trade associations/organizations will be selected from the applicant pool to participate in the trade mission.
After an applicant has been selected to participate in the mission, a payment to the U.S. Department of Commerce in the form of a participation fee is required. Upon notification of acceptance to participate, those selected have five (5) business days to submit payment or the acceptance may be revoked.
The participation fee for the trade mission to Saudi Arabia and Kuwait is $3,740 for small or medium-sized enterprises (SME) and $4,470 for large companies. The fee for each additional representative (large firm or SME or trade association/organization) is $750.
The mission fee does not include any personal travel expenses such as lodging, most meals, local ground transportation (except for transportation to and from meetings, airport transfers during the mission) and air transportation. Participants will, however, be able to take advantage of U.S. Government per diem rates for hotel rooms. Business or entry visas may be required for participation in the mission. Applying for and obtaining such visas will be the responsibility of the mission participant. Government fees and processing expenses to obtain such visas are not included in the participation fee. However, the U.S. Department of Commerce will provide instructions to each participant on the procedures required to obtain necessary business visas.
Applicants must submit a completed and signed mission application and supplemental application materials, including information on their products and/or services, primary market objectives, and goals for participation by February 12, 2016, but applications will be reviewed on a rolling basis beginning October 15, 2015 (see timeframe below). If the U.S. Department of Commerce receives an incomplete application, the Department may either: request additional information/clarification, take the lack of information into account when evaluating the application, or reject the application.
Each applicant must also certify that the products and services it seeks to export through the mission are either produced in the United States, or, if not, are marketed under the name of a U.S. company and have at least fifty-one percent U.S. content by value. In the case of a trade association or organization, the applicant must certify that, for each firm or service provider to be represented by the association/organization, the products and/or services the represented firm or service provider seeks to export are either produced in the United States or, if not, marketed under the name of a U.S. company and have at least fifty-one percent U.S. content.
In addition, each applicant must:
• Certify that the products and services that it wishes to market through the mission would be in compliance with U.S. export controls and regulations;
• Certify that it has identified any matter pending before any bureau or office in the U.S. Department of Commerce;
• Certify that it has identified any pending litigation (including any administrative proceedings) to which it is a party that involves the U.S. Department of Commerce;
• Sign and submit an agreement that it and its affiliates (1) have not and will not engage in the bribery of foreign officials in connection with a company's/participant's involvement in this mission, and (2) maintain and enforce a policy that prohibits the bribery of foreign officials; and
• Certify that it meets the minimum requirements as stated in this announcement. In the case of a trade association/organization, the applicant must certify that each firm or service provider to be represented by the association/organization can make the above certifications.
Targeted mission participants are U.S. manufacturers, services providers, and trade associations/organizations providing or promoting healthcare products/services that have an interest in entering or expanding their business in the Saudi and Kuwaiti markets. The following criteria will be evaluated in selecting participants:
• Suitability of a firm's or trade association's products or services to these markets;
• Firm's or trade association/organization's potential for business in the markets, including likelihood of exports resulting from the mission; and
• Consistency of the firm's or trade association/organization goals and objectives with the stated scope of the mission.
Additional factors, such as diversity of company size, type, location, and demographics, may also be considered during the review process. Referrals from political organizations and any documents, including the application, containing references to partisan political activities (including political contributions) will be removed from an applicant's submission and not considered during the selection process.
Mission recruitment will be conducted in an open and public manner, including publication in the
LeeAnne Haworth, U.S. Department of Commerce, Pittsburgh, PA, Tel: 412-644-2816, Email:
Enforcement and Compliance, International Trade Administration, Department of Commerce.
On May 28, 2015, the Department of Commerce (the Department) published its
Hermes Pinilla or Minoo Hatten, AD/CVD Operations, Office I, Enforcement and Compliance, International Trade Administration, U.S. Department of Commerce, 14th Street and Constitution Avenue NW., Washington, DC 20230; telephone: (202) 482-3477 or (202) 482-1690, respectively.
In the
We received case and rebuttal briefs with respect to the
The merchandise covered by the order includes all small diameter graphite electrodes of any length, whether or not finished, of a kind used in furnaces, with a nominal or actual diameter of 400 millimeters (16 inches) or less, and whether or not attached to a graphite pin joining system or any other type of joining system or hardware. The subject merchandise is currently classifiable under the Harmonized Tariff Schedule of the United States (HTSUS) subheadings 8545.11.0010
As we explain in the Issues and Decision Memorandum, we continue to find that, because Jianglong is affiliated with an entity that had prior shipments of subject merchandise for consumption to the United States, and did not request a new shipper review within one year of those shipments, it is ineligible for a new shipper review. First, Jianglong did not certify its first U.S. entry or shipment and U.S. sale, as required under 19 CFR 351.214(b)(2)(iv)(A) and (C), respectively. Second, Jinaglong did not request a new shipper review within one year of reporting its first U.S. entry or shipment, thus failing to satisfy the requirement of 19 CFR 351.214(c). Because Jianglong's new shipper review request does not satisfy these regulatory requirements, we are rescinding the review.
All issues raised in the case and rebuttal briefs by parties to this new shipper review are addressed in the Issues and Decision Memorandum. A list of the issues raised is attached to this notice as an appendix. The Issues and Decision Memorandum is a public document and is on file electronically via Enforcement and Compliance's Antidumping and Countervailing Duty Centralized Electronic Service System (ACCESS). ACCESS is available to registered users at
Effective upon publication of the final rescission of the new shipper review of Jianglong, we will instruct U.S. Customs and Border Protection (CBP) to discontinue the option of posting a bond or security in lieu of a cash deposit for entries of subject merchandise by Jianglong, in accordance with section 751(a)(2)(B)(iii) of the Act and 19 CFR 351.214(e). Cash deposits will be required for exports of subject merchandise by Jianglong entered, or withdrawn from warehouse, for consumption on or after the publication date at the
Entries of subject merchandise made by Jianglong covered by this new shipper review are within the POR covered by the administrative review initiated on April 3, 2015 (February 1, 2014 through January 31, 2015).
This notice also serves as a reminder to importers of their responsibility under 19 CFR 351.402(f)(2) to file a certificate regarding the reimbursement of antidumping duties prior to liquidation of the relevant entries during this review period. Failure to comply with this requirement could result in the Department's presumption that reimbursement of antidumping duties occurred and the subsequent assessment of double antidumping duties.
This new shipper review and notice are in accordance with sections 751(a)(2)(B) and 777(i) of the Act and 19 CFR 351.214(f)(3).
National Marine Fisheries Service (NMFS), National Oceanic and Atmospheric Administration (NOAA), Commerce.
Notice; public meeting.
The Pacific Fishery Management Council's (Pacific Council) Highly Migratory Species Advisory Subpanel (HMSAS) and Highly Migratory Species Management Team (HMSMT) will hold a Webinar, which is open to the public.
The Webinar will be held on Tuesday, November 3, 2015, from 1:30 p.m. to 4:30 p.m. Pacific Time, or when business for the day is complete.
To attend the webinar, visit
Dr. Kit Dahl, Pacific Council; telephone: (503) 820-2422.
The HMSMT and HMSAS will develop recommendations for the North Pacific albacore management strategy evaluation to be conducted by the International Scientific Committee for Tuna and Tuna-Like Species in the North Pacific Ocean. Recommendations may include management objectives, harvest control rules, biological reference points, and evaluation criteria. Recommendations will be forwarded to U.S. government representatives to the planned special meeting of the Western and Central Pacific Fisheries Commission Northern Committee to be held in December 2015.
The HMSAS Chair and the HMSMT Chair will act as co-chairs and comments from the public during the webinar will be received from attendees at their discretion.
Although non-emergency issues not contained in the meeting agenda may be discussed, those issues may not be the subject of formal action during this meeting. Action will be restricted to those issues specifically listed in this document and any issues arising after publication of this document that require emergency action under section 305(c) of the Magnuson-Stevens Fishery Conservation and Management Act, provided the public has been notified of the intent to take final action to address the emergency.
The listening station is physically accessible to people with disabilities. Requests for sign language interpretation or other auxiliary aids should be directed to Mr. Kris Kleinschmidt at (503) 820-2280 at least 5 days prior to the meeting date.
National Marine Fisheries Service (NMFS), National Oceanic and Atmospheric Administration (NOAA), Commerce.
Notice; public meeting.
The Pacific Fishery Management Council's (Pacific Council) Salmon Technical Team (STT), Salmon Advisory Subpanel (SAS), and Model Evaluation Workgroup (MEW) will hold a webinar, which is open to the public.
The webinar will be held on Wednesday, November 4, 2015, from 1:30 p.m. until business for the day is complete.
To attend the webinar, visit:
(See
You may send an email to
Mr. Mike Burner, Pacific Council; telephone: (503) 820-2414.
The STT, SAS, and MEW will discuss items on the Pacific Council's November 2016 meeting agenda. Major topics include, but are not limited to: Salmon Methodology Review, Salmon Management Schedule for 2016, Habitat, and 2016 Pacific Halibut Catch Sharing Plan and Management Measures. The STT, SAS, and MEW may also address one or more of the Council's scheduled Administrative Matters. Public comments during the webinar will be received from attendees at the discretion of the STT, SAS, and MEW Chairs.
Although non-emergency issues not contained in the meeting agenda may be discussed, those issues may not be the subject of formal action during this meeting. Action will be restricted to those issues specifically listed in this document and any issues arising after publication of this document that require emergency action under section 305(c) of the Magnuson-Stevens Fishery Conservation and Management Act, provided the public has been notified of the intent to take final action to address the emergency.
The meeting is physically accessible to people with disabilities. Requests for sign language interpretation or other auxiliary aids should be directed to Mr. Kris Kleinschmidt at (503) 820-2280, extension 425 at least 5 days prior to the meeting date.
National Marine Fisheries Service (NMFS), National Oceanic and Atmospheric Administration (NOAA), Commerce.
Notice of public meeting.
The North Pacific Fishery Management Council (Council) Electronic Monitoring Workgroup (EMWG) will meet November 2 and November 3, 2015.
The meeting will be held on Monday, November 2, 2015, from 1 p.m. to 5 p.m. and on Tuesday, November 3, 2015, from 8 a.m. to 5 p.m.
The meeting will be held at the Anchorage Marriott Downtown Hotel, 820 W. 7th Ave., Juneau/Haines Room, Anchorage, AK 99501.
Diana Evans, Council staff; telephone: (907) 271-2809.
The agenda will include: (a) Update on 2015 cooperative research, (b) Discuss elements of 2016 EM Pre-implementation Program, (c) Review budget, (d) Plan for EM Integration Analysis, (e) Discuss other 2016 EM research, and (f) Other business and scheduling. The Agenda is subject to change, and the latest version will be posted at
These meetings are physically accessible to people with disabilities. Requests for sign language interpretation or other auxiliary aids should be directed to Shannon Gleason at (907) 271-2809 at least 7 working days prior to the meeting date.
National Marine Fisheries Service (NMFS), National Oceanic and Atmospheric Administration (NOAA), Commerce.
Notice of public meetings of the South Atlantic Fishery Management Council's Snapper Grouper Advisory Panel (AP) and Information and Education AP.
The South Atlantic Fishery Management Council (SAFMC) will hold meetings of its Snapper Grouper AP and Information & Education AP in North Charleston, SC.
The Snapper Grouper AP will meet from 1:30 p.m. on Tuesday, November 3, 2015 until 5 p.m. on Wednesday, November 4, 2015. The Information and Education AP meeting will be held Thursday, November 5, 2015, from 9 a.m. until 5 p.m.
Kim Iverson, Public Information Officer, SAFMC; phone: (843) 571-4366 or toll free: (866) SAFMC-10; fax: (843) 769-4520; email:
The items of discussion in the individual meeting agendas are as follows:
1. The AP will receive updates on the status of Amendments under development and recently implemented and the October meeting of the SAFMC Scientific and Statistical Committee
2. The AP will review and provide recommendations as appropriate on the following Amendments currently under development:
a. Amendment 37 to the Snapper Grouper Fishery Management Plan (hogfish)
b. Amendment 25 (blueline tilefish, yellowtail snapper, and black sea bass)
c. Amendment 36 (Spawning Special Management Zones)
d. Joint South Atlantic (SA)/Gulf of Mexico (GM) Amendment on South Florida Issues (Yellowtail Snapper Acceptable Biological Catch and Annual Catch Limits & Accountability Measures)
e. Joint SA/GM Charterboat Electronic Reporting Amendment
3. Update on Atlantic Coastal Cooperative Statistics Program proposal for electronic reporting for charter fleet
4. Update on the October 2015 Council Visioning Workshop
The Information and Education AP will receive updates on the following and provide recommendations as appropriate:
1. SAFMC System Management Plan—Outreach Sections
2. SAFMC Vision Blueprint for the Snapper Grouper Fishery—Communication Goal
3. SAFMC Technical Documents and Public Input Strategies
4. SAFMC Fishery Citizen Science Initiative
5. Marine Resource Education Program—South East
6. 2016 SAFMC Outreach Projects
These meetings are physically accessible to people with disabilities. Requests for auxiliary aids should be directed to the council office (see
The times and sequence specified in this agenda are subject to change.
16 U.S.C. 1801
National Ocean Service, National Oceanic and Atmospheric Administration (NOAA), Department of Commerce.
Notice of open meeting.
Notice is hereby given of a meeting of the U.S. Integrated Ocean Observing System (IOOS®) Advisory Committee (Committee) in St. Thomas, USVI.
The meeting will be held on Tuesday, November 3, 2015, from 8:30 a.m. to 5:30 p.m. and on Wednesday, November 4, 2015, from 8:30 a.m.-3:00 p.m. These times and the agenda topics described below are subject to change. Refer to the Web page listed below for the most up-to-date meeting agenda.
The meeting will be held at the University of the Virgin Islands—St. Thomas, ACC Building 1st Floor
Jessica Snowden, Alternate Designated Federal Official, U.S. IOOS Advisory Committee, U.S. IOOS Program, 1315 East-West Highway, Second Floor, Silver Spring, MD 20910; Phone 301-713-3070 x 141; Fax 301-713-3281; Email
The Committee was established by the NOAA Administrator as directed by Section 12304 of the Integrated Coastal and Ocean Observation System Act, part of the Omnibus Public Land Management Act of 2009 (Pub. L. 111-11). The Committee advises the NOAA Administrator and the Interagency Ocean Observation Committee (IOOC) on matters related to the responsibilities and authorities set forth in section 12302 of the Integrated Coastal and Ocean Observation System Act of 2009 and other appropriate matters as the Under Secretary refers to the Committee for review and advice.
The Committee will provide advice on:
(a) Administration, operation, management, and maintenance of the System;
(b) expansion and periodic modernization and upgrade of technology components of the System;
(c) identification of end-user communities, their needs for information provided by the System, and the System's effectiveness in dissemination information to end-user communities and to the general public; and
(d) any other purpose identified by the Under Secretary of Commerce for Oceans and Atmosphere or the Interagency Ocean Observation Committee.
The meeting will be open to public participation with a 30-minute public comment period on November 3, 2015, from 3:30 p.m. to 4:00 p.m. and on November 4, 2015, from 2:15 p.m. to 2:45 p.m. (check agenda on Web site to confirm time.) The Committee expects that public statements presented at its meetings will not be repetitive of previously submitted verbal or written statements. In general, each individual or group making a verbal presentation will be limited to a total time of three (3) minutes. Written comments should be received by the Designated Federal Official by October 22, 2015 to provide sufficient time for Committee review. Written comments received after October 22, 2015, will be distributed to the Committee, but may not be reviewed prior to the meeting date. Seats will be available on a first-come, first-served basis.
National Marine Fisheries Service (NMFS), National Oceanic and Atmospheric Administration (NOAA), Commerce.
Notice of public meeting (Webinar).
The Pacific Fishery Management Council (Pacific Council) will convene a Webinar meeting of its Coastal Pelagic Species Advisory Subpanel (CPSAS). The meeting is open to the public.
The Webinar will be held Monday, November 2, 2015, from 1 p.m. to 2:30 p.m. Pacific Standard Time.
To attend the webinar, visit:
Kerry Griffin, Staff Officer; telephone: (503) 820-2409.
The primary purpose of the meeting is to discuss agenda items on the November 2015 Pacific Council meeting agenda. Topics may include the Pacific sardine distribution workshop report, anchovy general status, data-limited stock assessments for CPS, and/or methodology review topic selection.
Action will be restricted to those issues specifically listed in this notice and any issues arising after publication of this notice that require emergency action under Section 305(c) of the Magnuson-Stevens Fishery Conservation and Management Act, provided the public has been notified of the CPSAS's intent to take final action to address the emergency.
The public listening station is physically accessible to people with disabilities. Requests for sign language interpretation or other auxiliary aids should be directed to Mr. Kris Kleinschmidt, (503) 820-2280, at least 5 days prior to the meeting date.
National Marine Fisheries Service (NMFS), National Oceanic and Atmospheric Administration (NOAA), Commerce.
Notice; public meeting.
The Pacific Fishery Management Council's (Pacific Council) Groundfish Management Team (GMT) will hold a webinar that is open to the public.
The GMT meeting will be held Thursday, November 5, 2015, from 9 a.m. until 12 p.m.
To attend the webinar (1) join the meeting by visiting this link
You may send an email to
Ms. Kelly Ames, Pacific Council; telephone: (503) 820-2426.
The primary purpose of the GMT working meeting is to prepare for the November 2015 Pacific Council meeting. The GMT may also address other assignments relating to groundfish management. No management actions will be decided by the GMT. Public comment will be accommodated if time allows, at the discretion of the GMT Chair. The GMT's task will be to develop recommendations for consideration by the Pacific Council at its November 13-19, 2015 meeting in Garden Grove, CA.
Although non-emergency issues not contained in the meeting agenda may be discussed, those issues may not be the subject of formal action during these meetings. Action will be restricted to those issues specifically listed in this document and any issues arising after publication of this document that require emergency action under section 305(c) of the Magnuson-Stevens Fishery Conservation and Management Act, provided the public has been notified of the intent to take final action to address the emergency.
The public listening station is physically accessible to people with disabilities. Requests for sign language interpretation or other auxiliary aids should be directed to Mr. Kris Kleinschmidt at (503) 820-2425 at least 5 days prior to the meeting date.
Committee for Purchase from People Who Are Blind or Severely Disabled.
Addition to the Procurement List.
This action adds a product to the Procurement List that will be furnished by the nonprofit agency employing persons who are blind or have other severe disabilities.
Committee for Purchase from People Who Are Blind or Severely Disabled, 1401 S. Clark Street, Suite 715, Arlington, Virginia 22202-4149.
Barry S. Lineback, Telephone: (703) 603-7740, Fax: (703) 603-0655, or email
On 9/4/2015 (80 FR 53501-53502), the Committee for Purchase from People Who Are Blind or Severely Disabled published notice of proposed addition to the Procurement List.
After consideration of the material presented to it concerning capability of qualified nonprofit agency to provide the product and impact of the addition on the current or most recent contractors, the Committee has determined that the product listed below is suitable for procurement by the Federal Government under 41 U.S.C.s 8501-8506 and 41 CFR 51-2.4.
I certify that the following action will not have a significant impact on a substantial number of small entities. The major factors considered for this certification were:
1. The action will not result in any additional reporting, recordkeeping or other compliance requirements for small entities other than the small organization that will furnish the product to the Government.
2. The action will result in authorizing a small entity to furnish the product to the Government.
3. There are no known regulatory alternatives which would accomplish the objectives of the Javits-Wagner-O'Day Act (41 U.S.C. sections 8501-8506) in connection with the product proposed for addition to the Procurement List.
Accordingly, the following product is added to the Procurement List:
Consumer Product Safety Commission.
Notice.
In accordance with the requirements of the Paperwork Reduction Act (“PRA”) of 1995 (44 U.S.C. chapter 35), the Consumer Product Safety Commission (“Commission” or “CPSC”) announces that the Commission has submitted to the Office of Management and Budget (“OMB”) a request for extension of approval of a collection of information associated with notification requirements for coal and wood burning appliances (OMB No. 3041-0040). In the
Written comments on this request for extension of approval of information collection requirements
Submit comments about this request by email:
For further information contact: Robert H. Squibb, Consumer Product Safety Commission, 4330 East West Highway, Bethesda, MD 20814; (301) 504-7815, or by email to:
CPSC has submitted the following currently approved collection of information to OMB for extension:
Consumer Product Safety Commission.
Notice.
In accordance with the requirements of the Paperwork Reduction Act (“PRA”) of 1995 (44 U.S.C. chapter 35), the Consumer Product Safety Commission (“Commission” or “CPSC”) announces that the Commission has submitted to the Office of Management and Budget (“OMB”) a request for extension of approval of a collection of information associated with the Standard for the Surface Flammability of Carpets and Rugs (16 CFR part 1630) and the Standard for the Surface Flammability of Small Carpets and Rugs (16 CFR part 1631) previously approved under OMB No. 3041-0017. In the
Written comments on this request for extension of approval of information collection requirements should be submitted by November 16, 2015.
Submit comments about this request by email:
For further information contact: Robert H. Squibb, Consumer Product Safety Commission, 4330 East West Highway, Bethesda, MD 20814; (301) 504-7815, or by email to:
CPSC has submitted the following currently approved collection of information to OMB for extension:
Office of the Under Secretary of Defense for Personnel and Readiness/National Security Education Program, DoD.
Notice.
In compliance with the
Consideration will be given to all comments received by December 15, 2015.
You may submit comments, identified by docket number and title, by any of the following methods:
•
•
Any associated form(s) for this collection may be located within this same electronic docket and downloaded for review/testing. Follow the instructions at
To request more information on this proposed information collection or to obtain a copy of the proposal and associated collection instruments, please write to the Office of the Under Secretary of Defense for Personnel and Readiness/National Security Education Program,
The DD Form 2932,
The supplemental documents are used to determine eligibility for membership in the NLSC. The DD Form 2934,
The information collected in the application and the supplemental documents is used solely by the NLSC.
Office of the Secretary of Defense (OSD), DoD.
Notice of board membership.
This notice announces the appointment of the Department of Defense, Fourth Estate, Performance Review Board (PRB) members, to include the Office of the Secretary of Defense, Joint Staff, Defense Field Activities, U.S Court of Appeals for the Armed Forces, and the following Defense Agencies: Defense Advanced Research Projects Agency, Defense Commissary Agency, Defense Contract Audit Agency, Defense Contract Management Agency, Defense Finance and Accounting Service, Defense Health Agency, Defense Information Systems Agency, Defense Legal Services Agency, Defense Logistics Agency, Defense Prisoners of War/Missing in Action Accounting Agency, Defense Security Cooperation Agency, Defense Threat Reduction Agency, Missile Defense Agency, and Pentagon Force Protection Agency. The PRB shall provide fair and impartial review of Senior Executive Service and Senior Professional performance appraisals and make recommendations regarding performance ratings and performance awards to the Deputy Secretary of Defense.
Michael L. Watson, Assistant Director for Office of the Secretary of Defense Senior Executive Management Office, Office of the Deputy Chief Management Officer, Department of Defense, (703) 693-8373.
The publication of PRB membership is required by 5 U.S.C. 4314(c)(4). In accordance with 5 U.S.C. 4314(c)(4), the following executives are appointed to the Office of the Secretary of Defense PRB with specific PRB panel assignments being made from this group. Executives listed will serve a one-year renewable term, effective September 12, 2015.
Defense Nuclear Facilities Safety Board.
Notice of public business meeting.
Pursuant to the provisions of the “Government in the Sunshine Act” (5 U.S.C. 552b), notice is hereby given of the Defense Nuclear Facilities Safety Board's (Board) public business meeting described below.
Mark Welch, General Manager, Defense Nuclear Facilities Safety Board, 625 Indiana Avenue NW., Suite 700, Washington, DC 20004-2901, (800) 788-4016. This is a toll-free number.
The business meeting agenda is posted on the Board's public Web site. The public is invited to view this business meeting and provide comments. A transcript of the business meeting, along with a DVD video recording, will be made available by the Board for inspection and viewing by the public at the Board's Washington office. The Board specifically reserves its right to further schedule and otherwise regulate the course of the business meeting, to recess, reconvene, postpone, or adjourn the meeting, and otherwise exercise its rights under the Atomic Energy Act, the Government in the Sunshine Act and the Board's Operating Procedures.
Federal Student Aid (FSA), Department of Education (ED).
Notice.
In accordance with the Paperwork Reduction Act of 1995 (44 U.S.C. chapter 3501
Interested persons are invited to submit comments on or before December 15, 2015.
To access and review all the documents related to the information collection listed in this notice, please use
For specific questions related to collection activities, please contact Beth Grebeldinger, 202-377-4018.
The Department of Education (ED), in accordance with the Paperwork Reduction Act of 1995 (PRA) (44 U.S.C. 3506(c)(2)(A)), provides the general public and Federal agencies with an opportunity to comment on proposed, revised, and continuing collections of information. This helps the Department assess the impact of its information collection requirements and minimize the public's reporting burden. It also helps the public understand the Department's information collection requirements and provide the requested data in the desired format. ED is soliciting comments on the proposed information collection request (ICR) that is described below. The Department of Education is especially interested in public comment addressing the following issues: (1) Is this collection necessary to the proper functions of the Department; (2) will this information be processed and used in a timely manner; (3) is the estimate of burden accurate; (4) how might the Department enhance the quality, utility, and clarity of the information to be collected; and (5) how might the Department minimize the burden of this collection on the respondents, including through the use of information technology. Please note that written comments received in response to this notice will be considered public records.
Federal Student Aid (FSA), Department of Education (ED).
Notice.
In accordance with the Paperwork Reduction Act of 1995 (44 U.S.C. chapter 3501
Interested persons are invited to submit comments on or before December 15, 2015.
To access and review all the documents related to the information collection listed in this notice, please use
For specific questions related to collection activities, please contact Beth Grebeldinger, 202-377-4018.
The Department of Education (ED), in accordance with the Paperwork Reduction Act of 1995 (PRA) (44 U.S.C. 3506(c)(2)(A)), provides the general public and Federal agencies with an opportunity to comment on proposed, revised, and continuing collections of information. This helps the Department assess the impact of its information collection requirements and minimize the public's reporting burden. It also helps the public understand the Department's information collection requirements and provide the requested data in the desired format. ED is soliciting comments on the proposed information collection request (ICR) that is described below. The Department of Education is especially interested in public comment addressing the following issues: (1) Is this collection necessary to the proper functions of the Department; (2) will this information be processed and used in a timely manner; (3) is the estimate of burden accurate; (4) how might the Department enhance the quality, utility, and clarity of the information to be collected; and (5) how might the Department minimize the burden of this collection on the respondents, including through the use of information technology. Please note that written comments received in response to this notice will be considered public records.
In accordance with the National Environmental Policy Act of 1969 and the Federal Energy Regulatory Commission's (Commission or FERC's) regulations, 18 Code of Federal Regulations (CFR) Part 380, the Office of Energy Projects has reviewed Northern Indiana Public Service Company's application for amendment of the license for the Norway-Oakdale Hydroelectric Project (FERC Project No. 12514-074), on the Tippecanoe River near the city of Monticello in Carroll and White Counties, Indiana. The project does not occupy any federal lands.
Staff prepared a draft environmental assessment (EA) to analyze the potential environmental effects of implementing the proposed modified definition of abnormal flow conditions, as required by article 405 of the current license (issued October 2, 2007), that would be included in a revised article 403, which defines the operation of the project. Staff concludes that authorizing the amendment, with staff's recommended modification to the definition of abnormal river conditions, would not constitute a major federal action that would significantly affect the quality of the human environment.
A copy of the EA is available for review at the Commission in the Public Reference Room or may be viewed on the Commission's Web site at
You may also register online at
Any comments should be filed within 30 days from the date of this notice. Comments may be filed electronically via the Internet. See 18 CFR 385.2001(a)(1)(iii) and the instructions on the Commission's Web site at
For further information, contact Rebecca Martin by telephone at 202-502-6012 or Mark Pawlowski at 202-502-6052.
Section 309(a) of the Clean Air Act requires that EPA make public its comments on EISs issued by other Federal agencies. EPA's comment letters on EISs are available at:
Environmental Protection Agency (EPA).
Notice.
The Environmental Protection Agency (EPA) is planning to submit an information collection request (ICR), “Hazardous Chemical Reporting: The Emergency and Hazardous Chemical Inventory Forms (Tier I and Tier II)” (EPA ICR No. 2436.03, OMB Control No. 2050-0206) to the Office of Management and Budget (OMB) for review and approval in accordance with the Paperwork Reduction Act. Before doing so, EPA is soliciting public comments on specific aspects of the proposed information collection as described below. This is a proposed extension of the ICR, which is currently approved through March 31, 2016. An Agency may not conduct or sponsor and a person is not required to respond to a collection of information unless it
Comments must be submitted on or before December 15, 2015.
Submit your comments, referencing Docket ID No. EPA-HQ-SFUND-2010-0763 referencing the Docket ID numbers provided for each item in the text, online using
EPA's policy is that all comments received will be included in the public docket without change including any personal information provided, unless the comment includes profanity, threats, information claimed to be Confidential Business Information (CBI) or other information whose disclosure is restricted by statute.
Sicy Jacob, Office of Emergency Management, Mail Code 5104A, Environmental Protection Agency, 1200 Pennsylvania Ave. NW., Washington, DC 20460; telephone number: (202) 564-8019; fax number: (202) 564-2620; email address:
Supporting documents which explain in detail the information that the EPA will be collecting are available in the public docket for this ICR. The docket can be viewed online at
Pursuant to section 3506(c)(2)(A) of the PRA, EPA is soliciting comments and information to enable it to: (i) Evaluate whether the proposed collection of information is necessary for the proper performance of the functions of the Agency, including whether the information will have practical utility; (ii) evaluate the accuracy of the Agency's estimate of the burden of the proposed collection of information, including the validity of the methodology and assumptions used; (iii) enhance the quality, utility, and clarity of the information to be collected; and (iv) minimize the burden of the collection of information on those who are to respond, including through the use of appropriate automated electronic, mechanical, or other technological collection techniques or other forms of information technology,
Environmental Protection Agency (EPA).
Notice.
EPA is announcing its receipt of test data submitted pursuant to a test rule issued by EPA under the Toxic Substances Control Act (TSCA). As required by TSCA, this document identifies each chemical substance and/or mixture for which test data have been received; the uses or intended uses of such chemical substance and/or mixture; and describes the nature of the
Information about the following chemical substances and/or mixtures is provided in Unit IV.:
Section 4(d) of TSCA (15 U.S.C. 2603(d)) requires EPA to publish a notice in the
A docket, identified by the docket identification (ID) number EPA-HQ-OPPT-2013-0677, has been established for this
The docket for this
This unit contains the information required by TSCA section 4(d) for the test data received by EPA.
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Environmental Protection Agency (EPA).
Notice.
EPA has received applications to register new uses for pesticide products containing currently registered active ingredients. Pursuant to the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA), EPA is hereby providing notice of receipt and opportunity to comment on these applications.
Comments must be received on or before November 16, 2015.
Submit your comments, identified by docket identification (ID) number EPA-HQ-OPP-2015-0022 and the File Symbol or Registration Number of interest as shown in the body of this document, by one of the following methods:
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Susan Lewis, Registration Division (7505P), Office of Pesticide Programs, Environmental Protection Agency, 1200 Pennsylvania Ave. NW., Washington, DC 20460-0001; main telephone number: (703) 305-7090; email address:
You may be potentially affected by this action if you are an agricultural producer, food manufacturer, or pesticide manufacturer. The following list of North American Industrial Classification System (NAICS) codes is not intended to be exhaustive, but rather provides a guide to help readers determine whether this document applies to them. Potentially affected entities may include:
• Crop production (NAICS code 111).
• Animal production (NAICS code 112).
• Food manufacturing (NAICS code 311).
• Pesticide manufacturing (NAICS code 32532).
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EPA has received applications to register new uses for pesticide products containing currently registered active ingredients. Pursuant to the provisions of FIFRA section 3(c)(4) (7 U.S.C. 136a(c)(4)), EPA is hereby providing notice of receipt and opportunity to comment on these applications. Notice of receipt of these applications does not imply a decision by the Agency on these applications.
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Federal Communications Commission.
Notice and request for comments.
As part of its continuing effort to reduce paperwork burdens, and as required by the Paperwork Reduction Act (PRA) of 1995 (44 U.S.C. 3501-3520), the Federal Communications Commission (FCC or the Commission) invites the general public and other Federal agencies to take this opportunity to comment on the following information collection. Comments are requested concerning: Whether the proposed collection of information is necessary for the proper performance of the functions of the Commission, including whether the information shall have practical utility; the accuracy of the Commission's burden estimate; ways to enhance the quality, utility, and clarity of the information collected; ways to minimize the burden of the collection of information on the respondents, including the use of automated collection techniques or other forms of information technology; and ways to further reduce the information collection burden on small business concerns with fewer than 25 employees.
The FCC may not conduct or sponsor a collection of information unless it displays a currently valid control number. No person shall be subject to any penalty for failing to comply with a collection of information subject to the PRA that does not display a valid Office of Management and Budget (OMB) control number.
Written PRA comments should be submitted on or before December 15, 2015. If you anticipate that you will be submitting comments, but find it difficult to do so within the period of time allowed by this notice, you should advise the contact listed below as soon as possible.
Direct all PRA comments to Cathy Williams, FCC, via email
For additional information about the information collection, contact Cathy Williams at (202) 418-2918.
Section 90.443(c) requires that at least one licensee participating in the cost arrangement must maintain cost sharing records.
Federal Maritime Commission.
October 21, 2015; 10 a.m.
800 N. Capitol Street NW., First Floor Hearing Room, Washington, DC.
The first portion of the meeting will be held in Open Session; the second in Closed Session.
Karen V. Gregory, Secretary, (202) 523 5725.
Federal Trade Commission (FTC or Commission).
Notice.
The information collection requirements described below will be submitted to the Office of Management and Budget (OMB) for review, as required by the Paperwork Reduction Act (PRA). The FTC seeks public comments on its proposal to extend, for three years, the current PRA clearance for information collection requirements contained in the rules and regulations under the Health Breach Notification Rule. This clearance expires on March 31, 2016.
Comments must be received on or before December 15, 2015.
Interested parties may file a comment online or on paper by following the instructions in the Request for Comments part of the
Requests for copies of the collection of information and supporting documentation should be addressed to Cora Tung Han, 202-326-2441, Attorney, Privacy & Identity Protection, Bureau of Consumer Protection, 600 Pennsylvania Ave. NW., Washington, DC 20580.
On February 17, 2009, President Obama signed the American Recovery and Reinvestment Act of 2009 (the Recovery Act or the Act) into law. The Act included provisions to advance the use of health information technology and, at the same time, strengthen privacy and security protections for health information. The Act required the FTC to adopt a rule implementing the breach notification requirements applicable to vendors of personal health records, “PHR related entities,”
The Health Breach Notification Rule (Rule), 16 CFR part 318, requires vendors of personal health records and PHR related entities to provide: (1) Notice to consumers whose unsecured personally identifiable health information has been breached; and (2) notice to the Commission. The Rule only applies to electronic health records and does not include recordkeeping requirements. The Rule requires third party service providers (
These notification requirements are subject to the provisions of the PRA, 44 U.S.C. Chapter 35. Under the PRA, federal agencies must get OMB approval for each collection of information they conduct, sponsor, or require. “Collection of information” means agency requests or requirements to submit reports, keep records, or provide information to a third party. 44 U.S.C. 3502(3); 5 CFR 1320.3(c). As required by Section 3506(c)(2)(A) of the PRA, the FTC is providing this opportunity for public comment before requesting that OMB extend the existing PRA clearance for the information collection requirements associated with the Commission's rules and regulations under the Health Breach Notification Rule (or Rule), 16 CFR part 318 (OMB Control Number 3084-0150).
The FTC invites comments on: (1) Whether the proposed collection of information is necessary for the proper performance of the functions of the agency, including whether the information will have practical utility; (2) the accuracy of the agency's estimate of the burden of the proposed collection of information, including the validity of the methodology and assumptions used; (3) ways to enhance the quality, utility, and clarity of the information to be collected; and (4) ways to minimize the burden of the collection of information on those who are to respond. All
In the Commission's view, it has maximized the practical utility of the breach notification requirements in the Rule, consistent with the requirements of the Recovery Act. Under the Rule, consumers whose information has been affected by a breach of security receive notice of it “without unreasonable delay and in no case later than 60 calendar days” after discovery of the breach. Among other information, the notices must provide consumers with steps they can take to protect themselves from harm. Moreover, the breach notice requirements encourage entities to safeguard the information of their customers, thereby potentially reducing the incidence of harm.
The form entities must use to inform the Commission of a security breach requests minimal information, mostly as replies to check boxes; thus, entities do not require extensive time to complete it. For breaches involving the health information of 500 or more individuals, entities must notify the Commission as soon as possible, and in any event no later than ten business days after discovering the breach. Breaches involving the information of fewer than 500 individuals may be reported in an annual submission that includes all breaches within the calendar year that fall within this category. The form serves the Commission by providing the agency with information about breaches occurring in the PHR industry.
The Commission inputs the information it receives from entities into a database that the Commission updates periodically. The Commission makes certain information about these breaches available to the public. This publicly-available information serves businesses and the public. It provides businesses with information about potential causes of data breaches, which is particularly helpful to those setting up data security procedures. It also provides the public with information about the extent of data breaches. Thus, in the Commission's view, the Rule and form have significant practical utility.
Pursuant to § 318.5 of the Rule, entities must notify the FTC “according to instructions at the Federal Trade Commission's Web site.” In 2009, the Commission indicated that “[d]ue to security concerns associated with email transmission, the Commission will not accept emailed forms at this time.”
The PRA burden of the Rule's requirements depends on a variety of factors, including the number of covered firms; the percentage of such firms that will experience a breach requiring further investigation and, if necessary, the sending of breach notices; and the number of consumers notified. The annual hours and cost estimates below likely overstate the burden because, among other things, they assume, though it is not necessarily so, that all breaches subject to the Rule's notification requirements will be required to take all of the steps described below.
At the time the Rule was issued, insufficient data was available about the incidence of breaches in the PHR industry. Accordingly, staff based its burden estimate on data pertaining to private sector breaches across multiple industries. Staff estimated that there would be 11 breaches per year requiring notification of 232,000 consumers.
As described above, the Rule requires covered entities that have suffered a breach to notify the Commission. Since the Rule has now been in effect for over five years,
On average, about 2,500 consumers per year received notifications over the years 2010 and 2011. In 2012 and 2013, between 4,000 and 5,000 consumers received notifications each year. In 2014, approximately 17,993 consumers received notifications. In light of this upwards trend, staff bases its current burden estimate on an assumed two breach incidents per year that, together, require the notification of approximately 40,000 consumers. This estimate will likely overstate the burden; however, as consumers increasingly download their information into personal health records,
As explained in more detail within the next section, FTC staff projects that covered firms will require on average, per breach, 100 hours of employee labor to determine what information has been breached, identify the affected customers, prepare the breach notice, and make the required report to the Commission. Based on an estimated 2 breaches per year, yearly hourly burden would be 200 hours. Additionally, staff expects covered firms will require 3,067 annual hours (1,067 hours of telephone operator time + 2000 hours of information processor time) to process calls they may receive in the event of a data breach.
FTC staff projects that covered firms will require on average, per breach, 100 hours of employee labor to determine what information has been breached, identify the affected customers, prepare the breach notice, and make the required report to the Commission, at an estimated cost of $5,732
The breakdown of labor hours and costs is as follows: 50 hours of computer and information systems managerial time at approximately $66 per hour; 12 hours of marketing manager time at $66 per hour; 33 hours of computer programmer time at $40 per hour; and 5 hours of legal staff time at $64 per hour.
Additionally, covered entities will incur labor costs associated with processing calls they may receive in the event of a data breach. The rule requires that covered entities that fail to contact 10 or more consumers because of insufficient or out-of-date contact information must provide substitute
Individuals contacted directly will have already received this information. Staff estimates that no more than 10 percent of affected consumers will utilize the offered toll-free number. Thus, of the 40,000 consumers affected by a breach annually, staff estimates that 4,000 may call the companies over the 90 days they are required to provide such access. Staff additionally projects that 4,000 additional consumers who are not affected by the breach will also call the companies during this period. Staff estimates that processing all 8,000 calls will require an average of 3,067 hours of employee labor at a cost of $50,300.
Accordingly, estimated cumulative annual labor costs, excluding outside forensic services, is $62,000.
Commission staff anticipates that capital and other non-labor costs associated with the Rule will consist of the following:
1. The services of a forensic expert in investigating the breach;
2. notification of consumers via email, mail, web posting, or media; and
3. the cost of setting up a toll-free number, if needed.
Staff estimates that covered firms (breached entities) will require 30 hours of a forensic expert's time, at a cumulative cost of $3,960 for each breach. This is the product of hourly wages of an information security analyst ($44), tripled to reflect profits and overhead for an outside consultant ($132), and multiplied by 30 hours. Based on the estimate that there will be 2 breaches per year, the annual cost associated with the services of an outside forensic expert is $7,920.
As explained above, staff estimates that an average of 40,000 consumers per year will receive a breach notification. Given the online relationship between consumers and vendors of personal health records and PHR related entities, most notifications will be made by email and the cost of such notifications will be minimal.
In some cases, however, vendors of personal health records and PHR related entities will need to notify individuals by postal mail, either because these individuals have asked for such notification, or because the email addresses of these individuals are not current or not working. Staff estimates that the cost of a mailed notice is $0.06 for the paper and envelope, and $0.49 for a first class stamp. Assuming that vendors of personal health records and PHR related entities will need to notify by postal mail 10 percent of the 40,000 customers whose information is breached, the estimated cost of this notification will be $2,200 per year.
In addition, vendors of personal health records and PHR related entities sometimes may need to notify consumers by posting a message on their home page, or by providing media notice. Based on a recent study on data breach costs, staff estimates the cost of providing notice via Web site posting to be $0.06 per breached record, and the cost of providing notice via published media to be $0.03 per breached record.
Finally, staff estimates that the cost of providing a toll-free number will depend on the costs associated with T1 lines sufficient to handle the projected call volume and the cost of obtaining a toll-free telephone number.
In sum, the total estimate for non-labor costs is $49,960: $7,920 (services of a forensic expert) + $5,800 (costs of notifying consumers) + $36,240 (cost of providing a toll-free number).
The total estimated PRA annual cost burden is $61,764 (labor costs) + $49,960 (non-labor costs) = approximately $112,000 (rounded to the nearest thousand).
You can file a comment online or on paper. Write “Health Breach Notification Rule, PRA Comments, P-125402” on your comment. Your comment—including your name and your state—will be placed on the public record of this proceeding, including, to the extent practicable, on the public Commission Web site, at
Because your comment will be made public, you are solely responsible for making sure that your comment does not include any sensitive personal information, such as a Social Security number, date of birth, driver's license number or other state identification number or foreign country equivalent, passport number, financial account number, or credit or debit card number. You are also solely responsible for making sure that your comment does not include any sensitive health information, such as medical records or other individually identifiable health information. In addition, do not include any “[t]rade secret or any commercial or financial information which is . . . privileged or confidential,” as discussed in Section 6(f) of the FTC Act, 15 U.S.C. 46(f), and FTC Rule 4.10(a)(2), 16 CFR 4.10(a)(2). In particular, do not include competitively sensitive information such as costs, sales statistics,
If you want the Commission to give your comment confidential treatment, you must file it in paper form, with a request for confidential treatment, and you must follow the procedure explained in FTC Rule 4.9(c), 16 CFR 4.9(c). Your comment will be kept confidential only if the FTC General Counsel, in his or her sole discretion, grants your request in accordance with the law and the public interest. Postal mail addressed to the Commission is subject to delay due to heightened security screening. As a result, the Commission encourages you to submit your comments online. To make sure that the Commission considers your online comment, you must file it at
If you file your comment on paper, write “Health Breach Notification Rule, PRA Comments, P-125402” on your comment and on the envelope, and mail it to the following address: Federal Trade Commission, Office of the Secretary, 600 Pennsylvania Avenue NW., Suite CC-5610, (Annex J), Washington, DC 20580, or deliver your comment to the following address: Federal Trade Commission, Office of the Secretary, Constitution Center, 400 7th Street SW., 5th Floor, Suite 5610, (Annex J), Washington, DC 20024. If possible, submit your paper comment to the Commission by courier or overnight service.
The FTC Act and other laws that the Commission administers permit the collection of public comments to consider and use in this proceeding as appropriate. The Commission will consider all timely and responsive public comments that it receives on or before December 15, 2015. You can find more information, including routine uses permitted by the Privacy Act, in the Commission's privacy policy, at
Agency for Healthcare Research and Quality (AHRQ).
Notice of public meeting.
In accordance with section 10(a) of the Federal Advisory Committee Act, 5 U.S.C. App. 2, this notice announces a meeting of the National Advisory Council for Healthcare Research and Quality.
The meeting will be held on Tuesday, November 3, 2015, from 8:30 a.m. to 2:45 p.m.
The meeting will be held at the Hubert H. Humphrey Building, Room 800, 200 Independence Avenue SW., Washington, DC 20201.
Jaime Zimmerman, Designated Management Official, at the Agency for Healthcare Research and Quality, 540 Gaither Road, Rockville, Maryland, 20850, (301) 427-1456. For press-related information, please contact Alison Hunt at (301) 427-1244.
If sign language interpretation or other reasonable accommodation for a disability is needed, please contact the Food and Drug Administration (FDA) Office of Equal Employment Opportunity and Diversity Management on (301) 827-4840, no later than Friday, October 23, 2015. The agenda, roster, and minutes are available from Ms. Bonnie Campbell, Committee Management Officer, Agency for Healthcare Research and Quality, 540 Gaither Road, Rockville, Maryland, 20850. Ms. Campbell's phone number is (301) 427-1554.
The National Advisory Council for Healthcare Research and Quality is authorized by Section 941 of the Public Health Service Act, 42 U.S.C. 299c. In accordance with its statutory mandate, the Council is to advise the Secretary of the Department of Health and Human Services and the Director, Agency for Healthcare Research and Quality (AHRQ), on matters related to AHRQ's conduct of its mission including providing guidance on (A) priorities for health care research, (B) the field of health care research including training needs and information dissemination on health care quality and (C) the role of the Agency in light of private sector activity and opportunities for public private partnerships.
The Council is composed of members of the public, appointed by the Secretary, and Federal ex-officio members specified in the authorizing legislation.
On Tuesday, November 3, 2015, there will be a subcommittee meeting for the National Healthcare Quality and Disparities Report scheduled to begin at 7:30 a.m. The subcommittee meeting is open the public. The Council meeting will convene at 8:30 a.m., with the call to order by the Council Chair and approval of previous Council summary notes. The meeting is open to the public and will be available via webcast at
Agency for Toxic Substances and Disease Registry (ATSDR), Department of Health and Human Services (HHS).
Notice of availability and request for comment.
The Agency for Toxic Substances and Disease Registry (ATSDR), located within the Department of Health and Human Services (HHS) announces the availability of Set 27 Toxicological Profiles for review and comment. The Comprehensive Environmental Response, Compensation, and Liability Act of 1980 (CERCLA), as amended by
Comments can include additional information or reports on studies about the health effects of Set 27 substances. Although ATSDR considered key studies for each of these substances during the profile development process, the
Written comments on this draft Toxicological Profile must be received on or before January 14, 2016.
You may submit comments, identified by docket number ATSDR-2015-0002, by any of the following methods:
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Ms. Delores Grant, Division of Toxicology and Human Health Sciences, Agency for Toxic Substances and Disease Registry, 1600 Clifton Rd. NE., MS F-57, Atlanta, GA 30329. Phone: (800) 232-4636 or 770-488-3351.
The Superfund Amendments and Reauthorization Act (SARA) (Pub. L. 99-499) amends the Comprehensive Environmental Response, Compensation, and Liability Act (CERCLA or Superfund) (42 U.S.C. 9601
Each profile will include an examination, a summary, and an interpretation of available toxicological information and epidemiological evaluations. This information and these data identify the levels of significant human exposure for the substance and for the associated health effects. The profiles must also include a determination of whether adequate information on the health effects of each substance is available (or in the process of development) in order to identify levels of significant human exposure. If adequate information is not available, ATSDR, in cooperation with the National Toxicology Program (NTP), is required to ensure the initiation of a program of research to provide such information.
The Set 27 Toxicological Profiles are available online at
Centers for Medicare & Medicaid Services, HHS.
Notice.
The Centers for Medicare & Medicaid Services (CMS) is announcing an opportunity for the public to comment on CMS' intention to collect information from the public. Under the Paperwork Reduction Act of 1995 (the PRA), federal agencies are required to publish notice in the
Comments must be received by
When commenting, please reference the document identifier or OMB control number. To be assured consideration, comments and recommendations must be submitted in any one of the following ways:
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To obtain copies of a supporting statement and any related forms for the proposed collection(s) summarized in this notice, you may make your request using one of following:
1. Access CMS' Web site address at
2. Email your request, including your address, phone number, OMB number, and CMS document identifier, to
3. Call the Reports Clearance Office at (410) 786-1326.
Reports Clearance Office at (410) 786-1326.
This notice sets out a summary of the use and burden associated with the following information collections. More detailed information can be found in each collection's supporting statement and associated materials (see
Under the PRA (44 U.S.C. 3501-3520), federal agencies must obtain approval from the Office of Management and Budget (OMB) for each collection of information they conduct or sponsor. The term “collection of information” is defined in 44 U.S.C. 3502(3) and 5 CFR 1320.3(c) and includes agency requests or requirements that members of the public submit reports, keep records, or provide information to a third party. Section 3506(c)(2)(A) of the PRA requires federal agencies to publish a 60-day notice in the
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All information collected through the Evaluation of the GNE project will be used to meet the requirements specified under the ACA Section 5509. We will also use the information to determine the overall effectiveness of the GNE project. The process evaluation seeks to understand how the demonstration is implemented overall, how that implementation has changed over time, which aspects of the demonstration have been successful or unsuccessful, and what plans the sites have for the remainder of the implementation and after the demonstration formally ends. The process evaluation will answer both quantitative and qualitative questions.
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Medicare carriers use the data collected on the CMS-1500 and the CMS-1490S to determine the proper amount of reimbursement for Part B medical and other health services (as listed in section 1861(s) of the Social Security Act) provided by physicians and suppliers to beneficiaries. The CMS-1500 is submitted by physicians/suppliers for all Part B Medicare. Serving as a common claim form, the CMS-1500 can be used by other third-party payers (commercial and nonprofit health insurers) and other Federal programs (
The proposed F.A.S.T. form will be used in a pilot capacity in just one Administration for Native Americans' discretionary program areas: Native American Language Preservation and Maintenance. All applicants applying for funding in that program area will be required to use the F.A.S.T. form during the pilot competition proposed for FY16 unless they request and receive approval to submit a paper application. By using the F.A.S.T. form no applicant will be required to provide any information beyond what is already required by the FOA. Additionally, free training and technical assistance will be available to all applicants on use of the F.A.S.T. form.
ANA intends to use the project proposals submitted via the F.A.S.T. form to make funding decisions for Native American Language Preservation and Maintenance grant awards made in the FY 2016 pilot year. In addition, ANA will solicit feedback from applicants and panel reviewers to obtain feedback on the results, outcomes, and their recommendations regarding the F.A.S.T. form as a user friendly method of applying for funding opportunities. If the pilot is successful in making it easier for applicants to apply, ANA will consider potentially expanding use of the F.A.S.T. form to all Administration for Native Americans' discretionary funding areas in subsequent years.
Copies of the proposed collection may be obtained by writing to the Administration for Children and Families, Office of Planning, Research and Evaluation, 370 L'Enfant Promenade SW., Washington, DC 20447, Attn: ACF Reports Clearance Officer. All requests should be identified by the title of the information collection. Email address:
OMB is required to make a decision concerning the collection of information between 30 and 60 days after publication of this document in the
Food and Drug Administration, HHS.
Notice.
The Food and Drug Administration (FDA or Agency) is announcing the availability of draft recommendations for a new permitted daily exposure (PDE) for the residual solvent triethylamine and a revised PDE for the residual solvent methylisobutylketone, according to the maintenance procedures for the guidance for industry entitled “Q3C Impurities: Residual Solvents.” The draft recommendations were prepared under the auspices of the International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH). The document is intended to recommend acceptable amounts for the listed residual solvents in pharmaceuticals for the safety of the patient.
Although you can comment on any guidance at any time (see 21 CFR 10.115(g)(5)), to ensure that the Agency considers your comment on the draft recommendations before it begins work on the final recommendations, submit either electronic or written comments on the document by December 15, 2015.
You may submit comments as follows:
Submit electronic comments in the following way:
• Federal eRulemaking Portal:
• If you want to submit a comment with confidential information that you do not wish to be made available to the public, submit the comment as a written/paper submission and in the manner detailed (see “Written/Paper Submissions” and “Instructions”).
Submit written/paper submissions as follows:
• Mail/Hand delivery/Courier (for written/paper submissions): Division of Dockets Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
• For written/paper comments submitted to the Division of Dockets Management, FDA will post your comment, as well as any attachments, except for information submitted, marked and identified, as confidential, if submitted as detailed in “Instructions.”
• Confidential Submissions—To submit a comment with confidential information that you do not wish to be made publicly available, submit your comments only as a written/paper submission. You should submit two copies total. One copy will include the information you claim to be confidential with a heading or cover note that states “THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.” The Agency will review this copy, including the claimed confidential information, in its consideration of comments. The second copy, which will have the claimed confidential information redacted/blacked out, will be available for public viewing and posted on
Submit written requests for single copies of the draft recommendations to the Division of Drug Information (HFD-240), Center for Drug Evaluation and Research (CDER), Food and Drug Administration, 10001 New Hampshire Ave., Hillandale Building, 4th Floor, Silver Spring, MD 20993-0002, or the Office of Communication, Outreach and Development, Center for Biologics Evaluation and Research (CBER), Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 71, Rm. 3128, Silver Spring, MD 20993-0002. Send one self-addressed adhesive label to assist the office in processing your requests. The draft recommendations may also be obtained by mail by calling CBER at 1-800-835-4709 or 240-402-8010. See the
In recent years, many important initiatives have been undertaken by regulatory authorities and industry associations to promote international harmonization of regulatory requirements. FDA has participated in many meetings designed to enhance harmonization and is committed to seeking scientifically based harmonized technical procedures for pharmaceutical development. One of the goals of harmonization is to identify and then reduce differences in technical requirements for drug development among regulatory agencies.
ICH was organized to provide an opportunity for tripartite harmonization initiatives to be developed with input from both regulatory and industry representatives. FDA also seeks input from consumer representatives and others. ICH is concerned with harmonization of technical requirements for the registration of pharmaceutical products among three regions: Europe, Japan, and North America. The eight ICH sponsors are the European Commission; the European Federation of Pharmaceutical Industries Associations; the Japanese Ministry of Health, Labour, and Welfare; the Japanese Pharmaceutical Manufacturers Association; CDER and CBER, FDA; the Pharmaceutical Research and Manufacturers of America; Health Canada; and Swissmedic. The ICH Secretariat, which coordinates the preparation of documentation, is provided by the International Federation of Pharmaceutical Manufacturers Associations (IFPMA).
The ICH Steering Committee includes representatives from each of the ICH sponsors and the IFPMA, as well as observers from the World Health Organization.
In the
In 1999, ICH instituted a Q3C maintenance agreement and formed a maintenance EWG (Q3C EWG). The agreement provided for the revisitation of solvent PDEs and allowed for minor changes to the tables and list that include the existing PDEs. The agreement also provided that new solvents and PDEs could be added to the tables and list based on adequate toxicity data. In the
In June 2015, the ICH Steering Committee agreed that draft recommendations for a new PDE for the residual solvent triethylamine and a revised PDE for the residual solvent methylisobutylketone should be made available for public comment. The draft recommendations are the product of the Quality Expert Working Group of the ICH. Comments about this draft will be considered by FDA and the Quality Expert Working Group.
The draft recommendations provide guidance on the new PDE for the solvent trimethylamine and the revised PDE for the solvent methylisobutylketone. In addition, the data used to derive the PDEs are summarized. The document is intended to recommend acceptable amounts for the listed residual solvents in pharmaceuticals for the safety of the patient.
The draft recommendations are being issued consistent with FDA's good guidance practices regulation (21 CFR 10.115). The draft recommendations for the solvents trimethylamine and methylisobutylketone, when finalized, will represent the current thinking of FDA on this topic. They do not establish any rights for any person and are not binding on FDA or the public. You can use an alternative approach if it satisfies the requirements of the applicable statutes and regulations.
Persons with access to the Internet may obtain the document at
Food and Drug Administration, HHS.
Notice of public meeting.
Under the auspices of the National Science and Technology Council, the Food and Drug Administration (FDA or the Agency), along with the Office of Science and Technology Policy (OSTP), the Environmental Protection Agency (EPA), and the United States Department of Agriculture (USDA), is announcing a public meeting, to be held on October 30, 2015, to discuss the memorandum entitled, “Modernizing the Regulatory System for Biotechnology Products,” issued by the Executive Office of the President (EOP) in July 2015. The purpose of the meeting is to inform the public about the activities described in the July 2015 memorandum; invite oral comments from interested parties; and provide information about how to submit written comments, data, or other information to the docket.
See section II, “How to Participate in the Public Meeting” in the
See section II, “How to Participate in the Public Meeting” in the
You may submit comments as follows:
Submit electronic comments in the following way:
• Federal eRulemaking Portal:
• If you want to submit a comment with confidential information that you do not wish to be made available to the public, submit the comment as a written/paper submission and in the manner detailed (see “Written/Paper Submissions” and “Instructions”).
Submit written/paper submissions as follows:
• Mail/Hand delivery/Courier (for written/paper submissions): Division of Dockets Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
• For written/paper comments submitted to the Division of Dockets Management, FDA will post your comment, as well as any attachments, except for information submitted, marked and identified, as confidential, if submitted as detailed in “Instructions.”
• Confidential Submissions—To submit a comment with confidential information that you do not wish to be made publicly available, submit your comments only as a written/paper submission. You should submit two copies total. One copy will include the information you claim to be confidential with a heading or cover note that states “THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION”. The Agency will review this copy, including the claimed confidential information, in its consideration of comments. The second copy, which will have the claimed confidential information redacted/blacked out, will be available for public viewing and posted on
For general questions about the meeting, to request an opportunity to make an oral presentation at the public meeting, to submit the full text or summary of an oral presentation, or for special accommodations due to a disability, contact the Office of Policy, Office of the Commissioner, Food and Drug Administration, 10903 New Hampshire Ave., Silver Spring, MD 20993, 301-796-4830, email:
For questions about the memorandum entitled, “Modernizing the Regulatory System for Biotechnology Products,” or related activities described in that memorandum, contact the National Science and Technology Council: Emerging Technologies Interagency Policy Coordination Committee, Office of Science and Technology Policy, Executive Office of the President, Eisenhower Executive Office Building, 1650 Pennsylvania Ave., Washington DC 20504, 202-456-4444, online:
In 1986, OSTP issued the Coordinated Framework for Regulation of Biotechnology (CF), which outlined a comprehensive Federal regulatory policy for ensuring the safety of biotechnology products. The CF sought to achieve a balance between regulation adequate to ensure the protection of health and the environment while maintaining sufficient regulatory flexibility to avoid impeding innovation (51 FR 23302; June 26, 1986) (Ref. 1).
In 1992, OSTP issued an update to the CF that set forth a risk-based, scientifically sound basis for the oversight of activities that introduce biotechnology products into the environment (57 FR 6753; February 27, 1992) (Ref. 2). The update affirmed that Federal oversight should focus on the characteristics of the product, the environment into which it is being introduced, and the intended use of the product, rather than the process by which the product is created.
On July 2, 2015, the EOP issued a memorandum entitled, “Modernizing the Regulatory System for Biotechnology Products,” (the EOP memorandum) directing the primary federal Agencies that have oversight responsibilities for the products of biotechnology—EPA, FDA, and USDA—to update the CF to clarify current roles and responsibilities of the Agencies that regulate the products of biotechnology, develop a long-term strategy to ensure that the Federal biotechnology regulatory system is prepared for the future products of biotechnology, and commission an independent, expert analysis of the future landscape of biotechnology products (Ref. 3). These efforts will build on the regulatory principles described in the CF and the 1992 update to the CF. The EOP memorandum's objectives are to ensure public confidence in the regulatory system and to prevent unnecessary barriers to future innovation and competitiveness by improving the transparency, coordination, predictability, and efficiency of the regulation of biotechnology products while continuing to protect health and the environment.
The July 2, 2015, EOP memorandum stated that the update to the CF should clarify the current roles and responsibilities of the Agencies that regulate the products of biotechnology by accomplishing the following four objectives:
1. Clarifying which biotechnology product areas are within the authority and responsibility of each Agency.
2. Clarifying the roles that each Agency plays for different product areas, particularly for those product areas that fall within the responsibility of multiple agencies, and how those roles relate to each other in the course of a regulatory assessment.
3. Clarifying a standard mechanism for communication and, as appropriate, coordination among Agencies, while they perform their respective regulatory functions, and for identifying Agency designees responsible for this coordination function.
4. Clarifying the mechanism and timeline for regularly reviewing, and updating as appropriate, the CF to minimize delays, support innovation, protect health and the environment, and promote the public trust in the regulatory systems for biotechnology products.
As noted in the EOP memorandum, “biotechnology products” refers to products developed through genetic engineering or the targeted or in vitro manipulation of genetic information of organisms, including plants, animals, and microbes. It also covers some of the products produced by such plants, animals, and microbes or their derived products as determined by existing statutes and regulations. Products such as human drugs and medical devices are not the focus of the activities described in the EOP memorandum.
In addition, on October 6, 2015, OSTP issued a notice of request for information (RFI) to solicit data and information, including case studies, that can inform the development of the proposed update to the CF and the development of a long-term strategy consistent with the objectives described in the July 2, 2015, EOP memorandum (80 FR 60414). In addition to the RFI, the EOP noted that it will hold three public engagement sessions over the next 12 months (Ref. 4), and that the current update to the CF will undergo public notice and comment before it is finalized. This notice is announcing the first public engagement session.
The purpose of this first public meeting is to inform the public about the activities described in the EOP memorandum; invite oral, stakeholder comments relevant to those activities; and provide information about how to submit written comments, data, or other information to the docket. At this public meeting, OSTP will provide an overview of the CF and the 1992 update to the CF, and discuss the activities described in the EOP memorandum. EPA, FDA, and USDA will provide an overview of their current approaches to regulating products of biotechnology. The agenda for this public meeting will be posted approximately 5 days before the meeting at:
OSTP, EPA, FDA, and USDA (collectively referred to as “we” or “us”) are holding the public meeting under the auspices of the National Science and Technology Council. The meeting will be held on October 30, 2015, in the White Oak Great Room, at FDA's White Oak Campus, Building 31 Conference Center, the Great Room (Rm. 1503 B&C), 10903 New Hampshire Ave., Silver Spring, MD 20993-002. Entrance for the public meeting participants (non-FDA employees) is through Building 1 where routine security check procedures will be performed. For parking and security information, please refer to
Those requesting an opportunity to make an oral presentation during the time allotted for public comment at the meeting are asked to submit a request in advance and to provide information about any specific topic or issue to be addressed. There will not be an opportunity to display materials such as slide shows, videos, or other media during the meeting. If time permits, individuals or organizations that did not register in advance may be granted the opportunity to make an oral presentation. We would like to maximize the number of individuals who make a presentation at the meeting and will do our best to accommodate all persons who wish to make a presentation or express their opinions at the meeting.
We encourage persons and groups who have similar interests to consolidate their information for presentation by a single representative. After reviewing the presentation requests, we will notify each participant before the meeting of the approximate start time of their presentation and of the amount of time allotted for the comment.
While oral presentations from specific individuals and organizations will be necessarily limited due to time constraints during the public meeting, interested parties may submit electronic or written comments to the docket. All relevant data and documentation should be submitted with the comments to Docket No. FDA-2015-N-3403.
Table 1 provides information on participation in the public meeting.
Information and data submitted voluntarily to us will become part of the administrative record for this activity, and will be accessible to the public at
The following references have been placed on display in the Division of Dockets Management (see
In compliance with the requirement of Section 3506(c)(2)(A) of the Paperwork Reduction Act of 1995, for opportunity for public comment on proposed data collection projects, the Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD), National Institutes of Health (NIH), will issue a funding announcement for the Media-Smart Youth Leaders Program to the Office of Management and Budget (OMB) for review and approval.
Written comments and/or suggestions from the public and affected agencies are invited on one or more of the following points: Whether the proposed collection of information is necessary for the proper selection of facilitators to serve as local health educators, using the Media-Smart Youth curriculum; the accuracy of the agency's estimate of the burden of the proposed collection of information; ways to enhance the quality, utility, and clarity of the information to be collected; and ways to minimize the burden of the collection of
The purpose of this information collection is to solicit information from applicants about their qualifications that would make them effective Leaders, their reason for wanting to pursue this opportunity, and the details of their proposed program (including, but not limited to, location, community partner(s), and proposed budget). This information will help NICHD staff select the candidates for the program who are most likely to succeed in implementing the full curriculum and teaching youth effective lessons about nutrition, physical activity, and media.
OMB approval is requested for 3 years. There are no costs to respondents other than their time. The total estimated annualized burden hours are 800.
The Department of Health and Human Services (HHS) (Department) has created the Interagency Pain Research Coordinating Committee and is seeking nominations for this committee.
Nominations are due by 5 p.m. on November 19, 2015.
Nominations must be submitted through the web form on the IPRCC Web site:
Linda Porter,
As specified in Public Law 111-148 (“Patient Protection and Affordable Care Act”) the Committee will: (a) Develop a summary of advances in pain care research supported or conducted by the Federal agencies relevant to the diagnosis, prevention, and treatment of pain and diseases and disorders associated with pain; (b) identify critical gaps in basic and clinical research on the symptoms and causes of pain; (c) make recommendations to ensure that the activities of the National Institutes of Health and other Federal agencies are free of unnecessary duplication of effort; (d) make recommendations on how best to disseminate information on pain care; and (e) make recommendations on how to expand partnerships between public entities and private entities to expand collaborative, cross-cutting research.
Membership on the committee will include six (6) non-Federal members from among scientists, physicians, and other health professionals and six (6) non-Federal members of the general public who are representatives of leading research, advocacy, and service organizations for individuals with pain-related conditions. Members will serve overlapping three year terms. It is anticipated that the committee will meet at least once a year.
The Department strives to ensure that the membership of HHS Federal advisory committees is fairly balanced in terms of points of view represented and the committee's function. Every effort is made to ensure that the views of diverse ethnic and racial groups and
The Department is soliciting nominations for two non-federal members from among scientists, physicians, and other health professionals and for one non-federal member of the general public who is a representative of a leading research, advocacy, or service organization for people with pain-related conditions. These candidates will be considered to fill positions opened through completion of current member terms. Nominations are due by 5 p.m. on November 19, 2015, using the IPRCC nomination web form:
National Institutes of Health (NIH), HHS.
Notice of proposed changes to the
The NIH seeks public comment on its proposal to amend the
To ensure consideration, comments must be submitted in writing by November 30, 2015.
Comments may be submitted by email at
If you have questions, or require additional background information about these proposed changes, please contact the NIH by email at
The NIH Office of the Director requested that the IOM review whether gene transfer research raises issues of concern that warrant the current level of RAC oversight of individual clinical trials involving gene transfer techniques. The IOM noted that the RAC has served a valuable role, but concluded that the current level of oversight over individual clinical trials is no longer justifiable. In an effort to maximize the benefits of the RAC review process, the IOM recommended that the NIH maintain its protocol submission and safety reporting requirements, but restrict individual gene transfer protocol reviews to exceptional cases that meet specified criteria (full recommendations are listed in the IOM report
After careful consideration of the IOM's recommendations, the NIH proposes amendments to the
A.
1. An oversight body (an Institutional Biosafety Committee (IBC) or an Institutional Review Board (IRB)) determines that a human gene transfer protocol submitted to it for approval would significantly benefit from RAC review; and
2. One or more of the criteria below are satisfied:
a. The protocol uses a new vector, genetic material, or delivery methodology that represents a first-in-human experience, thus presenting an unknown risk.
b. The protocol relies on preclinical safety data that were obtained using a new preclinical model system of unknown and unconfirmed value.
c. The proposed vector, gene construct, or method of delivery is associated with possible toxicities that are not widely known and that may render it difficult for oversight bodies to evaluate the protocol rigorously.
The chair of an oversight body or an authorized oversight body representative may submit a request for RAC review by sending the request to the NIH as part of the submission materials provided by the PI. This request must include the rationale for why the protocol satisfies both items 1 and 2 of the NIH RAC review criteria. The NIH will review the request and notify the requestor of a decision in no more than ten working days.
1. If the NIH determines that the criteria listed in both 1 and 2 above are satisfied, the NIH Director will convene the RAC.
2. If the NIH receives a request for RAC review of a protocol that the NIH determines does not meet both of these criteria, the NIH would:
a. Inform the requestor that RAC review is not warranted, and
b. offer to provide the requestor with information about previous protocols that have used similar products, the outcome of those studies, if available, and a summary of relevant safety data.
3. Even if the protocol does not meet the proposed criteria listed in both items 1 and 2 above, the NIH Director, in consultation (if necessary) with appropriate regulatory authorities (
B.
1. The Principal Investigator (PI) will continue to be responsible for submitting documentation regarding a proposed human gene transfer protocol to his or her local oversight bodies. The PI will also continue to be responsible for submitting documentation as outlined in Appendix M-I-A to the NIH. As part of the submission to the NIH, the PI shall provide documentation from oversight bodies regarding their assessment of whether RAC review is warranted.
2. Completion of the protocol registration process:
a. If no oversight body requests RAC review, the IBC may proceed with its approval process upon receipt of documentation from the NIH indicating that the protocol registration process is complete. No research participant shall be enrolled (see definition of enrollment in Section I-E-7) in the human gene transfer protocol until the protocol registration process has been completed.
b. If an oversight body requests review and the NIH agrees that the submission has met the criteria in A above, the protocol will undergo RAC review and public discussion. The IBC may not approve a protocol until the RAC review process has been completed. The IBC may proceed with its approval process upon receipt of documentation from the NIH indicating that the protocol registration process is complete. No research participant shall be enrolled (see definition of enrollment in Section I-E-7) in the human gene transfer protocol until the protocol registration process has been completed.
C.
The proposed changes to the RAC review process, outlined above, will require amendment of multiple portions of the
Throughout the document the following global changes will be made: (i) The NIH OSP will replace the NIH OBA, (ii) the term “RAC review” will be replaced with the term “NIH protocol registration process” as appropriate; (iii) the title for Appendix M-I-B will be changed; and (iv) the requirement for a CV/biosketch of key personnel will be deleted.
Human gene transfer is the deliberate transfer into human research participants of either:
1. Recombinant nucleic acid molecules, or DNA or RNA derived from recombinant nucleic acid molecules, or
2. Synthetic nucleic acid molecules, or DNA or RNA derived from synthetic nucleic acid molecules that meet any one of the following criteria:
a. Contain more than 100 nucleotides; or
b. Possess biological properties that enable integration into the genome (
c. Have the potential to replicate in a cell; or
d. Can be translated or transcribed.
No research participant shall be enrolled (see definition of enrollment in Section I-E-7) until the RAC review process has been completed (see Appendix M-I-B, RAC Review Requirements).
In its evaluation of human gene transfer proposals, the RAC will consider whether a proposed human gene transfer experiment presents characteristics that warrant public RAC review and discussion (See Appendix M-I-B-2). The process of public RAC review and discussion is intended to foster the safe and ethical conduct of human gene transfer experiments. Public review and discussion of a human gene transfer experiment (and access to relevant information) also serves to inform the public about the technical aspects of the proposal, the meaning and significance of the research, and any significant safety, social, and ethical implications of the research.
Public RAC review and discussion of a human gene transfer experiment may be: (1) Initiated by the NIH Director; or (2) initiated by the NIH OBA Director following a recommendation to NIH OBA by: (a) Three or more RAC members; or (b) a Federal agency other than NIH. After a human gene transfer experiment is reviewed by the RAC at a regularly scheduled meeting, NIH OBA will send a letter, unless NIH OBA determines that there are exceptional circumstances, within 10 working days to the NIH Director, the Principal Investigator, the sponsoring institution, and other DHHS components, as appropriate, summarizing the RAC recommendations.
For a clinical trial site that is added after the RAC review process, no research participant shall be enrolled (see definition of enrollment in Section I-E-7) at the clinical trial site until the following documentation has been submitted to NIH OBA: (1) Institutional Biosafety Committee approval (from the clinical trial site); (2) Institutional Review Board approval; (3) Institutional Review Board-approved informed consent document; (4) curriculum vitae of the Principal Investigator(s) (no more than two pages in biographical sketch format); and (5) NIH grant number(s) if applicable.
In order to maintain public access to information regarding human gene transfer (including protocols that are not publicly reviewed by the RAC), NIH OBA will maintain the documentation described in Appendices M-I through M-V. The information provided in response to Appendix M should not contain any confidential commercial information or trade secrets, enabling all aspects of RAC review to be open to the public.
Human gene transfer is the deliberate transfer into human research participants of either:
1. Recombinant nucleic acid molecules, or DNA or RNA derived from recombinant nucleic acid molecules, or
2. Synthetic nucleic acid molecules, or DNA or RNA derived from synthetic nucleic acid molecules that meet any one of the following criteria:
a. Contain more than 100 nucleotides; or
b. Possess biological properties that enable integration into the genome (
c. Have the potential to replicate in a cell; or
d. Can be translated or transcribed.
No research participant shall be enrolled (see definition of enrollment in Section I-E-7) until the NIH protocol registration process has been completed (see Appendix M-I-B, Selection of Individual Protocols for Public RAC Review and Discussion).
In its evaluation of human gene transfer protocols, the NIH will make a
Public RAC review and discussion of a human gene transfer experiment may be initiated in two exceptional circumstances: (1) The NIH will determine, following a request for RAC public review from an oversight body, whether the protocol has one or more of the following characteristics: (i) The protocol uses a new vector, genetic material, or delivery methodology that represents a first-in-human experience, thus presenting an unknown risk; (ii) the protocol relies on preclinical safety data that were obtained using a new preclinical model system of unknown and unconfirmed value; or (iii) the proposed vector, gene construct, or method of delivery is associated with possible toxicities that are not widely known and that may render it difficult for oversight bodies to evaluate the protocol rigorously. If an oversight body requests public RAC review, but the protocol does not have one or more of the above characteristics (listed in i, ii, or iii), then the NIH will inform the requesting oversight body that public RAC review is not warranted. (2) Public RAC review and discussion of protocols not requested for review by an oversight body may be initiated by the NIH Director if: (a) The protocol has one or more of the three characteristics listed above (i, ii, or iii) and public RAC review and discussion would provide a clear and obvious benefit to the scientific community or the public; or (b) the protocol otherwise raises significant scientific, societal, or ethical concerns.
For a clinical trial site that is added after completion of the NIH protocol registration process, no research participant shall be enrolled (see definition of enrollment in Section I-E-7) at the clinical trial site until the following documentation has been submitted to the NIH OSP: (1) Institutional Biosafety Committee approval (from the clinical trial site); (2) Institutional Review Board approval; (3) Institutional Review Board-approved informed consent document; and (4) the NIH grant number(s) if applicable.
In order to maintain public access to information regarding human gene transfer (including protocols that are not publicly reviewed by the RAC), the NIH OSP will maintain the documentation described in Appendices M-I through M-II. The information provided in response to Appendix M should not contain any confidential commercial or financial information or trade secrets, enabling all aspects of RAC review to be open to the public.
Section IV-B-1-f. Ensure that when the institution participates in or sponsors recombinant or synthetic nucleic acid molecule research involving human subjects: (i) The Institutional Biosafety Committee has adequate expertise and training (using
Section IV-B-1-f. Ensure that when the institution participates in or sponsors recombinant or synthetic nucleic acid molecule research involving human subjects: (i) The Institutional Biosafety Committee has adequate expertise and training (using
Section IV-B-2-a-(1). The Institutional Biosafety Committee must be comprised of no fewer than five members so selected that they collectively have experience and expertise in recombinant or synthetic nucleic acid molecule technology and the capability to assess the safety of recombinant or synthetic nucleic acid molecule research and to identify any potential risk to public health or the environment. At least two members shall not be affiliated with the institution (apart from their membership on the Institutional Biosafety Committee) and who represent the interest of the surrounding community with respect to health and protection of the environment (
Section IV-B-2-a-(1). The Institutional Biosafety Committee must be comprised of no fewer than five members so selected that they collectively have experience and expertise in recombinant or synthetic nucleic acid molecule technology and the capability to assess the safety of recombinant or synthetic nucleic acid molecule research and to identify any potential risk to public health or the environment. At least two members shall not be affiliated with the institution (apart from their membership on the Institutional Biosafety Committee) and who represent the interest of the surrounding community with respect to health and protection of the environment (
Section IV-B-2-b-(1). Reviewing recombinant or synthetic nucleic acid molecule research conducted at or sponsored by the institution for compliance with the
Section IV-B-2-b-(1). Reviewing recombinant or synthetic nucleic acid molecule research conducted at or sponsored by the institution for compliance with the
When the institution participates in or sponsors recombinant or synthetic nucleic acid molecule research involving human subjects, the institution must ensure that: (i) the Institutional Biosafety Committee has adequate expertise and training (using ad hoc consultants as deemed necessary) and (ii) all aspects of Appendix M, Points to Consider in the Design and Submission of Protocols for the Transfer of Recombinant or Synthetic Nucleic Acid Molecules into One or More Human Subjects (Points to Consider), have been appropriately addressed by the Principal Investigator prior to submission to NIH/OBA.
When the institution participates in or sponsors recombinant or synthetic nucleic acid molecule research involving human subjects, the institution must ensure that: (i) the Institutional Biosafety Committee has adequate expertise and training (using ad hoc consultants as deemed necessary) and (ii) all aspects of Appendix M, Points to Consider in the Design and Submission of Protocols for the Transfer of Recombinant or Synthetic Nucleic Acid Molecules into One or More Human Subjects (Points to Consider), have been appropriately addressed by the Principal Investigator prior to its approval.
Section IV-B-7-b-(6). Ensure that all aspects of Appendix M have been appropriately addressed prior to submission of a human gene transfer experiment to NIH OBA, and provide a letter signed by the Principal Investigator(s) on institutional
For a clinical trial site that is added after the RAC review process, no research participant shall be enrolled (see definition of enrollment in Section I-E-7) at the clinical trial site until the following documentation has been submitted to NIH OBA: (1) IBC approval (from the clinical trial site); (2) IRB approval; (3) IRB-approved informed consent document; (4) curriculum vitae of the Principal Investigator(s) (no more than two pages in biographical sketch format); and (5) NIH grant number(s) if applicable.
Section IV-B-7-b-(6). Ensure that all aspects of Appendix M have been appropriately addressed prior to submission. No research participant shall be enrolled (see definition of enrollment in Section I-E-7) in a human gene transfer experiment until the NIH protocol registration process has been completed (see Appendix M-I-B, Selection of Individual Protocols for Public RAC Review and Discussion); IBC approval (from the clinical trial site) has been obtained; Institutional Review Board (IRB) approval has been obtained; and all applicable regulatory authorization(s) have been obtained.
For a clinical trial site that is added after completion of the NIH protocol registration process, no research participant shall be enrolled (see definition of enrollment in Section I-E-7) at the clinical trial site until the following documentation has been submitted to the NIH OSP: (1) IBC approval (from the clinical trial site); (2) IRB approval; (3) IRB-approved informed consent document; and (4) NIH grant number(s) if applicable.
To implement this new process, the NIH proposes to amend Appendix M, Points to Consider in the Design and Submission of Protocols for the Transfer of Recombinant or Synthetic Nucleic Acid Molecules into One or More Human Research Participants (Points to Consider).
Appendix M applies to research conducted at or sponsored by an institution that receives any support for recombinant or synthetic nucleic acid molecule research from NIH. Researchers not covered by the
The acceptability of human somatic cell gene transfer has been addressed in several public documents as well as in numerous academic studies. In November 1982, the President's Commission for the Study of Ethical Problems in Medicine and Biomedical and Behavioral Research published a report,
RAC will not at present entertain proposals for germ line alterations but will consider proposals involving somatic cell gene transfer. The purpose of somatic cell gene transfer is to treat an individual patient,
The RAC continues to explore the issues raised by the potential of
Research proposals involving the deliberate transfer of recombinant or synthetic nucleic acid molecules, or DNA or RNA derived from such nucleic acid molecules, into human subjects (human gene transfer) will be considered through a review process involving both NIH/OBA and RAC. Investigators shall submit their relevant information on the proposed human gene transfer experiments to NIH/OBA. Submission of human gene transfer protocols to NIH will be in the format described in Appendix M-I-A, Submission Requirements for Protocol Submission. Submission to NIH shall be for registration purposes and will ensure continued public access to relevant human gene transfer information conducted in compliance with the
Institutional Biosafety Committee approval must be obtained from each institution at which recombinant or synthetic nucleic acid molecule material will be administered to human subjects (as opposed to each institution involved in the production of vectors for human application and each institution at which there is
Factors that may contribute to public discussion of a human gene transfer experiment by RAC include: (i) New vectors/new gene delivery systems, (ii) new diseases, (iii) unique applications of gene transfer, and (iv) other issues considered to require further public discussion. Among the experiments that may be considered exempt from RAC discussion are those determined not to represent possible risk to human health or the environment. Full, public RAC review and discussion of a human gene transfer experiment may be (1) initiated by the NIH Director; or (2) initiated by the NIH OBA Director following a recommendation to NIH OBA by: (a) Three or more RAC members, or (b) a Federal agency other than NIH. An individual human gene transfer experiment that is recommended for full RAC review should represent novel characteristics deserving of public discussion. If it is determined that an experiment will undergo full RAC discussion, NIH/OBA will immediately notify the Principal Investigator. RAC members may forward individual requests for additional information relevant to a specific protocol through NIH/OBA to the Principal Investigator. In making a determination whether an experiment is novel, and thus deserving of full RAC discussion, reviewers will examine the scientific rationale, scientific context (relative to other proposals reviewed by RAC), whether the preliminary
Public discussion of human gene transfer experiments (and access to relevant information) shall serve to inform the public about the technical aspects of the proposals, meaning and significance of the research, and significant safety, social, and ethical implications of the research. RAC discussion is intended to ensure safe and ethical conduct of gene transfer experiments and facilitate public understanding of this novel area of biomedical research.
In its evaluation of human gene transfer proposals, RAC will consider whether the design of such experiments offers adequate assurance that their consequences will not go beyond their purpose, which is the same as the traditional purpose of clinical investigation, namely, to protect the health and well being of human subjects being treated while at the same time gathering generalizable knowledge. Two possible undesirable consequences of the transfer of recombinant or synthetic nucleic acid molecules would be unintentional: (i) Vertical transmission of genetic changes from an individual to his/her offspring, or (ii) horizontal transmission of viral infection to other persons with whom the individual comes in contact. Accordingly, Appendices M-I through M-V request information that will enable RAC and NIH/OBA to assess the possibility that the proposed experiment(s) will inadvertently affect reproductive cells or lead to infection of other people (
Appendix M will be considered for revisions as experience in evaluating proposals accumulates and as new scientific developments occur. This review will be carried out periodically as needed.
Appendix M applies to research conducted at or sponsored by an institution that receives any support for recombinant or synthetic nucleic acid molecule research from NIH. Researchers not covered by the
The acceptability of human somatic cell gene transfer has been addressed in several public documents as well as in numerous academic studies. In November 1982, the President's Commission for the Study of Ethical Problems in Medicine and Biomedical and Behavioral Research published a report,
The NIH will not at present entertain proposals for germ line alterations but will consider proposals involving somatic cell gene transfer. The purpose of somatic cell gene transfer is to treat an individual patient,
The NIH continues to explore the issues raised by the potential of
Research proposals involving the deliberate transfer of recombinant or synthetic nucleic acid molecules, or DNA or RNA derived from such nucleic acid molecules, into one or more human subjects (human gene transfer) will be considered through a registration process involving the NIH, oversight bodies, and regulatory authorities, when appropriate. Investigators shall submit the relevant information on the proposed human gene transfer experiment to the oversight bodies and then to the NIH. The format of the submission is described in Appendix M-I-A, Requirements for Protocol Submission. Submission to the NIH OSP shall be for registration purposes and will ensure continued public access to relevant human gene transfer information conducted in compliance with the
Public RAC review and discussion of a human gene transfer experiment may be initiated in two exceptional circumstances: (1) The NIH will determine, following a request for RAC review from an oversight body, whether the protocol has one or more of the following characteristics: i) The protocol uses a new vector, genetic material, or delivery methodology that represents a first-in-human experience, thus presenting an unknown risk; ii) the protocol relies on preclinical safety data that were obtained using a new preclinical model system of unknown and unconfirmed value; or iii) the proposed vector, gene construct, or method of delivery is associated with possible toxicities that are not widely known and that may render it difficult for oversight bodies to evaluate the protocol rigorously. If an oversight body requests public RAC review, but the NIH determines that the protocol does not have one or more of the above characteristics (listed in i, ii, or iii), then the NIH will inform the requesting oversight body that public RAC review is not warranted. (2) Public RAC review and discussion of protocols not requested for review by an oversight body may be initiated by the NIH Director, after consultation (if needed) with appropriate regulatory authorities, if: (a) The protocol has one or more of the three characteristics listed above (i, ii, or iii) and public RAC review and discussion would provide a clear and obvious benefit to the scientific community or the public; or (b) the protocol otherwise raises significant scientific, societal, or ethical concerns.
If it is determined that a human gene transfer trial will undergo RAC review, the NIH will immediately notify the Principal Investigator. RAC recommendations following public review on a specific human gene transfer experiment shall be forwarded to the Principal Investigator, oversight bodies, and regulatory authorities, as appropriate. Relevant documentation will be included in the material for the RAC meeting at which the human gene transfer trial is scheduled to be discussed. RAC meetings will be open to the public except where trade secrets and proprietary information are reviewed (see Section IV-D-5,
Some but not all sections of Appendix M-I Requirements for Protocol Submission, Review, and Reporting—Human Gene Transfer Experiments are proposed to be amended to decrease the number and amount of supporting documentation that must be submitted upon protocol registration, and to modify the timing of the registration processes. As proposed, Principal Investigators must submit the material as outlined below to oversight bodies at the proposed clinical trial sites; however, submission of responses to Appendices M-II through M-V or curriculum vitae will no longer be required.
Appendix M-I-A currently states:
The following documentation must be submitted (see exemption in Appendix M-III-A, Footnotes of Appendix M) in printed or electronic form to the: Office of Biotechnology Activities, National Institutes
1. A cover letter on institutional letterhead, signed by the Principal Investigator(s), that: (1) Acknowledges that the documentation submitted to NIH OBA complies with the requirements set forth in Appendix M-I-A, Requirements for Protocol Submission; (2) identifies the Institutional Biosafety Committee (IBC) and Institutional Review Board (IRB) at the proposed clinical trial site(s) responsible for local review and approval of the protocol; and (3) acknowledges that no research participant will be enrolled (see definition of enrollment in Section I-E-7) until the RAC review process has been completed (see Appendix M-I-B, RAC Review Requirements); IBC approval (from the clinical trial site) has been obtained; IRB approval has been obtained; and all applicable regulatory authorizations have been obtained.
2. The scientific abstract.
3. The non-technical abstract.
4. The proposed clinical protocol, including tables, figures, and relevant manuscripts.
5. Responses to Appendices M-II through M-V, Description of the Proposal, Informed Consent, Privacy, and Special Issues. Responses to Appendices M-II through M-V may be provided either as an appendix to the clinical protocol or incorporated in the clinical protocol. If responses to Appendices M-II through M-V are incorporated in the clinical protocol, each response must refer to the appropriate Appendix M-II through M-V.
6. The proposed informed consent document.
7. Curriculum vitae of the Principal Investigator(s) (no more than two pages in biographical sketch format).
The following documentation must be submitted according to institutional policy, to the appropriate oversight bodies and subsequently in electronic form to the NIH OSP:
1. A scientific abstract.
2. The proposed clinical protocol, including tables, figures, and any relevant publications.
3. Summary of preclinical studies conducted in support of the proposed clinical trial or reference to the specific section of the protocol providing this information.
4. A description of the product:
a. Describe the derivation of the delivery vector system including the source (
b. Describe the genetic content of the transgene or nucleic acid delivered including the species source of the sequence and whether any modifications have been made (
c. Describe any other material to be used in preparation of the agent (vector and transgene) that will be administered to the human research subject (
d. Describe the methods for replication-competent virus testing, if applicable.
e. Describe the intended
f. Describe the gene transfer agent delivery method.
5. The proposed informed consent document.
6. Specifically for submission to the NIH OSP, the PI shall provide additional documentation from oversight bodies regarding their assessment of whether RAC review is warranted. In the event that review is requested, the documentation shall include a justification that the protocol characteristics (see Section III-C-1) that would warrant RAC public review have been met.
Appendix M-I-B, RAC Review Requirements is proposed to be amended to change the process and timing of initial and RAC review. Currently, investigators are informed within 15 working days whether or not the protocol requires public RAC review. Public discussion of selected protocols then occurs at the next quarterly RAC meeting, which occurs, at a minimum of, eight weeks after receipt of a complete protocol submission. Under the proposal, individual RAC members will no longer make a recommendation regarding whether a protocol should be selected for review at a public meeting.
As part of the NIH protocol registration process, documentation from oversight bodies regarding their assessment of whether RAC review is warranted. If no oversight body would significantly benefit from public RAC review and discussion, then the Principal Investigator shall submit all of the documentation required to register the submission (see Appendix M-I-A) to the NIH OSP at any time but shall occur not less than three working days prior to the anticipated date of enrollment of the first subject (see definition of enrollment in Section I-E-7), and shall be provided in electronic form to the Office of Science Policy, National Institutes of Health, 6705 Rockledge Drive, Suite 750, Bethesda, MD 20892-7985 (20817 for non-USPS mail), 301-496-9838, 301-496-9839 (fax), Email:
If an oversight body determines that: (1) A protocol submission would significantly benefit from public RAC review and discussion and (2) that one or more of the following NIH RAC review criteria are met: (i) The protocol uses a new vector, genetic material, or delivery methodology that represents a first-in-human experience, thus presenting an unknown risk; or (ii) the protocol relies on preclinical safety data that were obtained using a new preclinical model system of unknown and unconfirmed value; or (iii) the proposed vector, gene construct, or method of delivery is associated with possible toxicities that are not widely known and that may render it difficult for local and federal regulatory bodies to evaluate the protocol rigorously, and is therefore requesting RAC review and public discussion, the Principal Investigator shall submit the documentation as outlined in Appendix M-I-A at least 8 weeks prior to the next scheduled meeting in order to be reviewed at that RAC meeting. The submission shall include documentation from oversight bodies regarding their assessment of whether RAC review is warranted and that one or both have justified their request according the NIH RAC review criteria listed above. The submission shall be provided to the NIH in electronic form to the Office of Science Policy, National Institutes of Health, 6705 Rockledge Drive, Suite 750, Bethesda, MD 20892-7985 (20817 for non-USPS mail), 301-496-9838, 301-496-9839 (fax), Email:
If an oversight body requests that the RAC review a protocol and the NIH determines that the protocol does not satisfy one or more of the above NIH RAC review criteria, the NIH OSP will inform the Principal Investigator, oversight bodies, and regulatory authorities, as appropriate, that RAC review is not warranted.
Even if an oversight body does not request that a particular protocol be reviewed by the RAC, the NIH Director, after consultation (if needed) with appropriate regulatory authorities, may initiate RAC review if (a) the protocol has one or more of the characteristics listed above (i, ii, or iii) and public RAC review and discussion would provide a clear and obvious benefit to the scientific community or public; or (b) the protocol otherwise raises significant scientific, societal, or ethical concerns.
Completion of the registration process is defined as: (1) Receipt by the Principal Investigator of a letter from the NIH OSP indicating that protocol registration process is complete and that enrollment may proceed; or (2) receipt by the Principal Investigator of a letter from the NIH after public RAC review that summarizes the committee's key comments and recommendations (if any).
A complete human gene transfer protocol package must be submitted at least eight weeks before a scheduled RAC meeting to be reviewed at that upcoming meeting.
After a human gene transfer experiment is publicly reviewed by the full RAC at a regularly scheduled meeting, the NIH OSP will send a letter summarizing the RAC's key comments and recommendations (if any) regarding the protocol to the Principal Investigator(s), oversight bodies, and regulatory authorities as appropriate. Completion of RAC review is defined as receipt by the Principal Investigator(s) of a letter from the NIH OSP summarizing the committee's findings. Unless the NIH determines that there are exceptional circumstances, the letter containing recommendations and comments made following public review will be sent within 10 working days after the completion of the RAC meeting at which the protocol was reviewed.
RAC meetings will be open to the public except where trade secrets or confidential commercial information are reviewed. To enable all aspects of the protocol review process to be open to the public, information provided in response to Appendix M-I-A should not contain trade secrets or confidential commercial or financial information. An application submitted to the NIH OSP shall not contain any document that is designated as `confidential' in its entirety. In the event that a determination has been made that a specific portion of a document submitted as one of the items described in Appendix M should be considered as confidential commercial or financial information or a trade secret, each item must be clearly identified as such. The cover letter (attached to the submitted material) shall: (1) Clearly designate the information that is considered as confidential commercial or financial information or a trade secret; and (2) explain and justify each designation to demonstrate
Appendix M-II is proposed to be amended as follows:
To permit evaluation of long-term safety and efficacy of gene transfer, prospective subjects should be informed that they are expected to cooperate in long-term follow-up that extends beyond the active phase of the study. A list of persons who can be contacted in the event that questions arise during the follow-up period should be provided to the investigator. In addition, the investigator should request that subjects continue to provide a current address and telephone number.
The subjects should be informed that any significant findings resulting from the study will be made known in a timely manner to them and/or their parent or guardian including new information about the experimental procedure, the harms and benefits experienced by other individuals involved in the study, and any long-term effects that have been observed.
Additional guidance is available in the FDA Guidance for Industry: Gene Therapy Clinical Trials—Observing Subjects for Delayed Adverse Events (available at the following URL:
Pursuant to section 10(d) of the Federal Advisory Committee Act, as amended (5 U.S.C. App.), notice is hereby given of a meeting of the Board of Scientific Counselors, NIEHS.
The meeting will be open to the public as indicated below, with attendance limited to space available. Individuals who plan to attend and need special assistance, such as sign language interpretation or other reasonable accommodations, should notify the Contact Person listed below in advance of the meeting.
The meeting will be closed to the public as indicated below in accordance with the provisions set forth in section 552b(c)(6), Title 5 U.S.C., as amended for the review, discussion, and evaluation of individual intramural programs and projects conducted by the National Institute of Environmental Health Sciences, including consideration of personnel qualifications and performance, and the competence of individual investigators, the disclosure of which would constitute a clearly unwarranted invasion of personal privacy.
Any interested person may file written comments with the committee by forwarding the statement to the Contact Person listed on this notice. The statement should include the name, address, telephone number and when applicable, the business or professional affiliation of the interested person.
Coast Guard, DHS.
Notice of meeting.
The Coast Guard will conduct a public workshop in Washington, DC to discuss sewage treatment technologies, issues concerning testing of marine sanitation devices for type approval, and issues concerning gray water. This workshop is intended to be an interactive exchange of information between policymakers, industry experts, and interested members of the public.
The workshop will be held on Tuesday and Wednesday, December 8 and 9, 2015 beginning at 9:30 a.m. and ending at 4 p.m., Eastern Time. This workshop is open to the public. Please note that the workshop has a limited number of seats and may close early if all business is finished. Contact the Coast Guard (see
The workshop will be held in conference rooms 8, 9, and 10 of the Department of Transportation Headquarters Building, 1200 New Jersey Ave. SE., Washington, DC 20590. The building is accessible by public transportation (Navy Yard subway station) or taxi. Parking for privately-owned vehicles is available nearby. Due to security requirements, each visitor must present a valid government-issued photo identification (for example, a driver's license) in order to gain entrance to the building. Contact the Coast Guard (see
You may submit comments identified by docket number USCG-2015-0950 using the Federal eRulemaking Portal at
If you have questions concerning the workshop, please call or email Mr. Wayne Lundy, U.S. Coast Guard; telephone 202-372-1379, email
Your comment is important to us. If you submit a comment, please include the docket number shown at the beginning of this notice and provide a reason for each suggestion or recommendation.
We encourage you to submit comments through the Federal eRulemaking Portal at
We accept anonymous comments. All comments received will be posted without change to
This workshop is sponsored by the Coast Guard and the Environmental Protection Agency and is intended to be an interactive exchange of information between policymakers, industry experts, and interested members of the public. The primary topics that will be discussed include:
• Sewage treatment technologies;
• Issues concerning testing of marine sanitation devices for type approval;
• Simple on board checks for verifying performance of marine sanitation devices;
• Impact of gray water on the environment;
• Impact on the ship from processing gray water;
• Technologies for processing of gray water;
• Analytes for considering technologies treating gray water;
• Issues associated with existing federal standards and MARPOL Annex IV equipment standards (International Maritime Organization (IMO) resolution MEPC.227(64));
• Impact of No Discharge Zones; and
• Revision of an industry consensus standard, ASTM F2363—“Standard Specification for Sewage and Graywater Flow Through Treatment Systems”.
Please note that the workshop has a limited number of seats and may close early if all business is finished.
We encourage you to participate and join in discussions, subject to the discretion of the moderator. If you wish to attend the meeting via teleconference, arrange for assistance in attending the meeting in person, or make a presentation, contact us (see
This notice is issued under the authority of 5 U.S.C. 552(a).
Coast Guard, DHS.
Notice of Policy and request for comments.
The Coast Guard announces its acceptance of sewage treatment plants (also referred to as marine sanitation devices) for type-approval to International Maritime Organization resolution MEPC.227(64) as meeting the requirements for marine sanitation devices. This action will allow manufacturers as well as shipowners and operators the option to take advantage of building and using equipment that meets both domestic and international requirements while also benefitting the environment. The Coast Guard is also seeking information on simple on board checks to verify performance of sewage treatment plants.
Comments and related material must be received by the Coast Guard on or before November 16, 2015.
You may submit comments identified by docket number USCG-2015-0880 using the Federal eRulemaking Portal at
For information about this document call or email Wayne M. Lundy, CG-ENG-3, U.S. Coast Guard; telephone 202-372-1379, email
If you submit a comment, please include the docket number for this notice, indicate the specific section of this document to which each comment applies, and provide a reason for each suggestion or recommendation.
We encourage you to submit comments through the Federal eRulemaking Portal at
We accept anonymous comments. All comments received will be posted without change to
Documents mentioned in this notice as being available in the docket, and all public comments, will be in our online docket at
We are also planning to hold a two-day public workshop in Washington DC in the fall of 2015. We will issue a separate
Title 33 of the Code of Federal Regulations (CFR), part 159, prescribes requirements for the design and construction of marine sanitation devices (“MSDs”, also referred to as sewage treatment plants) and procedures for certifying that MSDs meet the regulations and standards of the Environmental Protection Agency promulgated under Section 312 of the Federal Water Pollution Control Act (Pub. L. 92-500, § 312, 86 Stat. 871 (October 18, 1972),
In recognition of this, the Coast Guard believes MSDs type-approved in accordance with the requirements of IMO resolution MEPC.227(64) and installed on U.S. flagged ships comply with those threshold effluent limits in 33 CFR 159.53(b). MSDs must still meet the other requirements contained in part 159, and any inconsistencies between part 159 and MEPC.227(64) must be resolved in favor of part 159. Manufacturers may submit their equipment to a recognized testing facility recognized by the Coast Guard for testing of such equipment and may make a submission to the Coast Guard requesting type approval.
Resolution MEPC.227(64) also contains a process allowing the Coast Guard to certify that a type-approved MSD meets the specific effluent discharge requirements for a vessel to enter Special Areas listed in MARPOL Annex IV. The Coast Guard would certify that the MSD meets the enhanced
However, U.S.-flagged vessels voluntarily installing MSDs in accordance with MARPOL Annex IV standards must comply with the U.S. application of MEPC.227(64), as follows, to receive U.S. certification. Currently, MEPC.227(64), is vague on the amount of reduction required for thermotolerant coliform (TC), total suspended solids (TSS), biochemical oxygen demand without nitrification (BOD
IMO Resolution MEPC.227(64) states that an approved MSD not rely solely on dilution of wastewater in order to meet the effluent limits stipulated in resolution MEPC.227(64). Resolution MEPC.227(64) further states that, where amounts of dilution are deemed essential to a treatment process, the effluent standards in Section 4 should be adjusted proportionally using dilution compensation factor Qi/Qe to account for dilution Qd.
Effluent (Qe)—is treated wastewater produced by the sewage treatment plant, see figure 1 of resolution MEPC.227(64).
Influent (Qi)—is liquid containing sewage, grey water or other liquid streams, to be processed by the treatment plant, see figure 1of resolution MEPC.227(64).
In order for a MSD to be able to be technically evaluated for type approval under MEPC.227(64), the concentration value of the effluent for that analyte being considered must be readable,
To make the above determination for Annex IV certification, the Coast Guard will use the approved test methods that are listed in the Environmental Protection Agency regulations (40 CFR 136, Guidelines Establishing Test Procedures for the Analysis of Pollutants). The following methods must be used:
• Thermotolerant Coliform (TC) Test Method EPA 600/8-78-017 Chapter III
• Total Suspended Solids (TSS) Test Method 160.2 (Detection Limit = 4.0 mg/L),
• Biochemical Oxygen Demand (BOD
• Chemical Oxygen Demand (COD) Test Method 410.4 (Detection Limit = 3.0 mg/L),
• pH Test Method 150.1 (none stated but not normally reported below 0.01),
• Total Nitrogen
Total Phosphorus Test Method 365.2 (Detection Limit = 0.01 mg/L) and Disinfectant residual
• Chlorine Test Method 330.5 (Detection Limit = 0.2 mg/L)
The Coast Guard is also seeking information on possible simple on board checks that may be available and easily used to verify performance of a sewage treatment plant with effluent requirements.
This notice is issued under authority of 5 U.S.C. 552(a).
Federal Emergency Management Agency, DHS.
Notice.
This notice lists communities where the addition or modification of Base Flood Elevations (BFEs), base flood depths, Special Flood Hazard Area (SFHA) boundaries or zone designations, or the regulatory floodway (hereinafter referred to as flood hazard determinations), as shown on the Flood Insurance Rate Maps (FIRMs), and where applicable, in the supporting Flood Insurance Study (FIS) reports, prepared by the Federal Emergency Management Agency (FEMA) for each community, is appropriate because of new scientific or technical data. The FIRM, and where applicable, portions of the FIS report, have been revised to reflect these flood hazard determinations through issuance of a Letter of Map Revision (LOMR), in accordance with Title 44, Part 65 of the Code of Federal Regulations (44 CFR part 65). The LOMR will be used by insurance agents and others to calculate appropriate flood insurance premium rates for new buildings and the contents of those buildings. For rating purposes, the currently effective community number is shown in the table below and must be used for all new policies and renewals.
These flood hazard determinations will become effective on the dates listed in the table below and revise the FIRM panels and FIS report in effect prior to this determination for the listed communities.
From the date of the second publication of notification of these changes in a newspaper of local circulation, any person has 90 days in which to request through the community that the Deputy Associate Administrator for Mitigation reconsider the changes. The flood hazard determination information may be changed during the 90-day period.
The affected communities are listed in the table below. Revised flood hazard information for each community is available for inspection at both the online location and the respective community map repository address listed in the table below. Additionally, the current effective FIRM and FIS report for each community are accessible online through the FEMA Map Service Center at
Submit comments and/or appeals to the Chief Executive Officer of the community as listed in the table below.
Luis Rodriguez, Chief, Engineering Management Branch, Federal Insurance and Mitigation Administration, FEMA, 500 C Street SW., Washington, DC 20472, (202) 646-4064, or (email)
The specific flood hazard determinations are not described for each community in this notice. However, the online location and local community map repository address where the flood hazard determination information is available for inspection is provided.
Any request for reconsideration of flood hazard determinations must be submitted to the Chief Executive Officer of the community as listed in the table below.
The modifications are made pursuant to section 201 of the Flood Disaster Protection Act of 1973, 42 U.S.C. 4105, and are in accordance with the National Flood Insurance Act of 1968, 42 U.S.C. 4001
The FIRM and FIS report are the basis of the floodplain management measures that the community is required either to adopt or to show evidence of having in effect in order to qualify or remain qualified for participation in the National Flood Insurance Program (NFIP).
These flood hazard determinations, together with the floodplain management criteria required by 44 CFR 60.3, are the minimum that are required. They should not be construed to mean that the community must change any existing ordinances that are more stringent in their floodplain management requirements. The community may at any time enact stricter requirements of its own or pursuant to policies established by other Federal, State, or regional entities. The flood hazard determinations are in accordance with 44 CFR 65.4.
The affected communities are listed in the following table. Flood hazard determination information for each community is available for inspection at both the online location and the respective community map repository address listed in the table below. Additionally, the current effective FIRM and FIS report for each community are accessible online through the FEMA Map Service Center at
Federal Emergency Management Agency, DHS.
Notice.
This notice lists communities where the addition or modification of Base Flood Elevations (BFEs), base flood depths, Special Flood Hazard Area (SFHA) boundaries or zone designations, or the regulatory floodway (hereinafter referred to as flood hazard determinations), as shown on the Flood Insurance Rate Maps (FIRMs), and where applicable, in the supporting Flood Insurance Study (FIS) reports, prepared by the Federal Emergency Management Agency (FEMA) for each community, is appropriate because of new scientific or technical data. The FIRM, and where applicable, portions of the FIS report, have been revised to reflect these flood hazard determinations through issuance of a Letter of Map Revision (LOMR), in accordance with Title 44, Part 65 of the Code of Federal Regulations (44 CFR part 65). The LOMR will be used by insurance agents and others to calculate appropriate flood insurance premium rates for new buildings and the contents of those buildings. For rating purposes, the currently effective community number is shown in the table below and must be used for all new policies and renewals.
These flood hazard determinations will become effective on the dates listed in the table below and revise the FIRM panels and FIS report in effect prior to this determination for the listed communities.
From the date of the second publication of notification of these changes in a newspaper of local circulation, any person has 90 days in which to request through the community that the Deputy Associate Administrator for Mitigation reconsider the changes. The flood hazard determination information may be changed during the 90-day period.
The affected communities are listed in the table below. Revised flood hazard information for each community is available for inspection at both the online location and the respective community map repository address listed in the table below. Additionally, the current effective FIRM and FIS report for each community are accessible online through the FEMA Map Service Center at
Submit comments and/or appeals to the Chief Executive Officer of the community as listed in the table below.
Luis Rodriguez, Chief, Engineering Management Branch, Federal Insurance and Mitigation Administration, FEMA, 500 C Street SW., Washington, DC 20472, (202) 646-4064, or (email)
The specific flood hazard determinations are not described for each community in this notice. However, the online location and local community map repository address where the flood hazard determination information is available for inspection is provided.
Any request for reconsideration of flood hazard determinations must be submitted to the Chief Executive Officer of the community as listed in the table below.
The modifications are made pursuant to section 201 of the Flood Disaster Protection Act of 1973, 42 U.S.C. 4105, and are in accordance with the National Flood Insurance Act of 1968, 42 U.S.C. 4001
The FIRM and FIS report are the basis of the floodplain management measures that the community is required either to adopt or to show evidence of having in effect in order to qualify or remain qualified for participation in the National Flood Insurance Program (NFIP).
These flood hazard determinations, together with the floodplain management criteria required by 44 CFR 60.3, are the minimum that are required. They should not be construed to mean that the community must change any existing ordinances that are more stringent in their floodplain management requirements. The community may at any time enact stricter requirements of its own or pursuant to policies established by other Federal, State, or regional entities. The flood hazard determinations are in accordance with 44 CFR 65.4.
The affected communities are listed in the following table. Flood hazard determination information for each community is available for inspection at both the online location and the respective community map repository address listed in the table below. Additionally, the current effective FIRM and FIS report for each community are accessible online through the FEMA Map Service Center at
Office of the Assistant Secretary for Community Planning and Development, HUD.
Notice.
This Notice identifies unutilized, underutilized, excess, and surplus Federal property reviewed by HUD for suitability for use to assist the homeless.
Juanita Perry, Department of Housing and Urban Development, 451 Seventh Street SW., Room 7266, Washington, DC 20410; telephone (202) 402-3970; TTY number for the hearing- and speech-impaired (202) 708-2565 (these telephone numbers are not toll-free), or call the toll-free Title V information line at 800-927-7588.
In accordance with 24 CFR part 581 and section 501 of the Stewart B. McKinney Homeless Assistance Act (42 U.S.C. 11411), as amended, HUD is publishing this Notice to identify Federal buildings and other real property that HUD has reviewed for suitability for use to assist the homeless. The properties were reviewed using information provided to HUD by Federal landholding agencies regarding unutilized and underutilized buildings and real property controlled by such agencies or by GSA regarding its inventory of excess or surplus Federal property. This Notice is also published in order to comply with the December 12, 1988 Court Order in
Properties reviewed are listed in this Notice according to the following categories: Suitable/available, suitable/unavailable, and suitable/to be excess, and unsuitable. The properties listed in the three suitable categories have been reviewed by the landholding agencies, and each agency has transmitted to HUD: (1) Its intention to make the property available for use to assist the homeless, (2) its intention to declare the property excess to the agency's needs, or (3) a statement of the reasons that the property cannot be declared excess or made available for use as facilities to assist the homeless.
Properties listed as suitable/available will be available exclusively for homeless use for a period of 60 days from the date of this Notice. Where property is described as for “off-site use only” recipients of the property will be required to relocate the building to their own site at their own expense. Homeless assistance providers interested in any such property should send a written expression of interest to HHS, addressed to: Ms. Theresa M. Ritta, Chief Real Property Branch, the Department of Health and Human Services, Room 5B-17, Parklawn Building, 5600 Fishers Lane, Rockville, MD 20857, (301) 443-2265 (This is not a toll-free number.) HHS will mail to the interested provider an application packet, which will include instructions for completing the application. In order to maximize the opportunity to utilize a suitable property, providers should submit their written expressions of interest as soon as possible. For complete details concerning the processing of applications, the reader is encouraged to refer to the interim rule governing this program, 24 CFR part 581.
For properties listed as suitable/to be excess, that property may, if subsequently accepted as excess by GSA, be made available for use by the homeless in accordance with applicable law, subject to screening for other Federal use. At the appropriate time, HUD will publish the property in a Notice showing it as either suitable/available or suitable/unavailable.
For properties listed as suitable/unavailable, the landholding agency has decided that the property cannot be declared excess or made available for use to assist the homeless, and the property will not be available.
Properties listed as unsuitable will not be made available for any other purpose for 20 days from the date of this Notice. Homeless assistance providers interested in a review by HUD of the determination of unsuitability should call the toll free information line at 1-800-927-7588 for detailed instructions or write a letter to Ann Marie Oliva at the address listed at the beginning of this Notice. Included in the request for review should be the property address (including zip code), the date of publication in the
For more information regarding particular properties identified in this Notice (
Bureau of Land Management, Interior.
Notice.
The United States Forest Service (USFS) has filed an application (COC 77206) with the Bureau of Land Management (BLM) requesting the Secretary of the Interior to withdraw approximately 4,200 acres of National Forest System lands within the White River National Forest from location and entry under the United States mining laws for a period of 20 years to protect multiple outstanding features, including scenic, recreational, geologic, ecologic, wildlife, and fisheries values, in the Deep Creek canyon and corridor.
The character of the canyon and corridor is natural and essentially primitive, and the lands and free-flowing waters were found to be eligible for Wild and Scenic designation under the Wild and Scenic Rivers Act in the 2002 White River National Forest, Land and Resource Management Plan Revision. The Forest Plan decision recommended withdrawal of the canyon and corridor from location and entry under the United States mining laws.
This notice temporarily segregates the land for up to 2 years from location and entry under the United States mining laws while the application is being processed. This notice also provides the public an opportunity to comment on the application and to request a public meeting. The lands have been and will remain open to mineral and geothermal leasing, and to such forms of disposition as may be allowed by law on National Forest System lands.
Comments and public meeting requests must be received by January 14, 2016.
Comments and meeting requests should be sent to Steve Craddock, Branch of Lands and Realty, BLM Colorado State Office, 2850 Youngfield Street, Lakewood, CO 80215-7093.
Steve Craddock, BLM Colorado State Office, 303-239-3707, or Carole Huey, White River National Forest, 970-945-3219, during regular business hours 7:45 a.m. to 4:15 p.m., Monday through Friday, except holidays. Persons who use a telecommunications device for the deaf (TDD) may call the Federal Information Relay Service (FIRS) at 1-800-877-8339 to contact the above individual. The FIRS is available 24 hours a day, 7 days a week, to leave a message or question with the above individual. You will receive a reply during normal business hours.
The USFS has filed an application with the BLM pursuant to the Federal Land Policy and Management Act of 1976, 43 U.S.C. 1714, requesting the Secretary of the Interior to withdraw the following described National Forest System lands from location and entry under the United States mining laws (30 U.S.C. Ch. 2), but not from leasing under the mineral or geothermal leasing laws, for a period of 20 years, subject to valid existing rights:
The areas described aggregate approximately 4,200 acres in Garfield County.
The purpose of the withdrawal is to protect multiple outstanding features, including scenic, recreational, geologic, ecologic, wildlife, and fisheries values, in the Deep Creek canyon and corridor.
The use of a right-of-way, interagency or cooperative management agreement would not adequately constrain non-discretionary uses that could irrevocably destroy the area's scenic and recreational values.
No alternative sites are feasible as the described lands contain the natural resource and recreation values in need of protection.
No water rights will be needed to fulfill the purpose of the proposed withdrawal.
For a period until January 14, 2016, all persons who desire to submit comments, suggestions, or objections in connection with the withdrawal application may present their views in writing to the BLM Colorado State Office at the address listed above. Comments, including names and street addresses of respondents, will be available for public review at the BLM Colorado State Office at the above address during regular business hours 7:45 a.m. to 4:15 p.m. Monday through Friday, except Federal holidays.
Notice is also hereby given that the opportunity for a public meeting is afforded in connection with the withdrawal application. All interested parties who desire a public meeting for the purpose of being heard on the proposed withdrawal application must submit a written request to the BLM Colorado State Office at the address listed above by January 14, 2016.
If the authorized officer decides that a public meeting will be held, a notice of the time and place will be published
Before including your address, phone number, email address, or other personal identifying information in your comment, you should be aware that your entire comment—including your personal identifying information—may be made publicly available at any time. While you can ask us in your comment to withhold your personal identifying information from public review, we cannot guarantee that we will be able to do so.
Records related to the application may be examined at the White River National Forest, Supervisor's Office at 900 Grand Avenue, Glenwood Springs, Colorado 81601.
For a period until October 16, 2017, subject to valid existing rights, the lands described in this notice will be segregated from location and entry under the United States mining laws unless the application is denied or cancelled or the withdrawal is approved prior to that date. The lands will remain open to other uses within the statutory authority pertinent to National Forest System lands and subject to discretionary approval.
The application will be processed in accordance with the regulations set forth in 43 CFR part 2300.
Bureau of Land Management, Interior
Notice.
In compliance with the National Environmental Policy Act of 1969, as amended (NEPA); and the Federal Land Policy and Management Act of 1976, as amended (FLPMA); the Bureau of Land Management (BLM) White River Field Office (WRFO), Meeker, Colorado, intends to prepare a Resource Management Plan (RMP) amendment with an associated Environmental Assessment (EA) for the WRFO. By this notice the WRFO is announcing the beginning of the scoping process to solicit public comments and identify issues.
Comments on issues may be submitted in writing until November 16, 2015. The BLM will announce the date(s) and location(s) of any scoping meetings at least 15 days in advance through local news media, newspapers and the BLM Web site at:
You may submit comments on issues and planning criteria related to the WRFO's Travel and Transportation Management RMP amendment/EA by any of the following methods:
•
•
•
•
Documents pertinent to this proposal may be examined at the White River FO.
Heather Sauls, Planning and Environmental Coordinator; telephone 970-878-3855; address White River FO (see address above); email
This document provides notice that the WRFO, Meeker, Colorado, intends to prepare an RMP amendment with an associated EA for the White River Planning Area, announces the beginning of the scoping process, and seeks public input on issues and planning criteria. The RMP amendment will address comprehensive transportation and travel management planning and will amend the 1997 WRFO RMP. At a minimum, the RMP amendment will consider designation of all public lands within the planning area as “open areas” for off-road vehicle use, “limited areas” for off-road vehicle use, or “closed areas” to off-road vehicle use. The RMP amendment will also consider whether to further restrict other modes of transport (
The purpose of the public scoping process is to determine relevant issues that will influence the scope of the environmental analysis, including alternatives, and guide the planning process. BLM personnel; Federal, State and local agencies; and other stakeholders identified the following preliminary issues for the RMP amendment area:
• Is there a recreational need for an open area?
• Are there areas that should be managed with seasonal closures on motorized vehicle use to allow for non-motorized hunting experiences?
• Should the White River FO provide exceptions for off-road motorized travel in limited areas for the purposes of camping, firewood gathering, or retrieval of downed big game?
• Should the WRFO provide exceptions for physically challenged individuals to travel off-road?
• Should the WRFO limit motorized over-the-snow travel by vehicle type, season, snow-depth, or other conditions?
• Should Pike Ridge be managed as closed to motorized vehicles?
• Should travel on existing energy and mineral development access roads be restricted to authorized use?
• Should right-of-way exclusion areas also be managed as closed areas?
• What types of uses are appropriate (
• Should the WRFO implement seasonal or permanent road or trail closures in Greater Sage-Grouse habitat?
• Should construction of new roads be allowed within lands with wilderness characteristics?
• What types of uses are appropriate (
1. The RMP amendment will be limited to making land use planning decisions specific to transportation and travel management.
2. The BLM will designate all public lands within the planning area as open, limited, or closed areas to off-road vehicle use.
3. Lands addressed in the RMP amendment will be surface lands managed by the BLM and will not include split-estate lands (
4. The RMP amendment, if approved, will comply with FLPMA, NEPA, Council on Environmental Quality regulations at 40 CFR 1500-1508, Department of the Interior regulations at 43 CFR 46 and 43 CFR 1600, the BLM Land Use Planning Handbook (H-1601-1), the BLM NEPA Handbook (H-1790-1), the BLM Travel and Transportation Management Handbook (H-8342-1), and all other applicable laws and BLM policies and guidance.
5. Land use decisions in Greater Sage-Grouse habitat considered in the RMP amendment will be consistent with land use decisions in the Northwest Colorado Greater Sage-Grouse RMP amendment.
6. The RMP amendment will recognize valid existing rights.
7. The BLM will use a collaborative approach to planning.
8. The BLM will consult with Indian tribes to identify sites, areas and objectives important to their cultural and religious heritage.
9. The BLM will coordinate and communicate with State, local and tribal governments to ensure the BLM considers provisions of pertinent plans; seek to resolve inconsistencies between State, local and tribal plans; and provide ample opportunities for State, local and tribal governments to comment on the development of the amendment.
10. The BLM will address socioeconomic and Environmental Justice impacts of the alternatives.
11. Land use allocations made for Wilderness Study Areas (WSA) must be consistent with the BLM Management of WSA manual (BLM Manual 6330) and with other laws, regulations and policies related to WSA management.
12. The BLM will consider public welfare and safety when addressing fire management in the context of travel and transportation management planning.
13. The BLM will not consider creating any new special designations, such as Areas of Critical Environmental Concern, through this RMP amendment.
14. The BLM will conduct implementation (route-by-route designations) travel management planning in a separate effort subsequent to completing this RMP amendment.
You may submit comments on issues and planning criteria in writing to the BLM at any public scoping meeting, or you may submit them to the BLM using one of the methods listed in the
The BLM will use the NEPA public participation requirements to assist in satisfying the public involvement requirements under Section 106 of the National Historic Preservation Act (NHPA) (16 U.S.C. 470(f)) pursuant to 36 CFR 800.2(d)(3). The information about historic and cultural resources within the area potentially affected by the proposed action will assist the BLM in identifying and evaluating impacts to such resources in the context of both NEPA and Section 106 of the NHPA.
The BLM will consult with Indian tribes on a government-to-government basis in accordance with Executive Order 13175 and other policies. The BLM will give tribal concerns, including impacts on Indian trust assets and potential impacts to cultural resources, due consideration. Federal, State and local agencies, along with tribes and other stakeholders that may be interested in or affected by the proposed action the BLM is evaluating, are invited to participate in the scoping process and, if eligible, may request or be requested by the BLM to participate in the development of the environmental analysis as a cooperating agency.
Before including your address, phone number, email address, or other personal identifying information in your comment, you should be aware that your entire comment—including your personal identifying information—may be made publicly available at any time. While you can ask us in your comment to withhold your personal identifying information from public review, we cannot guarantee that we will be able to do so.
The BLM will evaluate identified issues to be addressed in the plan, and will place them into one of three categories:
1. Issues to be resolved in the RMP amendment;
2. Issues to be resolved through policy or administrative action; or
3. Issues beyond the scope of this RMP amendment.
The BLM will provide an explanation in the Draft RMP amendment/preliminary EA as to why an issue was placed in category two or three. The BLM also encourages the public to help identify any management questions and concerns that should be addressed in the plan. The BLM will work collaboratively with interested parties to identify the management decisions that are best suited to local, regional, and national needs and concerns.
The BLM will use an interdisciplinary approach to develop the plan amendment in order to consider the variety of resource issues and concerns identified. Specialists with expertise in the following disciplines will be involved in the planning process: Rangeland management, vegetation, riparian and wetlands, invasive and noxious weeds, minerals and geology, forestry, outdoor recreation, visual resource management, cultural resources and Native American concerns, paleontology, wildlife and fisheries, threatened and endangered species, lands and realty, hydrology, soils, wild horses, fire ecology and management, sociology and economics, public safety, law enforcement, and geographic information systems.
40 CFR 1501.7 and 43 CFR 1610.2.
Bureau of Land Management, Interior.
Notice of filing of plats of survey; Wisconsin.
The Bureau of Land Management (BLM) will officially file the plats of survey of the lands described below in the BLM-Eastern States Office, Washington, DC at least 30 calendar days from the date of publication in the
Bureau of Land Management, Eastern States Office, 20 M Street SE., Washington, DC 20003. Attn: Cadastral Survey. Persons who use a telecommunications device for the deaf (TDD) may call the Federal Information Relay Service (FIRS) at 1-800-877-8339 to contact the above individual during normal business hours. The FIRS is available 24 hours a day, 7 days a week, to leave a message or question with the
These surveys were requested by the Bureau of Indian Affairs.
The lands surveyed are:
The plat of survey represents the Dependent Resurvey of a portion of the south boundary, a portion of the subdivisional lines, and a portion of the certified survey map recorded on Page 149, volume 2, in section 26, the retracement of a portion of the eastern right of way of county road “AA” in section 35, the survey of the subdivision of sections 25, 26, 35, and 36 and the western boundary of document No. 310, recorded on Page 31, volume 3, in section 35, and the informational traverse of the northern shore and a portion of the eastern shore of Vejo Lake in section 35 in Township 30 North, Range 16 East, of the 4th Principal Meridian, in the State of Wisconsin, and was accepted September 16, 2015.
The plat of survey represents the retracement of a portion of Blocks 4 and 5 of Buffalo's Subdivision and the retracement, resurvey and monumentation of specified lot and block corners and right of way intersection points, in Blocks 1, 2, and 3 of Buffalo's Subdivision, lands held in trust for the Red Cliff Band of Lake Superior Chippewa Indians in Government Lot 3, Section 31 of Township 51 North, Range 3 West, 4th Principle Meridian, in the State of Wisconsin, and was accepted September 1, 2015.
We will place a copy of the plats we described in the open files. They will be available to the public as a matter of information.
If BLM receives a protest against these surveys, as shown on the plats, prior to the date of the official filing, we will stay the filing pending our consideration of the protest.
We will not officially file the plats until the day after we have accepted or dismissed all protests and they have become final, including decisions on appeals.
Bureau of Land Management, Interior.
Notice.
The Colorado State Board of Land Commissioners (State) has filed a petition for classification and application to obtain public lands and mineral estate in lieu of lands to which the State was entitled but did not receive under its Statehood Act. The State did not receive title because the lands had been included in an Indian Reservation, Forest Reserve, National Forest, or other encumbrance at the time of statehood. Under the Taylor Grazing Act of 1934, the Bureau of Land Management (BLM) may classify sufficient public lands and/or minerals in Colorado for title transfer to the State to satisfy this obligation.
Interested parties may submit written comments regarding the classification of lands and minerals on or before November 16, 2015. Persons asserting a claim to or interest in the lands or mineral estate described in this notice will find the requirements for filing such claims in the
Written comments concerning this Notice should be addressed to: State Director, Bureau of Land Management, Colorado State Office, 2850 Youngfield Street, Lakewood, CO 80215-7093.
John D. Beck, Chief, Branch of Lands and Realty; telephone 303-239-3882; email
Sections 2275 and 2276 of the Revised Statutes, as amended (43 U.S.C. 851 and 852), provide authority for Colorado to receive title to public lands in lieu of lands to which it was entitled under Section 7 of its statehood act of March 3, 1875, where it did not receive title because those lands had otherwise been encumbered.
Section 7 of the Taylor Grazing Act of June 8, 1934, clarified by the Supreme Court in Andrus v. Utah, 446 U.S. 500 (1980), requires that such public lands and/or minerals identified for proposed transfers out of Federal ownership under this authority must first be classified. The BLM is classifying these lands and minerals pursuant to 43 CFR 2400 and Section 7 of the Act of June 8, 1934 (48 Stat. 1272, as amended), 43 U.S.C. 315(f). The final acres conveyed will be determined after further environmental analysis is completed, will be based on a dollar value, and may be less than the aggregate acreage described in this notice.
All persons who wish to submit comments on a motion of any protestant with this initial classification may present their views by any means shown under the
The BLM Colorado State Director will evaluate any adverse comment and issue a notice of determination to proceed with, modify, or cancel the proposed action. In the absence of any action by the BLM State Director, this initial classification action will become the final determination of the Department of the Interior.
The BLM will review any comments and may sustain, vacate, or modify this realty action. In the absence of any adverse comments, the classification of the land described in this notice will become effective on December 15, 2015.
Before including your address, phone number, email address, or other personal identifying information in your comment, you should be aware that your entire comment—including your personal identifying information—may be made publicly available at any time. While you can ask us in your comment to withhold your personal identifying information from public review, we cannot guarantee that we will be able to do so. As provided by 43 CFR 2462.1, the BLM Colorado State Director will schedule a public hearing. The BLM will announce the public hearing date 15 days prior to the hearing.
The lands and minerals included within this initial classification are in Chaffee, Custer, Dolores, Eagle, El Paso, Garfield, Grand, Huerfano, Jackson, Kiowa, La Plata, Moffat, Montezuma, Ouray, Park, Pueblo, Routt, San Miguel and Weld counties, Colorado, and are described as follows:
If and when the selection is approved and certified to the State, the Clear List may either be subject to or reserve any rights-of-way granted by the BLM. Oil and gas, geothermal, or other leases issued under the authority of the Mineral Leasing Act of 1920 (30 U.S.C 181
The segregative effect of a classification for this form of disposal will terminate in one of the following ways:
(1) Disposal of the lands.
(2) Publication in the
(3) An Act of Congress.
43 CFR 2400.
National Park Service, Interior.
Notice.
The U.S. Department of the Interior, National Park Service, Natchez Trace Parkway has completed an inventory of human remains and associated funerary objects, in consultation with the appropriate Indian tribes or Native Hawaiian organizations, and has determined that there is no cultural affiliation between the human remains and associated funerary objects and any present-day Indian tribes or Native Hawaiian organizations. Representatives of any Indian tribe or Native Hawaiian organization not identified in this notice that wish to request transfer of control of these human remains and associated funerary objects should submit a written request to Natchez Trace Parkway. If no additional requestors come forward, transfer of control of the human remains and associated funerary objects to the Indian tribes or Native Hawaiian organizations stated in this notice may proceed.
Representatives of any Indian tribe or Native Hawaiian organization not identified in this notice that wish to request transfer of control of these human remains and associated funerary objects should submit a written request with information in support of the request to Natchez Trace Parkway at the address in this notice by November 16, 2015.
Mary Risser, Superintendent, Natchez Trace Parkway, 2680 Natchez Trace Parkway, Tupelo, MS 38804-9715, telephone (662) 680-4005, email
Notice is here given in accordance with the Native American Graves Protection and Repatriation Act (NAGPRA), 25 U.S.C. 3003, of the completion of an inventory of human remains and associated funerary objects under the control of the U.S. Department of the Interior, National Park Service, Natchez Trace Parkway, Tupelo, MS. The human remains and associated funerary objects were removed from Lee, Prentiss, and Tishomingo Counties, MS.
This notice is published as part of the National Park Service's administrative responsibilities under NAGPRA, 25 U.S.C. 3003(d)(3) and 43 CFR 10.11(d). The determinations in this notice are the sole responsibility of the Superintendent, Natchez Trace Parkway.
A detailed assessment of the human remains was made by Natchez Trace Parkway professional staff in consultation with representatives of the Alabama-Coushatta Tribe of Texas, The Chickasaw Nation, and the United Keetoowah Band of Cherokee Indians in Oklahoma.
On an unknown date, human remains representing, at minimum, three individuals, were removed from the Citizens Bank Property site in Lee County, MS. The exact details of removal are unknown, but documentation indicates that the remains were likely removed by Natchez Trace naturalist Francis Elmore. No known individuals were identified. No associated funerary objects are present.
In 1940, human remains representing, at minimum, four individuals were removed from the Carr site in Lee County, MS, during Works Progress Administration (WPA) excavations. The site is dated to the Late Woodland-Early Mississippian period (circa 1000 B.C.-A.D. 1200). No known individuals were identified. The 287 associated funerary objects are 140 Mulberry Creek vessel fragments, 3 Furrs Cord Marked vessel fragments, 1 Mississippi Plain vessel fragment, 8 Baytown Plain vessel fragments, 1 Baldwin Plain vessel fragment, 6 untyped vessel fragments, 1 piece of daub, 5 flakes, 3 pieces of shatter, 1 piece of ochre, 2 flake tools, 1 scraper, 2 bifaces, 1 core tool, 2 pieces of sandstone, 29 deer bones, 1 turkey bone, 6 box turtle bones, 26 mammal bones, and 48 animal bones.
In 1940, human remains representing, at minimum, one individual were removed from Jennings Dig Number One in Lee County, MS, during WPA excavations. The site is dated to the Miller I-II periods (100 B.C.-A.D. 500). No known individuals were identified. The 22 associated funerary objects are 1 biface, 1 piece of shatter, 1 concretion, 3 Baytown Plain vessel fragments, 1 untyped vessel fragment, and 15 fossil fragments.
In 1940, human remains representing, at minimum, 35 individuals were removed from Miller Mounds in Lee County, MS, during WPA excavations. The site is dated to the Woodland period (A.D. 500-1000). No known individuals were identified. The 39 associated funerary objects are 4 Saltillo Fabric Marked vessel fragments, 3 Saltillo Plain vessel fragments, 2 Baldwin Plain vessel fragments, 5 untyped vessel fragments, 7 projectile points, 1 Lowe Cluster projectile point, 3 bifaces, 4 flakes, 1 platform pipe, 1 busycon shell, 1 chert knife, 1 piece of shatter, 1 unmodified stone, 2 flake tools, 2 Baldwin Plain bowls, and 1 Furrs Cord Marked jar.
In 1947-1951, human remains representing, at minimum, one individual were removed from the Chewapa site in Lee County, MS, by an unknown individual who gave the remains to the WPA survey in the area. The site is dated to the Miller III/Late Woodland period (circa A.D. 500-1200). No known individuals were identified. No associated funerary objects are present.
In 1948, human remains representing, at minimum, one individual were removed from Headquarters Mound in Lee County, MS, during excavation and survey. The site dates to the Late Woodland period (circa A.D. 500-1000). No known individuals were identified. No associated funerary objects are present.
In 1948, human remains representing, at minimum, three individuals were removed from Old Rodgers Place Number One in Lee County, MS, during a WPA survey. The site is prehistoric Native American, but an exact date is unknown. No known individuals were identified. No associated funerary objects are present.
In 1949, human remains representing, at minimum, one individual, were removed from the Coonewah Creek site in Lee County, MS, during a site survey. The site dates to the Miller III/Late Woodland Period (circa A.D. 500-1200). No known individuals were identified. No associated funerary objects are present.
In 1965, human remains representing, at minimum, three individuals were removed from Bear Creek Temple Mound in Tishomingo County, MS, during archeological investigations. The site dates to the Late Mississippian period (circa A.D. 1400-1600). No known individuals were identified. The three associated funerary objects are one untyped vessel fragment and two deer bones.
In 1972, human remains representing, at minimum, six individuals were removed from Pharr Mounds in Prentiss County, MS, during excavations of the village area and four mounds. The site dates to the Miller I-II phases of the Middle Woodland period (circa A.D. 0-500). No known individuals were identified. The 14 associated funerary objects are 7 Saltillo Fabric vessel fragments, 6 Baldwin Plain vessel fragments, and 1 untyped vessel fragment.
In 1978, human remains representing, at minimum, two individuals were removed from Pharr Mounds in Prentiss County, MS. The remains were removed during excavations to investigate the impact of construction near the site. No known individuals were identified. No associated funerary objects are present.
Cultural affiliation of the human remains described above could not be determined due to uncertain burial provenience, lack of culturally affiliated historic artifacts, and/or the antiquity of the remains.
Officials of Natchez Trace Parkway have determined that:
• Pursuant to 25 U.S.C. 3001(9), the human remains described in this notice are Native American based on archeological context.
• Pursuant to 25 U.S.C. 3001(9), the human remains described in this notice represent the physical remains of 60 individuals of Native American ancestry.
• Pursuant to 25 U.S.C. 3001(3)(A), the 365 objects described in this notice are reasonably believed to have been placed with or near individual human remains at the time of death or later as part of the death rite or ceremony. The National Park Service intends to convey the associated funerary objects to the tribes pursuant to 16 U.S.C. 18f-2.
• Pursuant to 25 U.S.C. 3001(2), a relationship of shared group identity cannot be reasonably traced between the Native American human remains and associated funerary objects and any present-day Indian tribe.
• Treaties, Acts of Congress, or Executive Orders, indicate that the land from which the Native American human remains and associated funerary objects were removed is the aboriginal land of The Chickasaw Nation.
• Pursuant to 43 CFR 10.11(c)(1), the disposition of the human remains and associated funerary objects may be to The Chickasaw Nation.
Representatives of any Indian tribe or Native Hawaiian organization not identified in this notice that wish to request transfer of control of these human remains and associated funerary objects should submit a written request with information in support of the request to Mary Risser, Superintendent, Natchez Trace Parkway, 2680 Natchez Trace Parkway, Tupelo, MS 38804-9715, telephone (662) 680-4005, email
Natchez Trace Parkway is responsible for notifying the Alabama-Coushatta Tribe of Texas, The Chickasaw Nation, and the United Keetoowah Band of Cherokee Indians in Oklahoma that this notice has been published.
30-day notice.
To comply with the Paperwork Reduction Act of 1995 (PRA), the Bureau of Ocean Energy Management (BOEM) is notifying the public that we have submitted an information collection request (ICR) to the Office of Management and Budget (OMB) for review and approval. The ICR concerns a new survey on the potential impacts of Atlantic offshore wind energy development on coastal tourism and recreation. This notice provides the public a second opportunity to comment on the paperwork burden of this collection.
Submit written comments by November 16, 2015.
Submit comments on this ICR to the Desk Officer for the Department of the Interior at OMB-OIRA at (202) 395-5806 (fax) or
Kye Mason, Office of Policy, Regulations, and Analysis at
Under a cooperative agreement awarded by the Department of the Interior, the University of Delaware will conduct a survey to assess the impact of offshore wind power projects on coastal recreation and tourism from Massachusetts to South Carolina. The survey will gauge public perceptions of offshore wind energy projects and how development could impact future recreation and visitation choices. BOEM will use this information, along with other economic and environmental information, in our offshore wind decision making process and marine spatial planning efforts. States and coastal communities will use the information for local coastal planning efforts.
The data collection will be done by an Internet-based survey. We decided to use an internet-based approach in part to improve the images respondents are shown. The internet also allows us to easily accommodate different skip patterns and variation in wind projects shown to respondents.
• Whether or not the collection of information is necessary, including whether or not the information will have practical utility;
• The accuracy of our burden estimates;
• Ways to enhance the quality, utility, and clarity of the information to be collected; and
• Ways to minimize the burden on respondents.
To comply with the public consultation process, on July 1, 2014, BOEM published a
• Establish clear goals for the information collection, which then drives the design.
• Use Dillman's Tailored Design Method.
• Create stratums that are approximately homogeneous. Suggested stratums: Near Ocean Beaches (SC coast, Outer Banks, Tidewater VA, Delmarva, Jersey shore, Long Island, Rhode Island, Cape Cod), Metro Areas (Washington, Baltimore, Philadelphia, New York City, Boston metro areas), Inland (Other parts of SC, NC, VA, MD, Central PA, NJ, CT, MA), Distant Areas (OH, WV, TN, KY, Western PA, Upstate NY, VT, NH).
• Use zip codes for location of respondents.
• Publish the raw data so it can be independently analyzed.
U.S. International Trade Commission.
Notice.
Notice is hereby given that the U.S. International Trade Commission has determined not to review an initial determination (“ID”) (Order No. 10) granting an unopposed motion to add as complainants Baxalta, Inc. of Deerfield, Illinois; Baxalta US Inc. of Deerfield, Illinois; and Baxalta GmbH of Glattpark, Switzerland.
Lucy Grace D. Noyola, Office of the General Counsel, U.S. International Trade Commission, 500 E Street SW., Washington, DC 20436, telephone 202-205-3438. Copies of non-confidential documents filed in connection with this investigation are or will be available for inspection during official business hours (8:45 a.m. to 5:15 p.m.) in the Office of the Secretary, U.S. International Trade Commission, 500 E Street SW., Washington, DC 20436, telephone 202-205-2000. General information concerning the Commission may also be obtained by accessing its Internet server (
The Commission instituted this investigation on May 22, 2015, based on a complaint filed by Baxter International Inc. of Deerfield, Illinois; Baxter Healthcare Corporation of Deerfield, Illinois; and Baxter Healthcare SA of Glattpark, Switzerland (“Baxter”). 80
On September 3, 2015, Baxter filed a motion to amend the complaint and notice of investigation to add Baxalta, Inc., Baxalta US Inc., and Baxalta GmbH (“the Baxalta entities”) as complainants. Neither Novo Nordisk nor OUII opposed the motion.
On September 16, 2015, the presiding administrative law judge (“ALJ”) issued an ID, Order No. 10, granting the motion to amend the complaint and notice of investigation. The ALJ found good cause for the amendment. The ALJ found the amendment would not prejudice the parties because (1) they have been aware of a corporate transition involving Baxter and the Baxalta entities since the service of the complaint and the notice of investigation and (2) Baxter has been responding to discovery requests as though they were directed to Baxter and the Baxalta entities and will continue to do so. The ALJ found that having the correct parties in the investigation would simplify and streamline the discovery process. No petitions for review of the ID were filed.
The Commission has determined not to review the subject ID.
The authority for the Commission's determination is contained in section 337 of the Tariff Act of 1930, as amended (19 U.S.C. 1337), and in Part 210 of the Commission's Rules of Practice and Procedure (19 CFR part 210).
By order of the Commission.
U.S. International Trade Commission.
Notice.
Notice is hereby given that the U.S. International Trade Commission has determined not to review an initial determination (“ID”) (Order No. 9) issued by the presiding administrative law judge (“ALJ”), granting the complainant's unopposed motion to amend the complaint and notice of investigation to change the corporate name of the complainant.
Robert Needham, Office of the General Counsel, U.S. International Trade Commission, 500 E Street SW., Washington, DC 20436, telephone (202) 708-5468. Copies of non-confidential documents filed in connection with this investigation are or will be available for inspection during official business hours (8:45 a.m. to 5:15 p.m.) in the Office of the Secretary, U.S. International Trade Commission, 500 E Street SW., Washington, DC 20436, telephone (202) 205-2000. General information concerning the Commission may also be obtained by accessing its Internet server (
The Commission instituted this investigation on June 9, 2015, based on a complaint filed by Global Cash Access, Inc. (“Complainant”). 80
On August 26, 2015, Complainant filed an unopposed motion to amend the complaint and the notice of investigation to change the name of Complainant to Everi Payments Inc. to reflect a corporate name change. Complainant asserts that good cause exists for the amendments.
On September 15, 2015, the ALJ issued the subject ID, granting Complainant's motion to amend the complaint and the notice of investigation. The ALJ found good cause for granting the motion because it is early in the investigation and the amendments will not affect discovery or any issue to be litigated. No petitions for review of the ID were filed.
The Commission has determined not to review the subject ID.
The authority for the Commission's determination is contained in section 337 of the Tariff Act of 1930, as amended (19 U.S.C. 1337), and in Part 210 of the Commission's Rules of Practice and Procedure (19 CFR part 210).
By order of the Commission.
Federal Bureau of Investigation, Department of Justice.
30-Day notice.
The Department of Justice, Federal Bureau of Investigation, Criminal Justice Information Services Division has submitted the following information collection request to the
The purpose of this notice is to allow for an additional 30 days for public comment until November 16, 2015.
Written comments and/or suggestions regarding the items contained in this notice, especially the estimated public burden and associated response time, should be directed to Mr. Samuel Berhanu, Unit Chief, Federal Bureau of Investigation, Criminal Justice Information Services (CJIS) Division, Module E-3, 1000 Custer Hollow Road, Clarksburg, West Virginia 26306; facsimile (304) 625-3566. Written comments and/or suggestions can also be directed to the Office of Management and Budget, Office of Information and Regulatory Affairs, Attention Department of Justice Desk Officer, Washington, DC 20503 or sent to
Written comments and suggestions from the public and affected agencies concerning the proposed collection of information are encouraged. Comments should address one or more of the following four points:
(1) Evaluate whether the proposed collection of information is necessary for the proper performance of the functions of the agency, including whether the information will have practical utility;
(2) Evaluate the accuracy of the agency's estimate of the burden of the proposed collection of information, including the validity of the methodology and assumptions used;
(3) Enhance the quality, utility, and clarity of the information to be collected; and
(4) Minimize the burden of the collection of information on those who are to respond including through the use of appropriate automated, electronic, mechanical, or other technological collection techniques of other forms of information technology,
(1)
(2)
(3)
(4)
Abstract: Under U.S. Code, Title 28, Section 534, Acquisition, Preservation, and Exchange of Identification Records; Appointment of Officials, June 11, 1930; Public Law 109-177 (H.R. 3199), March 9, 2006, USA Patriot Improvement and Reauthorization Act of 2005; Public Law 110-457, Title II, Section 237(a), (b), December 23, 2008, the William Wilberforce Trafficking Victims Reauthorization Act of 2008, and Matthew Shepard Hate Crimes Prevention Act, April 28, 2009, this collection requests Incident data from city, county, state, tribal and federal law enforcement agencies in order for the FBI UCR Program to serve as the national clearinghouse for the collection and dissemination of crime data and to publish these statistics in Crime in the United States, Hate Crime Statistics, and Law Enforcement Officers Killed and Assaulted. NIBRS is an incident-based reporting system in which law enforcement collects data on each crime occurrence. Designed to be generated as a byproduct of local, state, and federal automated records systems, currently, the NIBRS collects data on each incident and arrest within 23 crime categories made up of 49 specific crimes called Group A offenses. For each of the offenses coming to the attention of law enforcement, various facts about the crime are collected. In addition to the Group A offenses, there are 10 Group B offense categories for which only arrest data are reported. The most significant difference between NIBRS and the traditional Summary Reporting System (SRS) is the degree of detail in reporting. In reporting data via the traditional SRS, law enforcement agencies tally the occurrences of eight Part I crimes. NIBRS is capable of producing more detailed, accurate, and meaningful data because data are collected about when and where crime takes place, what form it takes, and the characteristics of its victims and perpetrators. Although most of the general concepts for collecting, scoring, and reporting UCR data in the SRS apply in the NIBRS, such as jurisdictional rules, there are some important differences in the two systems. The most notable differences that give the NIBRS an advantage over the SRS are: No Hierarchy Rule, in a multiple-offense incident NIBRS reports every offense occurring during the incident where SRS would report just the most serious offense and the lower-listed offense would not be reported; NIBRS provides revised, expanded, and new offense definitions; NIBRS provides more specificity in reporting offenses, using NIBRS offense and arrest data for 23 Group A offense categories can be reported while in the SRS eight Part I offenses can be reported; NIBRS can distinguish between attempted and completed Group A crimes; NIBRS also provides crimes against society while the SRS does not; the victim-to-offender data, circumstance reporting, drug related offenses, offenders suspected use of drugs, and computer crime is expanded in NIBRS; the NIBRS update reports are directly tied to the original incident submitted. The Group A offense categories include arson, assault offenses, bribery, burglary/breaking and entering, counterfeiting/forgery, destruction/damage/vandalism of property, drug/narcotic offenses, embezzlement, extortion/blackmail, fraud offenses, gambling offenses, homicide offenses, human trafficking, kidnapping/abduction, larceny/theft offenses, motor vehicle theft, pornography/obscene material, prostitution offenses, robbery, sex offenses, sex offenses/nonforcible, stolen property offenses, and weapon law violations. The Group B offense categories include bad checks, curfew/loitering/vagrancy violations, disorderly conduct, DUI, drunkenness, family offenses/nonviolent, liquor law violations, peeping tom, trespass of real property, and all other offenses.
(5)
(6)
If additional information is required contact: Jerri Murray, Department Clearance Officer, Policy and Planning Staff, Justice Management Division, United States Department of Justice, Two Constitution Square, 145 N Street NE., Room 3E.405B, Washington, DC 20530.
Federal Bureau of Investigation, Department of Justice.
30-Day notice.
The Department of Justice, Federal Bureau of Investigation, Criminal Justice Information Services (CJIS) Division will be submitting the following Information Collection Request to the Office of Management and Budget (OMB) for review and clearance in accordance with the established review procedures of the Paperwork Reduction Act of 1995. The proposed information collection is published to obtain comments from the public and affected agencies. This proposed information collection was previously published in the
Comments are encouraged and will be accepted for an additional 30 days until November 16, 2015.
Written comments and/or suggestions regarding the items contained in this notice, especially the estimated public burden and associated response time, should be directed to Mr. Samuel Berhanu, Unit Chief, Federal Bureau of Investigation, CJIS Division, Module E-3, 1000 Custer Hollow Road, Clarksburg, West Virginia 26306; facsimile (304) 625-3566. Written comments and/or suggestions can also be directed to the Office of Management and Budget, Office of Information and Regulatory Affairs, Attention Department of Justice Desk Officer, Washington, DC 20503 or sent to
Written comments and suggestions from the public and affected agencies concerning the proposed collection of information are encouraged. Comments should address one or more of the following four points:
(1) Evaluate whether the proposed collection of information is necessary for the proper performance of the functions of the agency, including whether the information will have practical utility;
(2) Evaluate the accuracy of the agency's estimate of the burden of the proposed collection of information, including the validity of the methodology and assumptions used;
(3) Enhance the quality, utility, and clarity of the information to be collected; and
(4) Minimize the burden of the collection of information on those who are to respond, including through the use of appropriate automated, electronic, mechanical, or other technological collection techniques of other forms of information technology,
(1)
(2)
(3)
(4)
(5)
(6)
If additional information is required contact: Jerri Murray, Department Clearance Officer, Policy and Planning Staff, Justice Management Division, United States Department of Justice, Two Constitution Square, 145 N Street NE., Room 3E.405B, Washington, DC 20530.
Employment and Training Administration (ETA); Labor.
Notice.
The Department of Labor (Department), as part of its continuing effort to reduce paperwork and respondent burden, conducts a preclearance consultation program to provide the general public and Federal agencies with an opportunity to comment on proposed and/or continuing collections of information in accordance with the Paperwork Reduction Act of 1995 (PRA) [44 U.S.C. 3506(c)(2)(A)]. This program helps to ensure that required data can be provided in the desired format, reporting burden (time and financial resources) is minimized, collection instruments are clearly understood, and the impact of collection requirements on respondents can be properly assessed.
The Department notes that a Federal agency cannot conduct or sponsor a collection of information unless it is approved by the Office of Management
This information collection request (ICR) is to obtain extended clearance for Mathematica Policy Research, under contract to ETA, to administer the follow-up survey for the SET Evaluation. A 20-month extension is requested to the data-collection period for the follow-up survey.
Written comments must be submitted to the office listed in the addressee section below on or before December 15, 2015.
Send comments to Janet Javar, U.S. Department of Labor, Room S-2312, 200 Constitution Avenue NW., Washington, DC 20210. Telephone number: (202) 693-5954 (this is not a toll-free number). Email address:
The SET Demonstration will implement a new service delivery model that seeks to better connect dislocated workers to self-employment services. This approach differs from previous large-scale demonstration programs, which have provided mixed evidence on the effectiveness of self-employment services on earnings and employment, because the SET Demonstration will: (1) Rely on self-employment advisors to offer more intensive business development counseling services than prior demonstrations have offered; and (2) concentrate on dislocated workers who have fairly limited traditional employment prospects but are well-positioned to benefit from self-employment counseling and training. The SET Evaluation will assess the effectiveness of the SET Demonstration model.
To achieve the study's target sample size, enrollment in the SET program began in July 2013 and will continue through December 2015. About 3,000 eligible applicants will be randomly assigned to either receive SET services or to a control group. All 3,000 applicants are asked to complete the 18-month follow-up survey.
An initial clearance request for the SET Evaluation was approved by OMB in January 2013 (ICR reference number 201209-1205-001; OMB control number 1205-0505). Clearance covered the study's consent and application forms, the program participation records, the evaluation team's site visit and case study protocols, and the study participant follow-up survey. This data collection was approved with an expiration date of January 31, 2016 and an annualized total allowable burden of 5,344 hours.
A subsequent non-substantive change request related to the follow-up survey (ICR reference number 201408-1205-005) was approved by OMB in October 2014. This non-substantive request sought to preserve the most critical outcome measures while shortening instrument length to reduce respondent burden. The non-substantive change did not affect any data collection efforts other than the follow-up survey. As with the originally approved OMB package, all 3,000 applicants would be asked to complete the survey, but the shortening of the instrument will reduce the total annualized burden across the entire study from 5,344 to 4,277 hours.
This new request is to extend OMB clearance of the follow-up survey administration, which will expire on January 31, 2016, for an additional 20 months, to September 30, 2017. Given that study enrollment has proceeded more slowly than originally planned, an 18-month follow-up survey could be administered to only approximately 25 percent of the demonstration applicants by the current expiration date of January 31, 2016. Assuming an 80 percent response rate, this would result in approximately 630 respondents (= 3,000 respondents × 0.80 response rate × 0.25 of study participants). Extending the expiration date to September 30, 2017 will allow sufficient time to field the survey to all study applicants. This request does not cover any of the other elements of the OMB-approved data collection; no extension is required for the consent and application forms, the program participation records, or the evaluation team's site visit and case study protocols.
The 18-month follow-up survey is administered 18 months after study participants apply to the SET program. It is the only source of information needed to evaluate the impact program on the six groups of study outcomes: (1) Current employment status; (2) receipt of self-employment assistance services; (3) business development activities; (4) self-employment experiences; (5) experiences in wage and salary employment; and (6) job satisfaction and program participation. These data will be used to determine the impacts of the SET Demonstration on participants' outcomes.
* Evaluate whether the proposed collection of information is necessary for the proper performance of the functions of the agency, including whether the information will have practical utility;
* evaluate the accuracy of the agency's estimate of the burden of the proposed collection of information, including the validity of the methodology and assumptions used;
* enhance the quality, utility, and clarity of the information to be collected; and
* minimize the burden of the information collection on those who are to respond, including the use of appropriate automated, electronic, mechanical, or other technological collection techniques or other forms of information technology,
This request includes no changes to the follow-up survey instrument, and therefore implies no change in total respondent burden. The study team expects to complete 2,400 interviews, as originally planned, for a response rate of 80 percent. A total of 210 burden hours ((= 630 responses × 20 minutes per response) ÷ 60 minutes/hour) are anticipated for surveys completed prior to the expiration date. As seen in the table above, another 590 burden hours ((= 1,770 responses × 20 minutes/response) ÷ 60 minutes/hour) would occur for surveys completed during the extension period, if granted. The total burden for the follow-up survey as a whole would remain unchanged at 800 hours, the amount originally approved by OMB.
The extension would also reduce the average annualized burden hours because the survey fielding would occur over a longer period than originally planned. The original OMB clearance package assumed that the fielding period would last for 18 months, which implied an average annualized hour burden of 533 (= 800 total hours/1.5 years). Given study enrollment patterns, the follow-up survey began in early April 2015, and the fielding period will last until September 2017 if the extension is granted, for a total of 30 months. The longer fielding period implied a reduction in the average annualized hour burden of 320 (= 800 total hours/2.5 years). If granted, the extension would result in an average annualized dollar burden of $5,737 ((= 2,400 responses × 20 minutes/response) ÷ (60 minutes/hour × $17.93 per hour/2.5 years)), which is lower than under the plan originally approved by OMB.
Comments submitted in response to this request will be summarized and/or included in the request for Office of Management and Budget approval; they will also become a matter of public record.
National Endowment for the Humanities, National Foundation on the Arts and the Humanities.
Notice of Meetings; correction.
The National Endowment for the Humanities published a document in the
Lisette Voyatzis, Committee Management Officer; (202) 606-8322;
In the
16. DATE: October 30, 2015.
TIME: 8:30 a.m. to 5:00 p.m.
ROOM: Virtual Meeting.
This meeting will discuss applications on the subject of Linguistics, for the Humanities Collections and Reference Resources grant program, submitted to the Division of Preservation and Access.
National Endowment for the Humanities, National Foundation on the Arts and the Humanities.
Notice of meetings.
The National Endowment for the Humanities will hold twenty-six meetings of the Humanities Panel, a federal advisory committee, during November, 2015. The purpose of the meetings is for panel review, discussion, evaluation, and recommendation of applications for financial assistance under the National Foundation on the Arts and Humanities Act of 1965.
See Supplementary Information section for meeting dates.
The meetings will be held at Constitution Center at 400 7th Street SW., Washington, DC 20506. See
Lisette Voyatzis, Committee Management Officer, 400 7th Street SW., Room 4060, Washington, DC 20506; (202) 606-8322;
Pursuant to section 10(a)(2) of the Federal Advisory Committee Act (5 U.S.C. App.), notice is hereby given of the following meetings:
1. DATE: November 2, 2015
TIME: 8:30 a.m. to 5:00 p.m.
ROOM: 4002
This meeting will discuss applications on the subjects of U.S. History and Culture, for Museums, Libraries, and Cultural Organizations: Implementation Grants, submitted to the Division of Public Programs.
2. DATE: November 2, 2015
TIME: 8:30 a.m. to 5:00 p.m.
ROOM: Conference Call
This meeting will discuss applications for Enduring Questions: Pilot Course Grants, submitted to the Division of Education Programs.
3. DATE: November 3, 2015
TIME: 8:30 a.m. to 5:00 p.m.
ROOM: P002
This meeting will discuss applications on the subjects of Music and Performing Arts, for the Humanities Collections and Reference Resources grant program, submitted to the Division of Preservation and Access.
4. DATE: November 3, 2015
TIME: 8:30 a.m. to 5:00 p.m.
ROOM: Conference Call
This meeting will discuss applications for Enduring Questions: Pilot Course Grants, submitted to the Division of Education Programs.
5. DATE: November 3, 2015
TIME: 8:30 a.m. to 5:00 p.m.
ROOM: Conference Call
This meeting will discuss applications on the subject of History, for Media Projects: Development Grants, submitted to the Division of Public Programs.
6. DATE: November 4, 2015
TIME: 8:30 a.m. to 5:00 p.m.
ROOM: 4002
This meeting will discuss applications on the subjects of U.S. History and Culture, for Museums, Libraries, and Cultural Organizations: Implementation Grants, submitted to the Division of Public Programs.
7. DATE: November 4, 2015
TIME: 8:30 a.m. to 5:00 p.m.
ROOM: Conference Call
This meeting will discuss applications for Enduring Questions: Pilot Course Grants, submitted to the Division of Education Programs.
8. DATE: November 5, 2015
TIME: 8:30 a.m. to 5:00 p.m.
ROOM: P002
This meeting will discuss applications on the subjects of Art and Architectural History, for the Humanities Collections and Reference Resources grant program, submitted to the Division of Preservation and Access.
9. DATE: November 5, 2015
TIME: 8:30 a.m. to 5:00 p.m.
ROOM: Conference Call
This meeting will discuss applications on the subjects of U.S. History and Culture, for Museums, Libraries, and Cultural Organizations: Planning Grants, submitted to the Division of Public Programs.
10. DATE: November 5, 2015
TIME: 8:30 a.m. to 5:00 p.m.
ROOM: Conference Call
This meeting will discuss applications for Enduring Questions: Pilot Course Grants, submitted to the Division of Education Programs.
11. DATE: November 9, 2015
TIME: 8:30 a.m. to 5:00 p.m.
ROOM: Conference Call
This meeting will discuss applications on the subjects of Arts and Culture, for Media Projects: Development Grants, submitted to the Division of Public Programs.
12. DATE: November 9, 2015
TIME: 8:30 a.m. to 5:00 p.m.
ROOM: Conference Call
This meeting will discuss applications for Enduring Questions: Pilot Course Grants, submitted to the Division of Education Programs.
13. DATE: November 10, 2015
TIME: 8:30 a.m. to 5:00 p.m.
ROOM: P002
This meeting will discuss applications on the subjects of Contemporary U.S. History and Culture, for the Humanities Collections and Reference Resources grant program, submitted to the Division of Preservation and Access.
14. DATE: November 10, 2015
TIME: 8:30 a.m. to 5:00 p.m.
ROOM: Conference Call
This meeting will discuss applications on the subject of American Studies, for Museums, Libraries, and Cultural Organizations: Planning Grants, submitted to the Division of Public Programs.
15. DATE: November 12, 2015
TIME: 8:30 a.m. to 5:00 p.m.
ROOM: Conference Call
This meeting will discuss applications on the subjects of Art and Design, for Museums, Libraries, and Cultural Organizations: Planning Grants, submitted to the Division of Public Programs.
16. DATE: November 13, 2015
TIME: 8:30 a.m. to 5:00 p.m.
ROOM: P002
This meeting will discuss applications on the subject of World Studies: Early Modern Era to Present, for the Humanities Collections and Reference Resources grant program, submitted to the Division of Preservation and Access.
17. DATE: November 16, 2015
TIME: 8:30 a.m. to 5:00 p.m.
ROOM: 4002
This meeting will discuss applications on the subjects of Archives and Digital Collections I (Level II), for Digital Humanities Start-Up Grants, submitted to the Office of Digital Humanities.
18. DATE: November 16, 2015
TIME: 8:30 a.m. to 5:00 p.m.
ROOM: P003
This meeting will discuss applications for the Dialogues on the Experience of War grant program, submitted to the Division of Education Programs.
19. DATE: November 17, 2015
TIME: 8:30 a.m. to 5:00 p.m.
ROOM: P002
This meeting will discuss applications on the subject of World Studies: Classic Era to Medieval, for the Humanities Collections and Reference Resources grant program, submitted to the Division of Preservation and Access.
20. DATE: November 17, 2015
TIME: 8:30 a.m. to 5:00 p.m.
ROOM: P003
This meeting will discuss applications for the Dialogues on the Experience of War grant program, submitted to the Division of Education Programs.
21. DATE: November 17, 2015
TIME: 8:30 a.m. to 5:00 p.m.
ROOM: 4002
This meeting will discuss applications on the subject of Geospatial and Visualization (Level II), for Digital Humanities Start-Up Grants, submitted to the Office of Digital Humanities.
22. DATE: November 18, 2015
TIME: 8:30 a.m. to 5:00 p.m.
ROOM: 4084
This meeting will discuss applications on the subjects of Media Studies and Scholarly Communication (Level II), for Digital Humanities Start-Up Grants, submitted to the Office of Digital Humanities.
23. DATE: November 18, 2015
TIME: 8:30 a.m. to 5:00 p.m.
ROOM: 4075
This meeting will discuss applications for the Dialogues on the Experience of War grant program, submitted to the Division of Education Programs.
24. DATE: November 23, 2015
TIME: 8:30 a.m. to 5:00 p.m.
ROOM: Virtual Panel
This meeting will discuss applications on the subjects of Public Programs and Education (Level I), for Digital Humanities Start-Up Grants, submitted to the Office of Digital Humanities.
25. DATE: November 23, 2015
TIME: 8:30 a.m. to 5:00 p.m.
ROOM: P003
This meeting will discuss applications for the Dialogues on the Experience of War grant program, submitted to the Division of Education Programs.
26. DATE: November 24, 2015
TIME: 8:30 a.m. to 5:00 p.m.
ROOM: P003
This meeting will discuss applications for the Dialogues on the Experience of War grant program, submitted to the Division of Education Programs.
Because these meetings will include review of personal and/or proprietary financial and commercial information given in confidence to the agency by grant applicants, the meetings will be closed to the public pursuant to sections 552b(c)(4) and 552b(c)(6) of Title 5, U.S.C., as amended. I have made this determination pursuant to the authority granted me by the Chairman's Delegation of Authority to Close Advisory Committee Meetings dated July 19, 1993.
October 19, 26, November 2, 9, 16, 23, 2015.
Commissioners' Conference Room, 11555 Rockville Pike, Rockville, Maryland.
Public and Closed.
This meeting will be webcast live at the Web address—
There are no meetings scheduled for the week of October 26, 2015.
There are no meetings scheduled for the week of November 2, 2015.
There are no meetings scheduled for the week of November 9, 2015.
(Contact: Gregory Bowman: 301-415-2939)
This meeting will be webcast live at the Web address—
(Contact: Tom Tai: 301-415-8484)
This meeting will be webcast live at the Web address—
There are no meetings scheduled for the week of November 23, 2015.
The schedule for Commission meetings is subject to change on short notice. For more information or to verify the status of meetings, contact Denise McGovern at 301-415-0681 or via email at
The NRC Commission Meeting Schedule can be found on the Internet at:
The NRC provides reasonable accommodation to individuals with disabilities where appropriate. If you need a reasonable accommodation to participate in these public meetings, or need this meeting notice or the transcript or other information from the public meetings in another format (
Members of the public may request to receive this information electronically. If you would like to be added to the distribution, please contact the Nuclear Regulatory Commission, Office of the Secretary, Washington, DC 20555 (301-415-1969), or email
By letter dated October 8, 2015 (the “Letter”), as supplemented by conversations with the staff of the Division of Trading and Markets, counsel for PowerShares Exchange-Traded Fund Trust II (the “Trust”), on behalf of the Trust, PowerShares DWA Tactical Sector Rotation Portfolio (the “Fund”), any national securities exchange on or through which shares issued by the Fund (“Shares”) may subsequently trade, Invesco Distributors, Inc. (the “Distributor”), and persons or entities engaging in transactions in Shares (collectively, the “Requestors”), requested exemptions, or interpretive or no-action relief, from Rule 10b-17 of the Securities Exchange Act of 1934, as amended (“Exchange Act”), and Rules 101 and 102 of Regulation M, in connection with secondary market transactions in Shares and the creation or redemption of aggregations of Shares of at least 50,000 shares (“Creation Units”).
The Trust is registered with the Securities and Exchange Commission (“Commission”) under the Investment Company Act of 1940, as amended (“1940 Act”), as an open-end management investment company. The Fund seeks to track the performance of the underlying index, the Dorsey Wright® Sector 4 Index (the “Index”).
The Requestors represent, among other things, the following:
• Shares of the Fund will be issued by the Trust, an open-end management investment company that is registered with the Commission;
• The Trust will continuously redeem Creation Units at net asset value (“NAV”), and the secondary market price of the Shares should not vary substantially from the NAV of such Shares;
• Shares of the Fund will be listed and traded on the NASDAQ Stock Market LLC or another exchange in accordance with exchange listing standards that are, or will become, effective pursuant to Section 19(b) of the Exchange Act (the “Exchange”);
• All ETFs in which the Fund is invested will meet all conditions set forth in a relevant class relief letter,
• At least 70% of the Fund is comprised of component securities that will meet the minimum public float and minimum average daily trading volume thresholds under the “actively-traded securities” definition found in Regulation M for excepted securities during each of the previous two months of trading prior to formation of the Fund;
• All the components of the Index will have publicly available last sale trade information;
• The intra-day proxy value of the Fund per share and the value of the Index will be publicly disseminated by a major market data vendor throughout the trading day;
• On each business day before the opening of business on the Exchange, the Fund's custodian, through the National Securities Clearing Corporation, will make available the list of the names and the numbers of securities and other assets of the Fund's portfolio that will be applicable that day to creation and redemption requests;
• The Exchange or other market information provider will disseminate (i) continuously every 15 seconds throughout the trading day, through the facilities of the consolidated tape, the market value of a Share, and (ii) every 15 seconds throughout the trading day, a calculation of the intra-day indicative value of a Share;
• The arbitrage mechanism will be facilitated by the transparency of the Fund's portfolio and the availability of the intra-day indicative value, the liquidity of securities held by the Fund, and the ability to acquire such securities, as well as the arbitrageurs' ability to create workable hedges;
• The Fund will invest solely in liquid securities;
• The Fund will invest in securities that will facilitate an effective and efficient arbitrage mechanism and the ability to create workable hedges;
• The Trust believes that arbitrageurs are expected to take advantage of price variations between the Fund's market price and its NAV; and
• A close alignment between the market price of Shares and the Fund's NAV is expected.
While redeemable securities issued by an open-end management investment company are excepted from the provisions of Rules 101 and 102 of Regulation M, the Requestors may not rely upon those exceptions for the Shares.
Generally, Rule 101 of Regulation M is an anti-manipulation rule that, subject to certain exceptions, prohibits any “distribution participant” and its “affiliated purchasers” from bidding for, purchasing, or attempting to induce any person to bid for or purchase any security that is the subject of a distribution until after the applicable restricted period, except as specifically permitted in the Rule. Rule 100 of Regulation M defines “distribution” to mean any offering of securities that is distinguished from ordinary trading transactions by the magnitude of the offering and the presence of special selling efforts and selling methods. The provisions of Rule 101 of Regulation M apply to underwriters, prospective underwriters, brokers, dealers, or other persons who have agreed to participate or are participating in a distribution of securities. The Shares are in a continuous distribution, and, as such, the restricted period in which distribution participants and their affiliated purchasers are prohibited from bidding for, purchasing, or attempting to induce others to bid for or purchase extends indefinitely.
Based on the representations and the facts presented in the Letter, particularly that the Trust is a registered open-end management investment company that will continuously redeem at the NAV Creation Unit size aggregations of the Shares of the Fund and that a close alignment between the market price of Shares and the Fund's NAV is expected, the Commission finds that it is appropriate in the public interest, and consistent with the protection of investors to grant the Trust an exemption under paragraph (d) of Rule 101 of Regulation M with respect to the Fund, thus permitting persons participating in a distribution of Shares of the Fund to bid for or purchase such Shares during their participation in such distribution.
Rule 102 of Regulation M prohibits issuers, selling security holders, and any affiliated purchaser of such person from bidding for, purchasing, or attempting to induce any person to bid for or purchase a covered security during the applicable restricted period in connection with a distribution of securities effected by or on behalf of an issuer or selling security holder.
Based on the representations and the facts presented in the Letter, particularly that the Trust is a registered open-end management investment company that will redeem at the NAV Creation Unit size aggregations of Shares of the Fund and that a close alignment between the market price of Shares and the Fund's NAV is expected, the Commission finds that it is appropriate in the public interest, and consistent with the protection of investors to grant the Trust an exemption under paragraph (e) of Rule 102 of Regulation M with respect to the Fund, thus permitting the Fund to redeem Shares of the Fund during the continuous offering of such Shares.
Rule 10b-17, with certain exceptions, requires an issuer of a class of publicly traded securities to give notice of certain specified actions (for example, a dividend distribution) relating to such class of securities in accordance with Rule 10b-17(b). Based on the representations and the facts presented in the Letter, and subject to the conditions below, the Commission finds that it is appropriate in the public interest, and consistent with the protection of investors, to grant the Trust a conditional exemption from Rule 10b-17 because market participants will receive timely notification of the existence and timing of a pending distribution, and thus the concerns that the Commission raised in adopting Rule 10b-17 will not be implicated.
This exemptive relief is subject to the following conditions:
• The Trust will comply with Rule 10b-17, except for Rule 10b-17(b)(1)(v)(a) and (b); and
• The Trust will provide the information required by Rule 10b-17(b)(1)(v)(a) and (b) to the Exchange as soon as practicable before trading begins on the ex-dividend date, but in no event later than the time when the Exchange last accepts information relating to distributions on the day before the ex-dividend date.
This exemptive relief is subject to modification or revocation at any time the Commission determines that such action is necessary or appropriate in furtherance of the purposes of the Exchange Act. This exemption is based on the facts presented and the representations made in the Letter. Any different facts or representations may require a different response. Persons relying upon this exemptive relief shall discontinue transactions involving the Shares of the Fund, pending presentation of the facts for the Commission's consideration, in the event that any material change occurs with respect to any of the facts or representations made by the Requestors, and as is the case with all preceding letters, particularly with respect to the close alignment between the market price of Shares and the Fund's NAV. In addition, persons relying on this exemption are directed to the anti-fraud and anti-manipulation provisions of the Exchange Act, particularly Sections 9(a), 10(b), and Rule 10b-5 thereunder. Responsibility for compliance with these and any other applicable provisions of the federal securities laws must rest with the persons relying on this exemption. This Order should not be considered a view with respect to any other question that the proposed transactions may raise, including, but not limited to, the adequacy of the disclosure concerning, and the applicability of other federal or state laws to, the proposed transactions.
For the Commission, by the Division of Trading and Markets, pursuant to delegated authority.
Pursuant to Section 19(b)(1) of the Securities Exchange Act of 1934 (“Act”)
FINRA is proposing to extend the pilot program in FINRA Rule 6730(e)(4) to October 27, 2017. The pilot program exempts from TRACE reporting transactions in TRACE-Eligible Securities that are executed on a facility of the New York Stock Exchange
Below is the text of the proposed rule change. Proposed new language is in italics; proposed deletions are in brackets.
(a) through (d) No Change.
(e) Reporting Requirements for Certain Transactions and Transfers of Securities
The following shall not be reported:
(1) through (3) No Change.
(4) Provided that a data sharing agreement between FINRA and NYSE related to transactions covered by this Rule remains in effect, for a pilot program expiring on [October 23, 2015]
(5) through (6) No Change.
(f) No Change.
.01 through .02 No Change.
In its filing with the Commission, FINRA included statements concerning the purpose of and basis for the proposed rule change and discussed any comments it received on the proposed rule change. The text of these statements may be examined at the places specified in Item IV below. FINRA has prepared summaries, set forth in sections A, B, and C below, of the most significant aspects of such statements.
FINRA Rule 6730(e)(4) exempts members from reporting to the Trade Reporting and Compliance Engine (“TRACE”) transactions in TRACE-Eligible Securities
FINRA is proposing to extend the pilot program for two years until October 27, 2017. Thus, members would continue to be exempted from reporting to TRACE transactions in TRACE-Eligible Securities that are executed on an NYSE facility in accordance with NYSE Rules 1400, 1401 and 86, where such transactions are reported to NYSE in accordance with NYSE's applicable trade reporting rules, and disseminated publicly by NYSE.
FINRA is proposing to extend the pilot to provide additional time to analyze the impact of the exemption and to avoid duplicative reporting requirements for members with regard to transactions in these securities, which otherwise would be subject to trade reporting to both FINRA and NYSE. However, FINRA supports a regulatory construct that, in the future, consolidates all last sale transaction information to provide better price transparency and a more efficient means to engage in market surveillance of TRACE-Eligible Securities transactions. The proposed extension would allow the pilot program to continue to operate without interruption while FINRA and NYSE continue to assess the effect of the exemption and issues regarding the consolidation of market data, market surveillance and price transparency.
FINRA has filed the proposed rule change for immediate effectiveness. The implementation date will be October 23, 2015.
FINRA believes that the proposed rule change is consistent with the provisions of Section 15A(b)(6) of the Act,
FINRA believes that extension of the pilot protects investors and the public because it continues to ensure that transactions are required to be reported and publicly disseminated; therefore, transparency will be maintained for these transactions. The continued condition that a data sharing agreement remain in effect between NYSE and FINRA for transactions covered by the FINRA Rule 6730(e)(4) exemption allows FINRA to continue to conduct surveillance in TRACE-Eligible Securities. In addition, extending the exemption permits members that are subject to both FINRA's and NYSE's trade reporting requirements to avoid a duplicative regulatory structure and the increased costs that may be incurred as a result of such duplicative requirements.
FINRA does not believe that the proposed rule change will result in any burden on competition that is not necessary or appropriate in furtherance of the purposes of the Act. FINRA believes that the extension of the exemptive provision does not result in any burden on competition since it allows members that are subject to both
Written comments were neither solicited nor received.
Because the foregoing proposed rule change does not: (i) Significantly affect the protection of investors or the public interest; (ii) impose any significant burden on competition; and (iii) become operative for 30 days after the date of the filing, or such shorter time as the Commission may designate, it has become effective pursuant to 19(b)(3)(A) of the Act
FINRA has asked the Commission to waive the 30-day operative delay so that the pilot may continue to operate without interruption. The Commission believes that waiving the 30-day operative delay is consistent with the protection of investors and the public interest. This action will continue to allow the benefits of the pilot—preventing duplicative reporting of transactions in TRACE-Eligible Securities that occur on NYSE—to continue without interruption. Therefore, the Commission hereby designates the proposed rule change as operative upon filing.
At any time within 60 days of the filing of the proposed rule change, the Commission summarily may temporarily suspend such rule change if it appears to the Commission that such action is necessary or appropriate in the public interest, for the protection of investors, or otherwise in furtherance of the purposes of the Act. If the Commission takes such action, the Commission shall institute proceedings to determine whether the proposed rule should be approved or disapproved.
Interested persons are invited to submit written data, views, and arguments concerning the foregoing, including whether the proposed rule change is consistent with the Act. Comments may be submitted by any of the following methods:
• Use the Commission's Internet comment form (
• Send an email to
• Send paper comments in triplicate to Secretary, Securities and Exchange Commission, 100 F Street NE., Washington, DC 20549-1090.
For the Commission, by the Division of Trading and Markets, pursuant to delegated authority.
On August 7, 2015, The NASDAQ Stock Market LLC (the “Exchange” or “Nasdaq”) filed with the Securities and Exchange Commission” (“Commission”), pursuant to Section 19(b)(1) of the Securities Exchange Act of 1934 (“Act” or “Exchange Act”)
The Exchange proposes to list and trade the Shares under Nasdaq Rule 5735, which governs the listing and trading of Managed Fund Shares on the Exchange. The Fund will be an actively-managed exchange-traded fund (“ETF”). The Shares will be offered by the Trust,
Etfis Capital LLC will be the investment adviser (“Adviser”) to the Fund, and Bramshill Investments, LLC will be the investment sub-adviser to the Fund (“Sub-Adviser”). ETF Distributors LLC (“Distributor”) will be the principal underwriter and distributor of the Fund's Shares. The Bank of New York Mellon Corporation (“BNY”) will act as the administrator, accounting agent, custodian, and transfer agent to the Fund. The Exchange states that the Adviser is not a broker-dealer, although it is affiliated with the Distributor, a broker-dealer.
The Exchange has made the following representations and statements in describing the Fund and its investment strategy, including the Fund's portfolio holdings and investment restrictions.
The investment objective of the Fund will be to seek current income and capital appreciation with reduced volatility over time. The Fund will seek to achieve its investment objective primarily by investing in a portfolio of “high yield” debt securities of U.S. companies. Under normal market conditions,
The Fund will not have any portfolio maturity limitation and may invest its assets in instruments with short-term, medium-term, or long-term maturities. Issuers of securities in which the Fund expects to invest will include large and medium capitalization companies, and may include small capitalization companies. According to the Exchange, the Sub-Adviser expects the Fund's investment portfolio to include up to 200 different securities positions with a target portfolio net exposure (the market value of the Long Position minus the market value of the Short Position) of between -20% and 100%.
In selecting securities for the Fund's portfolio, the Sub-Adviser generally will analyze debt securities included in the Bloomberg USD Corporate High Yield Bond Index. While the Fund may invest directly in high yield debt securities, the Sub-Adviser may also implement the Fund's strategy by investing in exchange-traded pools (which will consist of exchange-traded funds, exchange-traded notes, or closed-end funds, each of which will be listed for trading on a U.S. exchange, collectively, “ETPs”) that invest a significant portion of their portfolios in high yield debt instruments (“High Yield ETPs”).
Positions in high-yield debt securities also may include foreign debt securities traded on U.S. or foreign exchanges or in U.S. or foreign over-the-counter markets, which may be denominated in foreign currencies. Any currency hedging will be accomplished by taking long or short positions in ETPs.
The Exchange states that “high yield debt securities” generally include debt securities that are rated lower than “BBB-” by Standard & Poor's Ratings Group or “Baa3” by Moody's Investors Service, Inc. or at a similar level by another nationally recognized statistical rating organization, or are unrated but are deemed to be of comparable quality by the Sub-Adviser.
According to the Exchange, as a result of its trading strategy, the Fund expects to engage in frequent portfolio transactions that will likely result in higher portfolio turnover than other similar investment companies.
In addition to investing in High Yield ETPs, the Fund may invest in other fixed-income ETPs, but the Fund will not invest in leveraged ETPs. The Exchange states that the Fund will not purchase more than 3% of an ETF's outstanding shares unless: (i) The ETF or the Fund has received an order for exemptive relief from the 3% limitation from the Commission that is applicable to the Fund; and (ii) the ETF and the Fund take appropriate steps to comply with any conditions in such order.
In certain adverse market, economic, political, or other conditions, the Fund
According to the Exchange, the Fund anticipates investing entirely in fully liquid assets, but it has the flexibility to invest up to 15% of its net assets in illiquid securities and other illiquid assets.
The Fund will generally seek to invest in high-yield debt securities, bank loans, and other debt issuances that the Sub-Adviser deems to be liquid, with readily available prices. The Fund will only invest in bank loans that have a par amount outstanding of U.S. $100 million or greater at the time the loan is originally issued. The Fund will not enter into a long or short position in high yield debt securities with a par amount outstanding of less than U.S. $100 million at the time of issuance of such high yield debt securities, if upon establishing such position, the total value of such positions would represent fifty percent or greater of the Fund's net assets.
The Fund will not invest more than 25% of the value of its total assets in securities of issuers in any particular industry.
The Fund's investments (including investments in ETPs) will not be utilized to seek to achieve a leveraged return on the Fund's net assets. The Exchange represents that the Fund will not invest in futures contracts, options, swaps, or other derivative instruments.
After careful review, the Commission finds that the Exchange's proposal to list and trade the Shares is consistent with the Exchange Act and the rules and regulations thereunder applicable to a national securities exchange.
The Commission also finds that the proposal to list and trade the Shares on the Exchange is consistent with Section 11A(a)(1)(C)(iii) of the Exchange Act,
The Exchange further states that the intra-day, executable price quotations on the high yield debt securities, bank loans, warrants, other fixed-income and convertible securities, including cash and cash equivalents, ETPs, and other assets held by the Fund will be available from major broker-dealer firms or on the exchange on which they are traded, if applicable.
The Commission also believes that the proposal to list and trade the Shares is reasonably designed to promote fair disclosure of information that may be necessary to price the Shares appropriately and to prevent trading when a reasonable degree of transparency cannot be assured. The Exchange states that it will obtain a representation from the issuer of the Shares that the NAV per Share will be calculated daily and that the NAV and the Disclosed Portfolio will be made available to all market participants at the same time.
Nasdaq deems the Shares to be equity securities, thus rendering trading in the Shares subject to Nasdaq's existing rules governing the trading of equity securities. In support of this proposal, the Exchange represented that:
(1) The Shares will be subject to Nasdaq Rule 5735, which sets forth the initial and continued listing criteria applicable to Managed Fund Shares.
(2) Trading in the Shares will be subject to the existing trading surveillances administered by both Nasdaq and FINRA on behalf of the Exchange, which are designed to detect violations of Exchange rules and applicable federal securities laws, and these procedures are adequate to properly monitor Exchange trading of the Shares in all trading sessions and to detect and help deter violations of Exchange rules and applicable federal securities laws.
(3) FINRA, on behalf of the Exchange, will communicate as needed regarding trading in the Shares or other exchange-traded securities with other markets and other entities that are ISG
(4) The Exchange has appropriate rules to facilitate transactions in the Shares during all trading sessions.
(5) Prior to the commencement of trading, the Exchange will inform its members in an Information Circular of the special characteristics and risks associated with trading the Shares. Specifically, the Information Circular will discuss the following: (a) The procedures for purchases and redemptions of Shares in Creation Units (and that Shares are not individually redeemable); (b) Nasdaq Rule 2111A, which imposes suitability obligations on Nasdaq members with respect to recommending transactions in the Shares to customers; (c) how and by whom information regarding the Intraday Indicative Value and the Disclosed Portfolio is disseminated; (d) the risks involved in trading the Shares during the Pre-Market and Post-Market Sessions when an updated Intraday Indicative Value will not be calculated or publicly disseminated; (e) the requirement that members deliver a prospectus to investors purchasing newly issued Shares prior to or concurrently with the confirmation of a transaction; and (f) trading information.
(6) For initial and continued listing, the Fund must be in compliance with Rule 10A-3 under the Act.
(7) At least 90% of the convertible bonds, convertible preferred stocks, and warrants in which the Fund invests, and the equity securities into which these securities may be converted, and also preferred stocks (non-convertible) in which the Fund invests, will be traded on exchanges that are ISG members.
(8) The Fund may hold up to an aggregate amount of 15% of its net assets in illiquid assets.
(9) The Fund will only invest in bank loans that have a par amount outstanding of U.S. $100 million or greater at the time the loan is originally issued.
(10) The Fund will not enter into a long or short position in high yield debt securities with a par amount outstanding of less than U.S. $100 million at the time of issuance of such high yield debt securities, if upon establishing such position, the total value of such positions would represent fifty percent or greater of the Fund's net assets. In addition, the Fund will not invest in other types of high-yield debt securities, such as asset-backed securities.
(11) The Fund will not invest more than 25% of the value of its total assets in securities of issuers in any particular industry.
(12) The Fund's investments (including investments in ETPs) will not be utilized to seek to achieve a leveraged return on the Fund's net assets.
(13) The Fund will not invest in futures contracts, options, swaps, or other derivative instruments.
(14) A minimum of 100,000 Shares will be outstanding at the commencement of trading on the Exchange.
This approval order is based on all of the Exchange's representations, including those set forth above and in the Notice. The Commission notes that the Fund and the Shares must comply with the requirements of Nasdaq Rule 5735 to be listed and traded on the Exchange.
For the foregoing reasons, the Commission finds that the proposed rule change is consistent with Section 6(b)(5) of the Act
It is therefore ordered, pursuant to Section 19(b)(2) of the Exchange Act,
For the Commission, by the Division of Trading and Markets, pursuant to delegated authority.
On August 11, 2015, New York Stock Exchange LLC (“NYSE” or “Exchange”) filed with the Securities and Exchange Commission (“Commission”) pursuant to Section 19(b)(1) of the Securities Exchange Act of 1934 (“Act”)
In December 2013, the Exchange adopted a rule to expand the suite of complimentary products and services that it offers to certain current and newly listed companies on the Exchange.
The Exchange proposes to amend Section 907.00 of the Manual to (i) amend the suite of complimentary products and services that are offered to Eligible Current Listings and Eligible New Listings, (ii) update the value of complimentary products and services offered to such companies, and (iii) provide that any U.S. or non-U.S. company that transfers its listing of common stock or equity securities, respectively, to the Exchange from another national securities exchange (“Eligible Transfer Companies”) would be eligible to receive an enhanced package of complimentary products and services comparable to the package offered to Eligible New Listings, with the exception of corporate governance tools.
The Exchange proposes to update the approximate commercial value of the following offerings to Eligible Current Listings, Eligible New Listings, and Eligible Transfer Companies: Market surveillance products and services from $45,000 to $55,000 per annum, corporate governance tools from $20,000 to $50,000 per annum, web-hosting products and services from a range of $12,000-16,000 to $16,000 per annum, market analytics products and services from $20,000 to $30,000 per annum, and news distribution products and services from $10,000 to $20,000 per annum. The Exchange also proposes to include web-casting services (with a commercial value of approximately $6,500 annually) as a separate category of complimentary products and services offered to certain issuers.
Currently, all listed issuers receive some complimentary products and services through NYSE Market Access Center. The Exchange also offers Eligible Current Listings a suite of products and services, varying based on the number of shares such companies have issued and outstanding. Eligible Current Listings that have at least 270 million shares issued and outstanding (“Tier One Eligible Current Listing”) are presently offered (i) a choice of market surveillance, corporate governance tools and advisory services or market analytics products and services and (ii) web-hosting products and services, on a complimentary basis. Eligible Current Listings that have between 160 million and up to 270 million shares issued and outstanding (“Tier Two Eligible Current Listing”) are presently offered a choice of market analytics, corporate governance tools, or web-hosting products and services. The Exchange proposes to amend Section 907.00 to delete corporate governance tools and advisory services from the suite of products offered to a Tier One Eligible Current Listing and corporate governance tools from the suite of products offered to a Tier Two Eligible Current Listing. In both cases, the proposed rule replaces the deleted service with web-casting products and services.
The Exchange currently offers Eligible New Listings different products and services based on such companies' global market value. Eligible New Listings with a global market value of $400 million or more (each a “Tier A Eligible New Listing”) are presently offered web-hosting and news distribution products and services for a period of 24 months and either (i) market surveillance products and services for a period of 12 calendar months from the date of listing or (ii) a choice of market analytics products and services or corporate governance tools for a period of 24 calendar months from the date of listing. Eligible New Listings with a global market value of less than $400 million (each a “Tier B Eligible New Listing”) are presently offered web-hosting and news distribution products and services for a period of 24 months from the date of listing. The Exchange proposes to amend Section 907.00 to offer 24 months each of market analytics, market surveillance products, web-hosting, web-casting, corporate governance tools, and news distribution products and services to Tier A Eligible New Listings. Accordingly, the Exchange proposes to delete text from Section 907.00 that discusses providing market surveillance products and services for only 12 months, as well as the option for continuing such services at the end of the initial 12 month period. The proposed rule further amends Section 907.00 to offer 24 months of web-casting, market analytics, and corporate governance tools to Tier B Eligible New Listings, in addition to the currently-offered web-hosting and news distribution products.
Pursuant to the proposed rule change, Eligible Transfer Companies would be offered a package of complimentary products and services that are similar to Eligible New Listings, with one exception.
Regarding the timing of complimentary products and services, the proposed rule amends Section 907.00 to specify that if an Eligible New Listing or Eligible Transfer Company
In addition to the foregoing, the Exchange proposes making several changes to its rule to reflect a change in terminology. The proposed rule change amends Section 907.00 to change the terms “newly listed issuer” and “currently listed issuers” to “Eligible New Listing” and “Eligible Current Listings,” respectively. The Exchange also proposes to amend Section 907.00 to include a definition of Eligible Transfer Companies.
The Exchange also proposes to amend the first paragraph of Section 907.00 of the Manual to specify that it will offer certain complimentary products and services, and access to discounted third-party products and services through the NYSE Market Access Center to both currently and newly listed issuers, whereas previously it stated such services were only offered to currently listed issuers.
While the Exchange will implement the proposed rule upon approval, any Eligible New Listing that listed on the Exchange prior to approval of the proposed rule will continue to receive services under the terms of the current rule. Therefore, for as long as any Eligible New Listing is receiving services under the terms of Section 907.00 of the Manual as currently in effect, the Exchange will maintain a link to such section in the Introductory Note to Section 907.00.
With respect to Eligible Current Listings, to the extent that the Exchange has already paid a third-party provider (prior to approval) for corporate governance services to an Eligible Current Listing, such complimentary service will continue until the payments run out. Once any pre-approval payments run out, such services will be discontinued. The Exchange expects all corporate governance services to Eligible Current Listings to be completely discontinued no later than early 2016.
The specific products and services offered by the Exchange will be developed by the Exchange or by third-party vendors. In its filing, the Exchange represented that NYSE Governance Services
The Commission has carefully reviewed the proposed rule change and finds that it is consistent with the requirements of Section 6 of the Act.
As described above, the Exchange proposes to alter the complimentary products and services it offers companies. Specifically, the Exchange proposes to (i) remove corporate governance tools and advisory services for Tier One companies, (ii) remove corporate governance tools for Tier Two companies, (iii) expand the services provided to Tier A Eligible New Listings to include all of the services listed, as described above, for a period of 24 months, not just provide a choice of services, (iv) expand the services provided to Tier B Eligible New Listings to include market analytics and corporate governance tools, (v) offer Eligible Transfer Companies the same products and services offered to Eligible New Listings, except for corporate governance tools,
The Commission believes that it is consistent with the Act for the Exchange to revise the products and services it offers to companies. The Exchange has represented that the corporate governance services are not as helpful to more established companies as they are to newly listed companies and that web-casting may be more useful to them.
In addition, the Exchange believes that it is appropriate to expand the suite of complimentary products and services it offers to Tier A and Tier B Eligible New Listings, because such companies are listing on the Exchange for the first time and frequently have greater needs with respect to developing their corporate governance and shareholder outreach capabilities.
Moreover, the Commission believes that it is appropriate for the Exchange to offer varying services to different categories of issuers. The Commission has previously found that the tiers originally established under the corporate products and services rule was consistent with the Act.
As noted above, under the proposal, while newly listed companies and transfers will receive similar services there is one exception involving corporate governance tools (valued at $50,000) which newly listed companies will receive but not transfers. NYSE argues that this approach is consistent with the changes being proposed for currently listed companies in that in the Exchange's experience these tools are not as useful for already established companies and as a result are in low demand by such listed companies. Based on these representations, the Commission does not believe that the exception for transfers violates the unfair discrimination standard under Section 6(b)(5) of the Act and appears to provide equal treatment among established companies, whether currently listed or transferring. The Commission notes that all listed companies will continue to receive some level of free services, including the addition of the whistleblower hotline services being approved in this order. The Commission also notes that within each tier all issuers receive the exact same package of services. The approval of this proposal, including the updated dollar values and specific services provided within each tier, will therefore help to ensure that individual listed companies are not given specially negotiated packages of products and services to list or remain listed which would raise unfair discrimination issues under the Act. The Commission also believes that it is reasonable, and in fact required by Section 19(b) of the Act, that the Exchange amend its rule to update the commercial values of the products it offers to Eligible Current Listings, Eligible Transfer Companies, and Eligible New Listings.
The Commission also believes that it is consistent with the Act for the Exchange to allow the complimentary period for a particular service offered to Eligible New Listings and Eligible Transfer Companies to begin on the date of first use if a company begins to use the service within 30 days after the date of listing. According to the Exchange, companies listing on the Exchange for the first time often require a period of time after listing to complete the contracting and training process with vendors providing the complimentary products and services.
Based on the factors noted above, the Commission continues to believe that NYSE's products and services, and their commercial value, are equitably allocated among issuers, consistent with Section 6(b)(4) of the Act.
For the Commission, by the Division of Trading and Markets, pursuant to delegated authority.
Pursuant to the provisions of Section 19(b)(1) of the Securities Exchange Act of 1934 (“Act”)
The Exchange filed a proposal to amend the fee schedule applicable to Members
The text of the proposed rule change is available at the Exchange's Web site at
In its filing with the Commission, the Exchange included statements concerning the purpose of and basis for the proposed rule change and discussed any comments it received on the proposed rule change. The text of these statements may be examined at the places specified in Item IV below. The Exchange has prepared summaries, set forth in Sections A, B, and C below, of the most significant parts of such statements.
The Exchange proposes to modify the fee schedule applicable to the Exchange's options platform (“BATS Options”) effective immediately, in order to: (i) Increase the fees for certain logical ports; and (ii) provide for separate fees based upon the number of logical ports utilized.
A logical port represents a port established by the Exchange within the Exchange's system for trading and billing purposes. Each logical port established is specific to a Member or non-member and grants that Member or non-member the ability to operate a specific application, such as FIX order entry or PITCH data receipt. The Exchange's Multicast PITCH data feed is available from two primary feeds, identified as the “A feed” and the “C feed”, which contain the same information but differ only in the way such feeds are received. The Exchange also offers two redundant fees, identified as the “B feed” and the “D feed.” The Exchange also offers a bulk-quoting interface which allows Users
Logical ports, including Multicast PITCH Spin Server and GRP ports, which are used to request and receive a retransmission of data from the Exchange, are currently subject to a fee of $400 per month per port and ports with bulk quoting capabilities are charged $1,500 per month per port. These fees are set and do not currently vary based on the number of ports purchased. In addition, logical port fees are limited to logical ports in the Exchange's primary data center and no logical port fees are assessed for redundant secondary data center ports. The Exchange assesses the monthly per logical port fees for all of a Member and non-Member's logical ports.
The Exchange now proposes to increase the fees for logical ports (including Multicast PITCH Spin Server and GRP ports) from $400 per port per month to $550 per port per month for the first five ports. Multicast PITCH Spin Server Ports and GRP Ports would now be subject to a fee of $550 per month for a set of primary ports (A or C feed). The Exchange will continue to offer for free the ports necessary to receive the Exchange's redundant Multicast “B feed” and “D feed”, as well as all ports made available in the Exchange's secondary data center. Accordingly, this proposal only applies to ports used to receive an Exchange primary Multicast PITCH feeds at the Exchange's primary data center. Other than as described below, the Exchange does not propose to amend the monthly fee for ports with bulk quoting capabilities.
Where a User subscribes to more than five ports, the Exchange proposes to charge for each port in excess of five $650 per logical port per month and $2,000 per month for logical ports with bulk quoting capabilities. For example, if a User subscribes to seven logical ports, it would pay $550 per port per month for ports one through five and
The Exchange proposes to implement these amendments to its fee schedule effective immediately.
The Exchange believes that the proposed rule change is consistent with the requirements of the Act and the rules and regulations thereunder that are applicable to a national securities exchange, and, in particular, with the requirements of Section 6 of the Act.
The Exchange operates in a highly competitive market in which exchanges offer connectivity services as a means to facilitate the trading activities of members and other participants. Accordingly, fees charged for connectivity are constrained by the active competition for the order flow of such participants as well as demand for market data from the Exchange. If a particular exchange charges excessive fees for connectivity, affected members will opt to terminate their connectivity arrangements with that exchange, and adopt a possible range of alternative strategies, including routing to the applicable exchange through another participant or market center or taking that exchange's data indirectly. Accordingly, the exchange charging excessive fees would stand to lose not only connectivity revenues but also revenues associated with the execution of orders routed to it by affected members, and, to the extent applicable, market data revenues. The Exchange believes that this competitive dynamic imposes powerful restraints on the ability of any exchange to charge unreasonable fees for connectivity.
The Exchange believes that the proposal to increase fees for logical ports is equitably allocated, reasonable, and not unfairly discriminatory in that the proposal will help the Exchange to cover increasing infrastructure costs associated with offering and maintaining logical ports connections. The Exchange notes its proposal to increase the fee for logical ports equals that currently charged by the New York Stock Exchange, Inc. (“NYSE”) and NYSE Arca, Inc. (“NYSE Arca”).
Lastly, the Exchange also believes that the proposed amendments to its fee schedule are non-discriminatory because they will apply uniformly to all Members. All Members that voluntarily select various service options will be charged the same amount for the same services. All Members have the option to select any connectivity option, and there is no differentiation among Members with regard to the fees charged for the services offered by the Exchange.
The Exchange believes its proposed amendments to its fee schedule would not impose any burden on competition that is not necessary or appropriate in furtherance of the purposes of the Act. The Exchange does not believe that the proposed change represents a significant departure from previous pricing offered by the Exchange or pricing offered by the Exchange's competitors. Additionally, Members may opt to disfavor the Exchange's pricing if they believe that alternatives offer them better value. Accordingly, the Exchange does not believe that the proposed change will impair the ability of Members or competing venues to maintain their competitive standing in the financial markets.
The Exchange believes that fees for connectivity are constrained by the robust competition for order flow among exchanges and non-exchange markets. Further, excessive fees for connectivity, including logical port fees, would serve to impair an exchange's ability to compete for order flow rather than burdening competition. The Exchange also does not believe the proposed rule change would impact intramarket competition as it would apply to all Members and non-Members equally.
The Exchange has not solicited, and does not intend to solicit, comments on this proposed rule change. The Exchange has not received any written comments from members or other interested parties.
The foregoing rule change is effective upon filing pursuant to Section 19(b)(3)(A)
At any time within 60 days of the filing of such proposed rule change, the Commission summarily may temporarily suspend such rule change if it appears to the Commission that such action is necessary or appropriate in the public interest, for the protection of investors, or otherwise in furtherance of the purposes of the Act. If the Commission takes such action, the
Interested persons are invited to submit written data, views, and arguments concerning the foregoing, including whether the proposed rule change is consistent with the Act. Comments may be submitted by any of the following methods:
• Use the Commission's Internet comment form (
• Send an email to
• Send paper comments in triplicate to Brent J. Fields, Secretary, Securities and Exchange Commission, 100 F Street NE., Washington, DC 20549-1090.
For the Commission, by the Division of Trading and Markets, pursuant to delegated authority.
Pursuant to Section 19(b)(1)
The Exchange proposes to amend the Exchange's Schedule of Fees and Charges (“Fee Schedule”) to eliminate the $20,000 one-time consultation fee when a first time sponsor, managing owner, general partner or equivalent is listing a new Derivative Securities Product on the Exchange. The text of the proposed rule change is available on the Exchange's Web site at
In its filing with the Commission, the self-regulatory organization included statements concerning the purpose of, and basis for, the proposed rule change and discussed any comments it received on the proposed rule change. The text of those statements may be examined at the places specified in Item IV below. The Exchange has prepared summaries, set forth in sections A, B, and C below, of the most significant parts of such statements.
Currently, the Exchange's Schedule of Fees and Charges (“Schedule”) provides that, where a first time sponsor, managing owner, general partner or equivalent (“Sponsor”) lists a new Derivative Securities Product
The Exchange proposes to amend the Fee Schedule to eliminate the Sponsor Fee. The Exchange has determined to eliminate the Sponsor Fee to permit the Exchange to better compete for listings of Derivative Securities Products with other exchanges that do not impose a fee similar to the Sponsor Fee. Elimination of the Sponsor Fee would benefit Sponsors by providing a cost savings and by permitting them to select their listing venue for a new Derivative Securities Product based on level of service and without consideration of
Listing Fees and Annual Fees applicable to Derivatives Securities Products would remain unchanged.
NYSE Arca believes that the proposal is consistent with Section 6(b)
The Exchange does not believe that the proposed rule change will impose any burden on competition that is not necessary or appropriate in furtherance of the purpose of the Act. The Exchange believes the proposed rule change would promote competition because it will permit the Exchange to better compete with other exchanges that do not charge a fee similar to the Sponsor Fee.
No written comments were solicited or received with respect to the proposed rule change.
The foregoing rule change is effective upon filing pursuant to Section 19(b)(3)(A)
At any time within 60 days of the filing of such proposed rule change, the Commission summarily may temporarily suspend such rule change if it appears to the Commission that such action is necessary or appropriate in the public interest, for the protection of investors, or otherwise in furtherance of the purposes of the Act. If the Commission takes such action, the Commission shall institute proceedings under Section 19(b)(2)(B)
Interested persons are invited to submit written data, views, and arguments concerning the foregoing, including whether the proposed rule change, as modified by Amendment No. 1, is consistent with the Act. Comments may be submitted by any of the following methods:
• Use the Commission's Internet comment form (
• Send an email to
• Send paper comments in triplicate to Secretary, Securities and Exchange Commission, 100 F Street, NE., Washington, DC 20549-1090.
For the Commission, by the Division of Trading and Markets, pursuant to delegated authority.
On August 7, 2015, The NASDAQ Stock Market LLC filed with the Securities and Exchange Commission (“Commission”), pursuant to Section 19(b)(1) of the Securities Exchange Act of 1934 (“Act”)
The Exchange proposes to offer to all its members a new optional risk protection functionality for options to
To use the Kill Switch, a Participant will send a message
The NOM Participant will be unable to enter any new quotes or orders using the affected Identifier(s) until the Participant makes a verbal request to the Exchange and Exchange staff enables re-entry. Once enabled for re-entry, the Exchange will send a message to the Participant and, if it requests to receive such notifications, to the Participant's clearing firm as well.
After careful review, the Commission finds that the proposed rule change is consistent with the requirements of the Act and the rules and regulations thereunder applicable to a national securities exchange,
According to the Exchange, the proposed rule change is designed to protect Participants in the event that the Participant encounters a situation, like a systems issue, for which they would like to withdraw temporarily from the market.
Further, the Commission agrees that it would be appropriate to notify a Participant's clearing member, at the clearing member's request, once a Participant's selected Identifiers are re-enabled following the Participant's use of the Kill Switch. Because the clearing member accepts financial responsibility for clearing the Participant's trades, notifying the applicable clearing member of a Participant's re-enabled Identifiers following use of the Kill Switch may be appropriate and help the clearing member manage the risk associated with the Participant's trading activity.
The Commission notes that the Exchange represented in its proposal that the Kill Switch will operate consistently with a broker-dealer's firm quote obligations pursuant to Rule 602 of Regulation NMS,
Accordingly, the Commission finds that the Exchange's proposal is consistent with the Act, including Section 6(b)(5) thereof, in that it is designed to promote just and equitable principles of trade, foster cooperation and coordination with persons engaged in facilitating transactions in securities, remove impediments to and perfect the mechanism of a free and open market and a national market system, and, in general, protect investors and the public interest.
For the Commission, by the Division of Trading and Markets, pursuant to delegated authority.
Securities and Exchange Commission.
Notice; correction.
The Securities and Exchange Commission published a document in the
Marc F. McKayle, Division of Trading and Markets, Securities and Exchange Commission, 100 F Street NE., Washington, DC 20549, (202) 551-5633.
In the
Pursuant to Section 19(b)(1) of the Securities Exchange Act of 1934 (“Act”),
The purpose of the proposed changes is to make revisions to the ICC Clearing Rules (the “Rules”) related to the ICC rule enforcement process for Missed Submissions.
In its filing with the Commission, ICC included statements concerning the purpose of and basis for the proposed rule change and discussed any comments it received on the proposed rule change. The text of these statements may be examined at the places specified in Item IV below. ICC has prepared summaries, set forth in sections A, B, and C below, of the most significant aspects of these statements.
As part of ICC's end-of-day price discovery process, ICC Clearing Participants (“CPs”) are required to submit end-of-day prices for specific instruments related to their open interest at ICC, in accordance with Rule 404(b) and ICC Procedures. Failure of a CP to provide submissions required by ICC pursuant to Rule 404(b) and ICC Procedures constitute a Missed Submission. In order to provide incentive against Missed Submissions, ICC has adopted a summary assessment approach described in Rule 702(e) and Schedule 702 of the Rules.
Currently, under Rule 702(e)(ii)(2), a CP may be eligible for a once-in-a-lifetime conditional waiver from such assessments, if one or more Missed Submissions are the first instance(s) of a Missed Submission for the type of instrument (index or single name) and the CP provides adequate explanation of the cause and plans for remedial actions.
Given the increased automation of price submissions, ICC recognizes that there may be circumstances, due to technological failures, which may result in Missed Submissions. Furthermore, due to the significant length of time since the inception of the end-of-day process, many CPs have utilized their once-in-a-lifetime waiver. As such, ICC believes it is reasonable to provide, under limited circumstances, a conditional once-a-year waiver for such Missed Submissions caused by technical failures, as described below. Such Rule changes will not affect the integrity and effectiveness of the end-of-day price discovery process. ICC believes such Rule changes provide a valuable and practical balance between the technicalities of the price discovery process and appropriate penalization for Missed Submissions.
The proposed Rule text provides for the replacement of ICC's current once-in-a-lifetime waiver for Missed Submissions with a conditional once-a-year waiver for Missed Submissions caused by technical failures. Under revised Rule 702(e)(ii)(2), a CP would be eligible for one waiver per year for single name Missed Submissions, and one waiver per year for index Missed Submissions. A CP may request such wavier(s) be applied against all Missed Submissions for a given instrument class on a given day. A CP would be required to provide documentation with a waiver request, explaining that the root-cause of the Missed Submission was a technology issue and including a remediation plan to fix the cause of the Missed Submission. ICC would review and evaluate the waiver request and accept unless it had legitimate concerns that the root-cause of the Missed Submission had not been adequately identified, was not due to a technical issue, and/or would not be corrected by the provided remediation plan. ICC would maintain its current ability to provide waivers for Missed Submissions deemed to be due to extraordinary circumstances outside of a CP's control, as set forth in Rule 702(e)(ii)(3). Pending regulatory approval, ICC plans to implement these changes on January 1, 2016, and apply the once-a-year waiver to the 2016 calendar year, and each calendar year going forward. There are no changes to ICC policies and procedures as a result of the Rule changes.
Section 17A(b)(3)(F) of the Act
Furthermore, such proposed changes are designed to ensure that CPs are appropriately disciplined for violations of ICC's rules, specifically Missed Submissions, through an appropriate fining structure, in accordance with Section 17A(b)(3)(G).
ICC does not believe the proposed rule changes would have any impact, or impose any burden, on competition. The Rule changes related to the ICC rule enforcement process for Missed Submissions apply uniformly across all market participants. Therefore, ICC does not believe the proposed rule changes impose any burden on competition that is inappropriate in furtherance of the purposes of the Act.
Written comments relating to the proposed rule change have not been solicited or received. ICC will notify the Commission of any written comments received by ICC.
Within 45 days of the date of publication of this notice in the
(A) By order approve or disapprove the proposed rule change or
(B) institute proceedings to determine whether the proposed rule change should be disapproved.
Interested persons are invited to submit written data, views, and arguments concerning the foregoing, including whether the proposed rule change is consistent with the Act. Comments may be submitted by any of the following methods:
• Use the Commission's Internet comment form (
• Send an email to
• Send paper comments in triplicate to Secretary, Securities and Exchange Commission, 100 F Street NE., Washington, DC 20549-1090.
All comments received will be posted without change; the Commission does not edit personal identifying information from submissions. You should submit only information that you wish to make available publicly. All submissions should refer to File Number SR-ICC-2015-015 and should be submitted on or before
For the Commission, by the Division of Trading and Markets, pursuant to delegated authority.
Notice is hereby given of the following determinations: Pursuant to the authority vested in me by the Act of October 19, 1965 (79 Stat. 985; 22 U.S.C. 2459), Executive Order 12047 of March 27, 1978, the Foreign Affairs Reform and Restructuring Act of 1998 (112 Stat. 2681,
For further information, including a list of the imported objects, contact the Office of Public Diplomacy and Public Affairs in the Office of the Legal Adviser, U.S. Department of State (telephone: 202-632-6471; email:
Notice is hereby given of the following determinations: Pursuant to the authority vested in me by the Act of October 19, 1965 (79 Stat. 985; 22 U.S.C. 2459), Executive Order 12047 of March 27, 1978, the Foreign Affairs Reform and Restructuring Act of 1998 (112 Stat. 2681,
For further information, including a list of the imported objects, contact the Office of Public Diplomacy and Public Affairs in the Office of the Legal Adviser, U.S. Department of State (telephone: 202-632-6471; email:
Notice is hereby given of the following determinations: Pursuant to the authority vested in me by the Act of October 19, 1965 (79 Stat. 985; 22 U.S.C. 2459), Executive Order 12047 of March 27, 1978, the Foreign Affairs Reform and Restructuring Act of 1998 (112 Stat. 2681,
For further information, including a list of the imported objects, contact the Office of Public Diplomacy and Public Affairs in the Office of the Legal Adviser, U.S. Department of State (telephone: 202-632-6471; email:
Maritime Administration, Department of Transportation.
Notice.
As authorized by 46 U.S.C. 12121, the Secretary of Transportation, as represented by the Maritime Administration (MARAD), is authorized to grant waivers of the U.S.-build requirement of the coastwise laws under certain circumstances. A request for such a waiver has been received by MARAD. The vessel, and a brief description of the proposed service, is listed below.
Submit comments on or before November 16, 2015.
Comments should refer to docket number MARAD-2015-0118. Written comments may be submitted by hand or by mail to the Docket Clerk, U.S. Department of Transportation, Docket Operations, M-30, West Building Ground Floor, Room W12-140, 1200 New Jersey Avenue SE., Washington, DC 20590. You may also send comments electronically via the Internet at
Linda Williams, U.S. Department of Transportation, Maritime Administration, 1200 New Jersey Avenue SE., Room W23-453, Washington, DC 20590. Telephone 202-366-0903, Email
As described by the applicant the intended service of the vessel PAESANA is:
The complete application is given in DOT docket MARAD-2015-0118 at
Anyone is able to search the electronic form of all comments received into any of our dockets by the name of the individual submitting the comment (or signing the comment, if submitted on behalf of an association, business, labor union, etc.). You may review DOT's complete Privacy Act Statement in the
By Order of the Maritime Administrator.
Maritime Administration, Department of Transportation.
Notice of availability; notice of public hearing; request for comments.
The Maritime Administration (MARAD) and the U.S. Coast Guard (USCG) announce: (1) The schedule and locations of public hearings; and (2) the availability of the Final Environmental Impact Statement (FEIS) for the Liberty Natural Gas LLC, Port Ambrose Liquefied Natural Gas Deepwater Port license application for the importation of natural gas.
The Port Ambrose application describes an offshore natural gas deepwater port facility that would be located 16.1 nautical miles southeast of Jones Beach, New York, 24.9 nautical miles east of Long Branch, New Jersey, and 27.1 nautical miles from the entrance to New York Harbor in a water depth of approximately 103 feet. The FEIS complies with the Deepwater Port Act of 1974, as amended (33 U.S.C. 1501
Publication of this notice begins a 45-day comment period, requests public participation in the process, provides information on how to participate in the process and announces informational open houses and public hearings in New York and New Jersey. Pursuant to the criteria provided in the DWPA, both New Jersey and New York have been designated as Adjacent Coastal States (ACS) for this application.
Please note that this application is only for the construction and operation of a deepwater port that could only be used as a natural gas import facility. The considerable technical, operational and environmental differences between import and export operations for natural gas deepwater ports is such that any licensed deepwater port facility that proposed to convert from import to export operations would be required to submit a new license application (including application fee) and conform to all licensing requirements and regulations in effect at such time of application. In addition to payment of the application fee, licensing requirements include, but are not limited to, completion of an extensive environmental impact assessment which would include public participation and a financial responsibility review which would include public participation.
There will be a total of four public hearings held in connection with the application and the FEIS; two public hearings will be held in Long Beach, New York on November 2, 2015 and November 3, 2015, from 6:00 to 10:00 p.m.; and two public hearings will be held in Eatontown, New Jersey on November 4, 2015 and November 5, 2015, from 6:00 to 10:00 p.m. Each public hearing will be preceded by an open house from 4:30 to 5:30 p.m. The public hearing may end later than the stated time, depending on the number of persons wishing to speak. Additionally, materials submitted in response to the request for comments must reach the Docket Management Facility as detailed below, by close of business Monday, November, 30, 2015, or 45 days after publication of this notice in the
Federal and State agencies must also submit comments, recommended conditions for licensing, or letters of no objection by Monday, November 30, 2015, or 45 days after publication of this notice in the
MARAD must issue a Record of Decision (ROD) to approve, approve with conditions, or deny the deepwater port license application, within 90 days following the final license hearing, on or prior to February 3, 2016.
The open houses and public hearings in Long Beach, New York will be held at the Long Beach Hotel, 405 East Broadway, Long Beach, New York, 11561; phone 516-544-4444. Free street parking is available, and the parking lot at the Long Island Railroad (LIRR) Long Beach Train Station, near Park Place and Park Avenue is available from 5:00 p.m. to 5:00 a.m. The City of Long Beach operates local bus public transportation services between the LIRR Long Beach Train Station and the Long Beach Hotel. The open houses and public hearings in Eatontown, New Jersey will be held at the Sheraton Eatontown Hotel, 6 Industrial Way East, Eatontown, NJ 07724; phone 732-542-6500. Free parking is available on site at the hotel.
The FEIS, license application, comments, supporting information and other associated documentation are available for viewing at the Federal Docket Management System (FDMS) Web site:
Docket submissions for USCG-2013-0363 should be addressed to: Department of Transportation, Docket Management Facility, West Building, Ground Floor, Room W12-140, 1200 New Jersey Avenue SE., Washington, DC 20590-0001.
The Federal Docket Management Facility accepts hand-delivered submissions and makes docket contents available for public inspection and copying at this address between 9:00 a.m. and 5:00 p.m., Monday through Friday, except Federal holidays. The Facility telephone number is 202-366-
Mr. Roddy Bachman, U.S. Coast Guard, telephone 202-372-1451, email:
You are invited to learn about the proposed Port Ambrose Deepwater Port at one of the above noticed informational open houses, and to comment on the application and the environmental impact analysis contained in the FEIS at any of the above public hearings or directly to the docket. The open houses, public hearings and docket comments will be used by MARAD to inform the Maritime Administrator's decision making process, including the ROD and any conditions that may be placed on a subsequent license to own, construct and operate a deepwater port.
Speakers may register upon arrival (registration by proxy is not authorized) and will be recognized in the following order: Elected officials, public agencies, individuals or groups in the order in which they registered. In order to accommodate all speakers, speaker time may be limited, hearing hours may be extended, or both. Speakers' transcribed remarks will be included in the public docket. Written material may also be submitted for inclusion in the public docket. Written material must include the author's name. We request attendees respect the hearing procedures in order to ensure a constructive hearing. Please do not bring signs or banners inside the hearing venue. The presiding officer will use his/her discretion to conduct the hearing in an orderly manner. In the interest of allowing all interested parties to speak, and because all comments that are received, both verbal and written, are included in the record and will be considered by MARAD before making a licensing decision, it is not necessary to sign up more than once to provide duplicate comments at subsequent meetings.
Public hearing locations are wheelchair-accessible. However, attendees who require special assistance such as sign language interpretation or other reasonable accommodation, please notify the USCG at least five business days in advance. See
We request public comments on the FEIS and the application. The public hearing is not the only opportunity you have to comment. In addition to, or in place of, attending a hearing, you may submit comments to the Federal Docket Management Facility during the public comment period. See
Submissions should include:
• Docket number USCG-2013-0363.
• Your name and address.
Submit comments or material using only one of the following methods:
• Electronic submission (preferred to expedite processing) to the FDMS,
• Fax, mail, or hand delivery to the Federal Docket Management Facility. See
Regardless of the method used for submitting comments or material, all submissions will be posted, without change, to the FDMS Web site (
Information about deepwater ports, DWPA, other applicable statutes, regulations governing deepwater port licensing, including the application review process and the receipt of the current application for the proposed Port Ambrose liquefied natural gas (LNG) deepwater port was published in the
USCG and MARAD are co-lead Federal agencies for the preparation of the FEIS; MARAD is the Federal licensing agency (action agency). The proposed action requiring environmental review is the Federal licensing of the proposed deepwater port described in the “Summary of the Application” below. The alternatives to licensing the proposed port are: (1) Licensing with conditions (including conditions designed to mitigate environmental impact) and (2) denying the application, which, for purposes of environmental review, is the “no-action” alternative. These alternatives are more fully discussed in the FEIS. You can address any questions about the proposed action or the FEIS to USCG or MARAD project managers identified in
Liberty Natural Gas, LLC is proposing to construct, own and operate a LNG deepwater port import facility, known as Port Ambrose, located in the New York Bight. The Port Ambrose facility will be located at a different proposed location and include a different design than the previous deepwater port license application submitted by Liberty Natural Gas, LLC in 2010. Port Ambrose would consist of two Submerged Turret Loading Buoys (STL Buoys) in Federal waters 16.1 nautical miles southeast of Jones Beach, New York, 24.9 nautical miles east of Long Branch, New Jersey and 27.1 nautical miles from the entrance to New York Harbor, in a water depth of approximately 103 feet.
LNG would be delivered from purpose-built LNG regasification vessels (LNGRVs), vaporized on site and delivered through the STL Buoys, flexible riser/umbilical, subsea manifold and lateral pipelines to a buried 18.8 nautical mile subsea mainline connecting to the existing Transco Lower New York Bay Lateral in New York State waters 2.2 nautical miles southwest of Long Beach, New York and 13.1 nautical miles east of Sandy Hook, New Jersey. The STL Buoys would be lowered to rest on a landing pad when not in use and would also include a suction anchor mooring array.
STL Buoy 1 is located at Latitude: 40°19′24.61″ N and Longitude: 73°25′45.33″ W. STL Buoy 2 is located at Latitude: 40°20′09.26″ N and Longitude 73°23′51.92″ W. The Port
Buoy 1 (6708, 6709, 6758); Buoy 2 (6709); Lateral 1 (6708); Lateral 2 (6708, 6709); “Y” Assembly (6708); Mainline Pipeline (6708, 6658, 6657, 6607, 6606, 6556, 6555, 6554, 6504 and 6503).
The 145,000 cubic meter LNGRVs would have onboard closed-loop vaporization and metering and odorant capability. Each vessel would have three vaporization units capable of maximum send-out of 750 million standard cubic feet per day (MMscfd) (maximum pipeline system flow rate is 660 MMscfd with two buoys) with annual average expected to be 400 MMscfd. The LNGRVs have been designed to use a ballast water cooling system that will entirely re-circulate onboard the vessel during Port operations, eliminating vessel discharges associated with regasification while at the Port. Deliveries through Port Ambrose would be focused during peak demand winter and summer months, and it is anticipated that approximately 45 deliveries will occur each year.
As proposed, the LNGRVs would access the port inbound from the Hudson Canyon to Ambrose Traffic Lane and depart via the Ambrose to Nantucket Traffic Lane. MARAD and USCG are aware that Port Ambrose falls within the proposed area of interest for the Long Island—New York City Offshore Wind Collaborative wind energy project. This project has been acknowledged and considered in the cumulative impacts analysis section of the FEIS based on currently available information. If approved, the majority of the port and pipeline construction and installation would occur in 2017, with commissioning estimated to be in December 2018.
In addition, pipelines and structures such as the STL Buoy moorings will require permits under Section 404 of the Clean Water Act and Section 10 of the Rivers and Harbors Act, which are administered by the U.S. Army Corps of Engineers (USACE). Port Ambrose will also require permits from the Environmental Protection Agency (EPA) pursuant to the provisions of the Clean Air Act, as amended, and the Clean Water Act, as amended.
The new pipeline is included in the NEPA review as part of the deepwater port application process. The EPA and the USACE, among others, are cooperating agencies (40 CFR 1501.6) and have assisted in development of the FEIS. See 40 CFR 1501.6. To the extent required, each agency will incorporate the FEIS into their permitting processes. Comments sent to the EPA or USACE will be incorporated in the USCG Port Ambrose docket and considered under this notice to ensure consistency with the NEPA Process.
There have been some proposed project changes since the original Port Ambrose application was submitted, which were set forth in the Notice of Availability of the Draft EIS (DEIS). In summary, these include: (1) The original Application proposed a plowed mainline pipeline burial depth of three (3) feet to top of pipe. Pursuant to USACE requirements, the mainline pipeline is now proposed to be plow-buried to seven (7) feet (4 feet to top of pipe), and for approximately three (3) miles within the Ambrose Anchorage Area, buried to 10 feet (7 feet to top of pipe). The pipeline within the Ambrose Anchorage Area will then be backfilled and covered with three (3) feet of 8-inch rock to a point. Once the rock has been placed, gravelly sand will be deposited on top of the rock covered pipeline to restore the seabed to near its original seafloor bottom elevation; (2) the originally proposed impact driven mooring pile anchors are now proposed to be suction anchors; (3) the original port construction and commissioning was proposed to occur in 2015. This timetable has been amended to occur in 2018 (assuming license is approved and issued). Should a license be issued, the deepwater port would be designed, fabricated, constructed, commissioned, maintained, inspected and operated in accordance with applicable codes and standards.
The electronic form of all comments received into the FDMS can be searched by the name of the individual submitting the comment (or signing the comment, if submitted on behalf of an association, business, labor union, etc.). The DOT Privacy Act Statement can be viewed in the
The Deepwater Port Act of 1974, as amended, 33 U.S.C. 1501
By Order of the Maritime Administrator.
Soo Line Railroad Company d/b/a Canadian Pacific (Soo Line) has filed a verified notice of exemption under 49 CFR part 1152 subpart F—
Soo Line has certified that: (1) No local traffic has moved over the Line for at least two years; (2) any overhead traffic can be and has been rerouted over other lines; (3) no formal complaint filed by a user of rail service on the Line (or by a state or local government entity acting on behalf of such user) regarding cessation of service over the Line either is pending with the Surface Transportation Board (Board) or with any U.S. District Court or has been decided in favor of complainant within the two-year period; and (4) the requirements at 49 CFR 1105.7(c) (environmental report), 49 CFR 1105.11 (transmittal letter), 49 CFR 1105.12 (newspaper publication), and 49 CFR 1152.50(d)(1) (notice to governmental agencies) have been met.
As a condition to this exemption, any employee adversely affected by the abandonment shall be protected under
Provided no formal expression of intent to file an offer of financial assistance (OFA) has been received, this exemption will be effective on November 17, 2015, unless stayed pending reconsideration. Petitions to stay that do not involve environmental issues,
A copy of any petition filed with the Board should be sent to Soo Line's representative: W. Karl Hansen, Stinson Leonard Street LLP, 150 South Fifth Street, Suite 2300, Minneapolis, MN 55402.
If the verified notice contains false or misleading information, the exemption is void ab initio.
Soo Line has filed environmental and historic reports that address the effects, if any, of the abandonment on the environment and historic resources. OEA will issue an environmental assessment (EA) by October 23, 2015. Interested persons may obtain a copy of the EA by writing to OEA (Room 1100, Surface Transportation Board, Washington, DC 20423-0001) or by calling OEA at (202) 245-0305. Assistance for the hearing impaired is available through the Federal Information Relay Service at (800) 877-8339. Comments on environmental and historic preservation matters must be filed within 15 days after the EA becomes available to the public.
Environmental, historic preservation, public use, or trail use/rail banking conditions will be imposed, where appropriate, in a subsequent decision.
Pursuant to the provisions of 49 CFR 1152.29(e)(2), Soo Line shall file a notice of consummation with the Board to signify that it has exercised the authority granted and fully abandoned the Line. If consummation has not been effected by Soo Line's filing of a notice of consummation by October 16, 2016, and there are no legal or regulatory barriers to consummation, the authority to abandon will automatically expire.
Board decisions and notices are available on our Web site at “
By the Board, Rachel D. Campbell, Director, Office of Proceedings.
Surface Transportation Board.
Issuance of Draft Environmental Assessment; Request for Comments.
On February 24, 2015, Applicants, Lone Star Railroad, Inc. (LSR) and Southern Switching Company (SSC), filed a petition with the Surface Transportation Board (Board) pursuant to 49 United States Code (U.S.C.) 10502 and 49 Code of Federal Regulations (CFR) 1121.1. The Board's Office of Environmental Analysis (OEA) is responsible for ensuring the Board's compliance with the requirements of the National Environmental Policy Act. Applicants seek Board authority for LSR to construct and SSC to operate approximately 3.18 miles of rail line that would connect to an existing Union Pacific Railroad Company mainline and provide rail service to an industrial park property near Big Spring, in Howard County, Texas. The primary purpose for the proposed action is the efficient delivery of frac sand by rail to the industrial park property, where it would be transloaded to trucks for delivery to crude oil wellhead locations in the Permian Basin. Applicants anticipate that the proposed rail line would support an average of five trains per week.
Today, OEA has issued the Draft Environmental Assessment (EA), which is available on the Board's Web site,
Interested parties are invited to submit written comments on the Draft EA by November 16, 2015. OEA will consider and respond to comments received on the Draft EA in the Final EA. The Board will issue a final decision on the proposed transaction after issuance of the Final EA.
Filing Environmental Comments: Comments submitted by mail should be addressed to: Kenneth Blodgett, Surface Transportation Board, 395 E Street SW., Washington, DC 20423-0001, Attention: Environmental Filing, Docket No. FD 35874. Comments may also be submitted electronically on the Board's Web site,
Kenneth Blodgett at the address above or by phone at 202-245-0305. Assistance for the hearing impaired is available through the Federal Information Relay Service (FIRS) at 1-800-877-8339.
By the Board, Victoria Rutson, Director, Office of Environmental Analysis.
a. Persons in Cuba
b. Persons in Eurasia and the Baltics
c. Persons in Iraq
d. Persons in Honduras, Guatemala, and El Salvador
e. In exceptional circumstances, persons identified by a United States Embassy in any location
(1) is a regional program, project, or activity under which the total benefit to Zimbabwe does not exceed 10 percent of the total value of such program, project, or activity;
(2) has as its primary objective the addressing of basic human needs, as defined by the Department of the Treasury with respect to other, existing legislative mandates concerning U.S. participation in the multilateral development banks;
(3) is complementary to or has similar policy objectives to programs being implemented bilaterally by the United States Government;
(4) has as its primary objective the improvement of Zimbabwe's legal system, including in areas that impact Zimbabwe's ability to investigate and prosecute trafficking cases or otherwise improve implementation of its anti-trafficking policy, regulations, or legislation;
(5) is engaging a government, international organization, or civil society organization, and seeks as its primary objective(s) to: (a) increase efforts to investigate and prosecute trafficking in persons crimes; (b) increase protection for victims of trafficking through better screening, identification, rescue and removal, aftercare (shelter, counseling), training, and reintegration; or (c) expand prevention efforts through education and awareness campaigns highlighting the dangers of trafficking in persons or training and economic empowerment of populations clearly at risk of falling victim to trafficking; or
(6) is targeted macroeconomic assistance from the International Monetary Fund that strengthens the macroeconomic management capacity of
Office of the National Coordinator for Health Information Technology (ONC), Department of Health and Human Services (HHS).
Final rule.
This final rule finalizes a new edition of certification criteria (the 2015 Edition health IT certification criteria or “2015 Edition”) and a new 2015 Edition Base Electronic Health Record (EHR) definition, while also modifying the ONC Health IT Certification Program to make it open and accessible to more types of health IT and health IT that supports various care and practice settings. The 2015 Edition establishes the capabilities and specifies the related standards and implementation specifications that Certified Electronic Health Record Technology (CEHRT) would need to include to, at a minimum, support the achievement of meaningful use by eligible professionals (EPs), eligible hospitals, and critical access hospitals (CAHs) under the Medicare and Medicaid EHR Incentive Programs (EHR Incentive Programs) when such edition is required for use under these programs.
These regulations are effective January 14, 2016, except for § 170.523(m) and (n), which are effective on April 1, 2016.
The incorporation by reference of certain publications listed in the rule is approved by the Director of the
Michael Lipinski, Office of Policy, Office of the National Coordinator for Health Information Technology, 202-690-7151.
Building on past rulemakings, we issued a proposed rule (“Proposed Rule”) (80 FR 16804) that identified how health IT certification to the proposed 2015 Edition health IT certification criteria could support the establishment of an interoperable nationwide health information infrastructure. The Proposed Rule reflected stakeholder feedback received through various outreach initiatives, including the regulatory process, and was designed to broadly support the health care continuum through the use of certified health IT. This final rule, taking into account public comments received on the Proposed Rule, continues to focus on the establishment of an interoperable nationwide health information infrastructure, through the same means identified in the Proposed Rule and recited below, but with an additional focus on reducing health IT developer and provider burden as compared to the Proposed Rule. To this end, this final rule will:
• Improve interoperability for specific purposes by adopting new and updated vocabulary and content standards for the structured recording and exchange of health information, including a Common Clinical Data Set composed primarily of data expressed using adopted standards; and rigorously testing an identified content exchange
• Facilitate the accessibility and exchange of data by including enhanced data export, transitions of care, and application programming interface (API) capabilities in the 2015 Edition Base Electronic Health Record (EHR) definition;
• Establish a framework that makes the Office of the National Coordinator for Health Information Technology (ONC) Health IT Certification Program open and accessible to more types of health IT, health IT that supports a variety of care and practice settings, various HHS programs, and public and private interests;
• Support the Centers for Medicare & Medicaid Services (CMS) Medicare and Medicaid EHR Incentive Programs (EHR Incentive Programs) through the adoption of a set of certification criteria that align with proposals for Stage 3;
• Address health disparities by providing certification: to standards for more granular capture of race and ethnicity; the collection of sexual orientation, gender identity, social, psychological, and behavioral data; for the exchange of sensitive health information (Data Segmentation for Privacy); and for the accessibility of health IT;
• Ensure all health IT presented for certification possess the relevant privacy and security capabilities;
• Improve patient safety by: applying enhanced user-centered design principles to health IT, enhancing patient matching, requiring health IT to be capable of exchanging relevant patient information (
• Increase the reliability and transparency of certified health IT through surveillance and disclosure requirements; and
• Provide health IT developers with more flexibility, opportunities, and
The 2015 Edition health IT certification criteria (“2015 Edition” or “2015 Edition certification criteria”) facilitates greater interoperability for several clinical health information purposes and enables health information exchange through new and enhanced certification criteria, standards, and implementation specifications. It incorporates changes that are designed to spur innovation, open new market opportunities, and provide more choices to providers when it comes to electronic health information exchange. To achieve these goals, new “application access” (also known as “API”) certification criteria have been adopted that will require the demonstration of an API that responds to data requests for any one category of the data referenced in the Common Clinical Data Set as well as for all of the data referenced in the Common Clinical Data Set. We note that in response to comments, we have separated this criterion into 3 criteria to provide health IT developers and providers more flexibility. To further validate the continued interoperability of certified health IT and the ability to exchange electronic health information with health IT certified to the 2014 Edition, 2015 Edition, and potentially future editions, a new “transitions of care” certification criterion will rigorously assess a product's ability to create and receive an interoperable C-CDA. We have also adopted certification criteria that both support interoperability and other settings and use cases, such as the “Common Clinical Data Set summary record,” “data segmentation for privacy,” and “care plan” certification criteria.
We refer readers to section III.A for an overview table (Table 2) of certification criteria adopted in this final rule as compared to the certification criteria proposed in the Proposed Rule and the adopted 2014 Edition. We also refer readers to sections III.A.3 and III.A.5 of this preamble for full discussions of certification criteria adopted as part of the 2015 Edition in this final rule (III.A.3) and the proposed certification criteria not adopted in this final rule (III.A.5).
This final rule adopts a Base EHR definition specific to the 2015 Edition (
• It does not include privacy and security capabilities and certification criteria.
• It only includes capabilities to record and export clinical quality measure (CQM) data (§ 170.315(c)(1)) and not other CQM capabilities such as import, calculate, and “report to CMS.”
• It includes the 2015 Edition “smoking status” certification criterion as patient demographic and clinical health information data consistent with statutory requirements.
• It includes the 2015 Edition “implantable device list” certification criterion as patient demographic and clinical health information data consistent with statutory requirements.
• It includes the 2015 Edition “API” certification criteria as capabilities that support both the capture and query of information relevant to health care quality and exchange electronic health information with, and integrate such information from other sources.
• It includes the proposed 2015 Edition certification criteria that correspond to the remaining 2014 Edition certification criteria referenced in the “2014 Edition” Base EHR definition (
We refer readers to section III.B.1 of this preamble for a more detailed discussion of the 2015 Edition Base EHR definition and to section III.A.3 of this preamble for a full discussion of the criteria that have been included in the Base EHR definition. Of note, the “demographics” certification criterion (§ 170.315(a)(5)) now includes sexual orientation and gender identity as data elements, the “smoking status” certification criterion (§ 170.315(a)(11)) is now only a functional requirement, the “API” criterion has been separated into 3 distinct criteria as mentioned above, and the Direct-related criteria have been updated from “unchanged” to “revised” to incorporate updated and necessary interoperability standards.
As discussed in more detail under the “privacy and security” heading in section IV.C.1 of this preamble, Health
The CQM capabilities noted above as not included in the 2015 Edition Base EHR definition have, however, been included the Certified EHR Technology (CEHRT) definition under the EHR Incentive Programs. We refer readers to the next section (“b. CEHRT definition”) for further information and guidance on the relationship of the 2015 Edition Base EHR definition and the 2015 Edition certification criteria with the CEHRT definition. We also refer readers to the CEHRT definition finalized in the EHR Incentive Programs Stage 3 and Modifications final rule published elsewhere in this issue of the
This final rule removes the CEHRT definition from § 170.102 for the following reasons. The CEHRT definition has always been defined in a manner that supports the EHR Incentive Programs. As such, the CEHRT definition more appropriately resides solely within the EHR Incentive Programs regulations. This is also consistent with our approach in this final rule to make the ONC Health IT Certification Program more open and accessible to other types of health IT beyond EHR technology and for health IT that supports care and practice settings beyond those included in the EHR Incentive Programs. Further, this adds administrative simplicity in that regulatory provisions, which EHR Incentive Programs participants must meet (
We note that the CEHRT definition finalized by CMS continues to include the Base EHR definition(s) defined by ONC, including the 2015 Edition Base EHR definition adopted in this final rule. We also refer readers to Table 4 (“2015 Edition Health IT Certification Criteria Associated with the EHR Incentive Programs Stage 3”) found in section III.A.3 of this preamble. Table 4 crosswalks 2015 Edition certification criteria with the finalized CEHRT definition and EHR Incentive Programs Stage 3 objectives. It also identifies mandatory and conditional certification requirements (
For the full requirements to meet the CEHRT definition under the EHR Incentive Programs, including for years before 2018 and for 2018 and subsequent years, we refer readers to the EHR Incentive Programs Stage 3 and Modifications final rule published elsewhere in this issue of the
We revised the “Common MU Data Set” definition in § 170.102. We changed the name to “Common Clinical Data Set,” which aligns with our approach throughout this final rule to make the ONC Health IT Certification Program more open and accessible to other types of health IT beyond EHR technology and for health IT that supports care and practice settings beyond those included in the EHR Incentive Programs. We also changed references to the “Common MU Data Set” in the 2014 Edition (§ 170.314) to “Common Clinical Data Set.”
We revised the definition to account for the new and updated standards and code sets we have adopted in this final rule for the 2015 Edition that will improve and advance interoperability through the exchange of the Common Clinical Data Set. We also revised the definition to support patient safety and improve care through clearly referenced data elements (“care plan data”) and the inclusion of new patient data (
We refer readers to section III.B.3 of this preamble for a detailed discussion of the Common Clinical Data Set and a table listing the data and standards included in the Common Clinical Data Set for both the 2014 and 2015 Editions.
We have changed the name of the ONC HIT Certification Program to the “ONC Health IT Certification Program.” We have also modified the ONC Health IT Certification Program in ways that will make it more accessible to other types of health IT beyond EHR technology and for health IT that supports care and practice settings beyond the ambulatory and inpatient settings. These modifications will also serve to support other public and private programs that may reference the use of health IT certified under the ONC Health IT Certification Program. When we established the certification program (76 FR 1262),
This final rule permits other types of health IT, such as technology implemented by health information service providers (HISPs) and health information exchanges (HIEs), to receive appropriate attribution and not be referenced by a certificate with “EHR” included in it. This final rule also supports health IT certification for other care and practice settings, such as long-term post-acute care (LTPAC), behavioral health, and pediatrics. Further, this final rule will make it simpler for certification criteria and certified health IT to be referenced by other HHS programs (
As part of our approach to evolve the ONC Health IT Certification Program, we have replaced prior rulemaking use of “EHR” and “EHR technology” with “health IT.” The term health IT is reflective of the scope of ONC's authority under the Public Health Service Act (§ 3000(5) as “health information technology” is so defined), and represents a broad range of technology, including EHR technology. It also more properly represents some of the technology, as noted above, that has been previously certified to editions of certification criteria under the ONC Health IT Certification Program and may be certified to the 2015 Edition. Similarly, to make the ONC Health IT Certification Program more open and accessible, we have renamed the EHR Module as “Health IT Module.”
We have adopted our proposed approach in that we will not require ONC-Authorized Certification Bodies (ONC-ACBs) to certify Health IT Modules to the 2015 Edition “meaningful use measurement” certification criteria. We note, however, that
We have adopted a new, simpler, straight-forward approach to privacy and security certification requirements for Health IT Modules certified to the 2015 Edition. In sum, the privacy and security certification criteria applicable to a Health IT Module presented for certification is based on the other capabilities included in the Health IT Module and for which certification is sought. Under the 2015 Edition privacy and security certification framework, a health IT developer will know exactly what it needs to do in order to get its Health IT Module certified and a purchaser of a Health IT Module will know exactly what privacy and security functionality against which the Health IT Module had to be tested in order to be certified.
We have adopted new and revised PoPC for ONC-ACBs. ONC-ACBs are now required to report an expanded set of information to ONC for inclusion in the open data file that would make up the Certified Health IT Product List (CHPL). ONC-ACBs must ensure that health IT developers provide more meaningful disclosure of certain types of costs and limitations that could interfere with the ability of users to implement certified health IT in a manner consistent with its certification. ONC-ACBs must retain records for a period of time that will support HHS program needs. ONC-ACBs must also obtain a record of all adaptations and updates affecting “safety-enhanced design” criteria on a quarterly basis each calendar year. ONC-ACBs must also report to the National Coordinator complaints received on certified health IT. We have also adopted new requirements for “in-the-field” surveillance under the ONC Health IT Certification Program that clarify and expand ONC-ACBs' existing surveillance responsibilities by specifying requirements and procedures for in-the-field surveillance. We believe these new and revised PoPC promote greater transparency and accountability for the ONC Health IT Certification Program.
Our estimates indicate that this final rule is an economically significant rule as its overall costs for health IT developers may be greater than $100 million in at least one year. We have, therefore, projected the costs and benefits of the final rule. The estimated costs expected to be incurred by health IT developers to develop and prepare health IT to be tested and certified in accordance with the 2015 Edition certification criteria (and the standards and implementation specifications they include) are represented in monetary terms in Table 1 below. We note that this final rule does not impose the costs cited as compliance costs, but rather as investments which health IT developers voluntarily take on and may expect to recover with an appropriate rate of return. We further note that, based on the estimates provided by a health IT developer association in response to the Proposed Rule, we have reduced the estimated burden of the 2015 Edition by over 40,000 burden hours per health IT developer by not adopting certain proposed certification criteria, functionality and standards.
The dollar amounts expressed in Table 1 are expressed in 2014 dollars.
As noted above, we expect that health IT developers will recover an appropriate rate of return for their investments in developing and preparing their health IT for certification to the 2015 Edition certification criteria adopted in this final rule. However, we do not have data available to quantify these benefits or other benefits that will likely arise from health IT developers certifying their health IT to the 2015 Edition.
We believe that there will be several significant benefits that may arise from this final rule for patients, health care providers, and health IT developers. The 2015 Edition continues to improve health IT interoperability through the adoption of new and updated standards and implementation specifications. For example, many proposed certification criteria include standards and implementation specifications for interoperability that directly support the EHR Incentive Programs, which include objectives and measures for the interoperable exchange of health information and for providing patients electronic access to their health information in structured formats. In addition, the adopted certification criteria that support the collection of patient data that could be used to address health disparities would not only benefit patients, but the entire health care delivery system through improved quality of care. The 2015 Edition also supports usability and patient safety through new and enhanced certification requirements for health IT.
This final rule also makes the ONC Health IT Certification Program open and accessible to more types of health IT and for health IT that supports a variety of care and practice settings. This should benefit health IT developers, providers practicing in
The Health Information Technology for Economic and Clinical Health (HITECH) Act, Title XIII of Division A and Title IV of Division B of the American Recovery and Reinvestment Act of 2009 (the Recovery Act) (Pub. L. 111-5), was enacted on February 17, 2009. The HITECH Act amended the Public Health Service Act (PHSA) and created “Title XXX—Health Information Technology and Quality” (Title XXX) to improve health care quality, safety, and efficiency through the promotion of HIT and electronic health information exchange.
The HITECH Act established two new federal advisory committees, the Health IT Policy Committee (HITPC) and the Health IT Standards Committee (HITSC) (sections 3002 and 3003 of the PHSA, respectively). Each is responsible for advising the National Coordinator for Health Information Technology (National Coordinator) on different aspects of standards, implementation specifications, and certification criteria. The HITPC is responsible for, among other duties, recommending priorities for the development, harmonization, and recognition of standards, implementation specifications, and certification criteria. Main responsibilities of the HITSC include recommending standards, implementation specifications, and certification criteria for adoption by the Secretary under section 3004 of the PHSA, consistent with the ONC-coordinated Federal Health IT Strategic Plan.
Section 3004 of the PHSA identifies a process for the adoption of health IT standards, implementation specifications, and certification criteria and authorizes the Secretary to adopt such standards, implementation specifications, and certification criteria. As specified in section 3004(a)(1), the Secretary is required, in consultation with representatives of other relevant federal agencies, to jointly review standards, implementation specifications, and certification criteria endorsed by the National Coordinator under section 3001(c) and subsequently determine whether to propose the adoption of any grouping of such standards, implementation specifications, or certification criteria. The Secretary is required to publish all determinations in the
Section 3004(b)(3) of the PHSA titled, Subsequent Standards Activity, provides that the Secretary shall adopt additional standards, implementation specifications, and certification criteria as necessary and consistent with the schedule published by the HITSC. We consider this provision in the broader context of the HITECH Act to grant the Secretary the authority and discretion to adopt standards, implementation specifications, and certification criteria that have been recommended by the HITSC and endorsed by the National Coordinator, as well as other appropriate and necessary health IT standards, implementation specifications, and certification criteria.
Section 3001(c)(5) of the PHSA provides the National Coordinator with the authority to establish a certification program or programs for the voluntary certification of health IT. Specifically, section 3001(c)(5)(A) specifies that the National Coordinator, in consultation with the Director of the National Institute of Standards and Technology (NIST), shall keep or recognize a program or programs for the voluntary certification of health information technology as being in compliance with applicable certification criteria adopted under this subtitle (i.e., certification criteria adopted by the Secretary under section 3004 of the PHSA).
The certification program(s) must also include, as appropriate, testing of the technology in accordance with section 13201(b) of the [HITECH] Act. Overall, section 13201(b) of the HITECH Act requires that with respect to the development of standards and implementation specifications, the Director of the NIST, in coordination with the HITSC, shall support the establishment of a conformance testing infrastructure, including the development of technical test beds. The HITECH Act also indicates that the development of this conformance testing infrastructure may include a program to accredit independent, non-Federal laboratories to perform testing.
The Secretary issued an interim final rule with request for comments titled, “Health Information Technology: Initial Set of Standards, Implementation Specifications, and Certification Criteria for Electronic Health Record Technology” (75 FR 2014, Jan. 13, 2010) (the “S&CC January 2010 interim final rule”), which adopted an initial set of standards, implementation specifications, and certification criteria. After consideration of the comments received on the S&CC January 2010 interim final rule, a final rule was issued to complete the adoption of the initial set of standards, implementation specifications, and certification criteria and realign them with the final objectives and measures established for the EHR Incentive Programs Stage 1 (formally titled: Health Information Technology: Initial Set of Standards, Implementation Specifications, and Certification Criteria for Electronic Health Record Technology; Final Rule, (75 FR 44590, July 28, 2010) and referred to as the “2011 Edition final rule”). The 2011 Edition final rule also established the first version of the CEHRT definition. Subsequent to the 2011 Edition final rule (October 13, 2010), we issued an interim final rule with a request for comment to remove certain implementation specifications related to public health surveillance that had been previously adopted in the 2011 Edition final rule (75 FR 62686).
The standards, implementation specifications, and certification criteria adopted by the Secretary in the 2011 Edition final rule established the capabilities that CEHRT must include in order to, at a minimum, support the achievement of EHR Incentive Programs Stage 1 by eligible professionals (EPs), eligible hospitals, and critical access hospitals (CAHs) under the Medicare and Medicaid Programs; Electronic Health Record Incentive Program; Final Rule (75 FR 44314) (the “EHR Incentive Programs Stage 1 final rule”).
The Secretary issued a proposed rule with request for comments titled “Health Information Technology: Standards, Implementation Specifications, and Certification Criteria for Electronic Health Record Technology, 2014 Edition; Revisions to the Permanent Certification Program for Health Information Technology” (77 FR 13832, March 7, 2012) (the “2014 Edition proposed rule”), which proposed new and revised standards, implementation specifications, and certification criteria. After consideration of the comments received on the 2014 Edition proposed rule, a final rule was issued to adopt the 2014 Edition set of standards, implementation specifications, and certification criteria and realign them with the final objectives and measures established for
On December 7, 2012, an interim final rule with a request for comment was jointly issued and published by ONC and CMS to update certain standards that had been previously adopted in the 2014 Edition final rule. The interim final rule also revised the EHR Incentive Programs by adding an alternative measure for the Stage 2 objective for hospitals to provide structured electronic laboratory results to ambulatory providers, corrected the regulation text for the measures associated with the objective for hospitals to provide patients the ability to view online, download, and transmit information about a hospital admission, and made the case number threshold exemption policy for clinical quality measure (CQM) reporting applicable for eligible hospitals and CAHs beginning with FY 2013. In addition, the interim final rule provided notice of CMS's intent to issue technical corrections to the electronic specifications for CQMs released on October 25, 2012 (77 FR 72985). On September 4, 2014, a final rule (Medicare and Medicaid Programs; Modifications to the Medicare and Medicaid Electronic Health Record (EHR) Incentive Program for 2014 and Other Changes to the EHR Incentive Program; and Health Information Technology: Revisions to the Certified EHR Technology Definition and EHR Certification Changes Related to Standards; Final Rule) (79 FR 52910) was published adopting these proposals.
On November 4, 2013, the Secretary published an interim final rule with a request for comment, 2014 Edition Electronic Health Record Certification Criteria: Revision to the Definition of “Common Meaningful Use (MU) Data Set” (78 FR 65884), to make a minor revision to the Common MU Data Set definition. This revision was intended to allow more flexibility with respect to the representation of dental procedures data for EHR technology testing and certification.
On February 26, 2014, the Secretary published a proposed rule titled “Voluntary 2015 Edition Electronic Health Record (EHR) Certification Criteria; Interoperability Updates and Regulatory Improvements” (79 FR 10880) (“Voluntary Edition proposed rule”). The proposed rule proposed a voluntary edition of certification criteria that was designed to enhance interoperability, promote innovation, and incorporate “bug fixes” to improve upon the 2014 Edition. A correction notice was published for the Voluntary Edition proposed rule on March 19, 2014, entitled “Voluntary 2015 Edition Electronic Health Record (EHR) Certification Criteria; Interoperability Updates and Regulatory Improvements; Correction” (79 FR 15282). This correction notice corrected the preamble text and gap certification table for four certification criteria that were omitted from the list of certification criteria eligible for gap certification for the 2015 Edition EHR certification criteria. On September 11, 2014, a final rule was published titled “2014 Edition Release 2 Electronic Health Record (EHR) Certification Criteria and the ONC HIT Certification Program; Regulatory Flexibilities, Improvements, and Enhanced Health Information Exchange” (79 FR 54430) (“2014 Edition Release 2 final rule”). The final rule adopted a small subset of the original proposals in the Voluntary Edition proposed rule as optional and revised 2014 Edition EHR certification criteria that provide flexibility, clarity, and enhance health information exchange. It also finalized administrative proposals (i.e., removal of regulatory text from the Code of Federal Regulations (CFR)) and proposals for the ONC HIT Certification Program that provide improvements.
On May 23, 2014, CMS and ONC jointly published the “Medicare and Medicaid Programs; Modifications to the Medicare and Medicaid Electronic Health Record Incentive Programs for 2014; and Health Information Technology: Revisions to the Certified EHR Technology Definition” proposed rule (79 FR 29732). The rule proposed to update the EHR Incentive Programs Stage 2 and Stage 3 participation timeline. It proposed to revise the CEHRT definition to permit the use of EHR technology certified to the 2011 Edition to meet the CEHRT definition for FY/CY 2014. It also proposed to allow EPs, eligible hospitals, and CAHs that could not fully implement EHR technology certified to the 2014 Edition for an EHR reporting period in 2014 due to delays in the availability of such technology to continue to use EHR technology certified to the 2011 Edition or a combination of EHR technology certified to the 2011 Edition and 2014 Edition for the EHR reporting periods in CY 2014 and FY 2014. On September 4, 2014, a final rule (“CEHRT Flexibility final rule”) was published (79 FR 52910) adopting these proposals.
On March 30, 2015, the Secretary published a proposed rule titled “2015 Edition Health Information Technology (Health IT) Certification Criteria; 2015 Edition Base Electronic Health Record (EHR) Definition, and ONC Health IT Certification Program Modifications” (80 FR 16804) (“2015 Edition Proposed Rule” or “Proposed Rule”). The Proposed Rule proposed an edition of certification criteria that was designed to enhance interoperability and is the subject of this final rule.
On January 13, 2010, CMS published the Medicare and Medicaid Programs; Electronic Health Record Incentive Program; Proposed Rule (75 FR 1844). The rule proposed the criteria for Stage 1 of the EHR Incentive Programs and regulations associated with the incentive payments made available under Division B, Title IV of the HITECH Act. Subsequently, CMS published a final rule (75 FR 44314) for Stage 1 of the EHR Incentive Programs on July 28, 2010, simultaneously with the publication of the 2011 Edition final rule. The EHR Incentive Programs Stage 1 final rule established the objectives, associated measures, and other requirements that EPs, eligible hospitals, and CAHs must satisfy to meet Stage 1.
On March 7, 2012, CMS published the Medicare and Medicaid Programs; Electronic Health Record Incentive Program—Stage 2; Proposed Rule (77 FR 13698). Subsequently, CMS published a final rule (77 FR 53968) for the EHR Incentive Programs on September 4, 2012, simultaneously with the publication of the 2014 Edition final rule. The EHR Incentive Programs Stage 2 final rule established the objectives, associated measures, and other requirements that EPs, eligible hospitals, and CAHs must satisfy to meet Stage 2. It also revised some Stage 1 requirements.
As described above in Section II.B.1, ONC and CMS jointly issued an interim final rule with a request for comment that was published on December 7, 2012 and a final rule that was published on
On March 30, 2015, CMS published the Medicare and Medicaid Programs; Electronic Health Record Incentive Program—Stage 3; Proposed Rule (80 FR 16732) (“EHR Incentive Programs Stage 3 proposed rule”) outlining objectives, associated measures, and other requirements that EPs, eligible hospitals, and CAHs would need to meet to participate in Stage 3 of the EHR Incentives Programs.
On April 15, 2015, CMS published the Medicare and Medicaid Programs; Electronic Health Record Incentive Program—Modifications to Meaningful Use in 2015 Through 2017; Proposed Rule (80 FR 20346) (“EHR Incentive Programs Modifications proposed rule”) proposing modifications to the EHR Incentive Programs for the EHR reporting periods and meaningful use measures in 2015 through 2017.
On March 10, 2010, ONC published a proposed rule (75 FR 11328) titled, “Proposed Establishment of Certification Programs for Health Information Technology” (the “Certification Programs proposed rule”). The rule proposed both a temporary and permanent certification program for the purposes of testing and certifying HIT. It also specified the processes the National Coordinator would follow to authorize organizations to perform the certification of HIT. A final rule establishing the temporary certification program was published on June 24, 2010 (75 FR 36158) (“Temporary Certification Program final rule”) and a final rule establishing the permanent certification program was published on January 7, 2011 (76 FR 1262) (“the Permanent Certification Program final rule”).
On May 31, 2011, ONC published a proposed rule (76 FR 31272) titled “Permanent Certification Program for Health Information Technology; Revisions to ONC-Approved Accreditor Processes.” The rule proposed a process for addressing instances where the ONC-Approved Accreditor (ONC-AA) engaged in improper conduct or did not perform its responsibilities under the permanent certification program, addressed the status of ONC-Authorized Certification Bodies in instances where there may be a change in the accreditation organization serving as the ONC-AA, and clarified the responsibilities of the new ONC-AA. All these proposals were finalized in a final rule published on November 25, 2011 (76 FR 72636).
The 2014 Edition final rule made changes to the permanent certification program. The final rule adopted a proposal to change the Permanent Certification Program's name to the “ONC HIT Certification Program,” revised the process for permitting the use of newer versions of “minimum standard” code sets, modified the certification processes ONC-ACBs need to follow for certifying EHR Modules in a manner that provides clear implementation direction and compliance with the new certification criteria, and eliminated the certification requirement that every EHR Module be certified to the “privacy and security” certification criteria.
The Voluntary Edition proposed rule included proposals that focused on improving regulatory clarity, simplifying the certification of EHR Modules that are designed for purposes other than meeting requirements of the EHR Incentive Programs, and discontinuing the use of the Complete EHR definition. As noted above, we issued the 2014 Edition Release 2 final rule to complete the rulemaking for the Voluntary Edition proposed rule. The 2014 Edition Release 2 final rule discontinued the “Complete EHR” certification concept beginning with the proposed 2015 Edition, adopted an updated standard (ISO/IEC 17065) for the accreditation of ONC-ACBs, and adopted the “ONC Certified HIT” certification and design mark for required use by ONC-ACBs under the ONC Health IT Certification Program.
As noted above, on March 30, 2015, the Secretary published the Proposed Rule which, in addition to proposing the 2015 Edition, proposed revisions to the ONC Health IT Certification Program.
This rule finalizes new, revised, and unchanged certification criteria that establish the capabilities and related standards and implementation specifications for the certification of health IT, including EHR technology. We refer to these new, revised, and unchanged certification criteria as the “2015 Edition health IT certification criteria” and have added this term and its definition to § 170.102. As noted in the Executive Summary, we also refer to these criteria as the “2015 Edition” in this preamble. We codified the 2015 Edition in § 170.315 to set them apart from other editions of certification criteria and make it easier for stakeholders to quickly determine the certification criteria included in the 2015 Edition.
In the Proposed Rule, we identified the 2015 Edition certification criteria as new, revised, or unchanged in comparison to the 2014 Edition. In the 2014 Edition final rule we gave meaning to the terms “new,” “revised,” and “unchanged” to both describe the differences between the 2014 Edition certification criteria and the 2011 Edition certification criteria, as well as establish what certification criteria in the 2014 Edition were eligible for gap certification (see 77 FR 54171, 54202, and 54248). Given that beginning with the 2015 Edition, “Complete EHR” certifications will no longer be issued (see also 79 FR 54443-45) and that we proposed to make the ONC Health IT Certification Program more open and accessible to other health care/practice settings, we also proposed to give new meaning to these terms for the purpose of a gap certification analysis as so specified:
• “
• “
• “
As described in the Proposed Rule and Executive Summary of this final rule as well as discussed in more detail in section IV.B of this preamble, we believe the availability and use of certified health IT for other use cases and health care settings beyond the EHR Incentive Programs has significant value. Therefore, we have adopted certification criteria that support those purposes. Table 2 below provides an overview of certification criteria adopted in this final rule as compared to the certification criteria proposed in the Proposed Rule and the adopted 2014 Edition.
We proposed that readers should interpret the following terms used in the 2015 Edition with the same meanings we adopted in the 2014 Edition final rule (77 FR 54168-54169), in response to comment: “User,” “record,” “change,” “access,” “incorporate,” “create,” and “transmit,” but apply to all health IT, not just “EHR technology.” For the term “incorporate,” we also proposed that readers should interpret the term as we further explained it under the “transitions of care” certification criterion (77 FR 54218) in the 2014 Edition final rule and in the Voluntary Edition proposed rule (79 FR 10898). We proposed that the scope of a 2015 Edition certification criterion was the same as the scope previously assigned to a 2014 Edition certification criterion (for further explanation, see the discussion at 77 FR 54168). That is, certification to the 2015 Edition certification criteria at § 170.315 would occur at the second paragraph level of the regulatory section and encompass all paragraph levels below the second paragraph level. We also proposed to continue to use the same specific descriptions for the different types of “data summaries” established in the 2014 Edition final rule (77 FR 54170-54171) for the 2015 Edition certification criteria (
We received no specific comments on these proposals and have adopted these meanings and approaches for certification to the 2015 Edition.
As with the adoption of the 2011 and 2014 editions of certification criteria (see the introductory text to §§ 170.302, 170.304, 170.306, and 170.314), all capabilities mentioned in certification criteria are expected to be performed electronically, unless otherwise noted. Therefore, we no longer include “electronically” in conjunction with each capability included in a certification criterion under § 170.315 because the introductory text to § 170.315 (which covers all the certification criteria included in the section) clearly states that health IT must be able to
Health IT certified to the 2015 Edition certification criteria and associated standards and implementation specifications can be implemented as part of an EP's, eligible hospital's, or CAH's CEHRT and used to demonstrate meaningful use (as identified in Table 4 of section III.A.3 below). We note that Table 4 also identifies certification criteria that are mandatory and conditional certification requirements for Health IT Modules, such as safety-enhanced design (conditional), and quality management system (mandatory), accessibility-centered design (mandatory), and privacy and security certification criteria (conditional). To note, we use the term mandatory to mean that all Health IT Modules must be certified to the certification criterion (see also § 170.550(g)(2) and (3)). Conditional means that certification to the certification criterion (e.g., the “Consolidated CDA creation performance,” “safety-enhanced design,” “automatic access timeout,” or “integrity” certification criterion) depends on what other certification criteria a Health IT Module is presented for certification to (see § 170.550(g)(1) and (4) and § 170.550(f)). For more information on “conditional” certification related to privacy and security, we also refer readers to section IV.C.1 (“Privacy and Security”) of this preamble.
Health IT certified to the 2015 Edition certification criteria and associated standards and implementation specifications can also be used to meet other HHS program requirements (
Section 170.300 establishes the applicability of subpart C—Certification Criteria for Health Information Technology. We proposed to revise paragraph (d) of § 170.300 to add in a reference to § 170.315 and revise the parenthetical in the paragraph to say “
We received no comments on these specific proposed revisions and have adopted the proposed revisions. As noted in the Proposed Rule, these revisions clarify which specific capabilities
We note that, with the 2015 Edition, we no longer label an entire certification criterion as either optional or ambulatory/inpatient (at the second paragraph level of § 170.315). For example, the 2015 Edition certification criterion for transmission to cancer registries is simply “transmission to cancer registries” instead of “optional—ambulatory setting only—transmission to cancer registries.” Similarly, the 2015 Edition certification criterion for “accounting of disclosures” is simply “accounting of disclosures” instead of “optional—accounting of disclosures.” These simplifications are possible given that, beginning with the 2015 Edition certification criteria, “Complete EHR” certifications will no longer be issued (see 79 FR 54443-45). Therefore, there is no longer a need to designate an entire certification criterion in this manner. Again, this approach also supports our goal to make the ONC Health IT Certification Program more agnostic to health care settings and accessible to health IT that supports care and practice settings beyond the ambulatory and inpatient settings. We note that we still use “optional,” “inpatient setting only,” and “ambulatory setting only” designations within certification criteria to provide flexibility and reduce burden where feasible and appropriate.
We proposed to replace the term “EHR technology” in paragraphs (d)(1) and (d)(2) of § 170.300 with “health IT” to align with our approach to make the ONC Health IT Certification Program more clearly open to the certification of all types of health IT. We received no comments on this specific proposal and have replaced “EHR technology” with “health IT” in the referenced paragraphs. Again, we refer readers to section IV.B of this preamble for a detailed discussion of modifications to the ONC Health IT Certification Program and responses to public comments received on the proposed modifications.
The National Technology Transfer and Advancement Act (NTTAA) of 1995 (15 U.S.C. 3701
• The standards adopted in § 170.202. (These industry standards were developed by groups of industry stakeholders committed to advancing the Direct Project,
• The standards adopted at § 170.205(d)(4) and (e)(4) for reporting of syndromic surveillance and immunization information to public health agencies, respectively (These standards go through a process similar within the public health community to those used by other industry stakeholders and voluntary consensus standards bodies.);
• The standard adopted at § 170.207(f)(2) for race and ethnicity; and
• Certain standards related to the protection of electronic health information adopted in § 170.210.
We are aware of no voluntary consensus standard that would serve as an alternative to these standards for the purposes that we have identified in this final rule.
In accordance with Office of the
The Office of the Federal Register has established new requirements for materials (
In the Proposed Rule, we proposed to adopt newer versions of four previously adopted minimum standards code sets for the 2015 Edition. The code sets proposed were: The September 2014 Release of the U.S. Edition of SNOMED CT®, LOINC® version 2.50, the February 2, 2015 monthly version of RxNorm, and the February 2, 2015 version of the CVX code set. We also proposed to adopt two new minimum standards code sets (the National Drug Codes (NDC)—Vaccine Codes, updates through January 15, 2015 and the “Race & Ethnicity—CDC” code system in the PHIN Vocabulary Access and Distribution System (VADS) Release 3.3.9 (June 17, 2011)). We reiterated, as we have previously articulated (77 FR 54170), the adoption of newer versions improve interoperability and health IT implementation, while creating little additional burden through the inclusion of new codes. We further stated that, as many of these minimum standards code sets are updated frequently throughout the year, we would consider whether it may be more appropriate to adopt a version of a minimum standards code set that is issued before we publish a final rule for the Proposed Rule.
A few commenters suggested that we do not specify an exact version and release of a standard (
We have adopted newer versions of four 2014 Edition minimum standards code sets in this final rule for the 2015 Edition. These code sets are the September 2015 Release of the U.S. Edition of SNOMED CT®, LOINC® version 2.52, the September 8, 2015 monthly version of RxNorm, and the August 17, 2015 version of the CVX code set. We have also adopted three new minimum standards code sets. These code sets are the National Drug Codes (NDC)—Vaccine NDC Linker, updates through August 17, 2015; the CDC Race and Ethnicity Code Set Version 1.0 (March 2000);
We have not adopted MVX codes for vaccine manufacturers as detailed further in the discussion on the “transmission to immunization registries” certification criterion in section III.A.3 of the preamble. Therefore, we do not see a need to include MVX codes in this list of code sets.
We confirm that CDC continues to steward the CDC Race and Ethnicity Code Set, Version 1.0 (March 2000). We also confirm that we have reviewed this version and believe it is appropriate to adopt it as the minimum standard code set for race and ethnicity. Any updates to the code set, including the issuance of newer versions, are within the oversight of the CDC.
As we stated in the 2014 Edition final rule (77 FR 54169-54170), the Office of the Federal Register regulations related to “incorporation by reference” are limited to a specific version that is approved rather than future versions or revisions of a given publication. Thus, we do not include regulation language that refers to a version/release as, for example “Version/Release 1.X” when “X” remains variable. Further, to remain in compliance with the Administrative Procedure Act and address any potential interoperability concerns, we would need to issue regulations to adopt a newer version minimum standards code set as a “baseline” standard and cannot
We are providing the following table (Table 3) of OIDs for certain code systems to assist health IT developers in the proper identification and exchange of health information coded to the vocabulary standards referenced in this final rule.
We proposed to remove the term “EHR Modules” from § 170.200 and add in its place “Health IT Modules” We proposed to remove the term “EHR technology” from § 170.210 and add in its place “health IT.” We noted that these proposals were consistent with our overall approach to this rulemaking as discussed in the Proposed Rule Executive Summary and recited in this final rule's Executive Summary. We received no comments on these specific proposals and have adopted these proposals. We refer readers to section IV.B of this preamble for a detailed discussion of modifications to the ONC Health IT Certification Program and responses to public comments received on the proposed modifications.
We discuss the certification criteria that we have adopted as part of the 2015 Edition in this section. We discuss each certification criterion in the chronological order in which it would appear in the CFR. In other words, the preamble that follows discusses the adopted certification criteria in § 170.315(a) first, then § 170.315(b), and so on through section (h). Due to certain proposed certification criteria not being adopted as well as further consideration of proper categorization of criteria, the designation of some criteria within § 170.315 has changed in comparison to the Proposed Rule (
We note that we have restructured the regulatory text of certification criteria to remove the use of “or” in many places where it was proposed to indicate certification optionality. We have replaced it with language that we believe will better convey that same optionality. This restructuring of the regulatory text will provide further clarity regarding when a health IT developer has flexibility to select one of two or more options for certifying its Health IT Module as compared to when it is expected that the Health IT Module demonstrate all listed methods for certification. This restructuring, by itself, did not alter any of the proposed certification criteria requirements.
Table 4 below identifies the 2015 Edition certification criteria associated with the EHR Incentive Programs Stage 3 as finalized in EHR Incentive Programs Stage 3 and Modifications final rule published elsewhere in this issue of the
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We proposed to adopt three separate 2015 computerized provider order entry (CPOE) certification criteria based on the clinical purpose (
We requested comment on whether we should specify, for the purposes of testing and certification to the 2015 Edition CPOE criteria, certain data elements that a Health IT Module must be able to include in a transmitted order. In particular, we requested comment on whether a Health IT Module should be able to include any or all of the following data elements: secondary diagnosis codes; reason for order; and comment fields entered by the ordering provider, if they are provided to the ordering provider in their order entry screen. We also requested comment on whether there are any other data elements that a Health IT Module should be able to include as part of an order for the purposes of testing and certification.
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We proposed to adopt a 2015 Edition CPOE certification criterion specific to medication ordering that was unchanged in comparison to the 2014 Edition CPOE—medications criterion adopted at § 170.314(a)(18) as well as § 170.314(a)(1)(i). The proposed criterion does not reference any standards or implementation specifications.
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We proposed to adopt a 2015 Edition CPOE certification criterion specific to laboratory ordering that was revised in comparison to the CPOE—laboratory criterion adopted at § 170.314(a)(19) as well as § 170.314(a)(1)(ii). For the ambulatory setting, we proposed that this criterion would include the HL7 Version 2.5.1 Implementation Guide: S&I Framework Laboratory Orders (LOI) from EHR, Draft Standard for Trial Use, Release 2—US Realm (“Release 2”). We proposed to adopt the most recent version of the HL7 Version 2.5.1 Implementation Guide: S&I Framework Laboratory Test Compendium Framework, Release 2, (also referred to as the “electronic Directory of Services (eDOS) IG”) for certification to all health care settings. We also proposed to require that a Health IT Module use, at a minimum, version 2.50 of Logical Observation Identifiers Names and Codes (LOINC®) as the vocabulary standard for laboratory orders.
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We proposed to adopt a 2015 Edition CPOE certification criterion specific to diagnostic imaging ordering that was unchanged in comparison to the 2014 Edition CPOE—diagnostic imaging criterion adopted at § 170.314(a)(20) as well as § 170.314(a)(1)(iii). The proposed criterion does not reference any standards or implementation specifications. We also proposed to adopt the title of “diagnostic imaging,” which is the title we gave to the 2014 Edition version of this certification criterion in the 2014 Edition Release 2 final rule (79 FR 54436).
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We proposed to adopt a revised 2014 Edition “drug-drug, drug-allergy interaction checks” criterion (§ 170.314(a)(2)) to clarify that the capabilities included in this criterion are focused on CPOE. We proposed that a Health IT Module must record at least one action taken and by whom, and must generate either a human readable display or human readable report of actions taken and by whom in response to drug-drug or drug-allergy interaction checks (DD/DAI). We explained that the benefits of recording user actions for DD/DAI interventions that assist with quality improvement and patient safety outweigh the development burden associated with this functionality. However, to address development concerns, we proposed that a Health IT Module must only record, at a minimum, one user action for DD/DAI checks; and asked for comment on focusing the requirement to record at least one user action taken for DD/DAI interventions on a subset of DD/DAI interventions and what sources we
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We proposed to adopt a revised 2015 Edition “demographics” certification criterion in comparison to the 2014 Edition certification criterion (§ 170.314(a)(3)). We received comments that focused on each of the specific data elements in the certification criterion. We have categorized and responded to these comments in a similar manner.
We proposed the requirement to record sex in accordance with HL7 Version 3 (“AdministrativeGender”) and a nullFlavor value attributed as follows: male (M); female (F); and unknown (UNK), and noted that HL7 Version 3 for recording sex would be required under the “Common Clinical Data Set” definition for certification to the 2015 Edition. In the Proposed Rule's section III.B.3 (“Common Clinical Data Set”), we stated that this approach would become the method for capturing sex under the “Common Clinical Data Set” definition for certification to the 2015 Edition.
We proposed the requirement to record each one of a patient's races and ethnicities in accordance with, at a minimum, the “Race & Ethnicity—CDC” code system in the PHIN Vocabulary Access and Distribution System (VADS), Release 3.3.9
In the Proposed Rule, we proposed to require the use of the Internet Engineering Task Force (IETF) Request for Comments (RFC) 5646
In the Proposed Rule, we proposed that, for the inpatient setting, a Health IT Module must include the functionality to record, change, and access the “date of death.” We stated that this functionality would be in addition to the requirement to enable a user to electronically record, change, and access “preliminary cause of death” in case of mortality, as is included in the 2014 Edition “demographics” certification criterion.
We did not propose to include a requirement to capture a patient's sexual orientation or gender identity as part of this criterion. Rather, we proposed the capture of SO/GI data as part of the proposed “social, psychological, and behavioral data” certification criterion.
We note that like all information in the “demographics” criterion, certification does not require that a provider collect this information, only that certified Health IT Modules enable a user to do so. We believe including SO/GI in the “demographics” criterion represents a crucial first step forward to improving care for LGBT communities.
We have not included it in the Common Clinical Data Set at this time. We refer readers to section III.B.3 of this preamble for further discussion of the Common Clinical Data Set.
• Do you think of yourself as:
○ Straight or heterosexual;
○ Lesbian, gay, or homosexual;
○ Bisexual;
○ Something else, please describe.
○ Don't know.
• What is your current gender identity? (Check all that apply.)
○ Male;
○ Female;
○ Transgender male/Trans man/Female-to-male;
○ Transgender female/Trans woman/Male-to-female;
○ Genderqueer, neither exclusively male nor female;
○ Additional gender category/(or other), please specify.
○ Decline to answer.
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We proposed to adopt a 2015 Edition “problem list” certification criterion that was revised as compared to the 2014 Edition “problem list” certification criterion (§ 170.314(a)(5)) by requiring the September 2014 Release of the U.S. Edition of SNOMED CT® as the baseline version permitted for certification to this criterion. The Proposed Rule's section III.A.2.d (“Minimum Standards” Code Sets) discussed our adoption of SNOMED CT® as a minimum standards code set and the adoption of the September 2014 Release (U.S. Edition),
A couple of commenters stated that the problem list should not be limited to the duration of a hospitalization because it may be needed when the patient is out of the hospital, suggesting “for the duration of an entire hospitalization” be struck from the criterion. Another commenter suggested that the distinction between inpatient and ambulatory records should be dropped in favor of a “patient” record stating that several major healthcare systems have dropped the distinction and are focusing on a patient problem list where one or more problems on the problem list are addressed in a particular encounter (outpatient visit or inpatient stay).
Commenters suggested that if this criterion was adopted as proposed that health IT developers should have the ability to attest that their health IT previously certified to the 2014 Edition “problem list” criterion meets the newer baseline version of SNOMED CT® for the purposes of testing and certification to this criterion.
We did not propose as part of this criterion to test and certify a Health IT Module's ability to enable a user to record, change, and access a patient's active problem list and problem history across health care settings as this criterion is focused on the ambulatory and inpatient settings in support of the EHR Incentive Programs. We believe the use of “for the duration of an entire hospitalization” is appropriate for this criterion and refer readers to our detailed discussed of this determination in the 2014 Edition final rule (77 FR 54211-54212).
We agree with commenters that efficient testing and certification processes should be available to Health IT Modules previously certified to the 2014 Edition “problem list” criterion for certification to this criterion. Accordingly, we will consider such options, such as attestation, in developing the test procedure for this criterion and in issuing guidance to the ONC-AA and ONC-ACBs.
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We proposed to adopt a 2015 Edition “medication list” certification criterion that was unchanged as compared to the 2014 Edition “medication list” certification criterion (§ 170.314(a)(6)). To note, the proposed criterion does not reference any standards or implementation specifications.
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We proposed to adopt a 2015 Edition “medication allergy list” certification criterion that was unchanged as compared to the 2014 Edition “medication allergy list” certification criterion (§ 170.314(a)(7)).
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We proposed to adopt a 2015 Edition “clinical decision support” (CDS) certification criterion that was revised in comparison to the 2014 Edition “CDS” criterion (§ 170.314(a)(8)). We proposed to require a Health IT Module to follow the updated Infobutton standard (Release 2, June 2014)
We have reordered the provisions of the criterion/regulation text to better align with testing procedures. We have moved the CDS intervention interaction provision to the beginning, followed by the CDS configuration, evidence-based decision support interventions, linked referential CDS, and source attributes. This reordering does not alter the requirements of the criterion in any way.
We received no comments on our proposal to revise the cross-reference in § 170.314(a)(8)(iii)(B)(2) (CDS configuration) to more specifically cross-reference the 2014 “transitions of care” (“ToC”) criterion (§ 170.314(b)(1)(iii)(B)). Accordingly, we have adopted this proposed revision.
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In the Proposed Rule, we proposed to adopt a 2015 Edition “drug formulary checks and preferred drug list” certification criterion that was split based on drug formularies and preferred drug lists. We proposed that a Health IT Module must (1) automatically check whether a drug formulary exists for a given patient and medication and (2) receive and incorporate a formulary and benefit file according to the National Council for Prescription Drug Programs (NCPDP) Formulary and Benefit Standard v3.0 (“v3.0”). We proposed that a Health IT Module must automatically check whether a preferred drug list exists for a given patient and medication. For drug formularies and
Many commenters stated that there is not an industry-wide accepted standard for real-time individual patient-level formulary checking, but recommended ONC adopt certification to a standard once the industry moves to an agreed-upon standard. A few commenters noted that an NCPDP task group is analyzing use cases to support a real-time prescription benefit inquiry and is planning to make recommendations to the NCPDP membership on the creation of a new transaction and/or standard or modification of existing transactions or standards.
We believe that certification for individual-level, real-time prescription pricing information will provide the most value to inform provider prescribing decisions and discussions between providers and patients on the most appropriate medication options for the patient. However, at this time, there is no real-time patient-level standard with consensus stakeholder support that would be appropriate for certification. Based on the comments received, we strongly urge the industry to accelerate its work on identifying the need to create a new transaction and/or standard or modify existing transactions or standards for real-time prescription benefit inquiries. We intend to continue our participation in this area and will consider proposing certification functionalities for real-time prescription benefit inquiries in future rulemaking.
With consideration of comments supporting our proposed split of functionality between drug formularies and preferred drug lists, we have adopted a 2015 Edition “drug-formulary and preferred drug list checks” criterion that simply separates drug formulary and preferred drug list functionality, but does
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We proposed to adopt a 2015 Edition “smoking status” certification criterion that was revised in comparison to the 2014 Edition “smoking status” criterion (§ 170.314(a)(11)) and to include the 2015 Edition certification criterion in the 2015 Edition Base EHR definition. To be certified, we proposed that a Health IT Module must record, change, and access smoking status to any of the September 2014 Release of the U.S. Edition of SNOMED CT® available codes for smoking status, at a minimum. We noted that a Health IT Module certified to certification criteria that reference the Common Clinical Data Set (
As discussed in more detail under section III.B.3 of this preamble, we have adopted the 8 specified SNOMED CT® smoking codes as part of the Common Clinical Data Set (and for purposes of exchange). This is a continuation of our approach first adopted with the 2014 Edition.
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We proposed to adopt a 2015 Edition “family health history” (FHH) certification criterion that was revised in comparison to the 2014 Edition FHH certification criterion adopted at § 170.314(a)(13). In particular, we proposed to require a Health IT Module to enable a user to record, change, and access a patient's FHH electronically according to, at a minimum, the concepts or expressions for familial conditions included in the September 2014 Release of the U.S. Edition of SNOMED CT®, which would be a newer baseline version of SNOMED CT® than adopted for the 2014 Edition FHH criterion. The proposed rule's section III.A.2.d (“Minimum Standards” Code Sets) discussed our adoption of SNOMED CT® as a minimum standards code set and the adoption of the September 2014 Release (U.S. Edition), or potentially a newer version if released before a this final rule, as the baseline for certification to the 2015 Edition.
We note that our intent is not to limit the use of LOINC® for associated FHH “questions” or the specific SNOMED CT® code that is used to label FHH. Rather, the intent is to capture this information in SNOMED CT® instead of billing terminologies like ICD-10-CM. We also do not intend to prohibit the exchange of this information using the C-CDA 2.1. As we have noted in this and prior rulemakings, certification serves as a baseline. This baseline can be built upon through future regulation or simply through a decision by a health IT developer and/or its customer to include functionality that goes beyond the baseline. As present, we have set the certification baseline for FHH information at recording it in SNOMED CT®.
We agree with commenters that efficient testing and certification processes should be available to Health IT Modules previously certified to the 2014 Edition FHH criterion for certification to this criterion. Accordingly, we will consider such options, such as attestation, in developing the test procedure for this criterion and in issuing guidance to the ONC-AA and ONC-ACBs.
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In the Proposed Rule, we proposed to adopt a 2015 Edition “patient-specific education resources” certification criterion that was revised in comparison to the 2014 Edition “patient-specific education resources” certification criterion (§ 170.314(a)(15)). We proposed that certification would only focus on the use of Infobutton for this certification criterion instead of Infobutton
We proposed to adopt the updated Infobutton standard (Release 2 and the associated updated IGs (SOA-based IG and URL-based IG)). We also noted that we would not include a requirement that health IT be capable of electronically identifying patient-specific education resources based on “laboratory values/results” because the Infobutton standard cannot fully support this level of data specificity.
We proposed that a Health IT Module be able to request patient-specific education resources based on a patient's preferred language as this would assist providers in addressing and mitigating certain health disparities. More specifically, we proposed that a Health IT Module must be able to
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In the Proposed Rule, we proposed to adopt a new 2015 Edition certification criterion focused on the ability of health IT to exchange, record, and allow a user to access a list of Unique Device Identifiers (UDIs)
We explained that the purpose of the proposed implantable device list certification criterion was to enable the baseline functionality necessary to support the exchange and use of UDIs in certified health IT. The need to exchange and have access to this information wherever patients seek care is broadly relevant to all clinical users of health IT, regardless of setting or specialty, so that they may know what devices their patients are using (or have used) and thereby prevent device-related adverse events and deliver safe and effective care.
We acknowledged in the Proposed Rule that fully implementing UDIs in health IT will take time and require addressing a number of challenges. Nevertheless, we noted that substantial progress has been made. In particular, we summarized the FDA's regulatory activities and timeline for implementing the Unique Device Identification System and extensive work by public and private sector stakeholders to advance standards and specifications in support of UDI use cases. On the basis of these developments and our own ongoing consideration of these and other issues,
In light of the foregoing and with the revisions discussed below in our analysis of the comments on this proposal, we have finalized a 2015 Edition “implantable device list” certification criterion. We have also finalized our proposals to include this certification criterion in the 2015 Base EHR definition and to include a patient's UDIs as data within the 2015 Common Clinical Data Set definition. Discussion of those proposals can be found elsewhere in this final rule.
Many commenters supported the proposed criterion in full and recommended that we finalize it without any substantial revision. A significant number of commenters also urged to expand the scope of this criterion to include additional UDI-related capabilities. In contrast, a significant number of commenters stated that we should not finalize this criterion or should make all or part of it an optional certification criterion for the 2015 Edition. Commenters also offered a variety of suggested revisions and refinements with respect to the capabilities we proposed.
Some commenters understood our rationale for not requiring AIDC capabilities for all certified health IT and instead recommended we adopt a separate optional AIDC certification criterion that could be leveraged by certified health IT designed for operating rooms and other surgical settings in which devices are implanted or removed. While we appreciate the suggestion, such a certification criterion would be applicable to only a small subset of certified health IT, which in turn represents only a small subset of IT systems used to capture UDIs for implantable devices. Moreover, prescribing specific AIDC requirements for certified health IT may also be unnecessary. Given the obvious convenience, accuracy, and other advantages of AIDC, we anticipate that users of certified health IT designed for surgical settings will expect developers to include AIDC capabilities as a necessary complement to the baseline implantable device list functionality required by this criterion. Allowing developers and their customers to design and implement the most appropriate AIDC solutions for their individual needs is consistent with FDA's policy of permitting flexibility in the use of these technologies and avoids imposing unnecessary requirements and costs on developers, providers, and our testing and certification bodies.
Contrary to the suggestions of some commenters, our decision not to adopt a particular AIDC requirement for implantable devices does not mean that users of certified health IT systems will be forced to manually record UDIs. Again, for the reasons we have stated, this criterion has no bearing on how UDIs are entered or captured in upstream IT systems during a procedure or operation. It is tailored solely to bringing and providing capabilities for UDIs to downstream EHR and health IT systems used in physicians' offices, hospitals, and other places where patients with implantable devices seek care.
Similarly, at this time we believe that it would be premature to include other capabilities suggested by commenters. Some of those capabilities—such as the ability to record information about non-implantable devices—are beyond the scope of the proposal. For other capabilities, greater adoption and use of UDIs in certified health IT is needed before the capabilities will be useful to most health IT users. For example, we recognize that being able to generate a list of patients with a particular device will be necessary to respond to device recalls and analyze device performance and other characteristics. But those benefits cannot materialize until UDIs are more broadly and more readily accessible through interoperable health IT and health information exchange. Likewise, achieving these benefits will first require implementing other baseline functionality included in this criterion, such as the ability to retrieve key device attributes from the GUDID. We think that focusing the requirements of this criterion—and thus the efforts of developers and users of certified health IT—on these essential baseline functionalities is the quickest path to
• The lot or batch within which a device was manufactured;
• the serial number of a specific device;
• the expiration date of a specific device;
• the date a specific device was manufactured; and
• for an HCT/P regulated as a device, the distinct identification code required by 21 CFR 1271.290(c).
To avoid confusion and align our terminology with the UDI final rule, the commenter recommended we refer to these “data elements” as “identifiers” or “production identifiers.”
In our proposal, we used the term “data elements” to describe two distinct types of information associated with UDIs. First, we said that a Health IT Module certified to our proposed criterion would have to be able to parse certain “data elements from a UDI” and make these accessible to a user. 80 FR 16825. In that context, we were referring to what the UDI final rule describes as the “production identifiers that appear on the label of the device.” 21 CFR 830.310(b)(1). These are the identifiers listed above that compose and are required to be included in the Production Identifier when required to be included on the label of a device. 21 CFR 801.3. Because these identifiers are part of the UDI, health IT should be able to parse these identifiers from the UDI using the issuing agency's specifications. There is no need to query an external database or source, such as the GUDID.
Second, we also used the same term, “data element,” to refer to certain information not included in the UDI itself but that is associated with the UDI and can be retrieved using the GUDID. Specifically, we proposed that health IT be able to retrieve and make accessible the optional “Device Description” attribute associated with the Device Identifier portion of the UDI (assuming the attribute has been populated in the GUDID).
To distinguish these separate concepts and for consistency with the UDI final rule, this preamble and the corresponding regulation at § 170.315(a)(14) use the terms “identifier” and “attribute” to refer to the two distinct types of information described above.
A number of commenters pointed out that we had omitted from this requirement the Distinct Identification Code required by 21 CFR 1271.290(c), which is one of the five identifiers that make up the Production Identifier and applies to human cells, tissues, or cellular and tissue-based products (HCT/P) regulated as a device, including certain kinds of implantable devices (
We disagree that the requirement to parse a UDI should be postponed until the emergence of a single canonical UDI format. It is unclear at this time when or if such a canonical format will be developed and whether it would support the functionality we are requiring. It is also unclear whether implementing a canonical format would reduce or increase the overall technical complexity and burden of implementing these capabilities for multiple UDI formats. Meanwhile, postponing these capabilities would frustrate the purpose of this certification criterion. Without the ability to parse a UDI, health IT would be unable to provide users with useful information identifying and safety-related information about a device, such as the device's expiration date (which will be parsed from the Production Identifier) or a description of the device (which will be retrieved by parsing and looking up the Device Identifier in the GUDID).
The omission of “Distinct Identification Code required by 21 CFR 1271.290(c)” among the identifiers that health IT must be able to parse was an oversight, and we thank commenters for bringing it to our attention. We agree that to avoid misalignment with the UDI final rule, health IT should be required to parse this identifier and make it accessible in the same manner required for the other identifiers that compose the Production Identifier, as referenced in the Proposed Rule. We therefore
• “GMDN PT Name”;
• “Brand Name”;
• “Version or Model”;
• “Company Name”;
• “What MRI safety information does the labeling contain?”; and
• “Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437).”
As commenters acknowledged, including many who objected to this requirement, the availability of dedicated web services for retrieving the attributes associated with a UDI from the GUDID will significantly streamline and reduce the costs of including this functionality in certified health IT. We take the commenters at their word and believe that the availability of these dedicated web services—which will be specifically designed for health IT developers and aligned with this certification criterion—will substantially mitigate the concerns raised by developers and other commenters regarding the potential burden or technical challenges of implementing GUDID functionality.
Several commenters also urged us to require retrieval of additional GUDID attributes. Several commenters noted that certain safety-related attributes—specifically “What MRI safety information does the labeling contain?” and “Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437)”—are required to be submitted to the GUDID, are already available, and would significantly further the patient safety aims outlined in our proposal. Along the same lines, other commenters identified additional GUDID attributes that would enable identification of the manufacturer or labeler (i.e., company name), brand, and specific version or model of a device.
As discussed above, the GUDID web interface is now available via the NLM AccessGUDID website, which will soon be augmented with dedicated web services designed to support health IT certified to this criterion. With this increased readiness of the GUDID, health IT should be able to retrieve additional GUDID attributes with little additional effort. Therefore, we are also including the following attributes among those that must be retrieved and made accessible to users of health IT certified to this criterion:
• “Brand Name”;
• “Version or Model”;
• “Company Name”;
• “What MRI safety information does the labeling contain?”; and
• “Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437).”
For the reasons that commenters identified, these particular attributes will further the core goals of this criterion by significantly enhancing the ability of clinicians to identify and access important safety-related information about their patients' implantable devices.
The comments on this aspect of our proposal suggest some confusion surrounding the concept of an “implantable device list” contemplated in the Proposed Rule. Different commenters used the term “implantable device list” to refer to at least three distinct constructs: (1) The list of UDIs that would be recorded and exchanged as structured data; (2) the presumably more detailed list of information about a patient's implantable devices that would subsist separately and locally in EHR systems; and (3) the list of UDIs and other information that would be formatted and presented to users of an EHR system. Some commenters recognized this ambiguity and asked us to be more precise. But several commenters oscillated between these different constructs and imputed them to different parts of our proposal, depending on the context. As a result, some of these commenters perceived in our proposal elements that had not been proposed, such as the ability to enable a user to manually record a UDI or to exchange certain kinds of information about implantable devices.
As noted above, the comments on this aspect of our proposal suggest the need for greater precision regarding the concept of an “implantable device list.” In this final rule, we use the term “implantable device list” to refer to the visible list that is displayed to the user of health IT certified to this criterion and that must show, at a minimum: (1) A patient's active UDIs, meaning all UDIs recorded for the patient that have not been designated inactive; (2) the corresponding description of each UDI in the list (which, as discussed above, may be either the GUDID attribute “GMDN PT Name” or the “SNOMED CT® Description” mapped to that attribute); and (3) if one or more inactive UDIs are not included in the list, a method of accessing those UDIs and their associated information from within the list. The implantable device list may but need not also include the identifiers and attributes associated with each UDI that the health IT must be able to retrieve and make accessible to a user. If the implantable device list does not contain these identifiers and attributes, then the health IT would need to enable a user to access them (for example, by presenting them when a user clicks on an item in the implantable device list). Similarly, the implantable device list may but need not include inactive UDIs, so long as these UDIs are accessible from within the list. For example, the implantable device list could display only active UDIs so long as it also contained a link or other obvious way for a user to access all other UDIs recorded for the patient.
The discussion above should make clear that we are using the term “implantable device list” to refer to the
Beyond these basic parameters, we believe it is premature to prescribe the exact content and form of contextual information associated with UDIs. The comments confirm our observation in the Proposed Rule that additional standards and use cases will be needed to support this functionality.
Some commenters who otherwise supported our proposal felt that we should not include this certification criterion in the Base EHR or should make some of the proposed requirements optional in the 2015 Edition. Similarly, some commenters objected to the inclusion of a patient's Unique Device Identifiers in the CCDS definition. Some of these commenters objected in principle to including any requirements that are not correlated with a meaningful use objective or measure, while others objected on the basis that this certification criterion would be unduly costly and burdensome for developers and could place significant and unnecessary burdens on providers.
Several commenters claimed that this criterion was not ripe and there were a lack of available standards for certain aspects of our proposal. Commenters also cited potential implementation challenges, especially the fact that UDIs and other information about implantable devices are often captured in IT systems that are not part of certified health IT. Because bridging these systems will be challenging without more mature standards or customized interfaces, the information in these systems may not be recorded in certified health IT.
Because all providers should have access to information about their patients' implantable devices, we are including a patient's Unique Device Identifiers in the CCDS definition. To ensure that all certified health IT has the basic ability to exchange, record, and make this information available, we are including this certification criterion in the 2015 Base EHR definition. These definitions are not limited to the EHR Incentive Programs and must support other programs as well as the broader needs of health IT users throughout the health care system. We refer commenters to our discussion of these definitions elsewhere in this final rule. We decline to postpone this criterion until the Unique Device Identification System is fully implemented for all devices and across the entire medical device industry, or until additional standards are fully developed and harmonized for additional use cases. While this work is ongoing, UDIs are required to be available for all implantable devices by September 2015. Similarly, standards already exist for recording and exchanging UDIs for
Commenters concerns regarding potential “upstream” implementation challenges are valid, but we have addressed those concerns by focusing this certification criterion only on the baseline functionality necessary to ensure that, once recorded in a patient's electronic health record, UDIs can be exchanged among certified health IT and accessed by users of certified health IT wherever the patient seeks care.
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We proposed to adopt a new 2015 Edition “social, psychological, and behavioral data” certification criterion that would require a Health IT Module to be capable of enabling a user to record, change, and access a patient's social, psychological, and behavioral data based on SNOMED CT® and LOINC® codes, including sexual orientation and gender identity and the ability to record a patient's decision not to provide information. As the Proposed Rule explained, the proposed certification criterion is designed to advance the collection and use of such patient data, to transform health delivery, to reduce health disparities, and to achieve the overarching goals of the National Quality Strategy. We proposed that social, psychological, and behavioral data be coded in accordance with, at a minimum, version 2.50 of LOINC®, and we explained that LOINC® codes will be established in a newer version of LOINC® for the question-answer sets that do not currently have a LOINC® code in place, prior to the publication of the final rule. We proposed that sexual orientation be coded in accordance with, at a minimum, the September 2014 Release of the U.S. Edition of SNOMED CT® and HL7 Version 3 that gender identity be coded in accordance with, at a minimum, the September 2014 Release of the U.S. Edition of SNOMED CT® and HL7 Version 3, as enumerated in tables in the Proposed Rule. We sought comment on inclusion of the appropriate social, psychological, and behavioral data measures, on standardized questions for collection of sexual orientation and gender identity data, on a minimum number of data measures for certification, on combining and separating the measures in certification criteria, and on inclusion of additional data and available standards.
Some commenters were against certification for this data. These commenters cited lack of uses cases for the data, overburdening providers with data collection, and lack of maturity of data standards. A few commenters were not supportive of additional certification for criteria that are not proposed to specifically support Stage 3 of the EHR Incentive Programs.
In regard to comments expressing privacy and security concerns, we first note that the functionality in this criterion is focused on capture and not privacy and security. Second, we have established a privacy and security certification framework for all Health IT Modules that are certified to the 2015 Edition (please see section IV.C.1 of this preamble). Third, we recommend that institutions develop and maintain policies for the collection and dissemination of this data that is consistent with applicable federal and state laws.
We appreciate comments on additional data to consider for inclusion in this criterion. We have, however, determined that the proposed list presents an appropriate first step for the standardized collection of social, behavioral, and psychological data. We note, based on feedback from commenters, we have included the capture of sexual orientation and gender identity (SO/GI) data in the 2015 Edition “demographics” certification criterion. We will continue to consider whether this list should be expanded through future rulemaking.
We have verified the LOINC® codes that were proposed and obtained the codes for those listed as pending in the Proposed Rule, and have provided the proper codes and answer list IDs for all eight domains we are adopting in this criterion (please refer to § 170.207(p)) for the full list of LOINC® codes).
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We proposed to adopt a 2015 Edition certification criterion for “transitions of care” (“ToC”) that is a continuation and extension of the “ToC” certification criterion adopted as part of the 2014 Edition Release 2 final rule at § 170.314(b)(8). We proposed the following revisions and additions.
We proposed to adopt C-CDA Release 2.0 at § 170.205(a)(4) and noted that compliance with the C-CDA Release 2.0 cannot include the use of the “unstructured document” document-level template for certification to this criterion. To address “bilateral asynchronous cutover,” we proposed that the 2015 Edition “ToC” certification criterion reference both the C-CDA Release 1.1 and Release 2.0 standards and that a Health IT Module presented for certification to this criterion would need to demonstrate its conformance and capability to create and parse both versions (Release 1.1 and 2.0) of the C-CDA standards. While we recognized that this proposal was not ideal, we proposed this more conservative approach as a way to mitigate the potential that there would be interoperability challenges for transitions of care as different health care providers adopted Health IT Modules certified to the 2015 Edition criterion (including CCDA Release 2.0 capabilities) at different times. We requested comment on an alternative approach related to the creation of C-CDA-formatted documents. We noted that the adoption of C-CDA Release 2.0 would be applicable to all of the other certification criteria in which the C-CDA is referenced and that, unless C-CDA Release 2.0 is explicitly indicated as the sole standard in a certification criterion, we would reference both C-CDA versions in each of these criteria.
• A 2015 Edition certified Health IT Module to be able to send documents conformant to C-CDA Release 2.0;
• A 2015 Edition certified Health IT Module to be able to parse both a C-CDA Release 1.1 and 2.0 document;
• A 2014 Edition certified Health IT Module to be able to parse a C-CDA Release 1.1 document, and display but not parse a document conformant to C-CDA Release 2.0.
A few commenters requested clarification on the different kinds of null values and guidance on what constitutes an “indication of none” since blank values will not meet the requirements of the corresponding measure for transitions of care for Stage 3 of the EHR Incentive Programs.
We believe that adopting Release 2.1 largely achieves the goal to ensure systems can send, receive, and parse both C-CDA documents formatted according to Release 1.1 or 2.0 and minimizes the burden raised by commenters. However, we are aware that a system developed strictly to Release 2.1 might not automatically support receiving Release 1.1 C-CDAs without additional development (e.g., additional generation and import effort since different vocabulary requirements apply in several places when comparing the two versions of the C-CDA). Therefore, we have adopted C-CDA Release 2.1 (both Volumes 1 and 2) as a requirement for the 2015 Edition “ToC” criterion at § 170.314(b)(1), and have also adopted the requirement that a Health IT Module must demonstrate its ability to receive, validate, parse, display, and identify errors to C-CDA Release 1.1 documents to ensure compatibility and interoperability. Note that for consistency, all 2015 Edition certification criteria that reference C-CDA creation (e.g., clinical information reconciliation and incorporation; view, download, and transmit to 3rd party) require conformance to Release 2.1. 2015 Edition certification criteria that include a “receipt” of C-CDA documents function (
Regarding the questions of clarification on the use of null values and what constitutes an “indication of none” for the purposes of meeting the EHR Incentive Program Stage 3 measure, this issue concerns the information needed to fulfill the “automated numerator recording” and “automated
We also highly recommend that health IT developers and providers follow the guidance provided in the HL7 Implementation Guide: S&I Framework Transitions of Care Companion Guide to Consolidated-CDA for Meaningful Use Stage 2, Release 1—US Realm
We proposed to require that all certified Health IT Modules be able to parse C-CDA Release 2.0 documents formatted according to the following document templates:
• Continuity of Care Document (CCD);
• Consultation Note;
• History and Physical;
• Progress Note;
• Care Plan;
• Transfer Summary;
• Referral Note; and
• Discharge Summary.
Regarding the use of the unstructured document template, we believe that it limits interoperability as data is not exchanged in a structured and standardized (
We proposed that Health IT Modules would need to demonstrate the ability to detect valid and invalid C-CDA documents, including document, section, and entry level templates for data elements specified in 2014 and 2015 Editions. Specifically, that this would include the ability to detect invalid C-CDA documents, to identify valid C-CDA document templates, to detect invalid vocabularies and codes not specified in either the C-CDA 1.1 or 2.0 standards or required by this regulation, and to correctly interpret empty sections and nullFlavor combinations per the C-CDA 1.1 or 2.0 standards. Last, we proposed that technology must be able to display in human readable format the data included in a transition of care/referral summary document. We explained that we expected that Health IT Modules to have some mechanism to track errors encountered when assessing received C-CDA documents and we proposed that health IT be able to track the errors encountered and allow for a user to be notified of errors or review the errors produced. We stated these functionalities are an important and necessary technical prerequisite in order to ensure that as data in the system is parsed from a C-CDA for incorporation as part of the “clinical information reconciliation and incorporation” certification criterion the user can be assured that the system has appropriately interpreted the C-CDA it received.
Regarding the burden to the receiving system to process incorrectly formatted C-CDA errors, we note that all Health IT Modules certified to a 2015 Edition criterion that includes the functionality to create a C-CDA are also required to be certified to the “C-CDA Creation
However, we recognize that there may still be errors in created C-CDA documents from a sending system and therefore continue to believe in the value of the receiving system to process and validate C-CDA documents, including notifying the user of errors. We clarify that the error notification should be available to the receiving user. Regarding error notification, systems would be required to demonstrate its ability to notify the user of errors or allow the user to review the errors for the purposes of certification. Per commenters' concerns about “alert fatigue,” we note there is no explicit requirement that the user be interrupted regarding the availability of errors. Rather, that the user needed to be able to access such errors. We anticipate that validation and display would be tested through visual inspection that test data in the form of C-CDA documents with and without errors can be correctly parsed and errors correctly identified.
We have finalized the requirement as part of this criterion that Health IT Modules must be able to detect valid and invalid transition of care/referral summaries received and formatted in accordance with C-CDA Release 1.1 and Release 2.1 for the CCD, Referral Note, and (inpatient settings only) Discharge Summary document templates, including detection of invalid vocabulary standards and codes, correct interpretation of empty sections and null combinations, recording of errors/notification of errors to the user, and the ability to display a human readable formatted C-CDA (for both Releases 1.1 and 2.1). We discuss additional clarifications regarding the display of C-CDA sections below.
We have received feedback from providers expressing difficulty finding or locating the pertinent and relevant clinical information on a patient from a transition of care/referral summary received as a C-CDA document. Commenters have indicated that data included in a transition of care/referral summary document may be rendered and displayed as a long, multi-page document, which makes it challenging for a provider to quickly find the clinical information they seek to make a care decision.
We note that CMS has finalized in the EHR Incentive Programs Stage 3 and Modifications final rule guidance that permits a provider and organization (
While the guidance in the EHR Incentive Programs Stage 3 and Modifications final rule does address “clinical relevance” from the sending side and could result in a reduction in the quantity of data potentially viewed by a recipient as “unnecessary” or not useful, we recognize that certain patients, such as those with complex and/or chronic conditions may have a transition of care/referral summary sent to receiving providers with large quantities of data included. In that respect, we included as part of the 2014 Edition Final Rule a specific “section views” capability in the “transitions of care” certification criterion (adopted at 45 CFR 170.314(b)(1)(iii)(C)), which we described as having been added to the certification criterion in order to make sure that health IT would be able to extract and allow for individual display each additional section or sections (and the accompanying document header information (
We indicated that this functionality would be useful in situations when a user wanted to be able to review other sections of the transition of care/referral summary that were not incorporated (as required by this certification criterion at 45 CFR 170.314(b)(1)), such as a patient's procedures and smoking status, and that the technology would need to provide the user with a mechanism to select and just view those sections
The section views capability remains as part of the 2015 Edition version of this criterion. Additionally, to address comments that raised concerns and requested that we act to address a C-CDA's “length” and users' ability to more easily navigate to particular data within the C-CDA, we have included more precise requirements in this portion of the certification criterion. Specifically, the 2015 Edition version includes that a user must be able to: (1) Directly display only the data within a particular section, (2) set a preference for the display order of specific sections, and (3) set the initial quantity of sections to be displayed. We also clarify that the sole use of the CDA.xsl style sheet provided by HL7 to illustrate how to generate an HTML document from a CDA document will not be acceptable to meet these requirements. We believe these clarifications will help address stakeholder concerns regarding the difficulty finding or locating the pertinent and relevant clinical information on a patient from a ToC/referral summary received as a C-CDA document. We intend to ensure that the test procedure for this criterion thoroughly tests these aspects consistent with the certification criterion's requirements. We also strongly urge the health IT industry to dedicate additional focus toward improving the rendering of data when it is received. Putting such data to use in ways that enable providers to quickly view and locate the information they deem necessary can help improve patient care and prevent important information from being inadvertently missed. We further note that standards experts are aware of the stakeholder concerns discussed above, and that the HL7 Structured Documents Work Group is working on contributing positive momentum to this issue.
We proposed to “carry-over” a requirement from the 2014 Edition Release 2 “transitions of care” criterion at § 170.314(b)(8) that would require a certified Health IT Module be able to send and receive transition of care/referral summaries through a method that conforms to the ONC Implementation Guide for Direct Edge Protocols, Version 1.1 at § 170.202(d).
We note that we inadvertently left out a provision of the proposed regulation text related to Edge Protocol requirements. As noted above and in the Proposed Rule, we intended to “carry over” the Edge Protocol requirements included in § 170.314(b)(8) for this criterion. Therefore, we have added to the provision in § 170.315(b)(1)(i)(A) about sending transition of care/referral summaries through a method that conforms with the Edge Protocol and a requirement that it must also lead to the summaries being processed by a service that has implemented Direct. This addition parallels the Direct Edge Protocol “receiving” requirements we proposed and have finalized. It also clarifies a consistent set of technical capabilities for sending the Edge Protocol and technologies interacting with services that have implemented Direct, which again are the exact same requirements included in § 170.314 (b)(8) that we intended to duplicate in this 2015 Edition criterion.
We proposed to include a specific capability in this certification criterion that would require a Health IT Module presented for certification that is also being certified to the SMTP-based edge to demonstrate its ability to accept and process an XDM package it receives, which would include extracting relevant metadata and document(s). We explained that this additional requirement only applies to a Health IT Module presented for certification with an SMTP-based edge implementation and not an XDR edge implementation. Because we expect XDM packaging to be created in accordance with the specifications included in IHE IT Infrastructure Technical Framework Volume 2b, Transactions Part B—Sections 3.29—2.43, Revision 7.0, August 10, 2010 (ITI TF-2b),
SMTP-based transport systems use standard Multi-Purpose Internet Mail Extension (MIME) to identify email attachments and to enable receiving computer systems to process attachments seamlessly. For example, a MIME type of “text/html” identifies text styled in HTML format. C-CDA documents are commonly identified using “text/xml” and “application/xml” MIME types. In addition, XDM packages are commonly identified with “application/zip” and “application/octet-stream” MIME types. However, these MIME types have not been standardized by the community for transporting C-CDA and XDM files. Systems could potentially use other valid MIME types to send the documents. While these standard MIME types provide sufficient information for receiving systems to render content, they do not provide a way to distinguish the C-CDA and XDM documents from all the other documents that could be sent using the same MIME types. Until an appropriate set of MIME types are developed that can uniquely identify C-CDA and XDM, there is widespread acknowledgement that the receiving systems should accept all common MIME types, and use the information within the actual documents, to process C-CDA and XDM accordingly. Hence, in order to facilitate interoperability, we expect Health IT Modules to be able to support all commonly used MIME types when receiving C-CDA and XDM packages. We intend to update the test procedure to include guidance on specific MIME types that we expect Health IT Modules to support, at a minimum.
We proposed to require Health IT Modules to enable a user to create a transition of care/referral summary that includes, at a minimum, the Common Clinical Data Set for the 2015 Edition that includes references to new and updated vocabulary standards code sets.
We proposed to continue the requirement from the 2014 Edition “ToC” certification criterion that a Health IT Module must enable a user to create a transition of care/referral summary that also includes encounter diagnoses using either SNOMED CT® (September 2014 Release of the U.S.
We note that our certification requirement does not dictate what encounter diagnoses providers would include in a transitions of care document, only that certified Health IT Modules can enable a provider to include encounter diagnoses using SNOMED CT® or ICD-10-CM.
As a part of the “Create” portion of the “ToC” criterion in the 2015 Edition, we proposed to require a Health IT Module to be able to create a transition of care/referral summary that included a limited set of standardized data in order to improve the quality of the data that could potential be used for patient matching by a receiving system. The proposed standardized data included: First name, last name, maiden name, middle name (including middle initial), suffix, date of birth, place of birth, current address, historical address, phone number, and sex, with constrained specifications for some of the proposed standardized data.
In consideration of public comments, we have finalized the requirement that Health IT Modules must be able of creating a transition of care/referral summary in accordance with just C-CDA Release 2.1 as part of this certification criterion that includes the following data formatted to the associated standards/constraints where applicable:
• First name;
• Last name;
• Previous name;
• Middle name (including middle initial);
• Suffix;
• Date of birth—The year, month, and day of birth are required fields. Hour, minute, and second are optional fields; however, if hour, minute, and second are provided then the time zone offset must be included. If date of birth is unknown, the field should be marked as null;
• Address;
• Phone number—Represent phone number (home, business, cell) in the ITU format specified in ITU-T E.123
• Sex in accordance with the standard we are adopting at § 170.207(n)(1).
We note that we corrected the date of birth requirements to specify the year, month, and
Given feedback from stakeholders regarding health IT developers limiting the transmission or receipt of different file types via Direct, we reminded all stakeholders in the Proposed Rule of the following best practices for the sharing of information and enabling the broadest participation in information exchange with Direct:
We noted that no proposed 2015 Edition certification criterion includes just the C-CDA Release 2.0 and/or the Common Clinical Data Set, particularly with the 2015 Edition not including a proposed “clinical summary” certification criterion as discussed in the 2015 Edition Proposed Rule (80 FR 16850). We requested comment on whether we should adopt a separate 2015 Edition certification criterion for the voluntary testing and certification of health IT to the capability to create a summary record formatted to the C-CDA Release 2.0 with or without the ability to meet the requirements of the Common Clinical Data Set definition.
We requested comment on the maturity and appropriateness of the HL7 IG for CDA Release 2: Data Provenance, Release 1 (US Realm) (DSTU)
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We proposed to adopt a 2015 Edition “clinical information reconciliation and incorporation” certification criterion that is a revised (but largely similar to the 2014 Edition Release 2) version of the “clinical information reconciliation and incorporation” criterion adopted at § 170.314(b)(9). First, we proposed that Health IT Modules must be able to incorporate and reconcile information upon receipt of C-CDA's formatted to both Release 1.1 and Release 2.0 for similar reasons (
We proposed that a certified Health IT Module be able to receive, reconcile, and incorporate information from the C-CDA Release 2.0 CCD, Discharge Summary, and Referral Note document templates at a minimum. Note that we incorrectly referenced the “Referral Summary” document template. There is no “Referral Summary” document template and we intended the “Referral Note” document template.
We proposed that a Health IT Module must be able to reconcile and incorporate, at a minimum: problems, medications, and medication allergies from multiple C-CDAs, with testing for this specific system performance to verify the ability to incorporate valid C-CDAs with variations of data elements to be reconciled (
We proposed to require that a C-CDA be created based on the reconciliation and incorporation process in order to validate the incorporation results. We expected that the generated C-CDA would be verified using test tools for conformance and can be checked against the information that was provided to incorporate.
With respect to the comments that mentioned an apparent contradiction with the requirement for “creating” a C-CDA as part of this certification criterion, we disagree, and remind commenters that the changes we made in the 2014 Edition Release 2 final rule were to better position the “incorporation” functionality in the right certification criterion (79 FR 54438-54439). Therefore, we have adopted the requirement that Health IT Modules be able to create a C-CDA Release 2.1 based on the reconciliation and incorporation process that will be verified during testing and certification. Note that this requirement applies to the ability to create a C-CDA formatted to the C-CDA Release 2.1 CCD document template only.
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We proposed to adopt a 2015 Edition certification criterion for e-prescribing that is revised in comparison to the 2014 Edition “e-prescribing” criterion (§ 170.314(b)(3)).
First, we proposed to require a Health IT Module certified to this criterion be able to receive and respond to additional National Council for Prescription Drug Programs (NCPDP) SCRIPT Standard Implementation Guide Version 10.6 (v10.6) transactions or segments in addition to the New Prescription transaction, namely Change Prescription, Refill Prescription, Cancel Prescription, Fill Status, and Medication History. We proposed to require that a Health IT Module be able to send and receive end-to-end prescriber-to-receiver/sender-to-prescriber transactions (bidirectional transactions). The proposed transactions and reasons for inclusion for testing and certification are outlined in Table 5 below.
We solicited comment on other NCPDP SCRIPT v10.6 transactions that should be considered for testing and certification, and for what use cases/value, and the factors to consider for end-to-end prescriber-to-receiver testing.
Second, we proposed to require that a Health IT Module certified to this criterion enable a user to enter, receive, and transmit codified Sig instructions in a structured format in accordance with NCPDP Structured and Codified Sig Format Implementation Guide v1.2 which is embedded within NCPDP SCRIPT v10.6 for certification to the e-prescribing criterion in the 2015 Edition.
We solicited comment on whether we should require testing and certification to a subset of the structured and codified Sig format component composites that represent the most common Sig instructions rather than the full NCPDP Structured and Codified Sig Format Implementation Guide v1.2. NCPDP published recommendations for implementation of the structured and Codified Sig format for a subset of component composites that represent the most common Sig segments in the NCPDP SCRIPT Implementation Recommendations Version 1.29.
Third, we proposed that a Health IT Module certified to this criterion be capable of limiting a user's ability to electronically prescribe all medications only in the metric standard, and be capable of always inserting leading zeroes before the decimal point for amounts less than one when a user electronically prescribes medications. We also proposed that the Health IT Module not allow trailing zeroes after a decimal point. We stated our intent for proposing these requirements was to support more precise prescription doses in order to reduce dosing errors and improve patient safety.
Last, we proposed to adopt and include the February 2, 2015 monthly version of RxNorm in this criterion as the baseline version minimum standards code set for coding medications.
• New prescription transaction;
• Prescription change request transaction;
• Prescription change response transaction;
• Refill prescription request transaction;
• Refill prescription response transaction;
• Cancel prescription request transaction;
• Cancel prescription response transaction; and
• Fill status notification.
We believe that providers that are e-prescribing under Part D should have already adopted NCPDP SCRIPT v10.6 for these transactions as required effective November 1, 2013. Further, by requiring these transactions as part of certification, we are supporting the use of additional NDPCP SCRIPT v10.6 transactions in a standardized way.
• New prescription transaction (NEWRX);
• Prescription change request transaction (RXCHG);
• Prescription change response transaction (CHGRES);
• Refill prescription request transaction (REFREQ);
• Refill prescription response transaction (REFRES);
• Cancel prescription request transaction (CANRX);
• Cancel prescription response transaction (CANRES);
• Fill status notification (RXFILL);
• Medication history request transaction (RXHREQ); and
• Medication history response transaction (RXHRES).
We have confirmed the official name of these transactions with NCPDP. We note that the requirements we have
Regarding how message notifications are presented to health IT users, we believe this is a design feature that should be left to providers and health IT developers to determine, including whether batch notification is preferable to real-time messaging alerts.
We look forward to testing tools that allow pharmacy communications to either be simulated or sent by a pharmacy system that has agreed to participate in the ONC Health IT Certification Program as a pilot test system that is able to emulate real-life e-prescribing scenarios. We note that we intend to analyze any differences between our requirements for testing and certification to this certification criterion and other industry certification programs for e-prescribing to determine opportunities for alignment. However, we note that industry certification programs may address a different use case and potentially test more functionality than required by this certification criterion.
While we are not adopting the NCPDP SCRIPT Structured and Codified Sig Format v1.2 in its entirety, we agree with commenters on the potential benefits of a field that captures the reason for the prescription. This information has value for care coordination between prescribers, pharmacists, and care team members. NCPDP SCRIPT v10.6 supports the exchange of the reason for the prescription in a few ways, including (1) medication-associated diagnosis using diagnosis elements in the DRU (Drug Segment) and (2) medication indication using the indication elements in the SIG (Structured Sig Segment).
For the first method, NCPDP SCRIPT v10.6 supports use of ICD-9-CM codes or ICD- 10-CM codes with an additional qualifier. However, the standard does not permit the medication-associated diagnosis to be exchanged using SNOMED CT® codes until version 2013011 and later. We continue to support SNOMED CT® as the vocabulary code set for clinical diagnoses. Despite the limitation of NCPDP SCRIPT v10.6 regarding exchange of SNOMED CT® codes for medication-associated diagnoses, e-prescribing transactions that include the reason for the prescription support patient safety and align with initiatives underway at HHS.
The second method described above (medication indication using indication elements in the SIG) does support the use of SNOMED CT® vocabulary. In order to implement the indication elements in the SIG, developers would need to implement at least a subset of the structured and codified Sig format component composites that represent the most common Sig instructions as described in the SCRIPT Implementation Recommendations Version 1.29
Given the options discussed above, we have finalized a requirement that requires a Health IT Module to enable a user to receive and transmit the reason for the prescription using the diagnosis elements in the DRU Segment. This requirement would apply to the new, change request and response, cancel request and response, refill request and response, fill status, and medication history request and response NCPDP SCRIPT v10.6 transactions that we have required in this criterion (see discussion above). Again, we note that this requirement would only apply to the capability that a certified Health IT Module certified to this criterion has to demonstrate, not that a provider is required to populate the field for reason for the prescription when e-prescribing. For the first method described above, we note that with compliance deadline of October 1, 2015, for use of ICD-10-CM and the effective date of this final rule, we intend to test compliance with ICD-10-CM for the purposes of testing and certification under the ONC Health IT Certification Program.
We are also including an optional provision that would test a Health IT Module's ability to enable a user to receive and transmit the reason for the prescription using the indication elements in the SIG Segment for those developers that may have voluntarily chosen to implement the Structured and Codified Sig Format v1.2.
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In the Proposed Rule under the proposed 2015 Edition “transitions of care” certification criterion, we solicited comment on whether we should adopt and make available for testing and certification a separate certification criterion focused on the capability to create a summary record formatted to the C-CDA Release 2.0 with or without the ability to meet the requirements of the Common Clinical Data Set definition.
This new criterion would require a Health IT Module enable a user to create a transition of care/referral summary formatted in accordance with C-CDA Release 2.1 and that includes, at a minimum, the Common Clinical Data Set and patient matching data. For the same reasons described in the “ToC” certification criterion above, the patient match data represent a first step forward to improving the quality of data included in an outbound summary care record to improve patient matching. Please refer to our decision to adopt C-CDA Release 2.1 for all certification criteria that reference C-CDA standard creation in the 2015 Edition as described further in the preamble for the “ToC” certification criterion. Consistent with our decision for the “ToC,” “clinical information reconciliation and incorporation,” and “C-CDA creation performance” criteria described elsewhere in this section of the preamble, this certification criterion references the C-CDA Release 2.1 CCD, Referral Note, and (for inpatient settings only) Discharge Summary document templates for this certification criterion.
We have also included the encounter diagnoses (with either the September 2015 Release of the US Edition of SNOMED CT® or ICD-10 codes), cognitive status, functional status, reason for referral (ambulatory only), referring or transitioning provider's name and office contact information (ambulatory only), and discharge instructions (inpatient only) which are contained in the “transitions of care” criterion. This data has value for providing additional context and information for providers to make care decisions when receiving and sending transition of care/referral summary documents. As noted above, certain CMS programs have required or encouraged that this data be transmitted between care settings. Inclusion of this data will promote consistency for transitions of care across care settings and highlight ongoing efforts to develop standards for representing this data electronically.
In addition to adopting a new certification criterion for “Common Clinical Data Set summary record—create,” we have also adopted a complementary certification criterion focused on the receipt and proper processing of a transition of care/referral summary formatted to C-CDA and with the Common Clinical Data Set. Our goal is to ensure that when a C-CDA document is created consistent with the “Common Clinical Data Set summary record—create” certification criterion that the receiving system can properly process the information for informing care coordination. This has value for stakeholders such as providers who may be participating in other programs that require the use of the “Common Clinical Data Set summary record—create” functionality as well as registries that may be recipients of this information. As stated in the Federal Health IT Strategic Plan, core technical standards form the foundation for interoperability, and systems that send and receive information in these common standards will help ensure the meaning of information is consistently understood.
In order to ensure the receiving system correctly processes the C-CDA document, we will test that a system can properly validate the information in accordance with the same requirements of the “ToC” criterion (
Consistent with our decision for the “ToC” and “clinical information reconciliation and incorporation” certification criteria described above, we have required certification to the C-CDA Releases 1.1 and 2.1 CCD, Referral Note, and (for inpatient settings only) Discharge Summary document templates for this certification criterion. As previously discussed, while C-CDA Release 2.1 largely promotes compatibility with C-CDA Release 1.1, receiving systems may have to perform additional processing to ensure Release 1.1 conformance with Release 2.0. We have included a requirement that Health IT Modules be able to receive C-CDA documents with the encounter diagnoses (with either the September 2015 Release of the U.S. Edition of SNOMED CT® or ICD-10-CM codes), cognitive status, functional status, reason for referral (ambulatory only), referring or transitioning provider's name and office contact information (ambulatory only), and discharge instructions (inpatient only) for the same reasons we have included these data in the “Common Clinical Data Set summary record—create” criterion described above.
We have also included the “section views” capability from the “ToC” certification criterion to ensure that Health IT Modules certified to this certification criterion will be able to extract and allow for individual display each section (and the accompanying document header information (
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We proposed to adopt a 2015 Edition “data portability” certification criterion that was revised in comparison to the 2014 Edition “data portability” certification criterion (§ 170.314(b)(7)). Similar to the 2014 Edition version, we proposed to include the 2015 Edition “data portability” criterion in the Base EHR definition (
This certification criterion's purpose is to enable a user to export clinical data from health IT for one patient, a set of patients, or a subset of that set of patients. The functionality included in the criterion is intended to support a range of uses determined by a user and it was not our intention to prescribe or imply particular uses for this functionality. We also note that this functionality is not intended to and may not be sufficient to accomplish a full migration from one product to another without additional intervention because of the scope of this criterion. Specifically, the data and document templates specified in this criterion would not likely support a full migration, which could include administrative data such as billing information. The criterion's functionality could, however, support the migration of clinical data between health IT systems and can play a role in expediting such an activity if so determined by the user.
The “inpatient only” and “ambulatory only” portions of the criterion that require referral and discharge information, respectively, were part of the scope of 2014 Edition “data portability” certification criterion, are part of the transition of care criterion, and are also referenced in by the “VDT” criterion. As such, we see no compelling reason to change this criterion's scope and have adopted the criterion with these distinctions and data.
We have also not adopted the proposed time requirement that technology would need to include the ability to set a date at least three years into the past from the current date. We have determined that we could not properly test and certify to such a requirement. We acknowledge that some Health IT Modules presented for certification, particularly in 2016, will not have access to three or even one year's worth of patient health information that is conformant to the standards requirements of this criterion. A health IT developer's and Health IT Module's access to such health information, and the quality of such health information, will also likely vary considerably based on the customers (providers) it serves. This would further complicate testing and certification, and potentially place certain health IT developers and products at a disadvantage. Therefore, we have not adopted this proposed requirement.
We have finalized as part of this criterion a specific capability that expresses time-based configuration requirements. This first portion of this part of the criterion expresses that a user must be able to configure a time period within which data would be used to create export summaries, which must include the ability to express a start and end date range. The second portion of this part of the criterion expresses three time-based actions/configurations a user must be able to complete based on the date range they have specified. A user would need to be able to: (1) Create export summaries in real-time (
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We proposed to adopt two new 2015 Edition certification criteria referred to as “data segmentation for privacy (DS4P)-send” and data segmentation for privacy (DS4P)-receive.” These criteria were not proposed to be in scope for the EHR Incentive Programs. Rather, they were proposed to be available for health IT developers and other programs. The proposed certification criteria focused on technical capabilities to apply and recognize security labels (
We proposed to adopt the DS4P standard as outlined in the HL7 Version 3 Implementation Guide: DS4P, Release 1 (DS4P IG), Part 1: CDA R2 and Privacy Metadata.
Commenters that expressed opposition to the DS4P certification criteria and proposed standard stated that the standard was immature and not widely adopted. The commenters expressed concern that segmentation can lead to incomplete records and that receiving systems may not know how to handle the DS4P tagged data, which could lead to incomplete records that may subsequently contribute to patient safety issues. Several comments stated that DS4P has only been piloted with Part 2 data. One commenter requested clarification on how a sending system will know if a receiving system supports DS4P. Commenters also requested guidance on how to visualize in the system that data may be incomplete or what workflows should be used when segmented data is received. Several commentators requested that we consider the Integrating the Healthcare Enterprise (IHE) IT Infrastructure Technical Framework Volume 4—National Extensions—Section 3.1 Data Segmentation for Privacy (DS4P)
In reference to the DS4P standard's maturity, we note that it is considered a “normative” standard from the HL7 perspective—a status which requires substantially higher HL7 membership participation compared to a Draft Standard for Trial Use (DSTU) status. While we recognize that to date the standard has not been widely adopted, it has been used with Part 2 data and other sensitive health information by the Substance Abuse and Mental Health Services Administration (SAMHSA), the U.S. Department of Veterans Affairs (VA), and private companies.
In consideration of the comments we received and several of HHS' overarching policy goals (enabling interoperability, supporting delivery system reform, reducing health disparities, and supporting privacy compliance), we have adopted the proposed DS4P criteria. We note that these criteria are not part of the 2015 Edition Base EHR definition, are not required in the certification program policies for health IT developers to seek certification to, and are not required for providers to participate in the EHR Incentive Programs. As we have stated, DS4P enables sensitive health information to be exchanged electronically and we strongly encourage health IT developers to include DS4P functionality and pursue certification of their products to these criteria in order to help support their users' compliance with relevant state and federal privacy laws that protect sensitive health information.
We agree with commenters that we should explicitly state that document-level tagging is the scope required for certification and have made this modification to criteria. We have also clearly indicated in the DS4P-receive criterion that the ability to receive a summary record in accordance with the C-CDA R2.1 is required. This was inadvertently omitted from the criterion's proposed regulation text, but was referenced in the DS4P-send criterion.
In response to the broader comments that were critical of the notion of DS4P, we reiterate that DS4P is a technical standard that helps healthcare providers comply the laws applicable to them. As such, healthcare providers should already have processes and workflows to address their existing compliance obligations. The DS4P standard does not itself create incomplete records. Under existing law patients already have the right to prevent re-disclosure of certain types of data by withholding consent to its disclosure or to place restrictions on its re-disclosure. DS4P allows providers to tag data as sensitive and express re-disclosure restrictions and other obligations in an electronic form. DS4P does not determine whether a segmentation obligation exists legally or what that legal obligation means to the recipient. Instead, DS4P allows for tagging and exchange of health information that has already been determined to be sensitive and in need of special protections. In the absence of DS4P, this specially protected data may still be exchanged, if consent is given for disclosure, by fax or mail, but these methods may make the data unavailable in electronic form in the receiving provider's EHR.
We recognize that the current privacy law landscape is complex. Despite the
The current DS4P standard does not have a service discovery mechanism to determine if a potential recipient is able to receive a tagged document. We expect that providers will have to determine the receiving capabilities of their exchange partners, similar to how they have to work with their exchange partners today when they are manually exchanging sensitive health information via fax. Additionally, the DS4P standard contains a human-readable text block that will render in the recipients system—putting the human healthcare user on notice that they are viewing sensitive health information, allowing them to take appropriate actions in their system manually.
We are not aware of implementations that have used the IHE National Extensions for Data Segmentation for Privacy and do not agree with permitting it as an alternative approach to DS4P for the purposes of certification at this time.
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We proposed to adopt a new 2015 Edition certification criterion that would require a Health IT Module to enable a user to record, change, access, create and receive care plan information in accordance with the Care Plan document template in the HL7 Implementation Guide for CDA® Release 2: Consolidated CDA Templates for Clinical Notes.
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We proposed to adopt a 2015 Edition “clinical quality measures (CQM)—record and export” certification criterion that was revised in comparison to the 2014 Edition “CQM—capture and export” certification criterion (§ 170.314(c)(1)). In the Proposed Rule, we explained that we would align our use of the term “record” used in other 2014 and 2015 Edition certification criteria and proposed to call this certification criterion “CQM—record and export.” We proposed to require that a system user be able to export CQM data formatted to the Quality Reporting Document Architecture (QRDA) Category I standard at any time the user chooses for one or multiple patients and without subsequent developer assistance to operate. We also proposed to require that this certification criterion be part of the set of criteria necessary to satisfy the “2015 Edition Base EHR” definition (see also section III.B.1 of this preamble for a discussion of the 2015 Edition Base EHR definition). We solicited comment on the standard, including versions of QRDA Category I, we should adopt for this certification criterion with consideration given to where the industry may be with adoption of CQM and CDS standards over the next few years. In particular, we identified industry efforts to harmonize CQM and CDS standards. We asked for comment on the following version of QRDA or QRDA-like standards:
• HL7 Implementation Guide for CDA Release 2: Quality Reporting Document Architecture (QRDA), DSTU Release 2 (July 2012);
• HL7 Implementation Guide for CDA Release 2: Quality Reporting Document Architecture (QRDA), DSTU Release 2 (July 2012) and the September 2014 Errata; or
• A QRDA-like standard based on the anticipated Quality Improvement and Clinical Knowledge (QUICK) Fast Healthcare Interoperability Resources (FHIR)-based DSTU.
In asking for comment, we sought to understand the tradeoffs stakeholders perceive in adopting each standard considering that the EHR Incentive Programs Stage 3 proposed rule proposed that health IT certified to the 2015 Edition would not be required until January 1, 2018, but that EPs, eligible hospitals, and CAHs participating in the EHR Incentive Programs Stage 3 objectives and measures could upgrade to health IT certified to the 2015 Edition “CQM—record and export” certification criterion in 2017.
While commenters were supportive of the work and direction on harmonized CQM and CDS standards to produce an anticipated QUICK FHIR-based DSTU, all commenters noted that no such standard is currently available and that it is premature to require any such standard for the 2015 Edition. Many commenters stated that stakeholders are still in the process of implementing QRDA and that we should adopt an incremental version of QRDA rather than pivot to the QUICK standard at this time.
We agree with commenters that it is too early to adopt the QUICK CQM standards, but will continue to support the development and piloting of these harmonized CQM and CDS standards and reassess their appropriateness for certification at the time of a relevant future rulemaking.
As we discussed in the 2015 Edition proposed rule (80 FR 16843), our intent is for users of certified health IT to be able to export CQM data formatted to the QRDA Category I standard for one or more patients without needing to request support from a developer. Stakeholders have noted that some health IT certified to the 2014 Edition “CQMs—capture and export” criterion do not provide users the ability to export QRDA Category I files “on demand” and that users must submit requests for the health IT developer to assist or perform the export function on their behalf. For testing and certification to the 2015 Edition “CQM—record and export” criterion, we would expect demonstration that the Health IT Module enables the user to export CQM data formatted to the QRDA Category I standard for one or more patients without needing additional developer support. We believe that providers and health systems should determine the protocols around when and how providers export CQM data, and we do not address this issue as part of certification as it is outside the scope of the ONC Health IT Certification Program.
We previously described a “user” in the 2014 Edition final rule (77 FR 54168) and continue to use the same description for the 2015 Edition. We expect the functionalities of this criterion to be available to any user, but the specification or limitation of types of users for this functionality is outside the scope of certification to this criterion. Providers have the discretion to determine the protocols for when and which users should use this functionality.
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We proposed to adopt a 2015 Edition “clinical quality measures (CQM)—import and calculate” certification criterion that was revised in comparison to the 2014 Edition “CQM—import and calculate” certification criterion (§ 170.314(c)(2)). We proposed to require that a system user be able to import CQM data formatted to the QRDA standard for one or multiple patients at any time the user chooses and without additional assistance to operate. We proposed to no longer include an exemption that would allow a Health IT Module presented for certification to § 170.315(c)(1), (c)(2), and (c)(3) to not demonstrate the data import capability. Rather, we proposed that a Health IT Module would be required to demonstrate that it could import data in order to be certified to this certification criterion even if it is also certified to provide “record and export” and “electronic submission/report” functions. We solicited comment on the version of QRDA or QRDA-like standards for individual patient-level CQM reports we should adopt for this certification criterion.
We stated that we intend testing to the 2015 Edition “CQM—import and calculate” certification criterion to include the import of a larger number of test records compared to testing for the 2014 Edition and to automatically de-duplicate records for accurate CQM calculation. We requested comment on this intent and the number of test records we should consider testing a Health IT Module for performing import and calculate functions.
As we discussed in the 2015 Edition proposed rule (80 FR 16843), our intent is for users of certified health IT to be able to import CQM data formatted to the QRDA Category I standard for one or more patients without needing to request support from a developer. Stakeholders have noted that some health IT certified to the 2014 Edition “CQMs—import and calculate” criterion do not provide users to import QRDA Category I files “on demand” and that users must submit requests for the developer to assist or perform the import function on their behalf. For testing and certification to the 2015 Edition “CQM—import and calculate” criterion, we would expect demonstration that the Health IT Module enables the user to import CQM data formatted to the QRDA Category I standard for one or more patients without needing additional developer support. We believe that providers and health systems should determine the protocols around when and how providers import CQM data, and we do not address this issue as part of certification as it is outside the scope of the ONC Health IT Certification Program.
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In the Proposed Rule, we stated that we intend to better align with the reporting requirements of other CMS programs, and thus, would propose certification policy for reporting of CQMs in or with annual PQRS and/or Hospital IQR program rulemaking anticipated in CY 2015. We explained that we anticipated proposing standards for reporting of CQMs that reflect CMS' requirements for the “form and manner” of CQM reporting (
We subsequently proposed a 2015 Edition “CQMs—report” certification criterion in the 2016 IPPS/LTCH PPS proposed rule that would require a Health IT Module to enable a user to electronically create a data file for transmission of clinical quality measurement data using the “base” (
As detailed in the FY 2016 IPPS/LTCH PPS proposed rule, we solicited comment on the appropriate versions of the Quality Reporting Document Architecture—Category I (individual patient level quality reports) and Category III (aggregate level quality reports) standards that should be adopted. In order to give full consideration to the comments received on the appropriate versions of the standards we should adopt, we did not adopt a “CQMs-report” certification criterion in the 2016 IPPS/LTCH PPS final rule (80 FR 49760). We stated that we anticipate adopting both the certification criterion and the appropriate versions of the standards in a subsequent final rule later this year. We also noted we intended to address comments received on both the proposed “CQMs-report” certification criterion and the versions of the standards in that same rule. We have used this final rule to address the comments and adopt the criterion and standards as specified below.
Our adoption of an optional provision to certify CQM reporting in the form and manner of CMS submission allows CMS to determine as part of its program requirements whether this optional provision of the CQM reporting criterion is required for participation in certain CMS programs. For example, CMS has proposed to revise the CEHRT definition to require health IT be certified to the provision of the “CQMs—report” criterion we have deemed optional (80 FR 41880-41881), which would affect, at a minimum, providers participating in the EHR Incentive Programs.
We agree with the comments supporting the adoption of Release 3 of the QRDA Category I IG as the IG will improve eCQM processing and reduce errors. The IG will also better align with the C-CDA Release 2.1 for purposes of interoperability as compared to QRDA Category I Release 2 with the 2014 Errata. Further, Release 3 of the QRDA Category I IG also aligns with the CMS 2015 update to eCQM measures for 2016 e-reporting (
We agree with commenters that it is too early to adopt the QUICK CQM standards, but will continue to support the development and piloting of these harmonized CQM and CDS standards and reassess their appropriateness for certification at the time of a relevant future rulemaking.
In sum, after consideration of public comments, we have adopted a 2015 Edition “CQMs—report” criterion that requires a Health IT Module to enable a user to (electronically) create a data file for transmission of CQM data in accordance with:
• HL7 CDA® R2 Implementation Guide: Quality Reporting Document Architecture—Category I (QRDA I); Release 1, DSTU Release 3 (US Realm) (both Volumes 1 and 2); and
• HL7 Implementation Guide for CDA® Release 2: Quality Reporting Document Architecture—Category III, DSTU Release 1 (US Realm) with September 2014 Errata.
All Health IT Modules must certify to the above standards to meet the criterion. As noted above, the criterion also includes an optional provision that requires the electronic creation of a data file for transmission of CQM data that can be electronically accepted by CMS (
In order to accommodate the new QRDA standards in the regulation text, we have revised the paragraph levels at § 170.205(h) and (k) to move the QRDA standards adopted in the 2014 Edition to § 170.205(h)(1) and (k)(1) respectively. We have also made a technical amendment to the regulation text for the 2014 Edition certification criteria for capturing, calculating, and reporting CQMs (at 45 CFR 170.314(c)(1), (c)(2), and (c)(3), respectively) to continue to reference the appropriate implementation specifications.
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We proposed to adopt a new 2015 Edition certification criterion that would require health IT to be able to record data (according to specified standards, where applicable) and filter CQM results at both patient and aggregate levels. We listed proposed data elements and vocabulary standards for some data elements to maintain consistency in the use of adopted national standards, and we clarified that a Health IT Module must be able to filter by any combination of the proposed data elements (
• HL7 CDA® R2 Implementation Guide: Quality Reporting Document Architecture—Category I (QRDA I); Release 1, DSTU Release 3 (US Realm) (both Volumes 1 and 2); and
• HL7 Implementation Guide for CDA® Release 2: Quality Reporting Document Architecture—Category III, DSTU Release 1 (US Realm) with September 2014 Errata.
Testing and validation to the HL7 postal format in the QRDA standard is already available as part of Cypress testing
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We proposed to adopt a 2015 Edition “authentication, access control, and authorization” certification criterion that was unchanged in comparison to the 2014 Edition “authentication, access control, and authorization” criterion (§ 170.314(d)(1)).
In response to comments on multi-factor authentication, we have not adopted multi-factor authentication as part of this criterion or in another criterion or requirement as we did not propose such functionality. We will, however, continue to track NSTIC. We will also monitor industry progress with multi-factor authentication and may consider multi-factor authentication certification for a future rulemaking as noted in our discussion of the HITSC recommendations below.
Digital signatures were proposed as part of the “electronic submission of medical documentation” criterion, but were not proposed as part of this criterion. Accordingly, we have not adopted such a requirement as part of this criterion. We may, however, consider digital signatures as part of a future rulemaking.
We received recommendations from the HITSC after the close of the public comment period for the Proposed Rule. The HITSC recommended the adoption of a certification criterion that would include capabilities to “continuously protect the integrity and confidentiality of information used to authenticate users.” The HITSC stated that the adoption of such a criterion would strengthen the authentication capabilities in currently certified health IT. The HITSC also recommended the adoption of a certification criterion for multi-factor authentication. These recommendations for the adoption of certification criteria must proceed through the processes outlined in sections 3001 and 3004 of the Public Health Service Act (HITECH Act), which may lead to a future rulemaking proposing the adoption of criteria that include capabilities recommended by the HITSC.
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We proposed to adopt a 2015 Edition “auditable events and tamper-resistance” certification criterion that was unchanged in comparison to the 2014 Edition “auditable events and tamper-resistance” criterion (§ 170.314(d)(2)) and sought comment on two issues. First, given that it does not appear that the ASTM standard indicates recording an event when an individual's user privileges are changed, we asked for comment on whether we need to explicitly modify/add to the overall auditing standard adopted in 170.210(e) to require such information to be audited or if this type of event is already audited at the point of authentication (
Most commenters, including the HITSC TSSWG, recommended that there should be no change in the requirements related to disabling and enabling the audit log. A commenter noted that determining when the audit log should or should not be enabled is best defined by end-users of Health IT Modules and not the health IT developers. Commenters representing consumer organizations suggested that the audit log should not be able to be disabled, which they argued would enhance consumer trust. Another commenter stated that any allowance for disabling the audit logs, for any reason, compromises the integrity of the auditing.
Commenters did not identify a critical subset of those auditable events that we should require remain enabled at all times. However, one commenter suggested that as an alternative to requiring the audit log to always be enabled, we should provide regulatory guidance on the specific information to be included in the audit log, such as is stipulated in the ASTM E2147 standard. The commenter also recommended that we provide clarity on the scope of the applicability of the ASTM standard as a part of that guidance when it comes to whether the intent is to include only natural person/end user accesses or other access such as “machine to machine.”
We did not receive an overwhelming response or rationale from commenters that convinced us to change our approach to require that a Health IT Module not permit an audit log to be disabled. In fact, comments remained mixed and the HITSC continued to support our current approach. As recited in the Proposed Rule, there are valid reasons for disabling the audit log. We continue to believe that it is appropriate to restrict the ability to disable the audit log to a limited set of users, which permits the end user to determine if, when, and by whom the audit log may be disabled. As to the alternative approach to always enabling the audit log, we note that we have chosen to maintain the current approach, but will consider as part of the finalizing of the 2015 Edition test procedure for this criterion what additional guidance we can provide related to auditable actions consistent with the ASTM E2147 standard.
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We proposed to adopt a 2015 Edition “audit reports(s)” certification criterion that was unchanged in comparison to the 2014 Edition “audit reports(s)” criterion (§ 170.314(d)(3)).
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We proposed to adopt a 2015 Edition “amendments” certification criterion that was unchanged in comparison to the 2014 Edition “amendments” criterion (§ 170.314(d)(4)). We noted that this certification criterion only partially addresses the amendment of protected health information (PHI) requirements of 45 CFR 164.526.
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We proposed to adopt a 2015 Edition “automatic access time-out” certification criterion that was unchanged in comparison to the 2014 Edition “automatic log-off” criterion (§ 170.314(d)(5)). In terms of the functionality within the criterion, we proposed to restate the language to require a Health IT Module to demonstrate that it can automatically stop user access to health information after a predetermined period of inactivity and require user authentication in order to resume or regain the access that was stopped. This proposal was based on feedback previously received from the HITSC Privacy and Security Workgroup (PSWG).
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We proposed to adopt a 2015 Edition “emergency access” certification criterion that was unchanged in comparison to the 2014 Edition “emergency access” criterion (§ 170.314(d)(6)).
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We proposed to adopt a 2015 Edition “end-user device encryption” certification criterion that was unchanged in comparison to the 2014 Edition “end-user device encryption” criterion (§ 170.314(d)(7)). We proposed to require certification to this criterion consistent with the most recent version of Annex A: Approved Security Functions (Draft, October 8, 2014) for Federal Information Processing Standards (FIPS) Publication 140-2.
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We proposed to adopt a 2015 Edition “integrity” certification criterion that was unchanged in comparison to the 2014 Edition “integrity” criterion (§ 170.314(d)(8)). We did, however, propose a change in how a Health IT Module would be tested and certified to this criterion. We explained that the 2015 Edition “integrity” criterion would be tested and certified to support the context for which it was adopted—upon receipt of a summary record in order to ensure the integrity of the information exchanged (see § 170.315(d)(8)(ii)). Therefore, we stated that we expect that this certification criterion would most frequently be paired with the “ToC” certification criterion for testing and certification.
We sought comment on if, and when, we should set the baseline for certification to the 2015 Edition “integrity” certification criterion at SHA-2.
Consistent with this decision, we have also updated this criterion and standard to reference the most recent version of FIPS PUB 180-4, Secure Hash Standard, 180-4 (August 2015).
Please see the discussion under the “Application Access To Common Clinical Data Set” certification criteria later in this section of the preamble.
Please see the discussion under the “Application Access To Common Clinical Data Set” certification criteria later in this section of the preamble.
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We proposed to adopt a 2015 Edition “accounting of disclosures” certification criterion that was unchanged in comparison to the 2014 Edition “accounting of disclosures” criterion (§ 170.314(d)(9)). We noted that the 2015 Edition criterion is no longer designated “optional” because such a designation is no longer necessary given that we have discontinued the Complete EHR definition and Complete EHR certification beginning with the 2015 Edition certification criteria.
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We proposed to adopt a 2015 Edition “view, download, and transmit to 3rd party” (VDT) criterion that was revised in comparison to the 2014 Edition “VDT” criterion (§ 170.314(e)(1)).
We proposed to revise the introductory text to lead with “Patients (and their authorized representatives) must be able to use health IT to . . .” We also proposed to use this same phrase at the beginning of each specific capability for VDT to reinforce this point. We noted that this does not override or substitute for an individual's right to access protected health information (PHI) in a designated record set under 45 CFR 164.524.
Additionally, consistent with our certification program approach to apply particular privacy and security certification criteria to a product's certification based on the scope of capabilities presented, we have determined that this certification criterion would be clearer and more focused if we were to remove the secure access language included in (e)(1)(i) in favor of having a specific privacy and security certification criterion that would be applicable to this criterion. In transitioning this text, we have also made a conforming revision to note that the “technology” used would need to be “internet-based” which we believe is a more generally applicable and innovation supportive term compared to the user of the word “online,” which was part of the sentence that included the security specific language that we have removed.
We proposed to reference the updated version of the C-CDA (Draft Standard for Trial Use, Release 2.0) for the “VDT” criterion and noted that compliance with Release 2.0 cannot include the use of the “unstructured document” document-level template for certification to this criterion. We also solicited comment on whether we should limit the scope of the C-CDA
We have included an updated Common Clinical Data Set for the 2015 Edition that includes references to new and updated vocabulary standards code sets. Please also see the Common Clinical Data Set definition in section III.B.3 of this preamble.
In consideration of public comments that focused on our comment solicitation around the addition of date and time filtering capabilities, we have decided to adopt such requirements as part of this criterion. We believe that adding this explicit functionality to the certification criterion provides specific clarity that patients should have certain baseline capabilities available to them when it comes to selecting the data (or range of data) they wish to view, download, or transmit. Specifically, we have adopted within this criterion two timeframe filters that patients must be able to select and configure on their own. The first would ensure that a patient can select data associated with a specific date (to be viewed, downloaded, or transmitted) and the second would ensure that the patient could select data within an identified date range (to be viewed, downloaded, or transmitted), which must be able to accommodate the patient selecting a range that includes all data available to them. We also clarify that we are not including the ability to select a specific data element category as part of this requirement, but reiterate that these requirements represent a floor rather than a ceiling, and health IT developers may choose to add other functionalities as appropriate. The technology specifications should be designed and implemented in such a way as to provide maximum clarity to a patient (and their authorized representative) about what data exists in the system and how to interpret it, and we expect that health IT developers will make choices following design and usability best practices that will make it easier and clearer for patients to find and use their records.
We proposed to require that a Health IT Module would need to demonstrate that it can make diagnostic image reports available to the patient in order to be certified. We explained that a diagnostic image report contains a consulting specialist's interpretation of image data, that it is intended to convey the interpretation to the referring (ordering) physician, and that it becomes part of the patient's medical record.
We have addressed all comments on this proposed provision under the “Application Access to Common Clinical Data Set” in this section of the preamble.
We proposed to include “addressee” as a new data element in the 2015 Edition “VDT” criterion related to the activity history log. In the Proposed Rule, we noted that this transactional history is important for patients to be able to access, especially if a patient actively transmits his or her health information to a 3rd party or another health care provider.
In the Proposed Rule, we noted recent regulatory changes addressing the intersection of the CLIA rules, state laws governing direct patient access to their laboratory test reports, and the HIPAA Privacy Rule. These regulatory changes converged in a final rule that permits a patient, or his or her “personal representative,” as applicable, to request a copy of the patient's completed test reports directly from the laboratory or to request that the test results be transmitted to a designated person. To ensure fidelity of such reports regardless of the system delivering laboratory results to a patient, we proposed that a Health IT Module presented for certification to this criterion must demonstrate that it can provide laboratory test reports that include the information for a test report specified in 42 CFR 493.1291(c)(1) through (7); the information related to reference intervals or normal values as specified in 42 CFR 493.1291(d); and the information for corrected reports as specified in 42 CFR 493.1291(k)(2).
We proposed to modify the regulatory text hierarchy at § 170.204(a) to designate the WCAG 2.0 Level A (Level A) conformance at § 170.204(a)(1) instead of § 170.204(a). This would also require the 2014 Edition “VDT” certification criterion to be revised to correctly reference § 170.204(a)(1). We also sought comment on whether we should adopt WCAG 2.0 Level AA (Level AA) conformance requirements for the “view” capability included in the 2015 Edition VDT criterion, instead of the current Level A.
We requested comment on (1) whether we should include the Direct Project's Implementation Guide for Direct Project Trust Bundle Distribution specification as part of certification for the “VDT” certification criterion; and (2) whether any additional requirements are needed to support scalable trust between Security/Trust Agents (STAs) as well as ways in which we, in collaboration with other industry stakeholders, could support or help coordinate a way to bridge any gaps.
(1) Email transmission (of a CCD) to any email address;
(2) An encrypted method of electronic transmission.
This approach will provide patients with a readily understood and convenient option to simply send their health information via email. Patients, under current HIPAA regulations,
In adding flexibility to this portion of the certification criterion, the other proposals and topics on which we sought comment are moot. However, we wish to reiterate that for the purposes of meeting the second form of transmission, the Direct protocol is an encouraged and viable method, especially since health IT developers have already been certified to this functionality for the purposes of 2014 Edition certification, and will also be
We refer readers to our response to this request for comment under the “ToC” criterion.
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We proposed to adopt a 2015 Edition “secure messaging” certification criterion that was unchanged in comparison to the 2014 Edition “secure messaging” criterion (§ 170.314(e)(3)).
This criterion is no longer eligible for gap certification as the new hashing standard (a hashing algorithm with a security strength equal to or greater than SHA-2) applies to this criterion.
We appreciate the suggested additional functionalities for inclusion in this criterion (tracking responses, use of languages beyond English, and other forms of communication, and preloaded trust bundles), but the functionalities are beyond the scope of our proposal. We will consider these additional functionalities for a future edition of this criterion. We clarify in this final rule that the encryption requirements only apply to the message content and not to patients' devices.
We cannot prescribe the fees health IT developers charge for their certified health IT, but note that our transparency provisions (§ 170.523(k)) require ONC-ACBs to ensure that health IT developers make public the types of costs they charge to enable certified health IT. ONC-ACBs also conduct surveillance of certified health IT under the ONC Health IT Certification Program to ensure that health IT continues to function as initially certified. Surveillance can be initiated randomly or in response to complaints.
For concerns and questions related to the EHR Incentive Programs, we refer readers to CMS and the EHR Incentive Programs Stage 3 and Modifications final rule published elsewhere in this issue of the
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In following the HITSC recommendation for Health IT Module functionality to store an advance directive and/or include more information about the advance directive, we proposed a 2015 Edition “patient health information capture” certification criterion that would “replace” the 2014 Edition “advance directives” certification criterion (§ 170.314(a)(17)) and apply to various patient health information documents. We stated that a Health IT Module would need to enable a user to: (1) Identify (
We received general comments and comments on each of the capabilities included in the proposed criterion. We have divided and responded to the comments in a similar manner.
This criterion is subject to the 2015 Edition privacy and security (P&S) certification framework adopted in this final rule. In this regard, a Health IT Module certified to this criterion would also need to be certified to the P&S certification criteria in § 170.315(d)(1) (authentication, access control, and authorization), (d)(2) (auditable events and tamper resistance), (d)(3) (audit reports), (d)(4) (amendments), (d)(5) (automatic log-off), and (d)(9) (trusted connection).
This criterion was specifically included in the CEHRT definition to ensure, at a minimum, providers participating in the EHR Incentive Programs had this capability. While it could potentially be used to support the Stage 3 objective and measure regarding patient-generated health data, it was not proposed with the intention of it being the only means available for meeting the Stage 3 objective and measure. Rather, the goal was to set a foundation for accepting information directly from patients.
We do not seek to define the types of health information that could be accepted as we believe this should be as broad as possible. The types of health information could be documents as described in the Proposed Rule (
We have determined that it is most appropriate to keep all the functionality in one criterion and combine capabilities as noted above. We emphasize that it is always possible to have multiple technologies certified together as a one “Health IT Module” to meet this criterion.
We note that we intend for “patient” to be interpreted broadly to include an authorized representative. For clarity, we have specified this intent in regulation.
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We proposed to adopt a 2015 Edition “transmission to immunization registries” certification criterion that was revised in comparison to the 2014 Edition “transmission to immunization registries” criterion (§ 170.314(f)(2)). To note, we have structured the comments we received and our responses based on the specific proposed provisions of this criterion.
We proposed to adopt the CDC's updated implementation guide for immunization messaging, HL7 Version 2.5.1: Implementation Guide for Immunization Messaging, Release 1.5 (October 2014) (“Release 1.5”). We explained that the updated IG promotes greater interoperability between immunization registries and health IT systems, addresses issues from the previous release, and revises certain HL7 message elements to reduce data element recording differences between states and public health jurisdictions.
We proposed to require for certification that a Health IT Module be able to electronically create immunization information for electronic transmission to immunization registries using NDC codes for vaccines administered (
We solicited comment on whether we should allow use of NDC codes for administered vaccines as an option for certification, but continue to require CVX codes for administered vaccines for the 2015 Edition. We also solicited comment on whether we should require CVX plus the HL7 Standard Code Set MVX—Manufacturers of Vaccines Code Set (October 30, 2014 version)
Some commenters suggested that mapping NDC codes to CVX could be burdensome for health IT developers and immunization registries, especially for a multiple component vaccine. Commenters noted that NDC codes are subject to change and codes are added and changed more frequently than CVX and MVX codes. Commenters further noted that the reuse of NDC codes by FDA can present difficulties regarding the transmission of immunization data using such codes. One commenter requested clarification on when NDC and CVX codes are required and noted the importance of clear requirements by states when NDC, CVX, or both codes would be needed.
We proposed that a Health IT Module would need to enable a user to request, access, and display a patient's immunization history and forecast from an immunization registry in accordance with Release 1.5. We requested comment on whether we should include an immunization history information reconciliation capability in this criterion and the factors we should consider regarding the reconciliation of immunization history information. We explained that we believe that bidirectional exchange between health IT and immunization registries is important for patient safety and improved care. Immunization registries can provide information on a patient's immunization history to complement the data in the health IT system. We noted that immunization registries also provide immunization forecasting recommendations according to the Advisory Committee on Immunization Practices (ACIP)'s recommendations. This information allows for the provider to access the most complete and up-to-date information on a patient's immunization history to inform discussions about what vaccines a patient may need based on nationally recommended immunization recommendations.
Many commenters also expressed concern regarding reconciliation of forecasting data. One commenter noted that we should permit innovation to occur by not prescribing the workflows related to reconciliation. Another commenter noted that where bi-directional exchange is already in production, several different workflows exist within health IT products for reconciliation of immunization history.
Commenters expressed support for vaccine forecasting, but many commenters also stated that incorporating a forecast from an immunization registry into a health IT system could be difficult. Other commenters noted that some products already have forecasting functions, such as CDS functions for forecasting immunizations and, by association with forecasting, more complete data for allergies and contraindications.
While we agree with commenters that some health IT (
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We proposed to adopt a 2015 Edition certification criterion for transmission of syndromic surveillance to public health agencies that was revised in comparison to the 2014 Edition version (§ 170.314(f)(3)) for the inpatient setting. We noted, however, that this proposed certification criterion is unchanged (for the purposes of gap certification) for the ambulatory setting. Given the varied adoption of methods for transmitting syndromic surveillance information to public health agencies from ambulatory settings, we proposed to continue to distinguish between ambulatory and emergency department, urgent care, and inpatient settings.
We proposed to adopt the PHIN Messaging Guide for Syndromic Surveillance: Emergency Department, Urgent Care, Inpatient and Ambulatory Care Settings, Release 2.0, September 2014 (“Release 2.0”), due to its improvements over previous versions.
We believe that the additional IG requirements for laboratory information are critical for public health as not all laboratory information is reportable to public health through electronic laboratory reporting. These additional data elements enable public health jurisdictions to monitor the nation's public health. We also clarify that the aggregated OMB value sets for race and ethnicity are acceptable within Release 2.0. We decline to make the optional elements of the IG required for certification as we believe that certification to the IG as published appropriately supports the use case. We also note that any IG instructions regarding the frequency of submission are outside the scope of certification as certification focuses on the technical capabilities of the Health IT Module presented for certification.
We proposed to permit, for ambulatory setting certification, the use of any electronic means for sending syndromic surveillance data to public health agencies as well as optional certification to certain syndromic surveillance data elements. Due to the continued lack of mature IGs, we proposed to provide the option for health IT to electronically produce syndromic surveillance information that contains patient demographics, provider specialty, provider address, problem list, vital signs, laboratory results, procedures, medications, and insurance.
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We proposed to adopt a 2015 Edition certification criterion that was revised in comparison to the 2014 Edition “transmission of reportable laboratory tests and values/results” criterion (§ 170.314(f)(4)). We proposed to name this criterion “transmission to public health agencies—reportable laboratory tests and values/results” to clearly convey the capabilities included in this criterion as they relate to the intended recipient of the data. We proposed to include and adopt an updated IG, the HL7 Version 2.5.1 Implementation Guide: Electronic Laboratory Reporting to Public Health, Release 2 (US Realm), DSTU R1.1, 2014 or “Release 2, DSTU R1.1”) that addresses technical corrections and clarifications for interoperability with laboratory orders and other laboratory domain implementation guides. Given the improvements included in the updated IG (Release 2, DSTU R1.1), we proposed to adopt it at § 170.205(g)(2) and include it in the 2015 Edition “transmission of reportable laboratory tests and values/results” certification criterion at § 170.315(f)(3). We also proposed the September 2014 Release of the U.S. Edition of SNOMED CT® and LOINC® version 2.50. We also proposed to make a technical amendment to the regulation text for the 2014 Edition criterion in order to have it continue to reference the appropriate standard and implementation specifications
We have adopted a 2015 Edition “transmission to public health agencies—reportable laboratory tests and values/results” certification criterion that requires adherence to the same standards as we referenced in the 2014 Edition “transmission of reportable laboratory tests and values/results” criterion. Data from CDC and CMS indicates that over 80% of hospitals are already in the process of submitting electronic laboratory results using the previously adopted standards (HL7 Version 2.5.1 Implementation Guide: Electronic Laboratory Reporting to Public Health, Release 1 with Errata and Clarifications, ELR 2.5.1 Clarification Document for EHR Technology Certification, and versions of SNOMED CT® and LOINC®). Our decision to adopt these same standards for the 2015 Edition criterion will ensure continuity in reporting and reduce burden for providers as well as health IT developers as this criterion is eligible for gap certification. We will continue to monitor the development of the updated IG and may consider proposing it for adoption through a future rulemaking to give health IT developers and providers another option to meet EHR Incentive Programs requirements for use of certified health IT to meet public health objectives and measures.
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We proposed to adopt a 2015 Edition “transmission to cancer registries” certification criterion that was revised in comparison to the 2014 Edition “transmission to cancer registries” certification criterion (§ 170.314(f)(6)). We proposed to adopt the HL7 Implementation Guide for CDA
We have adopted this criterion with the updated IG, Release 1.1 (both Volumes 1 and 2). Commenters were supportive of our overall proposed approach and the proposed IG. As detailed above, Release 1.1 addresses errors, ambiguities, implementation issues, and commenters' concerns. Therefore, the adoption of Release 1.1 will lead to improved implementation and interoperability.
Mapping to the NAACCR format is not included in the IG because the mapping rules are complex, and can change over time based on continued input and refinement by the cancer registry community. It is our understanding that the
We have adopted a newer baseline versions of SNOMED CT® (September 2015 Release of the U.S. Edition) and LOINC® (version 2.52) for the purposes of certification. We refer readers to section III.A.2.c (“Minimum Standards” Code Sets) for further discussion of our adoption of minimum standards code sets and our decision to adopt these versions.
We did not propose a “cancer case information” criterion as part of the 2015 Edition (80 FR 16854-855), but welcomed comments on this approach.
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We proposed to adopt a new 2015 Edition “transmission to public health agencies—case reporting” certification criterion, which would support the electronic transmission of case reporting information to public health agencies. We proposed to require a Health IT Module to be able to electronically create case reporting information for electronic transmission in accordance with the IHE Quality, Research, and Public Health Technical Framework Supplement, Structured Data Capture, Trial Implementation (September 5, 2014) standard. We noted that a Health IT Module would need to demonstrate that it can create and send a constrained transition of care document to a public health agency, accept a URL in return, be able to direct end users to the URL, and adhere to the security requirements for the transmission of this information.
In addition, we requested comment on whether we should consider adopting the HL7 FHIR Implementation Guide: SDC DSTU that would be balloted in mid-2015 in place of, or together with, the IHE Quality, Research, and Public Health Technical Framework Supplement.
We understand the industry is moving towards RESTful approaches and considering FHIR for different exchange patterns, including case reporting. To accommodate this evolution, we have not adopted the proposed IHE profile as part of this certification criterion or another exchange standard. We understand that there are certain functional requirements that a Health IT Module would need to support to enable electronic case reporting. Specifically, a Health IT Module would need to support the ability to electronically: (1) Consume and maintain a table of trigger codes to determine which encounters should initiate an initial case report being sent to public health; (2) when a trigger is matched, create and send an initial case report to public health; (3) receive and display additional information, such as a “notice of reportability” and data fields to be completed; and (4) submit a completed form.
Public health agencies have, however, prioritized receiving the initial electronic case report form, while building the infrastructure to request supplemental data over time. Given the priority to receive the initial case report form, we have adopted the following functionality that supports the first two identified steps above. To meet this certification criterion, a Health IT Module must be able to (1) consume and maintain a table of trigger codes to determine which encounters should initiate an initial case report being sent to public health to determine reportability; and (2) when a trigger is matched, create an initial case report that includes specific data (Common Clinical Data Set; encounter diagnoses; provider name, office contact information, and reason for visit, and an identifier representing the row and version of the trigger table that triggered the case report).
The CCD template of the C-CDA Release 2.1 is currently the most viable approach for achieving step (2) above. We note, however, that the CDC and CSTE, with the HL7 Public Health and Emergency Response Working Group, are currently developing C-CDA and FHIR IGs to specify the data needed in the initial case report form and the data that would be provided in the information returned to the provider. As standards evolve, additional/supplemental data would likely be requested electronically about cases for which public health has received an initial case report that is deemed reportable. To support this additional data reporting, the future might include a FHIR-based approach that could utilize the FHIR Structured Data Capture (SDC) IG. Therefore, we believe this overall initial certification approach establishes necessary flexibility within the ONC Health IT Certification Program related to electronic case reporting in that as technical approaches evolve to accomplish electronic case reporting they can be certified. In the future, we may be able to consider a specific standard for certification through rulemaking.
We note that we have inserted “electronic” in the criterion name to emphasize the evolution of case reporting and the importance of
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We proposed to adopt a new 2015 Edition certification criterion that would require a Health IT Module to be able to electronically create antimicrobial use and resistance reporting information for electronic transmission in accordance with specific sections of the HL7 Implementation Guide for CDA® Release 2—Level 3: Healthcare Associated Infection Reports, Release 1, U.S. Realm (August 2013) (“HAI IG”). We explained that collection and analysis of data on antimicrobial use and antimicrobial resistance are important components of antimicrobial stewardship programs throughout the nation and electronic submission of antimicrobial use and antimicrobial resistance data to a public health registry can promote timely, accurate, and complete reporting, particularly if data is extracted from health IT systems and delivered using well established data exchange standards to a public health registry.
We proposed to test and certify a Health IT Module for conformance with the following sections of the IG in § 170.205(r)(1): HAI Antimicrobial Use and Resistance (AUR) Antimicrobial Resistance Option (ARO) Report (Numerator) specific document template in Section 2.1.2.1 (pages 69-72); Antimicrobial Resistance Option (ARO) Summary Report (Denominator) specific document template in Section 2.1.1.1 (pages 54-56); and Antimicrobial Use (AUP) Summary Report (Numerator and Denominator) specific document template in Section 2.1.1.2 (pages 56-58). We explained that we would expect a Health IT Module presented for certification to this criterion to conform to all named constraints within the specified document template.
A commenter expressed concern about the pace and volume of changes between versions of the standard, the burden on health IT developers related to the timing of deployments, and that NHSN does not accept data submitted using prior versions. Another commenter expressed concern about state variations that are not addressed by this criterion, suggesting that the criterion and standard not be adopted until at least 75% of public health agencies are committed to adopting this standard.
A commenter stated that there were inconsistences in the EHR Incentive Programs Stage 3 proposed rule related to this criterion regarding the standards available as well as a reference to meeting the measure four times. Another commenter suggested that the associated proposed measure under Stage 3 should be limited to eligible hospitals and CAHs (not EPs).
For concerns and questions related to the EHR Incentive Programs, we refer readers to CMS and the EHR Incentive Programs Stage 3 and Modifications final rule published elsewhere in this issue of the
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We proposed to adopt a new 2015 Edition certification criterion for transmission of health care surveys to public health agencies that would require a Health IT Module to be able to create health care survey information for electronic transmission in accordance with the HL7 Implementation Guide for CDA® Release 2: National Health Care Surveys (NHCS), Release 1—US Realm, Draft Standard for Trial Use (December 2014).
A commenter requested information on the number of public health agencies that can electronically accept data in accordance with the IG.
We clarify that, as proposed, certification would cover the entire NHCS IG. The NHCS IG consists of the National Hospital Care Survey, NHAMCS, and NAMCS. In the Proposed Rule, we focused on clarifying that the NHAMCS and NAMCS were included in the IG and the changes in the surveys as compared to past versions. However, all three surveys are covered by the NHCS IG and will be covered as part of testing and certification.
All public health agencies may not be able to receive this data electronically and that variability across jurisdictions could be problematic. However, this data will only be collected by the CDC at the national level. The CDC is the only public health agency that needs to be able to receive these surveys electronically, which it is capable of doing. The use of a national interface for receipt avoids the problems associated with jurisdictional variation.
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We proposed to adopt a 2015 Edition “automated numerator recording” certification criterion that was unchanged in comparison to the 2014 Edition “automated numerator recording” criterion. We noted that the test procedure for this criterion would be different from the 2014 Edition “automated numerator recording” certification criterion in order to remain consistent with the applicable objectives and measures required under the EHR Incentive Programs.
We have changed the term “meaningful use” to “EHR Incentive Programs” and removed “objective with a” in the first sentence of the criterion to more clearly align with the terminology and framework used under the EHR Incentive Programs.
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We proposed to adopt a 2015 Edition “automated measure calculation” certification criterion that was unchanged in comparison to the 2014 Edition “automated measure calculation” criterion. We proposed to apply the guidance provided for the 2014 Edition “automated measure calculation” certification criterion in the 2014 Edition final rule that a Health IT Module must be able to support all CMS-acceptable approaches for measuring a numerator and denominator in order for the Health IT Module to meet the proposed 2015 Edition “automated measure calculation” certification criterion.
Commenters were generally supportive of applying the guidance provided in the 2014 Edition final rule (77 FR 54244-54245) and the guidance in FAQ 32 to the 2015 Edition criterion. One commenter suggested that this criterion should be gap certification eligible if the associated EHR Incentive Programs measure has not changed from Stage 2. This commenter recommended that ONC provide revised draft test procedures for this criterion for public comment prior to the release of the final rule.
As stated in the 2015 Edition proposed rule (FR 80 16868), this certification criterion's gap certification eligibility is “fact-specific” and depends on any modifications made to the specific certification criteria to which this criterion applies. As mentioned above and in the Proposed Rule, it would also depend on changes to the test procedure that are made to align with applicable objectives and measures under the EHR Incentive Programs. We note that draft test procedures for the 2015 Edition were released with the publication of the Proposed Rule
We have changed the first use of the term “meaningful use” to “EHR Incentive Programs” and removed its second use in the criterion. We have also removed the phrase “objective with a.” We have made these revisions to more clearly align with the terminology and framework used under the EHR Incentive Programs.
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We proposed to adopt a 2015 Edition “safety-enhanced design” (SED) certification criterion that was revised in comparison to the 2014 Edition “safety-enhanced design” criterion. We proposed to include seventeen (17) certification criteria (seven new) in the 2015 Edition SED certification criterion (80 FR 16857), and for each of the referenced certification criteria and their corresponding capabilities presented for certification, we proposed to require that user-centered design (UCD) processes must have been applied in order satisfy this certification criterion. We stated we intend to continue submission of summative usability test results to promote transparency and foster health IT developer competition, spur innovation, and enhance patient safety. With this in mind, we sought comment on whether there are other certification criteria that we omitted from the proposed SED criterion that commenters believe should be included.
We believe the inclusion of criteria such as “demographics,” “implantable device list,” “drug-drug, drug-allergy interaction checks for CPOE,” and “CDS” are appropriate because data entry errors and poor user interfaces for responding to alerts and interventions can compromise patient safety. While we do not have empirical data related to the “effectiveness” of the SED criterion, we believe that our approach contributes to improving usability and patient safety through both the application of the SED criterion's requirements to a significant number of health technologies being used in the market today and in the future as well as through the SED information being available on the CHPL for stakeholder review and evaluation.
We proposed to include the specific information from the NISTIR 7742 “Customized Common Industry Format Template for Electronic Health Record Usability Testing” (NIST 7742)
We identified the table on page 11 of NISTIR 7742 for the submission of demographic characteristics of the test
We strongly advised health IT developers to select an industry standard process because compliance with this certification criterion requires submission of the name, description, and citation (URL and/or publication citation) of the process that was selected, and we provided examples of method(s) that could be employed for UCD, including ISO 9241-11, ISO 13407, ISO 16982, ISO/IEC 62366, ISO 9241-210 and NISTIR 7741. We explained that, in the event that a health IT developer selects a UCD process that was not an industry standard (i.e., not developed by a voluntary consensus standards organization), but is based on one or more industry standard processes, the developer may name the process(es) and provide an outline of the process in addition to a short description as well as an explanation of the reason(s) why use of any of the existing UCD standards was impractical. We also noted that health IT developers can perform many iterations of the usability testing, but the submission that is ultimately provided for summative usability testing and certification must be an expression of a final iteration, and the test scenarios used would need to be submitted as part of the test results. We noted that we do not expect developers to include trade secrets or proprietary information in the test results.
Many commenters expressed concern on the proposed limitation for measuring user satisfaction. Commenters mentioned that user satisfaction ratings are often now based on non-standard surveying processes. Commenters suggested that we not solely rely on task-based satisfaction measures and consider post-session satisfaction measures. Commenters suggested that we use industry standard, literature-recognized satisfaction measures such as the Single Ease-of-use Question, System Usability Scale, or Software Usability Measurement Inventory.
We recommended following NISTIR 7804
Commenters generally recommended that cohorts should be consistent with the capability under testing. Some commenters stated, for example, that clinicians would not be appropriate for a more administrative capability such as recording demographics. Commenters gave mixed responses on whether this described approach should be required or simply guidance.
We agree with commenters that cohorts should not be limited to clinicians but instead consist of test participants with the occupation and experience that aligns with the capability under testing. We believe, however, that it would be too restrictive and complicated to establish cohort requirements per criterion. Instead, we continue to recommend that health IT developers follow NISTIR 7804 for human factors validation testing of the final product to be certified. We will also work with NIST to provide further guidance as needed.
We requested comment regarding options that we might consider in addition to—or as alternatives to—summative testing. We asked whether a standardized report of formative testing
We stated that we believe that ONC-ACB determinations related to the ongoing applicability of the SED certification criterion to certified health IT for the purposes of inherited certified status (§ 170.550(h)), adaptations and other updates would be based on the extent of changes to user-interface aspects of one or more capabilities to which UCD had previously been applied. We specified that ONC-ACBs should be notified when applicable changes to user-interface aspects occur, and we included these types of changes in our proposal to address adaptations and updates under the ONC-ACB Principles of Proper Conduct (§ 170.523).
We discuss the comments received on this proposal and our response under section IV.D.6 of this preamble.
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We proposed to adopt a 2015 Edition “quality management system” certification criterion that was revised in comparison to the 2014 Edition and proposed that all Health IT Modules certified to the 2015 Edition would need to be certified to the 2015 Edition QMS criterion “quality management system” criterion. We proposed to require the identification of the Quality Management System (QMS) used in the development, testing, implementation, and maintenance of capabilities certified under the ONC Health IT Certification Program. We specified that the identified QMS must be compliant with a quality management system established by the federal government or a standards developing organization; or mapped to one or more quality management systems established by the federal government or standards developing organization(s). We stated that we will not permit health IT to be certified that has not been subject to a QMS and that we will require health IT developers to either use a recognized QMS or illustrate how the QMS they used maps to one or more QMS established by the federal government or a standards developing organization(s) (SDOs). We explained that we encourage health IT developers to choose an established QMS, however, developers may also use either a modified version of an established QMS, or an entirely “home grown” QMS. In cases where a health IT developer does not use a QMS established by the federal government or an SDO, we proposed to require the health IT developers illustrate how their QMS maps to one or more QMS established by the federal government or SDO through documentation and explanation that links the components of their QMS to an established QMS and identifies any gaps in their QMS as compared to an established QMS. We added that documentation of the current status of QMS in a health IT development organization would be sufficient. We also provided a list of QMS standards established by the federal government and SDOs (80 FR 16858).
A few commenters requested clarifications. A commenter noted that health IT developers use agile software development practices and requested clarification if these processes would be sufficient for certification. A commenter asked how this criterion would apply to a self-developer or open source software. A couple of commenters asked how Health IT Modules would be evaluated against this criterion, including what type of documentation would be required for mapping and whether a documented combined QMS approach for the entire Health IT Module would be sufficient in lieu of a capability by capability identification.
We expect that ONC-ACBs will certify health IT to this criterion in the same manner as they certify health IT to the 2014 Edition QMS criterion, but accounting for any differences that are finalized through the 2015 Edition ACD
As noted in the 2014 Edition final rule (77 FR 54191), we agree that existing standards may not explicitly state support for agile development methodologies and that such methods may be part of an optimal QMS. As such, documented agile development methodologies may be used in meeting the mapping provision of this criterion. We will issue further compliance guidance as necessary, including through the 2015 Edition QMS test procedure. This guidance will include updated identification of QMS standards and more specification of documentation requirements necessary to meet this criterion. Overall, we do not believe this criterion presents a significant burden as many health IT products have been previously certified to the 2014 Edition QMS criterion and most, if not all, developers (with previously certified products or not) should have QMS documentation readily available for their health IT products as a standard practice.
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We proposed to adopt a new 2015 Edition “accessibility-centered design” certification criterion that would apply to all Health IT Modules certified to the 2015 Edition and require the identification of user-centered design standard(s) or laws for accessibility that were applied, or complied with, in the development of specific capabilities included in a Health IT Module or, alternatively, the lack of such application or compliance.
We proposed to require that for each capability that a Health IT Module includes and for which that capability's certification is sought, the use of a health IT accessibility-centered design standard or compliance with a health IT accessibility law in the development, testing, implementation, and maintenance of that capability must be identified. Further, we proposed to permit that a health IT developer could document that no health IT accessibility-centered design standard or law was applied to the health IT's applicable capabilities as an acceptable means of satisfying this proposed certification criterion. We added that the method(s) used to meet this proposed criterion would be reported through the open data CHPL. We solicited comment on whether the standards and laws identified in the Proposed Rule were appropriate examples and whether we should limit the certification criteria to which this criterion would apply.
We explained that the proposed certification criterion would serve to increase transparency around the application of user-centered design standards for accessibility to health IT and the compliance of health IT with accessibility laws. We stated that this transparency would benefit health care providers, consumers, governments, and other stakeholders, and would encourage health IT developers to pursue the application of more accessibility standards and laws in product development that could lead to improved usability for health care providers with disabilities and health care outcomes for patients with disabilities.
We also proposed to revise § 170.550 to require ONC-ACBs follow this proposed approach and referred readers to section IV.C.2 of the Proposed Rule's preamble for this proposal.
We expect that ONC-ACBs will certify health IT to this criterion in the same manner as they certify health IT to the 2014 Edition QMS criterion, but accounting for any differences that are finalized through the 2015 Edition ACD test procedure. We will issue further compliance guidance as necessary.
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We proposed to adopt a new certification criterion at § 170.315(g)(6) that would rigorously assess a product's C-CDA creation performance (for both C-CDA Release 1.1 and 2.0) when it is presented for a Health IT Module certification that includes within its scope any of the proposed certification criteria that require C-CDA creation (
We noted that we coordinated with our colleagues at NIST and understand that NVLAP-Accredited Testing Laboratories would retain the C-CDA files created under test and contribute them to an ONC-maintained repository.
We intend to publish sample gold standard C-CDA documents on
We proposed that Health IT Modules would have to demonstrate compliance with the C-CDA creation performance functions of this criterion for the following C-CDA Release 2.0 document templates:
• Continuity of Care;
• Consultation Note;
• History and Physical;
• Progress Note;
• Care Plan;
• Transfer Summary;
• Referral Note; and
• Discharge Summary (for inpatient settings only).
If the scope of certification includes more than one certification criterion with C-CDA creation required, C-CDA creation performance only has to be demonstrated once for each C-CDA document template (
Due to past feedback from providers that indicated the variability associated with different functionalities and workflows within certified health IT can ultimately affect the completeness of the data included in a created C-CDA, we requested comment on a proposal that would result in a certification requirement to evaluate the completeness of the data included in a C-CDA. This additional requirement would ensure that the data recorded by a user in health IT is equivalent to the data included in a created C-CDA.
We did not receive any comments regarding our understanding that NVLAP-Accredited Testing Laboratories would retain the C-CDA files created under test and contribute them to an ONC-maintained repository. We note that we intend to implement this repository as noted in the Proposed Rule.
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We proposed a new 2015 Edition criterion at § 170.315(g)(7) that would require health IT to demonstrate it could provide application access to the Common Clinical Data Set via an application programming interface (API), and requiring that those same capabilities be met as part of the “VDT” criterion. We noted that providing API functionality could help to address many of the challenges currently faced by individuals and caregivers accessing their health data, including the “multiple portal” problem, by potentially allowing individuals to aggregate data from multiple sources in a web or mobile application of their choice. We emphasized that the proposed approach was intended to provide flexibility to health IT developers to implement an API that would be most appropriate for its customers and allow developers to leverage existing standards that most health IT developers would already need in order to seek certification for other criteria.
Because many commenters provided feedback on the “API” criterion within the context of the “VDT” criterion and in the order of this final rule the VDT discussion comes first, we address all comments to proposed § 170.315(g)(7) here.
For the purposes of testing for each of the “API” certification criteria, a health IT developer will need to demonstrate the response (
We appreciate suggestions as to a “sub-regulatory approach” and will consider whether such approaches could fit within our regulatory structure as well as lead to consistent and efficient testing and certification.
We proposed that the API include a means for the establishment of a trusted connection with the application that requests patient data. We stated that this would need to include a means for the requesting application to register with the data source, be authorized to request data, and log all interactions between the application and the data source.
We intend to pursue a standards-based approach for this criterion in the future, but believe that providing flexibility currently is more appropriate as emerging standards continue to mature and gain traction in industry, and consistent with our overall “functional” approach to the API certification criteria at § 170.315(g)(7), (g)(8), (g)(9). We recognize and encourage the work being done to develop emerging standards in this space, including OAuth, OpenID Connect, UMA, and the Open ID Foundation's HEART profile. Accordingly, we emphasize that the security controls mentioned in the Proposed Rule establish a floor, not a ceiling. We encourage organizations to follow security best practices and implement security controls, such as penetration testing, encryption, audits, and monitoring as appropriate, without adversely impacting a patient's access to data, following their security risk assessment. We expect health IT developers to include documentation on how to securely deploy their APIs in the public documentation required by the certification criteria and to follow industry best practices. We also seek to clarify that a “trusted connection” means the link is encrypted/integrity protected according to § 170.210(a)(2) or (c)(2). As such, we do not believe it is necessary to specifically name HTTPS and/or SSL/TLS as this standard already covers encryption and integrity protection for data in motion.
While we appreciate the concerns of commenters regarding privacy and security of third party applications, we note that the regulation of third party applications is outside the scope of certification, unless those applications are seeking certification as Health IT Modules. As consumer applications, third-party applications may fall under the authority of the Federal Trade Commission (FTC). In addition, if third-party applications are offered on behalf of a HIPAA covered entity or business associate, they would be governed by the HIPAA Privacy and Security Rules as applicable to those entities. We also note that the Federal Trade Commission and the National Institute of Standards and Technology (NIST) have issued guidance regarding third-party applications; we encourage third-party application developers to take advantage of these resources.
• Section 170.315(d)(1) “authentication, access control, and authorization;”
• Section 170.315(d)(9) “trusted connection;” and
• Section 170.315(d)(10) “auditing actions on health information” or § 170.315(d)(2) “auditable events and tamper resistance.”
We intended the trusted connection requirement to encompass encryption and integrity. The “trusted connection” criterion at § 170.315(d)(9) requires health IT to establish a trusted connection in accordance with the standards specified in § 170.210(a)(2) and (c)(2). We have adopted § 170.315(d)(10) “auditing actions on health information” as an abridged version of § 170.315(d)(2) “auditable events and tamper resistance” as some of the capabilities included in § 170.315(d)(2) would likely not apply to a Health IT Module certified only to the “API” criteria, such as recording the audit log status or encryption status of electronic health information locally stored on end-user devices by the technology. A Health IT Module presented for certification to the “API” criteria, depending on the capabilities it included for certification, could be certified to either § 170.315(d)(2) or (d)(10) as part of the 2015 Edition P&S certification framework.
We have removed the requirement that the API must include a means for the requesting application to register with the data source. Our intention was that APIs should support dynamic registration that does not require pre-approval before an application requests data from the API. However, from the comments received it was clear that our intention was not understood. Further, open source standards for dynamic registration are still under active development, there is currently no consensus-based standard to apply, and we do not want registration to become a barrier for use of Health IT Modules' APIs. We are removing this requirement at this time for the purposes of certification and will consider verifying this technical capability for a potential future rulemaking.
Provider organizations already transmit information outside their networks such as electronic claims submission, lab orders, and VDT messages. These transmissions may be occurring using APIs today. Therefore, provider organizations could already be implementing safeguards needed to secure APIs. We encourage providers to employ resources released by OCR and ONC, such as the Security Risk Assessment Tool
It is important to recognize that an API may be used to enable a patient to access data in the Designated Record Set for that individual, pursuant to 45 CFR 164.524(a)(1).
In circumstances where there is a requirement to document a patient's request or particular preferences, APIs can enable compliance with such documentation requirements. The HIPAA Privacy Rule
The existing legal framework would support the use of APIs to facilitate patient access to electronic health information or patient access requests
We proposed that the API would need to include a means for the application to query for an identification (ID) or other token of a patient's record in order to subsequently execute data requests for that record.
We proposed that the API would need to support two types of data requests and responses: “by data category” and “all.” In both cases, the proposed scope for certification was limited to the data specified in the Common Clinical Data Set. For “by data category,” the API would need to respond to requests for each of the data categories specified in the Common Clinical Data Set and return the full set of data for that data category. We also proposed that as the return format for the “by data category,” that either XML or JSON would need to be produced. “All” requests for a specific patient would return a patient's fully populated summary record formatted in accordance with the C-CDA version 2.0.
In response to concerns regarding the return format for the data-category request, we have decided to make that requirement more flexible and have removed the specific proposed language of XML or JSON to say in the final criterion that the returned data must be in a computable (i.e., machine readable) format.
In response to comments concerning the “all-request,” we clarify that the API functionality must be able to respond to requests for all of the data included in the CCDS on which there is data for patient, and that the return format for this functionality would be limited to the C-CDA's CCD document template. We believe that focusing on the CCD document template will reduce the implementation burden for health IT developers to meet this certification criterion and will help application developers connecting to Health IT Modules' APIs because they will know with specificity what document template they are going to receive.
With regard to requests for each “data category,” for the purposes of certification, the technology must demonstrate that it can respond to requests for each individual data category one at a time. However, this is a baseline for the purposes of testing and certification and health IT developers are free to enable the return of multiple categories at once if they choose to build out that functionality.
Similar to our response for “VDT” criterion, we clarify that patients should be provided access to any data included in the Common Clinical Data Set.
As with the VDT requirement, we have adopted date and time filtering requirements as part of this criterion. We agree with commenters that adding this functionality to these criteria will provide clarity that patients should have certain baseline capabilities available to them when it comes to selecting the data (or range of data) they wish to access using an application that interacts with the Health IT Module's APIs. Specifically, we have adopted two timeframe requirements: First, to ensure that an application can request data
We proposed that the required technical documentation would need to include, at a minimum: API syntax, function names, required and optional parameters and their data types, return variables and their types/structures, exceptions and exception handling methods and their returns. We also stated that the terms of use must include the API's developer policies and required developer agreements so that third-party developers could assess these additional requirements before engaging in any development against the API. We also proposed that health IT developers would need to submit a hyperlink to ONC-ACBs, which the ONC-ACB would then submit as part of its product certification submission to the Certified Health IT Product List (CHPL) that would allow any interested party to view the API's documentation and terms of use.
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We proposed two ways for providers to meet the 2015 Edition Base EHR definition using health IT certified to transport methods. The first proposed way to meet the proposed 2015 Edition Base EHR definition requirement would be for a provider to have health IT certified to § 170.315(b)(1) and (h)(1) (Direct Project specification). This would account for situation where a provider uses a health IT developer's product that acts as the “edge”
We received minimal comments on these proposals and discussed what comments we received under the “Direct Project, Edge Protocol, and XDR/XDM” certification criterion below.
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We proposed to adopt a certification criterion that includes the capability to send and receive according to the Applicability Statement for Secure Health Transport (the primary Direct Project specification). We noted that we previously adopted this capability for the 2014 Edition at § 170.314(b)(1), (b)(2) and (h)(1). We proposed to include as an optional capability for certification the capability to send and receive according to the Implementation Guide for Delivery Notification in Direct, Version 1.0, June 29, 2012 (“Delivery Notification IG”). We explained that the primary Direct Project lacked certain specificity and consistency guidance such that deviations from normal message flow could result if Security/Trust Agents (STAs) implemented only requirements denoted as “must” in Section 3 of the primary Direct Project. As a result, STAs may not be able to provide a high level of assurance that a message has arrived at its destination. We further stated that the Delivery Notification IG provides implementation guidance enabling STAs to provide a high level of assurance that a message has arrived at its destination and outlines the various exception flows that result in compromised message delivery and the mitigation actions that should be taken by STAs to provide success and failure notifications to the sending system.
We have also adopted as a requirement for this criterion the Implementation Guide for Delivery Notification in Direct, Version 1.0, June 29, 2012. While we proposed this IG as an optional provision, we agree with commenters that this functionality must be required to best support interoperability and exchange, particularly for both sending and receiving parties. As we stated in the 2014 Edition Release 2 proposed rule (79 FR 10914-915), the capabilities in this IG provide implementation guidance enabling HISPs to provide a high level of assurance to senders that a message has arrived at its destination, a
We appreciate the recommendations and questions regarding “ownership” of the Direct specifications. We clarify that although ONC played a significant role in the creation and coordination of the Direct specifications that ONC does
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We proposed a 2015 Edition “Direct, Edge Protocol, and XDR/XDM” certification criterion that included three distinct capabilities. The first proposed capability focused on technology's ability to send and receive according to the Applicability Statement for Secure Health Transport (the primary Direct Project specification). The second proposed capability focused on technology's ability to send and receive according to both Edge Protocol methods specified by the standard adopted in § 170.202(d). The third proposed capability focused on technology's ability to send and receive according to the XDR and XDM for Direct Messaging Specification. We noted that these three capabilities were previously adopted as part the 2014 Edition, including through the 2014 Edition and 2014 Edition Release 2 final rules, and we reminded health IT developers that best practices exist for the sharing of information and enabling the broadest participation in information exchange with Direct.
We have also adopted as a requirement for this criterion the Implementation Guide for Delivery Notification in Direct, Version 1.0, June 29, 2012. While we proposed this IG as an optional provision, we agree with commenters that this functionality must be required to best support interoperability and exchange, particularly for both a sending and receiving HISP. As we stated in the 2014 Edition Release 2 proposed rule (79 FR 10914-915), the capabilities in this IG provide implementation guidance enabling HISPs to provide a high level of assurance to senders that a message has arrived at its destination, a
We require the use of XDR/XDM to support interoperability and ensure that certain messages packaged using XDR/XDM can be received and processed. This is the same approach we required with the 2014 Edition. We also refer readers to the “ToC” certification criterion discussed earlier in this preamble for further explanation of the interoperability concerns related to the use of XDR/XDM. We clarify for commenters that for health IT to be certified to this criterion it must be able to support both of the Edge Protocols
We note that even though the Edge Protocol requires support for XDS limited metadata, XDR/XDM supports capability to transform messages using full metadata wherever appropriate. Therefore, we require that a Health IT Module must support both the XDS Metadata profiles (Limited and Full), as specified in the underlying IHE specifications, to ensure that the transformation between messages packaged using XDR/XDM are done with as much appropriate metadata as possible.
This criterion requires the three capabilities specified (Direct Project specification, Edge Protocol compliance, and XDR/XDM processing) because it must support interoperability and all potential certified exchange options as well as support a provider in meeting the Base EHR definition. As we discussed above, a provider could use an “independent” HISP to meet the Base EHR definition. In such a case, the HISP would need to be certified to this criterion in order for the provider to use it to meet the Base EHR definition, which is part of the CEHRT definition under the EHR Incentive Programs. Therefore, there is incentive for a HISP to be certified to this criterion.
Please see our prior response regarding the “ownership” of the Direct specifications under the “Direct Project” certification criterion.
We have previously defined gap certification at 45 CFR 170.502 as the certification of a previously certified Complete EHR or EHR Module(s) to: (1) all applicable new and/or revised certification criteria adopted by the Secretary at subpart C of part 170 based on the test results of a NVLAP-accredited testing laboratory; and (2) all other applicable certification criteria adopted by the Secretary at subpart C of part 170 based on the test results used to previously certify the Complete EHR or EHR Module(s) (for further explanation, see 76 FR 1307-1308). Our gap certification policy focuses on the differences between certification criteria that are adopted through rulemaking at different points in time. This allows health IT to be certified to only the differences between certification criteria editions rather than requiring health IT to be fully retested and recertified to certification criteria (or capabilities) that remain “unchanged” from one edition to the next and for which previously acquired test results are sufficient. Under our gap certification policy, “unchanged” criteria are eligible for gap certification, and each ONC-ACB has discretion over whether it will provide the option of gap certification.
For the purposes of gap certification, we included a table in the Proposed Rule to provide a crosswalk of the proposed “unchanged” 2015 Edition certification criteria to the corresponding 2014 Edition certification criteria (80 FR 16868). We noted that with respect to the 2015 Edition certification criteria at § 170.315(g)(1) through (g)(3) that gap certification eligibility for these criteria would be fact-specific and would depend on any modifications made to the specific certification criteria to which these “paragraph (g)” certification criteria apply.
This section of the preamble discusses proposed certification criteria included in the Proposed Rule that we have not adopted and requests for comments on potential certification criteria included in the Proposed Rule. We summarize the comments received on these proposed criteria and requests for comments and provide our response to those comments.
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We proposed to adopt a 2015 Edition “vital signs, BMI, and growth charts” certification criterion that was revised in comparison to the 2014 Edition “vital signs, BMI, and growth charts” criterion (§ 170.314(a)(4)). Specifically, we proposed to: (1) Expand the types of vital signs for recording;
Concerning the proposal to specify how vital signs are recorded natively in a health IT system, commenters noted that there would be workflow and usability issues, such as requiring the user to enter in metadata every time a vital sign is taken. As vital signs are routinely taken as a part of every patient visit in many provider settings, this could be burdensome and time-consuming.
Regarding the proposed approach to record vital signs using a less granular LOINC® code with associated metadata, commenters had a number of concerns. Some commenters were concerned that LOINC® was designed as a pre-coordinated code system (
Some commenters noted that SNOMED CT® is the international standard used for vital signs. One commenter noted that IHE is working with the Department of Veterans Affairs and other stakeholders to create a utility that would allow conversion from SNOMED CT® to LOINC® or to make data accessible from other countries that use SNOMED CT® for vital signs.
Many commenters suggested that the complexity of the proposed approach for recording vital signs with metadata would require extensive rework and mapping of existing systems resulting in little additional benefit for workflow, usability, and semantic interoperability. As such, commenters stated there was little incentive to certify to the proposed criterion for vital signs as it was not proposed as a requirement for participation in the EHR Incentive Programs. Commenters also noted that most 2014 Edition certified health IT capture vital signs data in different methods based on the product and provider setting, but all of them still support the exchange of vital signs as specified by the industry-accepted C-CDA standard. Thus, most health IT already supports mapping to accepted industry standards for exchange today.
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We proposed to adopt a 2015 Edition “image results” certification criterion that was unchanged in comparison to the 2014 Edition “image results” criterion (§ 170.314(a)(12)).
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In the Proposed Rule, we proposed a 2015 Edition “family health history—pedigree” certification criterion that required health IT to enable a user to create and incorporate a patient's FHH according to HL7 Pedigree standard and the HL7 Pedigree IG, HL7 Version 3 Implementation Guide: Family History/Pedigree Interoperability, Release 1.
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We proposed to adopt a 2015 Edition “patient list creation” certification criterion that was unchanged in comparison to the 2014 Edition “patient list creation” criterion (§ 170.314(a)(14)) and explained the expectation that a Health IT Module must demonstrate its capability to use at least one of the more specific data categories included in the “demographics” certification criterion (§ 170.315(a)(5)) (
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We proposed to adopt a 2015 Edition electronic medication administration record (eMAR) certification criterion that was unchanged in comparison to
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In the Proposed Rule, we proposed to adopt a new 2015 Edition “decision support—knowledge artifact” certification criterion that, for the purposes of certification, would require health IT to demonstrate that it could electronically send and receive clinical decision support (CDS) knowledge artifacts in accordance with a Health eDecisions (HeD) standard. To assist the industry in producing and sharing machine readable files for representations of clinical guidance, we proposed to adopt the HL7 Version 3 Standard: Clinical Decision Support Knowledge Artifact Specification, Release 1.2 DSTU (July 2014) (“HeD standard Release 1.2”)
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In the Proposed Rule, we proposed to adopt a new 2015 Edition “decision support—service” certification criterion that, for the purposes of certification, would require health IT to demonstrate that it could electronically make an information request with patient data and receive in return electronic clinical guidance in accordance with an HeD standard and the associated HL7 Implementation Guide: Decision Support Service, Release 1.1 (March 2014), US Realm DSTU Specification.
We have summarized and responded to comments on these “decision support” criteria together as the referenced HeD standards were developed by one S&I initiative to address two use cases, we received similar comments on both proposals, and have determined to not adopt both criteria.
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We proposed to adopt a 2015 Edition “incorporate laboratory tests and values/results” certification criterion that was revised in comparison to the 2014 Edition “incorporate laboratory tests and values/results” criterion (§ 170.314(b)(5)). We proposed to adopt and include the HL7 Version 2.5.1 Implementation Guide: S&I Framework Lab Results Interface, Draft Standard for Trial Use, Release 2, US Realm (“LRI Release 2”) in the final 2015 Edition “transmission of laboratory test reports” criterion for the ambulatory setting. We explained that the LRI Release 2 addresses errors and ambiguities found in LRI Release 1 and harmonizes interoperability requirements with other laboratory standards we proposed to adopt in this final rule (e.g., the HL7 Version 2.5.1 Implementation Guide: S&I Framework Laboratory Orders from EHR, DSTU Release 2, US Realm, 2013).
We proposed that a Health IT Module would be required to display the following information included in laboratory test reports it receives: (1)
We sought comment on the HL7 EHR-S Functional Requirements for the V2.5.1 Implementation Guide: S&I Framework Lab Results Interface R2, Release 1, US Realm, Draft Standard for Trial Use, Release 1 (“EHR-S IG”), under ballot reconciliation with HL7
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We proposed to adopt a 2015 Edition “transmission of laboratory test reports” certification criterion that was revised in comparison to the 2014 Edition “transmission of electronic laboratory tests and values/results to ambulatory providers” criterion (§ 170.314(b)(6)). We stated that we renamed the criterion to more clearly indicate its availability for the certification of health IT used by any laboratory. We proposed to adopt and include the HL7 Version 2.5.1 Implementation Guide: S&I Framework Lab Results Interface, Draft Standard for Trial Use, Release 2, US Realm (“LRI Release 2”) in the criterion and discussed our rationale for its inclusion in the 2015 Edition “incorporate laboratory tests and values/results.” We further explained that inclusion of this standard for certification should not only facilitate improved interoperability of electronically sent laboratory test reports, but also facilitate laboratory compliance with CLIA as it relates to the incorporation and display of test results in a receiving system. We also proposed to require a Health IT Module to be able to use, at a minimum, LOINC® version 2.50 as the vocabulary standard.
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We proposed to adopt a new 2015 Edition “accessibility technology compatibility” certification criterion that would offer health IT developers that present a Health IT Module for certification to one or more of the clinical, care coordination, and patient engagement certification criteria listed in proposed § 170.315(a), (b), or (e) the opportunity to have their health IT demonstrate compatibility with at least one accessibility technology for the user-facing capabilities included in the referenced criteria. By “opportunity,” we noted that we meant that the proposed criterion would be available for certification but not required (
We sought comment on the extent to which certification to this criterion would assist in complying with Section 504 of the Rehabilitation Act of 1973 (29 U.S.C. 794) and other applicable federal (e.g., Section 508 of the Rehabilitation Act of 1973) and state disability laws. We also sought comment on whether certification to this criterion
We also believe further research or evidence is needed to determine whether customers would make purchasing decisions based on whether a health IT product was
We do, however, believe that certification can currently support the accessibility of health IT through other means. As such, we have adopted the proposed “accessibility-centered design” certification criterion. We refer readers to section III.A.3 of this preamble for further discussion of this criterion. Independent of this certification requirement, we remind health IT developers seeking certification and providers using certified health IT of their independent obligations under applicable federal civil rights laws, including Section 504 of the Rehabilitation Act, Section 1557 of the Affordable Care Act, and the Americans with Disabilities Act that require covered entities to provide individuals with disabilities equal access to information and appropriate auxiliary aids and services as provided in the applicable statutes and regulations.
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We proposed to adopt a 2015 Edition “SOAP Transport and Security Specification and XDR/XDM for Direct Messaging” certification criterion that included the capability to send and receive according to the Transport and Security Specification (also referred to as the SOAP-Based Secure Transport RTM) and its companion specification XDR and XDM for Direct Messaging Specification. We noted that we previously adopted these capabilities for the 2014 Edition at § 170.314(b)(1), (b)(2) and (h)(3).
In response to the XDM comment, we had paired the “XDR/XDM for Direct” with SOAP to enable the testing of SOAP with XDR using XDM packaging. While the comments from the IIS community are beyond the scope of this proposal, we note for clarity that consistent with the approach under the EHR Incentive Programs Stage 2 final rule (77 FR 53979), in the EHR Incentive Programs Stage 3 and Modifications final rule published elsewhere in this edition of the
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We proposed a new 2015 Edition “healthcare provider directory—query request” certification criterion that would require a Health IT Module to be capable of querying a directory using the Integrating the Healthcare Enterprise (IHE)
Some commenters stated a preference for an approach that utilized a RESTful architecture, such as FHIR, noting that a service stack utilizing SOAP protocols (as used by the IHE HPD protocol) is more difficult to implement and maintain.
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We proposed to adopt a new certification criterion that would focus on the “query response” and include the corresponding set of capabilities to respond to a provider directory query. This proposed criterion was intended to complement the certification criterion we proposed for adoption related to health IT issuing a healthcare provider directory “query request,” and we explained that the proposed separation would provide developers with the flexibility to test and certify for provider directory “query” independent of the provider directory “response.” We stated that a health IT system would be able to be presented for testing and certification to both proposed certification criteria if applicable or just to one or the other as appropriate based on the product's capabilities.
We proposed that directory sources must demonstrate the capability to respond to provider directory queries according to the IHE HPD profile and must respond to the following provider directory queries: Query for an individual provider; query for an organizational provider; and query for relationships between individual providers and organizational providers.
In addition we proposed including an optional capability within this certification criterion to address federated requirements that would require a Health IT Module to follow the approved federation option of for IHE HPD to accomplish querying in federated environments. The federation change proposal was approved in September, 2014 and was incorporated into the IHE HPD Profile.
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We proposed to adopt a new 2015 Edition “electronic submission of medical documentation” (esMD) certification criterion that focused on the electronic submission of medical documentation through four specific capabilities.
We proposed Capability 1 would require a Health IT Module be able to support the creation of a document in accordance with the HL7 Implementation Guide for CDA Release
We proposed Capability 2 would require a Health IT Module be able to support the use of digital signatures embedded in C-CDA Release 2.0 and CDP1 IG documents templates by adopting the HL7 Implementation Guide for CDA Release 2: Digital Signatures and Delegation of Rights, Release 1 (DSDR IG).
We proposed Capability 3 would require a Health IT Module be able to support the creation and transmission of “external digital signatures” for documents that may be used to sign any document for the purpose of both data integrity and non-repudiation. The esMD Initiative defines the requirements in the Author of Record Level 1: Implementation Guide;
We proposed Capability 4 would require a Health IT Module to support the creation and transmission of digital signatures for electronic transactions for the purpose of both data integrity and non-repudiation authenticity. The esMD Initiative defines the requirements in the Provider Profiles Authentication: Registration Implementation Guide;
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In the Proposed Rule, we requested that commenters consider what additional support might be needed for health IT developers, implementers, and users to effectively include a certification criterion that would require health IT to enable a user to record, change, and access (all electronically) the following data elements in structured format:
• Patients' employment status and primary activities (
• Patients' current I/O, linked to one another and with time-stamp, including start date;
• Patients' usual I/O, linked to one another and with time-stamp, including start year and duration in years; and
• Patients' history of occupation with a time and date stamp for when the history was collected (to note, this is focused on the capability to record a history, not a requirement that a history must be recorded or that a patient
We also solicited public comment on the experience health IT developers and health care providers have had in recording, coding, and using I/O data, which included any innovation that is making I/O data more useful for providers.
To better understand the health care needs associated with work data, we specifically solicited public comment from
• The usefulness for providers to be able to access current and usual I/O and related data in the EHR, including whether additional data elements, such as work schedule, are useful.
• The usefulness of a history of positions provided as current I/O, with data from each position time-stamped, linked, retained, and accessible as part of the longitudinal patient care (medical) record.
• Narrative text (vs. codes) for both current and usual I/O.
• CDC_Census codes for both current and usual I/O; available through PHIN VADS at
• SNOMED CT® codes for occupation (current codes or potentially developed codes).
• Other standards and codes that may be in use by the health IT industry for both current and usual I/O.
Given the feedback about the immaturity of the standards currently available for supporting these goals, we have not adopted a 2015 Edition certification criterion for the collection of I/O information. We are, however, optimistic about the NIOSH-led effort to develop a tool based on the NAICS/SOC code set and believe that it can provide a much-needed authoritative standard that can enable the detailed recording of I/O titles. We intend to monitor the development of such a tool and will consider it and the additional comments we received regarding structured capture of I/O information for future rulemaking.
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To improve coding of military and all uniformed history, we stated in the Proposed Rule that a promising path forward would be to add codes to the U.S. Extension of SNOMED-CT®. Therefore, we requested comment on the following:
• Whether a potential certification criterion should be focused solely on U.S. military service or all uniformed service members (
• Whether the U.S. Extension of SNOMED-CT® is the most appropriate vocabulary code set or whether other vocabulary code sets may be appropriate; and
• The concepts/values we should use to capture U.S. military service or all uniformed service status. We ask commenters to consider the work of NIOSH on I/O information as it relates to capturing military service.
Some commenters supported and opposed the collection of non-military service uniformed service status (
In regard to vocabulary standards for collecting military service information, commenters submitted mixed comments on whether SNOMED CT® codes were sufficiently detailed and captured the right types of military service information. Commenters pointed out that SNOMED CT® contains some concepts to capture high-level military history, including current or past active military service and combat zone service. However, other commenters expressed concern that current SNOMED CT® codes for military history are not detailed enough to be of clinical value. As an example, commenters noted that while SNOMED CT® can document general information about whether the person served in the military, it does not allow for the capture of the individual's specific occupation.
Commenters stated that the NIOSH work on developing a tool for industry and occupation codes as described in the “Work Information—Industry/Occupation Data—Request for Comment” section above would include detailed codes for military service branch; service status; commissioned, warrant officer, non-commissioned and
Our long-term goal is for health care providers to use military service information to provide better care for our nation's veterans. However, given the feedback about SNOMED CT and the NIOSH tool under development, we have not adopted a 2015 Edition certification criterion for military service. We plan to continue to work with the appropriate stakeholders to develop the appropriate values and code sets that would enable consideration of a relevant certification criterion in a future rulemaking.
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Pharmacogenomics data identifies genetic variants in individuals that alter their metabolism or other interactions with medications and can lead to serious adverse events. This information is being included in an increasing number of FDA-approved drug labels. Health IT that can capture pharmacogenomics information could be used to improve patient safety and enhance patient outcomes. In the Proposed Rule, we stated that to our knowledge, in general, health IT has not yet captured genomic and genetic patient information—the presence of clinically significant genomic variants—in a structured manner such as exists for other categorical clinical findings or laboratory-derived data.
In collaboration with the National Institutes of Health, we solicited comment on whether:
• The 2015 Edition “medication allergy list” certification criterion should include the capability to integrate genotype-based drug metabolizer rate information;
• the 2015 Edition “drug-drug, drug-allergy interactions checks for CPOE” certification criterion or as a separate certification criterion should include pharmacogenomic CDS for “drug-genome interactions;”
• we should offer 2015 Edition certification for CDS that incorporate a patient's pharmacogenomic genotype data into the CPOE prescribing process with the goal of avoiding adverse prescribing outcomes for known drug-genotype interactions;
• there are certification approaches that could enhance the end-user's (provider's) adoption and continued use of health IT implementations that guide prescribing through CDS using pharmacogenomic data; and
• there are existing or developing standards applicable to the capture, storage, display, and exchange of potentially clinically relevant genomic data, including the pharmacogenomic subset.
In certain instances, commenters supported inclusion of the pharmacogenomic variant causing the allergy if such information is known for the patient. However, other commenters suggested that studies are needed to prove effectiveness and support inclusion of such data. Some commenters cited drug-drug and drug-allergy interaction alerts without an appropriate filter as the largest source of alert fatigue in relation to the value. Many other commenters also cited concerns over other CDS alert fatigue, poor return on investment, high costs of testing, and the staff resources needed to maintain the CDS in a rapidly evolving area with little evidence to show that it improves overall outcomes or reduces costs. A few commenters noted the existence of third-party web services that provide drug-genome interaction checking functionality that are easily integrated with EHRs.
We solicited comment on whether:
• We should offer certification for health IT functionality that could facilitate HIPAA-compliant sharing of discrete elements of a patient's genomic information from their record to the family history section of a relative's record;
• the proposed “data segmentation for privacy” criteria would provide needed health IT functions with respect to the storage, use, transmission, and disclosure of genetic, genomic, and pharmacogenomics information that is subject to protections under HIPAA and additional state and federal privacy and protection laws such as the Genetic Information Nondiscrimination Act (GINA);
• the proposed “data segmentation for privacy” criteria adequately balance complex genetic privacy issues, such as those related to behavioral health, with the clinical value of context-appropriate availability of a patient's actionable genetic and genomic information;
• health IT should be required to apply different rules for the use and exchange of genetic, genome, and pharmacogenomics data based on different groupings of diseases or conditions based on the sensitivity of
• there are other factors we should consider for health IT that allows the user to use or disclose genetic information in a manner compliant with federal and state privacy laws.
We proposed to adopt a Base EHR definition specific to the 2015 Edition (
• It would not include privacy and security capabilities and certification criteria.
• It would only include capabilities to record and export CQM data (§ 170.315(c)(1)) and not the other CQM capabilities such as import, calculate, and “report to CMS.”
• It would include the 2015 Edition “smoking status” certification criterion as patient demographic and clinical health information data consistent with statutory requirements.
• It would include the 2015 Edition “implantable device list” certification criterion as patient demographic and clinical health information data consistent with statutory requirements.
• It would include the 2015 Edition “application access to Common Clinical Data Set” certification criterion as a capability to both capture and query information relevant to health care quality and exchange electronic health information with, and integrate such information from other sources.
• It would include the proposed 2015 Edition certification criteria that correspond to the remaining 2014 Edition certification criteria referenced in the “2014 Edition” Base EHR definition (
Commenters provided varying recommendations for the criteria that should be included in the Base EHR definition. Some commenters stated that separating privacy and security certification criteria from the Base EHR definition is overly burdensome or confusing, or may create security gaps. A commenter recommended that the “data export” and “application access to Common Clinical Data Set” criteria are more appropriate as “modular” certification, rather than as part of the Base EHR definition. A commenter suggested that “drug-drug, drug-allergy interaction checks for CPOE” criterion be included in the Base EHR definition as it is specifically for CPOE, which is part of the Base EHR definition. Some commenters rejected the idea of including the “implantable device list” criterion in the Base EHR definition, while other commenters supported inclusion of this criterion and noted that this capability would improve care coordination. A few commenters voiced support for the inclusion of the Direct Edge Protocol as an alternative to Direct Project. Some commenters recommended that sexual orientation and gender identity data be included in the Base EHR definition.
Since the establishment of the 2014 Edition Base EHR definition (77 FR 54263-64), we have tried to limit the criteria included in the Base EHR definition to those necessary to meet the HITECH Act requirements and our policy goals. In this regard, we have not included “drug-drug, drug-allergy interaction checks for CPOE” criterion in the 2015 Edition Base EHR definition just as we did not for the 2014 Edition Base EHR definition (see 77 FR 54264). We have, however, included the “implantable device list” criterion in this 2015 Edition Base EHR definition for the reasons stated in the Proposed Rule (80 FR 16825) and discussed under the “implantable device list” criterion in section III.A.1 of this preamble. We have also included the Direct transport alternatives for the reasons discussed in the Proposed Rule (80 FR 16862) and under “transport methods and other protocols” in section III.A.1 of this
In regard to the lack of inclusion of privacy and security criteria in the 2015 Edition Base EHR definition, we believe commenters are confused by our approach. As discussed in more detail under the “privacy and security” heading in section IV.C.1 of this preamble, Health IT Modules presented for certification to criteria listed in the 2015 Base EHR definition and other 2015 Edition certification criteria
The CQM capabilities noted above as not included in the 2015 Edition Base EHR definition have, however, been included the Certified EHR Technology (CEHRT) definition under the EHR Incentive Programs. We refer readers to the next section (“2. Certified EHR Technology Definition”) and Table 4 found in section III.A.3 (“2015 Edition Health IT Certification Criteria Associated with the EHR Incentive Programs Stage 3”) of this preamble for further information and guidance on the relationship of the 2015 Edition Base EHR definition and the 2015 Edition certification criteria with the CEHRT definition. We also refer readers to the CEHRT definition finalized in the EHR Incentive Programs Stage 3 and Modifications final rule published elsewhere in this issue of the
We seek to clarify the 2015 Base EHR definition in response to comments. First, the Base EHR definition is just a definition not a single certified product. As noted in 2014 Edition final rule (77 FR 54263), the Base EHR definition may be met using multiple Health IT Modules. Therefore, to the commenter's point, Health IT Modules separately certified to the “data export,” “application access” criteria, and other criteria included in the 2015 Edition Base EHR definition can be combined to meet the definition. Second, we believe the defining of the Base EHR definition should remain in the rulemaking as the Base EHR definition is only one part of the CEHRT definition and may serve other purposes beyond its inclusion in the CEHRT definition and supporting the EHR Incentive Programs. Third, with the 2014 and 2015 Base EHR definitions' inclusion in the CEHRT definition and the CEHRT definition's included flexibility to use both health IT certified to the 2014 and 2015 Editions for the specified EHR reporting periods, we do not believe there would be a benefit to developing a single Base EHR definition that referenced both the 2014 and 2015 Editions. Rather, we believe this would cause confusion, particularly in relationship to the CEHRT definition.
In the Proposed Rule, we noted that we would continue the same marketing policy that we adopted for the 2014 Edition as it relates to the 2015 Edition Base EHR definition (
We proposed to remove the Certified EHR Technology (CEHRT) definition from § 170.102, effective with this final rule. We explained that the CEHRT definition has always been defined in a manner that supports the EHR Incentive Programs and would more appropriately reside solely within the EHR Incentive Programs regulations to be consistent with our approach in this final rule to make the ONC Health IT Certification Program more open and accessible to other types of health IT beyond EHR technology and for health IT that supports care and practice settings beyond those included in the EHR Incentive Programs. We noted that this removal of the definition should add administrative simplicity in that regulatory provisions, which EHR Incentive Programs participants must meet (
We received general comments on our overall proposal and comments on the data and vocabulary standards included in the proposed definition. We have divided and responded to the comments in a similar manner.
We proposed to revise the “Common MU Data Set” definition in § 170.102 and change the name to “Common Clinical Data Set,” which aligned with our proposed approach to make the ONC Health IT Certification Program more open and accessible to other types of health IT beyond EHR technology and for health IT that supports care and practice settings beyond those included in the EHR Incentive Programs. We explained the procedural requirement to remove the previous name from the CFR and add the new name. We also proposed to change references to the “Common MU Data Set” in the 2014 Edition (§ 170.314) to “Common Clinical Data Set.”
We refer readers to Table 8 below for a complete listing of the data included in the Common Clinical Data Set and the associated standards.
We proposed to revise the definition to include new and updated standards and code sets (HL7 Version 3 for sex; “Race & Ethnicity—CDC” code system in PHIN VADS and the OMB standard for race and ethnicity; RFC 5646 for preferred language, the September 2014 Release of the U.S. Edition of SNOMED CT® for problems and procedures; the February 2, 2015 monthly version of RxNorm for medications and medication allergies; and LOINC® version 2.50 for laboratory tests). We noted that for race and ethnicity a Health IT Module must be able to express both detailed races and ethnicities according to the “Race & Ethnicity—CDC” code system and the aggregate OMB code for each race and ethnicity identified by the patient.
We emphasized that the proposed revisions would
We proposed to include immunizations in the Common Clinical Data Set for 2015 Edition certification. We noted that the C-CDA Release 2.0 could support NDC codes as a translational data element, but the CVX code is required to accompany it. We stated that it would not be a heavy burden to map from an NDC code to a CVX code because a mapping from NDC codes to CVX codes is publicly available. Therefore, for the purposes of including immunizations in the Common Clinical Data Set for 2015 Edition certification, immunizations would be required to be coded according to the CVX code set (HL7 Standard Code Set CVX—Vaccines Administered, updates through February 2, 2015) and the NDC code set (NDC—Vaccine NDC Linker, updates through January 15, 2015).
We proposed to include vital signs in the Common Clinical Data Set according to specific LOINC® codes, metadata, and relevant UCUM unit of measures. We also proposed to offer optional certification to pediatric vital signs as part of the Common Clinical Data Set.
We have not adopted the proposed vital signs criterion as discussed in section III.A.5 above.
We continue to differentiate between systolic and diastolic blood pressure as two distinct vital signs, but note that Health IT Modules may store and display the two values in one field as long as they are exchanged as two separate fields. We have revised “body weight measured” to “body weight.” We have revised “oxygen saturation in arterial blood by pulse oximetry” to “pulse oximetry” and will allow implementers, for the purposes of testing and certification, to choose the LOINC® code with “pulse oximetry” in its name that best represents the method of measurement for exchange. We note that we believe that inhaled oxygen
In summary, we require that the following vital signs must be exchanged as part of the Common Clinical Data Set using a LOINC® code and with a UCUM code for the unit of measure associated with the vital sign measurement:
• Systolic blood pressure;
• Diastolic blood pressure;
• Body height;
• Body weight;
• Heart rate;
• Respiratory rate;
• Body temperature;
• Pulse oximetry; and
• Inhaled oxygen concentration.
We believe this list represents vital signs commonly collected across provider settings today and is a start at defining a minimum set of vital signs, but note that we will continue to work with stakeholders to determine and consider if this list should be revised through a future rulemaking.
We proposed to include the Unique Device Identifier(s) of a patient's Implantable Device(s) for certification to the 2015 Edition.
We proposed to include the “assessment and plan of treatment,” “goals,” and “health concerns” in the “Common Clinical Data Set” for certification to the 2015 Edition to replace the concept of the “care plan field(s), including goals and instructions” which is part of the “Common MU Data Set” in the 2014 Edition. We clarified that we intend “care plan field(s), including goals and instructions” to be a single provider's documentation of their assessment, plan of treatment, goals, and health concerns for the patient, and we stated that this clarification applies for 2014 Edition certification. We proposed this clarification to better align with the terms used in the C-CDA Release 2.0, which includes the “Assessment and Plan Section (V2),” “Assessment Section (V2),” “Plan of Treatment Section (V2),” “Goals Section,” and “Health Concerns Section.” In previous iterations of the C-CDA, we explained that the “Plan of Treatment Section” was called the “Plan of Care Section,” which resulted in confusion on whether the information was intended to represent a single encounter or the synthesis of multiple encounters. For that reason, the “Plan of Care Section” was proposed to be called the “Plan of Treatment Section” to indicate that it is intended to represent a single encounter and not to be confused with the “Care Plan document template.”
For certification to the 2015 Edition, we proposed to include in the Common Clinical Data Set “assessment and plan of treatment,” “goals,” and “health concerns” data in accordance with the C-CDA Release 2.0 “Assessment and Plan Section (V2)” or both the “Assessment Section (V2)” and “Plan of Treatment Section (V2);” the “Goals Section;” and the “Health Concerns Section.” We encouraged health IT developers to allow for structured documentation or tagging that would allow a provider to choose relevant pieces of assessment, plan of treatment, goals, and health concerns data that could be synthesized into a comprehensive care plan. We noted that all proposed 2015 Edition certification criteria that reference the “Common Clinical Data Set” (
We received recommendations for the inclusion of data in Common Clinical Data Set that we did not propose.
We requested comment in the Proposed Rule on ways in which we can engage the public to keep the Common Clinical Data Set relevant to clinical practice as the data included in the Common Clinical Data Set may change over time.
We proposed to adopt in § 170.102 new definitions for “Implantable Device,” “Unique Device Identifier,” “Device Identifier,” and “Production Identifier” as discussed in the Proposed Rule's sections for the “implantable device list” certification criterion. We proposed to adopt the same definitions already provided to these phrases at 21 CFR 801.3 and emphasized that capitalization was purposefully applied to each word in these defined phrases in order to signal to readers that they have specific meanings.
We proposed to replace the term “HIT” with the term “health IT” and to change the name of the “ONC HIT Certification Program” to the “ONC Health IT Certification Program” wherever these references occur in subpart E. In referring to the certification program, we noted that the term “health” is capitalized. We also proposed to remove § 170.553 “Certification of health information technology other than Complete EHRs and EHR Modules” as no longer relevant due to proposals in the Proposed Rule for the ONC Health IT Certification Program that would make the program more open and accessible to health IT beyond EHR technology.
In the Voluntary Edition proposed rule (79 FR 10929-30) we recited our authority and the history of the ONC Health IT Certification Program. The history includes multiple requests for comment and significant stakeholder feedback on making the certification program more accessible to health IT beyond EHR technology and health care settings and practices not directly tied to the EHR Incentive Programs. With consideration of stakeholder feedback and our policy goals, we attempted to make the ONC Health IT Certification Program more open and accessible through a proposal in the Voluntary Edition proposed rule (79 FR 10918-20) to create “meaningful use” (MU) and non-MU EHR Modules. We determined that our proposal was not the best approach in a subsequent final rule (79 FR 54472-73). Since that rulemaking, the HITPC issued recommendations supporting certification for care/practice settings beyond the ambulatory and inpatient settings.
We proposed to rename EHR Modules as Health IT Modules by removing the EHR Module definition from the CFR at § 170.102 and adding the “Health IT Module” definition. We proposed this change to be effective with this final rule, and we proposed to make this change applicable for certification to the 2014 Edition and 2015 Edition. We stated that the proposed change would have no substantive impact on the technologies that might be, or have been, certified under the ONC Health IT Certification Program. We also noted that technologies already certified to the 2014 Edition as EHR Modules, and their use to meet the CEHRT definition, would not be affected by this proposal.
The definition of a Health IT Module is any service, component, or combination thereof that can meet the requirements of at least one certification criterion adopted by the Secretary (see § 170.102). This essentially means any type of technology that could be certified to one
We proposed to
We commented in the Proposed Rule that we had proposed a diverse edition of health IT certification criteria with capabilities included that could support a wide range of providers practicing in various settings. We stated that we
We sought comment on potential future certification criteria that could include capabilities that would uniquely support LTPAC, behavioral health, or pediatrics care/practice settings, as well as other settings. In particular, we sought comment on whether certification criteria focused on patient assessments for certain settings would be of value to health IT developers and health care providers.
Multiple commenters suggested that modular certification should follow “tracks” or “pathways” for specialists to identify what they need. Some commenters requested that we publish guidelines as to which criteria are applicable to which care settings. These commenters suggested that “certification tracks” could be established for each different segment of the provider market (laboratories, behavioral health, long-term care, etc.) looking for alignment and interoperability across certification “tracks.” A commenter questioned how we and stakeholders would monitor claims that a set of independently certified Health IT Modules meet the requirements of the path or track.
As mentioned in the Proposed Rule and recited above, we do not intend to develop certification “tracks” or “pathways” for particular provider specialties or settings within this final rule because it would be difficult for us to independently devise such “paths” or “tracks” in a manner that was sure to align with other relevant programs and specific stakeholder needs. We are, however, working with our colleagues within HHS to identify capabilities and certification criteria that support other programs and use cases. We also continue to welcome the opportunity to collaborate with representatives from different provider and specialties societies as well as health IT developers to determine what certification criteria and “tracks” could be identified and developed to support various care and practice settings and particular use cases. We do not anticipate monitoring any developed certification “tracks.” Rather, we anticipate that a program or association, as applicable, would develop any necessary compliance requirements.
We stated in the Proposed Rule that the adoption of proposed criteria that support functionality for different care and practice settings and the proposals to make the ONC Health IT Certification Program open and accessible to more types of health IT and health IT that supports a variety of care and practice settings, would permit further referencing and use of certified health IT. We proceeded to cite other HHS programs that reference certification criteria and the ONC Health IT Certification Program (80 FR 16874).
We also agree with the commenter that sufficient lead time must be provided for development, testing, certification, and implementation before certified health IT is required for use. With this final rule and the EHR Incentive Programs Stage 3 and Modifications final rule, providers and health IT developers have 27 months before health IT certified to the 2015 Edition must be used to meet the CEHRT definition adopted in the EHR Incentive Programs Stage 3 and Modifications final rule published elsewhere in this issue of the
We continue to support the use of certified health IT and the ONC Health IT Certification Program to support interoperability and health information exchange across diverse care and practice settings. To note and building on the references we cited in the
We proposed a new approach for privacy and security (P&S) certification to the 2015 Edition. In our past rulemakings, we discussed and instituted two different policy approaches and sought comment on others for ensuring that health IT and providers have privacy and security capabilities while also trying to minimize the level of regulatory burden imposed on health IT developers. With the 2011 Edition, we included an upfront requirement that required Health IT Modules to meet all P&S certification criteria as a condition of certification unless the health IT developer could demonstrate that certain P&S capabilities were either technically infeasible or inapplicable. With the 2014 Edition, we eliminated the upfront requirement for each Health IT Module to be certified against the P&S criteria in favor of what we thought would better balance the burden potentially posed by our rulemaking. Thus, the P&S criteria were made part of the 2014 Edition Base EHR definition that all EPs, eligible hospitals, and CAHs participating in the EHR Incentive Programs must meet in order to satisfy the CEHRT definition (meaning each provider needed post-certification to ultimately have technology certified to the P&S criteria).
Based on recommendations from the HITSC, in the Proposed Rule, we proposed a revised P&S certification approach for the 2015 Edition so that each certification criterion has a set of appropriate P&S “safeguards” that must be in place. We proposed to require that an ONC-ACB must ensure that a Health IT Module presented for certification to any of the certification criteria that fall into each regulatory text “first level paragraph” category of § 170.315 (
We explained that under the P&S certification framework we proposed, a health IT developer would know exactly what it needed to do in order to get its Health IT Module certified and a purchaser of a Health IT Module would know exactly what privacy and security functionality against which the Health IT Module had to be tested in order to be certified. We further explained that, because we explicitly proposed which P&S certification criteria would be applicable to the associated criteria adopted in each regulatory text “first level paragraph” category and also proposed Approach 2, we did not propose to permit the 2011 Edition policy of allowing for a criterion to be met through documentation that the criterion is inapplicable or would be technically infeasible for the Health IT Module to meet.
• “Integrity” certification criterion (§ 170.315(d)(8)) to the clinical certification criteria (§ 170.315(a)) due to transmissions of laboratory data per the proposed “CPOE—laboratory” certification criterion (§ 170.315(a)(2));
• “Amendments” certification criterion (§ 170.315(d)(4)) to the care coordination criteria (§ 170.315(b)) to support patient requested amendments; and
• “Automatic access time-out” certification criterion (§ 170.315(d)(5)) to the clinical quality measures criteria (§ 170.315(c)) since patient health information is evident in many quality measurement implementations.
The application of the “amendment” criterion is not necessary for care coordination. We have made the “amendment” criterion applicable to the “clinical care” category of criteria (
We agree with commenters that the “automatic access time-out” criterion should apply to the clinical quality measures criteria for the reasons provided by the commenters and have included it as applicable to § 170.315(c) under the P&S certification framework. As discussed in the “application access to Common Clinical Data Set” section of this preamble, we have adopted and applied new P&S criteria (“trusted connection” (§ 170.315(d)(9) and “auditing actions on health information” (§ 170.315(d)(10)) to the three “API” certification criteria as part of the P&S certification framework. These new criteria are derived from the security requirements included in the proposed “API” criterion in the Proposed Rule and have been applied back to the “API” criteria adopted in this final rule.
We have separated out the “patient engagement” category (§ 170.315(e)) by criterion to provide clarity and appropriate application of privacy and security capabilities. In this regard, we do not apply “end-user device encryption” to the “secure messaging” and “patient health information capture” criteria as that was not our intention. We have added the new “trusted connection” criteria to the “patient engagement” category (§ 170.315(e)) to compliment the revisions we made to the “VDT” and “secure messaging” criteria as part of the overall P&S certification framework and to support the functionality included in the “patient health information capture” criterion. Please see the discussions of these criteria earlier in this preamble for further details.
In this final rule, we require that an ONC-ACB must ensure that a Health IT Module presented for certification to any of the certification criteria that fall into each regulatory text “first level paragraph” category of § 170.315 (
We clarify that of the adopted 2015 Edition certification criteria, only the privacy and security criteria and the criteria specified in § 170.315(g)(1) through (6) are exempt from the P&S certification framework due to the capabilities included in these criteria, which do not implicate privacy and security concerns.
In order to be issued a certification, a Health IT Module would only need to be tested once to each applicable privacy and security criterion identified as part of Approach 1 or Approach 2 so long as the health IT developer attests that such privacy and security capabilities apply to the full scope of capabilities included in the requested certification, except for the certification of a Health IT Module to § 170.315(e)(1) “VDT” and (e)(2) “secure messaging.” For each criterion, a Health IT Module must be separately tested to § 170.315(d)(9) because of the specific capabilities for secure electronic transmission and secure electronic messaging included in each criterion, respectively.
We proposed to revise § 170.550 to add paragraph (g), which would require ONC-ACBs to certify Health IT Modules to certain proposed certification criteria under § 170.315(g). We proposed to require ONC-ACBs to certify Health IT Modules to § 170.315(g)(3) (safety-enhanced design) and § 170.315(g)(6) (Consolidated CDA creation performance) consistent with the requirements included in these criteria. We noted that paragraph (g) also includes a requirement for ONC-ACBs to certify all Health IT Modules presented for certification to the 2015 Edition to § 170.315(g)(4) (quality system management) and (g)(8) (accessibility-centered design). We explained that the proposed certification requirements for § 170.315(g)(3) and (4) maintain the policy approach established with certification to the 2014 Edition (see § 170.550(f)(2) and (3)), which ensures Health IT Modules, as applicable, are certified to these specific safety and quality certification criteria. We also explained that the proposed certification requirement for § 170.315(g)(6) is associated with the new “Consolidated CDA creation performance” criterion we proposed for the 2015 Edition. We reiterated that the requirement is similarly designed to ensure that Health IT Modules (with Consolidated CDA creation capabilities within their scope) are also certified to the “Consolidated CDA creation performance” criterion. We noted the proposed certification requirements for § 170.315(g)(8) were associated with the new “accessibility-centered design” criterion we proposed for the 2015 Edition, which patterned the certification approach of the 2014 Edition “quality system management” criterion.
We proposed new requirements for “in-the-field” surveillance and maintenance of certification under the ONC Health IT Certification Program. The requirements would clarify and expand ONC-ACBs' existing surveillance responsibilities, including the responsibility to perform surveillance of certified capabilities “in the field.” We explained that in-the-field surveillance is necessary to provide assurance to customers, implementers, and users that health IT certified on behalf of ONC will continue to meet the requirements of its certification when it is implemented and used in a production environment.
Our proposal defined in-the-field surveillance and specified certain conditions and procedures under which ONC-ACBs would be required to initiate in-the-field surveillance of certified Complete EHRs and certified Health IT Modules. We delineated separate requirements for surveillance based on complaints or other information about potential non-conformities (“reactive surveillance”) and for surveillance based on a random sampling approach (“randomized surveillance”). In addition, we specified certain corrective action plan requirements and procedures that would apply in the context of randomized surveillance. ONC-ACBs would also be required to report the results of their in-the-field surveillance to the National Coordinator on at least a quarterly basis and, separately, to report corrective action plan information to the publicly accessible open data CHPL detailed in our separate proposal “Open Data Certified Health IT Product List (CHPL).”
To implement the new requirements for in-the-field surveillance outlined in the Proposed Rule, we proposed to add § 170.556 (In-the-field surveillance and maintenance of certification for health IT) and amend § 170.503 (ONC-AA Ongoing Responsibilities) and § 170.523 (ONC-ACB Principles of Proper Conduct).
We proposed to explicitly define in-the-field surveillance to mean an ONC-ACB's assessment of whether a certified Complete EHR or certified Health IT Module to which it has issued a certification continues to conform to the certification's requirements when the health IT is implemented and in use in the field. This assessment would require an ONC-ACB to assess the technology's capabilities in a production environment and, where applicable, would be based on the use of the capabilities with protected health information (PHI), unless the use of test data were specifically approved by the National Coordinator. We explained that such surveillance could be performed through an in-person site visit or by remote observation. We solicited comments on these and other approaches to in-the-field surveillance.
Several commenters described specific challenges they or their members had encountered with certified health IT capabilities that failed to perform in an acceptable manner when implemented in the field. For example, one commenter stated that it had witnessed several instances in which certified health IT that had successfully demonstrated the ability to send a single standards-compliant continuity of care document in a controlled testing environment could not “scale” and send multiple standards-compliant continuity of care documents when deployed in a production environment. Commenters stated that our proposed in-the-field surveillance requirements would help identify and address these kinds of apparent non-conformities.
While ONC-ACBs are already required to conduct in-the-field surveillance as part of their overall surveillance approaches, we agree with these commenters that establishing more explicit and more rigorous requirements will promote greater consistency and clarity regarding ONC-ACBs' responsibilities for conducting in-the-field surveillance, which will in turn improve the reliability and performance of certified health IT and help identify and address potential non-conformities.
Under the ONC Health IT Certification Program, ONC-ACBs' surveillance approaches must include the use of consistent, objective, valid, and reliable methods, subject to the ongoing supervision of the ONC-AA.
We also agree that ONC-ACBs should, where appropriate, involve health IT developers in their surveillance activities. For example, an ONC-ACB could require a health IT developer to provide technical assistance to the ONC-ACB in understanding and analyzing variations not seen during the testing and certification process and other complexities. ONC-ACBs could also require or permit health IT developers to assist in analyzing and determining the causes of issues, provided such assistance does not compromise the ONC-ACB's independence or the requirements of its accreditation.
In light of these complexities, we identified the basic principles that would guide an ONC-ACB's surveillance of certified health IT in the field. (80 FR 16877). In response to commenters' requests for additional clarity, we further elaborate on these principles below. We believe that with these additional clarifications, the principles we have identified will provide ONC-ACBs with clear and predictable guidance and ensure that in-the-field surveillance is conducted in a fair, reliable, and consistent manner across all health IT products and implementations.
Testing is an important part of an ONC-ACB's overall analysis of health IT under the ONC Health IT Certification Program. For practical reasons, however, testing focuses on particular use cases and necessarily reflects assumptions about how capabilities will be implemented and used in practice. Thus while test results provide a preliminary indication that health IT meets the requirements of its certification and can support the capabilities required by the certification criteria to which the technology was certified, that determination is always subject to an ONC-ACB's ongoing surveillance, including the ONC-ACB's evaluation of certified capabilities in the field. Indeed, a fundamental purpose of in-the-field surveillance is to identify deficiencies that may be difficult to anticipate or that may not become
A non-conformity arises when certified health IT fails to conform to the requirements of its certification under the ONC Health IT Certification Program. Those requirements take several forms and may apply to aspects of the design and performance of technology as well as the responsibilities of health IT developers. In particular, certified health IT must be able to support the capabilities and uses required by applicable certification criteria, and developers must make such capabilities available in ways that enable them to be implemented and used in production environments for their intended purposes.
While these requirements vary based on the specific certification criteria or program requirements at issue, all of them focus on the responsibilities of health IT developers and those aspects of their technology that they can reasonably influence or control. Accordingly, if an ONC-ACB finds that health IT, as implemented in the field, cannot demonstrate required capabilities in a compliant manner, the ONC-ACB must determine the reasons for the failure, including the roles of the technology as well as the health IT developer, users, and other parties. If the ONC-ACB finds that the developer or its technology were a substantial cause of the failure, the ONC-ACB would conclude that the health IT does not meet the requirements of its certification. By contrast, if the ONC-ACB finds that the failure was caused exclusively by factors far removed from the control or responsibility of the developer, the ONC-ACB would regard those factors as beyond the scope of the health IT's certification and would not find a non-conformity. The following contrasting scenarios provide an example of these requirements in practice.
•
Based on these facts, the ONC-ACB would find a non-conformity because the failure of the certified health IT to function as expected was due solely to the actions of the developer that prevented the user from accessing capabilities to which the health IT was certified.
•
Based on these facts, the ONC-ACB would not find a non-conformity because, while the technology was unable to perform required capabilities in the field, the failure was caused by
•
Based on these facts, the ONC-ACB would find a non-conformity. Specifically, the developer has restricted access to training materials and instructions that are needed to access and capability and successfully use it to achieve the technical outcomes contemplated by § 170.315(b)(6). Indeed, as the scenario illustrates, the restriction effectively prevents a user from using the data export capability at all. As such, the technology no longer conforms to the requirements of its certification.
•
Based on these facts, the ONC-ACB would find a non-conformity. Specifically, the developer has placed a technical limitation on its technology by disabling and thus preventing users from accessing functionality within the scope of the technology's certification to the data export capability. Indeed, the ability to create a set of export summaries based on a relative time and date is expressly required by § 170.315(b)(6)(iii)(B)(2). That a customer must specifically request that the developer turn on the functionality is a substantial interference with a user's ability to access and use this aspect of the certified capability. As such, the technology no longer conforms to the requirements of its certification.
As an example, if the developer in Scenario D above failed to disclose the technical limitation described in that scenario, the ONC-ACB would find a non-conformity to the disclosure requirements at § 170.523(k)(1). This determination would be warranted because the developer's failure to disclose the limitation could substantially interfere with the ability of a user or prospective user to implement the data export capability in a manner consistent with the technology's certification to § 170.315(b)(6).
Given the risk of non-conformity created by the failure of a developer to disclose the kinds of material information described above, and the concomitant requirement for ONC-ACBs to evaluate such disclosures in order to properly evaluate certified technology in the field, we have finalized elsewhere in this final rule our proposal to expand and clarify the types of information that developers are required to disclose as a condition of certification under the ONC Health IT Certification Program. We discuss these disclosure requirements in detail in section IV.D.2 of this preamble, “Transparency and Disclosure Requirements.”
For the foregoing reasons, and with the clarifications discussed above, we have finalized as proposed the definition of in-the-field surveillance at § 170.556(a).
We proposed to clarify and add to ONC-ACBs' responsibilities for
Some commenters, mostly ONC-ACBs, sought greater clarity regarding the interaction between the proposed reactive surveillance requirements and ONC-ACBs' existing responsibilities for conducting reactive and other forms of surveillance pursuant to the requirements of their accreditation to ISO/IEC 17065 and authorization to issue certifications under the ONC Health IT Certification Program. Relatedly, several commenters noted that the proposed duty to initiate reactive surveillance would require in all cases that such surveillance take place in the field; these commenters regarded this as an overly broad requirement that could unnecessarily supplant other forms of “traditional” surveillance that, depending on the circumstances, may be more effective and less burdensome.
The proposed reactive surveillance requirements focused primarily on an ONC-ACB's duty to initiate surveillance of certified health IT
Because our intent was to build upon—not supplant—these traditional forms of surveillance, we have revised the requirements at § 170.556(b) as follows. Under § 170.556(b), an ONC-ACB has a duty to initiate reactive surveillance—including, as necessary, in-the-field surveillance—whenever it becomes aware of facts or circumstances that would cause a reasonable person to question a certified Complete EHR or certified Health IT Module's continued conformity to the requirements of its certification. Such conformity includes both ongoing conformity to applicable certification criteria as well as compliance with other requirements of certification, including the disclosure requirements for health IT developers at § 170.523(k)(1).
Whether reactive surveillance must include in-the-field surveillance or may employ other methods is governed by the definition and principles for in-the-field surveillance described earlier in this preamble and codified at § 170.556(a), including the nature of the suspected non-conformity and the adequacy of other forms of surveillance under the circumstances. In most cases, the need to evaluate the certified health IT in the field will be obvious from the nature of the suspected non-conformity. For example, if a problem with a certified health IT capability is reported to arise only in connection with a specific local implementation option, an ONC-ACB would likely need to observe the relevant capabilities in the field in order to fully analyze the cause of the problem and determine whether it is the result of a non-conformity. In other cases, the need for in-the-field surveillance may become apparent only after other surveillance methods and techniques have failed to isolate the cause of the problem.
In-the-field surveillance may also be necessary to determine a developer's compliance with certification program requirements, such as the mandatory disclosure requirements at § 170.523(k)(1). While non-compliance with these requirements may often be established from complaints and a review of a developer's disclosures, certain kinds of undisclosed limitations on the capabilities of certified health IT may need to be confirmed through in-the-field surveillance of the technology, or may not be discovered at all except upon observing the operation of certified capabilities in the field.
In determining whether to initiate reactive surveillance, an ONC-ACB must consider and weigh the volume, substance, and credibility of complaints and other information received against the type and extent of the alleged non-conformity, in light of the ONC-ACB's expertise and experience with the particular capabilities, health IT, and certification requirements at issue. For example, if an ONC-ACB receives a number of anonymous complaints alleging general dissatisfaction with a particular certified Health IT Module, the ONC-ACB is not be required to initiate surveillance (though it would not be precluded from doing so). In contrast, if an ONC-ACB receives several complaints alleging, for example, that a particular certified Health IT Module is unable to electronically create a set of export summaries in accordance with the data export certification criterion at § 170.315(b)(6), the ONC-ACB must initiate surveillance of the Health IT Module unless a reasonable person in the ONC-ACB's position would doubt the credibility or accuracy of the complaints. A reasonable basis for doubt might exist if the ONC-ACB had recently responded to the very same issue and determined through in-the-field surveillance of the Health IT Module at several different locations that the reported problem was due to a “bug” arising from an unsupported use of the Health IT Module that the developer had specifically cautioned users about in advance.
An ONC-ACB's decision to initiate reactive surveillance must also take into account complaints and other information indicating whether a health IT developer has disclosed all known material information about certified capabilities, as required by § 170.523(k)(1). The failure to disclose this information calls into question the continued conformity of those capabilities because it creates a substantial risk that existing and prospective users will encounter problems implementing the capabilities in a manner consistent with the applicable certification criteria. Thus in the example above, if the complaints received by the ONC-ACB suggested that the developer knew about but failed to disclose the data export issue to users, the ONC-ACB would be required to initiate in-the-field surveillance of the certified Health IT Module to verify whether the developer had failed to disclose known material information and, if so, whether the failure to disclose that information prevented users from reasonably implementing and using the data export capability in accordance with the requirements of the certification criterion at § 170.315(b)(6).
We believe the foregoing principles and examples will provide sufficient clarity and practical guidance for ONC-ACBs regarding their responsibilities for conducting reactive surveillance pursuant to § 170.556(b). If necessary, we will issue additional guidance to ONC-ACBs to assist them in conducting such surveillance in a consistent, objective, and reliable manner.
Regardless of the form of the information or how it comes to an ONC-ACB's attention, if the information suggests that health IT the ONC-ACB has certified may no longer conform to the requirements of its certification, the ONC-ACB is required to initiate surveillance. For example, an ONC-ACB may become aware of a potential non-conformity through user surveys and other “behind-the-scenes” surveillance of users and products. Or an ONC-ACB may become aware of a potential non-conformity while auditing a developer's website and other disclosures. ONC will also share information with ONC-ACBs, which may well come from the trade press and other sources. And, of course, an ONC-ACB will receive complaints from a variety of sources, including, as one commenter suggested, entities such as public health agencies that may not be certified health IT users. All of this information would compose the facts and circumstances of which an ONC-ACB is aware and is required to consider in determining whether to initiate surveillance.
In addition to reactive surveillance, we proposed to require ONC-ACBs to initiate in-the-field surveillance on a “randomized” basis for the certification criteria prioritized by the National Coordinator. For those prioritized certification criteria, an ONC-ACB would be required each calendar year to randomly select at least 10% of the Complete EHRs and Health IT Modules to which it has issued a certification. The ONC-ACB would then be required to initiate in-the-field surveillance of each such certified Complete EHR or certified Health IT Module at the lesser of 10 or 5% of locations at which the technology is implemented and in use in the field. The locations would be selected at random, subject to certain sampling considerations and limited exclusions described in the Proposed Rule.
We stated that randomized surveillance would enable ONC-ACBs to identify non-conformities that are difficult to detect through complaint-based or other reactive forms of surveillance. Randomized surveillance would also enable an ONC-ACB to detect patterns of non-conformities that indicate a more widespread or recurring problem requiring a comprehensive corrective action plan. We proposed that a pattern of non-conformity would exist if an ONC-ACB found that a certified Complete EHR or certified Health IT Module failed to demonstrate conformity to any prioritized certification criterion at 20% or more of the locations surveilled. Upon such a finding, the ONC-ACB would deem the certified Complete EHR or certified Health IT Module “deficient” and impose a corrective action plan on the developer of the certified Complete EHR or certified Health IT Module. We specified certain elements and procedures that would be required for such corrective action plans.
A number of commenters—including the ONC-AA and the ONC-ACBs—raised concerns regarding this aspect of our proposal. The ONC-ACBs estimated that performing randomized surveillance on 10% of certified products, even at the relatively small number of locations specified in the Proposed Rule, would as much as double the total cost of certification and divert an inordinate amount of time and resources away from other important certification and surveillance activities. Meanwhile, commenters including the ONC-AA doubted that the proposed sample size would be sufficient to detect patterns of non-conformities or to determine with any degree of confidence how widespread a particular non-conformity may be. In this connection, commenters pointed out that surveilling a randomly selected certified Complete EHR or certified Health IT Module at the lesser of 10 or 5% of locations at which the technology is installed may not yield a statistically significant result. For example, if an ONC-ACB were to randomly select a Health IT Module installed at 40 locations, the ONC-ACB would only be required to perform in-the-field surveillance at 2 locations. The ONC-AA stated that performing surveillance of certain certified capabilities, such as interoperability or privacy and security, at only 2 locations would be insufficient to identify all but the grossest non-conformities.
Some commenters felt that it was premature to codify a specific approach to randomized surveillance and that we should instead create a “pilot study” or allow ONC-ACBs to continue to experiment with approaches to randomized surveillance in order to gauge the willingness of providers to participate, potential methodologies, and the costs and benefits of this type of surveillance.
Accordingly, we have revised the proposed randomized surveillance requirements as follows. First, we have reduced the annual sample size for randomized surveillance. Instead of 10% of all certified Complete EHRs and certified Health IT Modules, an ONC-ACB must perform randomized surveillance on 2% of certified Complete EHRs or certified Health IT Modules each year. Based on current data on the CHPL, we estimate this could require ONC-ACBs to perform randomized surveillance of up to 24 products per calendar year (depending on the total number of products the ONC-ACB has certified, which we expect will increase with the addition of Health IT Modules certified to the 2015 Edition). We believe this new minimum threshold will provide additional insight and experience related to randomized surveillance. This specific baseline will establish a randomized surveillance program that advances our policy aims while reducing the burden of randomized surveillance for all stakeholders and making this initial approach more manageable for ONC-ACBs. That being said, we intend to continually review surveillance results and experiences to determine whether and how to increase this threshold over time (e.g., whether an incrementally rising threshold over time would be appropriate and effective). We also intend to pursue and investigate other avenues that could add feedback to (and be combined with) this surveillance process. For example, we will explore other kinds of tools, such as those that may be able to be used directly by health care providers to test and report how their products performed. Overall, and over the long-term, we believe that other approaches can and should be included to complement the randomized in-the-field surveillance performed by ONC-ACBs.
Second, while an ONC-ACB must perform surveillance of randomly selected certified Complete EHRs and certified Health IT Modules in the field, we no longer specify a minimum number of locations at which the ONC-ACB will be required to conduct such surveillance. This revision reflects commenters' insight that requiring an ONC-ACB to surveil the technology at the lesser of 5% or 10 locations, as we had proposed, could be simultaneously both burdensome and yet unlikely to yield statistically significant or generalizable results. It also reflects our recognition, underscored by the comments, that well-established methodologies and standards for post-market surveillance used in other industries typically focus on conformity testing of discrete products or components in isolation and thus provide little guidance for formulating appropriate sampling and statistical methods under the ONC Health IT Certification Program. Given the lack of suitable reference models in other industries, we agree with commenters that this particular aspect of an ONC-ACB's randomized surveillance approach would benefit from additional experience and piloting. Thus we intend to work with ONC-ACBs and the ONC-AA and issue guidance as necessary to refine these aspects and ensure the use of consistent and reliable methods across ONC-ACBs and their surveillance approaches.
Finally, we have eliminated the concept of “deficient surveillance results” and instead applied the proposed corrective action plan requirements across-the-board to all types of surveillance and confirmed non-conformities. Thus, if an ONC-ACB performs randomized surveillance for a certified Complete EHR or certified Health IT Module and confirms a non-conformity, it must institute a corrective action plan under § 170.556(d) and report related information to the open data CHPL, as required by § 170.556(e)(3). This requirement applies regardless of whether the non-conformity meets the 20% “deficiency threshold” described in the Proposed Rule. These changes are described in more detail below in our responses to the comments on these aspects of our proposal.
We have finalized these revisions at § 170.556(c)-(e).
Commenters also suggested we clarify or specify additional requirements related to the number and types of locations at which an ONC-ACB must surveil certified Complete EHRs and certified Health IT Modules that it has randomly selected for in-the-field surveillance. One commenter stressed the importance of ensuring random selection of and diversity in the providers and locations selected for surveillance. Another commenter suggested that an ONC-ACB's approach to selecting locations would need to vary depending on the type of implementation (
In consideration of the comments provided, we have determined that an ONC-ACB's selection process under randomized surveillance will adhere to the following requirements. On an annual basis the ONC-ACB must ensure that it meets the threshold sample size, which is initially being established at 2% of all of the Complete EHRs and Health IT Modules to which the ONC-ACB has issued a certification. The ONC-ACB must randomly select products from those to which it has issued a certification, but is permitted to implement appropriate weighting and sampling considerations. After an ONC-ACB has randomly selected a product for surveillance, for each product selected, the ONC-ACB must select a random sample of one or more locations at which the ONC-ACB will initiate in-the-field surveillance of the certified Complete EHR or certified Health IT Module's prioritized capabilities. At both stages of the selection process, an ONC-ACB must ensure that every product selected and every provider location at which the product is in use has a chance of being randomly selected for in-the-field surveillance (unless a product is excluded from selection because it was already selected for randomized surveillance within the last 12 months). This prospect, that any product and location may be selected at random, is the essence of a “random sampling” approach and is a central feature of randomized surveillance because it ensures that all health IT developers' products and implementations are potential candidates for in-the-field surveillance. The possibility that any product may be surveilled at any provider location will encourage developers to proactively address issues and improve the real-world performance and reliability of health IT capabilities across all customers.
Consistent with these principles, we clarify that an ONC-ACB's selection of products and locations need not be random in the absolute sense of assigning an equal probability of selection to every product or location in the pool. Indeed, for the reasons stated by commenters, there may be strong justifications for assigning different probabilities or “weights” to products or locations based on a variety of factors that are relevant to maximizing the value and impact of randomized surveillance activities for providers and other stakeholders. For example, when selecting products for randomized surveillance, the ONC-ACB could assign greater weight to products that are more widely adopted and used so as to increase the likelihood that the products surveilled will include at least some products with a large number of installations and users. This would increase the overall impact of the ONC-ACB's surveillance activities by increasing the likelihood of discovering and addressing non-conformities that affect a large number of providers and users. As another example, when randomly selecting locations at which to perform in-the-field surveillance for any particular product, an ONC-ACB might ensure that no two locations selected are under the common ownership or control of a single person or entity, thereby addressing the concerns raised by commenters regarding the diversity of providers and locations selected for randomized surveillance.
To avoid any misinterpretation of the phrases “randomly select” and “selected at random,” we have clarified the regulation text at § 170.556(c)(2) and § 170.556(c)(4)(ii) to allow for appropriate weighting and sampling considerations in the random selection of products and locations, respectively.
Finally, we note that under the ONC Health IT Certification Program, it is an ongoing responsibility of the ONC-AA to ensure that the surveillance approaches used by ONC-ACBs, including the selection processes and methodologies for randomized surveillance discussed above, include the use of consistent, objective, valid, and reliable methods. (§ 170.503(e)(2)). We intend to work closely with the ONC-AA and the ONC-ACBs to ensure that such methods are in place and to identify and incorporate appropriate best practices and elements that serve the policies of this final rule.
Given these concerns, some commenters suggested that ONC-ACBs should not be required to conduct randomized surveillance unless providers are also required to participate in such surveillance as a condition of participation in the EHR Incentive Programs or other programs. Alternatively, other commenters suggested that we provide exceptions and other flexibility for ONC-ACBs in the event that a provider is selected for but does not cooperate with an ONC-ACB's in-the-field surveillance of the provider's certified health IT. Several commenters requested clarity on our expectations for providers' role as participants in in-the-field surveillance, especially randomized surveillance.
Because we agree that an ONC-ACB should not be penalized in such situations, we clarify that where an ONC-ACB makes a good faith effort but is nevertheless unable to complete in-the-field surveillance at a particular location for reasons beyond its control, the ONC-ACB may exclude the location and substitute another location that meets the random selection requirements described above. Similarly, in the event that the ONC-ACB exhausts all available locations for a particular certified Complete EHR or certified Health IT Module, the ONC-ACB may exclude that Complete EHR or Health IT Module and substitute another randomly selected Complete EHR or Health IT Module. In the case of exhaustion, we clarify that the excluded certified Complete EHR or Health IT Module would be counted towards the minimum number of products an ONC-ACB is required to randomly surveil during the calendar year surveillance period. We emphasize, however, that an ONC-ACB must carefully and accurately document its efforts to complete in-the-field surveillance for each product and at each location. The ONC-AA would be expected to review this documentation to ensure that ONC-ACBs have met the required random selection requirement and have made a good faith effort to perform in-the-field surveillance prior to excluding any product or location from randomized surveillance. We believe that these revisions—combined with the reduced minimum sample size for in-the-field surveillance and the clarifications noted above regarding the number of locations at which an ONC-ACB must observe capabilities in the field—will mitigate the concerns raised by commenters and make randomized surveillance more manageable for ONC-ACBs, providers, and developers.
It is our expectation that providers will cooperate with an ONC-ACB's authorized surveillance activities, including the surveillance of certified health IT in the field. While we understand that some providers may be reluctant to grant ONC-ACBs access to PHI, we point out that providers who commented on our proposal overwhelmingly supported and urged us to finalize requirements for the surveillance of certified health IT in the field (i.e., in production environments in which the technology is implemented and used). Such surveillance will only be successful if providers are actively engaged and cooperate with ONC-ACBs' surveillance activities, including by granting access to and assisting ONC-ACBs to observe the performance of production systems. We also note that, in consultation with the Office for Civil Rights, we have clarified that under the “health oversight agency” exception of the HIPAA Privacy Rule, a healthcare provider is permitted to disclose PHI to an ONC-ACB during the course of authorized in-the-field surveillance activities, without patient authorization and without a business associate agreement.
In the Proposed Rule, we stated that if an ONC-ACB found a pattern of nonconformity—defined as a failure to demonstrate conformity to any prioritized certification criterion at 20% or more of the locations surveilled—the ONC-ACB would be required to treat the certified Complete EHR or certified Health IT Module as “deficient.” This finding would also trigger special requirements for corrective action plans and the reporting of that information to the open data CHPL. Specifically, the ONC-ACB would have to contact the developer of the certified Complete EHR or certified Health IT Module and require the developer to submit a proposed corrective action plan to the ONC-ACB within 30 days of the date that the developer was notified by the ONC-ACB of the “deficient” finding. The ONC-ACB would be responsible for prescribing the form and content of corrective action plans and for developing specific procedures for submission and approval, with guidance from ONC to promote consistency across ONC-ACBs.
Particularly in light of the reduced emphasis on randomized surveillance in comparison to the Proposed Rule, we are persuaded that our policy objectives will be better served by requiring the same approach to corrective action across the board. Thus we have finalized the proposed requirements for corrective action plans for all certified Complete EHRs and certified Health IT Modules for which an ONC-ACB confirms a non-conformity, whether that non-conformity is confirmed through randomized, reactive, or any other form of surveillance under the ONC Health IT Certification Program.
For similar reasons, we have finalized the proposed reporting requirements for corrective action plans and extended these requirements to all cases in which an ONC-ACB confirms a non-conformity and subsequently approves a corrective action plan. Requiring the uniform submission of this information will promote transparency and alert health IT users, implementers, and purchasers to potential conformity issues in a more timely and effective manner. These reporting requirements are discussed further below in our response to the comments on this aspect of our proposal and also in our discussion of the “Open Data CHPL” requirements found elsewhere in this preamble.
Accordingly, we have added as a requirement of all corrective action plans approved by an ONC-ACB that the developer identify a process for ensuring that all affected and potentially affected customers and users are alerted to identified non-conformities and deficiencies, as applicable. This process must describe in detail: How the developer will assess the scope and impact of the problem, including identifying all potentially affected customers; how the developer will promptly ensure that all potentially affected customers are notified of the problem and plan for resolution; how and when the developer will resolve issues for individual affected customers; and how the developer will ensure that all issues are in fact resolved.
To ensure adherence to these requirements for notification and resolution across a developer's customer base, and to the other requirements of the approved corrective action plan, we have added as an additional requirement of all corrective action plans approved by an ONC-ACB that the developer attest to having completed all required elements of the plan, including the requirements for alerting customers and users described above.
Some commenters, including several health IT developers, objected to the reporting of corrective action plan information to the publicly accessible Open Data CHPL. Some commenters felt that information about non-conformities should not be made public unless and until the developer of the certified Complete EHR or certified Health IT Module at issue has been given a full and fair opportunity to contest the ONC-ACB's determination, including whether the developer was responsible or “at fault” for the non-conformity. Other commenters stated that such information should never be made public because it is bound to lack important context, could be misinterpreted, or would not offer substantial value to health IT customers and users. Separately, some commenters raised concerns regarding the reporting of proprietary or competitively sensitive information.
A few commenters suggested that to reduce reporting burden or improve the efficacy of the open data CHPL, we limit the types of information about corrective action that an ONC-ACB would be required to submit. One commenter suggested that the reporting of corrective action plan information be limited to 2015 Edition certified health IT and that reporting of surveillance results be limited to twice a year instead of quarterly. The commenter stated that these changes would reduce burden and enable us to assess the costs of these reporting requirements.
With regard to the reporting of corrective action plan information to the open data CHPL, we understand the concerns raised by some commenters but believe that it is both necessary and appropriate to require ONC-ACBs to submit this information. The public safety, transparency, and program integrity rationales for requiring timely and public reporting of this information are compelling. In comparison, and contrary to the assertions of some commenters, making this information available is not likely to cause customers and users to draw inaccurate or unfair conclusions about a health IT developer or its certified technology. By definition, this information will only be required when an ONC-ACB has confirmed a non-conformity and
We are confident that the concerns of some commenters regarding disclosure of proprietary or sensitive information will be adequately addressed through appropriate safeguards implemented at the discretion of ONC-ACBs. ONC-ACBs should not submit to the open data CHPL any information that is in fact legally privileged or protected from disclosure. ONC-ACBs may also implement other appropriate safeguards, as necessary, to protect information they believe should not be reported to a publicly available Web site. However, we caution ONC-ACBs to ensure that such safeguards are narrowly tailored and consistent with our goal of promoting the greatest possible degree of transparency with respect to certified health IT and the business practices of certified health IT developers. ONC-ACBs are required to accurately report the results of their surveillance and to explain in detail the facts and circumstances on which their conclusions are based. Similarly, health IT developers are required to cooperate with these efforts and may not prevent or seek to discourage an ONC-ACB from reporting the results of its authorized surveillance activities. We note that while the ONC Health IT Certification Program is a voluntary one, developers who choose to participate agree to comply with certification program requirements, including reporting requirements designed to ensure transparency and accountability for all participants and stakeholders.
We decline to limit the requirements for more frequent reporting of surveillance results to the National Coordinator and the submission of corrective action plan information to the open data CHPL to 2015 Edition certified health IT. The public safety, transparency, and program integrity reasons for requiring the reporting of this information apply to all, and not only 2015 Edition, certified health IT. However, we do agree that the reporting of corrective action information should be limited to the types of information that will be useful to customers and users, consistent with the goals of reporting this information to the open data CHPL explained above. We have therefore revised § 170.523(f)(1)(xxii) and (f)(2)(xi) to limit reporting to the following subset of information:
• The specific certification requirements to which the technology failed to conform, as determined by the ONC-ACB;
• A summary of the deficiency or deficiencies identified by the ONC-ACB as the basis for its determination of non-conformity;
• When available, the health IT developer's explanation of the deficiency or deficiencies;
• The dates surveillance was initiated and completed;
• The results of randomized surveillance, including pass rate for each criterion in instances where the Health IT Module is evaluated at more than one location;
• The number of sites that were used in randomized surveillance;
• The date of the ONC-ACB's determination of non-conformity;
• The date on which the ONC-ACB approved a corrective action plan;
• The date corrective action began (effective date of approved corrective action plan);
• The date by which corrective action must be completed (as specified by the approved corrective action plan);
• The date corrective action was completed; and
• A description of the resolution of the non-conformity or non-conformities.
We clarify that the 30 day period for submitting a proposed corrective action plan would begin to run only after an ONC-ACB has issued a non-conformity determination. In our experience, ONC-ACBs already work with health IT developers and users to investigate potential non-conformities prior to issuing a final determination. Because this back-and-forth will have occurred prior to the ONC-ACB's non-conformity determination, we believe that a developer should be able to submit a proposed corrective action plan within 30 days of being notified of the ONC-ACB's non-conformity determination under § 170.556(d)(1). Similarly, if after 90 days of notifying the developer of a non-conformity under § 170.556(d)(1), the ONC-ACB cannot approve a corrective action plan because the developer has not submitted a revised proposed corrective action plan in accordance with § 170.556(d)(4), the ONC-ACB must initiate suspension procedures. Finally, an ONC-ACB must initiate suspension procedures when it has approved a corrective action plan but the developer fails to comply with all of the requirements of the plan within the time specified therein. We have revised § 170.556(d)-(e) to reflect these requirements.
At the time of this Proposed Rule, ONC-ACBs had submitted their annual surveillance plans for calendar year 2015, which include their existing approaches and methodologies for randomized surveillance. To minimize disruption to ONC-ACBs' current surveillance activities, we proposed to make the requirements for randomized surveillance effective beginning on January 1, 2016. We said this would provide time for ONC-ACBs to implement these requirements in their annual surveillance plans and incorporate additional guidance and clarification from ONC and the ONC-AA as necessary. All other proposed surveillance requirements would be effective immediately. We requested comment on whether this timeline and plan for implementation was appropriate and on ways to minimize disruption and ensure that the requirements and purpose of this proposal are timely and effectively achieved.
One ONC-ACB suggested that the proposed requirements for in-the-field surveillance be applied only to 2015 Edition certified health IT so that ONC-ACBs could implement the requirements prospectively in new contracts with health IT developers.
We decline to adopt the commenter's suggestion to limit the requirements for in-the-field surveillance and maintenance of certification to only 2015 Edition certified health IT. The need to assure that certified health IT conforms to the requirements of its certification is applicable to all health IT certified under the ONC Health IT Certification Program, not just technology certified to the new 2015 Edition. Thus, as proposed, we have finalized the in-the-field surveillance and maintenance of certification requirements for all Health IT Modules certified to either the 2015 Edition or the 2014 Edition. With respect to Complete EHRs, because we have discontinued Complete EHR certification with the 2015 Edition, we have finalized these requirements for all Complete EHRs certified to the 2014 Edition. We note that Complete EHR certification to the 2014 Edition has and will continue to occur as providers may use health IT certified to the 2014 Edition to meet the CEHRT definition at least through 2017 based on the EHR Incentive Programs Stage 3 and Modifications final rule published elsewhere in this issue of the
We proposed to revise the Principles of Proper Conduct for ONC-ACBs to require greater and more effective disclosure by health IT developers of certain types of limitations and additional types of costs that could interfere with the ability to implement or use health IT in a manner consistent with its certification. We stated that these additional disclosure requirements were necessary to ensure that existing and potential customers, implementers, and users of certified health IT are fully informed about these implementation considerations that accompany capabilities certified under the ONC Health IT Certification Program.
Our proposal expanded on health IT developers' existing disclosure obligations at § 170.523(k)(1). Those obligations were adopted in the 2014 Edition final rule to promote greater price transparency in certified health IT capabilities required to meet meaningful use objectives and measures; to mitigate confusion in the marketplace; and to reduce the risk that EPs, eligible hospitals, and CAHs would encounter unexpected difficulties in the implementation or use of certified health IT.
As we explained in the Proposed Rule, despite our initial efforts to promote greater transparency and disclosure of information by health IT developers, many providers continue to lack reliable up-front information about health IT products and services. We described reports from providers who have encountered unexpected costs and limitations in connection with their certified health IT that were not disclosed or contemplated when the technology was initially purchased or licensed. (80 FR 16880-81). We said that the failure of developers to disclose “known material information” about limitations or additional types of costs associated with the capabilities of certified health IT diminishes both the reliability of certified health IT and of certifications issued under the ONC Health IT Certification Program. In particular, the failure of developers to disclose such information creates a substantial risk that existing or prospective users of certified health IT will encounter problems implementing and using the health IT in a manner consistent with its certification. Moreover, inadequate or incomplete information about health IT products and services distorts the marketplace by preventing customers from accurately assessing the costs and capabilities of different technologies and selecting the most appropriate solutions to their needs, which increases the likelihood of downstream implementation problems and, ultimately, reduced opportunities to use health IT to improve health and health care. Finally, customers who purchase or license inappropriate or suboptimal technologies may find it difficult to switch to superior alternatives due to the often significant financial and other “switching costs” associated with health IT.
For all of these reasons, we proposed to revise and strengthen our existing transparency and disclosure requirements in three key respects.
First, under our proposal, a health IT developer's obligation to disclose “additional types of costs” would no longer be confined to the use of capabilities to demonstrate a meaningful use objective or measure under the EHR Incentive Programs. Instead, ONC-ACBs would be required to ensure that developers disclose any additional types of costs that a user may incur in order to implement or use capabilities of
Second, in addition to “additional types of costs,” we proposed that health IT developers would be required to disclose other factors that may similarly interfere with a user's ability to successfully implement certified health IT, including information about certain “limitations” associated with its certified health IT. We explained that the failure to disclose information about limitations—including contractual, technical, and other restrictions or policies—associated with certified health IT creates a substantial risk that current or prospective users will encounter problems implementing the health IT in a manner consistent with its certification. Thus the disclosure of this information is no less important than the disclosure of information about additional types of costs.
Third, with regard to both “limitations” and “additional types of costs,” we proposed to significantly broaden the types of information and the level of detail that a health IT developer would be required to disclose. In contrast with the price transparency requirements adopted in the 2014 Edition final rule, which required disclosure only of additional types of costs that a user “would pay” to implement certain capabilities, we proposed to require health IT developers to be more proactive in identifying the kinds of limitations and additional types of costs that a user “may” pay or encounter in order to achieve any use of the health IT within the scope of its certification. Specifically, developers would be required to provide, in plain language, a detailed description of any “known material information” about limitations that a purchaser may encounter, and about additional types of costs that a user may be required to pay, in the course of implementing or using the capabilities of health IT to achieve any use within the scope of its certification. We also provided an extensive discussion of the types of information that would be deemed “material” and of the types of information that developers would and would not be required to disclose. Further, we described the manner in which the information would need to be disclosed as well as safeguards to avoid the disclosure of intellectual property and trade secrets.
Finally, in addition to these three aspects, we proposed one additional element designed to complement the disclosure requirements set forth in the Proposed Rule. We proposed that in addition to requiring health IT developers to disclose known material information about their certified health IT, an ONC-ACB would be required to obtain a public attestation from every health IT developer to which it issues or has issued a certification for any edition of certified health IT. The attestation would take the form of a written “pledge” by the health IT developer to take the additional, voluntarily step of proactively providing information (which it would already be required to disclose via its website and in marketing and other materials) to all current and prospective customers as well as to any other persons who request such information. While adherence to the attestation would be strictly voluntary, we explained that requiring developers to make the attestation could encourage a culture of greater transparency and accountability in the health IT marketplace. For example, health IT purchasers, implementers, and users (and organizations that represent them) would be invited to approach developers directly and request information most relevant to their health IT decisions and needs. The expectation that developers will provide this information in a way that is more meaningful for stakeholders, consistent with the attestation, would create greater competitive incentives for developers to do so. Developers would also receive important feedback about the types of information that stakeholders find important, which would assist developers in meeting their disclosure obligations under the ONC Health IT Certification Program. For example, requests for information about a particular cost or capability may alert the developer to a material limitation or additional type of cost that it is required to disclose.
Many commenters stated that the proposed transparency and disclosure requirements would help ensure that providers are informed of these and other considerations and enable them both to more reliably estimate the resources needed to successfully implement certified health IT capabilities and to arrive at a realistic expectation of how those capabilities will perform in the field. Commenters also noted that this increased ability of customers to assess and compare certified health IT products and services could reduce the problems of “lock in” and “unfair surprise” described in our proposal and put pressure on developers to compete to innovate and deliver better and more affordable technologies and solutions based on provider and consumer preferences. Commenters also stated that greater transparency in health IT products and services would help to expose and discourage information blocking and other business practices that frustrate interoperability and prevent the effective sharing of electronic health information. A number of commenters cited our discussion of these issues in our recent Report to Congress on Health Information Blocking.
In contrast, some commenters, mostly health IT developers, strongly opposed all of the proposed disclosure requirements. These commenters stated, among other objections, that requiring the disclosure of this information is unnecessary; would be burdensome for developers; and could limit developers' flexibility to design and market their products and services in ways that their customers value. Several commenters stated that the proposed disclosure requirements would be unfair to developers because developers may not be aware of capabilities or uses of their technology that are not specifically required to demonstrate the meaningful use of certified health IT under the EHR Incentive Programs. Some commenters also stated that developers should not be expected to know about—or required to disclose—limitations or additional types of costs that may apply to third-party components or that may flow from local implementation decisions.
First, we respectfully disagree with the assertion that these transparency and disclosure requirements are unnecessary. Our conclusion is based on the overwhelming support for this proposal from providers and other customers of certified health IT, whose comments and first-hand accounts of the health IT marketplace affirm our assessment in the Proposed Rule. Those comments suggest that many customers lack access to reliable information about certified health IT products and services and, as a result, are more likely to encounter unexpected costs and limitations that interfere with their ability to successfully implement and use certified health IT capabilities. The comments also provide insight into other deleterious consequences that flow from a lack of basic transparency in the marketplace, including the increased risk that developers will engage in information blocking and other business practices that undermine the goals of certification and the ONC Health IT Certification Program.
Second, we disagree that the transparency and disclosure requirements are burdensome or unfair to health IT developers. We note that developers are not required to disclose information of which they are not and could not reasonably be aware, nor to account for every conceivable cost or implementation hurdle that a customer may encounter in order to successfully implement and use the capabilities of a developer's certified health IT. Indeed, we recognized in the Proposed Rule that certified health IT often functions in combination with many third party technologies and services whose specific costs and limitations may be difficult for a health IT developer to precisely predict or ascertain. Local implementation factors and other individual circumstances also vary substantially among customers and impact the cost and complexity of implementing certified health IT. In addition, the costs of upgrading health IT to meet new regulatory requirements or compliance timelines, which are subject to change, may make some particular types of additional costs especially difficult to forecast.
Nevertheless, it is reasonable to assume that health IT developers are experts on their own products and services and possess sophisticated technical and market knowledge related to the implementation and use of health IT in a variety of settings in which their products are used. Through their accumulated experience developing and providing health IT solutions to their customers, health IT developers should be familiar with the types of costs and limitations that most users encounter, and therefore must describe these in sufficient detail so as to provide potential customers with the information they need to make informed purchasing or licensing and implementation decisions.
Finally, we disagree that the transparency and disclosure requirements will limit developers' flexibility to design and market their products and services in ways that their customers value. To the contrary, greater transparency in health IT developers' business practices will provide customers with the basic information they need to make informed decisions in the marketplace, which will in turn encourage and enable developers to experiment, innovate, and compete to deliver products and services that customers demand and on such prices and terms that meet their individual needs and requirements.
Nevertheless, based on the comments and in particular the feedback of the ONC-AA, we believe that the principles and examples provided in the Proposed Rule provide a workable starting point for ONC-ACBs to apply, and developers
For the sake of additional clarity, we clarify that to comply with the disclosure requirements, a developer must disclose in plain language—on its website and in all marketing materials, communications statements, and other assertions related to its certified health IT—a detailed description of all known material information concerning limitations and additional types of costs that a person may encounter or incur to implement or use certified health IT capabilities, whether to meet meaningful use objectives and measures or to achieve any other use within the scope of the health IT's certification. Such information is “material” (and its disclosure therefore required) if the failure to disclose it could substantially interfere with the ability of a user or prospective user to implement certified health IT in a manner consistent with its certification. Certain kinds of limitations and additional types of costs will always be material and thus, if known, must be disclosed. These include but are not limited to:
• Additional types of costs or fees (whether fixed, recurring, transaction-based, or otherwise) imposed by a developer (or any third-party from whom the developer purchases, licenses, or obtains any technology, products, or services in connection with its certified health IT) to purchase, license, implement, maintain, upgrade, use, or otherwise enable and support the use of capabilities to which health IT is certified; or in connection with any data generated in the course of using any capability to which health IT is certified.
• Limitations, whether by contract or otherwise, on the use of any capability to which technology is certified for any purpose within the scope of the technology's certification; or in connection with any data generated in the course of using any capability to which health IT is certified.
• Limitations, including but not limited to technical or practical limitations of technology or its capabilities, that could prevent or impair the successful implementation, configuration, customization, maintenance, support, or use of any capabilities to which technology is certified; or that could prevent or limit the use, exchange, or portability of any data generated in the course of using any capability to which technology is certified.
As already noted, developers are not required to disclose information of which they are not and could not reasonably be aware, nor to account for every conceivable type of cost or implementation hurdle that a customer may encounter in order to successfully implement and use the capabilities of the developer's certified health IT. Developers are required, however, to describe
A developer's disclosure obligations are limited to material information that the developer knows or should know about under the circumstances. The reference to third parties at § 170.526(k)(1)(iv)(A) and above is intended to limit the material types of costs a developer will be presumed to know about to those that the developer itself imposes or that are imposed by a third party from whom the developer purchases, licenses, or obtains any technology, products, or services in connection with its certified health IT. This reflects the reality that developers are unlikely to know about types of costs imposed by third parties with whom they do not have a contractual relationship. In contrast, because limitations include not only contractual restrictions but also technical and practical limitations of a developer's technology, developers will often be aware of material limitations notwithstanding the existence of a contractual relationship, and there is therefore no reason to expressly qualify the types of material limitations for which a developer may, in appropriate circumstances, be presumed to have knowledge.
In contrast, several health IT developers and a few other commenters strongly objected to a requirement to disclose any additional information about prices or costs. One commenter stated that this information and other “commercial terms and conditions” are too varied and complex to be disclosed in a useful manner to customers. Other commenters worried that requiring disclosure of this information could expose intellectual property, trade secrets, or other sensitive information.
We understand the importance of ensuring that health IT developers' disclosures provide meaningful information to customers and users of certified health IT. We believe it is important for developers to provide the kind of information and level of detail
At the same time, we appreciate that the disclosure of certain kinds of proprietary or confidential information may not be necessary to achieve these goals and may also lead to undesirable consequences. Requiring developers to disclose trade secrets and other confidential information, for example, could dampen innovation by making it difficult for developers to license and make their technologies available on terms that protect their research and investments.
We believe the approach described in the Proposed Rule accommodates these concerns by ensuring that developers' disclosures are comprehensive, and thus meaningful, while also providing certain safeguards against the unnecessary disclosure of proprietary or confidential information.
Consistent with that approach, and to comply with this final rule, a developer must make a comprehensive disclosure of all known material information regarding its certified health IT—including limitations and additional types of costs. With respect to types of costs, the disclosure must identify and describe the types of costs
The following scenario and discussion further illustrate these requirements.
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Under these facts, the developer must disclose the existence of the subscription fee and the transaction fee—each of which is a known material type of cost associated with the transitions of care capability. In addition, the developer must disclose the known material limitation (and any associated additional types of costs) presented by its HISP policy. The developer must describe each of these additional types of costs and limitations with particularity to the extent they impact the implementation and use of the transitions of care capability for any purpose to which it is certified.
Beginning with the “subscription fee,” the developer must disclose that there is such a fee along with any factors that impact the amount a customer would have to pay. Examples include number of licenses or limitations on the number of workstations where the software is deployed, additional types of costs related to the volume of transactions, or usage, or associated bandwidth costs for a customer's transactions. Such factors would need to be described with particularity. For example, for additional types of costs related to the volume of transactions, the developer would need to explain how the volume of transactions would be measured and if variations in volume or types of transactions may trigger additional fees or variations in the subscription fee.
Turning to the developer's HISP policy, the developer must disclose this material limitation and the additional types of costs a user may incur as a result. The developer must explain, for example, that as a result of its policy the transitions of care capability is restricted and users will be unable to exchange transitions of care summaries with users of third-party HISPs with whom the developer does not have a trust agreement. The developer must describe, in plain terms, its current network of HISPs and how such network would enable a user to exchange transitions of care summaries with users of other HISPs servicing a provider's local referral area, including HISPs that participate in trust networks. Further, the disclosure needs to clearly identify any HISPs with whom the developer will not permit exchange or which the developer knows will not agree to a trust agreement with the developer (e.g., because the developer is not a member of a particular trust network). If the developer offers the option to customers to connect to third-party HISPs with whom the developer currently has no relationship, the developer must describe the process for customers to request such connectivity. The developer must also describe any additional types of costs that may apply for this service, including a description of any factors (e.g., geographical considerations or variability in HISP technologies and trust policies) that impact the amount a customer would have to pay.
Finally, the developer would need to disclose the separate “transaction fee” charged for exchanging transitions of care summaries with users of third-party HISPs. Disclosure of all additional types of costs based on volume, geography, or exchange partner technology would be required. The developer would also be required to provide additional information to assist the customer in realistically understanding additional potential costs of sending and receiving transitions of care summaries via third-party HISPs.
The scenario and discussion above illustrate the substantial flexibility developers have in determining the content of their disclosures, including how they choose to describe the particular limitations and types of costs
For the reasons stated by the commenters, we agree that requiring a comprehensive disclosure in all marketing materials and other assertions may be burdensome and counterproductive to our goal of providing this information to customers in a manner that is meaningful and likely to inform. Therefore, we clarify that a developer may satisfy the requirement to disclose the information required by § 170.523(k)(1) in its marketing materials, communications statements, and other assertions related to a Complete EHR or Health IT Module's certification by providing an abbreviated disclaimer, appropriate to the material and medium, provided the disclaimer is accompanied by a hyperlink to the complete disclosure on the developer's website. Where a hyperlink is not feasible (for example, in non-visual media), the developer may use another appropriate method to direct the recipient of the marketing material, communication, or assertion to the complete disclosure on its website.
Because of the challenges and accommodations described above, and the need to ensure that customers and users are able to easily locate information about certified health IT products and services, we believe that developers' disclosures should be accessible from a single, authoritative source. Thus, we have included a developer's disclosures as part of the information that an ONC-ACBs must submit to ONC for inclusion in the open data CHPL. We have revised § 170.523(f)(1) and (f)(2) to reflect this requirement.
In keeping with the goal of making developers' disclosures accessible and useful to customers and other stakeholders, we have also revised § 170.523(k)(1)(ii), which requires developers to include in their disclosures certain types of administrative and programmatic information they are required to report to ONC. While the reporting and availability of this information is important and is still required by § 170.523(f)(1) and (2), requiring developers to insert all of this information in their disclosures could add unnecessary clutter and detract from the overall accessibility and clarity of those disclosures. Therefore, under § 170.523(k)(1)(ii), developers must include in their disclosures only a subset of this information that will be valuable to customers in making informed decisions about their certified health IT.
In the Proposed Rule, we explained that the attestation would take the form of a written “pledge” by the developer to take the additional, voluntarily step of proactively providing information (which it would already be required to disclose via its Web site and in marketing and other materials) to all current and prospective customers as well as to any other persons who request such information. While we stated that the attestation would not broaden or change a health IT developer's disclosure obligations under the ONC Health IT Certification Program, some commenters believed that in practice developers would be forced to comply with the attestation. Because that was and is not our intent, we have revised the attestation requirement. Under the revised
We proposed to require ONC-ACBs to report an expanded set of information to ONC for inclusion in the CHPL upon its conversion from its present form to an open data file represented in both XML and JSON and with accompanying API functionality. We are converting the CHPL to this new “open data CHPL” in response to feedback from stakeholders regarding the accessibility of information on the CHPL, especially the information contained in the publicly available test reports for certified health IT products.
To complement this conversion, we proposed to require ONC-ACBs to report an expanded set of information to ONC for inclusion in the open data CHPL. Specifically, we proposed to revise § 170.523(f) to move the current (f) to (f)(2) and to create a new paragraph (f)(1) that would require ONC-ACBs upon issuing a 2015 Edition (or any subsequent edition certification) to report on the same data elements they report to ONC under § 170.523(f), the information contained in the publicly available test report, and certain additional data listed in the Proposed Rule. We explained that the additional data reported to the open data CHPL would include the information ONC-ACBs would be required to report in connection with corrective action plans under the proposal “ ‘In-the-field’ Surveillance and Maintenance of Certification” in the Proposed Rule. Because this data would be required for all, and not only 2015 Edition, certified health IT, we also proposed to revise new § 170.523(f)(2) (former § 170.523(f)) accordingly.
Consistent with ONC-ACBs' current reporting practice required by § 170.523(f), ONC-ACBs would be required to submit the additional data no less frequently than weekly. Because this expanded list of data would largely subsume the data included in the test results summary, we would no longer require for 2015 Edition and subsequent edition certifications that ONC-ACBs provide a publicly accessible hyperlink to the test results used to certify a Health IT Module.
In submitting this data related to corrective action and surveillance, ONC-ACBs would be required to exclude any information that would identify any user or location that participated in or was subject to surveillance (as currently required for ONC-ACBs' annual surveillance results reported to the ONC). ONC-ACBs would not be required and should take care not to submit proprietary information to ONC for inclusion in the open data file. With respect to the reporting of corrective action plan and surveillance information for health IT, an ONC-ACB would be able to meet the requirement by summarizing the deficiencies leading to its non-conformity determination without disclosing information that the ONC-ACB believes could be proprietary or expose it to liability.
Consistent with these proposals, we also proposed to make a conforming modification to 45 CFR 170.523(k)(1)(ii) which currently cross references § 170.523(f) to cross reference proposed paragraph (f)(2) for 2014 Edition certifications and an equivalent set of data (minus the test results summary) in paragraph (f)(1) for 2015 Edition and subsequent certifications.
As discussed in section IV.D.2 of this preamble (“Transparency and Disclosure Requirements”), we have also added developers' disclosures required by § 170.523(k)(1) and their attestations required by § 170.523(k)(2) to the data that must be submitted to ONC for inclusion in the open data CHPL.
We proposed to change the records retention requirement in § 170.523(g) in two ways. We proposed to require that ONC-ACBs retain all records related to the certification of Complete EHRs and/or Health IT Module(s) (including EHR Modules) for a minimum of 6 years instead of 5 years as was required by regulation. We stated that this proposal would make certification records available for a longer time period, which may be necessary for HHS programmatic purposes such as evaluations or audits. We also proposed that records of certifications performed under the ONC Health IT Certification Program must be available to HHS upon request during the proposed 6-year period that a record is retained. We stated that this would help clarify the availability of certification records for agencies (
We proposed that ONC-ACBs provide ONC (the National Coordinator) with a list of complaints received on a quarterly basis. We proposed that ONC-ACB indicate in their submission the number of complaints received, the nature or substance of each complaint, and the type of complainant for each complaint (
We intend to provide, as necessary, more specific guidance to ONC-ACBs through the annual ONC Health IT Certification Program surveillance guidance on reporting complaints received regarding certified Health IT Modules.
We proposed to require that ONC-ACBs obtain monthly reports from health IT developers regarding their certified health IT. Specifically, we proposed to require that ONC-ACBs obtain a record of all adaptations and updates, including changes to user-facing aspects, made to certified health IT (
We proposed that the PoPC would become effective with this final rule and we would expect ONC-ACBs to begin complying with the PoPC at the beginning of the first full calendar month that is at least 30 days after the effective date of the final rule. We explained that we would not expect the information in these records to be reported to ONC and listed on the CHPL. Rather, we stated that the best course of action would be for ONC-ACBs to retain this information to provide awareness to the ONC-ACB on adaptations and updates made to technologies they certified.
2015 Edition certification criteria: CPOE—medications (§ 170.315(a)(1)); CPOE— laboratory (§ 170.315(a)(2)); CPOE—diagnostic imaging (§ 170.315(a)(3)); drug-drug, drug allergy interaction checks (§ 170.315(a)(4)); demographics (§ 170.315(a)(5)); problem list (§ 170.315(a)(6)); medication list (§ 170.315(a)(7)); medication allergy list (§ 170.315(a)(8)); clinical decision support (§ 170.315(a)(9)); implantable device list (§ 170.315(a)(14)); clinical information reconciliation and incorporation (§ 170.315(b)(2)); and electronic prescribing (§ 170.315(b)(3)).
We thank the commenter for the feedback on distinguishing major and minor updates. We first note that, as stated in the 2014 Edition final rule (77 FR 54268), unless adaptations are presented for separate certification, the CHPL would not independently list the adaptation because it is considered part of a previously certified Complete EHR or certified Health IT Module, including EHR Modules. Second, the CHPL does not list updates to products unless they are presented for separate certification. This policy allows a health IT developer to update a product for routine maintenance or to include new or modified capabilities without the need for recertification. However, in these instances, the product name and version on the CHPL would remain unchanged. We established an attestation process for a product to be approved for inherited certified status to provide a more efficient pathway for certification for a new version of a previously certified product in the Permanent Certification Program final rule (76 FR 1306). As part of this policy, we noted that we do not presume the version numbering schema that a health IT developer may choose to utilize. For compliance with this requirement, the focus on “updates” is for
We would expect that ONC-ACBs obtain a record of adaptations of certified health IT made by the health IT developer as those are the adaptations covered by the issued certification. An ONC-ACB has the discretion in determining how much time and resources should be devoted to reviewing the lists provided by health IT developers. As previously noted, we expect this information to inform ONC-ACBs surveillance activities for certified health IT. In terms of non-compliance by a health IT developer in providing the requisite list, we note that an ONC-ACB retains its authority and oversight over the certifications it issues and has the discretion to implement that authority and oversight in a manner that supports its role and responsibilities as well as the integrity of the ONC Health IT Certification Program.
The Proposed Rule proposed and the final rule take certain steps to support the certification of health IT that meets relevant program standards and permits the unrestricted use of certified capabilities that facilitate health information exchange (see the “In-The-Field Surveillance and Maintenance of Certification” and “Transparency and Disclosure Requirements” proposals in section IV.D of this preamble).
In the Proposed Rule, we stated that additional rulemaking would be necessary to implement any approach that would include ONC appropriating an ONC-ACB's delegated authority to issue and terminate a certification, including establishing new program requirements and processes by which ONC or an ONC-ACB would have the grounds to terminate an issued certification. We requested comment on the circumstances, due process, remedies, and other factors that we should consider regarding the termination of a certification. To assist commenters, we provided a brief background of the ONC Health IT Certification Program and examples of the complexities and potential impacts associated with terminating a certification. We asked commenters to account for the potentially profound asymmetric impacts revoking a certification could create, especially if based on the business practices (by health IT developers or their customers) associated with the health IT's use and not necessarily the health IT's performance according to certification requirements.
• The Office of the Federal Register has established new requirements for materials (
To make the materials we have incorporated by reference reasonably available, we provide a uniform resource locator (URL) for the standards and implementation specifications. In many cases, these standards and implementation specifications are directly accessible through the URL provided. In instances where they are not directly available, we note the steps and requirements necessary to gain access to the standard or implementation specification. In most of these instances, access to the standard or implementation specification can be gained through no-cost (monetary) participation, subscription, or membership with the applicable standards developing organization (SDO) or custodial organization. In certain instances, where noted, access requires a fee or paid membership.
The National Technology Transfer and Advancement Act (NTTAA) of 1995 (15 U.S.C. 3701
As required by § 51.5(b), we provide summaries of the standards and implementation specifications we have adopted and incorporated by reference in the
We have organized the following standards and implementation specifications that we have adopted through this final rule according to the sections of the Code of Federal Regulation (CFR) in which they are codified and cross-referenced for associated certification criteria that we have adopted in 45 CFR 170.315.
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Under the Paperwork Reduction Act of 1995 (PRA), agencies are required to provide 60-day notice in the
1. Whether the information collection is necessary and useful to carry out the proper functions of the agency;
2. The accuracy of the agency's estimate of the information collection burden;
3. The quality, utility, and clarity of the information to be collected; and
4. Recommendations to minimize the information collection burden on the
Under the PRA, the time, effort, and financial resources necessary to meet the information collection requirements referenced in this section are to be considered. We sought comment on proposed PRA requirements in the Proposed Rule (80 FR 16893-16895).
Under the ONC Health IT Certification Program, accreditation organizations that wish to become the ONC-Approved Accreditor (ONC-AA) must submit certain information, organizations that wish to become an ONC-ACB must submit the information specified by the application requirements, and ONC-ACBs must comply with collection and reporting requirements, records retention requirements, and submit annual surveillance plans and annually report surveillance results.
In the Permanent Certification Program final rule (76 FR 1312-14), we solicited public comment on each of the information collections associated with the requirements described above (and included in regulation at 45 CFR 170.503(b), 170.520, and 170.523(f), (g), and (i), respectively). In the 2014 Edition final rule (77 FR 54275-76), we sought comment on these collection requirements again and finalized an additional requirement at § 170.523(f)(8) for ONC-ACBs to report to ONC a hyperlink with each EHR technology they certify that provides the public with the ability to access the test results used to certify the EHR technology. These collections of information were approved under OMB control number 0955-0013 (previous OMB control number 0990-0378).
In the Proposed Rule, we estimated less than 10 annual respondents for all of the regulatory “collection of information” requirements under Part 170 of Title 45, including those previously approved by OMB and proposed in the Proposed Rule (80 FR 16894). The “collection of information” requirements that apply to the ONC-Approved Accreditor (ONC-AA) are found in § 170.503(b). The “collection of information” requirements that apply to the ONC-ACBs are found in § 170.520; § 170.523(f)(1) and (2), (g), (i), and (o); and § 170.540(c). As stated in the Proposed Rule, we estimated the number of respondents for § 170.503(b) (applicants for ONC-AA status) at two based on past selection processes for the ONC-AA, which have included no more than two applicants. As also stated in the Proposed Rule, we anticipate that there will be three ONC-ACBs participating in the ONC Health IT Certification Program as this is the current number of ONC-ACBs. Further, since the establishment of the ONC Health IT Certification Program in 2010, ONC has never had more than six applicants for ONC-ACB or ONC-ATCB status or selected more than six ONC-ACBs or ONC-ATCBs.
We concluded that the regulatory “collection of information” requirements under the ONC Health IT Certification Program described above are not subject to the PRA under 5 CFR 1320.3(c). We welcomed comments on this conclusion and the supporting rationale on which it was based.
We continue to estimate fewer than 10 respondents for all of the regulatory “collection of information” requirements under Part 170 of Title 45. Accordingly, the “collection of information” requirements/burden that are associated with this final rule are not subject to the PRA under 5 CFR 1320.3(c).
This final rule is being published to adopt the 2015 Edition. Certification criteria and associated standards and implementation specifications would be used to test and certify health IT in order to make it possible for EPs, eligible hospitals, and CAHs to adopt and implement health IT that can be used to meet the CEHRT definition. EPs, eligible hospitals, and CAHs who participate in the EHR Incentive Programs are required by statute to use CEHRT.
The certification criteria and associated standards and implementation specifications would also support the certification of more types of health IT and health IT that supports care and practice settings beyond the scope of the EHR Incentive Programs.
The adoption and implementation of health IT certified to the 2015 Edition promotes interoperability in support of a nationwide health information infrastructure and improves health care quality, safety and efficiency consistent with the goals of the HITECH Act.
We have examined the impact of this final rule as required by Executive Order 12866 on Regulatory Planning and Review (September 30, 1993), Executive Order 13563 on Improving Regulation and Regulatory Review (February 2, 2011), the Regulatory Flexibility Act (5 U.S.C. 601
Executive Orders 12866 and 13563 direct agencies to assess all costs and benefits of available regulatory alternatives and, if regulation is necessary, to select regulatory approaches that maximize net benefits (including potential economic, environmental, public health and safety effects, distributive impacts, and equity). A regulatory impact analysis (RIA) must be prepared for major rules with economically significant effects ($100 million or more in any 1 year). OMB has determined that this final rule is an economically significant rule as we have estimated the costs to develop and prepare health IT to be tested and certified may be greater than $100 million per year.
This final rule adopts standards, implementation specifications, and certification criteria that establish the capabilities that health IT would need to demonstrate to be certified to the 2015 Edition. Our analysis focuses on the direct effects of the provisions of this final rule—the costs incurred by health IT developers to develop and prepare health IT to be tested and certified in accordance with the certification criteria (and the standards and implementation specifications they include) adopted by the Secretary. That is, we focus on the technological development and preparation costs necessary for health IT
Because the costs that EPs, eligible hospitals, and CAHs would incur in adopting and implementing (including training, maintenance, and any other ongoing costs) health IT certified to the 2015 Edition is overwhelmingly attributable to the EHR Incentive Programs Stage 3 and Modifications final rule (published elsewhere in this issue of the
The development and preparation costs we estimate are derived through a health IT developer per criterion cost. In simple terms, we estimate: (1) How many health developers will prepare and develop products against the certification criteria; (2) how many products they will develop; and (3) what it will likely cost them to develop and prepare those products to meet the certification criteria.
We have also once again generally used the EHRA estimates as a basis for our high estimates. We have used the EHRA estimates in this manner because of the uncertain reliability of the information. It is our understanding that these estimates were based on a survey of EHRA's members. It is unclear how many of EHRA's members responded and how each member arrived at their estimates. Further, we cannot rely on these estimates as being generated from an independent, unbiased source because EHRA members must, in some respects, substantiate the costs and fees they charge providers for their certified health IT. We do note, however, that we have also used the EHRA estimates to significantly increase our low estimates.
Based on the estimates provided by the EHRA, by not adopting the 14 proposed certification criteria identified in Table 2 of this final rule and certain other functionality and standards, we have reduced the estimated burden of the 2015 Edition by over 40,000 burden hours per health IT developer. The 14 criteria that were not adopted saved over 25,000 burden hours. An additional 15,000 burden hours were saved through not adopting certain functionality and standards such as user response “tracking” for clinical decision support and drug-drug, drug-allergy interaction checks, a formulary benefit standard, a standard for recording smoking status, a standard for CPOE laboratory orders, and proposals for certain e-prescribing and C-CDA conformance.
We have divided the certification criteria into three categories, each with its own table below. Table 11 is for the new and revised certification criteria associated with the EHR Incentive Programs Stage 3 CEHRT definition and objectives and measures. Table 12 is for the unchanged certification criteria associated with the EHR Incentive Programs Stage 3 CEHRT definition and objectives and measures. These tables also include certification criteria that are mandatory and conditional certification requirements, such as “safety-enhanced design,” and “quality management system,” “accessibility-centered design,” and privacy and security certification criteria as certified Health IT Modules certified to these criteria would be used to meet the CEHRT definition under the EHR Incentive Programs.
We derive our estimates for the number of health IT developers by beginning with the number of Health IT developers certified to each of the 2014 Edition certification criteria as identified in CHPL data from November 10, 2014. For the new and revised Stage 3 Criteria that correspond to 2014 Edition certification criteria, we have reduced the number of Health IT developers by 30% from the number that certified against the 2014 Edition. We have done this because we have found a 22% drop in the number of health IT developers that certified technology against the 2014 Edition versus the 2011 Edition. We believe that as both interoperability requirements increase by edition and certain health IT developers gain more market share through competition and acquisition of other health IT developers, there will be an even greater drop in the number of
We estimate 2.5 products per health IT developer for each new and revised “Stage 3” criterion. We reached this estimate based both on the number of unique
We note that these estimates included any new health IT developers.
For unchanged “Stage 3” criteria, we estimate 5 new health IT developers, each with 1 product. We have attempted to establish a burden estimate for each criterion assuming a health IT developer would be in the same position as a health IT developer that sought certification to the 2011 or 2014 Edition as these 2015 certification criteria are unchanged as compared to those same 2011 and 2014 Edition certification criteria. We do not anticipate more than 5 new health IT developers to certify to these criteria for the market attrition reasons mentioned above. We note for health IT developers that have had products previously certified to the 2014 Edition version of these criteria, we estimate no new costs.
For the Independent Criteria, we have only estimated the development and preparation of one Health IT Module to meet these criteria. The Independent Criteria are not currently associated with the EHR Incentive Programs or another HHS payment program. Therefore, we continue to have no reliable basis on which to estimate how many developers and products will be certified to these criteria. We do
Our estimated average development hours are based on feedback we received in response to the RIA we completed for the Proposed Rule and internal estimates for criteria where there is no external data to validly rely upon. As noted above, we have generally used estimates from the Electronic Health Record Association as a basis for our high estimates, where applicable. We have accounted for the reduced burden hours related to functionality and standards not adopted (
We have also attempted to capture developmental synergies where development to a vocabulary and/or content exchange standard can significantly reduce a health IT developer's burden when certifying to multiple certification criteria that reference the same vocabulary or content exchange standard. For example, the “transitions of care,” “clinical information reconciliation and incorporation,” “data export,” “view, download, and transmit to 3rd party,” “application access—data category request,” and “application access—all data request” certification criteria included the same content exchange standard and many, if not all, the same vocabulary standards. Based on health IT products certified to the 2014 Edition, we expect health IT developers to certify their products to many or all of these criteria. This will create developmental efficiencies and reduced burden. Similarly, a health IT developer preparing a product for certification to the “social, psychological, and behavioral data” criterion would find synergies in meeting all the measures now included in the criterion as they all rely on LOINC®. We note that our estimates also take into account added burden such as with the Direct criteria, which is a result of adoption of a newer version of the standard and other included interoperability requirements.
We have based the effort levels on the hours necessary for a software developer to develop and prepare the health IT for testing and certification. These hours are identified in Tables 11-13 above.
The U.S. Department of Labor, Bureau of Labor Statistics estimates that the median hourly wage for a software developer is $45.92.
To calculate our cost estimates for each certification criterion in the tables below, we have multiplied both the average low and average high number of development and preparation hours in Tables 11-13 by $63. For tables 14, 15, and 16, dollar amounts are expressed in 2014 dollars.
We estimate the development and preparation costs over a four-year period because a four-year period aligns with our estimated publication date for a subsequent final rule (2015) and the year in which CMS proposes that participants in the EHR Incentive Programs
In total, we estimate the overall costs to develop and prepare health IT for certification over a four-year period to be $260.44 million to $403.19 million, with a cost mid-point of approximately $331.82 million. Evenly distributed over calendar years 2015 through 2018, the cost range would be $65.11 million to $100.79 million per year with an annual cost mid-point of approximately $82.95 million. However, we project these costs to be unevenly distributed. We estimate the distribution as follows: 2015 (15%); 2016 (35%); 2017 (35%); and 2018 (15%). We reached this distribution based on these assumptions and information:
• We expect for health IT developers to spend the rest of the year preparing and developing their health IT to meet the 2015 Edition. We note that we lowered the percentage to 15% for 2015 from 25% in the Proposed Rule due to the later-than-anticipated publication date of this final rule. We redistributed the 10% over 2016 and 2017.
• We expect health IT developers to aggressively work in 2016 and 2017 to prepare and develop their health IT to meet the 2015 Edition as the compliance date for the EHR Incentive Programs CEHRT definition draws near (
• We expect health IT developers to continue to prepare and develop health IT to the 2015 Edition in 2018 based on their approach to the 2014 Edition.
Table 17 below represents the costs attributable to this proposed rule distributed as discussed above. The dollar amounts expressed in Table 17 are expressed in 2014 dollars.
In the RIA of the Permanent Certification Program final rule, we estimated the costs for testing and certification of technologies that would be used for providers to attempt to achieve EHR Incentive Programs Stages 1-3.
We have estimated the costs associated with new and revised PoPC finalized in this final rule. For reporting requirements under 45 CFR 170.523(f), (m), and (n), we have used burden hour estimates provided in the Proposed Rule (80 FR 16893). For 45 CFR 170.523(i), we have increased the burden hours based on the quarterly reporting requirements and the nature of what must be reported. For 45 CFR 170.523(g) and (k), we have established burden hour estimates based on the number of certifications performed per year by ONC-ACBs.
We believe that an employee equivalent to the Federal Classification of GS-12 Step 1 could report the required information for 45 CFR 170.523(f), retain the records under 45 CFR 170.523(g), compile and submit surveillance results quarterly per 45 CFR 170.523(i), collect adaptations/updates quarterly per 45 CFR 170.523(m), and compile and submit complaints per 45 CFR 170.523(n). We believe that an employee equivalent to the Federal Classification of GS-14 Step 1 could verify health IT developers' compliance with 45 CFR 170.523(k). We have utilized the corresponding employee hourly rates for the locality pay area of Washington, D.C., as published by OPM, to calculate our cost estimates. We have also calculated the costs of the employee's benefits while completing the specified tasks. We have calculated these costs by assuming that an ONC-ACB expends thirty-six percent (36%) of an employee's hourly wage on benefits for the employee. We have concluded that a 36% expenditure on benefits is an appropriate estimate because it is the routine percentage used by HHS for contract cost estimates. Our cost estimates are expressed in Table 18 below and are expressed in 2015 dollars (rounded).
We estimate the total annual costs to be $406,650.12 based on three ONC-ACBs.
Certain new and revised PoPC create indirect costs on health IT developers, which we have attempted to estimate in this final rule below. We have estimated the burden hours to the extent possible. We have used the same cost factors as discussed above. We have estimated 402 health IT developers based on the highest estimated number of health IT developers we expect to be certified to a 2015 Edition certification criterion (see Table 11 above). Our cost estimates are expressed in Table 19 below and are expressed in 2015 dollars (rounded).
b. Benefits
As noted above, we expect that health IT developers will recover an appropriate rate of return for their investments in developing and preparing their health IT for certification to the 2015 Edition certification criteria adopted in this final rule. However, we do not have data available to quantify these benefits or other benefits that will likely arise from health IT developers certifying their health IT to the 2015 Edition.
We believe that there will be several significant benefits that may arise from this final rule for patients, health care providers, and health IT developers. The 2015 Edition continues to improve health IT interoperability through the adoption of new and updated standards and implementation specifications. For example, many adopted certification criteria include standards and implementation specifications for interoperability that directly support the EHR Incentive Programs, which include objectives and measures for the interoperable exchange of health information and for providing patients electronic access to their health information in structured formats. In addition, 2015 Edition certification criteria that support the collection of patient data that could be used to address health disparities would not only benefit patients, but the entire health care delivery system through improved quality of care. The 2015 Edition also supports usability and patient safety through new and enhanced certification requirements for health IT.
This final rule also makes the ONC Health IT Certification Program open and accessible to more types of health IT and for health IT that supports a variety of care and practice settings. This should benefit health IT developers, providers practicing in other care/practice settings, and consumers through the availability and use of certified health IT that includes capabilities that promote interoperability and enhanced functionality.
We note that, in general, these benefits will be realized only if health care providers actually adopt new technology. As discussed elsewhere in this RIA, we believe that such adoption—and thus the benefits noted in this section—would be overwhelmingly attributable to CMS's final rule.
The RFA requires agencies to analyze options for regulatory relief of small businesses if a rule has a significant impact on a substantial number of small entities.
The Small Business Administration (SBA) establishes the size of small businesses for federal government programs based on average annual receipts or the average employment of a firm. While health IT developers that pursue certification under the ONC Health IT Certification Program represent a small segment of the overall information technology industry, we believe that the entities impacted by this proposed rule most likely fall under the North American Industry Classification System (NAICS) code 541511 “Custom Computer Programming Services” specified in 13 CFR 121.201 where the SBA publishes “Small Business Size Standards by NAICS Industry.” The SBA size standard associated with this NAICS code is set at $27.5 million in
Based on our analysis, we believe that there is enough data generally available to establish that between 75% and 90% of entities that are categorized under the NAICS code 541511 are under the SBA size standard, but note that the available data does not show how many of these entities will develop a health IT product that will be certified to the 2015 Edition under the ONC Health IT Certification Program. We also note that with the exception of aggregate business information available through the U.S. Census Bureau and the SBA related to NAICS code 541511, it appears that many health IT developers that pursue certification under the ONC Health IT Certification Program are privately held or owned and do not regularly, if at all, make their specific annual receipts publicly available. As a result, it is difficult to locate empirical data related to many of these health IT developers to correlate to the SBA size standard. However, although not correlated to the size standard for NAICS code 541511, we do have information indicating that over 60% of health IT developers that have had Complete EHRs and/or EHR Modules certified to the 2011 Edition have less than 51 employees.
We estimate that this final rule would have effects on health IT developers that are likely to pursue certification under the ONC Health IT Certification Program, some of which may be small entities. However, we believe that we have adopted the minimum amount of requirements necessary to accomplish our policy goals, including a reduction in regulatory burden and additional flexibility for the regulated community, and that no additional appropriate regulatory alternatives could be developed to lessen the compliance burden associated with this final rule. We note that this final rule does not impose the costs cited in the RIA as compliance costs, but rather as investments which these health IT developers voluntarily take on and may expect to recover with an appropriate rate of return. Accordingly, we do not believe that the final rule will create a significant impact on a substantial number of small entities. Additionally, the Secretary certifies that this final rule will not have a significant impact on a substantial number of small entities.
Executive Order 13132 establishes certain requirements that an agency must meet when it promulgates a proposed rule (and subsequent final rule) that imposes substantial direct requirement costs on state and local governments, preempts state law, or otherwise has federalism implications. Nothing in this final rule imposes substantial direct compliance costs on state and local governments, preempts state law or otherwise has federalism implications. We are not aware of any State laws or regulations that are contradicted or impeded by any of the standards, implementation specifications, or certification criteria that we have adopted.
Section 202 of the Unfunded Mandates Reform Act of 1995 requires that agencies assess anticipated costs and benefits before issuing any rule whose mandates require spending in any one year of $100 million in 1995 dollars, updated annually for inflation. The current inflation-adjusted statutory threshold is approximately $144 million. This final rule will not impose an unfunded mandate on State, local, and tribal governments or on the private sector that will reach the threshold level.
OMB reviewed this final rule.
Computer technology, Electronic health record, Electronic information system, Electronic transactions, Health, Health care, Health information technology, Health insurance, Health records, Hospitals, Incorporation by reference, Laboratories, Medicaid, Medicare, Privacy, Reporting and recordkeeping requirements, Public health, Security.
For the reasons set forth in the preamble, 45 CFR subtitle A, subchapter D, part 170, is amended as follows:
42 U.S.C. 300jj-11; 42 U.S.C. 300jj-14; 5 U.S.C. 552.
The revisions read as follows:
(1) Includes patient demographic and clinical health information, such as medical history and problem lists;
(2) Has the capacity:
(i) To provide clinical decision support;
(ii) To support physician order entry;
(iii) To capture and query information relevant to health care quality;
(iv) To exchange electronic health information with, and integrate such information from other sources;
(v) To protect the confidentiality, integrity, and availability of health information stored and exchanged; and
(3) Has been certified to the certification criteria adopted by the Secretary:
(i) For at least one of the four criteria adopted at § 170.314(a)(1), (18), (19), or (20);
(ii) At § 170.314(a)(3);
(iii) At § 170.314(a)(5) through (8);
(iv) Both § 170.314(b)(1) and (2); or, both § 170.314(b)(8) and (h)(1); or § 170.314(b)(1) and (2) combined with either § 170.314(b)(8) or (h)(1), or both § 170.314(b)(8) and (h)(1);
(v) At § 170.314(b)(7);
(vi) At § 170.314(c)(1) through (3);
(vii) At § 170.314(d)(1) through (8);
(4) Has been certified to the certification criteria at § 170.314(c)(1) and (2):
(i) For no fewer than 9 clinical quality measures covering at least 3 domains from the set selected by CMS for eligible professionals, including at least 6 clinical quality measures from the recommended core set identified by CMS; or
(ii) For no fewer than 16 clinical quality measures covering at least 3 domains from the set selected by CMS for eligible hospitals and critical access hospitals.
(1) Includes patient demographic and clinical health information, such as medical history and problem lists;
(2) Has the capacity:
(i) To provide clinical decision support;
(ii) To support physician order entry;
(iii) To capture and query information relevant to health care quality;
(iv) To exchange electronic health information with, and integrate such information from other sources; and
(3) Has been certified to the certification criteria adopted by the Secretary in § 170.315(a)(1), (2), or (3); (a)(5) through (9); (a)(11); (a)(15); (b)(1) and (6); (c)(1); (g)(7) through (9); and (h)(1) or (2);
(1)
(2)
(ii) The standard specified in § 170.207(n)(1) for certification to the 2015 Edition health IT certification criteria.
(3)
(4)
(ii) For certification to the 2015 Edition health IT certification criteria:
(A) The standard specified in § 170.207(f)(2);
(B) The standard specified in § 170.207(f)(1) for each race identified in accordance § 170.207(f)(2).
(5)
(ii) For certification to the 2015 Edition health IT certification criteria:
(A) The standard specified in § 170.207(f)(2);
(B) The standard specified in § 170.207(f)(1) for each ethnicity identified in accordance § 170.207(f)(2).
(6)
(ii) The standard specified in § 170.207(g)(2) for certification to the 2015 Edition Health IT certification criteria.
(7)
(8)
(ii) At a minimum, the standard specified in § 170.207(a)(4) for certification to the 2015 Edition Health IT certification criteria.
(9)
(ii) At a minimum, the standard specified in § 170.207(d)(3) for certification to the 2015 Edition Health IT certification criteria.
(10)
(ii) At a minimum, the standard specified in § 170.207(d)(3) for certification to the 2015 Edition Health IT certification criteria.
(11)
(ii) At a minimum, the standard specified in § 170.207(c)(3) for certification to the 2015 Edition Health IT certification criteria.
(12)
(13)
(ii) For certification to the 2015 Edition Health IT certification criteria:
(A) The patient's diastolic blood pressure, systolic blood pressure, body height, body weight, heart rate, respiratory rate, body temperature, pulse oximetry, and inhaled oxygen concentration must be exchanged in numerical values only; and
(B) In accordance with the standard specified in § 170.207(c)(3) and with the associated applicable unit of measure for the vital sign measurement in the standard specified in § 170.207(m)(1).
(C)
(14)
(15)
(B) For technology primarily developed to record dental procedures, the standard specified in § 170.207(b)(3) for certification to both the 2014 Edition EHR certification criteria and the 2015 Edition health IT certification criteria.
(ii)
(16)
(17)
(18)
(19)
(i) In accordance with the “Assessment and Plan Section (V2)” of the standard specified in § 170.205(a)(4); or
(ii) In accordance with the “Assessment Section (V2)” and “Plan of Treatment Section (V2)” of the standard specified in § 170.205(a)(4).
(20)
(21)
The additions and revisions read as follows:
(a)
(2)
(e)
(2) [Reserved]
The additions and revisions read as follows:
(a)
(2)
(b) * * *
(2)
(3)
(4)
The additions and revisions read as follows:
(a) * * *
(4)
(d) * * *
(4)
(e) * * *
(4)
(h)
(2)
(i)
(2)
(k)
(2)
(l) [Reserved]
(m) [Reserved]
(n) [Reserved]
(o)
(2) [Reserved]
(p)
(2) [Reserved]
(q) [Reserved]
(r)
(i) HAI Antimicrobial Use and Resistance (AUR) Antimicrobial Resistance Option (ARO) Report (Numerator) specific document template in Section 2.1.2.1 (pages 69-72);
(ii) Antimicrobial Resistance Option (ARO) Summary Report (Denominator) specific document template in Section 2.1.1.1 (pages 54-56); and
(iii) Antimicrobial Use (AUP) Summary Report (Numerator and Denominator) specific document template in Section 2.1.1.2 (pages 56-58).
(2) [Reserved]
(s)
(2) [Reserved]
The additions and revisions read as follows:
(a) * * *
(4)
(c) * * *
(3)
(d) * * *
(3)
(e) * * *
(3)
(4)
(f)
(2)
(g)
(2)
(k) [Reserved]
(l) [Reserved]
(m)
(2) [Reserved]
(n)
(i)
(ii)
(iii)
(2) [Reserved]
(o)
(i)
(ii)
(iii)
(iv)
(v)
(vi)
(2)
(i)
(ii)
(iii)
(iv)
(v)
(vi)
(vii)
(p)
(2)
(3)
(4)
(5)
(6)
(7)
(8)
(q)
(2) [Reserved]
(r)
(2) [Reserved]
(s)
(2) [Reserved]
The addition and revisions read as follows:
(a) * * *
(2)
(c)
(2)
(e) * * *
(1)(i) The audit log must record the information specified in sections 7.2 through 7.4, 7.6, and 7.7 of the standard specified in § 170.210(h) and changes to user privileges when health IT is in use.
(h)
The additions and revisions read as follows:
(c) * * *
(1) ASTM E2147-01 (Reapproved 2013) Standard Specification for Audit and Disclosure Logs for Use in Health Information Systems, approved March 1, 2013, IBR approved for § 170.210(h).
(d) * * *
(10) PHIN Messaging Guide for Syndromic Surveillance: Emergency Department, Urgent Care, Inpatient and Ambulatory Care Settings, Release 2.0, April 21, 2015, IBR approved for § 170.205(d).
(11) Erratum to the CDC PHIN 2.0 Implementation Guide, August 2015; Erratum to the CDC PHIN 2.0 Messaging Guide, April 2015 Release for Syndromic Surveillance: Emergency Department, Urgent Care, Inpatient and Ambulatory Care Settings, IBR approved for § 170.205(d).
(12) HL7 2.5.1 Implementation Guide for Immunization Messaging, Release 1.5, October 1, 2014, IBR approved for § 170.205(e).
(13) HL7 Version 2.5.1 Implementation Guide for Immunization Messaging (Release 1.5)—Addendum, July 2015, IBR approved for § 170.205(e).
(14) HL7 Standard Code Set CVX—Vaccines Administered, updates through August 17, 2015, IBR approved for § 170.207(e).
(15) National Drug Code Directory (NDC)—Vaccine NDC Linker, updates through August 17, 2015, IBR approved for § 170.207(e).
(16) CDC Race and Ethnicity Code Set Version 1.0 (March 2000), IBR approved for § 170.207(f).
(e) * * *
(3) Crosswalk: Medicare Provider/Supplier to Healthcare Provider Taxonomy, April 2, 2015, IBR approved for § 170.207(r).
(f) * * *
(15) HL7 Version 3 Standard: Context Aware Retrieval Application (“Infobutton”), Knowledge Request, Release 2, 2014 Release, IBR approved for § 170.204(b).
(16) HL7 Implementation Guide: Service-Oriented Architecture Implementations of the Context-aware Knowledge Retrieval (Infobutton) Domain, Release 1, August 9, 2013, IBR approved for § 170.204(b).
(17) HL7 Version 3 Implementation Guide: Context-Aware Knowledge Retrieval (Infobutton), Release 4, June 13, 2014, IBR approved for § 170.204(b).
(18) HL7 Implementation Guide for CDA® Release 2: Consolidated CDA Templates for Clinical Notes (US Realm), Draft Standard for Trial Use, Volume 1—Introductory Material, Release 2.1, August 2015, IBR approved for § 170.205(a).
(19) HL7 Implementation Guide for CDA® Release 2: Consolidated CDA Templates for Clinical Notes (US Realm), Draft Standard for Trial Use, Volume 2—Templates and Supporting Material, Release 2.1, August 2015, IBR approved for § 170.205(a).
(20) HL7 CDA® R2 Implementation Guide: Quality Reporting Document Architecture—Category I (QRDA I); Release 1, DSTU Release 3 (US Realm), Volume 1—Introductory Material, June 2015, IBR approved for § 170.205(h).
(21) HL7 CDA® R2 Implementation Guide: Quality Reporting Document Architecture—Category I (QRDA I); Release 1, DSTU Release 3 (US Realm), Volume 2—Templates and Supporting Material, June 2015, IBR approved for § 170.205(h).
(22) HL7 CDA
(23) HL7 CDA
(24) Errata to the HL7 Implementation Guide for CDA® Release 2: Quality Reporting Document Architecture—Category III, DSTU Release 1 (US Realm), September 2014, IBR approved for § 170.205(k).
(25) HL7 Version 3 Implementation Guide: Data Segmentation for Privacy (DS4P), Release 1, Part 1: CDA R2 and Privacy Metadata Reusable Content Profile, May 16, 2014, IBR approved for § 170.205(o).
(26) HL7 Implementation Guide for CDA® Release 2—Level 3: Healthcare Associated Infection Reports, Release 1 (U.S. Realm), August 9, 2013, IBR approved for § 170.205(r).
(27) HL7 Implementation Guide for CDA® Release 2: National Health Care Surveys (NHCS), Release 1—US Realm, HL7 Draft Standard for Trial Use, Volume 1—Introductory Material, December 2014, IBR approved for § 170.205(s).
(28) HL7 Implementation Guide for CDA® Release 2: National Health Care Surveys (NHCS), Release 1—US Realm, HL7 Draft Standard for Trial Use, Volume 2—Templates and Supporting Material, December 2014, IBR approved for § 170.205(s).
(29) HL7 Version 3 (V3) Standard, Value Sets for AdministrativeGender and NullFlavor, published August 1, 2013, IBR approved for § 170.207(n) and (o).
(g) Integrating the Healthcare Enterprise (IHE), 820 Jorie Boulevard, Oak Brook, IL, Telephone (630) 481-1004,
(1) IHE IT Infrastructure Technical Framework Volume 2b (ITI TF-2b), Transactions Part B—Sections 3.29—2.43, Revision 7.0, August 10, 2010, IBR approved for § 170.205(p).
(2) [Reserved]
(h) Internet Engineering Task Force (IETF) Secretariat, c/o Association Management Solutions, LLC (AMS), 48377 Fremont Blvd., Suite 117, Fremont, CA, 94538, Telephone (510) 492-4080,
(3) Request for Comment (RFC) 5646, “Tags for Identifying Languages, September 2009,” copyright 2009, IBR approved for § 170.207(g).
(i) International Telecommunication Union (ITU), Place des Nations, 1211 Geneva 20 Switzerland, Telephone (41) 22 730 511,
(1) ITU-T E.123, Series E: Overall Network Operation, Telephone Service, Service Operation and Human Factors, International operation—General provisions concerning users: Notation for national and international telephone numbers, e-mail addresses and web addresses, February 2001, IBR approved for § 170.207(q).
(2) ITU-T E.164, Series E: Overall Network Operation, Telephone Service, Service Operation and Human Factors, International operation—Numbering plan of the international telephone service, The international public telecommunication numbering plan, November 2010, IBR approved for § 170.207(q).
(l) * * *
(3) Annex A: Federal Information Processing Standards (FIPS) Publication 140-2, Security Requirements for Cryptographic Modules, October 8, 2014, IBR approved for § 170.210(a).
(4) FIPS PUB 180-4, Secure Hash Standard (August 2015), IBR approved for § 170.210(c).
(m) Office of the National Coordinator for Health Information Technology (ONC), 330 C Street SW., Washington, DC 20201,
(n) Public Health Data Standards Consortium, 111 South Calvert Street, Suite 2700, Baltimore, MD 21202,
(1) Public Health Data Standards Consortium Source of Payment Typology Code Set Version 5.0 (October 2011), IBR approved for § 170.207(s).
(2) [Reserved]
(o) Regenstrief Institute, Inc., LOINC® c/o Regenstrief Center for Biomedical Informatics, Inc., 410 West 10th Street, Suite 2000, Indianapolis, IN 46202-3012,
(3) Logical Observation Identifiers Names and Codes (LOINC®) Database version 2.52, Released June 2015, IBR approved for § 170.207(c).
(4) The Unified Code of Units for Measure, Revision 1.9, October 23, 2013, IBR approved for § 170.207.
(p) The Direct Project, c/o the Office of the National Coordinator for Health Information Technology (ONC), 330 C Street SW., Washington, DC 20201,
(1) Applicability Statement for Secure Health Transport, Version 1.2, August 2015, IBR approved for § 170.202(a).
(2) Implementation Guide for Delivery Notification in Direct, Version 1.0, June 29, 2012, IBR approved for § 170.202(e).
(q) * * *
(6) International Health Terminology Standards Development Organization (IHTSDO) Systematized Nomenclature of Medicine Clinical Terms (SNOMED CT®) U.S. Edition, September 2015 Release, IBR approved for § 170.207(a).
(7) RxNorm, September 8, 2015 Full Release Update, IBR approved for § 170.207(d).
(d) In §§ 170.314 and 170.315, all certification criteria and all capabilities specified within a certification criterion have general applicability (
(1)
(2)
The Secretary adopts the following certification criteria for health IT. Health IT must be able to electronically perform the following capabilities in accordance with all applicable standards and implementation specifications adopted in this part:
(a)
(ii)
(2)
(ii)
(3)
(ii)
(4)
(ii)
(B) Limit the ability to adjust severity levels in at least one of these two ways:
(
(
(5)
(A)
(
(
(B)
(C)
(D)
(E)
(ii)
(6)
(i)
(ii)
(7)
(i)
(ii)
(8)
(i)
(ii)
(9)
(ii)
(B) Enable interventions:
(
(
(
(
(
(
(
(
(iii)
(iv)
(
(
(B) For paragraph (a)(9)(iv)(A) of this section, technology must be able to identify for a user diagnostic or therapeutic reference information based on each one and at least one combination of the data referenced in paragraphs (a)(9)(ii)(B)(
(v)
(A) For evidence-based decision support interventions under paragraph (a)(9)(iii) of this section:
(
(
(
(
(B) For linked referential CDS in paragraph (a)(9)(iv) of this section and drug-drug, drug-allergy interaction checks in paragraph (a)(4) of this section, the developer of the intervention, and where clinically indicated, the bibliographic citation of the intervention (clinical research/guideline).
(10)
(i)
(ii)
(11)
(12)
(13)
(A) The standard and implementation specifications specified in § 170.204(b)(3).
(B) The standard and implementation specifications specified in § 170.204(b)(4).
(ii)
(14)
(ii) Parse the following identifiers from a Unique Device Identifier:
(A) Device Identifier;
(B) The following identifiers that compose the Production Identifier:
(
(
(
(
(
(iii) Obtain and associate with each Unique Device Identifier:
(A) A description of the implantable device referenced by at least one of the following:
(
(
(B) The following Global Unique Device Identification Database attributes:
(
(
(
(
(
(iv) Display to a user an implantable device list consisting of:
(A) The active Unique Device Identifiers recorded for a patient; and
(B) For each active Unique Device Identifier recorded for a patient, the description of the implantable device specified by paragraph (a)(14)(iii)(A) of this section.
(C) A method to access all Unique Device Identifiers recorded for a patient.
(v) For each Unique Device Identifier recorded for a patient, enable a user to access:
(A) The Unique Device Identifier;
(B) The description of the implantable device specified by paragraph (a)(14)(iii)(A) of this section;
(C) The identifiers associated with the Unique Device Identifier, as specified by paragraph (a)(14)(ii) of this section;
(D) The attributes associated with the Unique Device Identifier, as specified by paragraph (a)(14)(iii)(B) of this section.
(vi) Enable a user to change the status of a Unique Device Identifier recorded for a patient.
(15)
(i)
(ii)
(iii)
(iv)
(v)
(vi)
(vii)
(viii)
(b)
(B) Receive transition of care/referral summaries through a method that conforms to the standard specified in § 170.202(d) from a service that has implemented the standard specified in § 170.202(a)(2).
(C)
(ii)
(
(
(
(
(
(
(
(B)
(C)
(
(
(
(iii)
(A) The Common Clinical Data Set.
(B)
(
(
(C) Cognitive status.
(D) Functional status.
(E)
(F)
(G)
(
(
(
(
(2)
(ii)
(iii)
(A) Simultaneously display (
(B) Enable a user to create a single reconciled list of each of the following: Medications; medication allergies; and problems.
(C) Enable a user to review and validate the accuracy of a final set of data.
(D) Upon a user's confirmation, automatically update the list, and incorporate the following data expressed according to the specified standard(s):
(
(
(
(iv)
(3)
(A) Create new prescriptions (NEWRX).
(B) Change prescriptions (RXCHG, CHGRES).
(C) Cancel prescriptions (CANRX, CANRES).
(D) Refill prescriptions (REFREQ, REFRES).
(E) Receive fill status notifications (RXFILL).
(F) Request and receive medication history information (RXHREQ, RXHRES).
(ii) For each transaction listed in paragraph (b)(3)(i) of this section, the technology must be able to receive and transmit the reason for the prescription using the diagnosis elements in DRU Segment.
(iii)
(iv) Limit a user's ability to prescribe all oral liquid medications in only metric standard units of mL (
(v) Always insert leading zeroes before the decimal point for amounts less than one and must not allow trailing zeroes after a decimal point when a user prescribes medications.
(4)
(i) The Common Clinical Data Set.
(ii)
(A) The standard specified in § 170.207(i).
(B) At a minimum, the version of the standard specified in § 170.207(a)(4).
(iii) Cognitive status.
(iv) Functional status.
(v)
(vi)
(vii)
(A)
(
(B)
(C)
(5)
(A) The Common Clinical Data Set.
(B)
(
(
(C) Cognitive status.
(D) Functional status.
(E)
(F)
(ii)
(A)
(
(
(
(
(
(
(
(B)
(C)
(
(
(
(6)
(B) Limit the ability of users who can create export summaries in at least one of these two ways:
(
(
(ii)
(A) The Common Clinical Data Set.
(B)
(
(
(C) Cognitive status.
(D) Functional status.
(E)
(F)
(iii)
(B) Consistent with the date and time period specified in paragraph (b)(6)(iii)(A) of this section, enable a user to do each of the following:
(
(
(
(iv)
(7)
(8)
(i) Receive a summary record that is formatted in accordance with the standard adopted in § 170.205(a)(4) that is document-level tagged as restricted and subject to restrictions on re-disclosure according to the standard adopted in § 170.205(o)(1);
(ii) Sequester the document-level tagged document from other documents received; and
(iii) View the restricted document without incorporating any of the data from the document.
(9)
(c)
(ii)
(A) Formatted in accordance with the standard specified in § 170.205(h)(2);
(B) Ranging from one to multiple patients; and
(C) That includes all of the data captured for each and every CQM to which technology was certified under paragraph (c)(1)(i) of this section.
(2)
(ii) Calculate each and every clinical quality measure for which it is presented for certification.
(3)
(i) At a minimum, in accordance with the standards specified in § 170.205(h)(2) and § 170.205(k)(1) and (2).
(ii)
(4)
(ii) Filter CQM results at the patient and aggregate levels by each one and any combination of the data listed in paragraph (c)(4)(iii) of this section and be able to:
(A) Create a data file of the filtered data in accordance with the standards adopted in § 170.205(h)(2) and § 170.205(k)(1) and (2); and
(B) Display the filtered data results in human readable format.
(iii)
(A) Taxpayer Identification Number.
(B) National Provider Identifier.
(C) Provider type in accordance with, at a minimum, the standard specified in § 170.207(r)(1).
(D) Practice site address.
(E) Patient insurance in accordance with, at a minimum, the standard specified in § 170.207(s)(1).
(F) Patient age.
(G) Patient sex in accordance with, at a minimum, the version of the standard specified in § 170.207(n)(1).
(H) Patient race and ethnicity in accordance with, at a minimum, the version of the standard specified in § 170.207(f)(2).
(I) Patient problem list data in accordance with, at a minimum, the version of the standard specified in § 170.207(a)(4).
(d)
(ii) Establish the type of access to electronic health information a user is permitted based on the unique identifier(s) provided in paragraph (d)(1)(i) of this section, and the actions the user is permitted to perform with the technology.
(2)
(A) Record actions related to electronic health information in accordance with the standard specified in § 170.210(e)(1);
(B) Record the audit log status (enabled or disabled) in accordance with the standard specified in § 170.210(e)(2) unless it cannot be disabled by any user; and
(C) Record the encryption status (enabled or disabled) of electronic health information locally stored on end-user devices by technology in accordance with the standard specified in § 170.210(e)(3) unless the technology prevents electronic health information from being locally stored on end-user
(ii)
(iii)
(iv)
(v)
(3)
(4)
(i)
(ii)
(A) To the affected record.
(B) Include a link that indicates this information's location.
(5)
(ii) Require user authentication in order to resume or regain the access that was stopped.
(6)
(7)
(i) Technology that is designed to locally store electronic health information on end-user devices must encrypt the electronic health information stored on such devices after use of the technology on those devices stops.
(A) Electronic health information that is stored must be encrypted in accordance with the standard specified in § 170.210(a)(2).
(B)
(ii) Technology is designed to prevent electronic health information from being locally stored on end-user devices after use of the technology on those devices stops.
(8)
(ii) Verify in accordance with the standard specified in § 170.210(c)(2) upon receipt of electronically exchanged health information that such information has not been altered.
(9)
(i)
(ii)
(10)
(ii) If technology permits auditing to be disabled, the ability to do so must be restricted to a limited set of users.
(iii) Actions recorded related to electronic health information must not be capable of being changed, overwritten, or deleted by the technology.
(iv) Technology must be able to detect whether the audit log has been altered.
(11)
(e)
(A)
(
(
(
(
(
(
(
(
(B)
(
(
(
(
(
(
(C)
(
(
(
(
(D)
(
(
(ii)
(
(
(
(
(B) Technology presented for certification may demonstrate compliance with paragraph (e)(1)(ii)(A) of this section if it is also certified to the certification criterion specified in § 170.315(d)(2) and the information required to be recorded in paragraph (e)(1)(ii)(A) of this section is accessible by the patient.
(2)
(3)
(i) Identify, record, and access information directly and electronically shared by a patient (or authorized representative).
(ii) Reference and link to patient health information documents.
(f)
(A) The standard and applicable implementation specifications specified in § 170.205(e)(4).
(B) At a minimum, the version of the standard specified in § 170.207(e)(3) for historical vaccines.
(C) At a minimum, the version of the standard specified in § 170.207(e)(4) for administered vaccines.
(ii) Enable a user to request, access, and display a patient's evaluated immunization history and the immunization forecast from an immunization registry in accordance with the standard at § 170.205(e)(4).
(2)
(3)
(i) The standard (and applicable implementation specifications) specified in § 170.205(g).
(ii) At a minimum, the versions of the standards specified in § 170.207(a)(3) and (c)(2).
(4)
(i) The standard (and applicable implementation specifications) specified in § 170.205(i)(2).
(ii) At a minimum, the versions of the standards specified in § 170.207(a)(4) and (c)(3).
(5)
(ii) Match a patient visit or encounter to the trigger code based on the parameters of the trigger code table.
(iii)
(A) Based on a matched trigger from paragraph (f)(5)(ii).
(B) That includes, at a minimum:
(
(
(
(
(
(
(6)
(7)
(g)
(2)
(3)
(ii)
(iii) One of the following must be submitted on the user-centered design processed used:
(A) Name, description and citation (URL and/or publication citation) for an industry or federal government standard.
(B) Name the process(es), provide an outline of the process(es), a short description of the process(es), and an explanation of the reason(s) why use of any of the existing user-centered design standards was impractical.
(iv) The following information/sections from NISTIR 7742 must be submitted for each capability to which
(A) Name and product version; date and location of the test; test environment; description of the intended users; and total number of participants;
(B) Description of participants, including: Sex; age; education; occupation/role; professional experience; computer experience; and product experience;
(C) Description of the user tasks that were tested and association of each task to corresponding certification criteria;
(D) The specific metrics captured during the testing of each user task performed in (g)(3)(iv)(C) of this section, which must include: Task success (%); task failures (%); task standard deviations (%); task performance time; and user satisfaction rating (based on a scale with 1 as very difficult and 5 as very easy) or an alternative acceptable user satisfaction measure;
(E) Test results for each task using the metrics identified above in paragraph (g)(3)(iv)(D) of this section; and
(F) Results and data analysis narrative, including: Major test finding; effectiveness; efficiency; satisfaction; and areas for improvement.
(v) Submit test scenarios used in summative usability testing.
(4)
(A) The QMS used is established by the Federal government or a standards developing organization.
(B) The QMS used is mapped to one or more QMS established by the Federal government or standards developing organization(s).
(ii) When a single QMS was used for applicable capabilities, it would only need to be identified once.
(iii) When different QMS were applied to specific capabilities, each QMS applied would need to be identified.
(5)
(i) When a single accessibility-centered design standard or law was used for applicable capabilities, it would only need to be identified once.
(ii) When different accessibility-centered design standards and laws were applied to specific capabilities, each accessibility-centered design standard or law applied would need to be identified. This would include the application of an accessibility-centered design standard or law to some capabilities and none to others.
(iii) When no accessibility-centered design standard or law was applied to all applicable capabilities such a response is acceptable to satisfy this certification criterion.
(6)
(i)
(ii)
(iii)
(iv)
(7)
(i)
(ii)
(
(
(
(B) The documentation used to meet paragraph (g)(7)(ii)(A) of this section must be available via a publicly accessible hyperlink.
(8)
(i)
(B) Respond to requests for patient data associated with a specific date as well as requests for patient data within a specified date range.
(ii)
(
(
(
(B) The documentation used to meet paragraph (g)(8)(ii)(A) of this section must be available via a publicly accessible hyperlink.
(9)
(i)
(B) Respond to requests for patient data associated with a specific date as well as requests for patient data within a specified date range.
(ii)
(
(
(
(B) The documentation used to meet paragraph (g)(9)(ii)(A) of this section must be available via a publicly accessible hyperlink.
(h)
(ii)
(2)
(A) The standard specified in § 170.202(a)(2), including formatted only as a “wrapped” message;
(B) The standard specified in § 170.202(b), including support for both limited and full XDS metadata profiles; and
(C) Both edge protocol methods specified by the standard in § 170.202(d).
(ii)
(e) * * *
(4) Verify that ONC-ACBs are performing surveillance as required by and in accordance with § 170.556, § 170.523(k), and their respective annual plans; and
The additions and revisions read as follows:
(f) Provide ONC, no less frequently than weekly, a current list of Health IT Modules, Complete EHRs, and/or EHR Modules that have been certified that includes, at a minimum:
(1) For the 2015 Edition health IT certification criteria and subsequent editions of health IT certification criteria:
(i) The Health IT Module developer name; product name; product version; developer Web site, physical address, email, phone number, and contact name;
(ii) The ONC-ACB Web site, physical address, email, phone number, and contact name, contact function/title;
(iii) The ATL Web site, physical address, email, phone number, and contact name, contact function/title;
(iv) Location and means by which the testing was conducted (
(v) The date(s) the Health IT Module was tested;
(vi) The date the Health IT Module was certified;
(vii) The unique certification number or other specific product identification;
(viii) The certification criterion or criteria to which the Health IT Module has been certified, including the test procedure and test data versions used, test tool version used, and whether any test data was altered (
(ix) The way in which each privacy and security criterion was addressed for the purposes of certification;
(x) The standard or mapping used to meet the quality management system certification criterion;
(xi) The standard(s) or lack thereof used to meet the accessibility-centered design certification criterion;
(xii)
(xiii)
(xiv)
(xv)
(xvi)
(xvii)
(xviii)
(xix)
(xx) A hyperlink to the disclosures required by § 170.523(k)(1) for the Health IT Module;
(xxi) The attestation required by § 170.523(k)(2);
(xxii)
(A) The specific certification requirements to which the technology failed to conform, as determined by the ONC-ACB;
(B) A summary of the deficiency or deficiencies identified by the ONC-ACB as the basis for its determination of non-conformity;
(C) When available, the health IT developer's explanation of the deficiency or deficiencies;
(D) The dates surveillance was initiated and completed;
(E) The results of randomized surveillance, including pass rate for each criterion in instances where the Health IT Module is evaluated at more than one location;
(F) The number of sites that were used in randomized surveillance;
(G) The date of the ONC-ACB's determination of non-conformity;
(H) The date on which the ONC-ACB approved a corrective action plan;
(I) The date corrective action began (effective date of approved corrective action plan);
(J) The date by which corrective action must be completed (as specified by the approved corrective action plan);
(K) The date corrective action was completed; and
(L) A description of the resolution of the non-conformity or non-conformities.
(2) For the 2014 Edition EHR certification criteria:
(i) The Complete EHR or EHR Module developer name (if applicable);
(ii) The date certified;
(iii) The product version;
(iv) The unique certification number or other specific product identification;
(v) The clinical quality measures to which a Complete EHR or EHR Module has been certified;
(vi) Where applicable, any additional software a Complete EHR or EHR Module relied upon to demonstrate its compliance with a certification criterion or criteria adopted by the Secretary;
(vii) Where applicable, the certification criterion or criteria to which each EHR Module has been certified; and
(viii) A hyperlink to the test results used to certify the Complete EHRs and/or EHR Modules that can be accessed by the public.
(ix) A hyperlink to the disclosures required by § 170.523(k)(1) for the Complete EHRs and/or EHR Modules; and
(x) The attestation required by § 170.523(k)(2); and
(xi)
(A) The specific certification requirements to which the technology failed to conform, as determined by the ONC-ACB;
(B) A summary of the deficiency or deficiencies identified by the ONC-ACB as the basis for its determination of non-conformity;
(C) When available, the health IT developer's explanation of the deficiency or deficiencies;
(D) The dates surveillance was initiated and completed;
(E) The results of randomized surveillance, including pass rate for each criterion in instances where the Complete EHR or EHR Module is evaluated at more than one location;
(F) The number of sites that were used in randomized surveillance;
(G) The date of the ONC-ACB's determination of non-conformity;
(H) The date on which the ONC-ACB approved a corrective action plan;
(I) The date corrective action began (effective date of approved corrective action plan);
(J) The date by which corrective action must be completed (as specified by the approved corrective action plan);
(K) The date corrective action was completed; and
(L) A description of the resolution of the non-conformity or non-conformities.
(g)
(2) Make the records available to HHS upon request during the retention period described in paragraph (g)(1) of this section;
(i)
(1) Conduct surveillance of certified Complete EHRs and Health IT Modules; and
(2) Report, at a minimum, on a quarterly basis to the National Coordinator the results of its surveillance.
(k) Ensure adherence to the following requirements when issuing any certification and during surveillance of Complete EHRs and Health IT Modules the ONC-ACB has certified.
(1)
(i) The disclaimer “This [Complete EHR or Health IT Module] is [specify Edition of EHR certification criteria] compliant and has been certified by an ONC-ACB in accordance with the applicable certification criteria adopted by the Secretary of Health and Human Services. This certification does not represent an endorsement by the U.S. Department of Health and Human Services.”
(ii) The following information an ONC-ACB is required to report to the National Coordinator:
(A) For a Health IT Module certified to 2015 Edition health IT certification criteria, the information specified by paragraphs (f)(1)(i), (vi), (vii), (viii), (xvi), and (xvii) of this section as applicable for the specific Health IT Module.
(B) For a Complete EHR or EHR Module certified to 2014 Edition health IT certification criteria, the information specified by paragraphs (f)(2)(i), (ii), (iv)-(v), and (vii) of this section as applicable for the specific Complete EHR or EHR Module.
(iii) In plain language, a detailed description of all known material information concerning:
(A) Additional types of costs that a user may be required to pay to implement or use the Complete EHR or Health IT Module's capabilities, whether to meet meaningful use objectives and measures or to achieve any other use within the scope of the health IT's certification.
(B) Limitations that a user may encounter in the course of implementing and using the Complete EHR or Health IT Module's capabilities, whether to meet meaningful use objectives and measures or to achieve any other use within the scope of the health IT's certification.
(iv) The types of information required to be disclosed under paragraph (k)(iii) of this section include but are not limited to:
(A) Additional types of costs or fees (whether fixed, recurring, transaction-based, or otherwise) imposed by a health IT developer (or any third-party from whom the developer purchases, licenses, or obtains any technology, products, or services in connection with its certified health IT) to purchase, license, implement, maintain, upgrade, use, or otherwise enable and support the use of capabilities to which health IT is certified; or in connection with any data generated in the course of using any capability to which health IT is certified.
(B) Limitations, whether by contract or otherwise, on the use of any capability to which technology is certified for any purpose within the scope of the technology's certification; or in connection with any data generated in the course of using any capability to which health IT is certified.
(C) Limitations, including but not limited to technical or practical limitations of technology or its capabilities, that could prevent or impair the successful implementation, configuration, customization, maintenance, support, or use of any capabilities to which technology is certified; or that could prevent or limit the use, exchange, or portability of any data generated in the course of using any capability to which technology is certified.
(v) Health IT self-developers are excluded from the requirements of paragraph (k)(1)(iii) of this section.
(2)
(i) An attestation that it will voluntarily and timely provide, in plain writing and in a manner calculated to inform, any part (including all of) the information required to be disclosed under paragraph (k)(1) of this section,
(A) to all customers, prior to providing or entering into any agreement to provide any certified health IT or related product or service (including subsequent updates, add-ons, or additional products or services during the course of an on-going agreement);
(B) to any person who requests or receives a quotation, estimate, description of services, or other assertion or information from the developer in connection with any certified health IT or any capabilities thereof; and
(C) to any person, upon request.
(ii) An attestation by the developer that it has been asked to make the voluntary transparency attestation described by paragraph (k)(2)(i) of this section and has elected not to make such attestation.
(3) A certification issued to a pre-coordinated, integrated bundle of Health IT Modules shall be treated the same as a certification issued to a Complete EHR for the purposes of paragraph (k)(1) of this section, except that the certification must also indicate each Health IT Module that is included in the bundle; and
(4) A certification issued to a Complete EHR or Health IT Module based solely on the applicable certification criteria adopted by the Secretary at subpart C of this part must be separate and distinct from any other certification(s) based on other criteria or requirements.
(m)
(1) All adaptations of certified Complete EHRs and certified Health IT Modules; and
(2) All updates made to certified Complete EHRs and certified Health IT Modules affecting the capabilities in certification criteria to which the “safety-enhanced design” criteria apply.
(n)
The additions read as follows:
(g) When certifying a Health IT Module to the 2015 Edition health IT certification criteria, an ONC-ACB must certify the Health IT Module in accordance with the certification criteria at:
(1) Section 170.315(g)(3) if the Health IT Module is presented for certification to one or more listed certification criteria in § 170.315(g)(3);
(2) Section 170.315(g)(4);
(3) Section 170.315(g)(5); and
(4) Section 170.315(g)(6) if the Health IT Module is presented for certification with C-CDA creation capabilities within its scope. If the scope of certification sought includes multiple certification criteria that require C-CDA creation, § 170.315(g)(6) need only be tested in association with one of those certification criteria and would not be expected or required to be tested for each. If the scope of certification sought includes multiple certification criteria that require C-CDA creation, § 170.315(g)(6) need only be tested in association with one of those certification criteria and would not be expected or required to be tested for each so long as all applicable C-CDA document templates have been evaluated as part of § 170.315(g)(6) for the scope of the certification sought.
(h)
(2) In order to be issued a certification, a Health IT Module would only need to be tested once to each applicable privacy and security criterion in paragraphs (h)(3)(i) through (viii) of this section so long as the health IT developer attests that such privacy and security capabilities apply to the full scope of capabilities included in the requested certification, except for the following:
(i) A Health IT Module presented for certification to § 170.315(e)(1) must be separately tested to § 170.315(d)(9); and
(ii) A Health IT Module presented for certification to § 170.315(e)(2) must be separately tested to § 170.315(d)(9).
(3)
(ii) Section 170.315(b) is also certified to the certification criteria specified in § 170.315(d)(1) through (3) and (d)(5) through (8);
(iii) Section 170.315(c) is also certified to the certification criteria specified in § 170.315(d)(1) through (3), and (5);
(iv) Section 170.315(e)(1) is also certified to the certification criteria specified in § 170.315(d)(1) through (3), (5), (7), and (9);
(v) Section 170.315(e)(2) and (3) is also certified to the certification criteria specified in § 170.315(d)(1) through (3), (5), and (9);
(vi) Section 170.315(f) is also certified to the certification criteria specified in § 170.315(d)(1) through (3) and (7);
(vii) Section 170.315(g)(7), (8) and (9) is also certified to the certification criteria specified in § 170.315(d)(1) and (9); and (d)(2) or (10);
(viii) Section 170.315(h) is also certified to the certification criteria specified in § 170.315(d)(1) through (3); and
(4)
(i) Directly, by demonstrating a technical capability to satisfy the applicable certification criterion or certification criteria; or
(ii) Demonstrate, through system documentation sufficiently detailed to enable integration, that the Health IT Module has implemented service interfaces for each applicable privacy and security certification criterion that enable the Health IT Module to access external services necessary to meet the privacy and security certification criterion.
(i) [Reserved]
(j)
(a)
(1)
(2)
(b)
(1)
(2) [Reserved]
(c)
(1)
(2)
(3)
(4)
(i) Evaluate the certified Complete EHR or certified Health IT Module's capabilities at one or more locations where the certified Complete EHR or certified Health IT Module is implemented and in use in the field.
(ii) Ensure that the locations are selected at random (subject to appropriate weighting and sampling considerations) from among all locations where the certified Complete EHR or certified Health IT Module is implemented and in use in the field.
(5)
(6)
(d)
(2) The ONC-ACB shall provide direction to the developer as to the required elements of the corrective action plan.
(3) The ONC-ACB shall verify the required elements of the corrective action plan, consistent with its accreditation and any elements specified by the National Coordinator. At a minimum, any corrective action plan submitted by a developer to an ONC-ACB must include:
(i) A description of the identified non-conformities or deficiencies;
(ii) An assessment of how widespread or isolated the identified non-conformities or deficiencies may be across all of the developer's customers and users of the certified Complete EHR or certified Health IT Module;
(iii) How the developer will address the identified non-conformities or deficiencies, both at the locations under which surveillance occurred and for all other potentially affected customers and users;
(iv) How the developer will ensure that all affected and potentially affected
(v) The timeframe under which corrective action will be completed.
(vi) An attestation by the developer that it has completed all elements of the approved corrective action plan.
(4) When the ONC-ACB receives a proposed corrective action plan (or a revised proposed corrective action plan), the ONC-ACB shall either approve the corrective action plan or, if the plan does not adequately address the elements described by paragraph (d)(3) of this section and other elements required by the ONC-ACB, instruct the developer to submit a revised proposed corrective action plan.
(5)
(i) 30 days after notifying the developer of a non-conformity pursuant to paragraph (d)(1) of this section, if the developer has not submitted a proposed corrective action plan;
(ii) 90 days after notifying the developer of a non-conformity pursuant to paragraph (d)(1) of this section, if the ONC-ACB cannot approve a corrective action plan because the developer has not submitted a revised proposed corrective action plan in accordance with paragraph (d)(4) of this section; and
(iii) Immediately, if the developer has not completed the corrective actions specified by an approved corrective action plan within the time specified therein.
(6)
(e)
(2)
(3)
(f)
Centers for Medicare & Medicaid Services (CMS), HHS.
Final rules with comment period.
This final rule with comment period specifies the requirements that eligible professionals (EPs), eligible hospitals, and critical access hospitals (CAHs) must meet in order to qualify for Medicare and Medicaid electronic health record (EHR) incentive payments and avoid downward payment adjustments under the Medicare EHR Incentive Program. In addition, it changes the Medicare and Medicaid EHR Incentive Programs reporting period in 2015 to a 90-day period aligned with the calendar year. This final rule with comment period also removes reporting requirements on measures that have become redundant, duplicative, or topped out from the Medicare and Medicaid EHR Incentive Programs. In addition, this final rule with comment period establishes the requirements for Stage 3 of the program as optional in 2017 and required for all participants beginning in 2018. The final rule with comment period continues to encourage the electronic submission of clinical quality measure (CQM) data, establishes requirements to transition the program to a single stage, and aligns reporting for providers in the Medicare and Medicaid EHR Incentive Programs.
In commenting, please refer to file code CMS-3310 & 3311-FC. Because of staff and resource limitations, we cannot accept comments by facsimile (FAX) transmission.
You may submit comments in one of four ways (no duplicates, please):
1.
2.
Please allow sufficient time for mailed comments to be received before the close of the comment period.
3.
4.
a. For delivery in Washington, DC—Centers for Medicare & Medicaid Services, Department of Health and Human Services, Room 445-G, Hubert H. Humphrey Building, 200 Independence Avenue SW., Washington, DC 20201.
(Because access to the interior of the Hubert H. Humphrey Building is not readily available to persons without Federal Government identification, commenters are encouraged to leave their comments in the CMS drop slots located in the main lobby of the building. A stamp-in clock is available for persons wishing to retain a proof of filing by stamping in and retaining an extra copy of the comments being filed.)
b. For delivery in Baltimore, MD—Centers for Medicare & Medicaid Services, Department of Health and Human Services, 7500 Security Boulevard, Baltimore, MD 21244-1850.
If you intend to deliver your comments to the Baltimore address, please call the telephone number (410) 786-9994 in advance to schedule your arrival with one of our staff members.
Comments mailed to the addresses indicated as appropriate for hand or courier delivery may be delayed and received after the comment period.
For information on viewing public comments, we refer readers to the beginning of the
This
This final rule with comment period addresses the proposals made in two separate CMS notices of proposed rulemaking (NPRM); the March 30, 2015 “Medicare and Medicaid Programs; Electronic Health Record Incentive Program Stage 3” NPRM (80 FR 16731 through 16804) (hereafter referred to as the “Stage 3 proposed rule”) and the April 9, 2015 “Medicare and Medicaid Programs; Electronic Health Record Incentive Program—Modifications to Meaningful Use in 2015 through 2017” NPRM (80 FR 20346 through 20399) (hereafter referred to as the “EHR Incentive Programs in 2015 through 2017 proposed rule”). However, the Medicare Access and CHIP Reauthorization Act of 2015 (MACRA) (Pub. L. 114-10) was enacted on April 16, 2015, after publication of the proposed EHR rule. Section 101(b)(1)(A) of MACRA amended section 1848(a)(7)(A) of the Act to sunset the meaningful use payment adjustment for EPs at the end of CY 2018. Section 101(c) of MACRA added section 1848(q) of the Act requiring the establishment of a Merit-Based Incentive Payment System (MIPS), which would incorporate meaningful use. In light of the passage of MACRA, this final rule with comment period also allows for a 60-day public comment period on certain provisions noted in the
The enactment of MACRA has altered the EHR Incentive Programs such that the existing Medicare payment adjustment for EPs under 1848(a)(7)(A) of the Act will end in CY 2018 and be incorporated under MIPS beginning in CY 2019. It is our intent to issue a notice of proposed rulemaking for MIPS by mid-2016. This final rule with comment period synchronizes reporting under the EHR Incentive Programs to end the separate stages of meaningful use, which we believe will prepare Medicare EPs for the transition to MIPS.
In the Stage 3 and the EHR Incentive Program in 2015 through 2017 proposed rules, and in this final rule with comment period, we have responded to public input and comments by providing for flexibility that may assist EPs in preparing for the transition to MIPS. This final rule with comment period establishes a number of key final policies in response to these concerns: A simplification of program requirements, an introduction of flexibility within certain objectives, an option to participate in Stage 3 in 2017 but not required until 2018, and an overall focus on interoperability. We have focused on leveraging health IT to support providers and reduce burdensome requirements within an evolving environment. In light of public interest and in recognition that this is an ongoing and continuous process, we are providing a 60-day public comment period on the final policies for the Stage 3 objectives and measures and the EHR reporting period for Stage 3 in 2017 and subsequent years. Public comments received may be considered as we plan for the incorporation of meaningful use into MIPS, and any policies developed would be addressed in future rulemaking.
The Stage 3 proposed rule (80 FR 16733 through 16735) described the final stage of the program, which would incorporate portions of the prior stages into Stage 3 requirements, while altering other requirements in response to CMS's progress toward policy goals, the widespread adoption of technology and clinical standards among providers, and high performance on certain objectives among providers. These proposed changes included simplifying and reducing the number of measures, and focusing the Medicare and Medicaid EHR Incentive Programs on the advanced use of EHR technology. In addition, the proposals set a path for providers to move toward aligned reporting on a single set of requirements, with the goal of moving all participants in the Medicare and Medicaid EHR Incentive Programs to a single set of requirements in 2018. The incorporation of the requirements into one stage for all providers is intended to respond to stakeholder concerns by creating simplicity in the program by focusing on the success of certain measures that are part of the meaningful use program to date, and setting a long- term, sustainable foundation based on key advanced use objectives for the Medicare and Medicaid EHR Incentive Programs.
In the EHR Incentive Programs for 2015 through 2017 proposed rule (80 FR 20346 through 20399), we proposed to make similar modifications to Stage 1 and Stage 2 of the Medicare and Medicaid EHR Incentive Programs in order to reduce reporting burden, to eliminate redundant and duplicative reporting, and to better align the objectives and measures of meaningful use with the proposed Stage 3 requirements, which would be optional in 2017 and required beginning in 2018.
In this final rule with comment period, we are finalizing the requirements for the EHR Incentive Programs for 2015 through 2017 and for 2018 and subsequent years. We note that our intent in finalizing the Stage 3 proposed rule along with the changes for 2015 through 2017 while continuing to solicit comments on certain provisions is multifold; we are creating consistency in the policies for the current program in 2015 through 2017 and for 2018 and subsequent years; and we have established a clear vision of how current participation will assist in meeting our long-term delivery system reform goals. We believe this sustained consistency in policy will support the planning and development for MIPS and the future use of EHR across a multitude of healthcare providers.
We are also finalizing changes to the EHR reporting period, timelines, and structure of the Medicare and Medicaid EHR Incentive Programs for 2015 through 2017 to better align EHR reporting periods for providers; support a flexible, clear framework to reduce provider burden; and support future sustainability of the Medicare and Medicaid EHR Incentive Programs. Overall, the requirements of the program finalized in this rule for 2015 through 2017 seek to support near-term goals for delivery system reform and lay a foundation for our broader efforts to pursue interoperability and quality initiatives focused on improving patient outcomes.
The American Recovery and Reinvestment Act of 2009 (ARRA) (Pub. L. 111-5) amended Titles XVIII and XIX of the Social Security Act (the Act) to authorize incentive payments to EPs, eligible hospitals, CAHs, and Medicare Advantage (MA) organizations to promote the adoption and meaningful use of CEHRT. Sections 1848(o), 1853(l) and (m), 1886(n), and 1814(l) of the Act provide the statutory basis for the Medicare incentive payments made to meaningful EHR users. These statutory provisions govern EPs, MA organizations (for certain qualifying EPs and hospitals that meaningfully use CEHRT), subsection (d) hospitals and CAHs, respectively. Sections 1848(a)(7), 1853(l) and (m), 1886(b)(3)(B), and 1814(l) of the Act also establish downward payment adjustments, beginning with calendar or fiscal year (FY) 2015, for EPs, MA organizations, subsection (d) hospitals, and CAHs that are not meaningful users of CEHRT for certain associated reporting periods. Sections 1903(a)(3)(F) and 1903(t) of the Act provide the statutory basis for Medicaid incentive payments. (There are no payment adjustments under Medicaid). (For a more detailed explanation of the statutory basis for the EHR incentive payments, see the July 28, 2010 Stage 1 final rule titled, “Medicare and Medicaid Programs; Electronic Health Record Incentive Program; Final Rule” (75 FR 44316 through 44317).)
The Stage 1 final rule established the foundation for the Medicare and Medicaid EHR Incentive Programs by establishing requirements for the electronic capture of clinical data, including providing patients with electronic copies of their health information. We outlined Stage 1 meaningful use criteria and finalized core and menu objectives for EPs, eligible hospitals, and CAHs. (For a full discussion of Stage 1 of meaningful use, we refer readers to the Stage 1 final rule (75 FR 44313 through 44588).)
In the September 4, 2012 Stage 2 final rule (77 FR 53967 through 54162), we focused on the next goal: The exchange of essential health data among health care providers and patients to improve care coordination. We also finalized a set of clinical quality measures (CQMs) that all providers participating in any stage of the program are required to report to CMS beginning in 2014. (For a full discussion of the meaningful use objectives and measures, and the CQMs we finalized under Stage 2, we refer readers to the Stage 2 final rule at 77 FR 53967 through 54162.)
In the March 30, 2015
One significant change we proposed in the Stage 3 proposed rule (80 FR 16734) included establishing a single set of objectives and measures (tailored to EPs or eligible hospitals/CAHs) to meet the definition of meaningful use for Stage 3 in 2017 and subsequent years. In the EHR Incentive Program in 2015 through 2017 proposed rule (80 FR 20351), we additionally proposed a
In the Stage 3 proposed rule (80 FR 16741), we outlined our proposed approach and method for measure selection that removed topped out, redundant, and duplicative measures from reporting requirements and focused on only those measures that represent the most advanced use of the functions and standards supported by CEHRT. In the EHR Incentive Program in 2015 through 2017 proposed rule (80 FR 20352), we proposed adopting this approach as applicable to the current objectives and measures in use for Stage 1 and Stage 2 of the program and aligning the current objectives and measures with those identified for long-term use in the Stage 3 proposed rule. In this final rule, we adopt the approach for the Stage 3 objectives and measures, as well as the similar approach for the objectives and measures of the EHR Incentive Program in 2015 through 2017.
In this final rule, we adopt changes to the EHR reporting period for the Medicare and Medicaid EHR Incentive Programs in 2015, 2016, and 2017 and finalize the changes that align reporting periods to the calendar year. We also finalize the proposal to adopt a 90-day reporting period for all providers in 2015 and new participants in 2016, and based on public comment we are finalizing a 90-day reporting period for new participants in 2017.
In the Stage 3 proposed rule (80 FR 16741), we outlined our method and approach for identifying the objectives and measures retained for Stage 3 of meaningful use beginning in 2017. We also identified those objectives and measures that are now redundant, duplicative, or topped out, and therefore will no longer be required for the successful demonstration of meaningful use for Stage 3. For further discussion of this approach, we refer readers to section II.B.1.b.(4).(a) of this final rule with comment period.
In this final rule, we are adopting the proposed approach from the EHR Incentive Program in 2015 through 2017 proposed rule to use a similar method to identify the objectives and measures from Stages 1 and 2 of meaningful use that we believe should no longer be required for a provider to demonstrate meaningful use in 2015 through 2017 because these measures have been identified as redundant, duplicative, or topped out. We are also finalizing changes to remove the menu and core structure of Stage 1 and Stage 2 and reduce the overall number of objectives to which a provider must attest. In addition, we are finalizing changes to individual objectives and measures for Stage 2 of meaningful use as follows:
• Changing the threshold for two measures requiring patient action (the second measure for the Stage 2 Objective for Patient Electronic Access and the measure for the Stage 2 Objective for Secure Electronic Messaging).
• Consolidating all public health reporting objectives into one objective with measure options similar to the structure of the Stage 3 Public Health Reporting Objective (80 FR 16762 through 16767).
• Changing the eligible hospital electronic prescribing objective from a menu objective to a required objective with an exclusion available for eligible hospitals and CAHs in 2015 and 2016.
We are additionally finalizing the proposal to maintain the existing definitions for the objectives and measures, including the numerator and denominator calculations, the proposal to maintain certain measure specifications for 2015, and the proposal to allow exclusions for certain measures in 2015 and 2016 in order to facilitate the transition for providers already engaged in the workflows, data capture, and measure calculation for meaningful use for an EHR reporting period in 2015 and 2016.For further discussion of this approach, we refer readers to section II.B.1.b.(4).(b).of this final rule.
In this final rule, we are adopting changes to the EHR reporting period for 2017, 2018, and subsequent years based on the Stage 3 proposed rule (80 FR 16739) and public comments received. We are finalizing the proposal for full calendar year reporting for providers beginning in 2018 with a limited exception for Medicaid providers in their first year of demonstrating meaningful use. We are also finalizing an optional 90-day reporting period for providers demonstrating the Stage 3 requirements for an EHR reporting period in 2017. For further discussion, we refer readers to section II.B.1.b.(3) of this final rule.
The methodology outlined in the Stage 3 proposed rule at 80 FR 16741 for the selection of objectives and measures for the Medicare and Medicaid EHR Incentive Programs for Stage 3 in 2017 and subsequent years included the following:
• Review attestation data for Stages 1 and 2 of meaningful use;
• Conduct listening sessions and interviews with providers, EHR system developers, regional extension centers, and health care provider associations; and
• Review recommendations from government agencies and advisory committees focused on health care improvement, such as the Health Information Technology (HIT) Policy Committee, the National Quality Forum (NQF), and the Centers for Disease Control and Prevention (CDC).
The information we gathered from these sources focused on analyzing measure performance, implementing discrete EHR functionalities and standards, and examining objectives and measures presenting the best opportunity to improve patient outcomes and enhance provider support.
Based on this analysis and consideration of public comment received, we are finalizing a set of 8 objectives with associated measures designed to meet the following policy goals:
• Align with national health care quality improvement efforts;
• Promote interoperability and health information exchange; and
• Focus on the 3-part aim of reducing cost, improving access, and improving quality.
We intend for Stage 3 to be the final stage of the meaningful use framework, which leverages the structure identified in the Stage 1 and Stage 2 final rules, while simultaneously establishing a single set of objectives and measures designed to promote best practices and continued improvement in health outcomes in a sustainable manner.
In the EHR Incentive Programs in 2015 through 2017 proposed rule (80 FR 20374), we proposed no changes to the individual certification requirements for the objectives and measures of meaningful use for an EHR reporting period in 2015 through 2017 using EHR technology certified to the 2014 Edition certification criteria. In the Stage 3 proposed rule (80 FR 16767), we proposed that providers use EHR technology certified to the 2015 Edition certification criteria for an EHR reporting period in 2018. In this rule, we are finalizing that providers may continue to usher technology certified to the 2014 Edition until EHR technology certified to the 2015 Edition is required with an EHR reporting period beginning in 2018. In the Stage 3 proposed rule, we also noted our intent to allow providers to upgrade to technology certified to the 2015 Edition as soon as such technology is available if they determine that the EHR technology certified to the 2015 Edition would support and meet the requirements of the EHR Incentive Programs in 2015 through 2017. We are finalizing that providers may use EHR technology certified to the 2014 Edition for an EHR reporting period in 2015; EHR technology certified to either the 2014 Edition, the 2015 Edition, or a combination of the two in 2016 and 2017; and EHR technology certified to the 2015 Edition for an EHR reporting period in 2018 and subsequent years.
We are also finalizing a definition of CEHRT within 42 CFR 495.4 that includes the functions and standards outlined for the certification of health information technology to the 2014 and 2015 Edition certification criteria for use in the Medicare and Medicaid EHR Incentive Programs. For further discussion of the definition and use of CEHRT, we direct readers to section II.B.3 of this final rule.
EPs, eligible hospitals, and CAHs must report CQMs in order to meet the requirements of the Medicare and Medicaid EHR Incentive Programs. We are committed to continuing to promote the electronic capture, calculation, and reporting of key clinical data through the use of CEHRT. We are also focused on improving alignment of reporting requirements for CMS programs that leverage EHR technology for clinical quality reporting and quality measurement to streamline reporting mechanisms for providers and increase quality data integrity.
This final rule addresses quality reporting alignment on several fronts. Our long-term vision seeks to have hospitals, clinicians, and other health care providers report through a single, aligned mechanism for multiple CMS programs. In order to facilitate continuous quality improvement, we noted in the Stage 3 proposed rule our intent to implement changes to quality reporting requirements in conjunction with the quality reporting programs through the annual Medicare payment rules, such as the Physician Fee Schedule (PFS) and the Inpatient Prospective Payment Systems (IPPS) rules. In the Stage 3 proposed rule, we proposed to continue encouraging CQM data submission through electronic submission for Medicare participants in 2017 and to require electronic submission of CQMs where feasible beginning in 2018 for Medicare providers demonstrating meaningful use. (We further discuss Medicaid CQM submission in section II.F.3 of this final rule.)
We did not propose changes to the CQM selection or reporting scheme (9 or 16 CQMs across at least 3 domains) from the CQM requirements previously established for all providers seeking to demonstrate meaningful use in the Medicare and Medicaid EHR Incentive Programs defined in earlier rulemaking (see 77 FR 54049 through 54089). In the EHR Incentive Programs in 2015 through 2017 proposed rule, for an EHR reporting period in 2015, and for providers demonstrating meaningful use for the first time in 2016 or 2017, we proposed that providers may—
• Attest to any continuous 90-day period of CQM data during the calendar year through the Medicare EHR Incentive Program registration and attestation site; or
• Electronically report CQM data using the established methods for electronic reporting.
We are finalizing these reporting periods for CQM reporting for 2015 and 2016. We are finalizing that for 2017, providers beyond their first year of meaningful use may attest to one full calendar year of CQM data or they may electronically report their CQM data using the established methods for electronic reporting outlined in section II.C. of this final rule. In addition, we are finalizing that for an EHR reporting period in 2018, all providers are required to submit CQM data for the Medicare EHR Incentive Program using these established methods for electronic reporting. We refer readers to section II.C. of this final rule for further information on clinical quality measurement.
We are finalizing our proposal to continue our common method for meaningful use in both the Medicare and Medicaid EHR Incentive Programs of attestation as the method for demonstrating that an EP, eligible hospital, or CAH has met the requirements of the Medicare and Medicaid EHR Incentive Programs. We are additionally finalizing changes to the attestation deadlines to accommodate the change to reporting based on the calendar year for eligible hospitals and CAHs beginning with an EHR reporting period in 2015, as well as the proposed change to a 90-day EHR reporting period for all providers in 2015. We are also finalizing changes to the attestation deadlines for new meaningful EHR users in 2015 and 2016 to avoid the Medicare payment adjustments in 2016 and 2017. Finally, we are adopting the alternate attestation method proposed in the EHR Incentive Program in 2015 through 2017 proposed rule for certain Medicaid providers to demonstrate meaningful use in 2015 and subsequent years to avoid Medicare payment adjustments. For further discussion, we refer readers to section II.D of this final rule.
The HITECH statute requires Medicare payment adjustments beginning in 2015. In this final rule, we are maintaining the payment adjustment policies for EPs, eligible hospitals, and CAHs as finalized in the Stage 2 final rule (77 FR 54093 through 54113 and 54115 through 54119), except for a change to the relationship between the EHR reporting period year, the payment adjustment year, and the attestation deadlines to avoid the payment adjustment. For the discussion of payment adjustments and hardship exceptions, we refer readers to section II.E of this final rule with comment period.
Sections 1903(a)(3)(F) and 1903(t) of the Act provide the statutory basis for the Medicaid EHR Incentive Program. In this final rule with comment period, we finalize the proposed changes to EHR reporting periods that would begin in 2017; Medicaid EPs and eligible hospitals demonstrating meaningful use for the first time in the Medicaid EHR Incentive Program would be required to attest for an EHR reporting period of any continuous 90-day period in the calendar year for purposes of receiving an incentive, as well as avoiding the payment adjustment under the Medicare Program (80 FR 16779).
We will continue to allow states to set up a CQM submission process that Medicaid EPs and eligible hospitals may use to report on CQMs for 2017 and subsequent years. We are also finalizing amendments to state reporting on providers who are participating in the Medicaid EHR Incentive Program, as well as state reporting on implementation and oversight activities.
The provisions included in this final rule with comment period will apply for the Medicaid EHR Incentive Program, including the changes to the EHR reporting period in 2015 and 2016, and the objectives and measures required to demonstrate meaningful use in 2015 through 2017. We will continue to allow states flexibility under the Medicaid EHR Incentive Program for the public health reporting objective. Specifically, for meaningful use in 2015 through 2017 and for Stage 3, we will continue the policy stated in the Stage 2 final rule (77 FR 53979) to allow states to specify the means of transmission of the data or otherwise change the public health measure (as long as it does not require EHR functionality above and beyond that which is included in the certification requirements specified under the 2014 Edition certification criteria). We refer readers to section II.G of this final rule with comment period for further information on the Medicaid EHR Incentive Programs.
Upon finalization, the provisions in this final rule with comment period are anticipated to have an annual effect on the economy of $100 million or more, making it an economically significant rule under the Executive Order and a major rule under the Congressional Review Act. Accordingly, we have prepared a Regulatory Impact Analysis that to the best of our ability presents the costs and benefits of the final rule with comment period.
Based on prior rulemaking, we expect spending under the EHR Incentive Programs for transfer payments to Medicare and Medicaid providers between 2015 and 2017 to be $14.2 billion; however, the policies in this final rule with comment period do not change estimates over the current period.
Our analysis of impacts for the policies in this final rule with comment period relate to the reduction in cost associated with provider reporting burden estimates for 2015 through 2017 as affected by the adopted changes to the current program. The estimates also relate to the transfer payments for incentives for Medicaid providers and reductions in payments for Medicare providers through payment adjustments for 2018 and subsequent years. For 2015 through 2017, we estimate the reduction in the reporting burden for providers demonstrating meaningful use in a calendar year as 1.45 to 1.9 hours per EP respondent and 2.62 hours per eligible hospital or CAH respondent. We estimate the total annual cost savings related to this reduction at $52,547,132 for a low estimate and $68,617,864 for a high estimate. We expect spending under the EHR Incentive Programs for transfer payments to Medicare and Medicaid providers between 2017 and 2020 to be $3.7 billion (this estimate includes net payment adjustments in the amount of $0.8 billion for Medicare providers who do not achieve meaningful use).
In this final rule with comment period, we do not estimate total costs and benefits to the provider industry, but rather provide a possible per EP and per eligible hospital outlay for implementation and maintenance. Nonetheless, we believe there are substantial benefits that can be obtained by society (perhaps accruing to eligible hospitals and EPs), including cost reductions related to improvements in patient safety and patient outcomes and cost savings benefits through maximizing efficiencies in clinical and business processes facilitated by certified HIT.
Executive Orders 12866 and 13563 direct agencies to assess all costs and benefits of available regulatory alternatives and, if regulation is necessary, to select regulatory approaches that maximize net benefits (including potential economic, environmental, public health and safety effects, distributive impacts, and equity). Accordingly, we have prepared a regulatory impact analysis that to the best of our ability presents the costs and benefits of the final rule with comment period.
The American Recovery and Reinvestment Act of 2009 (Pub. L. 111-5) (ARRA) amended Titles XVIII and XIX of the Act to authorize incentive payments to EPs, eligible hospitals, CAHs, and MA organizations to promote the adoption and meaningful use of CEHRT. In the July 28, 2010
In the September 4, 2012
In the December 7, 2012
• Adding an alternative measure for the Stage 2 meaningful use objective for hospitals to provide structured electronic laboratory results to ambulatory providers;
• Correcting the regulation text for the measures associated with the objective for hospitals to provide patients the ability to view online, download, and transmit information about a hospital admission; and
• Making the case number threshold exemption for CQM reporting applicable for eligible hospitals and CAHs beginning with FY 2013.
The December 7, 2012 IFC also provided notice of our intention to issue technical corrections to the electronic specifications for CQMs released on October 25, 2012.
In the September 4, 2014
• EHR technology certified to the 2011 Edition; or
• A combination of EHR technology certified to the 2011 Edition and EHR technology certified to the 2014 Edition for the EHR reporting periods.
Although the 2014 CEHRT flexibility final rule did not alter the attestation or hardship exception application deadlines for 2014, it did make changes to the attestation process to support these flexible options for CEHRT. This 2014 CEHRT Flexibility final rule also discussed the provisions of the December 7, 2012 IFC and finalized policies relating to the provisions contained in the December 7, 2012 IFC.
In the November 13, 2014
In the March 30, 2015
In the April 15, 2015
For Stage 1 and Stage 2, CMS and ONC worked closely to ensure that the definition of meaningful use of CEHRT and the standards and certification criteria for CEHRT were coordinated. Current ONC regulations may be found at 45 CFR parts 170. CMS and ONC have worked together to align the Stage 3 proposed rule and the ONC 2015 Edition proposed rule (80 FR 16731 through 16804 and 80 FR 16804 through 16921), and again are working together to align the final rules.
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When the Medicare and Medicaid EHR Incentive Programs began in 2011, the requirements for the objectives and measures of meaningful use were designed to begin a process of health care delivery system transformation aligning with foundational goals defined in the Health Information Technology for Economic and Clinical Health Act (HITECH) Act. The HITECH Act requires the Secretary to seek to improve the use of EHR and health care quality over time by requiring more stringent measures of meaningful use (see section 1848(o)(2)(A)(iii) of the Act); requiring the use of EHR technology, which defines both the functions that should be available within the EHR and the purpose to which those functions should be applied (see section 1848(o)(4) of the Act); and defining key foundational principles of meaningful use to support the improvement of care and care coordination, and the use of EHR technology to submit information on clinical quality measures and other measures (see section 1848(o)(2)(A) of the Act).
In 2015, we published two notices of proposed rulemaking in 2015 relating to the EHR Incentive programs to address near term goals in 2015 through 2017 and long-term goals for Stage 3 in 2017 and subsequent years.
In the March 30, 2015 Stage 3 proposed rule (80 FR 16734), we proposed the requirements for the Medicare and Medicaid EHR Incentive Programs for 2017 and subsequent years to build a long-term sustainable program
In the April 15, 2015 EHR Incentive Programs in 2015 through 2017 proposed rule (80 FR 20347), we proposed modifications to Stage 1 and Stage 2 to reflect this long-term vision and to be responsive to the changing environment and stakeholder concern over program complexity and redundant reporting requirements. The proposed rule included a reduced set of objectives and measures based on the Stage 2 objectives and measures that align with the policies for Stage 3. The proposed rule also proposed removing measures that had become topped out, redundant or duplicative, and easing requirements around measures requiring providers to be accountable for patient action. We proposed the modifications to address stakeholder concerns and to continue to support the overall goal of the widespread adoption and meaningful use of CEHRT in efforts to transform our health care delivery system and improve health care quality.
A few commenters indicated that CMS should update the measures and requirements to ensure they are appropriately aligned and would improve a provider's ability to successfully demonstrate meaningful use. A commenter stated that we should first receive provider input before adding or suggesting any changes to the requirements.
We proposed revisions to the requirements according to provider and stakeholder feedback received through correspondence, public forums, and listening sessions. Additionally, we proposed these changes through a notice of proposed rulemaking and accepted comments from the public during the comment periods for both proposed rules. We believe that providers helped to shape the requirements for meaningful use in part through those processes.
Additionally, we proposed to remove measures that we believe are redundant, duplicative, or topped out based on provider performance.
Patient-focused care is very important to us, and we have proposed to maintain measures specific to patient engagement and that support a patient's access to their health information. The measures promote increased communication between providers and their patients, while placing focus on a patient's involvement in their care.
As noted in the Stage 3 proposed rule, (80 FR 16734), Stage 3 is intended to align the timeline and requirements for clinical quality measure reporting in the Medicare and Medicaid EHR Incentive Programs with other CMS quality reporting programs that use CEHRT. This alignment is meant to reduce provider burden associated with reporting on multiple CMS programs and enhance CMS operational efficiency.
In addition, we understand that the increase in thresholds proposed in the Stage 3 rule may increase the work required to achieve an individual measure. However, we noted that part of our decision making process in the overall reduction of the number of objectives in the program was to reduce the burden on providers for those measures by allowing them to focus on advanced use objectives that support clinical effectiveness, patient safety, patient engagement, and care coordination. We believe providers should prioritize their efforts to strive to achieve high performance on these important measures. In addition, as noted in the proposed rule (80 FR 16740), the statute specifically requires the Secretary to seek to improve the use of EHRs and health care quality over time by requiring more stringent measures of meaningful use (see, for example, section 1848(o)(2)(A)(iii) of the Act). Therefore, for these reasons, we intend to continue to use measure thresholds that may increase over time and to incorporate advanced use functions of CEHRT into meaningful use objectives and measures.
The Stage 3 objectives and measures were designed to focus on the three-part aim of better health, better care, and lower costs. We believe that the costs associated with EHR adoption and continued maintenance are outweighed by the long-term benefits a provider may experience from meaningfully using CEHRT, including practice efficiencies and improvements in medical outcomes. For example, EHR supported processes such as drug-drug and drug-allergy interaction and clinical decision support, as well as electronic prescribing and computerized provider order entry for medication orders, can all work in tandem to support a provider's efforts to effectively and safely prescribe and administer medications and reduce costs and risks associated with adverse events. In addition, while there may be a cost associated with HIT supported patient engagement as compared to not engaging with patients, the use of HIT allows providers to leverage economies of scale and engage with a large number and wide range of patients in ways not otherwise possible. Patient education and patient engagement in many forms support improved care and reduced cost of care as patients who are engaged with their health care have better outcomes and cost savings for their care.
Hibbard, Judith H and Jessica Greene. “What The Evidence Shows About Patient Activation: Better Health Outcomes And Care Experiences; Fewer Data On Costs”
• Provider to provider exchange through the transmission of an electronic summary of care document;
• Provider to patient exchange through the provision of electronic access to view, download, or transmit health information; and
• Provider to public health agency exchange through the public health reporting objectives.
Research supports our belief that the policies established in the EHR Incentive Programs, the ONC HIT Certification Program, and the related effort to support provider participation at a state and national level have had a significant impact on the development of health information exchange infrastructure in the United States. For EHR reporting periods in 2014, more than 3,700 eligible hospitals and CAHs
The Stage 3 proposed rule focuses less on data capture and entry and more on interoperable health data sharing by including additional functions and requirements for the transmission and consumption of standardized health data through electronic exchange. The proposed Stage 3 objectives can essentially be broken into 2 categories:
• Category 1 objectives that support clinical effectiveness and patient safety, and
• Category 2 objectives that support health information exchange.
In addition, two of the three objectives that fall into the first category (for example, computerized provider order entry and electronic prescribing) may also be categorized as objectives that support the interoperable exchange of health information through the process of creating and transmitting prescriptions, medication orders, laboratory order, and diagnostic imaging orders using standards established by CEHRT for that purpose.
We believe this continued emphasis on requiring standards in the technology and the use of these standards in clinical settings will continue to support and promote interoperability. Furthermore, we believe the expansion of the requirements around data transmission will continue to drive use and the ongoing development and strengthening of an interoperable HIE infrastructure.
We also received numerous comments on the EHR Incentive Programs in 2015 through 2017 and Stage 3 proposed rules during the public comment periods that were either unrelated to the Medicare and Medicaid EHR Incentive Programs or outside the scope of the proposed rules. These comments included considerations for future rulemaking activities, requests for new incentives for various provider types that are not currently eligible to participate, requests to create a sliding scale for payment adjustments, and support or recommendations for ONC's 2015 Edition proposals. We thank all the commenters for their suggestions and feedback on the Medicare and Medicaid EHR Incentive Programs. However, comments unrelated to the proposals fall outside the scope of the proposed rule and are not addressed in this final rule with comment period.
We proposed changes to the uniform definitions in part 495 subpart A of the regulations, in both the Stage 3 proposed rule (80 FR 16736 through 16737) and the EHR Incentive Programs in 2015 through 2017 proposed rule (80 FR 20351 through 20352). We proposed to maintain these definitions, unless specifically stated otherwise in the proposed rule. We proposed moving to a single set of criteria for meaningful use, which we herein call Stage 3, in order to eliminate the varying stages of the Medicare and Medicaid EHR Incentive Programs. We proposed that a modified version of Stage 1 and Stage 2 would be applicable for 2015 through 2017. We proposed that the Stage 3 definition of meaningful use would be optional for providers in 2017 and mandatory for all providers beginning in 2018. To support these changes, we proposed revising the uniform definitions under 42 CFR 495.4 for “EHR reporting period” and “EHR reporting period for a payment adjustment year,” as discussed in sections II.B.1.b.(3) and section II.E.2.2 of this final rule with comment period.
In the Stage 3 proposed rule (80 FR 16737), we sought to streamline the criteria for meaningful use. We intended to do this by—
• Creating a single stage of meaningful use objectives and measures (herein called Stage 3) that would be optional for all providers in 2017 and mandatory for all providers in 2018;
• Allowing providers flexible options for 2017;
• Changing the EHR reporting period to a full calendar year for all providers; and
• Aligning with other CMS quality reporting programs using CEHRT, such as PQRS and Hospital IQR, for clinical quality measurement.
In the EHR Incentive Program in 2015 through 2017 proposed rule (80 FR 20352), we proposed changes to a number of definitions previously finalized for the EHR Incentive Programs in the Stage 1 and Stage 2 final rules in order to modify the program in response to the changing HIT environment and related stakeholder concerns. These changes address the following:
• An overall simplification of the program aligned to the overarching goals of sustainability, as discussed in the Stage 3 proposed rule (80 FR 16737) and in section II.B.1.b.(1) and (4) of this final rule with comment period, and a related change to requirements necessary to accommodate these changes, outlined in sections II.B.1.b.(2). and (3). of this final rule with comment period.
• Moving all providers to an EHR reporting period aligned with the calendar year, as outlined in section II.B.1.b.(3).A. of this final rule with comment period.
• Allowing flexibility for providers in 2015 to accommodate the proposed changes, as outlined in section II.B.1.b. of this final rule with comment period.
• Removing requirements for objectives and measures that are redundant or duplicative or that have “topped out,” as described in the Stage 3 proposed rule (80 FR 16741 through 16742) and outlined in section II.B.1.b.(4).(a). of this final rule with comment period.
• Restructuring the remaining measures and objectives to streamline requirements for 2015 through 2017 and to accommodate the changes for an EHR reporting period in 2015, as outlined in section II.B.1.b.(2). and (3). and II.B.1.b.(4).(b). of this final rule with comment period.
• Refocusing the existing program so that it is building toward advanced use
In the phased approach to meaningful use, we finalized the criteria for meaningful use through incremental rulemaking that covered Stage 1 and Stage 2 of the Medicare and Medicaid EHR Incentive Programs. (For further explanation of the criteria we finalized in Stage 1 and Stage 2, we refer readers to 75 FR 44314 through 44588, 77 FR 53968 through 54162, and 79 FR 52910 through 52933.)
In the Stage 3 proposed rule (80 FR 16737 through 16739), we proposed to set a new foundation for this evolving program by proposing a number of changes to the Medicare and Medicaid EHR Incentive Programs. First, we proposed a definition of meaningful use that would apply beginning in 2017. This definition, although herein referred to as Stage 3, would be the only definition for the Medicare and Medicaid EHR Incentive Programs and would incorporate certain requirements and aspects of Stage 1 and Stage 2. Beginning with 2018, we proposed to require all EPs, eligible hospitals, and CAHs, regardless of their prior participation in the Medicare and Medicaid EHR Incentive Programs, to satisfy the requirements, objectives, and measures of Stage 3. However, for 2017, we proposed that Stage 3 would be optional for providers. This proposed option would allow a provider to meet to Stage 3 in 2017 or to remain at Stage 2 or Stage 1, depending on their prior participation.
Furthermore, we proposed that Stage 3 would adopt a simplified reporting structure on a focused set of objectives and associated measures to replace all criteria under Stage 1 and Stage 2. Specifically, we proposed criteria for meaningful use for EPs, eligible hospitals, and CAHs (optional in 2017 and mandatory beginning in 2018), regardless of a provider's prior participation in the Medicare and Medicaid EHR Incentive Programs.
In the EHR Incentive Program in 2015 through 2017 proposed rule (80 FR 20352), we proposed to further reduce complexity in the program and to realign the current program to work toward this overall shift to a single set of objectives and measures in Stage 3 in 2018. We proposed to require that all providers attest to a single set of objectives and measures beginning with an EHR reporting period in 2015 instead of waiting until Stage 3 in 2018. Because this change may occur after providers have already begun their work toward meeting meaningful use in 2015, we proposed accommodations within individual objectives for providers in different stages of participation. These accommodations include retaining the different specifications between Stage 1 and Stage 2 and allowing special exclusions for certain objectives or measures for EPs previously scheduled to participate in Stage 1 for an EHR reporting period in 2015.
We proposed all providers would be required to attest to certain objectives and measures finalized in the Stage 2 final rule that would align with those objectives and measures proposed for Stage 3 of meaningful use. In effect, this would create a new progression using the existing objectives and measures where providers attest to a modified version of Stage 2 with accommodations for Stage 1 providers (equivalent to a reduced version of Stage 3) in 2015; a modified version of Stage 2 in 2016 (equivalent to a reduced version of Stage 3); either a modified version of Stage 2 (equivalent to a reduced version of Stage 3) or the full version of Stage 3 outlined in the Stage 3 proposed rule in 2017; and the full version of Stage 3 outlined in the Stage 3 proposed rule beginning in 2018 (80 FR 16738).
We sought comment on whether or not we should implement only the modifications proposed in the rule from 2015 through 2017 (80 FR 20351 through 20353) and begin Stage 3 in 2018 without an option year in 2017, or if we should allow providers the option to demonstrate Stage 3 beginning in 2017 as discussed in the Stage 3 proposed rule (80 FR 16738).
Numerous commenters on the EHR Incentive Program in 2015 through 2017 proposed rule supported the proposal to move all providers to Stage 3 in 2018. They stated it is very complicated to keep track of all providers and their various programs, stages, and years, and that the proposed approach would ease the burden associated with reporting different stages of meaningful use. Numerous commenters on the Stage 3 proposed rule supported the proposal to move all providers to Stage 3 in 2018.
We thank commenters for their support of the proposal to move all providers to Stage 3 in 2018. As noted in the EHR Incentive Programs in 2015 through 2017 proposed rule, the proposal was based in part on comments received in earlier rulemaking that relayed confusion and concerns regarding increased reporting burden related to the number of program requirements, the multiple stages of program participation, and the timing of EHR reporting periods.
We proposed to align the objectives and measures of meaningful use for 2015 through 2017 with the Stage 3 objectives and measures in part because we believe this will provide a smoother transition for providers to Stage 3. Additionally, we believe that interoperability and EHR functionalities will continue to advance prior to 2018, when Stage 3 would be required of all eligible providers, which should increase providers' success in meeting the program requirements. Multiple providers have expressed their support for the option to attest to Stage 3 in 2017, indicating confidence in the transition. Therefore, we are maintaining the timeframe for implementation of Stage 3.
A few commenters were concerned that many providers will have difficulty attesting to Stage 3 in 2017 if other collaborating partners are not operating with the same CEHRT.
A few commenters indicated that a provider electing to attest to a later stage was a rarity in previous years when given an option.
Some commenters on the EHR Incentive Program in 2015 through 2017 proposed rule indicated that in the case of unanticipated challenges or delays with the adoption and implementation of the technology certified to the 2015 Edition, CMS should preemptively detail alternative scenarios to avoid future rule changes.
However, other commenters stated that 2017 is not a realistic start date for Stage 3 due to the expected timing of the final rule; necessary upgrades to technology; transitional processes after deployment such as training, workflow, and validation of reporting; and full year reporting requirements. A commenter suggested there would be only 12-15 months from the publication date of the final rule (assuming publication in late 2015) until technology certified to the2015 Edition would need to be available from vendors and developers and implemented by organizations with necessary staff training completed for new workflows. Some commenters indicated EHR vendors and developers need on average 18 months to develop, test, market, and implement new functionality, while providers need lead time to re-work their processes and systems to new or revised requirements. Other commenters indicated concern about the timeline of transitioning to Stage 3 in 2017 and 2018, stating that 18 months is the minimum length of time needed between the final rules and the start of any stage of the EHR Incentive Program. Furthermore, as the change requires a technology upgrade, and given the likely timing for the publication of the final rules, the proposed Stage 3 timetable will not allow for a full 18-month timeline before the beginning of Stage 3 as an option in 2017.
Some commenters on the EHR Incentive Program in 2015 through 2017 proposed rule indicated that in case of unanticipated challenges or delays with the adoption and implementation of the technology certified to the 2015 Edition, CMS should proactively detail alternative scenarios to avoid future rule changes.
Providers who are seeking to demonstrate Stage 3 in 2017 cannot do so without the support of certain functions that are only available for certification as part of the 2015 Edition certification criteria. This means that for 2017 a provider must have at least a combination of EHR technology certified to the 2014 Edition and the 2015 Edition in order to support participation in Stage 3. However, as Stage 3 is optional, providers are not required to upgrade to technology certified to the 2015 Edition until 2018.
As discussed further in section II.B.3 of this final rule with comment period, this means providers have flexibility to use EHR technology certified to either the 2014 or 2015 Edition (or a combination of CEHRT modules certified to different Editions). We proposed the flexibility to allow providers to move forward with upgrading their EHR technology at their own speed and to optionally attest to Stage 3 in 2017 if they are able to do so.
In total, these proposals allow for a staggered upgrade timeline for developers and providers of more than 24 months between the date of the publication of this final rule with comment period and 2018, when providers must begin using EHR technology certified to the 2015 Edition.
Because of this more than 24 month lead time for development, we do not anticipate significant challenges or delays in the adoption and implementation of the 2015 Edition CEHRT. We will continue to monitor and assess providers' progress towards adoption and implementation as EHR technology certified to the 2015 Edition becomes available.
After consideration of the public comments received, we are finalizing our approach to the timing of the stages of meaningful use as proposed in the EHR Incentive Program in 2015 through 2017 proposed rule and the Stage 3 proposed rule. We are finalizing that all EPs, eligible hospitals, and CAHs must attest to the Modified version of Stage 2 beginning with an EHR reporting period in 2015, with alternate exclusions and specifications for certain providers, as discussed further in section II.B.1.b.(4).(b).(iii). of this final rule with comment period. We finalize as proposed the option for all EPs, eligible hospitals, and CAHs to attest to Stage 3 for an EHR reporting period in 2017 and the requirement for all providers to attest to Stage 3 beginning with an EHR reporting period in 2018.
We are adopting these provisions under the definition of a “Meaningful EHR user” at § 495.4 as noted in section II.B.1.b.(2) of this final rule with comment period and as noted in further detail in section II.B.2.a. and II.B.2.bof this final rule with comment period.
In the Stage 3 proposed rule (80 FR 16737), we proposed to modify the definition of “Meaningful EHR user” under 42 CFR 495.4 to include the Stage 3 objectives and measures defined at § 495.7.
In the EHR Incentive Program in 2015 through 2017proposed rule (80 FR 20353), we additionally proposed to redesignate some of the numbering of the regulation text under part 495 to more clearly identify which sections of the regulation apply to specific years of the program. The redesignated numerical references for the regulation text are as follows:
We received no comments specific to these proposals, and therefore, are finalizing them without modification.
In both the EHR Incentive Program in 2015 through 2017 and Stage 3 proposed rules (80 FR 16739 and 80 FR 20353), we proposed changes to the EHR reporting period in order to accomplish the following:
• Simplify reporting for providers, especially groups and diverse systems.
• Support further alignment with CMS quality reporting programs using certified health IT such as Hospital IQR and PQRS.
• Simplify HHS system requirements for data capture.
• Provide for greater flexibility in developing, implementing, stress testing, and conducting Quality Assurance (QA) of systems before deployment.
In the EHR Incentive Programs in 2015 through 2017 proposed rule (80 FR 20353), we proposed changes to the uniform definition of an “EHR reporting period” in § 495.4 beginning in 2015. We proposed similar changes to the definition of an “EHR reporting period for a payment adjustment year” in § 495.4 beginning in 2015, as discussed in section II.E.2of this final rule with comment period. We proposed changes to the attestation deadlines for purposes of the incentive payments and payment adjustments as discussed in section II.D of this final rule with comment period.
In the EHR Incentive Program 2015 through 2017 proposed rule (80 FR 20354), beginning in 2015, we proposed to change the definition of “EHR reporting period” at § 495.4 for EPs, eligible hospitals, and CAHs such that the EHR reporting period would begin and end in relation to a calendar year. We proposed all providers (EPs, eligible hospitals, and CAHs) would be required to complete an EHR reporting period within January 1 and December 31 of the calendar year in order to fulfill the requirements of the EHR Incentive Programs. We proposed that for 2015 only, eligible hospitals and CAHs may begin an EHR reporting period as early as October 1, 2014 and must end by December 31, 2015. Beginning with 2016, the EHR reporting period must be completed within January 1 and December 31 of a calendar year.
For the payment adjustments under Medicare, we proposed changes to the EHR reporting periods applicable for payment adjustment years in the EHR Incentive Program 2015 through 2017 proposed rule at 80 FR 20379.
After consideration of the public comments received, we are finalizing the proposal in the EHR Incentive Programs in 2015 through 2017 proposed rule (80 FR 20348) to align the EHR reporting period for eligible hospitals and CAHs with the calendar year beginning in 2015. For 2015 only, eligible hospitals and CAHs may begin an EHR reporting period as early as October 1, 2014 and must end by December 31, 2015. Beginning with 2016, the EHR reporting period must be completed within January 1 and December 31 of the calendar year. We made corresponding revisions to the definition of an “EHR Reporting Period” at § 495.4. For the payment adjustments under Medicare, we discuss the duration and timing of the EHR reporting period in relation to the payment adjustment year in section II.E.2 of this final rule with comment period.
In the EHR Incentive Program in 2015 through 2017 proposed rule (80 FR 20354), we proposed to allow a 90-day EHR reporting period in 2015 for all providers to accommodate implementation of the other changes proposed in that rule. For 2015 only, we proposed to change the definition of “EHR reporting period” at § 495.4 for EPs, eligible hospitals, and CAHs such that the EHR reporting period in 2015 would be any continuous 90-day period within the calendar year. We proposed that for an EHR reporting period in 2015, EPs may select an EHR reporting period of any continuous 90-day period from January 1, 2015 through December 31, 2015; eligible hospitals and CAHs may select an EHR reporting period of any continuous 90-day period from October 1, 2014 through December 31, 2015.
We proposed that in 2016, for EPs, eligible hospitals, and CAHs that have not successfully demonstrated meaningful use in a prior year, the EHR reporting period would be any continuous 90-day period between January 1, 2016 and December 31, 2016. However, for all returning participants that have successfully demonstrated meaningful use in a prior year, the EHR reporting period would be a full calendar year from January 1, 2016 through December 31, 2016.
For the payment adjustments under Medicare, we proposed changes to the EHR reporting periods applicable for payment adjustment years in the EHR Incentive Programs in 2015 through 2017 proposed rule at (80 FR 20379).
We also received numerous comments on the Stage 3 proposed rule strongly supporting the proposal for a 90-day EHR reporting period for all providers in 2015. Some commenters noted that the reduction to a 90-day EHR reporting period would assist providers transitioning from Stage 1 to Stage 2 without compromising patient care. Another commenter stated changing to any continuous 90 days (as opposed to calendar quarters) allows for needed flexibility in the event of unforeseen circumstances that could otherwise impede reporting within the originally planned timeframe.
In response to commenters who suggest that, in the future, demonstrating meaningful use for a 90-day period should serve as confirmation of a full year of compliance with program requirements, we note that if a provider does have the necessary workflows and processes in place for a full year there is no valid reason that provider should not demonstrate meaningful use for a full year. If extreme circumstances outside of the provider's control prohibit a full year of meaningful use, the provider may file for a hardship exception from the Medicare payment adjustments.
A few commenters strongly recommended in the EHR Incentive Program in 2015 through 2017 proposed rule that CMS retain the 90-day attestation option for providers who change employers during the year. Furthermore, the commenters further stated they do not believe an organization can sufficiently rely upon the actions of a previous employer to complete the necessary validation, analysis, and implementation of an EHR that would satisfy CMS audit requirements. If a previous employer's data is found to be faulty, the current organization is put at risk for the data reported.
EPs who are switching employment or practicing in multiple locations during an EHR reporting period may apply for a hardship exception that would be reviewed on a case-by-case basis. However, we disagree that CMS should take into account the business practices of individual EPs in establishing the requirements for the entirety of the program. It is incumbent on the individual EP to establish their own contractual or business arrangements for the purposes of attesting for the Medicare and Medicaid EHR Incentive Programs.
After consideration of the public comments received, we are finalizing a 90-day EHR reporting period in 2015 for all providers as proposed. Eligible professionals may select an EHR reporting period of any continuous 90-day period from January 1, 2015 through December 31, 2015; eligible hospitals and CAHs may select an EHR reporting period of any continuous 90-day period from October 1, 2014 through December 31, 2015. We are finalizing a 90-day
In the Stage 3 proposed rule (80 FR 16739), we proposed that beginning in 2017, and for all EPs, eligible hospitals, and CAHs, the EHR reporting period would be one full calendar year. We proposed to eliminate the 90-day EHR reporting period for new meaningful EHR users beginning in 2017, with a limited exception for Medicaid EPs and eligible hospitals demonstrating meaningful use for the first time. For that exception, we proposed to maintain the 90-day EHR reporting period for a provider's first payment year based on meaningful use for EPs and eligible hospitals participating in the Medicaid EHR Incentive Program. We noted that the EHR incentive payments under Medicare fee-for-service (FFS) and MA(sections1848(o), 1886(n), 1814(l)(3), 1853(l) and(m) of the Act) will end before 2017. We stated that under these proposals, EPs and eligible hospitals that seek to qualify for an incentive payment under Medicaid would have a full calendar year EHR reporting period if they are not demonstrating meaningful use for the first time.
These proposals would allow for a single EHR reporting period of a full calendar year for all providers across all settings. We proposed corresponding revisions to the definition of “EHR reporting period” under § 495.4. For the payment adjustments under Medicare, we proposed changes to the EHR reporting periods applicable for payment adjustment years in the Stage 3 proposed rule (80 FR 16774 through 16777).
• EPs change in place of service (POS).
• EPs joining a practice in the middle of the year.
• Ongoing software updates (for example, ICD-10).
• Difficulty in getting data from previous places of employment.
• Not enough time for the vendors and developers to make software updates.
• Timing of the data submission.
Other commenters stated full year reporting does not allow sufficient time for these practices to identify shortcomings in their adherence to meaningful use and implement corrective actions before the next reporting period.
After consideration of the public comments received, we are finalizing our proposal to require a full CY EHR reporting period for all providers (with a limited exception for new meaningful EHR users under Medicaid) beginning in CY 2017, with a modification for providers attesting to Stage 3 of meaningful use in 2017. For EPs, eligible hospitals, and CAHs that choose to meet Stage 3 in 2017, the EHR reporting period is any continuous 90-day period within CY 2017. For all other providers, the EHR reporting period is the full CY 2017. Beginning in CY 2018, for all EPs, eligible hospitals, and CAHs (including those attesting to Stage 3 for the first time), the EHR reporting period is the full CY.
We finalize our proposal to maintain the 90-day EHR reporting period for a provider's first payment year based on meaningful use for EPs and eligible hospitals participating in the Medicaid EHR Incentive Program for 2017 and subsequent years.
We revised the definition of “EHR reporting period” under § 495.4 to reflect these final policies. As we noted previously and in the Stage 3 proposed rule (80 FR 16739), the incentive payments under FFS and MA (sections1848(o), 1886(n), 1814(l)(3), 1853(l) and (m) of the Act) will end before 2017. Thus the final policies for the EHR reporting period we adopt here would apply only for EPs and eligible hospitals that seek to qualify for an incentive payment under Medicaid. For the payment adjustments under Medicare, we discuss the duration and timing of the EHR reporting period for a payment adjustment year in section II.E.2 of this final rule with comment period.
In the Stage 3 proposed rule (80 FR 16740), we noted that for the Stage 1 and Stage 2 final rules, the requirements of the EHR Incentive Programs included the concept of a core and a menu set of objectives that a provider needed to meet as part of demonstrating meaningful use of CEHRT. In Stage 2, we also combined some of the objectives of Stage 1 and incorporated them into objectives for Stage 2. In the Stage 2 final rule (77 FR 53973), we signaled that the Stage 2 core and menu objectives would all be included in the Stage 3 proposal.
However, since the Stage 2 final rule publication, we have reviewed program performance from both a qualitative and quantitative perspective including analyzing performance rates; reviewing the adoption and use of CEHRT; and considering information gained by engaging with providers through listening sessions, correspondence, and open forums like the HIT Policy Committee. The data supported the following key points for consideration:
• Providers are performing higher than the thresholds for some of the meaningful use measures using some EHR functionalities that—prior to the Stage 1 and Stage 2 final rules—were not common place (such as the maintenance of problem lists).
• Providers in different specialties and settings implemented CEHRT and met objectives in different ways.
• Providers express support for reducing the reporting burden on measures that have “topped out.”
• Providers expressed support for advanced functionality that would offer value to providers and patients.
• Providers expressed support for flexibility regarding how objectives are implemented in their practice settings.
• Providers in health systems and large group practices expressed frustration about the reporting burden of having to compile multiple reports spanning multiple stages and objectives.
Since the beginning of the Medicare and Medicaid EHR Incentive Programs in 2011, stakeholder associations and providers have requested that we consider changes to the number of objectives and measures required to meet the program requirements, including the recommendation to allow a provider to fail any two objectives, thus making all objectives “menu” objectives. We noted in the Stage 3 proposed rule (80 FR 16740) that we decline to follow these recommendations for several reasons. First, the statute specifically requires the Secretary to seek to improve the use of EHR and health care quality over time by requiring more stringent measures of meaningful use (see, for example, section 1848(o)(2)(A)(iii) of the Act). Second, there are certain objectives and measures that capture policies specifically required by the statute as core goals of meaningful use of CEHRT, such as electronic prescribing for EPs, HIE, and clinical quality measurement (see sections 1848(o)(2)(A) and 1886(n)(3)(A) of the Act). Furthermore, the statute requires that the CEHRT providers must be a “qualified EHR” as defined in section 3000(13) of the Public Health Service Act as an electronic record of health-related information on an individual that includes patient demographic and clinical health information, such as medical history and problem lists; and has the capacity to—
• Provide clinical decision support;
• Support physician order entry;
• Capture and query information relevant to health care quality; and
• Exchange electronic health information with, and integrate such
We analyzed the objectives and measures in Stage 1 and Stage 2 of the program to determine where measures are redundant, duplicative, or have topped out. “Topped out” is the term used to describe measures that have achieved widespread adoption at a high rate of performance and no longer represent a basis upon which provider performance may be differentiated. We considered redundant objectives and measures to include those where a viable health IT-based solution may replace paper-based actions, such as the Stage 2 Clinical Summary objective (77 FR 54001 through 54002). We considered duplicative objectives and measures to include those where some aspect is also captured in the course of meeting another objective or measure, such as recording vital signs.
We proposed (as discussed in sections II.B.1.b.(3) and II.C of this final rule with comment period) to reduce provider burden and simplify the program by aligning EHR reporting periods and CQM reporting. Our proposals for Stage 3 would continue the precedent of focusing on the advanced use of CEHRT and reduce the reporting burden; eliminate measures that are now redundant, duplicative, and topped out; create a single set of objectives for all providers with limited variation between EPs, eligible hospitals, and CAHs as necessary; and provide flexibility within the objectives to allow providers to focus on implementations that support their practice.
In the Stage 3 proposed rule (80 FR 16741 through 16742), we proposed to adopt an approach to evaluate whether objectives and measures have become topped out and, if so, whether a particular objective or measure should be considered for removal from reporting requirements. We proposed to apply the following two criteria, which are similar to the criteria used in the Hospital Inpatient Quality Reporting (IQR) and Hospital Value Based Purchasing (HVBP) Programs (79 FR 50203): (1) Statistically indistinguishable performance at the 75th and 99th percentile, and (2) performance distribution curves at the 25th, 50th, and 75th percentiles as compared to the required measure threshold.
For the 2014 EHR reporting period, more than 1,800 eligible hospitals and CAHs and 60,000 EPs attested for their performance on the Stage 2 objectives and measures. However, we did not limit our analysis to only Stage 2 providers. Instead, we looked at performance rates across the longevity of the program for providers in all levels of participation. Most of the measures identified are at exceptionally high performance among first time participants in Stage 1 as well, with little or no variation as compared to providers in 3 or more years of participation. For the Medicare and Medicaid EHR Incentive Programs, we additionally looked at measures that represent static data capture measures and measures for which the action is now automated by the EHR technology, as opposed to active measures that use the structure data to inform a clinical decision, provide patient specific education, or are used in care coordination. Once the performance on a static measure exceeds the point at which reasonable differentiation can be made among providers using CEHRT, we believe that the active use of the data elements is more beneficial for both provider and patient than the continued requirement to measure the capture of these elements.
For further information on the performance rates for new participants, as well as quartile performance rates for individual measures, we direct readers to the CMS EHR Incentive Program Web site data and reports page.
For the commenter mentioning pediatric versus adult populations, the EHR Incentive Programs do not include a separate set of meaningful use objectives and measures for adult populations versus pediatric populations. Nor does CMS collect individual patient data through the EHR Incentive Programs. While certain measures may include specifications related to age, CMS only collects summary-level data in the form of numerators and denominators. Therefore we are not able to compare performance on these measures for different patient populations. However, we would note that the measures we proposed to remove had significantly high performance, with providers in all specialties performing well above the required thresholds.
Some commenters stated removing the measures may lead to EHR vendors and developers not providing metrics on the measures in reports that are used for benchmarking and internal quality improvement work. These commenters recommended that providers should continue to be required to report on all topped out measures without a threshold, where the measure would be to attest that the provider is recording the information.
We disagree that threshold measures should be replaced with “check box” measures for each of the topped out measures as this would provide no value for measurement and is counter to the effort to reduce the reporting burden on providers. Providers who wish to independently measure the capture of a particular data element should work with their EHR developer and vendor to ensure they are receiving the most appropriate analytics for their practice and patient population—just as they would with any data element they wished to track that was not already required by the Medicare and Medicaid EHR Incentive Programs.
After consideration of the public comments received, we are finalizing as proposed our approach for evaluating whether objectives and measures are “topped out,” and if so, whether a particular objective or measure should be considered for removal from the EHR Incentive Programs.
In Stage 1 and Stage 2, we require or allow providers the option to include paper-based formats for certain objectives and measures, including the provision of a non-electronic summary of care document for a transition or referral, at § 495.6(j)(14)(i) for EPs and for eligible hospitals and CAHs at§ 495.6(l)(11)(i), and the provision of paper-based patient education materials, at § 495.6(j)(12)(i) for EPs and § 495.6(l)(9)(i) for eligible hospitals and CAHs. For these objectives and measures, providers would print, fax, mail, or otherwise produce a paper document and manually count these actions to include in the measure calculation. We proposed to discontinue this policy for Stage 3; paper-based formats would not be required or allowed for the purposes of the objectives and measures for Stage 3 of meaningful use.
This does not imply that we do not support the continued use of paper-based materials in a practice setting. We strongly recommend that providers continue to provide patients with visit summaries, patient health information, and preventative care recommendations in the format that is most relevant for each individual patient and easiest for that patient to access.
After consideration of the public comments, we are finalizing our proposal that paper-based formats will not be required or allowed for the purposes of the objectives and measures for Stage 3 of meaningful use.
In the Stage 3 proposed rule (80 FR 16742), we proposed to simplify requirements for meaningful use through an analysis of existing objectives and measures for Stages 1 and 2 to determine if they are redundant, duplicative, or “topped out”. We noted that some of the objectives and measures which meet these criteria involve EHR functions that are required by the statutory definition of “certified EHR technology” (see section 1848(o)(4) of the Act, which references the definition of “qualified EHR” in section 3000(13) of the Public Health Service Act) which a provider must use to demonstrate meaningful use. We stated that it was our intent that the objectives and measures proposed for Stage 3 would include uses of these functions in a more advanced form. For example, patient demographic information is included in an electronic summary of care document called a consolidated clinical document architecture (C-CDA) provided during a transition of care in the Stage 2 Summary of Care objective and measures (77 FR 54013 through 54021), which represents a more advanced use of the EHR function than in the Stage 1 and 2 objective to record patient demographic information (77 FR 53991 through 53993).
We received the following comments on this proposal and our response follows.
Some commenters objected to removing duplicative data capture from the program—specifically citing the measures for patient demographics, structured lab results, vital signs, advance directives, and smoking status—because they believe the measures should continue to be independently captured. One commenter requested clarification on how Stage 2 measures like family health history and electronic progress reports are incorporated into Stage 3. A commenter suggested that there needs to be more clarity with respect to how those measures which are duplicative of more advanced processes are still required for use and potentially tracked through other means, such as in the common clinical data set (CCDS).
We note that family health history is still a required data field within the definition of CEHRT at § 495.4. This means it will still be part of CEHRT available for provider use. This measure in particular was identified as having high performance, but also representing a significant burden for counting and measurement purposes. According to provider recommendations, family health history should not be recorded in an EHR in episodic fashion but should allow for linear capture as structured data that can be leveraged by more advanced functions, such as the Patient Specific Education measure under the Patient Electronic Access objective. Electronic notes are similar use cases within the CEHRT, as are the standards for advance directives and smoking status. In addition, the requirements for the fields within an electronic summary of care document, the C-CDA, include structured data elements such as demographics, medication list, medication allergy list, vital signs, and structure lab results, among others, which are required as part of the electronic summary of care document C-CDA a provider must send in conjunction with a transition of care or referral in support of effective care coordination. For further information, we refer readers to the ONC 2015 Edition Certification Criteria final rule published elsewhere in this
After consideration of the public comments received, we are finalizing our proposed approach for analyzing the objectives and measures to identify and maintain and promote the advanced use of health IT for Stage 3 of meaningful use.
In the EHR Incentive Programs in 2015 through 2017 proposed rule (80 FR 20354), we stated that we analyzed the existing objectives and measures of meaningful use to consider if they should be modified for the program beginning in 2015. Using the approach outlined in the Stage 3 proposed rule, we looked at the set of potential objectives and measures for inclusion in the program for 2017 and subsequent years and sought to determine if they were redundant, duplicative, or had reached a performance level considered to be topped out. We also considered the functions and standards included the technology certified to the 2014 Edition when determining if a measure is redundant or duplicative and adding a review of isolated performance rates for providers in the first year of meaningful use in addition to reviewing quartile performance rates for topped out measures.
Our analysis of the objectives and measures of meaningful use Stage 1 and Stage 2 identified a number of measures that met the criteria as either redundant, duplicative, or topped out, with new participants consistently performing at a statistically comparable rate to returning participants. Table 2 identifies the current objectives and measures that met the criteria. Therefore, we proposed (80 FR 20355) to no longer require providers to attest to these objectives and measures as currently codified in the CFR under § 495.6 in order to meet program requirements beginning in 2015.
We noted that many of these objectives and measures include actions that may be valuable to providers and patients, such as providing a clinical summary to a patient after an office visit. We encouraged providers to continue to conduct these activities as best suits their practice and the preferences of their patient population. The removal of these measures is in no way intended as a withdrawal of an endorsement for these best practices or to discourage providers from conducting and tracking these activities for their own quality improvement goals. Instead, we would no longer require providers to calculate and attest to the results of these measures in order to demonstrate meaningful use beginning in 2015.
Other commenters stated they believe this will have the effect of simplifying the EHR Incentive Programs and easing
Some commenters opposed the removal of specific objectives or measures, such as the imaging results measure, stating it should be retained as a menu set choice or as an alternate choice to implementing reporting for a second public health measure in addition to immunization reporting. Other commenters are concerned with the removal of the family history measure because this data can be a strong indicator for preventative services. A few commenters are concerned with the removal of the record demographics measure and stated, if removed, adherence may drop and reporting will be less useful.
As noted previously, we support the continued use of structured data within a certified EHR to support advanced clinical processes, care coordination, and quality improvement. The capture of this data in a structured format allows the provider to use the data for these processes and supports the efficacy of quality measurement and quality improvement. The removal of the requirement to count simple data capture allows providers to shift the focus of their use of technology to support effective use of the data.
After consideration of the public comments received, we are finalizing, as proposed, the list of objectives and measures in Table 2 identified as redundant, duplicative, or topped out and will no longer require these objectives and measures for meaningful use beginning with an EHR reporting period in 2015. The removal of these measures is reflected in the final objectives and measures adopted in the regulation text at § 495.22.
In the EHR Incentive Programs in 2015 through 2017 proposed rule, we noted that in order to implement the proposed changes to the program to align with long-term goals; there are a number of changes that must be made to other requirements of meaningful use (80 FR 20355). These changes fall into the following two major categories—
• Changes to streamline the structure in 2015 through 2017 to align with the proposed structure for Stage 3 of meaningful use in 2017 and subsequent years; and
• Changes to accommodate this shift to allow providers to demonstrate meaningful use for an EHR reporting period in 2015.
We recognized and considered the stakeholder and provider representatives' concerns in implementing the patient engagement objectives requiring patient action (see the Stage 2 final rule at 77 FR 54046 under the Health Outcomes Policy Priority “Engage patients and families in their care”), which include barriers to successful implementation of the required health IT or CEHRT functions necessary to support the measures. We proposed changes to these objectives to allow providers to focus on improvements without jeopardizing
In the EHR Incentive Programs in 2015 through 2017 proposed rule, we proposed to eliminate the distinction between core and menu objectives and purported that all retained objectives would be required for the program. We note that for Stage 1 providers, this means three current menu objectives would now be required; and for Stage 2 eligible hospitals and CAHs, one current menu objective would now be a required objective (80 FR 20356). These objectives are as follows:
Furthermore, we stated that the objectives and measures retained in each case for all providers would be the Stage 2 objectives and measures and proposed to establish alternate exclusions and specifications to mitigate any additional burden on providers for an EHR reporting period in 2015 (80 FR 20356).
For the public health reporting objectives and measures, we proposed to consolidate the different Stage 2 core and menu objectives into a single objective with multiple measure options. We proposed this approach for the Stage 3 public health reporting objective because we believe it allows for greater flexibility for providers and supports continued efforts to engage providers and public health agencies in the essential data capture and information exchange that supports quality improvement, emergency response, and population health management initiatives. For further discussion of the rationale for the Stage 3 objective, we direct readers to 80 FR 16731 through 16804. For the consolidated public health reporting objective in the EHR Incentive Programs in 2015 through 2017 proposed rule (80 FR 20366), we proposed that EPs report on any combination of two of the five available options, while eligible hospitals and CAHs report on any combination of three of the six available options. If a provider is scheduled to attest to Stage 1 of meaningful use in 2015, we proposed to allow EPs to report on only one of the five available options outlined and the eligible hospitals or CAHs to report on any combination of two of the six available options for an EHR reporting period in 2015 (80 FR 20366).
Therefore, we proposed that the structure of meaningful use for 2015 through 2017 would be nine required objectives for EPs using the Stage 2 objectives for EPs, with alternate exclusions and specifications for Stage 1 providers in 2015. We proposed that the structure of meaningful use for 2015 through 2017 would be eight required objectives for eligible hospitals and CAHs, with alternate exclusions and specifications for Stage 1 providers and some stage 2 providers in 2015. In addition, EPs would be required to report on a total of two measures from the public health reporting objective or meet the criteria for exclusion from up to five measures; eligible hospitals and CAHs would be required to report on a total of three measures from the public health reporting objective or meet the criteria for exclusion from up to six measures.
Other commenters believe that such changes will make it much easier for all providers to attest, for providers to know what Stage they are in, and for CMS to track providers who are in different reporting years. Some commenters stated that the transition to a single stage of meaningful use would drastically reduce the administrative burden, provide simplicity that will benefit EHR developers and users, and facilitate meeting interoperability goals. Other commenters stated that by reducing the amount of effort that a participant has to exert—especially for measures that are already a matter of clinical routine—participants will have an experience that is significantly less intrusive.
We disagree that the commenters' suggestion to retain a core and menu structure offers value to supporting program goals or to promoting flexibility in a meaningful way. Retaining a menu of objectives that includes topped out, redundant, or duplicative measures for the sole purpose of allowing providers to continue to choose among them is counter-productive to efforts to reduce program complexity and ease the reporting burden on providers. It also offers no benefit to CMS to continue to require reporting on measures that no longer represent a statistical value for measurement or a means of differentiating provider performance. The only other method by which a menu could be implemented would be to make formerly required objectives optional. As stated in the EHR Incentive Programs in 2015 through 2017 proposed rule (80 FR 20386), we do not believe that approach supports program goals or meets our statutory duty to require more stringent measures of meaningful use over time.
Furthermore, we believe the objectives that we proposed to retain represent the functions that any provider should apply to leverage HIT in support of improved outcomes for their patients. We believe that the existing exclusions for each measure are adequate to allow flexibility for providers. Additionally, we have proposed to include alternate exclusions and specifications for Stage 1 providers in 2015 to allow them to continue the workflows they have already established for 2015 and give them time to move forward with the more advanced measures.
After consideration of public comments received, we are finalizing the changes to the structure as proposed.
We proposed (80 FR 20357) several alternate exclusions and specifications for providers scheduled to demonstrate Stage 1 of meaningful use in 2015 that would allow these providers to continue to demonstrate meaningful use, despite the proposals to use only the Stage 2 objectives and measures identified for meaningful use in 2015 through 2017. These provisions fall into the following two major categories:
• Maintaining the specifications for objectives and measures that have a lower threshold or other measure differences between Stage 1 and Stage 2;
• Establishing exclusion for Stage 2 measures that do not have an equivalent Stage 1 measure associated with any Stage 1 objective, or where the provider did not plan to attest to the menu objective that would now be otherwise required.
For the first category, we proposed that for an EHR reporting period in 2015, providers scheduled to demonstrate Stage 1 of meaningful use may attest based on the specifications associated with the Stage 1 measure. We noted that for an EHR reporting period beginning in 2016, we proposed that all providers must attest to the specifications (including the measure thresholds) associated with the Stage 2 measure. For the second category, we proposed the alternate exclusions outlined for providers would only apply for an EHR reporting period in 2015. For an EHR reporting period in 2016, we proposed that all providers, including those who would otherwise be scheduled for Stage 1 in 2016, would be required to meet the Stage 2 specifications with no alternate exclusions.
The proposed alternate exclusions and specifications for certain objectives and measures of meaningful use for an EHR reporting period in 2015 are defined for each objective and measure in the description of each objective and measure in the EHR Incentive Programs in 2015 through 2017 proposed rule(80 FR 20358 through 20374).
After consideration of the public comments, we finalize the structure of the objectives and measures for the EHR Incentive Programs in 2015 through 2017 as proposed. In addition, we are finalizing as proposed the proposal for alternate exclusions and specifications for certain providers in 2015. We finalize that providers that were scheduled to demonstrate Stage 1 in 2015 or2016 (for certain exclusions only) may choose the alternate exclusions and specifications where applicable or may attest to the modified Stage 2 objectives and measures. We finalize that EPs, eligible hospitals and CAHs that were scheduled to be in Stage 1 in 2016 may claim an alternate exclusion for an EHR reporting period in 2016 for the Computerized Provider Order Entry Objective Measures 2 and 3 (lab and radiology orders) or choose the modified Stage 2 objective and measures. We finalize that eligible hospitals and CAHs that were scheduled to be in Stage 1 in 2016 may claim an alternate exclusion for an EHR reporting period in 2016 for the Electronic Prescribing Objective or choose the modified Stage 2 Objective. For further detail, we direct readers to the individual objectives and measures for the EHR Incentive Programs in 2015 through 2017 in section II.B.2.a of this final rule with comment period. We refer readers to Table 1 in the EHR Incentive Programs in 2015 through 2017 proposed rule (80 FR 20352) for an illustration of our policy on the prior progression of stages and whether a provider is scheduled to be in Stage 1 in 2015 or 2016.
As discussed in the EHR Incentive Program for 2015 through 2017 proposed rule (80 FR 20357), we proposed to make changes to two objectives that have measures related to patient engagement. We proposed to remove the threshold requirement for these two measures that count patient action in order for the provider to meet the measure. While we support patient engagement and believe that providers have a role in influencing patient behavior and supporting improved health literacy among their patients, data analysis on the measures supports concerns expressed by providers that significant barriers exist that heavily impact a provider's ability to meet the patient action measures. Therefore, we proposed to remove the thresholds for these two measures in order to allow for further maturity of the technology, greater saturation in the market, and increased awareness among patient population. We believe this allows for the necessary time for providers to work toward patient education and the availability of these resources, as well as allowing the industry as a whole time to develop a stronger infrastructure supporting patient engagement.
There are two objectives for EPs and one objective for eligible hospitals and CAHs that specifically contain measures requiring a provider to track patient action. We proposed to modify these measures as follows:
• Patient Action to View, Download, or Transmit (VDT) Health Information
++ Remove the 5 percent threshold for Measure 2 from the EP Stage 2 Patient Electronic Access (VDT) objective. Instead require that at least 1 patient seen by the provider during the EHR reporting period views, downloads, or transmits his or her health information to a third party.
++ Remove the 5 percent threshold for Measure 2 from the eligible hospital and CAH Stage 2 Patient Electronic Access (VDT) objective. Instead require that at least 1 patient discharged from the hospital during the EHR reporting period views, downloads, or transmits his or her health information to a third party.
• Secure Electronic Messaging Using CEHRT
++ Convert the measure for the Stage 2 EP Secure Electronic Messaging objective from the 5 percent threshold to a yes/no attestation to the statement: “The capability for patients to send and receive a secure electronic message was enabled during the EHR reporting period”.
These changes are reflected in the discussion of these objectives in section II.B.2.a of this final rule with comment period. We note that these changes are intended to allow providers to work toward meaningful patient engagement through HIT using the methods best suited to their practice and their patient population. Furthermore, we note that beginning in 2018 (and optionally in 2017); providers are required to meet an objective exclusively focused on patient engagement that has an expanded set of measures and increased thresholds. (For further information on that proposed objective, we direct readers to 80 FR 16755 through 16758.)
After analysis of the existing Stage 1 and Stage 2 objectives and measures as described in section II.B.1.b.(4)(a) and review of the recommendations of the HIT Policy Committee and the foundational goals and requirements under the HITECH Act, we identified in the Stage 3 proposed rule (80 FR 16743) eight key policy areas that represent the advanced use of EHR technology and align with the program's foundational goals and overall national health care improvement goals, such as those found in the CMS National Quality Strategy.
In the Stage 3 proposed rule (80 FR 16743), we proposed that providers must successfully attest to these eight objectives and the associated measures (or meet the exclusion criteria for the applicable measure) to meet the requirements of Stage 3 in the Medicare and Medicaid EHR Incentive Programs. These objectives and measures include advanced EHR functions, use a wide range of structured standards in CEHRT, employ increased thresholds over similar Stage 1 and Stage 2 measures, support more complex clinical and care coordination processes, and require enhanced care coordination through patient engagement through a flexibility structure of active engagement measures.
Several commenters appreciated the removal of the core and menu structure of the objectives, while establishing a single set of objectives and measures in Stage 3, and believed it would reduce the program's complexity.
In response to commenters who specifically cited a need to focus on outcomes and quality improvement based on outcomes measurement, we agree with this assessment. We note that the goal of the EHR Incentive Program is largely to spur the development and adoption of health HIT solutions that support these broader goals. We believe that technology itself cannot improve care coordination or patient outcomes, but the use of that technology can be a tool for providers to work toward these key policy areas. HIT can provide efficiencies in administrative processes which support clinical effectiveness, leveraging automated patient safety checks, supporting clinical decision making, enabling wider access to health information for patients, and allowing for dynamic communication between providers. That is why we proposed a set of priorities for Stage 3 that focus on these concepts. However, it is also the reason behind our efforts to align the EHR Incentive Program with the National Quality Strategy and with CMS quality measurement and quality improvement programs like PQRS, CPCI, Pioneer ACOs and Hospital IQR and HVBP programs. We welcome continued input from providers and stakeholder groups as we continue our efforts to support and promote patient-centered delivery system reform.
We note that public comments received on specific objectives and responses to comments for these objectives are included in the discussion of each objective and its
After consideration of the comments received, we are finalizing our approach for setting the eight key policy areas for Stage 3 as proposed. We address the individual objectives and measures in section II.B.2.b of this final rule with comment period.
We proposed to incorporate flexibility within certain objectives for Stage 3 for providers to choose the measures most relevant to their unique practice setting. As a result, as part of successfully demonstrating meaningful use, providers would be required to attest to the results for the numerators and denominators of all measures associated with an objective. However, a provider would only need to meet the thresholds for two of the three associated measures. The proposed Stage 3 objectives including flexible measure options are as follows:
• Coordination of Care through Patient Engagement—Providers must attest to the numerators and denominators of all three measures, but must only meet the thresholds for two of three measures.
• Health Information Exchange—Providers must attest to the numerators and denominators of all three measures, but must only meet the thresholds for two of three measures.
• Public Health Reporting—EPs must report on three measures and eligible hospitals and CAHs must report on four measures.
For the objectives that allow providers to meet the thresholds for two of three measures (for example, the Coordination of Care through Patient Engagement objective and the Health Information Exchange objective), we proposed that if a provider claims an exclusion for a measure the provider must meet the thresholds of the remaining two measures to meet the objective. If a provider meets the exclusion criteria for two measures for such an objective, the provider may exclude those measures and must meet the threshold of the remaining measure to meet the objective. If a provider meets the exclusion criteria for all three measures for such an objective, the provider may exclude those measures and would still meet the objective.
After consideration of the public comments received, we are finalizing our proposal to provide flexibility within certain measures as proposed.
For Stage 3, we proposed to maintain the policy from the Stage 2 final rule (77 FR 53981) that states that to be a meaningful user, an EP must have 50 percent or more of his or her outpatient encounters during the EHR reporting period at a practice/location or practices/locations equipped with CEHRT. An EP who does not conduct at least 50 percent of their patient encounters in any one practice/location would have to meet the 50 percent threshold through a combination of practices/locations equipped with CEHRT. In the Stage 2 final rule at (77 FR 53981), we defined patient encounter as any encounter where a medical treatment is provided or evaluation and management services are provided.
In addition, in the Stage 2 final rule at (77 FR 53981) we defined a practice/location as equipped with CEHRT if the record of the patient encounter that occurs at that practice/location is created and maintained in CEHRT. We stated that this can be accomplished in the following three ways:
• CEHRT could be permanently installed at the practice/location.
• The EP could bring CEHRT to the practice/location on a portable computing device.
• The EP could access CEHRT remotely using computing devices at the practice/location.
We proposed to maintain these definitions for Stage 3.
After consideration of the public comments received, we are finalizing our proposal to maintain this policy as finalized in the Stage 2 final rule at (77 FR 53981).
In the Stage 3 proposed rule (80 FR 16744), we note that the objectives for Stage 3 include percentage-based measures wherever possible. In the Stage 2 final rule, we included a discussion of the denominators used for the program that included the use of one of four denominators for each of the measures associated with the meaningful use objectives outlined in the Stage 2 final rule (77 FR 53982 for EPs and 77 FR 53983 for eligible hospitals and CAHs).
For EPs, the references used to define the scope of the potential denominators for measures include the following:
• Unique patients seen by the EP during the EHR reporting period.
• Office visits.
• All medication, laboratory, and diagnostic imaging orders created during the reporting period.
• Transitions of care and referrals including:
++ When the EP is the recipient of the transition or referral, first encounters with a new patient and encounters with existing patients where a summary of care record (of any type) is provided to the receiving EP.
++ When the EP is the initiator of the transition or referral, transitions and referrals ordered by the EP.
For the purposes of distinguishing settings of care in determining the movement of a patient, we proposed that a transition or referral may take place when a patient is transitioned or referred between providers with different billing identities, such as a different National Provider Identifier (NPI) or hospital CMS Certification Number (CCN). We also proposed that in the cases where a provider has a patient who seeks out and receives care from another provider without a prior referral, the first provider may include that transition as a referral if the patient subsequently identifies the other provider of care.
For eligible hospitals and CAHs, the references used to define the scope of the potential denominators for measures include the following:
• Unique patients admitted to the eligible hospital's or CAH's inpatient or emergency department during the EHR reporting period.
• All medication, laboratory, and diagnostic imaging orders created during the reporting period.
• Transitions of care and referrals including:
++ When the hospital is the recipient of a transition or referral, all admissions to the inpatient and emergency departments.
++ When the hospital is the initiator of the transition or referral, all discharges from the inpatient department, and after admissions to the emergency department when follow-up care is ordered by authorized providers of the hospital.
We proposed that the explanation of the terms “unique patients,” “transitions of care,” and “referrals” stated previously for EPs would also apply for eligible hospitals and CAHs, and we refer readers to the discussion of those terms in the hospital context in the Stage 2 final rule (77 FR 53983 and 53984). We proposed for Stage 3 to maintain the policy that admissions may be calculated using one of two methods (the observation services method and the all emergency department method), as described for Stage 2 at 77 FR 53984. We stated that all discharges from an inpatient setting are considered a transition of care. We also proposed for transitions from an emergency department, that eligible hospitals and CAHs must count any discharge where follow-up care is ordered by an authorized provider regardless of the completeness of information available to the receiving provider.
After consideration of the public comments received, we are finalizing these denominators and the related explanations of terms as proposed.
In the Stage 3 proposed rule at 80 FR 16745 we proposed the inclusion of patient-authorized representatives in the numerators of the Coordination of Care through Patient Engagement objective and the Patient Electronic Access objective as equivalent to the inclusion of the patient. We expect that patient-authorized representatives with access to such health information will always act on the patient's behalf and in the patient's best interests and will remain free from any potential or actual conflict of interest with the patient. Furthermore, we expect that the patient-authorized representatives would have the patient's best interests at heart and will act in a manner protective of the patient.
After consideration of the public comments received, we are finalizing this policy as proposed. We direct readers to the individual objectives and measures outlined in section II.B.2.b of this final rule with comment period for further discussion of this provision within the applicable objectives and measures.
We proposed to continue our policy of linking each objective to the CEHRT definition and to ONC-established certification criteria. As with Stage 1 and Stage 2, EPs, eligible hospitals, and CAHs must use technology certified to the certification criteria in the ONC HIT Certification Program to meet the objectives and associated measures for Stage 3.
We received no comments specific to this proposal and are finalizing as proposed. We direct readers to the individual objectives and measures outline in section II.B.2.b of this final rule with comment period for further discussion of this provision within the applicable objectives and measures and to section II.B.3 of this final rule with comment period for discussion of the definition of CEHRT for the Medicare and Medicaid EHR Incentive Programs.
We proposed to continue our Stage 1 and Stage 2 policy that regardless of any actual or perceived gaps between the measure of an objective and full compliance with the objective, meeting the criteria of the measure means that the provider has met the objective in Stage 3.
We received no comments specific to this proposal and are finalizing as proposed. We direct readers to the individual objectives and measures outlined in section II.B.2.b of this final with comment period rule for further discussion of this provision within the applicable objectives and measures.
In the EHR Incentive Programs in 2015 through 2017 proposed rule (80 FR 20358), we proposed the following objectives and measures for EPs, eligible hospitals, and CAHs to demonstrate meaningful use for an EHR reporting period in 2015 through 2017. We noted that there are nine proposed objectives for EPs plus one consolidated public health reporting objective, and eight proposed objectives for eligible hospitals and CAHs plus one consolidated public health reporting objective. We proposed these objectives would be mandatory for all providers for an EHR reporting period beginning in 2016 and proposed to allow alternate exclusions and specifications for some providers in 2015 depending on their prior participation.
In the EHR Incentive Programs in 2015 through 2017 proposed rule, we proposed at 80 FR 20358 to retain, with certain modifications, the Stage 2 objective and measure for Protect Electronic Health Information for meaningful use in 2015 through 2017. In the Stage 2 final rule (77 FR 54002 through 54003), we discussed the benefits of safeguarding ePHI, as doing so is essential to all other aspects of meaningful use. Unintended and/or unlawful disclosures of ePHI could diminish consumers' confidence in EHRs and health information exchange. Ensuring that ePHI is adequately protected and secured would assist in addressing the unique risks and challenges that EHRs may present.
We note that we were inconsistent with our naming of this objective calling it “protect patient health information” and alternately “protect electronic health information”. The former matches the Stage 3 Objective (section II.B.2.b.i) while the latter is what we called it in our Stage 2 final rule.
A review must be conducted for each EHR reporting period and any security updates and deficiencies that are identified should be included in the provider's risk management process and implemented or corrected as dictated by that process.
The HHS Office for Civil Rights (OCR) has issued guidance on conducting a security risk analysis in accordance with the Health Insurance Portability and Accountability Act of 1996 (HIPAA) Security Rule (
The scope of the security risk analysis for purposes of this meaningful use measure applies to ePHI created or maintained in CEHRT. However, we noted that other ePHI may be subject to the HIPAA rules, and we refer providers to those rules for additional security requirements.
Another commenter noted that larger healthcare networks have a dedicated IT staff; small practices do not, making it difficult and costly to meet the standards of an annual security risk analysis and implementing security changes.
We disagree that the elements of what constitutes a security risk analysis are not clear. In the proposed rule, we identified the specific requirements in the CFR and provided links to free tools and resources available to assist providers, including an SRA Tool developed by ONC and OCR. We decline to consider exclusions, including for small practices, as we believe it is of utmost importance for all providers to protect ePHI.
We maintain that a focus on protection of electronic personal health information is necessary for all providers due to the number of breaches reported to HHS involving lost or stolen devices.
Several commenters suggested that we incorporate the language from one of our frequently asked questions (FAQs) into the final rule—that the security risk assessment “may be completed outside of the EHR reporting period timeframe but must take place no earlier than the start of the EHR reporting year and no later than the provider attestation date.”
Many commenters suggested that we update our frequently asked questions that relate to security risk assessments.
We intend to update our FAQs to reflect policy changes and clarifications that flow from this final rule with comment period. Prior versions of FAQs and those related to past program years will be archived and maintained for public access on our Web site at
After consideration of public comments received, we are finalizing this objective and measure as proposed with a minor modification to adopt the title “Protect Patient Health Information” for EPs, eligible hospitals and CAHs as follows:
We are adopting Objective 1: Protect Patient Health Information at § 495.22(e)(1)(i) for EPs and § 495.22(e)(1)(ii) for eligible hospitals and CAHs. We further specify that in order to meet this objective and measure, an EP, eligible hospital, or CAH must use the capabilities and standards of as defined for as defined CEHRT at § 495.4. We direct readers to section II.B.3 of this final rule with comment period for a discussion of the definition of CEHRT and a table referencing the capabilities and standards that must be used for each measure.
In the EHR Incentive Programs in 2015 through 2017 proposed rule (80 FR 20358), we proposed to retain the Stage 2 objective and measures for Clinical Decision Support (CDS) for meaningful use in 2015 through 2017 such that CDS would be used to improve performance on high-priority health conditions. This is a consolidated objective, which incorporates the Stage 1 objective to implement drug-drug and drug-allergy interaction checks. It would be left to the provider's clinical discretion to select the most appropriate CDS interventions for his or her patient population.
We proposed that CDS interventions selected should be related to four or more of the CQMs on which providers would be expected to report. The goal of the proposed CDS objective is for providers to implement improvements in clinical performance for high-priority health conditions that would result in improved patient outcomes.
• Measure 1: Implement five clinical decision support interventions related to four or more clinical quality measures at a relevant point in patient care for the entire EHR reporting period. Absent four clinical quality measures related to an EP, eligible hospital, or CAH's scope of practice or patient population, the clinical decision support interventions must be related to high-priority health conditions.
• Measure 2: The EP, eligible hospital or CAH has enabled and implemented the functionality for drug-drug and drug allergy interaction checks for the entire EHR reporting period.
For the first measure, we suggested that one of the five clinical decision support interventions be related to improving healthcare efficiency.
Exclusion: For the second measure, any EP who writes fewer than 100 medication orders during the EHR reporting period.
For an EHR reporting period in 2015 only, we proposed that an EP, eligible hospital or CAH who is scheduled to participate in Stage 1 in 2015 may satisfy the following Stage 1 measure instead of the Stage 2 measure 1 as follows:
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A commenter was supportive of the flexibility provided by CMS and ONC in the use of homegrown alerts and for nurturing a supportive environment for those providers developing their own homegrown alerts and not deterring this type of innovation with overly onerous measure definitions or certification requirements. Many commenters expressed that the use of CDS will have a positive impact on the quality, safety, and efficiency of care. They also supported the proposed objective and measures to use CDS to improve performance on high-priority health conditions.
A commenter expressed concerned that the requirement for every EP to have five CDS elements pertaining to his or her scope of work may be overly burdensome for large organizations with highly specialized EPs where there may be circumstances necessary to build CDS tools that would only be useful for a few individuals.
Additionally, a commenter stated there is a struggle to interpret whether or not each of our implemented features meet ONC's referential link and source attribute requirements.
Other commenters requested the removal of the language requiring participants to have CDS enabled for “the entire reporting period,” as it is challenging for participants to meet. A commenter suggested that we change the requirement to provide that CDS be enabled within the first 45 days of the reporting period and remain enabled throughout the reporting period.
Another commenter believes that the level of interaction checks should be determined by the organizational directives, as well as the discretion of the clinical team.
Some commenters requested that CDS should be enabled to address conditions relevant to the EP's scope of practice. Others stated that children's hospitals or specialty providers should have the same level of choice that is available to adult hospitals and general practitioners, while others requested the removal of the link to CQMs completed. Still others requested that the five CDS interventions be related either to CQMs or to other metrics included in a nationally recognized quality improvement registry or a qualified clinical database registry.
One commenter on the EHR Incentive Programs for 2015 through 2017 proposed rule specifically requested clarification whether an example used in the Stage 3 proposed rule (for example, the appropriate use criteria for imaging services example at 80 FR 16750) could also be used to satisfy the CDS objective for the EHR Incentive Programs in 2015 through 2017.
We also agree with the commenter that providers should be allowed the flexibility to determine the most appropriate CDS intervention and timing of the CDS. The CDS measure for EPs, eligible hospitals, and CAHs allows this flexibility by allowing the implementation at a relevant point in patient care that refers to a relevant point in clinical workflows when the intervention can influence clinical decision making before diagnostic or treatment action is taken in response to the intervention. Further, many providers may associate CDS with pop-up alerts. However, these alerts are not the only method of providing CDS. CDS should not be viewed as simply an interruptive alert, notification, or explicit care suggestion. Well-designed CDS encompasses a variety of workflow optimized information tools, which can be presented to providers, clinical and support staff, patients, and other caregivers at various points in time. We believe that the examples outlined in the Stage 3 proposed rule and further discussed in the Stage 3 objective in section II.B.2.b.iii of this final rule with comment period are applicable for CDS in general and would apply for the EHR Incentive Programs in 2015 through 2017. We refer readers to the CDS objective description in the Stage 3 proposed rule for further information (80 FR 16749 through 16750).
After consideration of the public comments received, we are finalizing the objective, measures, exclusions, and alternate objective and measure as proposed for EPs, eligible hospitals, and CAHs as follows:
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We are adopting Objective 2: Clinical Decision Support at § 495.22(e)(2)(i) for EPs and § 495.22(e)(2)(ii) for eligible
In the EHR Incentive Programs in 2015 through 2017 proposed rule (80 FR 20359),we proposed to retain the Stage 2 objective and measures for CPOE for meaningful use in 2015 through 2017, with modifications proposed for alternate exclusions and specifications for Stage 1 providers for an EHR reporting period in 2015.
We define CPOE as entailing the provider's use of computer assistance to directly enter medical orders (for example, medications, consultations with other providers, laboratory services, imaging studies, and other auxiliary services) from a computer or mobile device. The order is then documented or captured in a digital, structured, and computable format for use in improving the safety and efficiency of the ordering process. CPOE improves quality and safety by allowing clinical decision support at the point of the order, and therefore, influences the initial order decision. CPOE improves safety and efficiency by automating aspects of the ordering process to reduce the possibility of communication and other errors.
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We proposed to retain the three distinct measures of the Stage 2 objective to calculate a separate percentage threshold for all three types of orders: Medication, laboratory, and radiology. We proposed to retain exclusionary criteria for those providers who so infrequently issue an order type that it is not practical to implement CPOE for that order type. To calculate the percentage, CMS and ONC have worked together to define the following for this objective:
An EP, through a combination of meeting the thresholds and exclusions (or both), must satisfy all three measures for this objective. A hospital must meet the thresholds for all three measures.
We proposed alternate exclusions and alternate specifications for this objective and measures for Stage 1 providers in 2015.
Other commenters stated they disagreed with the requirement that only credentialed staff may enter orders for CPOE, as not all medical assistants are required to be credentialed to practice. They further suggested that if a standard for medical assistant CPOE is required, then the standard should be that the medical assistant must be appropriately trained for CEHRT use (including CPOE) by the employer or CEHRT vendor in order to be counted.
Other commenters recommended that we allow medical assistants who were hired and handling the paper-based equivalent of CPOE prior to the Stage 2 final rules (September 2012), and still with the same employing organization (as of September 2012), to be referred to as “Veteran Medical Assistants” and be permitted to enter CPOE.
Another commenter proposed that the rule be revised to allow orders placed by licensed healthcare providers, medical interns, and certified medical assistants in the numerator of the measure.
A commenter requested clarification as to whether CEHRT entries completed by scribes are eligible for CPOE. Another commenter inquired as to whether orders entered by non-physician staff through the means of standing orders are eligible as CPOE. A commenter requested clarification on whether phone orders from physicians can be considered CPOE if they are entered at the time of the call by a licensed healthcare professional that is authorized to enter orders based on the state regulations.
Further, we note that we did not propose to change our prior policy on allowing providers to exclude standing orders as finalized in the Stage 2 final rule at 77 FR 53986.
Finally, we believe that a circumstance involving tele-health or remote communication may be included in the numerator as long as the order entry otherwise meets the requirements of the objective and measures.
Some commenters stated that the CPOE objective should be considered topped out.
Additionally, we note that when we analyzed attestation data from 2011 through 2013, provider performance on the CPOE measures is high, but high performance is not the only consideration in determining whether to retain an objective or measure in the program. We also review provider performance across varying levels of participation, the variance between provider types at different quartiles, stakeholder feedback on the potential value add of the objective and measure, and other similar considerations. Based on these factors, we believe the CPOE objective should be maintained in the program as it promotes patient safety and clinical efficiency. In addition, we believe there is room for significant improvement on measure performance.
After consideration of public comments received, we are finalizing the alternate exclusions and specifications with the following modifications based on the final policy we adopted in section II.B.1.b.(4)(b)(iii) of this final rule with comment period. We note that providers who would otherwise have been scheduled for Stage 1 in 2016 may be required to implement technology functions for certain Stage 2 measures if they do not already have these functions in place because there is no Stage 1 equivalent to the Stage 2 measure. In certain cases, the improper implementation of these functions could represent a patient safety issue and therefore we are finalizing an alternate exclusion in 2016 in order to allow sufficient time for implementation in these circumstances. The Stage 2 CPOE objective measure for lab orders and the measure for radiology orders both require functions that a provider who was expecting to be in Stage 1 in 2016 may not be able to safely implement in time for an EHR reporting period in 2016. Therefore a provider may elect to exclude from these two measures for an EHR reporting period in 2016 if they were previously scheduled to be in Stage 1 in 2016.
We are finalizing the objective, measures, exclusions and alternate specifications and exclusions for EPs, eligible hospitals, and CAHs as follows:
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We are adopting the Objective 3: Computerized Provider Order Entry at § 495.22(e)(3)(i) for EPs and § 495.22(e)(3)(ii) for eligible hospitals and CAHs. We further specify that in order to meet this objective and measures, an EP, eligible hospital, or CAH must use the capabilities and standards of as defined for as defined CEHRT at § 495.4. We direct readers to section II.B.3 of this final rule with comment period for a discussion of the definition of CEHRT and a table referencing the capabilities and standards that must be used for each measure.
In the EHR Incentive Programs in 2015 through 2017 proposed rule (80 FR 20360),we proposed to retain the Stage 2 objective and measure for Electronic Prescribing (eRx) for EPs, as well as for eligible hospitals and CAHs, for meaningful use in 2015 through 2017. We note that the Stage 2 objective for eligible hospitals and CAHs is currently a menu objective, but we proposed the objective would be required for 2015 through 2017, with an exception for Stage 1 eligible hospitals and CAHs for an EHR reporting period in 2015.
As noted in the Stage 2 final rule at 77 FR 54035, the use of electronic prescribing has several advantages over having the patient carry the prescription or the provider directly faxing handwritten or typewritten prescriptions to the pharmacy. These advantages include: Providing decision support to promote safety and quality in the form of adverse interactions and other treatment possibilities; efficiency of the health care system by alerting the EP to generic alternatives or to alternatives favored by the patient's insurance plan that are equally effective; reduction of communication errors; and automatic comparisons of the medication order to others the pharmacy or third parties have received for the patient. We proposed to maintain these policies in the EHR Incentive Programs in 2015 through 2017 proposed rule (80 FR 20361).
We proposed to retain the exclusion introduced for Stage 2 that would allow EPs to exclude this objective if no pharmacies within 10 miles of an EP's practice location at the start of his/her EHR reporting period accept electronic prescriptions.
We also proposed to retain the exclusion for EPs who write fewer than 100 permissible prescriptions during the EHR reporting period.
To calculate the percentage, CMS and ONC have worked together to define the following for this objective:
• Writes fewer than 100 permissible prescriptions during the EHR reporting period; or
• Does not have a pharmacy within his or her organization and there are no pharmacies that accept electronic prescriptions within 10 miles of the EP's practice location at the start of his or her EHR reporting period.
We proposed that for an EHR reporting period in 2015, EPs scheduled to demonstrate Stage 1 of meaningful use may attest to the specifications and threshold associated with the Stage 1 measure. We note that for an EHR
We proposed no alternate exclusions for this EP objective.
After consideration of the public comments received, we are finalizing changes to the language to continue to allow providers the option to include or exclude controlled substances in the denominator where such medications can be electronically prescribed. We are finalizing that these prescriptions may be included in the definition of “permissible prescriptions” at the providers discretion where allowable by law. We are modifying the measure language to maintain “permissible prescriptions” and remove the “or all prescriptions” language and changing the denominator to read “Number of permissible prescriptions written for drugs requiring a prescription in order to be dispensed during the EHR reporting period” in accordance with this change. We are finalizing the alternate specifications for providers scheduled to demonstrate Stage 1 of meaningful for an EHR reporting period in 2015 as proposed.
We are finalizing the objective, measure, exclusions and alternate specifications for EPs as follows:
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○ Writes fewer than 100 permissible prescriptions during the EHR reporting period; or
○ Does not have a pharmacy within his or her organization and there are no pharmacies that accept electronic prescriptions within 10 miles of the EP's practice location at the start of his or her EHR reporting period
We are adopting Objective 4: Electronic Prescribing at § 495.22(e)(4)(i) for EPs. We further specify that in order to meet this objective and measure, an EPm must use the capabilities and standards of as defined for as defined CEHRT at § 495.4. We direct readers to section II.B.3 of this final rule with comment period for a discussion of the definition of CEHRT and a table referencing the capabilities and standards that must be used for each measure.
(B)
In the Stage 2 final rule at 77 FR 54035, we describe how the use of electronic prescribing has several advantages over having the patient carry the prescription to the pharmacy or directly faxing a handwritten or typewritten prescription to the pharmacy. When the hospital generates the prescription electronically, CEHRT can provide support for a number of purposes, such as: Promoting safety and quality in the form of decision support around adverse interactions and other treatment possibilities; increasing the efficiency of the health care system by alerting the EP to generic alternatives or to alternatives favored by the patient's insurance plan that are equally effective; and reducing communication errors by allows the pharmacy or a third party to automatically compare the medication order to others they have received for the patient. This allows for many of the same decision support functions enabled at the generation of the prescription, but with access to potentially greater information. For this reason, we continue to support the use of electronic prescribing for discharge prescriptions in a hospital setting (80 FR 20361).
We proposed to retain the exclusion that would allow a hospital to exclude this objective if there is no internal pharmacy that can accept electronic prescriptions and is not located within 10 miles of any pharmacy that accepts electronic prescriptions at the start of their EHR reporting period.
To calculate the percentage, CMS and ONC have worked together to define the following for this objective:
We proposed that eligible hospitals and CAHs scheduled to report on Stage 1 objectives for an EHR reporting period in 2015 may claim an exclusion for the Stage 2 eRx measure as there is not an equivalent Stage 1 measure defined at 42 CFR 495.6. We further proposed that eligible hospitals and CAHs scheduled to report Stage 2 objectives for an EHR reporting period in 2015 that were not intending to attest to the eRx menu objective and measure may also claim an exclusion.
We proposed no alternate specifications for this eligible hospital and CAH objective.
A commenter noted that electronic prescribing would cause medication errors because the hospital often makes numerous changes to a patient's prescription at the time of discharge, and incorrect prescriptions (with the wrong medication or dosage) written on paper can simply be torn up rather than requiring a new prescription to be sent and causing confusion for the patient. Other commenters also stated similar scenarios related to current workflows, which would need to be changed in order to comply with electronic prescribing requirements.
Finally, other commenters provided feedback on the request for comment regarding refill prescriptions and continued medications and whether the measure language should be modified to only mention “new prescriptions” or “new or changed prescriptions” rather than the proposed continuation of including new, changed, and refilled prescriptions. The vast majority of commenters did not support including refilled prescriptions noting that these prescriptions should be included and monitored by the original prescriber. Commenters were divided on whether to include or exclude changed prescriptions. Some noting, again, that changed prescriptions should be monitored by the original prescriber while others noted that the change constitutes accountability for the prescription by the eligible hospital.
After consideration of the public comments received, we are modifying our proposal and finalizing changes to the language to continue to allow providers the option to include or exclude controlled substances in the denominator where such medications can be electronically prescribed. We are finalizing that these prescriptions may be included in the definition of “permissible prescriptions” at the providers discretion where allowable by law. We are modifying the denominator to read “Number of permissible new, changed, or refill prescriptions written for drugs requiring a prescription in order to be dispensed for patients discharged during the EHR reporting period” in accordance with this change.
Finally, we proposed that some of the Stage 2 objectives and measures do not have an equivalent Stage 1 measure and so for 2015 we proposed to allow providers to exclude from these measures. However, the eligible hospital electronic prescribing objective was included in this policy for both Stage 1 providers and Stage 2 providers in 2015 because it was previously a menu measure so many Stage 2 providers may not be able to meet the measure in 2015 if they had not prepared to do so. As noted in section II.B.1.b.(4)(c)(iii), based on public comment we determined to also allow alternate exclusions in 2016 for certain measures. We determined this to be necessary because, for certain measures providers may not have the specific CEHRT function required to support the measure if they were not prepared to attest to that measure in 2015. These providers may not be able to successfully obtain and fully and safely implement the technology in time to succeed at the measure for an EHR reporting period in 2016. In the case of electronic prescribing, accelerating the implementation of the technology in a short time frame could present a patient safety risk, and so therefore for the eligible hospital objective we are finalizing an alternate exclusion in 2016 for eligible hospitals scheduled for Stage 1 or Stage 2 in 2016. We believe this change will provide the time necessary to safely implement the technology for eligible hospitals and CAHs. Therefore, we are finalizing the alternate exclusion for providers scheduled to demonstrate meaningful for an EHR reporting period in 2015with an extension of the exclusion into 2016.
We are finalizing the objective, measure, exclusions, and alternate exclusion for eligible hospitals and CAHs as follows:
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We are adopting the Objective 4: Electronic Prescribing at § 495.22(e)(4)(ii) for eligible hospitals
For Objective 5: Summary of Care (here retitled to Health Information Exchange), we proposed to retain only the second measure of the existing Stage 2 Summary of Care objective for meaningful use in 2015 through 2017 (80 FR 20361) and directed readers to the full description in the Stage 2 final rule at 77 FR 54013 through 54021.
We proposed to retain an updated version of the second measure of the Stage 2 Summary of Care objective with modifications based on guidance provided through CMS responses to frequently asked questions we have received since the publication of the Stage 2 final rule. We proposed to retain this measure for electronic transmittal because we believe that the electronic exchange of health information between providers would encourage the sharing of the patient care summary from one provider to another and important information that the patient may not have been able to provide. This can significantly improve the quality and safety of referral care and reduce unnecessary and redundant testing. Use of common standards in creating the summary of care record can significantly reduce the cost and complexity of interfaces between different systems and promote widespread exchange and interoperability.
The proposed updates to this measure reflect stakeholder input regarding operational challenges in meeting this measure, and seek to increase flexibility for providers while continuing to drive interoperability across care settings and encouraging further innovation. Previously, the measure specified the manner in which the summary of care must be electronically transmitted stating: Providers must either—(1) Electronically transmit the summary of care using CEHRT to a recipient; or (2) where the recipient receives the summary of care record via exchange facilitated by an organization that is a Nationwide Health Information Network (NwHIN) Exchange participant or in a manner that is consistent with the governance mechanism ONC establishes for the nationwide health information network. We proposed to update this measure to state simply that a provider would be required to create the summary of care record using CEHRT and transmit the summary of care record electronically.
To calculate the percentage of the measure, CMS and ONC have worked together to define the following for this objective:
We proposed that providers scheduled to demonstrate Stage 1 of meaningful use for an EHR reporting period in 2015 may claim an exclusion for Measure 2 of the Stage 2 Summary of Care core objective because there is not an equivalent Stage 1 measure.
We proposed no alternate specifications for this objective.
Finally, some commenters asked if the omission was intentional and if we intended that the data elements would still be available for providers to use discretion on a case-by-case basis. Other commenters did not express confusion about the requirement, but did not that some flexibility would be welcome as their trading partners are often overwhelmed by the amount of unnecessary information they receive, especially in relation to extensive
“All summary of care documents used to meet this objective must include the following information if the provider knows it:
• Patient name.
• Referring or transitioning provider's name and office contact information (EP only).
• Procedures.
• Encounter diagnosis
• Immunizations.
• Laboratory test results.
• Vital signs (height, weight, blood pressure, BMI).
• Smoking status.
• Functional status, including activities of daily living, cognitive and disability status.
• Demographic information (preferred language, sex, race, ethnicity, date of birth).
• Care plan field, including goals and instructions.
• Care team including the primary care provider of record and any additional known care team members beyond the referring or transitioning provider and the receiving provider.
• Discharge instructions (Hospital Only)
• Reason for referral (EP only)
In circumstances where there is no information available to populate one or more of the fields listed previously, either because the EP, eligible hospital, or CAH can be excluded from recording such information (for example, vital signs) or because there is no information to record (for example, laboratory tests), the EP, eligible hospital, or CAH may leave the field(s) blank and still meet the objective and its associated measure.
In addition, all summary of care documents used to meet this objective must include the following in order to be considered a summary of care document for this objective:
• Current problem list (providers may also include historical problems at their discretion),
• Current medication list, and
• Current medication allergy list.
An EP or hospital must verify these three fields for current problem list, current medication list, and current medication allergy list are not blank and include the most recent information known by the EP or hospital as of the time of generating the summary of care document.”
We intend to maintain this policy of the required data elements for the C-CDA as previously finalized. However, we do understand provider concern over the ability to exercise some discretion over the amount of data transmitted, and as noted in the Stage 3 proposed rule (80 FR 16760) we recognize there may be reasons to apply a policy of determining clinical relevance for the amount of data in the lab results field and clinical notes field which should be included in the summary of care document. Specifically, it may be beneficial for a provider to limit the lab results transmitted in the record of an extended hospital stay to those which best represent the patient status upon admission, any outliers or abnormal results, and the patient status upon discharge. Further, we note that this is only one example and other definitions of clinical relevance for lab results may apply in other clinical settings and for other situations. We are therefore adopting a similar policy for this measure as the one outlined for Stage 3; however, we are limiting this policy to lab results. We are therefore requiring that a provider must have the ability to send all laboratory test results in the summary of care document, but that a provider may work with their system developer to establish clinically relevant parameters based on their specialty, patient population, or for certain transitions and referrals which allow for clinical relevance to determine the most appropriate results for given transition or referral. We further note that a provider who limits the results in a summary of care document must send the full results upon the request of the receiving provider or upon the request by the patient. For discussion of this proposal in relation to the Stage 3 objective in this final rule with comment period we direct readers to section II.B.2.b.vii.
We acknowledge that in some cases we have decided to extend the alternate exclusion for 2015 into 2016 where a provider may not have the appropriate CEHRT functions in place for a measure. However, we have limited those instances to those cases where rushed implementation of the function could present a risk to patient safety. We do not believe this objective and measure pose such a risk, and further maintain our assertion from the Stage 3 proposed rule (80 FR 16739) that overall success on in health information exchange is enhanced by increased participation.
Some commenters requested that we initiate the mandatory reporting of direct address directories to a central repository so that established standards will help providers meet future requirements in Stage 3.
While we encourage the use of query-based exchange for many use cases, we note that to count in the numerator the sending provider must reasonable certainty of receipt of the summary of care document. This means that a “push” to an HIE which might be queried by the recipient is insufficient. Instead, r the referring provider must confirmation that a query was made to count the action toward the measure. We further specify that the exchange must comply with the privacy and security protocols for ePHI under HIPAA.
We thank the commenters for the suggestion around the concept of an information exchange address repository. We agree that a potential model which might allow for easier access to health information exchange contact information could be a positive step toward supporting interoperability and an improved care continuum. We refer readers to section II.D.3 of this final rule with comment period for further discussion of the collection of direct addresses or health information exchange information for potential inclusion in a nationwide healthcare provider directory. After consideration of public comments received, we are finalizing this objective, measure, exclusion, and alternate exclusion as proposed for EPs, eligible hospitals, and CAHs as follows:
We are adopting Objective 5: Health Information Exchange at § 495.22(e)(5)(i) for EPs and § 495.22(e)(5)(ii) for eligible hospitals and CAHs. We further specify that in order to meet this objective and measures, an EP, eligible hospital, or CAH must use the capabilities and standards of as defined for as defined CEHRT at § 495.4. We direct readers to section II.B.3 of this final rule with comment period for a discussion of the definition of CEHRT and a table referencing the capabilities and standards that must be used for each measure.
In the EHR Incentive Programs in 2015 through 2017 proposed rule (80 FR 20362), we proposed to retain the Stage 2 objective and measure for Patient-Specific Education for meaningful use for 2015 through 2017.
In the Stage 2 proposed rule (77 FR 54011), we explained that providing clinically relevant education resources to patients is a priority for the meaningful use of CEHRT. While CEHRT must be used to identify patient-specific education resources, these resources or materials do not have to be maintained within or generated by the CEHRT. We are aware that there are many electronic resources available for patient education materials, such as through the National Library of Medicine's MedlinePlus (
We proposed to retain the exclusion for EPs who have no office visits in order to accommodate such EPs.
The resources would have to be those identified by CEHRT. If resources are not identified by CEHRT and provided to the patient, then it would not be counted in the numerator. We do not intend through this requirement to limit the education resources provided to patients to only those identified by CEHRT. The education resources would need to be provided prior to the calculation and subsequent attestation to meaningful use.
To calculate the percentage for EPs, CMS, and ONC have worked together to define the following for this objective:
To calculate the percentage for hospitals, CMS and ONC have worked together to define the following for this objective:
While the Patient-Specific Education objective is designated as an optional menu objective in Stage 1, the same objective is a mandatory core objective in Stage 2. We expect that not all Stage 1 scheduled providers were planning to choose this menu objective when attesting in an EHR reporting period in 2015. Therefore, we proposed that any provider scheduled to demonstrate Stage 1 of meaningful use for an EHR reporting period in 2015 who was not intending to attest to the Stage 1 Patient-Specific Education menu objective, may claim an exclusion to the measure. We note that for an EHR reporting period beginning in 2016, all providers must attest to the objective and measure and meet the Stage 2 specifications and threshold in order to successfully demonstrate meaningful use.
We proposed no alternate specifications for this objective.
However, we disagree with the recommendation to allow any action to count in perpetuity. We note that this measure refers to a single action for each unique patient seen during the EHR reporting period. This means that if a provider meets the minimum action, even for those patients who have multiple office visits within an EHR reporting period, the provider would be providing educational information a single time each year for only just over 10 percent of their patients. We strongly disagree that this represents an unreasonable burden or that this action should not be required to continue on an annual basis. We disagree with the commenter's suggestion that patient specific education is not useful or relevant for a patient for each year in which they receive medical care. We further disagree with the examples provided for specialists or other providers providing long-term care or working with a patient to manage a chronic disease that a single provision of patient specific education should be counted for the numerator in perpetuity. Research shows that continued patient engagement and education positively impacts patient outcomes, especially for patients with a chronic disease and patients who may experience health disparities.
Keolling,Todd M., MD; Monica L. Johnson, RN; Robert J. Cody, MD; Keith D. Aaronson, MD, MS: “Discharge Education Improves Clinical Outcomes in Patients with Chronic Heart Failure” Heart Failure: AHA Journals:
Therefore, as indicated in FAQ 8231, we believe that while the patient-specific education resources may be provided outside of the EHR reporting period, this action must occur no earlier than the start of the same year as the EHR reporting period if the EHR reporting period is less than one full calendar year and no later than the date of attestation. For the eligible hospital and CAH measure, the numerator includes the qualifier “subsequently” which indicates the patient-specific education resources must be provided after the patient's admission to the hospital, and consistent with FAQ 8231, no later than the date of attestation. As noted in section II.B.1.b.(4)(b), some EHRs may have previously been designed and certified to calculate this measure based on a prior assumption, and for that reason we will not require this method of calculation until the EHR reporting period in 2017 in order to allow sufficient time for the calculation to be updated in systems.
After consideration of public comments received, we are finalizing the objective, measures, exclusions, and alternate exclusion as proposed for EPs, eligible hospitals and CAHs.
The final objective is as follows:
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We are adopting Objective 6: Patient-Specific Education at § 495.22(e)(6)(i) for EPs and § 495.22(e)(6)(ii) for eligible hospitals and CAHs. We further specify that in order to meet this objective and measures, an EP, eligible hospital, or CAH must use the capabilities and standards of as defined for as defined CEHRT at § 495.4. We direct readers to section II.B.3 of this final rule with comment period for a discussion of the definition of CEHRT and a table referencing the capabilities and standards that must be used for each measure.
In the EHR Incentive Programs for 2015 through 2017 proposed rule (80 FR 20363), we proposed to retain the Stage 2 objective and measure for Medication Reconciliation for meaningful use in 2015 through 2017. Medication reconciliation allows providers to confirm that the information they have on the patient's medication is accurate. This not only assists the provider in his or her direct patient care, it also improves the accuracy of information they provide to others through health information exchange.
In the Stage 2 proposed rule at 77 FR 54012 through 54013, we noted that when conducting medication reconciliation during a transition of care, the EP, eligible hospital, or CAH that receives the patient into their care should conduct the medication reconciliation. We reiterated that the measure of this objective does not dictate what information must be included in medication reconciliation, as information included in the process is appropriately determined by the provider and patient. We defined medication reconciliation as the process of identifying the most accurate list of all medications that the patient is taking, including name, dosage, frequency, and route, by comparing the medical record to an external list of medications obtained from a patient, hospital or other provider. In the EHR Incentive Programs in 2015 through 2017 proposed rule (80 FR 20363), we proposed to maintain these definitions without modification.
To calculate the percentage, CMS and ONC have worked together to define the following for this objective:
We proposed that any provider scheduled to demonstrate Stage 1 of meaningful use for an EHR reporting period in 2015 who was not intending to attest to the Stage 1 Medication Reconciliation menu objective, may claim an exclusion to the measure.
We proposed no alternate specifications for this objective.
Many commenters provided recommendations for additional exclusions for the objective including exclusions for providers who do not have office visits; and providers who have fewer than 10 or 100 transitions of care rather than limiting the exclusion to providers who not the recipient of any transition or referral. Another commenter believes that medication reconciliation is out of scope for his practice while others requested excluding referrals for reading certain tests or imaging services. Commenters also requested that we revise the measure to allow an exclusion for providers with fewer than 100 transitions or referral received electronically or to limit the denominator to only those transitions or referrals where an electronic summary of care document was received.
Finally, one commenter stated a belief that the requirements for medication reconciliation objective depend upon the interoperability of EHR systems and may pose a significant burden to providers.
In addition, for those EPs who note that they have no office visits, or face-to-face encounters, and therefore should not have to include patient encounters for these services (such as only reading an EKG); we refer readers to the description in the Stage 2 final rule (77 FR 53982) which notes that a provider may choose to include these encounters in the denominator or to exclude them. However, if the provider chooses to include or exclude these encounters they must apply the policy universally across all such encounters and across all applicable measures. A provider should consider how the policy will affect their ability to meet all applicable measures, and then work with their EHR vendor to ensure that the calculation of denominators and numerators matches the provider's decision.
In terms of additional or expanded exclusions or concerns over scope of practice, we note that we did not propose any such changes and disagree that any such changes are necessary or beneficial. We believe medication reconciliation is an important part of maintaining a patient's record, that it is integral to patient safety, and that maintaining an accurate list of medications may be relevant to any provider's plan of care for a patient.
In addition, robust health information exchange is of great assistance to medication reconciliation, but an electronic summary of care document is not required for medication reconciliation. Nor is electronic HIE the only way EHRs can assist with medication reconciliation. Medication reconciliation may take many forms, from automated inclusion of ePHI to review of paper records, to discussion with the patient upon intake or during consultation with the provider. Going back to Stage 1 we have noted that medication reconciliation may become more automated as technology progresses, but may never reach a point of full automation as these other methods continue to offer value—especially conversation with the patient which may remain an important part of that process (75 FR 44362). Furthermore, while the measure does involve health information exchange, we see no value in limiting the medication reconciliation measure to only those patients for whom a record is received electronically. We believe that it is appropriate and important to conduct medication reconciliation for each patient regardless of the method that reconciliation may require. Therefore, while we believe that medication reconciliation will become easier as health information exchange capability increases and that robust health information exchange supports medication reconciliation, it is not a prerequisite to performing medication reconciliation. Further, we believe the continued inclusion of a broad requirement for medication reconciliation will encourage developers and providers to continue to focus on how HIT can be designed and leveraged to better support provider medication reconciliation workflows through innovative new tools and resources.
After considerations of public comments received, we are finalizing as proposed the objective, measure, exclusion and alternate exclusions for EPs, eligible hospitals, and CAHs as follows:
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We are adopting Objective 7: Medication Reconciliation at § 495.22(e)(7)(i) for EPs and § 495.22(e)(7)(ii) for eligible hospitals and CAHs. We further specify that in order to meet this objective and measures, an EP, eligible hospital, or CAH must use the capabilities and standards of as defined for as defined CEHRT at § 495.4. We direct readers to section II.B.3 of this final rule with comment period for a discussion of the definition of CEHRT and a table referencing the capabilities and standards that must be used for each measure.
We proposed to retain the Stage 2 objective for Patient Electronic Access for meaningful use in 2015 through 2017. We proposed to retain the first measure of the Stage 2 objective without modification. We proposed to retain the second measure for the Stage 2 objective with modification to the measure threshold.
In the Stage 2 proposed rule, we stated that the goal of this objective was to allow patients easy access to their health information as soon as possible, so that they can make informed decisions regarding their care or share their most recent clinical information with other health care providers and personal caregivers as they see fit.
The ability to have this information online means it is always retrievable by the patient, while the download function ensures that the patient can take the information with them when secure internet access is not available. The patient must be able to access this information on demand, such as through a patient portal or PHR. We note that while a covered entity may be able to fully satisfy a patient's request for information through VDT, the measure does not replace the covered entity's responsibilities to meet the broader requirements under HIPAA to provide an individual, upon request, with access to PHI in a designated record set. Providers should also be aware that while meaningful use is limited to the capabilities of CEHRT to provide online access there may be patients who cannot access their EHRs electronically because of their disability, or who require assistive technology to do so. Additionally, other health information may not be accessible. Finally, we noted that providers who are covered by civil rights laws, including the Americans with Disabilities Act, Section 504 of the Rehabilitation Act of 1973, or Section 1577 of the Affordable Care Act, must provide individuals with disabilities equal access to information and appropriate auxiliary aids and services as provided in the applicable statutes and regulations. For a useful reference of how to meet these obligations, we suggest covered providers reference the Department of Justice's Effective Communications guidance at
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In order to meet this objective, the following information must be made available to patients electronically within 4 business days of the information being made available to the EP:
++ Patient name.
++ Provider's name and office contact information.
++ Current and past problem list.
++ Procedures.
++ Laboratory test results.
++ Current medication list and medication history.
++ Current medication allergy list and medication allergy history.
++ Vital signs (height, weight, blood pressure, BMI, growth charts).
++ Smoking status.
++ Demographic information (preferred language, sex, race, ethnicity, date of birth).
++ Care plan field(s), including goals and instructions.
++ Any known care team members including the primary care provider (PCP) of record.
To calculate the percentage of the first measure for providing patient with timely online access to health information, CMS and ONC have worked together to define the following for this objective:
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(a) Neither orders nor creates any of the information listed for inclusion as part of the measures; or
(b) Conducts 50 percent or more of his or her patient encounters in a county that does not have 50 percent or more of its housing units with 4Mbps broadband availability according to the latest information available from the FCC on the first day of the EHR reporting period.
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The following information must be available to satisfy the objective and measure:
++ Patient name.
++ Admit and discharge date and location.
++ Reason for hospitalization.
++ Care team including the attending of record as well as other providers of care.
++ Procedures performed during admission.
++ Current and past problem list.
++ Vital signs at discharge.
++ Laboratory test results (available at time of discharge).
++ Summary of care record for transitions of care or referrals to another provider.
++ Care plan field(s), including goals and instructions.
++ Discharge instructions for patient.
++ Demographics maintained by hospital (sex, race, ethnicity, date of birth, preferred language).
++ Smoking status.
To calculate the percentage of the first measure for providing patients timely
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We proposed that providers scheduled to demonstrate Stage 1 of meaningful use for an EHR reporting period in 2015 may additionally claim an exclusion for the second measure of the Stage 2 Patient Electronic Access objective because there is not an equivalent Stage 1 measure defined at 42 CFR 495.6.
We proposed no alternate specifications for this objective.
Other commenters urged CMS to “preserve the existing thresholds for patient online access and secure, messaging” stating that requiring that only one patient has access is not meaningful enough. These commenters included statements advocating for patients to have the ability to access their EHR and that we should not reduce the threshold to let providers off the hook.
For the commenters who state that one patient having access is not meaningful enough, we believe these commenters may have misunderstood which measure we proposed to modify. As noted, we proposed no changes to the first measure under the Patient Electronic Access objective which is required for all providers in Stage 1 and Stage 2, in Medicare and Medicaid, and for both EPs, eligible hospitals, and CAHs. For this measure, each provider must demonstrate that more than 50 percent of their unique patients during the EHR reporting period have access to view, download, and transmit their health information. In the proposed rule, we proposed only to modify the second measure (which measures the patient's action, not the provider) from a threshold of 5 percent to at least one patient.
If a provider's CEHRT does require a patient email address, but the patient does not have or refuses to provide an email address or elects to “opt out” of participation, that is not prohibited by the EHR Incentive Program requirements nor does it allow the provider to exclude that patient from the denominator. Instead, the provider may still meet the measure by providing that patient all of the necessary information required for the patient to subsequently access their information, obtain access through a patient-authorized representative, or otherwise opt-back-in without further follow up action required by the provider. We note
Further commenters referenced EHR Incentive Programs FAQ 8231
For example, if a provider's CEHRT uses an enrollment process to issue a user ID to the patient, a provider does not need to create a new user ID for a patient each time the patient has an office visit. That initial enrollment can occur any time as it is not governed by the measure. What the measure addresses is the health information that results from care (
In relation to the suggestion that the second measure should be allowed to be calculated including any action in any time period before the EHR reporting period to count in the numerator, we strongly disagree. We do not believe a single instance of a patient accessing their record should be counted in perpetuity for the measure. The calculation may include actions taken before, during, or after the EHR reporting period if the period is less than one full year; however, consistent with FAQ 8231, these actions must be taken no earlier than the start of the same year as the EHR reporting period and no later than the date of attestation. We understand, as discussed in section II.B.1.b.(4), that some certified EHRs may not calculate the numerator in this fashion and therefore we will allow providers to use an alternate calculation for an EHR reporting period in 2015 and 2016 if that calculation is a part of their CEHRT to allow sufficient time to upgrade the calculation prior to providers attesting to data for an EHR reporting period in 2017.
Some commenters disagreed with the modifications to Measure 2 and are concerned with the large jump to meet the proposed Stage 3 meaningful use VDT requirement in 2018. Several commenters believe that the reduction of the patient engagement threshold will slow momentum of this measure leaving providers ill-prepared for the future of meaningful use. Many commenters believed that lowering the requirement to only one patient viewing, downloading, or transmitting their health information is counterproductive to improving patient outcomes nationally. Engaging patients by using technology is a critical path to move the healthcare system forward and demonstrate the core value of meaningful use. Several commenters recommended a phased approach for the threshold for the measure, increasing over time to the proposed
We wish to reiterate that we understand the concerns voiced by providers regarding patient populations that are unable to engage in their health care information electronically due to various factors, which include income, age, technological capabilities, or comprehension. We agree with the phased approach recommended by the commenters who noted that it provides additional time for the adoption of technology by patients, but also maintains the importance of the measure. We believe this approach will allow providers to set a progressive goal with incremental increases in performance through 2018. We believe this approach is in line with our policy to build from basic to advanced use and to increase measure thresholds over time and that it will also maintain the incentive for providers to focus on methods and approaches to increase patient engagement. Therefore, we are finalizing a change from our proposal for 2015 through 2017 to build toward the Stage 3 measure threshold required in 2018. We are setting the measure threshold at 1 patient for 2015 and 2016 and 5 percent in 2017 to work toward the increased threshold for Stage 3 in 2018 (see also section II.B.2.b.(vi) for the Stage 3 objective).
After consideration of public comment received, we are finalizing the objective and the alternate exclusion to Measure 2 as proposed for EPs, eligible hospitals and CAHs.
We are finalizing Measure 1 with modifications to improve the clarity of the measure language based on stakeholder feedback and Measure 2 with modifications to the thresholds and to specify the timing of the action for EPs to match the eligible hospital and CAH measure. We are maintaining our prior policy for the information that must be provided to the patient for the objective as proposed.
We are adopting the objective as follows:
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○ Neither orders nor creates any of the information listed for inclusion as part of the measures; or
○ Conducts 50 percent or more of his or her patient encounters in a county that does not have 50 percent or more of its housing units with 4Mbps broadband availability according to the latest information available from the FCC on the first day of the EHR reporting period.
For an EHR reporting period in 2017, more than 5 percent of unique patients seen by the EP during the EHR reporting period (or his or her authorized representatives) view, download or transmit to a third party their health information during the EHR reporting period.
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○ Neither orders nor creates any of the information listed for inclusion as part of the measures; or
○ Conducts 50 percent or more of his or her patient encounters in a county that does not have 50 percent or more of its housing units with 4Mbps broadband availability according to the latest information available from the FCC on the first day of the EHR reporting period.
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For an EHR reporting period in 2017, more than 5 percent of unique patients discharged from the inpatient or emergency department (POS 21 or 23) of an eligible hospital or CAH (or patient-authorized representative) view, download or transmit to a third party their health information during the EHR reporting period.
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We are adopting Objective 8: Patient Electronic Access at § 495.22(e)(8)(i) for EPs and § 495.22(e)(8)(ii) for eligible hospitals and CAHs. We further specify that in order to meet this objective and measures, an EP, eligible hospital, or CAH must use the capabilities and standards of as defined for as defined CEHRT at § 495.4. We direct readers to section II.B.3 of this final rule with comment period for a discussion of the definition of CEHRT and a table referencing the capabilities and standards that must be used for each measure.
We proposed to retain the EP Stage 2 objective for secure electronic messaging with modifications to the measure for meaningful use in 2015 through 2017.
We proposed to retain the exclusion for EPs who have no office visits and for those EPs who lack the infrastructure required for secure electronic messaging due to being located in areas with limited broadband availability as identified by the Federal Communications Commission (FCC).
We proposed that an EP scheduled to demonstrate Stage 1 of meaningful use for an EHR reporting period in 2015 may claim an exclusion for the secure electronic messaging objective measure as there is not an equivalent Stage 1 objective or measure defined at 42 CFR 495.6.
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We proposed no alternate specifications for this objective and there is no equivalent objective for eligible hospitals and CAHs in the Stage 2 objectives and measures for meaningful use.
Commenters expressing general opposition to secure messaging cited their patients' reluctance to sign up for the portal due to data breach fears, lack of internet familiarity, and overall lack of access. Other commenters also recommended continuing the reduced requirement in the future.
As noted in the Stage 3 proposed rule (80 FR 16756) and for the Stage 3 objective in section II.B.2.b.vi of this final rule with comment period, we included proposals for bi-directional communication and communications among and between the patient and multiple providers in a care team. We also expanded the potential role of patient-authorized representatives, and we sought to adopt a wider range of communications methods that could support and promote patient-centered care coordination. We proposed this objective because we believe that leveraging health IT to support care team communications in which a patient is actively engaged can lead to better care coordination and better outcomes for the patient. However, the current Stage 2 secure messaging objective as finalized in the 2012 Stage 2 final rule (77 FR 54031) does not include this flexibility of form, method and participation. It includes only patient-initiated communication rather than provider driven engagement, and it does not promote a wide range of use cases. Comments received indicate that this is a significant shortfall in the language of the current measure supporting the identified health care delivery system reform goal. In addition, commenters note that these factors and other environmental or patient related factors create a significant burden on providers and negatively impact a provider's ability to meet the measure. This means that providers are investing a large amount of resources to achieve a measure that is flawed, does not adequately meet the intended health goal, and provides only a limited value.
We believe that the measure should be modified to better serve as a foundation for a more dynamic use of HIT for patient engagement. For this reason, we proposed to continue support of the function and to adopt a more dynamic measure for Stage 3 that will help drive adoption and innovation to support the long-term goals of leveraging HIT for patient engagement.
In addition, some commenters opposed lowering the threshold believe that removing the current thresholds will not help or encourage providers to prepare for upcoming Stage 3 thresholds. These commenters recommended that we consider an incrementally phased-in approach towards measure thresholds to balance the challenges providers face in promoting patient engagement. These commenters suggested beginning with simple enabled functions as proposed and increasing the threshold incrementally year over year to work toward the proposed Stage 3 threshold of 35 percent rather than having a static low threshold and a sudden jump to a higher level in Stage 3.
Still other commenters requested expanding the definition of secure messaging in the current objective to reflect the options and methods proposed for the Stage 3 objective. These commenters requested that provider initiated messaging should be the action that counts toward the numerator for the current objective and that communications with a patient-authorized representative on the patient's behalf should also count toward the measure.
We cannot fully adopt the Stage 3 specifications as the commenters recommend because some parts, such as communications among care team members, would not be supported by EHR technology certified to the 2014 Edition certification criteria. However, we agree that it makes sense to focus the measure on provider action rather than on patient action and to allow provider initiated actions to be included in the numerator. As noted previously, we believe that a measure that more accurately reflects the policy goal for delivery system reform should include these provider initiated actions and we also agree with the inclusion of interactions involving a patient-authorized representative as this is an important factor for many patients in coordinating care. We will therefore modify the current objective to include provider initiated communications and communications with a patient-authorized representative in the numerator. We note that this change also means that a patient-initiated message would only count toward the numerator if the provider responded to the patient as that is part of measuring the provider action rather than the patient action for this measure. As this measurement would not be required until 2016 and then at a level of only 1 patient, we believe it is reasonable to make this change in the counting methodology in the current objective.
After consideration of the comments received, we are finalizing as proposed the objective, exclusion, and alternate exclusion as proposed. We are finalizing the measure with the modifications to the thresholds. We are adopting the objective as follows:
For an EHR reporting period in 2016, for at least 1 patient seen by the EP during the EHR reporting period, a secure message was sent using the electronic messaging function of CEHRT to the patient (or the patient-authorized representative), or in response to a secure message sent by the patient (or the patient-authorized representative) during the EHR reporting period.
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For an EHR reporting period in 2017, for more than 5 percent of unique patients seen by the EP during the EHR reporting period, a secure message was sent using the electronic messaging function of CEHRT to the patient (or the patient-authorized representative), or in response to a secure message sent by the patient (or the patient-authorized representative) during the EHR reporting period.
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Alternate Exclusion: An EP may claim an exclusion for the measure if for an EHR reporting period in 2015 they were scheduled to demonstrate Stage 1, which does not have an equivalent measure.
We are adopting Objective 9: Secure Electronic Messaging at § 495.22(e)(9)(i) for EPs. We further specify that in order to meet this objective and measures, an EP must use the capabilities and standards of as defined for as defined CEHRT at § 495.4. We direct readers to section II.B.3 of this final rule with comment period for a discussion of the definition of CEHRT and a table referencing the capabilities and standards that must be used for each measure.
In the EHR Incentive Programs in 2015 through 2017 proposed rule 80 FR 20366,we proposed to adopt a modified version of the consolidated Public Health and Clinical Data Registry Reporting objective proposed in the Stage 3 proposed rule for all providers to demonstrate meaningful use for an EHR reporting period in 2015 through 2017.
In the EHR Incentive Programs for 2015 through 2017 proposed rule 80 FR 20366, we highlighted our intention to align with the Stage 3 proposed rule and remove the prior ongoing submission requirement and replace it with an “active engagement” requirement. We reiterated our definition of “active engagement” as defined in the Stage 3 proposed rule at (80 FR 16739 and 16740) and noted our proposal to adopt the same definition for the Modified Stage 2 objective proposed for 2015 through 2017 as we believe this change is more aligned with the process providers undertake to report to a clinical registry or public health agency.
At (80 FR 20366), we proposed that “active engagement” may be demonstrated by any of the following options:
We noted that the change in definition is intended to better capture the activities a provider may conduct in order to engage with a PHA or CDR, and that any prior action taken to meet the non-consolidated public health reporting objectives of meaningful use Stages 1 and 2 would count toward
For clarification on the rationale behind this change, we note that over the past few years, we have received feedback on the Stage 1 and Stage 2 public health reporting objectives through letters, public forums, and individual inquiries from both providers/provider representatives and from public health agencies. The common trend in these communications is that the difference between the Stage 1 and Stage 2 requirements and the “ongoing submission” structure for the Stage 2 objectives created confusion around both the actions required and the timing of those actions for providers. The active engagement requirement clarifies what is expected of a provider who seeks to meet the measures within this objective and more accurately describes the actions necessary to meet each option within the structure. This does not mean that actions a provider has already taken in an attempt to meet the “ongoing submission” requirement would not be acceptable under the new objective. Any action which would be acceptable under the Stage 1 and Stage 2 public health reporting objectives would fit within the definition of the “active engagement” options. In addition, because of the similarity between the substantive requirements of the “ongoing submission” requirement and the “active engagement” requirement options included in this final rule with comment period, we do not believe that significant time will be needed to implement the updated requirement.
For example, in Stage 2 a provider could register their intent to submit data to successfully meet a measure in one of the public health reporting objectives. Our proposal in the EHR Incentive Programs for 2015 through 2017 proposed rule includes the exact same requirement under “Active Engagement Option 1: Completed Registration to Submit Data.”
We also believe that the flexibility within the active engagement options enables a provider additional time to determine the option that is best suited to their practice. For example, in Active Engagement Option 1, we also proposed that a provider would be required to register to submit data to the PHA within 60 days of the beginning of the EHR reporting period and not on the first day of the EHR reporting period. We believe that this 60-day timeframe will benefit providers who seek to determine whether Option 1 best captures their reporting status, or whether Option 2 or Option 3 are more appropriate. We further note that this requirement would allow a provider to begin their registration prior to the start of their EHR reporting period if such were necessary, so long as the action was completed within 60 days of the start of the EHR reporting period.
For EPs, we proposed that an exclusion for a measure does not count toward the total of two measures. Instead, in order to meet this objective an EP would need to meet two of the total number of measures available to them. If the EP qualifies for multiple exclusions and the remaining number of measures available to the EP is less than two, the EP can meet the objective by meeting the one remaining measure available to them and claiming the applicable exclusions. If no measures remain available, the EP can meet the objective by claiming applicable exclusions for all measures. An EP who is scheduled to be in Stage 1 in 2015 must report at least one measure unless they can exclude from all available measures. Available measures include ones for which the EP does not qualify for an exclusion.
For eligible hospitals and CAHs, we proposed that an exclusion for a measure does not count toward the total of three measures. Instead, in order to meet this objective, an eligible hospital or CAH would need to meet three of the total number of measures available to them. If the eligible hospital or CAH qualifies for multiple exclusions and the total number of remaining measures available to the eligible hospital or CAH is less than three, the eligible hospital, or CAH can meet the objective by meeting all of the remaining measures available to them and claiming the applicable exclusions. If no measures remain available, the eligible hospital or CAH can meet the objective by claiming applicable exclusions for all measures. An eligible hospital or CAH that is scheduled to be in Stage 1 in 2015 must report at least two measures unless they can—either;—(1) Exclude from all but one available measure and report that one measure; or (2) can exclude from all available measures. Available measures include ones for which the eligible hospital or CAH does not qualify for an exclusion.
We note that we proposed to allow EPs, eligible hospitals, and CAHs to choose to report to more than one public health registry to meet the number of measures required to meet the objective. We also proposed to allow EPs, eligible hospitals, and CAHs to choose to report to more than one clinical data registry to meet the number of measures required to meet the objective.
To calculate the measures:
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We proposed that to successfully meet the requirements of this measure, bi-directional data exchange between the provider's CEHRT system and the immunization registry/IIS is required.
++ Does not administer any immunizations to any of the populations for which data is collected by its jurisdiction's immunization registry or immunization information system during the EHR reporting period;
++ Operates in a jurisdiction for which no immunization registry or immunization information system is capable of accepting the specific standards required to meet the CEHRT definition at the start of the EHR reporting period; or
++ Operates in a jurisdiction where no immunization registry or immunization information system has declared readiness to receive immunization data from the EP, eligible hospital, or CAH at the start of the EHR reporting period.
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++ Does not treat or diagnose or directly treat any disease or condition associated with a syndromic surveillance system in his or her jurisdiction;
++ Operates in a jurisdiction for which no public health agency is capable of receiving electronic syndromic surveillance data from EPs in the specific standards required to meet the CEHRT definition at the start of the EHR reporting period; or
++ Operates in a jurisdiction where no public health agency has declared readiness to receive syndromic surveillance data from EPs at the start of the EHR reporting period.
++ Does not have an emergency or urgent care department;
++ Operates in a jurisdiction for which no public health agency is capable of receiving electronic syndromic surveillance data from eligible hospitals or CAHs in the specific standards required to meet the CEHRT definition at the start of the EHR reporting period; or
++ Operates in a jurisdiction where no public health agency has declared readiness to receive syndromic surveillance data from eligible hospitals or CAHs at the start of the EHR reporting period.
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++ Does not treat or diagnose any reportable diseases for which data is collected by their jurisdiction's reportable disease system during the EHR reporting period;
++ Operates in a jurisdiction for which no public health agency is capable of receiving electronic case reporting data in the specific standards required to meet the CEHRT definition at the start of the EHR reporting period; or
++ Operates in a jurisdiction where no public health agency has declared readiness to receive electronic case reporting data at the start of the EHR reporting period.
If a provider chooses to participate in Stage 3 in 2017, they must meet the requirements defined for the Stage 3 Public Health and Clinical Data Registry Reporting objective which may include the case reporting measure defined for the Stage 3 objectives discussed in section II.B.2.b.viii of this final rule with comment period.
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As noted in the EHR Incentive Programs in 2015 through 2017 proposed rule (80 FR 20368), in the Stage 2 final rule, we were purposefully general in our use of the term “specialized registry” (other than a cancer registry) for the Stage 2 Specialized Registry Reporting Objective to encompass both registry reporting to public health agencies and clinical data registries in order to prevent inadvertent exclusion of certain registries through an attempt to be more specific (77 FR 54030). In response to insight gained from the industry through listening sessions, public forums, and responses to a
In the EHR Incentive Programs in 2015 through 2017 proposed rule (80 FR 20367), we reiterated that any EP, eligible hospital, or CAH may report to more than one public health registry to meet the total number of required measures for the objective. For example, if a provider meets this measure through reporting to both the National Hospital Care Survey and the National Healthcare Safety Network registry, the provider could get credit for meeting two measures.
We further noted that ONC adopted standards for ambulatory cancer case reporting in its 2014 Edition final rule (see § 170.314(f)(6)) and CMS provided EPs the option to select the cancer case reporting menu objective in the Stage 2 final rule (77 FR 54029 through 54030). We included cancer registry reporting as a separate objective from specialized registry reporting because it was more mature in its development than other registry types, not because other reporting was intended to be excluded from meaningful use. In the EHR Incentive Program in 2015 through 2017 proposed rule (80 FR 20369), we proposed that EPs would have the option of counting cancer case reporting under the public health registry reporting measure, but that cancer case reporting is not an option for eligible hospitals and CAHs, because hospitals have traditionally diagnosed and treated cancers (or both) and have the infrastructure needed to report cancer cases.
++ Does not diagnose or directly treat any disease or condition associated with a public health registry in their jurisdiction during the EHR reporting period;
++ Operates in a jurisdiction for which no public health agency is capable of accepting electronic registry transactions in the specific standards required to meet the CEHRT definition at the start of the EHR reporting period; or
++ Operates in a jurisdiction where no public health registry for which the EP, eligible hospital, or CAH is eligible has declared readiness to receive electronic registry transactions at the beginning of the EHR reporting period.
Many commenters recommended changing this measure and the clinical data registry reporting measure back to the prior Stage 2 requirements for the specialized registry reporting objective for 2015 through 2017 instead of splitting that objective into two measures as proposed. Commenters noted that if the language in the Stage 2 specialized registry reporting objective were changed to include the “Active engagement” definition, it would provide a wide range of options which offers a value for providers and especially for certain EP specialties who may otherwise be excluding from all available measures. In addition, commenters note that maintaining the existing specialized registry reporting objective would provide continuity for providers and not inadvertently penalize providers who had selected to report to a registry under the specialized registry reporting objective which may not qualify under the definition of a public health registry or a clinical data registry from the proposed rule.
Instead, we will maintain for 2015 through 2017 a unified specialized registry reporting measure which adopts the change from “ongoing submission” to “active engagement”. We believe that this will allow providers flexibility to continue in the direction they may have already planned for reporting while still allowing for a wide range of reporting options in the future. We further note that we have previously supported the
We are also finalizing our proposed policy to incorporate cancer case reporting into the measure for EPs only. Therefore, EPs who were previously planning to attest to the cancer case reporting objective, may count that action toward the Specialized Registry Reporting measure. We believe this change is necessary to support continued provider reporting to cancer case registries. However, we note that EPs who did not intend to attest to the cancer case reporting menu objective are not required to engage in or exclude from cancer case reporting in order to meet the specialized registry reporting measure. We further note that providers may use electronic submission methods beyond the functions of CEHRT to meet the requirements for the Specialized Registry Reporting measure. Finally, we are adopting our proposal that providers may count the measure more than one time if they report to multiple specialized registries as proposed. For the Stage 3 public health registry reporting measure within the Public Health and Clinical Data Registry Reporting Objective, we direct readers to section II.B.2.b.viii of this final rule with comment period.
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As discussed in the Public Health Registry Reporting measure, we proposed to split specialized registry reporting into two separate, clearly defined measures: Public health registry reporting and clinical data registry reporting. In Stage 2 for EPs, reporting to specialized registries is a menu objective and this menu objective includes reporting to clinical data registries. For Stage 3, we proposed to include clinical data registry reporting as an independent measure. The National Quality Registry Network defines clinical data registries as those that record information about the health status of patients and the health care they receive over varying periods of time
We proposed that any EP, eligible hospital, or CAH may report to more than 1 clinical data registry to meet the total number of required measures for this objective. ONC would consider the adoption of standards and implementation guides in future rulemaking. Should these subsequently be finalized, they may then be adopted as part of the CEHRT definition as it relates to meeting the clinical data registry reporting measure through future rulemaking for the EHR Incentive Programs.
++ Does not diagnose or directly treat any disease or condition associated with a clinical data registry in their jurisdiction during the EHR reporting period;
++ Operates in a jurisdiction for which no clinical data registry is capable of accepting electronic registry transactions in the specific standards required to meet the CEHRT definition at the start of the EHR reporting period; or
++ Operates in a jurisdiction where no clinical data registry for which the EP, eligible hospital, or CAH is eligible has declared readiness to receive electronic registry transactions at the beginning of the EHR reporting period.
As noted previously, we are not finalizing our proposal to split the measure from the Stage 2 Specialized Registry Reporting Objective (77 FR 54030) into two measures. Therefore, we are not finalizing the clinical data registry reporting measure for 2015, 2016, and for 2017 for those providers who are not demonstrating Stage 3. If a provider chooses to participate in Stage 3 in 2017, they must meet the requirements defined for the Stage 3 Public Health and Clinical Data Registry Reporting objective as discussed in section II.B.2.b.viii of this final rule with comment period.
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++ Does not perform or order laboratory tests that are reportable in their jurisdiction during the EHR reporting period;
++ Operates in a jurisdiction for which no public health agency is capable of accepting the specific ELR standards required to meet the CEHRT definition at the start of the EHR reporting period; or
++ Operates in a jurisdiction where no public health agency has declared readiness to receive electronic reportable laboratory results from eligible hospitals or CAHs at the start of the EHR reporting period.
After consideration of public comments received, for EHR reporting periods in 2015 through 2017, we are finalizing the objective with a modification to the name to state Public Health Reporting Objective and to remove the reference to clinical data registries. We are finalizing the measures with modifications. For Measure 1, we remove the requirement for bi-directional data exchange and note that providers will not be required to receive a full immunization history and will not be required to display an immunization forecast from an Immunization Information System (IIS) to meet the measure. Providers will only need to electronically submit immunization data to the appropriate public health jurisdiction's IIS. For Measure 2, we are adopting a modification to the final policy to allow all EPs to submit syndromic surveillance data and to modify the exclusions to reflect that different categories of providers may or may not be able to report based on the requirements of the registry. For Measure 3, we are not finalizing the proposed case reporting measure. For Measure 4, we are not finalizing our proposal to split specialized registry reporting into two distinct measures. Instead, we will maintain a unified specification for specialized registry reporting which adopts the change from “ongoing submission” to “active engagement” and includes reporting for eligible hospitals and CAHs for 2015 through 2017. We include cancer case reporting as an option for EPs only under the adopted specialized registry reporting measure. We are redesignating this measure as “Measure 3”. For Measure 5, we are not finalizing the proposed clinical data registry reporting measure. For Measure 6, we are finalizing the measure language as proposed and redesignating the measure as “Measure 4”.
For the explanation of terms, we are finalizing the definition of active engagement with the additional clarification provided through response to public comment. We are finalizing that EPs must meet at least 2 measures with a modification to reference the selection from measures 1 through 3 (rather than 1 through 5). Similarly, we are finalizing that eligible hospitals and CAHs must meet at least 3 measures from measures 1 through 4 (rather than 1 through 6). We are also finalizing the alternate specification that in 2015 Stage 1 EPs may meet one measure to meet the threshold and Stage 1 eligible hospitals and CAHs may meet two measures to meet the threshold.
For EPs, we are finalizing that an exclusion for a measure does not count toward the total of two measures. Instead, in order to meet this objective an EP would need to meet two of the total number of measures available to them. If the EP qualifies for multiple exclusions and the remaining number of measures available to the EP is less than two, the EP can meet the objective by meeting the one remaining measure available to them and claiming the applicable exclusions. If no measures remain available, the EP can meet the objective by claiming applicable exclusions for all measures. An EP who is scheduled to be in Stage 1 in 2015 must report at least one measure unless they can exclude from all available measures. Available measures include ones for which the EP does not qualify for an exclusion.
For eligible hospitals and CAHs, we are finalizing that an exclusion for a measure does not count toward the total of three measures. Instead, in order to meet this objective an eligible hospital or CAH would need to meet three of the total number of measures available to them. If the eligible hospital or CAH qualifies for multiple exclusions and the total number of remaining measures available to the eligible hospital or CAH is less than three, the eligible hospital or CAH can meet the objective by meeting all of the remaining measures available to them and claiming the applicable exclusions. If no measures remain available, the eligible hospital or CAH can meet the objective by claiming applicable exclusions for all measures. An eligible hospital or CAH that is scheduled to be in Stage 1 in 2015 must report at least two measures unless they can either—(1) Exclude from all but one available measure and report that one measure; or (2) can exclude from all available measures. Available measures include ones for which the eligible hospital or CAH does not qualify for an exclusion.
Finally, we note that a provider may report to more than one specialized registry and may count specialized registry reporting more than once to meet the required number of measures for the objective.
We are adopting the final objective, measures, exclusions, and alternate specification as follows:
• Does not administer any immunizations to any of the populations for which data is collected by its jurisdiction's immunization registry or immunization information system during the EHR reporting period;
• Operates in a jurisdiction for which no immunization registry or immunization information system is capable of accepting the specific standards required to meet the CEHRT definition at the start of the EHR reporting period; or
• Operates in a jurisdiction where no immunization registry or immunization information system has declared readiness to receive immunization data from the EP, eligible hospital, or CAH at the start of the EHR reporting period.
• Is not in a category of providers from which ambulatory syndromic surveillance data is collected by their jurisdiction's syndromic surveillance system;
• Operates in a jurisdiction for which no public health agency is capable of receiving electronic syndromic surveillance data from EPs in the specific standards required to meet the CEHRT definition at the start of the EHR reporting period; or
• Operates in a jurisdiction where no public health agency has declared readiness to receive syndromic surveillance data from EPs at the start of the EHR reporting period.
• Does not have an emergency or urgent care department;
• Operates in a jurisdiction for which no public health agency is capable of receiving electronic syndromic surveillance data from eligible hospitals or CAHs in the specific standards required to meet the CEHRT definition at the start of the EHR reporting period; or
• Operates in a jurisdiction where no public health agency has declared readiness to receive syndromic surveillance data from eligible hospitals or CAHs at the start of the EHR reporting period.
• Does not diagnose or treat any disease or condition associated with or collect relevant data that is required by a specialized registry in their jurisdiction during the EHR reporting period;
• Operates in a jurisdiction for which no specialized registry is capable of accepting electronic registry transactions in the specific standards required to meet the CEHRT definition at the start of the EHR reporting period; or
• Operates in a jurisdiction where no specialized registry for which the EP, eligible hospital, or CAH is eligible has declared readiness to receive electronic registry transactions at the beginning of the EHR reporting period.
• Does not perform or order laboratory tests that are reportable in their jurisdiction during the EHR reporting period;
• Operates in a jurisdiction for which no public health agency is capable of accepting the specific ELR standards required to meet the CEHRT definition at the start of the EHR reporting period; or
• Operates in a jurisdiction where no public health agency has declared readiness to receive electronic reportable laboratory results from eligible hospitals or CAHs at the start of the EHR reporting period.
We are adopting Objective 10: Public Health Reporting at § 495.22(e)(10)(i) for EPs and § 495.22(e)(10)(ii) for eligible hospitals and CAHs. We further specify that providers must use the functions and standards as defined for CEHRT at § 495.4 where applicable; however, as noted for measure 3, providers may use functions beyond those established in CEHRT in accordance with state and local law. We direct readers to section II.B.3. of this final rule with comment period for a discussion of the definition of CEHRT and a table referencing the capabilities and standards that must be used for each measure.
In the Stage 3 proposed rule at 80 FR 16745 through 16747, we noted that, consistent with HIPAA and its implementing regulations and both the Stage 1 and Stage 2 final rules (75 FR 44368 through 44369 and 77 FR 54002 through 54003), protecting electronic protected health information (ePHI) remains essential to all aspects of meaningful use under the EHR Incentive Programs. We remain cognizant that unintended or unlawful disclosures of ePHI could diminish consumer confidence in EHRs and the overall exchange of ePHI. Therefore, in both the Stage 1 and 2 final rules, we created a meaningful use core objective aimed at protecting patients' health care information. Most recently, we finalized at (77 FR 54002 and 54003), a Stage 2 meaningful use core objective requiring providers to “protect ePHI created or maintained by the certified EHR technology through the implementation of appropriate technical capabilities.” The measure for this objective requires providers to conduct or review a security risk analysis in accordance with the requirements under 45 CFR 164.308(a)(1), including addressing the security (to include encryption) of data stored in CEHRT in accordance with requirements under 45 CFR 164.312 (a)(2)(iv) and 45 CFR 164.306(d)(3), implementing security updates as necessary, and correcting identified security deficiencies as part of the provider's risk management process. For further detail on this objective, we refer readers to the Stage 2 proposed and final rules (77 FR 13716 through 13717 and 77 FR 54002).
In the Stage 3 proposed rule, we noted that public comments on the Stage 2 final rule and subsequent comments received through public forums, suggest some confusion remains among providers between the requirements of this meaningful use objective and the requirements established under 45 CFR 164.308(a)(1), 45 CFR 164.312(a)(2)(iv) and 45 CFR 164.306(d)(3) of the HIPAA Security Rule. Although we stressed that the objective and measure finalized relating to ePHI are specific to the EHR Incentive Programs, and further added that compliance with the requirements in the HIPAA Security Rule falls outside the scope of this rulemaking, we nonetheless continued to receive inquiries about the relationship between our objective and the HIPAA Rules. Therefore, for Stage 3, in order to
For the proposed Stage 3 objective, we added language to the security requirements for the implementation of appropriate technical, administrative, and physical safeguards. We proposed to include administrative and physical safeguards because an entity would require technical, administrative, and physical safeguards to enable it to implement risk management security measures to reduce the risks and vulnerabilities identified. Technical safeguards alone are not enough to ensure the confidentiality, integrity, and availability of ePHI. Administrative safeguards (for example, risk analysis, risk management, training, and contingency plans) and physical safeguards (for example, facility access controls, workstation security) are also required to protect against threats and impermissible uses or disclosures to ePHI created or maintained by CEHRT.
Some commenters noted in their support of the objective that it is essential for privacy protection and consumer confidence in EHRs as electronic personal health information is vulnerable to unauthorized access, theft, tampering, and corruption. Several commenters noted the rise in data breaches and the importance of this objective in keeping health information well secured.
A commenter suggested triggers to remind providers to conduct the security risk assessment. Many commenters supported the requirement that providers conduct a security risk analysis upon installation or upgrade of CEHRT.
As noted in the proposed rule, a risk analysis must assess the risks and vulnerabilities to ePHI created or maintained by the CEHRT and must be conducted or reviewed for each EHR reporting period, and any security updates and deficiencies identified should be included in the provider's risk management process and implemented or corrected as dictated by that process.
To address inquiries about the relationship between this measure and the HIPAA Security Rule, we explained that the requirement of the proposed measure is narrower than what is required to satisfy the security risk analysis requirement under 45 CFR 164.308(a)(1). The requirement of the proposed measure is limited to annually conducting or reviewing a security risk analysis to assess whether the technical, administrative, and physical safeguards and risk management strategies are sufficient to reduce the potential risks and vulnerabilities to the confidentiality, availability, and integrity of ePHI created by or maintained in CEHRT. In contrast, the security risk analysis requirement under 45 CFR 164.308(a)(1) must assess the potential risks and vulnerabilities to the confidentiality, availability, and integrity of all ePHI that an organization creates, receives, maintains, or transmits. This includes ePHI in all forms of electronic media, such as hard drives, floppy disks, CDs, DVDs, smart cards or other storage devices, personal digital assistants, transmission media, or portable electronic media.
In the Stage 3 proposed rule at 80 FR 16746 through 16747, we further proposed that the timing or review of the security risk analysis to satisfy this proposed measure must be as follows:
• EPs, eligible hospitals, and CAHs must conduct the security risk analysis upon installation of CEHRT or upon upgrade to a new Edition. The initial security risk analysis and testing may occur prior to the beginning of the first EHR reporting period using that Edition of CEHRT.
• In subsequent years, a provider must review the security risk analysis of the CEHRT and the administrative, physical, and technical safeguards implemented, and make updates to its analysis as necessary, but at least once per EHR reporting period.
Many commenters requested clarification about the requirement to perform a security risk analysis when CEHRT is upgraded or patched. Others noted that requiring a security risk
A commenter recommended changing the requirement of “conduct
The proposed requirement is to perform the security risk analysis upon installation of CEHRT or upon upgrade to a new Edition. Thus, it would be required when a provider upgraded from EHR technology certified to the 2014 Edition to EHR technology certified to the 2015 Edition as established by ONC. We note that the second part of the requirement states a review must be conducted at least on an annual basis, and additional review may be required if additional implementation changes are subsequently made that were not included and planned for in the initial review.
We note that a security risk analysis is not a discrete item in time, but a comprehensive analysis covering the full period of time for which it is applicable; and the annual review of such an analysis is similarly comprehensive. In other words, the analysis and review are not merely episodic but should cover a span of the entire year, including a review planning for future system changes within the year or a review of prior system changes within the year. Therefore, we believe the commenters' concerns may be a semantic misunderstanding of the nature of an analysis and annual review. We proposed to maintain the previously finalized Stage 2 objective on protecting ePHI, which includes the statement “conduct or review” for both the EHR Incentive Programs in 2015 through 2017 and for Stage 3.
We note that for the proposed objective and measure, the measure must be completed in the same calendar year as the EHR reporting period. If the EHR reporting period is 90 days, it must be completed in the same calendar year. This may occur either before or during the EHR reporting period; or, if it occurs after the EHR reporting period, it must occur before the provider attests or before the end of the calendar year, whichever date comes first. Again, we reiterate that the security risk analysis and review should not be an episodic “snap-shot” in time, but rather include an analysis and review of the protection of ePHI for the full year no matter at what point in time that analysis or review are conducted within the year. In short, the analysis should cover retrospectively from the beginning of the year to the point of the analysis and prospectively from the point of the analysis to the end of the year.
In addition, other tools and resources are available to assist providers in the process. For example, the ONC provides guidance and an SRA tool created in conjunction with OCR on its Web site at:
Several commenters recommended that CMS collaborate with the OCR to develop more robust guidance on conducting security risk assessments and understanding and implementing encryption. A commenter suggested a national education campaign to help ensure that they are adequately equipped to protect ePHI.
In the Stage 3 proposed rule (80 FR 16747), we did note that OCR provides broad scale guidance on security risk analysis requirements and that other tools and resources are available to assist providers in the process. In addition, CMS and ONC will continue to work to provide tools and resources, tip sheets, and to respond to FAQs from providers and developers on the privacy and security requirements.
As noted in the Stage 1 final rule (75 FR 44314 at 44368), while this objective is intended to support compliance with
After consideration of the comments received on this objective and measure, we are finalizing the objective as proposed and finalizing the measure with a modification to replace the word “stored” with the phrase “created or maintained.” We are adopting this change to correct a discrepancy between the text of the objective and the measure as well as between the measure (the objective reads “created and maintained”) and to better reflect the HIPAA security rules. We are finalizing the objective and measure as follows:
We are adopting Objective 1: Protect Patient Health Information at § 495.24(d)(1)(i) for EPs and § 495.24(d)(1)(ii) for eligible hospitals and CAHs. We further specify that in order to meet this objective and measures, an EP, eligible hospital, or CAH must use the capabilities and standards of as defined for as defined CEHRT at § 495.4. We direct readers to section II.B.3 of this final rule with comment period for a discussion of the definition of CEHRT and a table referencing the capabilities and standards that must be used for each measure.
In the Stage 3 proposed rule (80 FR 16747 through16749), we proposed to maintain the objective and measure finalized in the Stage 2 final rule (77 FR 53989 through 53990) for electronic prescribing for EPs, with minor changes. We also proposed to maintain the previous Stage 2 menu objective for eligible hospitals and CAHs as a required objective for Stage 3 with an increased threshold.
Proposed Objective: EPs must generate and transmit permissible prescriptions electronically, and eligible hospitals and CAHs must generate and transmit permissible discharge prescriptions electronically (eRx).
We proposed to continue to define “prescription” as the authorization by a provider to dispense a drug that would not be dispensed without such authorization. This includes authorization for refills of previously authorized drugs. We proposed to continue to generally define a “permissible prescription” as all drugs meeting the definition of prescription not listed as a controlled substance in Schedules II-V (DEA Web site at
In the Stage 2 final rule at (77 FR 53989), we discussed several different workflow scenarios that are possible when an EP prescribes a drug for a patient and that these differences in transmissions create differences in the need for standards. For Stage 3, we proposed to maintain this policy for Stage 3 for EPs and extend it to eligible hospitals and CAHs so that only a scenario in which a provider (1) Prescribes the drug; (2) transmits it to a pharmacy independent of the provider's organization; and (3) The patient obtains the drug from that pharmacy requires the use of standards to ensure that the transmission meets the goals of electronic prescribing. In that situation, standards can ensure the whole process functions reliably. In all cases under this objective, the provider needs to use CEHRT as the sole means of creating the prescription, and when transmitting to an external pharmacy that is independent of the provider's organization, such transmission must be pursuant to ONC HIT Certification Program criteria.
We proposed to maintain for Stage 3 the exclusion from Stage 2 for EPs who write fewer than 100 permissible prescriptions during the EHR reporting period. We also proposed to maintain for Stage 3 the exclusion from Stage 2 if no pharmacies within a 10-mile radius of an EP's practice location at the start of his or her EHR reporting period accept electronic prescriptions (77 FR 53990). This is 10 miles in any straight line from the practice location independent of the travel route from the practice location to the pharmacy. For EPs practicing at multiple locations, they are eligible for the exclusion if any of their practice locations equipped with CEHRT meet this criterion. An EP would not be eligible for this exclusion if he or she is part of an organization that owns or operates its own pharmacy within the 10-mile radius regardless of whether that pharmacy can accept electronic prescriptions from EPs outside of the organization.
To calculate the percentage, CMS and ONC have worked together to define the following for this objective:
We proposed to limit this measure for Stage 3 to only new and changed prescriptions and invited public comment on whether a hospital would issue refills upon discharge for medications the patient was taking when they arrived at the hospital and, if so, whether distinguishing those refill prescriptions from new or altered prescriptions is unnecessarily burdensome for the hospital.
To calculate the percentage, CMS and ONC have worked together to define the following for this objective:
In the proposed rule, we recognized that not every patient will have a formulary that is relevant to him or her. If a relevant formulary is available, then the information can be provided. If there is no formulary for a given patient, the comparison could return a result of formulary unavailable for that patient and medication combination, and the provider may count the prescription in the numerator if they generate and transmit the prescription electronically as required by the measure.
Some of these commenters expressed that if the provider is required to query a drug formulary, the provider cannot be expected to meet the 80 percent threshold. Further commenters discussed the disconnect between the various options for formulary queries and discussed the ongoing evolution of standards specifically referencing the following issues:
• Formulary queries where no formulary exists may generate errors on some systems;
• Formulary queries of formularies with access restrictions, either technological restrictions or proprietary restrictions limit the ability to query even where such a formulary is available;
• Static formularies are often not fully electronic, are not a format that can be queried, or are updated infrequently so they provide limited benefit;
• Real time formulary query standards are split with as many as three primary options available in the industry.
Despite these concerns, many commenters noted that they agree with the concept of an automated, real-time formulary query. Commenters stated that they believe it provides a value for patients when the query is feasible and successful.
Therefore, we are changing the measure for this objective to remove the language regarding controlled substances. Instead, we are adopting that under “permissible prescriptions” for the Stage 3 objective providers must may include electronic prescriptions of controlled substances in the measure where creation of an electronic prescription for the medication is feasible using CEHRT and where allowed by law for the duration of the EHR reporting period.
After consideration of the comments received, we are adopting the objective and exclusion for electronic prescribing as proposed. We will continue to define “prescription” as the authorization by a provider to dispense a drug that would not be dispensed without such authorization. This includes authorization for refills of previously authorized drugs. We are finalizing changes to the language to continue to allow providers the option to include or exclude controlled substances in the denominator where such medications can be electronically prescribed. We are finalizing that these prescriptions may be included in the definition of “permissible prescriptions” at the provider's discretion where allowable by law.
We will not include OTC medicines in the definition of a prescription for this objective. We are maintaining the different workflow scenarios that are possible as discussed in the Stage 2 final rule at (77 FR 53989). We are maintaining this policy for Stage 3 for EPs and extending it to eligible hospitals and CAHs.
For EPs, eligible hospitals and CAHs we are finalizing the objective as follows:
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We are adopting Objective 2: Electronic Prescribing at § 495.24(d)(2)(i) for EPs and § 495.24(d)(2)(ii) for eligible hospitals and CAHs. We further specify that in order to meet this objective and measures, an EP, eligible hospital, or CAH must use the capabilities and standards of as defined for as defined CEHRT at § 495.4. We direct readers to section II.B.3 of this final rule with comment period for a discussion of the definition of CEHRT and a table referencing the capabilities and standards that must be used for each measure.
Clinical decision support at the relevant point of care is an area of HIT in which significant evidence exists for substantial positive impact on the quality, safety, and efficiency of care delivery. For Stage 3 of the EHR Incentive Programs, we proposed to maintain the Stage 2 objective with slight modifications and further explanation of the relevant point of care, the types of CDS allowed, and the selection of a CDS applicable to a provider's scope of practice and patient population.
First, we offered further explanation of the concept of the relevant point of care and note that providers should implement the CDS intervention at a relevant point in clinical workflows when the intervention can influence clinical decision making before diagnostic or treatment action is taken in response to the intervention. Second, many providers may associate CDS with pop-up alerts. However, these alerts are not the only method of providing CDS. CDS should not be viewed as simply an interruptive alert, notification, or explicit care suggestion. Well-designed CDS encompasses a variety of workflow-optimized information tools, which can be presented to providers, clinical and support staff, patients, and other caregivers at various points in time. These may include but are not limited to: computerized alerts and reminders for providers and patients; information displays or links; context-aware knowledge retrieval specifications which provide a standard mechanism to incorporate information from online resources (commonly referred to as InfoButtons); clinical guidelines; condition-specific order sets; focused patient data reports and summaries; documentation templates; diagnostic support; and contextually relevant reference information. These functionalities may be deployed on a variety of platforms (that is, mobile, cloud-based, installed).
We proposed to retain both measures of the Stage 2 objective for Stage 3 and that these additional options stated previously on the actions, functions, and interventions may constitute CDS for purposes of the EHR Incentive Programs and would meet the measure requirements outlined in the proposed measures.
Exclusion: For the second measure, any EP who writes fewer than 100 medication orders during the EHR reporting period.
Where possible, we recommend providers implement CDS interventions that relate to care quality improvement goals and a related outcome measure CQM. However, for specialty hospitals and certain EPs, if there are no CQMs that are outcome measures related to their scope of practice, the provider should implement a CDS intervention related to a CQM process measure; or if none of the available CQMs apply, the provider should apply an intervention that he or she believes will be effective in improving the quality, safety, or efficiency of patient care.
Other commenters requested clarification of the types of resources that will count towards meeting the requirements of the EHR Incentive Programs related to CDS. Specifically, commenters asked about the InfoButton standard, and the requirement that RCERHT enable users to review the attributes of CDS resources.
We proposed to embrace a broad definition of CDS, including (but not limited to) resources such as: Computerized alerts and reminders for providers and patients, clinical guidelines, condition-specific order sets, documentation templates, focused patient data reports and summaries, and contextually relevant reference information. We posted a tip sheet and guidance on the CMS Web site,
The InfoButton standard can be used to provide hyperlinks to information, such as clinical guidelines or patient data summaries, at the relevant point in the care continuum and therefore represents one type of CDS that EPs, eligible hospitals, and CAHs may use to meet the EHR Incentive Programs CDS requirements. There are also likely to be cases where it makes sense for a CDS resource to display certain attributes at the time of presentation, or for a resource to include an InfoButton linking to additional information with CDS attributes. The potential workflows and implementations of these resources within a CDS is varied and should be tailored to best meet the provider's needs. However, please note that in this example, the use of the InfoButton would not count as a separate or additional CDS intervention, but rather would be a supporting part of the one CDS of which it is a part.
Many commenters requested clarification of “high-priority health conditions.” A commenter suggested that “high-priority health conditions” be replaced with “conditions relevant to the EP's scope of practice”. Another suggested that the CDS be related to 4 or more CQMS
Providers who are not able to identify CQMs that apply to their scope of practice or patient population may implement CDS interventions that they believe are related to high-priority health conditions relevant to their patient population and will be effective in improving the quality, safety or efficiency of patient care. These high priority conditions must be determined prior to the start of the EHR reporting period in order to implement the appropriate CDS to allow for improved performance. We proposed to require a minimum number of CDS interventions, and providers must determine whether a greater number of CDS interventions are appropriate for their patient populations.
Several commenters requested clarification in the area of audit readiness and guidance related to expectations for the use of specific CDS at the individual level. They requested that we to consider identifying this objective as an organizational or group objective rather than a specific eligible professional objective and allow the organization's efforts to meet the requirements for each provider practicing in that organization.
However, a commenter recommended that we allow exclusions from the drug-drug and drug-allergy interaction checks if the EP is a low-volume prescriber.
After consideration of the public comments received, we are finalizing the objective, measures and exclusion as proposed for EPs, eligible hospitals and CAHs as follows:
We are adopting Objective 3:Clinical Decision Support at § 495.24(d)(3)(i) for EPs and § 495.24(d)(3)(ii) for eligible hospitals and CAHs. We further specify that in order to meet this objective and measures, an EP, eligible hospital, or CAH must use the capabilities and standards of as defined for as defined CEHRT at § 495.4. We direct readers to section II.B.3 of this final rule with comment period for a discussion of the definition of CEHRT and a table referencing the capabilities and standards that must be used for each measure.
In the Stage 2 final rule, we expanded the use of computerized provider order entry (CPOE) from the Stage 1 objective requiring only medication orders to be entered using CPOE to include laboratory orders and radiology orders. For a full discussion of this expansion, we direct readers to (77 FR 53985 through 53989). We maintain CPOE continues to represent an opportunity for providers to leverage technology to capture these orders to reduce error and maximize efficiencies within their practice, therefore we proposed to maintain the use of CPOE for these orders as an objective of meaningful use for Stage 3.
We proposed to continue our policy from the Stage 2 final rule that the orders to be included in this objective are medication, laboratory, and radiology orders. However, we proposed to expand the third measure of the objective to include diagnostic imaging. This change was intended to address the needs of specialists and allow for a wider variety of clinical orders relevant to particular specialists to be included for purposes of measurement.
For Stage 3, we proposed to continue our policy from the Stage 2 final rule that the orders to be included in this objective are medication, laboratory, and radiology orders as such orders are commonly included in CPOE implementation and offer opportunity to maximize efficiencies for providers. However, for Stage 3, we proposed to expand the objective to include diagnostic imaging, which is a broader category including other imaging tests such as ultrasound, magnetic resonance, and computed tomography in addition to traditional radiology. This change addressed the needs of specialists and allowed for a wider variety of clinical orders relevant to particular specialists to be included for purposes of measurement.
We further proposed to continue the policy from the Stage 2 final rule at 77 FR 53986 that orders entered by any licensed healthcare professional or credentialed medical assistant would count toward this objective. A credentialed medical assistant may enter orders if they are credentialed to perform the duties of a medical assistant by a credentialing body other than the employer. If a staff member of the eligible provider is appropriately credentialed and performs assistive services similar to a medical assistant, but carries a more specific title due to either specialization of their duties or to the specialty of the medical professional they assist, orders entered by that staff member would be included in this objective. We further noted that medical staff whose organizational or job title, or the title of their credential, is other than medical assistant may enter orders if these staff are credentialed to perform the equivalent duties of a credentialed medical assistant by a credentialing body other than their employer and perform such duties as part of their organizational or job title. We deferred to the provider's discretion to determine the appropriateness of the credentialing of staff to ensure that any staff entering orders have the clinical training and knowledge required to enter orders for CPOE. This determination must be made by the EP or representative of the eligible hospital or CAH based on—
• Organizational workflows;
• Appropriate credentialing of the staff member by an organization other than the employing organization;
• Analysis of duties performed by the staff member in question; and
• Compliance with all applicable federal, state, and local laws and professional guidelines.
However, as stated in the Stage 2 final rule at 77 FR 53986, it is apparent that the prevalent time when CDS interventions are presented is when the order is entered into CEHRT, and that not all EHRs also present CDS when the order is authorized (assuming such a multiple step ordering process is in place). This means that the person entering the order would be required to enter the order correctly, evaluate a CDS intervention either using their own judgment or through accurate relay of the information to the ordering provider, and then either make a change to the order based on the information provided by the CDS intervention or bypass the intervention. The execution of this role represents a significant impact on patient safety; therefore, we continued to maintain for Stage 3 that a layperson is not qualified to perform these tasks. We believe that the order must be entered by a qualified individual. We further proposed that if the individual entering the orders is not the licensed healthcare professional, the order must be entered with the direct supervision or active engagement of a licensed healthcare professional.
We proposed to maintain for Stage 3 our existing policy for Stages 1 and 2 that the CPOE function should be used the first time the order becomes part of the patient's medical record and before any action can be taken on the order. The numerator of this objective also includes orders entered using CPOE initially when the patient record became part of the CEHRT, but does not include paper orders entered initially into the patient record or orders entered into technology not compliant with the CEHRT definition and then transferred into the CEHRT at a later time.
In addition, we proposed to maintain for Stage 3 that “protocol” or “standing” orders may but are not required to be excluded from this objective.
We proposed to maintain the Stage 2 description of “laboratory services” as any service provided by a laboratory that could not be provided by a non-laboratory for the CPOE objective for Stage 3 (77 FR 53984). We also proposed to maintain for Stage 3 the Stage 2 description of “radiologic services” as any imaging service that uses electronic product radiation (77 FR 53986). Even though we proposed to expand the CPOE objective from radiology orders to all diagnostic imaging orders, this description would still apply for radiology services within the expanded objective.
We received public comment on our proposals and our response follows.
However, the descriptive phrase “direct supervision or active engagement” was not meant to capture a hierarchical organizational or contractual arrangement, but rather to signify that any required assistance and direction to assess and act upon a CDS and ensure the order is accurately entered should be provided in real time.
We note that a simple search online returns dozens of medical assistant training and credentialing programs as well as local industry associations for Medical Assistants offering resources on training in the Commonwealth of Massachusetts. We note that any such program which met a provider's requirements for their practice would also be an example of an acceptable credentialing for the purposes of this objective.
We disagree that the training on the use of CEHRT is adequate for the purposes of entering an order under CPOE and executing any relevant action related to a CDS. We believe CPOE and CDS duties should be considered clinical in nature, not clerical. Therefore, CPOE and CDS duties, as noted, should be viewed in the same category as any other clinical task, which may only be performed by a qualified medical or clinical staff.
We proposed to continue a separate percentage threshold for all three types of orders: Medication, laboratory, and diagnostic imaging. We continue to believe that an aggregate denominator cannot best capture differentiated performance on the individual order types within the objective, and therefore maintain a separate denominator for each order type. We proposed to retain exclusionary criteria from Stage 2 for those EPs who so infrequently issue an order type specified by the measures (write fewer than 100 of the type of order), that it is not practical to implement CPOE for that order type.
We proposed to retain exclusionary criteria from Stage 2 for those EPs who so infrequently issue an order type specified by the measures (write fewer than 100 of the type of order), that it is not practical to implement CPOE for that order type.
Finally, we sought public comment on whether to continue to allow, but not require, providers to limit the measure of this objective to those patients whose records are maintained using CEHRT.
After consideration of public comments received, we maintain the distinction between measures that include only those patients whose records are maintained using CEHRT
We further sought public comment on if there are circumstances which might warrant an additional exclusion for an EP, such as a situation representing a barrier to successfully implementing the technology required to meet the objective. We also sought comment on if there are circumstances where an eligible hospital or CAH, which focuses on a particular patient population or specialty, may have an EHR reporting period where the calculation results in a zero denominator for one of the measures, how often such circumstances might occur, and whether an exclusion would be appropriate.
Many commenters noted that the change from radiology orders to diagnostic imaging orders increases relevance for specialty hospitals. A few commenters requested clarification around the inclusion of diagnostic imaging and how this is different from Stage 2.
Some commenters stated that the increase in thresholds, especially for laboratory and radiology orders, were appropriate and they would be able to meet them. Some commenters supported the increased thresholds noting that our inclusion of this objective provided additional pressure on their organization to work toward a higher goal and maximize the potential benefits CPOE offers. However, some commenters noted that the 80 percent threshold could present a problem for providers who are transitioning between certified EHR technologies within a reporting period. These commenters noted that for CPOE medication orders, and the related CDS interventions for drug-drug and medication-allergies, it is extremely important to allow adequate time for product and process implementation to ensure patient safety and minimize the risk of serious adverse events.
We appreciate the support for the inclusion of diagnostic imaging for measure 3. We proposed the expansion for diagnostic imaging to include other imaging tests such as ultrasound, magnetic resonance, and computed tomography in addition to traditional radiology orders which were the limit of the scope of the Stage 2 objective at 80 FR 16750. We believe this change addresses the needs of specialists and allows for a wider variety of clinical orders relevant to particular specialists to be included for purposes of measurement, benchmarking, and process improvement initiatives within healthcare organizations.
Finally, we thank those commenters who supported the increased thresholds for Stage 3. We have reconsidered the increase for the medication orders measure and are in agreement with commenters who suggested this potential measure should not be raised to this level in order to avoid inadvertently encouraging rushed implementation if a provider is switching between products or implementing an upgrade to the technology. As we explained in our discussion regarding the threshold of the Electronic Prescribing Objective for Stage 3, we believe the appropriate management of medications can be critical for both acute and chronic patient care, and therefore the risk associated with CPOE for medication orders during transitions may be significant. Therefore we will maintain the Stage 2 threshold for that measure only which also aligns the three measures at the same level.
After consideration of the public comments received, at we are finalizing the objective and the measures for CPOE for laboratory orders and CPOE for diagnostic imaging orders and the exclusions for all measures as proposed. We are finalizing the measure for CPOE for medication orders with a modified threshold. We are adopting the objective for EPs, eligible hospitals and CAHs as follows:
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We are adopting Objective 4: Computerized Provider Order Entry at § 495.24(d)(4)(i) for EPs and § 495.24(d)(4)(ii) for eligible hospitals and CAHs. We further specify that in order to meet this objective and measures, an EP, eligible hospital, or CAH must use the capabilities and standards of as defined for as defined CEHRT at § 495.4. We direct readers to section II.B.3 of this final rule with comment period for a discussion of the definition of CEHRT and a table referencing the capabilities and standards that must be used for each measure.
In the Stage 3 proposed rule (80 FR 16752), we identified two related policy goals within the overall larger goal of improved patient access to health information and patient-centered communication. The first is to ensure patients have timely access to their full health record and related important health information; and that the second is to engage in patient-centered communication for care planning and care coordination. While these two goals are intricately linked, we noted that we see them as two distinct priorities requiring different foci and measures of success. For the first goal, we proposed to incorporate the Stage 2 objectives related to providing patients with access to health information, including the objective for providing access for patients (or their authorized representatives) to view online, download, and transmit their health information and the objective for patient-specific education resources, into a new Stage 3 objective entitled, “Patient Electronic Access” (Objective 5), focused on using CEHRT to support increasing patient access to important health information. For the second goal, we proposed an objective entitled Coordination of Care through Patient Engagement (Objective 6) incorporating the policy goals of the Stage 2 objectives related to secure messaging, patient reminders, and the ability for patients (or their authorized representatives) to view online, download, and transmit their health information using the functionality of the CEHRT.
In the Stage 3 Patient Electronic Access Objective, we proposed to incorporate certain measures and objectives from Stage 2 into a single objective focused on providing patients with timely access to information related to their care. We also proposed to no longer require or allow paper-based methods to be included in the measures (80 FR 16753) and to expand the options through which providers may engage with patients under the EHR Incentive Programs. Specifically, we proposed an additional functionality, known as application programming interfaces (APIs), which would allow providers to enable new functionalities to support data access and patient exchange.
We sought comment on what additional requirements might be needed to ensure that for the API— (1) the functionality supports a patient's right to have his or her protected health information sent directly to a third party designated by the patient; and (2) patients have at least the same access to and use of their health information that they have under the view, download, and transmit option.
We continue to believe that patient access to their electronic health information, and to important information about their care, is a high priority for the EHR Incentive Programs.
We noted that for this objective, the provider is only required to provide access to the information through these means; the patient is not required to take action in order for the provider to meet this objective. We also stated that to “provide access” means that the patient has all the tools and information they need to gain access to their health information including, but not limited to, any necessary instructions, user identification information, or the steps required to access their information if they have previously elected to “opt-out” of electronic access. If this information is provided to the patient in a clear and actionable manner, the provider may count the patient for this objective. We further stated that providers may withhold from online disclosure any information either prohibited by federal, state, or local laws or if such information provided through online means may result in significant harm.
Further, we noted that this objective is a requirement for meaningful use and it does not affect an individual's right under HIPAA to access his or her health information. Providers must continue to comply with all applicable requirements under the HIPAA Privacy Rule, including the access provisions of 45 CFR 164.524.
We received the following comments and our response follows:
First, we do not consider the API to be a “second” patient portal and that the current trend to use a patient portal to meet the view, download and transmit functions, while prevalent and acceptable, is not the only way a provider might meet the current objective. We recognize the value in these systems and support the implementation of patient portals to allow patients to engage with their health care providers for both clinical and administrative information.
However, at a basic level, the EHR Incentive Program currently requires only that providers give their patients access to their health information to be able to do three activities: View their information, download their information, and transmit their information. This is a nuanced but important distinction between the existing Stage 2 requirement and the current systems, which are used to meet it. This distinction is important, as not only do we not require a “patient portal” format for VDT, we also do not advocate such a limit on innovation in software or systems designed to allow patients to access and engage with their health information. We believe that the efficacy of the health IT environment now and the potential for future innovation, relies on the establishment of clear standards and functionality requirements paired with the flexibility to develop differentiated technical specifications, functions, and user interface design that meet those requirements.
This proposed Stage 3 objective for Patient Electronic Access is not a “patient portal” versus “API” requirement or a requirement to support two patient portals. Instead, this proposed objective is supporting four basic actions that a patient should be able to take:
• View their health information;
• Download their health information;
• Transmit their health information to a third party; and
• Access their health information through an API.
We also believe that these actions may be supported by a wide range of system solutions, which may overlap in terms of the software function used to do an action or multiple actions. This intent to allow for innovation and change within the scope of health IT development is part of a broader goal to lay the foundation for health care systems to support the patient and provider.
An API is a set of programming protocols established for multiple purposes. APIs may be enabled by a provider or provider organization to provide the patient with access to their health information through a third-party application with more flexibility than is often found in many current “patient portals.”
From the provider perspective, an API could complement a specific provider “branded” patient portal or could also potentially make one unnecessary if patients were able to use software applications designed to interact with an API that could support their ability to view, download, and transmit their health information to a third party.
From the patient perspective, an API enabled by a provider will empower the patient to receive information from their provider in the manner that is most valuable to the patient. Patients could collect their health information from multiple providers and potentially incorporate all of their health information into a single portal, application, program, or other software. Such a solution may be offered on a state, local, or regional basis, for instance, through a health information exchange, or through another commercial vendor. In addition, we recognize that a large number of patients consult with and rely on trusted family members and other caregivers to help coordinate care, understand health information, and make decisions. For this reason, we proposed the inclusion of patient-authorized representatives within the measures.
Additionally, similar to how providers support patient access to VDT capabilities, we expect that providers will continue to have identity verification processes to ensure that a patient using an application, which is leveraging the API, is provided access to their health information.
We proposed for the Patient Electronic Access objective to allow providers to enable API functionality in accordance with the proposed ONC requirements in the 2015 Edition proposed rule. The certification criteria proposed by ONC would establish API criteria, which would allow patients, through an application of their choice (including third-party applications), to pull certain components of their unique health data directly from the provider's CEHRT. This could also potentially allow a patient to pull such information from multiple providers engaged in their care. For further discussion on the technical requirements for APIs, we direct readers to the 2015 Edition proposed rule (80 FR 16840 through 16850).
Several comments also included concerns about patients not using or accessing patient portals, which make it difficult for providers and hospitals to meet patient electronic access requirements. Eligible providers and hospitals do not want to be penalized if patients choose not to use the patient portal or send them secure messages. A commenter recommended that compliance with access occur when the patient has been given documentation on how to sign up for the patient portal, and that a patient's decision to opt-out be counted as compliance. The same commenter also recommended that the denominator for compliance with the portal usage measure be counted as the total number of patients in the portal, not the total number of qualified patients discharged in that period.
Many commenters supported the inclusion of patient-authorized representatives within this objective noting that this change is essential for patient care and provides greater flexibility for providers. These commenters noted specific patient populations, such as disabled persons, elderly patients, and newborn patients or young children where the more comprehensive inclusion of non-physician caregivers, family members, and other patient-authorized representatives within the measure more accurately captures the inclusiveness of these interactions and the role that health IT can provide in supporting communications with patients and their caregivers.
We believe that the overall focus of this objective on the provision of access allows providers the flexibility to work with patients with a wide range of backgrounds and IT adoption. We further believe that it prevents any negative unintended consequences of assumptions which may be placed on patients to use or not use various technologies. We believe that no patient should be excluded from access to their health care information for any reason, especially reasons which would allow for a blanket exclusion of any patient based on a demographic factor. We note that we proposed to maintain our current policy, which applies to the Stage 2 Patient Electronic Access Objective, which requires that access be provided, even for those who choose to opt-out via providing them the information and resources they would need to opt back in. We further thank those commenters for their support of the expansion of the concept of access for patient-authorized representatives and note that this inclusion is designed to recognize the existing relationships and expand the access to information for family members and other caregivers who may serve as patient-authorized representatives. Patient-authorized representatives encompass both “personal representatives” as defined by HIPAA, as well as those authorized or designated by an individual.
(1) The patient (or patient-authorized representative) is provided access to view online, download, and transmit their health information within 24 hours of its availability to the provider; or
(2) The patient (or patient-authorized representative) is provided access to an ONC-certified API that can be used by third-party applications or devices to provide patients (or patient-authorized representatives) access to their health information, within 24 hours of its availability to the provider.
We proposed that for measure 1, the patient must be able to access this information on demand, such as through a patient portal, personal health record (PHR), or API and have everything necessary to access the information even if they opt out. We proposed that all three functionalities (view, download, and transmit) or an API must be present and accessible to meet the measure. We further proposed that the functionality must support a patient's right to have his or her protected health information sent directly to a third party designated by the patient consistent with the provision of access requirements at 45 CFR
Any EP that conducts 50 percent or more of his or her patient encounters in a county that does not have 50 percent or more of its housing units with 4Mbps broadband availability according to the latest information available from the FCC on the first day of the EHR reporting period may exclude the measure.
Any eligible hospital or CAH will be excluded from the measure if it is located in a county that does not have 50 percent or more of their housing units with 4Mbps broadband availability according to the latest information available from the FCC at the start of the EHR reporting period.
Any EP that conducts 50 percent or more of his or her patient encounters in a county that does not have 50 percent or more of its housing units with 4Mbps broadband availability according to the latest information available from the FCC on the first day of the EHR reporting period may exclude the measure.
Any eligible hospital or CAH will be excluded from the measure if it is located in a county that does not have 50 percent or more of their housing units with 4Mbps broadband availability according to the latest information available from the FCC at the start of the EHR reporting period.
We proposed that both measures for this objective must be met using CEHRT.
Further, we encourage health IT system developers to leverage the existing API platforms and applications as this would allow developers to immediately begin offering providers no-cost, or low-cost solutions to implement and enable an API as part of their current systems even prior to the implementation of Stage 3 in 2018.
In terms of cost, as we have stated in the past with the view, download, and transmit functions, we do not believe it would be appropriate for EPs and hospitals or CAHs to charge patients a fee for accessing their information using an API or VDT. We believe the economies of scale provided by enabling an API render the cost of use by an individual patient minimal and we do not believe that providing free access to patients represents a burden to the provider.
However, we recognize that the potential usage of APIs extends beyond
We are therefore finalizing Measure 2 as proposed for the method of delivery and with a modification to specify that for the numerator of for measure 2 for each year, the action must occur within the same calendar year as the EHR reporting period, but may occur before, during, or after the EHR reporting period if the EHR reporting period for the provider is less than a full calendar year. We note that the action must occur prior to the provider submitting their attestation if they attest prior to the end of the calendar year. For measure 1, we refer readers to the discussion on the Alternate Proposals for the measure immediately following.
Alternate Proposals:
For measure 1, we sought comment on the following set of alternate proposals for providers to meet the measure using the functions of CEHRT outlined previously in this section. These alternate proposals involve the requirements to use a view, download, and transmit function or an API to provide patients access to their health information. Measure 1 as proposed would allow providers the option either to give patients access to the view, download, and transmit functionality, or to give patients access to an API. Specifically, we sought comment on whether the API option should be required rather than optional for providers, and if so, should providers also be required to offer the view, download, and transmit function.
(1) The patient (or patient-authorized representative) is provided access to view online, download, and transmit their health information within 24 hours of its availability to the provider; or
(2) The patient (or the patient-authorized representative) is provided access to an ONC-certified API that can be used by third-party applications or devices to provide patients (or patient-authorized representatives) access to their health information, within 24 hours of its availability to the provider.
(1) The patient (or the patient-authorized representative) is provided access to view online, download, and transmit his or her health information within 24 hours of its availability to the provider; and
(2) The patient (or patient-authorized representatives) is provided access to an ONC-certified API that can be used by third-party applications or devices to provide patients (or patient-authorized representatives) access to their health information within 24 hours of its availability to the provider.
(1) The patient (or patient-authorized representative) is provided access to view online, download, and transmit their health information within 24 hours of its availability to the provider; and the patient (or patient-authorized representative) is provided access to an ONC-certified API that can be used by third-party applications or devices to provide patients (or patient-authorized representatives) access to their health information within 24 hours of its availability to the provider; or,
(2) The patient (or patient-authorized representatives) is provided access to an ONC-certified API that can be used by third-party applications or devices to provide patients (or patient-authorized representatives) access to their health information within 24 hours of its availability to the provider.
We welcomed public comment on these proposals. We received the following comments and our response follows:
After consideration of public comments received, we are finalizing the objective with a modification based on the change to the 24 hour requirement proposed as well as to better represent the functions of CEHRT use. For Measure 1 we are finalizing Alternate A which includes the requirement that providers offer all four functionalities (view, download, transmit, and access through API) to their patients. We further specify that any patient health information must be made available to the patient within 48 hours of its availability to the provider for an EP and 36 hours of its availability to the provider for an eligible hospital or CAH. For measure two, we are finalizing measure a modification to the numerator to specify the timing of the action in relation to the EHR reporting period.
(1) The patient (or the patient-authorized representative) is provided timely access to view online, download, and transmit his or her health information; and
(2) The provider ensures the patient's health information is available for the patient (or patient-authorized representative) to access using any application of their choice that is configured to meet the technical specifications of the API in the provider's CEHRT.
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• An EP may exclude from the measure if they have no office visits during the EHR reporting period.
• Any EP that conducts 50 percent or more of his or her patient encounters in a county that does not have 50 percent or more of its housing units with 4Mbps broadband availability according to the latest information available from the FCC on the first day of the EHR reporting period may exclude the measure.
• Any eligible hospital or CAH will be excluded from the measure if it is located in a county that does not have 50 percent or more of their housing units with 4Mbps broadband availability according to the latest information available from the FCC at the start of the EHR reporting period.
We are adopting Objective 5: Patient Electronic Access at § 495.24(d)(5)(i) for EPs and § 495.24(d)(5)(ii) for eligible hospitals and CAHs. We further specify that in order to meet this objective and measures, an EP, eligible hospital, or CAH must use the capabilities and standards of as defined for as defined CEHRT at § 495.4. We direct readers to section II.B.3 of this final rule with comment period for a discussion of the definition of CEHRT and a table referencing the capabilities and standards that must be used for each measure.
For Stage 3, as previously noted, we proposed to incorporate the Stage 2
The Stage 3 proposed rule focused on encouraging the use of EHR functionality for secure dialogue and efficient communication between providers, care team members, and patients about their care and health status, as well as important health information such as preventative and coordinated care planning. Similar to the Patient Electronic Access Objective, we also proposed to expand the options through which providers may engage with patients under the Medicare and Medicaid EHR Incentive Programs including the use of APIs. An API can enable a patient—through a third-party application—to access and retrieve their health information from a care provider in a way that is most valuable to that patient. We proposed the Coordination of Care through Patient Engagement Objective for Stage 3 to support this provider and patient engagement continuum based on the foundation already created within the EHR Incentive Programs but using new methods and expanded options to advance meaningful patient engagement and patient-centered care. We also proposed that for purposes of this objective, patient engagement may include patient-centered communication between and among providers facilitated by authorized representatives of the patient and of the EP, eligible hospital, or CAH.
We proposed three measures for this objective, which are discussed below. We proposed that providers must attest to the numerator and denominator for all three measures, but would only be required to successfully meet the threshold for two of the three proposed measures to meet the Coordination of Care through Patient Engagement Objective.
(1) More than 25 percent of all unique patients (or patient-authorized representatives) seen by the EP or discharged from the eligible hospital or CAH inpatient or emergency department (POS 21 or 23) during the EHR reporting period view, download or transmit to a third party their health information; or
(2) More than 25 percent of all unique patients (or patient-authorized representatives) seen by the EP or discharged from the eligible hospital or CAH inpatient or emergency department (POS 21 or 23) during the EHR reporting period access their health information through the use of an ONC-certified API that can be used by third-party applications or devices.
• Any EP who has no office visits during the EHR reporting period may exclude from the measure.
• Any EP that conducts 50 percent or more of his or her patient encounters in a county that does not have 50 percent or more of its housing units with 4Mbps broadband availability according to the latest information available from the FCC
• Any eligible hospital or CAH operating in a location that does not have 50 percent or more of its housing units with 4Mbps broadband availability according to the latest information available from the FCC on the first day of the EHR reporting period may exclude from the measure.
For measure 1, for the API option, we proposed that providers must attest that they have enabled an ONC-certified API and that at least one application, which leverages the API, is available to patients (or the patient-authorized representatives) to retrieve health information from the provider's CEHRT. We also stated that we recognize that there may be inherent challenges in measuring patient access to CEHRT through third-party applications that utilize an ONC-certified API, and we solicited comment on the nature of those challenges and what solutions can be put in place to overcome them. We also solicited comment on suggested alternate proposals for measuring patient access to CEHRT through third-party applications that utilize an API, including the pros and cons of measuring a minimum number of patients (one or more) who must access their health information through the use of an API in order to meet the measure of this objective.
1. View their information.
2. Download their information.
3. Transmit their information to a third party.
4. Access their information through an API.
We further agree that these actions may overlap and that a provider should be able to count any and all actions in the single numerator. Therefore, we believe it is a reasonable modification to change the first measure to state that a provider may meet a combined threshold of for VDT and API actions or if their technology functions overlap then any and view, download, transmit, or API actions taken by the patient using CEHRT would count toward the threshold.
We do agree that the threshold should represent a goal, but that we should seek to set a goal that will be attainable for providers who make the effort to achieve this measure. As noted in section II.B.1.b.(4)(b)(iv) of this final rule with comment period, we adopted a phased approach for the two measures related to patient action for reporting in 2015 through 2017 (Objective 8—Patient Electronic Access measure 2 and the Objective 9—Secure Electronic Messaging.) This phased approach includes a 5 percent threshold in 2017, and we believe it is appropriate to adopt a 5 percent threshold for measures 1 of this objective also (Objective 6—Coordination of Care through Patient Engagement) for an EHR reporting period in 2017. We believe that the primary barrier to performance on the measure is the lag in the adoption of technology by patients as well as the influence of self-selective participation. We further believe that these influences can be mitigated by providing additional time for the technologies to mature as noted in our rationale for adoption of the phased approach. Therefore, it is appropriate for the 5 percent threshold in 2017 to apply for all applicable measures based on the timeline established.
We believe that 10 percent is a reasonable threshold for providers participating in 2018 as compared to the proposed 25 percent threshold, and should be attainable by providers. In addition, we will continue to monitor performance on the measure to determine if any further adjustment is needed prior to 2018 and to potentially set another incremental increase toward the proposed 25 percent threshold in a subsequent year.
Any EP that conducts 50 percent or more of his or her patient encounters in a county that does not have 50 percent or more of its housing units with 4Mbps broadband availability according to the latest information available from the FCC on the first day of the EHR reporting period may exclude from the measure.
Any eligible hospital or CAH operating in a location that does not have 50 percent or more of its housing units with 4Mbps broadband availability according to the latest information available from the FCC on the first day of the EHR reporting period may exclude from the measure.
For measure 2, we proposed that “communicate” means when a provider sends a message to a patient (or the patient's authorized representatives) or when a patient (or the patient's authorized representatives) sends a message to the provider. In patient-to-provider communication, the provider must respond to the patient (or the patient's authorized representatives) for purposes of this measure. We further proposed to include in the measure numerator situations where providers communicate with other care team members using the secure messaging function of CEHRT, and the patient is engaged in the message and has the ability to be an active participant in the conversation between care providers. However, we sought comment on how this action could be counted in the numerator, and the extent to which that interaction could or should be counted for eligible providers engaged in the communication. In addition, we sought comment on what should be considered a contribution to the patient-centered communication; for example, a contribution must be active participation or response, a contribution may be viewing the communication, or a contribution may be simple inclusion in the communication.
We specified that the secure messages sent should contain relevant health information specific to the patient in order to meet the measure of this objective. We believe the provider is the best judge of what health information should be considered relevant in this context. We noted that messages with content exclusively relating to billing questions, appointment scheduling, or other administrative subjects should not be included in the numerator. For care team secure messaging with the patient included in the conversation, we also believe the provider may exercise discretion if further communications resulting from the initial action should be excluded from patient disclosure to prevent harm. We noted that if such a message is excluded, all subsequent actions related to that message would not count toward the numerator.
Specifically, commenters also supported the ability for providers to select to focus on this measure rather than on measure 1 as for some specialists, the ability to quickly and effectively communicate with a patient and other care team members is paramount. These commenters noted that for their patients, the information they provide through VDT is often duplicative of that provided by the patient's primary care provider. However, they note they often receive request for clarification around specific results or recommendations so the ability to provide that support through secure messaging with the patient and other care team members is a significant benefit.
Some commenters opposed the measure in general, again highlighting that providers should not be held accountable for patient action. Still others disagreed with the requirement that a provider must respond to a patient-initiated communication in order for such an action to count in the numerator.
Again, commenters both opposed to and in support of the measure suggested a lower threshold to ensure the measure is attainable for providers who make the effort to engage in this action. Finally, some commenters requested clarity about what the content of the message needs to be to count toward the numerator.
We disagree that this proposed measure holds providers accountable for patient action, as the Stage 3 proposed measure specifically puts the control over communications in the hands of the provider. For this measure, we proposed to include provider-initiated communications, provider-to-provider communications if the patient is included, and allows the provider to count any patient-initiated communication if the provider responds to the patient (80 FR 16757). We disagree that the provider should not be required to respond to the patient in order to meet the measure, the goal of the measure is to promote provider-patient communication where the action driving the communication rests with provider initiated communication. We note that this does not require the provider to respond to every message received if no response is necessary. In addition, the denominator is not based on the number of messages received from the patient nor are patient-initiated messages required to meet the measure. Therefore we believe that it is reasonable to only allow providers to count messages in the numerator when the provider participates in the communication, in this case by responding to the patient.
Again, we do agree that the threshold should represent a goal, but that we should seek to set a goal that will be attainable for providers who make the effort to achieve this measure. As discussed for Measure 1, we adopted a phased approach for the two measures related to patient action for reporting in 2015 through 2017 (Objective 8—Patient Electronic Access measure 2 and the Objective 9—Secure Electronic Messaging.) This phased approach includes a 5 percent threshold in 2017 and we believe it is appropriate to adopt a 5 percent threshold for measures 2 of this objective (Stage 3 Objective 6—Coordination of Care through Patient Engagement) for an EHR reporting period in 2017. In this case, it is not the barrier of patient action which is a potential risk factor, as the measure itself has been changed, but instead the adoption of new CEHRT and implementing the related workflows which would be required for providers participating in Stage 3 in 2017. We also believe a 25 percent threshold would be an attainable goal for providers in 2018 because the measure focuses on provider-initiated action and offers multiple paths for success; while the reduction from 35 percent reduces the risk of failure for those providers who may require additional time to implement the functions and workflows within their practice. As stated in the Stage 3 proposed rule (80 FR 16757), the types of communications which cannot count toward the measure are communications dealing exclusively with billing, appointment scheduling, or other administrative processes.
Any EP that conducts 50 percent or more of his or her patient encounters in a county that does not have 50 percent or more of its housing units with 4Mbps broadband availability according to the latest information available from the FCC on the first day of the EHR reporting period may exclude from the measure.
Any eligible hospital or CAH operating in a location that does not have 50 percent or more of its housing units with 4Mbps broadband availability according to the latest information available from the FCC on the first day of the EHR reporting period may exclude from the measure.
For measure 3, we noted that the use of the term “clinical” means different things in relation to place of service for billing for Medicare and Medicaid services. However, for purposes of this measure only, we proposed that a non-clinical setting be defined as a setting with any provider who is not an EP, eligible hospital or CAH as defined for the Medicare and Medicaid EHR Incentive Programs and where the care provider does not have shared access to the EP, eligible hospital, or CAH's CEHRT. This may include, but is not limited to, health and care-related data from care providers such as nutritionists, physical therapists, occupational therapists, psychologists, and home health care providers, as well as data obtained from patients themselves. We specifically noted this last item and referred to this sub-category as patient-generated health data, which may result from patient self-monitoring of their health (such as recording vital signs, activity and exercise, medication intake, and nutrition), either on their own, or at the direction of a member of the care team.
We sought comment on how the information for measure 3 could be captured, standardized, and incorporated into an EHR. For the purposes of this measure, the types of data that would satisfy the measure is broad. It may include, but is not limited to, social service data, data generated by a patient or a patient's authorized representative, advance directives, medical device data, home health monitoring data, and fitness monitor data.
We also sought comment on whether this proposed measure should have a denominator limited to patients with whom the provider has multiple encounters, such as unique patients seen by the provider two or more times during the EHR reporting period. We also sought comment on whether this measure should be divided into two distinct measures—for example, (1) patient-generated health data, or data generated predominantly through patient self-monitoring rather than by a provider; and (2) all other data from a non-clinical setting. This would result in the objective including four measures, with providers having an option of which two measures to focus on for the EHR reporting period.
We also sought comment on whether the third measure should be proposed for eligible hospitals and CAHs, or remain an option only for eligible professionals. For those commenters who believe it should not be applicable for eligible hospitals and CAHs, we sought further comment on whether eligible hospitals and CAHs should then choose one of the remaining two measures or be required to attest to both. We received the following comments and our response follows:
A number of commenters opposed the measure, expressed concern over the efficacy of data originating from a source other than a clinician, stated that patient generated data is not relevant to their practice, or stated that all data is patient generated so the measure is useless.
Most commenters requested further information on what types of data would count toward the measure. Some commenters asked if provider questionnaires sent via secure message might count while others asked if patient self-assessment screenings done in the physician's office may count. Some commenters questioned whether a patient that provided information on family health history may count toward the measure if the information were provided outside an office visit via an electronic means. Finally, commenters requested an episodic designation for the measure to identify when the inclusion of such information must occur and if the inclusion must be repetitive for each EHR reporting period.
We also disagree with the suggestion that the data may be information the patient provides to the EP, eligible hospital or CAH on location during the office visit or hospital stay as such data does not meet the intent of the measure to support care coordination and patient engagement in a wide range of settings outside the provider's immediate scope of practice. However, we agree that if a patient separately provides clinical information including family health history and the information noted previously through other means, that such information may count toward the numerator if it is incorporated into the patient record using the adopted specifications for CEHRT for the measure.
With regard to the efficacy of the data, we do not specify the manner in which providers are required to incorporate the data. Providers may work with their EHR developers to establish the methods and processes which work best for their practice and needs. We note that in cases where the data provided can be easily incorporated in a structured format or into an existing field within the EHR (such as a C-CDA or care team member reported vital signs or patient reported family health history and demographic information) the provider may elect to do so. Alternately, a provider may maintain an isolation between the data and the patient record and instead include the data by other means such as attachments, links, and text references again as best meets their needs. We believe there may be a wide range of potential methods by which a provider may ensure the data is relevant for their needs and that provenance and purpose are identified.
Finally, we note that measure 3 includes longitudinal measurement within the EHR reporting period, rather than purely episodic measurement. This means that for more than 5 percent of unique patients during the EHR reporting period, this information must be included. If information is obtained and incorporated for a patient following their first visit during the EHR reporting period, the provider may count the patient in the numerator even if no further information is provided after a subsequent visit.
After consideration of public comments received, we are finalizing the objective with a modification to remove the reference to communications functions due to the adoption of the use of an API (which is broader than a communication function). We are finalizing the exclusions as proposed and the measures with the modifications for the threshold as previously discussed. We are finalizing that providers must attest to all three measures and must meet the thresholds for at least two measures to meet the objective. We are adopting finalizing the objective and measures as follows:
(1) View, download or transmit to a third party their health information; or
(2) access their health information through the use of an API that can be used by applications chosen by the patient and configured to the API in the provider's CEHRT; or
(3) a combination of (1) and (2).
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• An EP may exclude from the measure if they have no office visits during the EHR reporting period.
• Any EP that conducts 50 percent or more of his or her patient encounters in a county that does not have 50 percent or more of its housing units with 4Mbps broadband availability according to the latest information available from the FCC on the first day of the EHR reporting period may exclude the measure.
• Any eligible hospital or CAH will be excluded from the measure if it is located in a county that does not have 50 percent or more of their housing units with 4Mbps broadband availability according to the latest information available from the FCC at the start of the EHR reporting period.
We are adopting Objective 6: Coordination of Care Through Patient Engagement at § 495.24(d)(6)(i) for EPs and § 495.24(d)(6)(ii) for eligible hospitals and CAHs. We further specify that in order to meet this objective and measures, an EP, eligible hospital, or CAH must use the capabilities and standards of as defined for as defined CEHRT at § 495.4. We direct readers to section II.B.3 of this final rule with comment period for a discussion of the definition of CEHRT and a table referencing the capabilities and standards that must be used for each measure.
In the Stage 3 proposed rule 80 FR 16758, we stated that improved communication between providers caring for the same patient can help providers make more informed care decisions and coordinate the care they provide. Electronic health records and the electronic exchange of health information, either directly or through health information exchanges, can reduce the burden of such communication. We noted that the purpose of the proposed objective is to ensure a summary of care record is transmitted or captured electronically and incorporated into the EHR for patients seeking care among different providers in the care continuum, and to encourage reconciliation of health information for the patient. We further stated that the proposed objective promotes interoperable systems and supports the use of CEHRT to share information among care teams.
In the Stage 2 final rule at 77 FR 53983, we described transitions of care as the movement of a patient from one setting of care (hospital, ambulatory primary care practice, ambulatory specialty care practice, long-term care, home health, rehabilitation facility) to another. For additional information, see section II.B.1.b.(4).(f) of this final rule with comment period. Referrals are cases where one provider refers a patient to another provider, but the referring provider also continues to provide care to the patient. We also recognized there may be circumstances when a patient refers himself or herself to a setting of care without a provider's prior knowledge or intervention. These referrals may be included as a subset of the existing referral framework and they are an important part of the care coordination loop for which summary of care record exchange is integral. Therefore, a provider should include these instances in their denominator for the measures if the patient subsequently identifies the provider from whom they received care. In addition, the provider may count such a referral in the numerator for each measure if they undertake the action required to meet the measure upon disclosure and identification of the provider from whom the patient received care.
In the Stage 2 final rule, we indicated that a transition or referral within a single setting of care does not qualify as a transition of care (77 FR 53983). We received public comments and questions requesting clearer characterization of when a setting of care can be considered distinct from another setting of care. For example, questions arose whether EPs who work within the same provider practice are considered the same or two distinct settings of care. Similarly, questions arose whether an EP who practices in an outpatient setting that is affiliated with an inpatient facility is considered a separate entity. Therefore, in the Stage 3 proposed rule at 80 FR 16759 for the purposes of distinguishing settings of care in determining the movement of a patient, we explained that for a transition or referral, it must take place between providers which have, at minimum, different billing identities within the EHR Incentive Programs, such as different National Provider Identifiers (NPI) or hospital CMS Certification Numbers (CCN) to count toward this objective.
Please note that a “referral” as defined here only applies to the EHR Incentive Programs and is not applicable to other federal regulations.
We stated in the Stage 2 final rule at 77 FR 13723 that if the receiving provider has access to the medical record maintained by the provider initiating the transition or referral, then the summary of care record would not need to be provided and that patient may be excluded from the denominators of the measures for the objective. We further noted that this access may vary from read-only access of a specific record, to full access with authoring capabilities, depending on provider agreements and system implementation among practice settings. In many cases, a clinical care summary for transfers within organizations sharing access to an EHR may not be necessary, such as a hospital sharing their CEHRT with affiliated providers in ambulatory settings who have full access to the patient information. However, public comments received and questions submitted by the public on the Stage 2 Summary of Care Objective reveal that there may be benefits to the provision of a summary of care document following a transition or referral of a patient, even when access to medical records is already available. For example, a summary of care document would notify the receiving provider of relevant information about the latest patient encounter as well as highlight the most up-to-date information. In addition, the “push” of a summary of care document may function as an alert to the recipient provider of the transition that a patient has received care elsewhere and would encourage the provider to review a patient's medical record for follow-up care or reconciliation of clinical information.
Therefore, we proposed to revise this objective for Stage 3 to allow the inclusion of transitions of care and referrals in which the recipient provider may already have access to the medical record maintained in the referring provider's CEHRT, as long as the providers have different billing identities within the EHR Incentive Program. We noted that for a transition or referral to be included in the numerator, if the receiving provider already has access to the CEHRT of the initiating provider of the transition or referral, simply accessing the patient's health information does not count toward meeting this objective. However, if the initiating provider also creates and sends a summary of care document, this transition can be included in the denominator and the numerator, as long as this transition is counted consistently across the organization.
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For the first measure, we maintained the requirements established in the Stage 2 final rule to capture structured data within the certified EHR and to generate a summary of care document using CEHRT for purposes of this measure (77 FR 54014). For purposes of this measure, we required that the summary of care document created by CEHRT be sent electronically to the receiving provider.
In the Stage 2 final rule at 77 FR 54016, we specified all summary of care documents must include the following information in order to meet the objective, if the provider knows it:
• Patient name.
• Referring or transitioning provider's name and office contact information (EP only).
• Procedures.
• Encounter diagnosis.
• Immunizations.
• Laboratory test results.
• Vital signs (height, weight, blood pressure, BMI).
• Smoking status.
• Functional status, including activities of daily living, cognitive and disability status.
• Demographic information (preferred language, sex, race, ethnicity, date of birth).
• Care plan field, including goals and instructions.
• Care team including the primary care provider of record and any additional known care team members beyond the referring or transitioning provider and the receiving provider.
• Discharge instructions (Eligible hospitals and CAHs Only).
• Reason for referral (EP only).
For the 2015 Edition proposed rule, ONC proposed a set of criteria called the Common Clinical Data Set that include the required elements for the summary of care document, the standards required for structured data capture of each, and further definition of related terminology and use. Therefore, for Stage 3 of meaningful use we proposed that summary of care documents used to meet the Stage 3 Health Information Exchange objective must include the requirements and specifications included in the CCDS specified by ONC for certification to the 2015 Edition proposed rule.
In the Stage 3 proposed rule (80 FR 16760), we stated that the CCDS may include additional fields beyond those initially required for Stage 2 of meaningful use as new standards are developed to accurately capture vital information on patient health. For example, the 2015 Edition proposed rule includes a criterion and standard for capturing the unique device identifier (UDI) for implantable medical devices. As we noted in the Stage 3 proposed rule at 80 FR 16760, we believe the inclusion of the UDI in the CCDS reflects the understanding that UDIs are an important part of patient information that should be exchanged and available to providers who care for patients with implanted medical devices. The documentation of UDIs in a patient medical record and the inclusion of that data field within the CCDS requirements for the summary of care documents is a key step toward improving the quality of care and ensuring patient safety. This example highlights the importance of capturing health data in a structured format using specified, transferable standards. For further information on the CCDS standards, please see ONC's 2015 Edition final rule, published elsewhere in this issue of the
However, all summary of care documents used to meet this objective must be populated with the following information using the CCDS certification standards for those fields:
• Current problem list (Providers may also include historical problems at their discretion).
• Current medication list.
• Current medication allergy list.
We defined allergy in the proposed rule as an exaggerated immune response or reaction to substances that are generally not harmful (80 FR 16760). Information on problems, medications, and medication allergies could be obtained from previous records, transfer of information from other providers (directly or indirectly), diagnoses made by the EP or hospital, new medications ordered by the EP or in the hospital, or through querying the patient.
We proposed to maintain that all summary of care documents contain the most recent and up-to-date information on all elements. In the event that there are no current diagnoses for a patient, the patient is not currently taking any medications, or the patient has no known medication allergies; the EP, eligible hospital, or CAH must record or document within the required fields that there are no problems, no medications, or no medication allergies recorded for the patient to satisfy the measure of this objective. The EP or hospital must verify that the fields for problem list, medication list, and medication allergy list are not blank and include the most recent information known by the EP, eligible hospital, or CAH as of the time of generating the summary of care document.
In the Stage 3 proposed rule 80 FR 176760, we encouraged providers to send a list of items that he or she believes to be pertinent and relevant to the patient's care, rather than a list of all problems, whether active or resolved, that have ever populated the problem list. While a current problem list must always be included, the provider can use his or her judgment in deciding which items historically present on the problem list, medical history list (if it exists in CEHRT), or surgical history list are relevant given the clinical circumstances.
Similarly, we noted comments from stakeholders and through public forums and correspondence on the potential of allowing only clinically relevant
For the second measure, we proposed to address the other end of the transition of care continuum. In the Stage 2 final rule, we limited the action required by providers to sending an electronic transmission of a summary of care document (77 FR 54017 through 54018). We did not have a related requirement for the recipient of that transmission. We did not adopt a certification requirement for the receiving end of a transition or referral or for the measure related to sending the summary, as that is a factor outside the sending provider's immediate control. However, in Stage 3 of meaningful use, we proposed a measure for the provider as the recipient of a transition or referral requiring him or her to actively seek to incorporate an electronic summary of care document into the patient record when a patient is referred to them or otherwise transferred into their care. This proposal was designed to complete the electronic transmission loop and support providers in using CEHRT to support the multiple roles a provider plays in meaningful health information exchange.
For the purposes of defining the cases in the denominator, we proposed that what constitutes “unavailable” and, therefore, may be excluded from the denominator, will be that a provider—
• Requested an electronic summary of care record to be sent and did not receive an electronic summary of care document; and
• Queried at least one external source via HIE functionality and did not locate a summary of care for the patient, or the provider does not have access to HIE functionality to support such a query.
We sought comment on whether electronic alerts received by EPs from hospitals when a patient is admitted, seen in the emergency room or discharged from the hospital—so called “utilization alerts”—should be included in measure 2two, or as a separate measure. Use of this form of health information exchange is increasingly rapidly, driven by hospital and EP efforts to improve care transitions and reduce readmissions. We also sought comment on which information from a utilization alert would typically be incorporated into a patient's record and how this is done today.
For both the first and second measures, we proposed that a provider may use a wide range of health IT systems for health information exchange to receive or send an electronic summary of care document, but must use their certified EHR technology to create the summary of care document sent or to incorporate the summary of care document received into the patient record. We also proposed that the receipt of the summary of care document may be passive (provider is sent the C-CDA and incorporates it) or active (provider requests a direct transfer of the C-CDA or provider queries an HIE for the C-CDA). In the Stage 2 proposed rule, we noted the benefits of requiring standards for the transport mechanism for health information exchange consistently nationwide (77 FR 13723). In the Stage 2 final rule, a governance mechanism option was included in the second measure for the summary of care objective at 77 FR 54020. In the Stage 3 proposed rule 80 FR 16762,we again sought comment on a health information exchange governance mechanism. Specifically we sought comment on whether providers who create a summary of care record using CEHRT for purposes of Measure 1 should be permitted to send the created summary of care record either—(1) Through any electronic means; or (2) in a manner that is consistent with the governance mechanism ONC establishes for the nationwide health information network. We additionally sought comment on whether providers who are receiving a summary of care record using CEHRT for the purposes of Measure 2 should have a similar requirement for the transport of summary of care documents requested from a transitioning provider. Finally, we sought comment on how a governance mechanism established by ONC at a later date could be incorporated into the EHR Incentive Programs for purposes of encouraging interoperable exchange that benefits patients and providers, including how the governance mechanism should be captured in the numerator, denominator, and thresholds for both the first (send) and second (receive) measures of this HIE objective.
For the third measure, we proposed a measure of clinical information reconciliation, which incorporates the Stage 2 objective for medication reconciliation and expands the options to allow for the reconciliation of other clinical information. Clinical information such as medication allergies and problems will allow providers additional flexibility in meeting the measure in a way that is relevant to their scope of practice. In the Stage 2 final rule, we outlined the benefits of medication reconciliation, which enables providers to validate that the patient's list of active medications is accurate (77 FR 54011 through 54012). This activity improves patient safety, improves care quality, and improves the validity of information that the provider shares with others through health information exchange. We believe that reconciliation of medication allergies and problems affords similar benefits.
For this proposed measure, we specified that the EP, eligible hospital, or CAH that receives the patient into their care should conduct the clinical information reconciliation. It is for the receiving provider that up-to-date information will be most crucial to make informed clinical judgments for patient care. We reiterated that this measure does not dictate what subset of information must be included in reconciliation. Information included in the process is determined by the provider's clinical judgment of what is most relevant to patient care.
For this measure, we proposed to define clinical information
As with medication reconciliation, we believe that an electronic exchange of information following the transition of care of a patient is the most efficient method of performing clinical information reconciliation.
We recognized that workflows to reconcile clinical information vary widely across providers and settings of care, and we requested comment on the challenges that this objective might present for providers, and how such challenges might be mitigated, while preserving the policy intent of the measure. In particular, we solicited comment on the following:
• Automation and Manual Reconciliation. The Stage 2 measure does not specify whether reconciliation must be automated or manual. Some providers have expressed concern over the automatic inclusion of data in the patient record from referring providers, while others have indicated that requiring manual reconciliation imposes significant workflow burden. We also sought comment on whether the use and display of meta-tagged data could address concerns related to the origin of data and thereby permit more automated reconciliation of these data elements.
• Review of Reconciled Information. Depending on clinical setting, this measure could be accomplished through manual reconciliation or through automated functionality. In either scenario, should the reconciliation or review of automated functionality be performed only by the same staff allowed under the Stage 3 requirements for the CPOE objective?
• What impact would the requirement of clinical information reconciliation have on workflow for specialists? Are there particular specialties where this measure would be difficult to meet?
• What additional exclusions, if any, should be considered for this measure?
We also encouraged comment on the proposal to require reconciliation of all three clinical information reconciliation data sets, or if we should potentially require providers to choose 2 of 3 information reconciliation data sets relevant to their specialty or patient population. We explained that we expect that most providers would find that conducting clinical information reconciliation for medications, medication allergies, and problem lists is relevant for every patient encountered. We solicited examples describing challenges and burdens that providers who deliver specialist care or employ unique clinical workflow practices may experience in completing clinical information reconciliation for all three data sets and whether an exclusion should be considered for providers for whom such reconciliation may not be relevant to their scope of practice or patient population. Additionally, we solicited comments around the necessity to conduct different types of clinical information reconciliation of data for each individual patient. For example, it is possible that the data for certain patients should always be reviewed for medication allergy reconciliation, when it may not be as relevant to other patient populations.
We proposed that to meet this objective, a provider must attest to the numerator and denominator for all three measures but would only be required to successfully meet the threshold for two of the three proposed measures.
Any EP that conducts 50 percent or more of his or her patient encounters in a county that does not have 50 percent or more of its housing units with 4Mbps broadband availability according to the latest information available from the FCC on the first day of the EHR reporting period may exclude the measures.
Any eligible hospital or CAH will be excluded from the measure if it is located in a county that does not have 50 percent or more of their housing units with 4Mbps broadband availability according to the latest information available from the FCC at the start of the EHR reporting period.
Any EP that conducts 50 percent or more of his or her patient encounters in a county that does not have 50 percent or more of its housing units with 4Mbps broadband availability according to the latest information available from the FCC on the first day of the EHR reporting period may exclude the measures.
Any eligible hospital or CAH will be excluded from the measure if it is located in a county that does not have 50 percent or more of their housing units with 4Mbps broadband availability according to the latest information available from the FCC at the start of the EHR reporting period.
Any EP that conducts 50 percent or more of his or her patient encounters in a county that does not have 50 percent or more of its housing units with 4Mbps broadband availability according to the latest information available from the FCC on the first day of the EHR reporting period may exclude the measure.
Any eligible hospital or CAH will be excluded from the measure if it is located in a county that does not have 50 percent or more of their housing units with 4Mbps broadband availability according to the latest information available from the FCC at the start of the EHR reporting period.
We received the following comments and our response follows:
Some commenters specifically mentioned that people with cancer often receive fragmented and uncoordinated care because their treatments frequently require multiple clinicians including surgeons, oncologists, primary care physicians, and other specialists. These commenters noted that providing coordinated care requires access to all of a patient's data by all of his or her providers, an essential function that EHRs can provide.
Still others expressed conceptual support for the proposed objective as the measures rationally seeks to organize the care of the patient on the care continuum and takes the next step in closing the transitions of care loop by incorporating outside medical information and promoting the reconciliation of medical data from transitioning patients. These commenters expressed a belief that the efforts to improve communication between providers for the same patient promotes better care decisions and care coordination. The ability to communicate information electronically decreases the chance of errors, missing information, or misunderstandings due to lack of standardization. Finally many commenters noted that the ability to send and receive data from other providers throughout the care continuum is imperative to transforming healthcare and improving patient care.
Many commenters stated that there are not enough providers and practices that can electronically receive transition of care documents because many (especially those in rural areas) do not have the capabilities needed to meet the HIE requirements (for example, Direct technologies, HIE access). Other commenters stated a lack of trading partners, including health care providers who are not subject to these regulations) as one of the main obstacles to meeting the Stage 3 HIE requirements. Several commenters requested that providers only be required to engage eligible professionals and eligible hospitals who are also working toward meeting the requirements of the EHR Incentive Programs, and that there should be exclusions based on the capabilities of surrounding practices or a lack of trading partners. Other commenters indicated statewide and regional health information exchanges are at varying levels of development and vary widely in their capabilities and sophistication. Other commenters stated the HIE technology and interoperability capabilities are not mature enough to meet these HIE requirements and will lead to provider failure or providers being held responsible for criteria they cannot control and standards they cannot meet.
Another commenter stated there are no national or regional data repositories in place for direct email addresses to be shared which has made it extremely challenging for providers to comply with this objective and measure, even if the provider has the capability to generate and transmit a C-CDA.
We disagree that there should be additional exclusions for this objective. As stated previously, we believe that the increased participation in the EHR Incentive Programs will help to support the overall ability for providers to electronically exchange health information. Further, we note that performance for providers in rural areas on the Stage 2 objective does not differ from the overall performance on the
We intend to support policies that mitigate the impact that a lack of trading partners or a lack of transport mechanisms have on providers. As we note throughout this final rule with comment period, we are seeking to increase participation among EHR Incentive Program participants and expand the methods by which providers may exchange information. These policies are aimed at ensuring that a lack of trading partners will not continue to be a significant hurdle for providers as the widespread adoption of certified EHRs continues and new flexible innovations for transport are supported.
In addition, CMS and ONC share a mutual understanding of the issue relating to importance of provider access to health information exchange contact information and agree that a method to facilitate this access would support interoperable health information exchange. We are committed to exploring potential models and opportunities to enable providers to more readily share their own electronic exchange contact information and access the contact information of potential trading partners. It is our intent to populate the National Plan and Provider Enumeration System (NPPES) with direct addresses and/or electronic service endpoints of EHR Incentive Program participants as a means of creating a health care provider directory resource. For more information, we direct readers to section II.D.3 of this final rule with comment period.
• Transitions of care for providers with a shared EHR
• Patient-reported referrals and patient self-referrals
• New patients and patient encounters in which the provider has never before encountered the patient
Commenters further went on to express support for the option to include providers with a shared EHR and support for the ability to include patient-self referrals as an option, and asked specific questions relating to how these items impact any variation in the denominators between the measures.
For our policy regarding transitions or referrals among providers with a shared EHR, in the Stage 3 proposed rule, we proposed that providers may count a transition of care or referral as long as the receiving provider would at least be considered a different provider if attesting for the EHR Incentive Programs (individual NPI or CCN level) in the denominator if they do so universally across all settings. They may also count these transitions with providers who share a certified EHR if they do so universally across all settings and for all such transitions. However, for any action to count in the numerator of a measure within this objective, the provider may not simply deem the shared access to the record sufficient, they would instead need to complete the required action associated with each measure. We maintain that this option to include or not include such transitions is entirely at the provider's discretion, but the policy must be applied universally for all transitions or referrals related to the denominator for Measure 1 and Measure 2. We believe that these transitions and referrals should not be excluded from Measure 3, as clinical information reconciliation may include actions beyond the electronic exchange of a patient record. We further clarify that the use of the reference to a billing identity within the program is intended to establish the baseline that if a provider chooses to included exchanges with providers with a shared EHR they may do so as long as the recipient would be considered a different provider in the EHR Incentive Programs (
We note that in the Stage 3 proposed rule (80 FR 16759) we stated that we believe a provider should count a referral in the denominator in the case of patient-self referrals if the patient subsequently identifies the provider from whom they received care. We further stated that the provider may count such a referral in the numerator for each measure if they undertake the action required to meet the measure upon disclosure and identification of the provider from whom the patient received care. However, we have reconsidered this requirement based on feedback from commenters who note that variations in timing and provider specialty might impact the feasibility and value proposition for a provider to count patient self-referrals in this manner. For example, if a primary care provider is notified of a self-referral to a specialist months after the resulting visit with the specialist has occurred, the receipt and incorporation (Measure 2) and reconciliation (Measure 3) of the summary of care record by the primary care provider from the specialist is important for the patient's continued care by the primary care provider. In this scenario, it may not make sense for Measure 1 to be required. Under measure 1 as proposed, the primary care provider would be required to send a summary of care record to the specialist. If the specialist has already seen the patient and no follow-up or continued treatment is needed, we believe the referring provider is best suited to determine whether the summary of care record should still be sent. We note that there are further examples of such instances which provide further complications for feasibility of this requirement as proposed. We are, therefore, modifying our initial proposal so that patient self-referrals may be included, but are not required, for measure 1. The provider should determine in what cases they would include or not include patient-self referrals and apply that policy across all such referrals for the duration of the reporting period. We note that providers
For the definition of new patient and never before seen by the provider, we stated that we use the same definition of “new patient” as described in Objective 7 Medication Reconciliation for the EHR Incentive Programs in 2015 through 2017 in section II.B.2.a.v of this final rule with comment period.
Some commenters further suggested that providers be able to limit the C-CDA itself or not be required to send the full C-CDS on all transitions of care. Many commenters addressed the C-CDS itself stating that they support renaming the clinical data sets from “Common MU Data Set” to a new term, as the data sets are relevant beyond the EHR Incentive Programs. Some noted that CCDS is close to C-CDA however commenters were split on if that was a problem or a benefit.
Some commenters opposed the changes to the required data set in the CCDS stating that the additional data fields that are incorporated into the proposed Stage 3 CCDS would involve significant effort to implement and transition the data elements necessary to support the standard summary of care record.
Other commenters noted agreement with the expansion of captured data elements and recommended we maintain capture of this information in a format supported by the C-CDA data structure, but that they should not be mandatory to be populated on the C-CDA in order to meet the numerator of sending an electronic summary of care. These commenters supported continuing to require that the current problem list, medication list, and medication allergy must be populated within the C-CDA.
We disagree with the suggestion that the C-CDA not be required and that any electronic transmission of patient health information may be accepted for attestation. Furthermore, we disagree with suggestions that the C-CDA should not include all required elements of the ONC defined CCDS for purposes of CEHRT. We note that both the CCDS and C-CDA support the interoperable exchange of data elements for provider use. Without standards, the data from one system cannot readily be translated into usable data in another system.
However, we clarify that not all elements of the CCDS are required to include data if no such data is available or known to the provider. The only three fields which must include data are the current problem list, medication list, and medication allergy list, which must at least include a reference that no such data is known or available. This is an important patient safety element finalized in the Stage 2 final rule which we maintain for Stage 3.
Certain other types of information, while not required within the CCDS, have associated standards and capabilities for data capture that are included in certification criteria that compose the Base EHR definition. As such, while these types of information are not required within the CCDS, the ability to capture this information is required under the definition of CEHRT. This distinction means the provider would have the data element available for use within their certified EHR and would have the ability to capture the data in a structured format as appropriate for their individual practice and patient population. For example, the Base EHR definition included in the 2015 Edition final rule provides for the capture of demographic data within certified EHR technology, including the capture of more granular data on race and ethnicity and of data that extends beyond a more limited understanding of clinical care data—such as the collection of social, psychological, and behavioral health information. The ability to capture this information in CEHRT supports provider efforts to provide improved, patient-centered care and reduce health disparities.
The 2015 Edition proposed rule also included a criterion to record a patient's sexual orientation and gender identity (SO/GI) in a structured way with standardized data. Where the patient chooses to disclose this information, the inclusion of this information can help those within the patient's care team to have more information on the patient that can aid in identifying interventions and treatments most helpful to the particular patient. Additionally, sexual orientation and gender identity can be relevant to individual treatment decisions; for example, transgender men who were assigned female at birth should be offered a cervical exam, as appropriate. In the final rule, ONC is requiring that Health IT modules enable a user to record, change, and access SO/GI to be certified to the 2015 Edition “demographics” certification criterion. By doing so, SO/GI is now included in the 2015 Edition Base EHR definition, which is a part of the definition of CEHRT (see section II.B.3). We note that certification does not require that a provider collect this information; it requires only that their CEHRT enable the provider to do so. CMS and ONC believe including SO/GI in the “demographics” criterion represents a crucial step forward to improving care for LGBT communities.
We also note that we received comments specific to the composition of the CCDS and addressing the C-CDA, which are out of scope for this rule. We refer readers to the 2015 Edition final rule included elsewhere in this
Many commenters strongly supported the expansion of the available methods by which secure electronic exchange could occur. Some strongly encouraged us to continue to require summary of care record exchange in a manner that is consistent with a governance mechanism ONC establishes for the nationwide health information network. These commenters noted that transmission of a summary of care record could be accomplished in various ways and requested that CMS and ONC should provide resources outside the regulations to support and clarify these requirements for developers and providers.
Other commenters specifically supported the requirement for the transmission of electronic summary of care document in a manner that is consistent with the governance mechanism ONC establishes for the nationwide health information network and believe that allowing any other transmission method will increase the cost and complexity of receiving and incorporating data into the EHR.
We further note that the security of the transmission is of paramount importance to CMS. We, therefore, remind providers and emphasize that any transmission method chosen by a provider must comply with the privacy and security protocols for ePHI outlined in HIPAA.
We requested comment from providers on how the governance mechanism could be considered for purposes of the objectives and measures in Stage 3 and we thank commenters for their comments. We will continue to consider these comments as we work with ONC to address governance as it relates to health information exchange, and look forward to continuing to work with stakeholders in this area.
Other commenters requested we add the word “electronically” to the measure language so that the measure reads “For 40 percent of transitions or referrals received electronically”. Other commenters noted that a provider may have the capacity to query an HIE in their CEHRT, but is unable to do so because there is no HIE in their area or their organization is still in the process of on-boarding with a potential HIE network. These commenters expressed concern that the denominator calculation would not allow them to exclude patients for whom they were unable to query in this instance. Others expressed a similar concern over the understanding of an HIE noting that many do not require the provider to possess additional functionality, but instead allow a provider to query for a document and receive that document via direct transport from the HIE.
We also decline to add the qualifier to the measure to specify only counting existing electronic transitions or referrals in the requirement to receive, request or query for an electronic summary of care record. If we were to change the measure to read “received electronically” it eliminates any further follow up to request or query for an electronic record when an electronic record was not already received with the transition or referral. This change would fundamentally alter the measure and render it meaningless.
The proposed measure denominator already allows providers to exclude patients for whom no electronic document is available after a reasonable effort is made, such as a request to the referring provider and a query of any HIE or service. As stated in the proposed rule, for the purposes of defining the cases in the denominator, we proposed that what constitutes “unavailable” and, therefore, may be excluded from the denominator, will be that a provider—
• Requested an electronic summary of care record to be sent and did not receive an electronic summary of care document; and
• Queried at least one external source via HIE functionality and did not locate a summary of care for the patient, or the provider does not have access to HIE functionality to support such a query.
However, we do agree with commenters and are adopting a change to state that the reference to HIE functionality within the denominator calculation should be revised to reflect whether or not there is an HIE from which the provider is able to query and receive a C-CDA using their CEHRT. We are therefore adding an additional qualifier to the statement to include that the HIE functionality supporting a query for a summary of care document is not currently operational in the provider's geographic region or EHR network. Therefore, for the purposes of defining the cases in the denominator, we are modifying our proposal to state that what constitutes, “unavailable” and therefore may be excluded from the denominator,—is as follows:
• The provider requested an electronic summary of care record to be sent and did not receive an electronic summary of care document; and
• The provider either:
1. Queried at least one external source via HIE functionality and did not locate a summary of care for the patient, or
2. Confirmed that HIE functionality supporting query for summary of care documents was not operational in the provider's geographic region and not available within the provider's EHR network as of the start of the EHR reporting period.
Some commenters discussed the administrative burden, various workflow challenges involved in reviewing, and incorporating data from other providers including the amount of time required to review inbound summary of care reports. Other commenters discussed how the CCDS are not helpful because they contain too much unnecessary and redundant information as well as the risk associated with receiving summary of care information that has not been
Other commenters stated that not all new patient referrals require comprehensive data reconciliation. For example a dermatologist evaluating a simple skin lesion or an orthopedist evaluating a painful joint may not need to perform in depth reconciliation to provide quality care.
In addition, many commenters discussed the means of measurement for medications, problems, and allergies such as if duplicate records needed to be reconciled or if data that is verified as requiring no further update would also count toward the measure. Several commenters requested clarification on whether the reconciliation should be automated or manual. Some requested we offer both options to allow providers to choose the means that best fits their practice, and many commenters had concerns about the liability associated with automated reconciliation.
We note that this measure builds on the existing Medication Reconciliation Objective for the EHR Incentive Programs in 2015 through 2017 (see section II.B.2.a.v). We agree that this process may include both automated and manual reconciliation to allow the receiving provider to work with both the electronic data provided with any necessary review, and to work directly with the patient to reconcile their health information. We further note that the point of reconciliation is to assist in maintaining the most relevant, complete, and up to date information for a given patient. If no update is necessary, the process of reconciliation may consist of simply verifying that fact or reviewing a record received on referral and determining that such information is merely duplicative of existing information in the patient record. Both such examples would count toward the measure if the provider established their reconciliation process to include such verification.
After consideration of public comments received, we are finalizing the objective with a minor modification to the language to clarify receiving or retrieving a summary of care through query as discussed for measure 2. We are finalizing the measures and exclusions as proposed for EPs, eligible hospitals and CAHs. We are finalizing that providers must attest to all three measures and must meet the thresholds for at least two measures to meet the objective. The final objective and measures are as follows:
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○ Any EP who transfers a patient to another setting or refers a patient to another provider less than 100 times during the EHR reporting period.
○ Any EP that conducts 50 percent or more of his or her patient encounters in a county that does not have 50 percent or more of its housing units with 4Mbps broadband availability according to the
○ Any eligible hospital or CAH will be excluded from the measure if it is located in a county that does not have 50 percent or more of their housing units with 4Mbps broadband availability according to the latest information available from the FCC at the start of the EHR reporting period.
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○ Any EP, eligible hospital or CAH for whom the total of transitions or referrals received and patient encounters in which the provider has never before encountered the patient, is fewer than 100 during the EHR reporting period is excluded from this measure.
○ Any EP that conducts 50 percent or more of his or her patient encounters in a county that does not have 50 percent or more of its housing units with 4Mbps broadband availability according to the latest information available from the FCC on the first day of the EHR reporting period may exclude the measures.
○ Any eligible hospital or CAH will be excluded from the measure if it is located in a county that does not have 50 percent or more of their housing units with 4Mbps broadband availability according to the latest information available from the FCC at the start of the EHR reporting period.
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We are adopting Objective 7: Health Information Exchange at § 495.24(d)(7)(i) for EPs and § 495.24(d)(7)(ii) for eligible hospitals and CAHs. We further specify that in order to meet this objective and measures, an EP, eligible hospital, or CAH must use the capabilities and standards of as defined for as defined CEHRT at § 495.4. We direct readers to section II.B.3 of this final rule with comment period for a discussion of the definition of CEHRT and a table referencing the capabilities and standards that must be used for each measure.
In the Stage 3 proposed rule (80 FR 16763) we proposed this objective to build on the requirements set forth in the Stage 2 final rule (77 FR 54021 through 54026). We proposed this objective to include improvements to the Stage 2 measures, support innovation that has occurred since the Stage 2 final rule was released, and add flexibility in the options that an eligible provider has to successfully report.
We further noted that this objective places increased focus on the importance of the ongoing lines of communication that should exist between providers and public health agencies or as further discussed later in this section, between providers and clinical data registries. Providers' use of certified EHR technology can increase the flow of secure health information and reduce the burden that otherwise could attach to these important communications. The purpose of this Stage 3 objective is to further advance communication between providers and public health agencies and clinical data registries, as well as strengthen the capture and transmission of such health information within the care continuum.
For Stage 3, we proposed changes to the Stage 1 and Stage 2 public health and specialty registry objectives to consolidate the prior objectives and measures into a single objective in alignment with efforts to streamline the program and support flexibility for providers. We proposed to include a new measure for electronic case reporting to reflect the diverse ways that providers can electronically exchange data with public health agencies. In addition, we used new terms such as public health registries and clinical data registries to incorporate the Stage 2 designations for cancer registries and specialized registries under these categories which are known in the health care industry to designate a broader range of registry types. We further explained the use of these terms within the specifications outlined for each applicable measure.
For Stage 3, we proposed to remove the prior “ongoing submission” requirement and replace it with an “active engagement” requirement. Depending on the measure, the ongoing submission requirement from the Stage 1 and Stage 2 final rules required the successful ongoing submission of applicable data from certified EHR technology to a public health agency or clinical data registry for the entire EHR reporting period. As part of the Stage 2 final rule, we provided examples demonstrating how ongoing submission could satisfy the measure (77 FR 54021). However, stakeholders noted that the
For purposes of meeting this new objective, EPs, eligible hospitals and CAHs would be required to demonstrate that “active engagement” with a public health agency or clinical data registry has occurred. Active engagement means that the provider is in the process of moving towards sending “production data” to a public health agency or clinical data registry, or is sending production data to a public health agency or clinical data registry. We noted that the term “production data” refers to data generated through clinical processes involving patient care and it is used to distinguish between this data and “test, data” which may be submitted for the purposes of enrolling in and testing electronic data transfers. We proposed that “active engagement” may be demonstrated by any of the following options:
We also proposed to provide support to providers seeking to meet the requirements of this objective by creating a centralized repository of national, state, and local public health agency and clinical data registry readiness. In the Stage 2 final rule (77 FR 54021), we noted the benefits of developing a centralized repository where a public health agency could post readiness updates regarding their ability to accept electronic data using specifications prescribed by ONC for the public health objectives. In accordance with the Paperwork Reduction Act of 1995, we also published a notice in the
The active engagement requirement clarifies what is expected of a provider who seeks to meet the measures within this objective and renames the requirement to better describe the provider's role in meeting each option within the structure. There is an intentional similarity between some of the broad descriptions of the Stage 2 “ongoing reporting” and the requirements for the “active engagement” options. This is both to provide continuity and to define a more comprehensive progression for providers in meeting the measure. For example, in the Stage 2 rule (77 FR 54021), we generally stated that a provider could register their intent to submit data to successfully meet a measure in the public health objective. This concept is defined with additional guidance in the Stage 3 proposed rule as Active Engagement Option 1: Completed Registration to Submit Data.
For the commenters discussing the submission of production data as defined in Action Engagement Option 3: Production, we note that under this option a provider only may successfully attest to meaningful use when the receiving public health agency or clinical data registry moves the provider into a production phase. We recognize that live data may be sent during the Testing and Validation phase of Option 2, but the data received in Option 2 is not sufficient for purposes of meeting Option 3 unless the public health agency and clinical data registry is
For EPs, we proposed that an exclusion for a measure does not count toward the total of three measures. Instead, in order to meet this objective, an EP would need to meet three of the total number of measures available to them. If the EP qualifies for multiple exclusions and the remaining number of measures available to the EP is less than three, the EP can meet the objective by meeting all of the remaining measures available to them and claiming the applicable exclusions. Available measures include ones for which the EP does not qualify for an exclusion.
For eligible hospitals and CAHs, we proposed that an exclusion for a measure does not count toward the total of four measures. Instead, in order to meet this objective an eligible hospital or CAH would need to meet four of the total number of measures available to them. If the eligible hospital or CAH qualifies for multiple exclusions and the total number of remaining measures available to the eligible hospital or CAH is less than four, the eligible hospital or CAH can meet the objective by meeting all of the remaining measures available to them and claiming the applicable exclusions. Available measures include ones for which the eligible hospital or CAH does not qualify for an exclusion.
We also proposed to allow EPs, eligible hospitals, and CAHs to choose to report to more than one public health registry to meet the number of measures required to meet the objective. We also proposed allowing EPs, eligible hospitals, and CAHs to choose to report to more than one clinical data registry to meet the number of measures required to meet the objective. We explained that we believe that this flexibility allows for EPs, eligible hospitals, and CAHs to choose reporting options that align with their practice and that will aid the provider's ability to care for their patients.
In the Stage 3 proposed rule (80 FR 16764), we noted that the immunization registry reporting measure remains a priority because the exchange of information between certified EHR technology and immunization registries allows a provider to use the most complete immunization history available to inform decisions about the vaccines a patient may need. Public health agencies and providers also use immunization information for emergency preparedness and to estimate population immunization coverage levels of certain vaccines.
We proposed that to successfully meet the requirements of this measure, bi-directional data exchange between the provider's certified EHR technology and the immunization registry/IIS is required. We understand that many states and local public health jurisdictions are exchanging immunization data bi-directionally with providers, and that the number of states and localities able to support bi-directional exchange continues to increase. In the 2015 Edition proposed rule, ONC proposed to adopt a bi-directional exchange standard for reporting to immunization registries/IIS. We believe this functionality is important for patient safety and improved care because it allows the provider to use the most complete immunization record possible to make decisions on whether a patient needs a vaccine. Immunization registries and health IT systems also are able to provide immunization forecasting functions which can inform discussions between providers and patients on what vaccines they may need in the future and the timeline for the receipt of such immunizations. Therefore, we believe that patients, providers, and the public health community would benefit from technology that can accommodate bi-directional immunization data exchange. We welcomed comment on this proposal.
Regarding the bi-directionality requirement, we note that we have modified the requirements of bi-directionality for the EHR Incentive Program for 2015 through 2017 (see section II.B.2.a.x). However, for Stage 3, we believe that the bi-directionality requirement should remain. We believe that by the time Stage 3 begins, the bi-directional components of immunization registry reporting will be ready. At the time of publication of this final rule with comment period, more than half of public health jurisdictions can support bi-directional messaging and the remaining public health jurisdictions are on their way to supporting the bi-directional capability. Therefore, we are finalizing this measure, with the modification that a provider's health IT system may layer additional information on the immunization history, forecast, and still successfully meet this measure.
In the Stage 3 proposed rule (80 FR 16764), we noted that this measure remains a policy priority because electronic syndromic surveillance is valuable for early detection of outbreaks, as well as monitoring disease and condition trends. We distinguished between EPs and eligible hospitals or CAHs reporting locations because, as discussed in the Stage 2 final rule, few public health agencies appeared to have the ability to accept non-emergency or non-urgent care ambulatory syndromic surveillance data electronically (77 FR 53979). We continued to observe differences in the infrastructure and current environments for supporting electronic syndromic surveillance data submission to public health agencies between eligible hospitals or CAHs and EPs. Because eligible hospitals and CAHs send syndromic surveillance data using different methods as compared to EPs, we defined slightly different exclusions for each setting as described later in this section.
This proposed new reporting option was not part of Stage 2. The collection of electronic case reporting data greatly improves reporting efficiencies between providers and the public health agency. Public health agencies collect “reportable, conditions”, as defined by the state, territorial, and local public health agencies, to monitor disease trends and support the management of outbreaks. In many circumstances, there has been low reporting compliance because providers do not know when, where, or how to report. In some cases,
In the Stage 2 final rule, we were purposefully general in our use of the term “specialized registry” (other than a cancer registry) to encompass both registry reporting to public health agencies and clinical data registries in order to prevent inadvertent exclusion of certain registries through an attempt to be more specific (77 FR 54030). In response to insight gained from the industry through listening sessions, public forums, and responses to the February 2014 Public Health Reporting Request for Information, we proposed to carry forward the concept behind this broad category from Stage 2, but also proposed to split public health registry reporting from clinical data registry reporting into two separate measures which better define the potential types of registries available for reporting. We proposed to define a “public health registry” as a registry that is administered by, or on behalf of, a local, state, territorial, or national public health agency and which collects data for public health purposes. While immunization registries are a type of public health registry, we proposed to keep immunization registry reporting separate from the public health registry reporting measure to retain continuity from Stage 1 and 2 policy in which immunization registry reporting was a distinct and separate objective (77 FR 54023). We believe it is important to retain the public health registry reporting option for Stage 3 because these registries allow the public health community to monitor health and disease trends, and inform the development of programs and policy for population and community health improvement.
We reiterated that any EP, eligible hospital, or CAH may report to more than one public health registry to meet the total number of required measures for the objective. For example, if a provider meets this measure through reporting to both the National Hospital Care Survey and the National Healthcare Safety Network registry, the provider could get credit for meeting two measures. ONC will consider the adoption of standards and implementation guides in future rulemaking. Should these subsequently be finalized, they may then be adopted as part of the certified EHR technology definition as it relates to meeting the public health registry reporting measure through future rulemaking for the EHR Incentive Programs.
We further noted that ONC adopted standards for ambulatory cancer case reporting in its final rule “2014 Edition, Release 2 EHR Certification Criteria and the ONC HIT Certification Program; Regulatory Flexibilities, Improvements, and Enhanced Health Information Exchange” (79 FR 54468) and we provided EPs the option to select the cancer case reporting menu objective in the Stage 2 final rule (77 FR 54029 through 54030). We included cancer registry reporting as a separate objective from specialized registry reporting because it was more mature in its development than other registry types, not because other reporting was intended to be excluded from meaningful use. For the Stage 3 public health registry reporting measure, given the desire to provide more flexible options for providers to report to the registries most applicable for their scope of practice, we proposed that EPs would have the option of counting cancer case reporting under the public health registry reporting measure. We noted that cancer case reporting is not an option for eligible hospitals and CAHs under this measure because hospitals have traditionally diagnosed or treated cancers and have the infrastructure needed to report cancer cases.
However we note that providers would not be able to count production reporting to a specialized registry under the Public Health Reporting Objective for 2015 through 2017, if there are standards and requirements referenced in the ONC 2015 Edition regulations for Public Health and Clinical Data Registry Stage 3 Measures:
• Example 1, EPs would not receive credit for cancer reporting under the Specialized Registry measure in Stage 3; rather the EPs would need to be in active engagement with the public health agency under the Public Health Registry Measure to submit cancer case data to the PHA using the standards mandated in the 2015 Edition Certification Criteria.
• Example 2, EPs would not receive credit for case reporting under the Specialized Registry measure in Stage 3 for production data submission that started in Modified Stage 2; rather the EPs would need to be in active engagement with the public health agency under the Case Reporting Measure using the standards mandated in the 2015 Edition Certification Criteria.
In future years, as standards are developed and referenced in future ONC regulations, CMS may require further specialized registries to meet these future requirements under the ONC Health IT Certification Program.
As discussed in the Public Health Registry Reporting measure, in the Stage 3 proposed rule (80 FR 16766) we proposed to split specialized registry reporting into two separate, clearly defined measures: Public health registry reporting and clinical data registry reporting. In Stage 2 for EPs, reporting to specialized registries is a menu objective and this menu objective includes reporting to clinical data registries. For Stage 3, we proposed to include clinical data registry reporting as an independent measure. The National Quality Registry Network defines clinical data registries as those that record information about the health status of patients and the health care they receive over varying periods of time.
In the Stage 3 proposed rule, we reiterated that any EP, eligible hospital,
As proposed previously, the Public Health and Clinical Data Registry Reporting objective requires active engagement with a public health agency to submit electronic public health data from certified EHR technology. ONC defined the standards and certification criteria to meet the definition of CEHRT in its 2011, 2014, and 2014 Release 2 Edition EHR certification criteria rules (see section II.B. of the “2014 Edition, Release 2 EHR Certification Criteria and the ONC HIT Certification Program; Regulatory Flexibilities, Improvements, and Enhanced Health Information Exchange” for a full description of ONC's regulatory history (79 FR 54434)). For example, ONC adopted standards for immunization reporting (see § 170.314(f)(1) and (f)(2)), inpatient syndromic surveillance (see § 170.314(f)(3) and (f)(7)), ELR (see § 170.314(f)(4)), and cancer case reporting (see § 170.314(f)(5) and (f)(6)) in its 2014 Edition final rule.
We support ONC's intent to promote standardized and interoperable exchange of public health data across the country. Therefore, to meet all of the measures within this public health objective EPs, eligible hospitals, and CAHs must use CEHRT as we proposed to define it under § 495.4 in the proposed rule and use the standards included in the 2015 Edition proposed rule. We anticipate that as new public health registries and clinical data registries are created, ONC and CMS will work with the public health community and clinical specialty societies to develop ONC-certified electronic reporting standards for those registries so that providers have the option to count participation in those registries under the measures of this objective. ONC will look to adopt such standards, as appropriate, in future rulemaking.
After consideration of public comment received, we are finalizing the objectives, measures, and exclusions as proposed except for the items previously discussed in this section. Specifically we are adopting modifications to include the 6 month lead time for the declaration of readiness for all exclusions for all 6 measures, to clarify the setting specificity for syndromic surveillance reporting, and to specify electronic case reporting, We are finalizing a total of 6 measures for this objective, and EPs would be required to choose from measures 1 through 5, and would be required to successfully attest to any combination of two measures. Eligible hospitals and CAHs would be required to choose from measures one through six, and would be required to successfully attest to any combination of four measures. We are finalizing that providers may attest to measure 4 and measure 5 more than once, and that an exclusion to a measure does not count toward the total in the manner proposed. The final objective and measures are as follows:
We are adopting Objective 8: Public Health and Clinical Data Registry Reporting at § 495.24(d)(8)(i) for EPs and § 495.24(d)(8)(ii) for eligible hospitals and CAHs. We further specify that in order to meet this objective and measures, an EP, eligible hospital, or CAH must use the capabilities and standards of as defined for as defined CEHRT at § 495.4. We direct readers to section II.B.3 of this final rule with comment period for a discussion of the definition of CEHRT and a table referencing the capabilities and standards that must be used for each measure.
The definition of CEHRT establishes the requirements for EHR technology that must be used by providers to meet the meaningful use objectives and measures. The Stage 2 final rule requires that CEHRT must be used by EPs, eligible hospitals, and CAHs to satisfy their CQM reporting requirements in the Medicare and Medicaid EHR Incentive Programs. In addition, the CQM data reported to CMS must originate from EHR technology that is certified to “capture and export” in accordance with 45 CFR 170.314(c)(1) and “electronic submission” in accordance with 45 CFR 170.314(c)(3) (77 FR 54053). Certified EHR technology is defined for the Medicare and Medicaid EHR Incentive Programs at 42 CFR 495.4 and previously referenced ONC's definition of CEHRT in 45 CFR 170.102.
In the Stage 3 proposed rule 80 FR 16767, rather than establishing a specific CEHRT definition for the EHR Incentive Programs in the ONC 2015 Edition proposed rule, we instead proposed to define the term “Certified EHR Technology” at § 495.4. This proposed change is designed to simplify the overall regulatory relationship between ONC and CMS rules for stakeholders and to ensure that relevant CMS policy for the Medicare and Medicaid EHR Incentive Programs is clearly defined in CMS regulations.
We also proposed that providers must use EHR technology certified at least to the 2014 Edition in 2016 and 2017. We further proposed that providers may adopt EHR technology certified to the 2015 Edition prior to the beginning of Stage 3 in 2017 or 2018, and that technology could be used to satisfy the definition of CEHRT under § 495.4 to demonstrate meaningful use (80 FR 16767 through 16768).
Several commenters addressed proposals specific to the Health IT Certification Program, the scope and focus of the certification criteria and standards for health IT under consideration by the ONC, testing of health IT systems presented for certification to ONC, and the specifics on how the newly created interoperability standards apply to the certification process.
Regarding references in to “health IT,” we do not agree that the use of the term “health IT” and the use of the term “certified EHR technology” is evidence of a disconnect between the Stage 3 and the ONC Health IT Certification Program. Rather, certified EHR technology is one type of health IT and is mandated required by the HITECH Act as part of for purposes of meeting attestation requirements and becoming a meaningful user. The ONC Health IT Certification Program and the associated 2015 Edition final rule provides certification criteria and standards integral to the CEHRT definition for Stage 3, but also is designed to address the needs of a broader set of settings that
Finally, comments related to the specific certification criteria proposed in the 2015 Edition proposed rule are outside the scope of this rulemaking. We direct commenters to the 2015 Edition proposed rule published on March 30, 2015. (80 FR 16804 through 16921) and the 2015 Edition final rule published elsewhere in this
After consideration of public comments received, we are finalizing the provision to include a full EHR Incentive Programs specific definition of CEHRT at 495.4 as proposed.
In adopting a CEHRT definition specific for the EHR Incentive Programs, we proposed in the EHR Incentive Programs in the Stage 3 proposed rule 80 FR 16767 to include, as currently for the ONC CEHRT definition under 45 CFR 170.102, the relevant Base EHR definitions adopted by ONC in 45 CFR 170.102 and other ONC certification criteria relevant to the EHR Incentive Programs. We referred readers to ONC's 2015 Edition proposed rule for the proposed 2015 Edition Base EHR definition and a discussion of the 2014 Edition Base EHR definition. We included the Base EHR definition(s) because, as ONC explained in the 2014 Edition certification final rule (77 FR 54443 through 54444), the “Base EHR” essentially serves as a substitute for the term “Qualified EHR” in the definition of CEHRT. The term “Qualified EHR” is defined in section 3000(13) of the Public Health Service Act (PHSA), to include certain capabilities listed in that section, and is included in the statutory definition of “certified EHR technology” for the EHR Incentive Programs (for example, see section 1848(o)(4) of the Act). The Base EHR definition(s) also includes additional capabilities as proposed by ONC that we agreed all providers should have that are participating in the EHR Incentive Programs to support their attempts to meet meaningful use objectives and measures, as well as to support interoperable health information exchange.
We also proposed to define the editions of certification criteria that may be used for years 2015 through 2017 to meet the CEHRT definition. At a minimum, EPs, eligible hospitals, and CAHs would be required to use EHR technology certified to the 2014 Edition certification criteria for their respective EHR reporting periods in 2015 through 2017. We stated that a provider may also upgrade to the 2015 Edition prior to 2018 to meet the required certified EHR technology definition for the EHR reporting periods in 2015, 2016, or 2017, or they may use a combination of 2014 and 2015 Editions prior to 2018 if they have modules from both Editions which that meet the requirements for the objectives and measures or if they fully upgrade during an EHR reporting period.
Additionally, because ONC proposed, for the 2015 Edition, to no longer require certification of Health IT Modules to capabilities that support meaningful use objectives with percentage-based measures, we proposed to include these capabilities (45 CFR 170.314(g)(1) or (2) or 45 CFR 170.315(g)(1) or (2)), as applicable, in the CEHRT definition for 2015 through 2017, so that providers have technology that can appropriately record and calculate meaningful use measures. In the EHR Incentive Program in the Stage 3 proposed rule, we noted that there are many combinations of 2014 and 2015 Edition certified technologies that could be used to successfully meet the transitions of care requirements included in the 2014 and 2015 Edition Base EHR definitions for the purposes of meeting meaningful use objectives and measures. We explained that we believe we have identified all combinations in the proposed regulation text under § 495.4 that could be used to meet the CEHRT definition through 2017 and be used for the purposes of meeting meaningful use objectives and measures. We sought comments on the accuracy of the identified available options. We received the following comments and our responses follow:
For EHR reporting periods in 2017:
• A provider who has technology certified to the 2015 Edition may attest to Stage 3 or to the modified Stage 2 requirements identified elsewhere in this rule.
• A provider who has technology certified to a combination of 2015 Edition and 2014 Edition may attest to: (1) The modified Stage 2 requirements; or (2) potentially to the Stage 3 requirements if the mix of certified technologies would not prohibit them from meeting the Stage 3 measures.
• A provider who has technology certified to the 2014 Edition only may attest to the modified Stage 2 requirements and may not attest to Stage 3.
For EHR reporting periods in 2018:
• All providers must use technology certified to the 2015 Edition to meet Stage 3 requirements.
The Base EHR definition is designed to include specific criteria that would apply to a broad cross section of developers seeking to support provider needs. The Base EHR definition is not designed solely for the use of the EHR Incentive Programs. For this reason, a product that a provider seeks to use to attest to meaningful use must be certified to the Base EHR definition and additional criteria that is determined by (a) the requirements of this CEHRT definition and (b) the specific objectives and measures the provider intends to use to meet meaningful use. Therefore, we do not believe it is appropriate to limit the CEHRT definition to the criteria included in ONC's Base EHR definition.
In this final rule with comment period, we have specifically identified the privacy and security certification criteria that EHR technology must be certified to meet the CEHRT definition for any federal fiscal year or calendar year before 2018, when an EP, eligible hospital, or CAH is using EHR certified to both the 2014 Edition and 2015 Edition to meet the definition.
We proposed provisions in the CEHRT definition for any federal fiscal year or calendar year before 2018 that would permit the use of a mix of EHR technology certified to 2014 and 2015 editions. This was designed to account for providers upgrading from EHR technology certified to the 2014 Edition to the 2015 Edition to meet the requirements of the CEHRT definition for 2018 and subsequent years (
Our proposal did not, however, account for the unlikely, but plausible, scenario where a new entrant to the EHR Incentive Programs in 2016 or 2017 was able to meet the CEHRT definition for a federal fiscal year or calendar year before 2018 with EHR technology only or mostly certified to the 2014 Edition that did not include the requisite privacy and security capabilities which are part of the 2014 Base EHR definition. Therefore, we have specifically included privacy and security certification criteria in the definition to guard against this possibility.
We note that we encourage providers to work closely with their developers to determine what compilation of technology certified under the ONC Health IT Certification Program would allow the provider to successfully attest to meaningful use in an EHR reporting period covered under this rule. We also have provided a chart of the technology that would be required for a provider seeking to attest to an objective or measure (See Table 2, 80 FR 16810 through 16811). In addition, we encourage providers to review the Web site of the ONC Health IT Certification Program and the Certified Health IT Products List (CHPL), which include real time information on what products are certified for what functionalities (see
We note that some commenters expressed concern regarding fraudulent statements and claims regarding the technology offered to meet meaningful use. We encourage providers to use the CHPL as a resource for identifying whether a product is certified and to contact ONC if fraudulent activity is suspected.
After consideration of public comments received, we are finalizing and adopting this provision without modification at § 495.4.
In the Stage 3 proposed rule at 80 FR 16767, we proposed that starting with 2018, all EPs, eligible hospitals, and CAHs would be required to use technology certified to the 2015 Edition to meet the CEHRT definition and to demonstrate meaningful use for an EHR reporting period in 2018 and subsequent years. The CEHRT definition would include, for the reasons discussed previously, meeting the 2015 Edition Base EHR definition and having other important capabilities that include the capabilities to:
• Record or create and incorporate family health history;
• Capture patient health information such as advance directives;
• Record numerators and denominators for meaningful use objectives with percentage-based measures and calculate the percentages;
• Calculate and report clinical quality measures; and
• Any other capabilities needed to be a Meaningful EHR User.
For information on 2015 Edition certification criteria that include these capabilities and are associated with proposed Meaningful Use objectives for Stage 3, we referred readers to the 2015 Edition proposed rule. We noted that we expect that the certification criteria with capabilities that support CQM calculation and reporting would be jointly proposed with CQM reporting requirements in a separate rulemaking.
Some commenters requested that providers in 2018 be allowed to use technology certified to the 2014 Edition and the 2015 Edition to meet Stage 3 requirements. A commenter expressed a concern that requiring use of 2015 Edition in 2018 may be problematic for certain providers that need radiation oncology EHR products. The commenter requested that the 2018 year be a flex year as well as 2017. Another commenter suggested that making the 2015 Edition optional in 2017 could create confusion and that we should simply adopt a single edition.
Further, we note that many of the requirements of Stage 3 are similar to those of Stage 2 and would use the same certification criteria with slight updates to vocabulary standards. For those criteria that are new to meaningful use in Stage 3 or for which significant updates are required, we agree with developers who confirm that 18 to 24 months provide enough time to develop and implement certified technology for purposes of meaningful use. We refer readers to section III.A. Table 2 of the ONC 2015 Edition Certification Criteria final rule published elsewhere in this
We further note that 2018 is the required year for the use of 2015 Edition and for attesting to Stage 3. We proposed and are finalizing in this rule a 2017 flex year that allows providers options in the edition of CEHRT used and the stage of meaningful use to which the provider attests. This flexibility is in place in recognition of the implementation needed for technology. However, by 2018, all providers will be required to attest to Stage 3 using 2015 Edition technology.
We caution providers to carefully make determinations regarding the technology they will need to attest to meaningful use and encourage providers to work closely with their developers to ensure that the technology they possess will meet their attestation needs. Please refer to Tables 11 through 16, which we have developed in conjunction with ONC of the technology requirements that support the CEHRT definition and each measure in section II.B.3.(d). of this final rule with comment period.
We also note that the CEHRT definition provides a baseline of functionality, but a provider may choose to possess technology that goes beyond the requirements of this CEHRT definition. We encourage providers to review products available to meet their needs and to review the Certified Health IT Products List that is available online at
After consideration of public comments received, we are finalizing and adopting this provision as proposed at § 495.4.
To facilitate readers identifying the requirements of CEHRT for each objective and measure defined in sections II.B.2.a and II.B.2.b of this final rule with comment period, ONC and CMS have developed a set of tables providing the appropriate certification criteria reference under the 2014 Edition and 2015 Edition certification criteria for the objectives and measures of meaningful use. These tables are provided for references purposes and reflect the definition of CEHRT adopted at § 495.4 for each year. We note that providers must also have the capabilities defined at § 495.4 for clinical quality measures (1)(ii)(B) or (2)(ii)(B), privacy and security (1)(ii)(C) or (2), and the certification criteria that are necessary to be a Meaningful EHR User (1)(ii)(D) or (2)(ii)(A).
Under sections 1848(o)(2)(A), 1886(n)(3)(A), and 1814(l)(3)(A) of the Act and 42 CFR 495.4, EPs, eligible hospitals, and CAHs must report on CQMs selected by CMS using certified EHR technology, as part of being a meaningful EHR user under the Medicare and Medicaid EHR Incentive Programs.
In the EHR Incentive Programs in 2015 through 2017 proposed rule (80 FR 20375 through 20376), we proposed to maintain the existing requirements established in earlier rulemaking for the reporting of CQMs. We summarized the options for CQM submission for providers in the Medicare EHR Incentive Program as follows:
• EP Options for Medicare EHR Incentive Program Participation
++ Option 1: Attest to CQMs through the EHR Registration & Attestation System
++ Option 2: Electronically report CQMs through Physician Quality Reporting System (PQRS) Portal
• EP Options for Electronic Reporting for Multiple Programs
++ Option 1: Report individual EP's CQMs through PQRS Portal
++ Option 2: Report group's CQMs through PQRS Portal
We note that under option 2, this may include an EP reporting using the group reporting option, either electronically using QRDA, or via the GPRO Web Interface.
• Eligible hospital and CAH Options for Medicare EHR Incentive Program Participation
++ Option 1: Attest to CQMs through the EHR Registration & Attestation System
++ Option 2: Electronically report CQMs through QualityNet Portal
• Eligible hospital and CAH Options for Electronic Reporting for Multiple Programs
++ Electronically report through QualityNet Portal
For the Medicaid EHR Incentive Program, we stated that states would continue to be responsible for determining whether and how electronic reporting of CQMs would occur, or if they wish to allow reporting through attestation. Any changes that states make to their CQM reporting methods must be submitted through the State Medicaid Health IT Plan (SMHP) process for our review and approval prior to being implemented.
We proposed to maintain the existing CQM reporting requirements of nine CQMs covering at least three NQS domains for EPs and 16 CQMs covering at least three NQS domains for eligible hospitals and CAHs (77 FR 54058 for EPs and 77 FR 54056 for eligible hospitals and CAHs).
Beginning in 2015, we proposed to change the definition of “EHR reporting period” in § 495.4 for eligible hospitals and CAHs such that the EHR reporting period would begin and end in relation to a calendar year. In connection with this proposal, we also proposed that in 2015 and for all methods of reporting, eligible hospitals and CAHs would be required to complete a reporting period for clinical quality measures aligned with the calendar year in order to demonstrate meaningful use.
For 2015 only, we proposed to change the EHR reporting period for all EPs, eligible hospitals, and CAHs to any continuous 90-day period within the calendar year. In connection with this proposal, we proposed a 90-day reporting period in 2015 for clinical quality measures for all EPs, eligible hospitals, and CAHs that report clinical quality measures by attestation. We proposed that EPs may select any continuous 90-day period from January 1, 2015 through December 31, 2015, while eligible hospitals and CAHs may select any continuous 90-day period from October 1, 2014 through December 31, 2015, to report CQMs via attestation using the EHR Incentive Program registration and attestation system. We proposed that a provider may choose to attest to a CQM reporting period of greater than 90 days up to and including 1 full calendar year of data.
We further proposed to continue our existing policy that providers in any year of participation for the EHR Incentive Programs for 2015 through 2017 may instead electronically report CQM data using the options previously outlined for electronic reporting either for single program participation in the Medicare EHR Incentive Programs, or for participation in multiple programs if the requirements of the aligned quality program are also met. We noted that EPs seeking to participate in multiple programs with a single electronic submission would be required to submit a full calendar year of CQM data using
We noted that an EHR certified for CQMs under the 2014 Edition certification criteria does not need to be recertified each time it is updated to a more recent version of the eCQMs.
After consideration of the public comments, we are finalizing all of the proposals discussed previously as proposed. We note that after these proposals were published, we published the August 17, 2015 FY 2016 IPPS final rule (80 FR 49756 through 49761), which includes additional final policies for eligible hospitals and CAHs reporting CQMs in 2016 for the Medicare EHR Incentive Program.
In the Stage 3 proposed rule (80 FR 16768), we noted that to further our goals of alignment and avoiding redundant or duplicative reporting across the various CMS quality reporting programs, we intend to address CQM reporting requirements for the Medicare and Medicaid EHR Incentive Program for EPs for 2017 and subsequent years in the Medicare Physician Fee Schedule (PFS) rulemaking, which also establishes the requirements for PQRS and other quality programs affecting EPs. We noted that the form and manner of reporting of CQMs for Medicare EPs would also be included in the PFS, while for Medicaid we would continue to allow the states to determine form and method requirements subject to CMS approval.
We proposed to continue the policy of establishing certain CQM requirements
After consideration of the public comments we received, we intend to continue our policy of establishing certain CQM requirements that apply for both the Medicare and Medicaid EHR Incentive Programs, including a common set of CQMs and the reporting periods for CQMs. We intend to address CQM reporting requirements for the Medicare and Medicaid EHR Incentive Programs for EPs in the PFS rulemaking. We intend to continue to allow the states to determine form and manner of reporting CQMs for their respective state Medicaid EHR Incentive Programs subject to CMS approval.
In the Stage 3 proposed rule (80 FR 16769), similar to our intentions for EPs discussed previously, we noted that to further our alignment goal among CMS quality reporting programs for eligible hospitals and CAHs, and avoid redundant or duplicative reporting among hospital programs, we intend to address CQM reporting requirements for the Medicare and Medicaid EHR Incentive Program for eligible hospitals and CAHs for 2016, 2017, and future years, in the Inpatient Prospective Payment System (IPPS) rulemaking. We stated that we intend to include all Medicare EHR Incentive Program requirements related to CQM reporting in the IPPS rulemaking including, but not limited to, new program requirements, reporting requirements, reporting and submission periods, reporting methods, and information regarding the CQMs.
As with EPs, for the Medicaid EHR Incentive Program we would continue to allow the states to determine form and method requirements subject to CMS approval. We proposed to continue the policy of establishing certain CQM requirements that apply for both the Medicare and Medicaid EHR Incentive Programs including a common set of CQMs and the reporting periods for CQMs in the EHR Incentive Programs.
After consideration of the public comments we received, we intend to continue our policy of establishing certain CQM requirements that apply for both the Medicare and Medicaid EHR Incentive Programs, including a common set of CQMs and the reporting periods for CQMs. We intend to address CQM reporting requirements for the Medicare and Medicaid EHR Incentive Programs for eligible hospitals and CAHs in the IPPS rulemaking. We intend to continue to allow the states to determine form and manner of reporting CQMs for their respective state Medicaid EHR Incentive Programs subject to CMS approval.
In the Stage 3 proposed rule (80 FR 16771), we proposed to remove the QRDA-III option for eligible hospitals and CAHs, as we believe the CQM calculations, per the QRDA-III, are not advantageous to quality improvement in a hospital setting. We noted that as the EHR Incentive Programs further aligns with the Hospital IQR Program, we intend to continue utilizing the electronic reporting standard of QRDA-I patient level data that we finalized in the FY 2015 IPPS rule (79 FR 50322), which will allow the same level of CQM reporting, and use and analysis of these data for quality improvement initiatives.
We also proposed that states would continue to have the option, subject to our prior approval, to allow or require QRDA-III for CQM reporting.
We received comments regarding these proposals in response to the Stage 3 proposed rule, as well as comments regarding the QRDA-III option in response to the FY 2016 IPPS/LTCH PPS proposed rule. We considered these comments and responded to them in the FY 2016 IPPS/LTCH PPS final rule, and we finalized our proposal to remove the QRDA-III as an option for reporting under the Medicare EHR Incentive Program. We stated that for 2016 and future years, we are requiring QRDA-I for CQM electronic submissions for the Medicare EHR Incentive Program. We also noted that states would continue to have the option, subject to our prior approval, to allow or require QRDA-III for CQM reporting. For more information, we refer readers to the discussion in the FY 2016 IPPS/LTCH PPS final rule (80 FR 49759 through 49760).
In the Stage 3 proposed rule (80 FR 16773), we proposed to require an EHR reporting period of one full calendar year for meaningful use for providers participating in the Medicare EHR Incentive Program, with a limited exception for Medicaid providers demonstrating meaningful use for the first time (80 FR 16779). We proposed to require the same length for the CQM reporting period for EPs, eligible hospitals, and CAHs beginning in 2017. We proposed a limited exception for Medicaid providers demonstrating meaningful use for the first time who would have a CQM reporting period of any continuous 90 days that is the same 90-day period as their EHR reporting period.
We proposed to require a CQM reporting period of one full calendar year for all EPs participating in the Medicare and Medicaid EHR Incentive Program, with a limited exception for Medicaid providers demonstrating meaningful use for the first time who would have a CQM reporting period of any continuous 90 days that is the same 90-day period as their EHR reporting period. We proposed these reporting periods would apply beginning in CY 2017 for all EPs participating in the EHR Incentive Program.
Note that there is also a 90-day EHR reporting period permitted in 2017 for EPs participating for the first time in either the Medicare or Medicaid EHR Incentive Programs. Consistent with prior program years, we are permitting EPs participating for the first time in 2017 to use a 90-day reporting period for CQMs.
After considering the public comments we received, we are finalizing our proposal to require a CQM reporting period of one full calendar year for EPs participating in the Medicare and Medicaid EHR Incentive Programs starting in 2017. We are finalizing with modification our proposal of a limited exception for EPs demonstrating meaningful use for the first time under the Medicaid EHR Incentive Program. For these EPs, the reporting period for CQMs would be any continuous 90-day period within the CY, with the modification that it could be a different 90-day period than their EHR reporting period for the incentive payment under Medicaid.
For eligible hospitals and CAHs in 2017 and subsequent years, in the Stage 3 proposed rule (80 FR 16770)we proposed to require a reporting period of one full calendar year which consists of 4 quarterly data reporting periods for providers participating in the Medicare and Medicaid EHR Incentive Program, with a limited exception for Medicaid providers demonstrating meaningful use for the first time who would have a CQM reporting period of any continuous 90 days that is the same 90-day period as their EHR reporting period. We stated that more details of the form and manner will be provided in the IPPS rulemaking cycle.
While we are allowing a 90-day EHR reporting period for eligible hospitals and CAHs who demonstrate Stage 3 in 2017, we do not believe it is necessary to similarly allow returning participants who are participating in Stage 3 to also use a 90-day reporting period for CQMs for 2017. The shorter reporting period for Stage 3 participants is intended to ease the transition to the new Stage 3 objectives and measures and higher thresholds. There is no such difference between the CQM requirements for Stage 3 participation in 2017 versus participation meeting the objectives and measures outlined for use in 2015 through 2017 in section II.B.2.a. of this final rule with comment period.
Note that there is also a 90-day EHR reporting period permitted in 2017 for eligible hospitals and CAHs participating for the first time in either the Medicare or Medicaid EHR Incentive Programs. Consistent with prior program years, we are permitting eligible hospitals and CAHs
After consideration of the public comments that we received, we are finalizing our proposal to require a reporting period of one full calendar year which consists of 4 quarterly data reporting periods starting in 2017 for eligible hospitals and CAHs participating in the Medicare and Medicaid EHR Incentive Program. We are finalizing with modification our proposal of a limited exception for eligible hospitals and CAHs demonstrating meaningful use for the first time under the Medicaid EHR Incentive Program. For these eligible hospitals and CAHs, the reporting period for CQMs would be any continuous 90-day period within the CY, with the modification that it could be a different 90-day period than their EHR reporting period for the incentive payment under Medicaid. More details of the form and manner will be provided in the IPPS rulemaking cycle.
We proposed that EPs, eligible hospitals, and CAHs would be able to have more flexibility to report CQMs in one of two ways in 2017—via electronic reporting or attestation (80 FR 16770). First EPs, eligible hospitals, and CAHs may choose to report eCQMs electronically using the CQMs finalized for use in 2017 using the most recent version of the eCQMs (electronic specifications), which would be the electronic specifications of the CQMs published by CMS in 2016. Alternately, a provider may choose to continue to attest also using the most recent (2016 version) eCQM electronic specifications.
After consideration of these public comments, we are finalizing this policy as proposed.
In the Stage 3 proposed rule (80 FR 16770), starting in 2017, we proposed to continue to encourage electronic submission of CQM data for all EPs, eligible hospitals, and CAHs where feasible. However, as outlined in section II.C.1.b. of the Stage 3 proposed rule (80 FR 16770), we would allow attestation for CQMs in 2017.
For 2018 and subsequent years, we proposed that providers participating in the Medicare EHR Incentive program must electronically report where feasible and that attestation to CQMs would no longer be an option except in certain circumstances where electronic reporting is not feasible. This would include providers facing circumstances which render them unable to electronically report (such as a data submission system failure, natural disaster, or certification issue outside the control of the provider) who may attest to CQMs if they also attest that electronically reporting was not feasible for their demonstration of meaningful use for a given year. We noted that we intend to address the form and manner of electronic reporting in future Medicare payment rules.
For the Medicaid EHR Incentive Program, as in the Stage 2 rulemaking (77 FR 54089), we proposed that states would continue in Stage 3 to be responsible for determining whether and how electronic reporting of CQMs would occur, or whether they wish to continue to allow reporting through attestation. If a state does require such electronic reporting, the state is responsible for sharing the details of the process with its provider community. We proposed for Stage 3 that the states would establish the method and requirements, subject to our prior approval, for the electronic capture and reporting of CQMs from CEHRT. We have included Table 17 in this final rule with comment period as a summary of our proposals (80 FR 16770).
We are finalizing our policy as proposed, that in 2017 all providers have two options to report CQM data, either through attestation or through use of established methods for electronic reporting where feasible. Starting in 2018, providers participating in the Medicare EHR Incentive Program must electronically report where feasible and that attestation to CQMs would no longer be an option except in certain circumstances where electronic reporting is not feasible. We are also finalizing our proposal that for the Medicaid EHR Incentive Program states would continue to be responsible for determining whether and how electronic reporting of CQMs would occur, or whether they wish to continue to allow reporting through attestation. We note that if a state does require such electronic reporting, the state is responsible for sharing the details of the process with its provider community. We also note that the states would establish the method and requirements, subject to our prior approval, for the electronic capture and reporting of CQMs from CEHRT.
In the Stage 3 proposed rule (80 FR 16771), we recognized that it may be necessary to update CQM specifications after they have been published to ensure their continued clinical relevance, accuracy, and validity. CQM specification updates may include administrative changes, such as adding the NQF endorsement number to a CQM, correcting faulty logic, adding or deleting codes as well as providing additional implementation guidance for a CQM. These changes are described through the annual updates to the electronic specifications for EHR submission published by CMS. Because we require the most recent version of the CQM specifications to be used for electronic reporting methods, we understand that EHR vendors must make CQM updates on an annual basis and providers must regularly implement those updates to stay current with the most recent CQM version.
In the Stage 3 proposed rule (80 FR 16771), we proposed no changes to our policy on updating CQM specifications. However, we stated that we will continue to evaluate the CQM update timeline and look for ways to provide CQM updates timely, so that vendors can develop, test, and deploy these updates and providers can implement those updates as necessary.
We received many comments in response to our request for comments. However, we note that we did not make any specific proposal in regard to the annual update process for CQMs.
In the 2014 Edition EHR Certification Criteria Final Rule, ONC finalized certain certification criteria to support the meaningful use objectives and CQMs set forth by CMS. In that rule, ONC also specified that in order for an EP, eligible hospital, or CAH to have EHR technology that meets the Base EHR definition, the EHR technology must be certified to a minimum of nine CQMs for EPs or 16 CQMs for eligible hospitals and CAHs (77 FR 54264 through 54265; see also 45 CFR 170.102). This is the same number required for quality reporting to the Medicare and Medicaid EHR Incentive Programs, the PQRS EHR reporting and, beginning in 2015, the electronic reporting option under the Hospital IQR Program.
As stated in the Stage 3 proposed rule (80 FR 16771 through 16772), we believe EHRs should be certified to more than the minimum number of CQMs required by one or more CMS quality reporting programs so that EPs, eligible hospitals, and CAHs have a choice of which CQMs to report, and could therefore choose to report on CQMs most applicable to their patient population or scope of practice.
We realize that requiring EHRs to be certified to more than the minimum number of CQMs required by the Medicare and Medicaid EHR Incentive Programs may increase the burden on EHR vendors. However, in the interest of EPs, eligible hospitals, and CAHs being able to choose to report eCQMs that represent their patient populations, we would like to see EP vendors certify to all eCQMs that are in the EP selection list, or eligible hospital/CAH vendors certify to all eCQMs in the selection list for those stakeholders.
We are also considering a phased approach such that the number of CQMs required for the vendors to have certified would increase each year until EHR products are required to certify all CQMs required for reporting by EPs, eligible hospitals, and CAHs. For example, in year one of this phased plan, we might require that EHRs be certified to at least 18 of 64 available CQMs for EPs and 22 of 29 available CQMs for eligible hospitals and CAHs; in year two, we might require at least 36 CQMs for EPs and all 29 CQMs for eligible hospitals and CAHs; in subsequent years of the plan, we would increase the number of required CQMs for EPs until the EHR is certified to all applicable CQMs for EPs, eligible hospitals, and CAHs.
We have also considered alternate plans that would require EHRs to be certified to more than the minimum number of CQMs required for reporting, but would not require the EHR to be certified to all available CQMs. For example, we might require that EHRs be certified to a certain core set of CQMs plus an additional 9 CQMs for EPs, and a certain core set of CQMs plus an additional 16 CQMs for eligible hospitals and CAHs, which the EHR vendor could choose from the list of available CQMs.
We note that the specifics of this plan would be outlined in separate notice-and-comment rulemaking such as the PFS or IPPS rules. In the Stage 3 proposed rule (80 FR 16771 through 16772), we sought comment on a plan to increase the number of CQMs to which an EHR is certified.
A few commenters opposed any plan to require a certain number of CQMs to which EHRs must be certified stating that EHR vendors should be allowed to choose CQMs based on their provider population or specialty product. Some commenters opposed the plan to certify to all CQMs because of the burden it would place on EHR vendors, and because it would force EHRs to be certified to CQMs that are not relevant to the EHR's provider population. Other commenters expressed concern about a plan to certify to all CQMs, even in a phased approach, because they were unclear about the number and quality of the CQMs to be included in future years of the EHR Incentive Program. Lastly, some commenters expressed concern about the burden this plan could place on EPs, eligible hospitals, and CAHs because of the added effort it would take to implement these measures in their provider setting.
As previously stated in the Medicare and Medicaid EHR Incentive Programs Stage 2 final rule (77 FR 54051 through 54053) and restated in the Stage 3 proposed rule (80 FR 16772), CQM data submitted by EPs, eligible hospitals, and CAHs are required to be captured, calculated, and reported using certified EHR technology. We do not consider the manual abstraction of data from a patient's chart to be capturing the data using certified EHR technology. We believe that electronic information interfaced or electronically transmitted from non-certified EHR technology, such as lab information systems, automated blood pressure cuffs, and electronic scales, into the certified EHR, would satisfy the “capture” requirement, as long as that data is visible to providers in the EHR.
In the EHR Incentive Programs for 2015 through 2017 and the Stage 3 proposed rules, we proposed to continue our common method for demonstrating meaningful use in both the Medicare and Medicaid EHR Incentive Programs (80 FR 20376 and 80 FR 16772). The demonstration methods we adopt for Medicare will automatically be available to the states for use in their Medicaid programs.
As mentioned previously in section II.B.1.b.(2). of this final rule with comment period, we are redesignating the numbering of certain sections of the regulation text under part 495. In prior rules, we defined the criteria for the demonstration of meaningful use at § 495.8, which is redesignated as § 495.40. We defined the criteria for the demonstration of meaningful use at § 495.40, including references to the objectives and measures as well as the requirement to report CQMs. In order to demonstrate meaningful use in 2015 through 2017, we proposed (80 FR 20374) that the requirements at § 495.40 include a reference to the objectives and measures for 2015 through 2017 outlined at § 495.22 which the provider must satisfy (80 FR 20376).
We proposed to continue the use of attestation as the method for demonstrating that an EP, eligible hospital, or CAH has met the objectives and measures of meaningful use. Instead of individual Medicare EP attestation through the CMS Registration and Attestation System, we also proposed to continue the existing optional batch file process for attestation. Further, we proposed changes to the deadlines for EPs, eligible hospitals, and CAHs to demonstrate meaningful use in 2015 and 2016; as well as specific changes to the deadlines for providers to demonstrate meaningful use for the first time in 2015 and 2016 in order to avoid a payment adjustment in the subsequent year.
After consideration of the comments received, we are finalizing our proposal to maintain attestation as the demonstration method for EHR reporting periods in 2015 through 2017 and the corresponding regulation text at § 495.40.
In the EHR Incentive Program in 2015 through 2017 proposed rule (80 FR 20376), we proposed changes to the attestation deadlines for eligible hospitals and CAHs in connection with the proposal that these providers must complete an EHR reporting period between October 1, 2014 and the end of the calendar year (CY) on December 31, 2015, and complete an EHR reporting period for 2016 between January 1, 2016 and December 31, 2016. Specifically, we proposed changes to the attestation deadlines as follows:
• For an EHR reporting period in 2015, an eligible hospital or CAH must attest by February 29, 2016.
• For an EHR reporting period in 2016, an eligible hospital or CAH must attest by February 28, 2017.
In addition, we noted that providers would not be able to attest for an EHR reporting period in 2015 prior to January 1, 2016 in order to allow adequate time to make the system changes necessary to accept attestations. This change would not delay incentive payments for Medicare EPs because 2015 cannot be an EP's first payment year under section 1848(o)(1)(B)(v) of the Act. Thus, all EPs who qualify for an incentive payment for 2015 would be returning participants in the program and would have had the full CY 2015 as their EHR reporting period under our current policy. We received the following comments and our response follows:
We refer the commenter to sections II.B.1.b.(4).(a). and II.E. of this final rule with comment period for an explanation of when in 2015 the 90-day EHR reporting period and EHR reporting period for a payment adjustment year may occur. We further note that CMS will not be accepting attestations for an EHR reporting period in 2015 and subsequent years for any objective or measure which has been removed in this final rule with comment period in section II.B.1.b.(4).(b).
After consideration of the comments received, we are finalizing the attestation deadlines for meaningful use in 2015 and 2016 as proposed. We note that any EP, eligible hospital or CAH that attested to meaningful use for the first time under Medicare or Medicaid for an EHR reporting period in 2015 prior to the effective date of this final rule with comment period will not be required to submit a new attestation.
In § 495.4, the definition of an EHR reporting period for a payment adjustment year establishes special deadlines for attestation for EPs and eligible hospitals that are demonstrating meaningful use for the first time in the year immediately preceding a payment adjustment year. In the EHR Incentive Programs in 2015 through 2017 proposed rule (80 FR 20376), we noted that we are proposing a later deadline for attestation for 2015 only to allow enough time for all providers to complete a 90-day EHR reporting period after the anticipated effective date of the final rule. We proposed changes to the attestation deadlines for purposes of the payment adjustment years for EPs, eligible hospitals, and CAHs in the EHR Incentive Programs in 2015 through 2017 proposed rule at 80 FR 20380 and 20381. We address those proposals and respond to the comments received in section II.E.2. of this final rule with comment period.
We proposed to continue the use of attestation as the method for demonstrating that an EP, eligible hospital, or CAH has met the Stage 3 objectives and measures. We proposed to continue the existing optional batch file process for attestation in lieu of individual Medicare EP attestation through our registration and attestation system. This batch reporting process ensures that the objectives and measures of the program and the use of certified EHR technology continues to be measured at the individual level, while promoting efficiencies for group practices that must submit attestations on large groups of individuals (77 FR 54089).
We stated that we would continue to leave open the possibility for CMS and the states to test options for demonstrating meaningful use that utilize existing and emerging HIT products and infrastructure capabilities. These options could involve the use of registries or the direct electronic reporting of measures associated with the objectives. We would not require any EP, eligible hospital, or CAH to participate in this testing in order to receive an incentive payment or avoid the payment adjustment.
For 2017 only, we proposed changes to the attestation process for the meaningful use objectives and measures, which would allow flexibility for providers during this transitional year (80 FR 16772).
After consideration of the comments received, we are finalizing our proposal to maintain attestation as the method of demonstration of meaningful use for the EHR Incentive Programs for 2017 and
In the Stage 3 proposed rule (80 FR 16772), in order to allow all providers to successfully transition to Stage 3 of the EHR Incentive Programs for a full year-long EHR reporting period in 2018, we proposed to allow flexibility for the EHR Incentive Programs in 2017. We stated that this transition period would allow providers to establish and test their processes and workflows for Stage 3 of the EHR Incentive Programs prior to 2018. Specifically, for 2017, we proposed that providers may either repeat a year at their current stage or move up stage levels. We also proposed that for 2017, a provider may not move backward in their progression and that providers who participated in Stage 1 in 2016 may choose to attest to the Stage 1 objective and measures, or they may move on to Stage 2 or Stage 3 objectives and measures for an EHR reporting period in 2017. Providers who participated in Stage 2 in 2016 may choose to attest to the Stage 2 objectives and measures or move on to Stage 3 objectives and measures for an EHR reporting period in 2017. However, under no circumstances may providers return to Stage 1.
Finally, we proposed that in 2018, all providers, regardless of their prior participation or the stage level chosen in 2017, would be required to attest to Stage 3 objectives and measures for an EHR reporting period in 2018.
After consideration of public comment received, we are finalizing our proposal with modifications to allow providers to attest to the Stage 3 objectives and measures defined at § 495.24 for an EHR reporting period in 2017 instead of the objectives and measures for 2015 through 2017 defined at § 495.22 if they so choose.
In the Stage 3 proposed rule (80 FR 16772 through 16773), we also proposed to allow providers flexible CEHRT options for an EHR reporting period in 2017 and noted that these options may impact the selection of objectives and measures to which a provider can attest. Specifically, under the CEHRT options for 2017, we proposed that providers would have the option to continue to use EHR technology certified to the 2014 Edition, in whole or in part, for an EHR reporting period in 2017. We noted that providers who use only EHR technology certified to the 2014 Edition for an EHR reporting period in 2017 may not choose to attest to the Stage 3 objectives and measures as those objectives and measures require the support of EHR technology certified to the 2015 Edition. We further explained this proposal at 80 FR 16773 stating that providers using only EHR technology certified in whole or in relevant part to the 2014 Edition certification criteria may attest to the Stage 1 or Stage 2 objectives and measures; and, providers using EHR technology certified in whole or in relevant part to the 2015 Edition certification criteria may elect to attest to the Stage 1 or Stage 2 objectives and measures or to the Stage 3 objectives and measures if they have all the 2015 Edition functionality required to meet all Stage 3 objectives.
We noted that all providers would be required to fully upgrade to EHR technology certified to the 2015 Edition for the EHR reporting period in 2018. We also reiterated that providers may elect to attest to Stage 3 of the program using EHR technology certified to the 2015 Edition beginning in 2017. Finally, in the Stage 3 proposed rule we stressed that the use of 2011 CEHRT, although an option under the 2014 CEHRT Flexibility final rule (79 FR 52913 through 52914), is not an option under this proposal (80 FR 16773).
We sought comment on this flexibility option including alternate flexibility options and received the following comments on these proposals and our response follows:
However, we do reiterate that a provider must have the necessary functions certified to the 2015 Edition in order to successfully demonstrate Stage 3 if they so choose. As discussed in section II.B.3. of this final rule with
We believe providing flexibility in 2017 will allow for an easier transition and full scale upgrade to EHR technology certified to the 2015 Edition for participation in 2018. We did not propose an extension of this flexibility into 2018 as we are committed to moving toward a single streamlined program to support long term sustainability and reduce the overall complexity for providers participating in the EHR Incentive Programs. We note that, as mentioned in section II.B.1.b.(3). of this final rule with comment period, we are finalizing a 90-day EHR reporting period for providers demonstrating Stage 3 in 2017 to further support providers seeking to move to Stage 3 in 2017.
After consideration of the comments received, we are finalizing a modification to our proposal to allow providers using EHR technology certified to the 2015 Edition, in whole or in part, the option to attest to Stage 3 objectives and measures if they have the relevant CEHRT modules certified to the 2015 Edition certification criteria necessary to support Stage 3. (See Tables 14, 15, 16 in section II.B.3. for more information about which modules support specific Stage 3 objectives and measures.) We further note that CMS will not be accepting attestations for an EHR reporting period in 2015 and subsequent years for any objective or measure which has been removed in this final rule with comment period in section II.B.1.b.(4).(b). Further we reiterate that certification to the 2011 Edition is no longer valid for use in the EHR Incentive Programs and a provider may not attest to a system with that certification in any year after 2014. Finally, we note that providers using only EHR technology certified to the 2014 Edition may not attest to the Stage 3 objectives and measures for an EHR reporting period in 2017. Therefore, we reiterate the following options for providers for Stage and CEHRT flexibility for an EHR reporting period in 2017:
Providers using only EHR technology certified in whole or in relevant part to the2014 Edition certification criteria may attest to the objectives and measures of meaningful use defined at § 495.22.
Providers using EHR technology certified in relevant parts to the2014 Edition certification criteria and EHR technology certified in relevant parts to the 2015 Edition certification criteria may elect to:
• Attest to the objectives and measures at § 495.22.
• Attest to the Stage 3 objectives and measures at § 495.24 if they have the 2015 Edition functionality required to meet the Stage 3 objectives and measures. (See Tables 14, 15, and 16 in section II.B.3. for more information about which modules support specific Stage 3 objectives and measures.)
Providers using only EHR technology certified in whole or in relevant parts to the 2015 Edition certification criteria may elect to:
• Attest to the objectives and measures at § 495.22.
• Attest to the Stage 3 objectives and measures at § 495.24.
We are adopting these policies at § 495.40 with references to the objectives and measures outlined in § 495.22 and § 495.24 for the applicable years.
In the Stage 3 proposed rule (80 FR 16773), we proposed to allow greater flexibility by proposing to split the use of CEHRT for CQM reporting from the use of CEHRT for the objectives and measures for 2017. This means that providers would be able to separately report CQMs using EHR technology certified to the 2015 Edition even if they use EHR technology certified to the 2014 Edition for the meaningful use objectives and measures for an EHR reporting period in 2017. Providers may also use EHR technology certified to the 2015 Edition for their meaningful use objectives and measures in 2017 and use EHR technology certified to the 2014 Edition for their CQM reporting for an EHR reporting period in 2017.
For an EHR reporting period in 2017, we proposed that EPs, eligible hospitals, and CAHs may choose to report eCQMs electronically using the CQMs finalized for use in 2017 using the most recent version of the eCQMs (electronic specifications), which would be the electronic specifications of the CQMs published by CMS in 2016, or a provider may choose to continue to attest to the CQMs established for use in 2017 also using the most recent (2016 version) eCQM electronic specifications.
Similar to our rationale under the 2014 CEHRT Flexibility final rule (79 FR 52910 through 52933), we stated that we believe the proposals outlined for attestation in 2017 would allow providers the flexibility to choose the option which applies to their particular circumstances and use of CEHRT (80 FR 16773). We proposed that upon attestation, providers may select one of the proposed options available for their participation year and EHR Edition, and the EHR Incentive Program Registration and Attestation System would then prompt the provider to attest to meeting the objectives, measures, and CQMs applicable under that option. We further proposed that auditors would be provided guidance related to reviewing attestations associated with the options for using CEHRT in 2017, as was done for 2014.
We received comments related to the reporting requirements for CQMs, which are addressed in section II.C. of this final rule with comment period. We also received a number of questions and comments on reporting clinical quality measures for the Medicaid program, which are addressed in section II.C. and II.G. of this final rule with comment period. We received no comments specific to the demonstration of these requirements beyond those previously addressed in section II.D.1.(e).(1). and (2) of this final rule with comment period in relation to the selection of stage, the selection of certified EHR technology, and the overall demonstration of meaningful use in 2017 and subsequent years via attestation.
We are finalizing as proposed the policy to allow providers the flexibility to electronically report CQMs or to attest to CQMs using either EHR technology certified to the 2014 Edition or EHR technology certified to the 2015 Edition, independently of the Edition they use for their objectives and measures for an EHR reporting period in 2017. For further discussion of this final
In the EHR Incentive Programs in 2015 through 2017 proposed rule (80 FR 20377), we proposed that certain Medicaid EPs would have the option of attesting through the EHR Incentive Program Registration and Attestation system for the purpose of avoiding the Medicare payment adjustment. This alternate method would allow EPs who have previously received an incentive payment under the Medicaid EHR Incentive Program (for either AIU or meaningful use) to demonstrate that they are meaningful EHR users in situations where they fail to meet the eligibility criteria for the Medicaid EHR Incentive Program in a subsequent year.
We note that Medicaid EPs can avoid the Medicare payment adjustment by successfully demonstrating meaningful use to the state Medicaid agency under the Medicaid EHR Incentive Program, even if it occurs after the Medicare attestation period closes, as long as the attestation is accepted by the state. It would then be the state's responsibility to include that EP in the quarterly report on meaningful users, which we discuss in section II.G. of this final rule with comment period.
Attestations from Medicaid EPs that come through the CMS registration and attestation system will be treated the same as other provider attestations that are submitted to that system for purposes of data sharing. We recognize that states collect, analyze, and use EHR Incentive Program attestation information for a number of purposes, such as informing other state programs and making policy decisions. However, we will not send information from those attestations to states, consistent with preceding practice.
We reiterate that an EP's attestation using this alternate method would not constitute a switch from the Medicaid EHR Incentive Program to the Medicare EHR Incentive Program. For the purposes of the Medicaid EHR Incentive Program, an EP's use of this alternate method would be treated the same as if the EP had not attested to meaningful use for that year. For an EP who uses this alternate method, their EHR reporting period in a subsequent year for the Medicaid EHR Incentive Program would be determined without regard to any previous attestations using this alternate method. For example, an EP could still have a 90-day EHR reporting period for the Medicaid EHR Incentive Program for their first year of demonstrating meaningful use even though they had demonstrated meaningful use through this alternate method in a previous year.
• For an EHR reporting period 2015, an EP who has not successfully attested to AIU or meaningful use in either the Medicare or Medicaid program may use the alternate attestation option under the Medicare EHR Incentive Program to avoid a payment adjustment in 2016 and 2017. This EP cannot qualify for an incentive payment under Medicare for 2015 because 2014 is the last first year that an EP may begin receiving Medicare incentive payments under section 1848(o) of the Act. The EP may attest to meaningful use in the Medicaid program for an EHR reporting period in 2016 if they meet the eligibility and other requirements for the Medicaid EHR Incentive Program.
• A provider may not use the alternate attestation option to attest to meaningful use in Medicare to avoid a payment adjustment in conjunction with an attestation for an incentive payment for AIU in the Medicaid program in the same year.
After consideration of the comments received, we are finalizing the proposal for this alternate method of demonstrating meaningful use for certain Medicaid EPs to avoid the Medicare payment adjustment with a modification allowing the alternate attestation for new participants in 2015 as described previously.
We proposed to continue posting Stage 1 and Stage 2 aggregate and individual performance and participation data resulting from the EHR Incentive Programs online regularly for public use. We further noted our intent to potentially publish the performance and participation data on Stage 3 objectives and measures of meaningful use in alignment with quality programs, which utilize publicly available performance data such as Physician Compare.
In addition to the data already being collected under our regulations, as outlined in the Stage 3 proposed rule (80 FR 16774), we proposed to collect the following information from providers to ensure providers keep their information up-to-date through the system of record for their NPI in the NPPES:
• Primary Practice Address (address, city, state zip, country code, etc.).
• Primary Business/Billing Address (address, city, state, zip, country code, etc.).
• Primary License information (for example, provide medical license in at least one state (or territory)).
• Contact Information (phone number, fax number, and contact email address).
• Health Information Exchange Information:
++ Such as DIRECT address required (if available).
++ If DIRECT address is not available, Electronic Service Information is required.
++ If DIRECT address is available, Electronic Service Information is optional in addition to DIRECT address.
We did not propose any changes to the registration for the Medicare and Medicaid EHR Incentive Programs.
We received the following comments and our response follows:
After consideration of the public comments received, we are finalizing these proposals as proposed.
As noted in the EHR Incentive Programs in 2015 through 2017 proposed rule (80 FR 20378), several hospital associations, individual providers, and other stakeholders have raised concerns with our current definition of a hospital-based EP. Specifically, these stakeholders asserted that the limitation of hospital-based POS codes 21 and 23, covering inpatient and emergency room settings only, does not adequately capture all settings where services might be furnished by a hospital-based EP. They stated that POS 22, which covers an outpatient hospital place of service, is also billed by hospital-based EPs, especially in relation to certain CPT codes. These stakeholders expressed the belief that our current definition of hospital-based EP in the regulations is too narrow and will unfairly subject many EPs who are not hospital-based under our definition, but whom stakeholders would consider to be hospital-based, to the downward payment adjustment under Medicare in 2015. Accordingly, these stakeholders recommended that we consider adding additional place of service codes or settings to the regulatory definition of hospital-based EP. We noted that we appreciate this feedback from stakeholders and requested public comment on our current definition of a hospital-based EP under § 495.4 for the EHR Incentive Programs. We sought public comment on whether additional place of service codes or settings should be included in our definition of a hospital-based EP. In addition, we sought comments on whether and how the inclusion of additional POS codes or settings in our definition of hospital-based EP might affect the eligibility of EPs for the EHR incentive payments under Medicare or Medicaid.
We received the following comments and our response follows:
On the hospital side, a commenter expressed support for a change in the hospital-based designation because they are currently struggling with the hospital-based designation for the inclusion of services provided in hospital settings by providers who are designated EPs and that the hospital performance on the measures would be higher if these patient encounters were included. The provider recommended that all POS codes should be revisited and the requirements for hospital-based eligibility could be expanded to include all hospital-based POS codes that are rendered in the hospital settings including rehabilitation hospitals and hospital observations, which are otherwise not included in the numerators of their percentages.
Commenters in support of a change were split on when such a change should be implemented. A commenter recommended that CMS change its definition beginning with 2017. Other commenters believe that CMS should retroactively make this correction, and refund physicians who were penalized because of this issue stating physicians who use POS 22 typically are using the hospital-based EHR during the patient observation period, and should not be penalized.
Many commenters opposed any change in the hospital-based designation. Some commenters stated that this proposal could compromise the purpose of the program. A commenter stated that changing the definition of hospital-based eligible professional at this time in the program could encourage fraud. If an EP who was previously eligible for the incentive would now be ineligible for payment adjustments due to the change, this would be unfair. Some commenters stated that redefining EP by once again including POS 22 in the “hospital” definition would not be reasonable so long as provider-based billing exists. The commenter suggested considering some combination of place of service and NPPES classification which does not exclude the large base of ambulatory providers who bill provider based.
Another commenter stated that including POS 22 in the definition of a hospital-based EP could have major implications for the eligible hospital numerators and denominators. Additionally, the design and implementation of the various parts of a hospital's EHR system would have to be redesigned in order to change the status in addition to changing work flows and training to match that change, which would drastically impact the hospital's ability to meet the measures as well as their overall IT expenditures.
Some commenters stated that adding POS 22 or another change to the designation may undermine the current understanding of the program and would require additional education and guidance to ambulatory providers who have already successfully attested. A commenter stated that they do not support re-classifying services provided in an outpatient hospital (POS 22) setting as hospital-based because of a concern that expanding the hospital-based definition to reduce the number of EPs for EHR Incentives may inhibit continuous hospital investments in ambulatory EHRs. The commenter noted that the ambulatory EHR space is an important component to the overall HIT ecosystem and that CMS should encourage investment in this area by excluding outpatient services from the hospital-based calculation. The commenter stated that the current definition of a hospital-based provider is consistent with the hospital's payment calculation, which is based on inpatient discharges and emergency department services, and is consistent with the collection of EHR Incentive Program information for hospitals. The commenter continued by stating that if CMS included POS 22 services in the hospital-based provider definition, CMS would need to revisit whether the inclusion of these services affects the hospital payment calculation and collection of EHR Incentive Program encounters for hospitals. Another commenter expressed a similar concern that changing the hospital-based designation may have unintended consequences on the hospital payment calculation, necessitating adjustments to all payments made to date if CMS chooses to make a change to the definition of hospital based.
Other commenters stated this is a very complex issue and sought further clarification on the impact of a potential change, noting organizations that have many subspecialists who see patients in the hospital outpatient setting using an office or ambulatory workflow and that these providers may be required to bill with POS 22 due to the physical location of their offices. The commenter stated that the majority of these EPs are currently meeting the requirements of the program and will continue to practice medicine in the same manner going forward. However, the commenter also noted that there are EPs who are truly “hospital-based,” such as hospitalists, who are currently being held to the same standard as ambulatory providers, even though their workflow is not conducive to easily meeting such standards. The commenter then recommended that CMS allow providers who see both inpatient and ambulatory patients with a significant volume to choose whether they want to be excluded from the program or continue to participate as an individual eligible professional.
Other recommendations from commenters included a mention of hardship exceptions for POS 22-related issues, a suggestion to allow EPs the right, in an expedited fashion, to petition for a change in their hospital-based status when there is a material change in their organizational affiliation (that is, a physician leaving a hospital-based practice to join an outpatient physician practice), excluding patient encounters in POS 21 and POS 23 for an EP, and excluding the POS 21 and POS 23 encounters from Medicare payment adjustment.
Therefore, we are not finalizing changes to the definition of hospital-based EP at this time. We will continue to consider this issue in the future as we explore program requirements for the MIPS.
We proposed no changes to the ability of providers to participate in the Medicare and Medicaid EHR Incentive Programs and other CMS programs. We continue to work on aligning the data collection and reporting of the various CMS programs, especially in the area of clinical quality measurement. See sections II.C. of this final rule with comment period for the policies and requirements for CQM reporting.
Sections 4101(b) and 4102(b) of the HITECH Act, amending sections 1848, 1853, and 1886 of the Act, require reductions in payments to EPs, eligible hospitals, and CAHs that are not meaningful users of certified EHR technology, beginning in CY 2015 for EPs, FY 2015 for eligible hospitals, and in cost EHR reporting periods beginning in FY 2015 for CAHs.
Section 1848(a)(7) of the Act provides for payment adjustments, effective for CY 2015 and subsequent years, for EPs as defined in § 495.100, who are not meaningful EHR users during the relevant EHR reporting period for the year. Section 1848(a)(7) of the Act provides that beginning in 2015, if an EP is not a meaningful EHR user for the EHR reporting period for the year, then the Medicare physician fee schedule (PFS) amount for covered professional services furnished by the EP during the year (including the fee schedule amount for purposes of determining a payment based on the fee schedule amount) is adjusted to equal the “applicable percent” of the fee schedule amount that would otherwise apply.
The Medicare Access and CHIP Reauthorization Act of 2015 (MACRA) (Pub. L. 114-10) was enacted on April 16, 2015, after the publication of the Stage 3 proposed rule and the EHR Incentive Program in 2015 through 2017 proposed rule. Section 101(b)(1)(A) of MACRA amended section 1848(a)(7)(A) of the Act to sunset the meaningful use payment adjustment for EPs at the end of CY 2018. Section 101(c) of MACRA added section 1848(q) of the Act requiring the establishment of a MIPS, which would incorporate certain existing provisions and processes related to meaningful use. The term “applicable percent” is defined in section 1848(a)(7)(A)(ii) of the Act, as amended by section 101(b)(1)(A) of MACRA, as: (I) for 2015, 99 percent (or, in the case of an EP who was subject to the application of the payment adjustment [if the EP was not a successful electronic prescriber] under section 1848(a)(5) of the Act for 2014, 98 percent); (II) for 2016, 98 percent; and (III) for 2017 and 2018, 97 percent.
In addition, section 1848(a)(7)(A)(iii) of the Act, as amended by section 101(b)(1)(A) of MACRA, provides that if, for CY 2018, the Secretary finds the proportion of EPs who are meaningful EHR users is less than 75 percent, the applicable percent shall be decreased by 1 percentage point for EPs who are not meaningful EHR users from the applicable percent in the preceding year.
Section 1848(a)(7)(B) of the Act provides that the Secretary may, on a case-by-case basis, exempt an EP who is not a meaningful EHR user for the EHR reporting period for the year from the application of the payment adjustment if the Secretary determines that compliance with the requirements for being a meaningful EHR user would result in a significant hardship, such as in the case of an EP who practices in a rural area without sufficient internet access. The exception is subject to annual renewal, but in no case may an EP be granted an exception for more than 5 years.
We established regulations implementing these statutory provisions under § 495.102. We refer readers to the final rules for Stages 1 and 2 (75 FR 44447 through 44448 and 77 FR 54093 through 54102) for more information.
Section 1886(b)(3)(B)(ix)(I) of the Act, as amended by section 4102(b)(1) of the HITECH Act, provides for an adjustment to the applicable percentage increase to the IPPS payment rate for those eligible hospitals that are not meaningful EHR users for the associated EHR reporting period for a payment adjustment year, beginning in FY 2015. Specifically, section 1886(b)(3)(B)(ix)(I) of the Act provides that, for FY 2015 and each subsequent fiscal year, an eligible hospital that is not “a meaningful EHR user . . . for an EHR reporting period” will receive a reduced update to the IPPS standardized amount. This reduction applies to “three-quarters of the percentage increase otherwise applicable” prior to the application of statutory adjustments under sections 1886(b)(3)(B)(viii), 1886(b)(3)(B)(xi), and 1886(b)(3)(B)(xii) of the Act, or three-quarters of the applicable market basket update. The reduction to three-quarters of the applicable update for an eligible hospital that is not a meaningful EHR user will be “33⅓ percent for FY 2015, 66⅔ percent for FY 2016, and 100 percent for FY 2017 and each subsequent FY.” In other words, for eligible hospitals that are not meaningful EHR users, the Secretary must reduce the applicable percentage increase (prior to the application of other statutory adjustments) by 25 percent (33⅓ of 75 percent) in FY 2015, 50 percent (66⅔ percent of 75 percent) in FY 2016, and 75 percent (100 percent of 75 percent) in FY 2017 and subsequent years. Section 4102(b)(1)(B) of the HITECH Act also provides that the reduction shall apply only with respect to the fiscal year involved and the Secretary shall not take into account such reduction in computing the applicable percentage increase for a subsequent fiscal year.
Section 1886(b)(3)(B)(ix)(II) of the Act, as amended by section 4102(b)(1) of the HITECH Act, provides that the Secretary may, on a case-by-case basis, exempt a hospital from the application of the applicable percentage increase adjustment for a fiscal year if the Secretary determines that requiring such hospital to be a meaningful EHR user will result in a significant hardship, such as in the case of a hospital in a rural area without sufficient internet access. This section also provided that such determinations are subject to annual renewal and that in no case may
Section 412.64(d) sets forth the adjustment to the percentage increase in the market basket index for those eligible hospitals that are not meaningful EHR users for the EHR reporting period for a payment year, beginning in FY 2015.
We established regulations implementing these statutory provisions under § 412.64. We refer readers to the final rules for Stages 1 and 2 (75 FR 44460 and 77 FR 54102 through 54109) for more information.
Section 4102(b)(2) of the HITECH Act amended section 1814(l) of the Act to include an adjustment to a CAH's Medicare reimbursement for inpatient services if the CAH is not a meaningful EHR user for an EHR reporting period. The adjustment will be made for cost EHR reporting periods that begin in FY 2015, FY 2016, FY 2017, and each subsequent FY thereafter. Specifically, sections 1814(l)(4)(A) and (B) of the Act provide that, if a CAH does not demonstrate meaningful use of CEHRT for an applicable EHR reporting period, then for a cost EHR reporting period beginning in FY 2015, the CAH's reimbursement shall be reduced from 101 percent of its reasonable costs to 100.66 percent of reasonable costs. For a cost EHR reporting period beginning in FY 2016, its reimbursement would be reduced to 100.33 percent of its reasonable costs. For a cost EHR reporting period beginning in FY 2017 and each subsequent fiscal year, its reimbursement would be reduced to 100 percent of reasonable costs. We established regulations implementing these statutory provisions under § 413.70. We refer readers to the final rules for Stages 1 and 2 (75 FR 44464 and 77 FR 54110 through 54111) for more information.
However, as provided for eligible hospitals, a CAH may, on a case-by-case basis, be granted an exception from this adjustment if CMS or its Medicare contractor determines, on an annual basis, that a significant hardship exists, such as in the case of a CAH in a rural area without sufficient internet access. However, in no case may a CAH be granted this exception for more than 5 years.
In the EHR Incentive Programs in 2015 through 2017 proposed rule and the Stage 3 proposed rule, we proposed several changes to the definition of the EHR reporting period for a payment adjustment year for EPs, eligible hospitals, and CAHs at § 495.4, in connection with other proposals made in those rules. For an explanation of these proposals, we refer readers to 80 FR 16774 through 16779 and 80 FR 20378 through 20381.
As follows is a summary of the comments received on the proposals for the EHR reporting period for a payment adjustment year for EPs (80 FR 16774 through 16779 and 80 FR 20378 through 20381):
We agree with the concerns expressed by commenters regarding our proposal to discontinue the 90-day EHR reporting period for a payment adjustment year for new participants who attest under Medicare beginning in 2017. We agree that a full year EHR reporting period could be a barrier for new entrants and could deter participation in the program especially as new entrants need time to install and learn to use technology before beginning their first EHR reporting period. However, we maintain that it is important to move all providers to the same EHR reporting period to simplify the program. So in 2018 all providers will attest to the Stage 3 definition of meaningful use for an EHR reporting period of the entire calendar year, with a limited exception for Medicaid providers who demonstrated AIU prior to 2017 and are demonstrating meaningful use for the first time. For these reasons, we will adopt a final policy that for EPs demonstrating meaningful use for the first time in 2017 under Medicare or Medicaid, the EHR reporting period for a payment adjustment year is any continuous 90-day period in CY 2017 and applies for purposes of the payment adjustments in CY 2018. To avoid the payment adjustment in CY 2018, the 90-day period must occur within the first three quarters of CY 2017 and the EP must attest by October 1, 2017.
For Medicare EPs, we note that the EHR reporting period for a payment adjustment year for returning participants in 2017 and for all Medicare EPs in 2018 and subsequent years will be established through future rulemaking in association with the MIPs program discussed further in the comments and responses immediately following.
After consideration of the public comments, we are finalizing the following changes to the EHR reporting period for a payment adjustment year for EPs as proposed, with a modification for 2017. In CY 2015, the EHR reporting period for a payment adjustment year for EPs who have not successfully demonstrated meaningful use in a prior year (“new participants”) is any continuous 90-day period in CY 2015. An EP who successfully demonstrates meaningful use for this period and satisfies all other program requirements will avoid the payment adjustments in CYs 2016 and 2017 if the EP successfully attests by February 29, 2016.
In CY 2015, the EHR reporting period for a payment adjustment year for EPs who have successfully demonstrated meaningful use in a prior year (“returning participants”) is any continuous 90-day period in CY 2015. An EP who successfully demonstrates meaningful use for this period and satisfies all other program requirements will avoid the payment adjustment in CY 2017 if the EP successfully attests by February 29, 2016.
In CY 2016, the EHR reporting period for a payment adjustment year for EPs who are new participants is any continuous 90-day period in CY 2016. An EP who successfully demonstrates meaningful use for this period and satisfies all other program requirements will avoid the payment adjustment in CY 2017 if the EP successfully attests by October 1, 2016, and will avoid the payment adjustment in CY 2018 if the EP successfully attests by February 28, 2017.
In CY 2016, the EHR reporting period for a payment adjustment year for EPs who are returning participants is the full CY 2016. An EP who successfully demonstrates meaningful use for this period and satisfies all other program requirements will avoid the payment adjustment in CY 2018 if the EP successfully attests by February 28, 2017.
In CY 2017, the EHR reporting period for a payment adjustment year for EPs who are new participants is any continuous 90-day period in CY 2017. An EP who successfully demonstrates meaningful use for this period and satisfies all other program requirements will avoid the payment adjustment in CY 2018 if the EP successfully attests by October 1, 2017.
We have revised the definition of “EHR reporting period for a payment adjustment year” under § 495.4 to reflect these final policies. Table 18 contains a summary of the final policies.
As follows is a summary of the comments received on the proposals for the EHR reporting period for a payment adjustment year for eligible hospitals (80 FR 16776 through 16778 and 80 FR 20380 through 20381):
Some commenters noted that new participants in 2018 would be moving to Stage 3 and should have a 90 day EHR reporting period for that purpose. Other commenters stated that any provider in their first year, and all providers in the first year of a new stage, should have a 90 day reporting period.
However, we will adopt a final policy beginning in 2018 to require eligible hospitals (new participants and returning participants) that attest to meaningful use under Medicare to complete a full CY EHR reporting period that is 2-years before the payment adjustment year. We are adopting a limited exception of a 90-day EHR reporting period the year that is 2 years before the payment adjustment year for Medicaid participants demonstrating meaningful use for the first time that previously demonstrated AIU prior to 2017 to allow these providers to earn an incentive payment in the Medicaid program for 2018 without receiving an penalty in the Medicare program.
We disagree that the change to a full-year EHR reporting period unfairly impacts new participant. We note that the prior exception to allow a 90-day EHR reporting period favors new participants over returning participants who have no such opportunity to avoid a payment adjustment in the subsequent year. We further note that new participants could have chosen to begin the program at any time since 2011 unless they are newly practicing providers who are already afforded a hardship exception from the penalty.
After consideration of the public comments, we are finalizing the following changes to the EHR reporting period for a payment adjustment year for eligible hospitals as proposed, with a modification for the EHR reporting period in 2017. For the reasons stated in section II.E.2.a. of this final rule with comment period for Medicaid EPs participating in Stage 3 in 2017, we are finalizing a similar policy for eligible hospitals to establish a 90-day EHR reporting for Stage 3 participants in 2017 for the purposes of avoiding the payment adjustment in 2019 for returning participants and for the payment adjustment in 2018 for new participants who attest to Stage 3 prior to October 1, 2017. For further discussion of the policy related to the EHR reporting period in 2017 we direct readers to section II.B.1.b.(3).iii. of this final rule with comment period.
In CY 2015, the EHR reporting period for a payment adjustment year for eligible hospitals that have not successfully demonstrated meaningful use in a prior year (new participants) is any continuous 90-day period beginning on October 1, 2014 and ending on December 31, 2015. An eligible hospital that successfully demonstrates meaningful use for this period and satisfies all other program requirements will avoid the payment adjustment in FYs 2016 and 2017 if the eligible hospital successfully attests by February 29, 2016.
In CY 2015, the EHR reporting period for a payment adjustment year for eligible hospitals that have successfully demonstrated meaningful use in a prior year (returning participants) is any continuous 90-day period beginning on October 1, 2014 and ending on December 31, 2015. An eligible hospital that successfully demonstrates meaningful use for this period and satisfies all other program requirements will avoid the payment adjustment in FY 2017 if the eligible hospital successfully attests by February 29, 2016.
In CY 2016, the EHR reporting period for a payment adjustment year for eligible hospitals that are new participants is any continuous 90-day period in CY 2016. An eligible hospital that successfully demonstrates meaningful use for this period and satisfies all other program requirements will avoid the payment adjustment in FY 2017 if the eligible hospital successfully attests by October 1, 2016, and will avoid the payment adjustment in FY 2018 if the eligible hospital successfully attests by February 28, 2017.
In CY 2016, the EHR reporting period for a payment adjustment year for eligible hospitals that are returning participants is the full CY 2016. An eligible hospital that successfully demonstrates meaningful use for this period and satisfies all other program requirements will avoid the payment adjustment in FY 2018 if the eligible hospital successfully attests by February 28, 2017.
In CY 2017, the EHR reporting period for a payment adjustment year for eligible hospitals that are new participants is any continuous 90-day period in CY 2017. An eligible hospital that successfully demonstrates meaningful use for this period and satisfies all other program requirements will avoid the payment adjustment in FY 2018 if the eligible hospital successfully attests by October 1, 2017 and will avoid the payment adjustment in FY 2019 if the eligible hospital successfully attests by February 28, 2018.
In CY 2017, the EHR reporting period for a payment adjustment year for eligible hospitals that are demonstrating Stage 3 is any continuous 90-day period in CY 2017. An eligible hospital that successfully demonstrates meaningful use for this period and satisfies all other program requirements will avoid the payment adjustment in FY 2019 if the eligible hospital successfully attests by February 28, 2018.
In CY 2017, the EHR reporting period for a payment adjustment year for eligible hospitals that are returning participants and are not demonstrating Stage 3, is the full CY 2017. An eligible hospital that successfully demonstrates meaningful use for this period and satisfies all other program requirements will avoid the payment adjustment in FY 2019 if the eligible hospital successfully attests by February 28, 2018.
Beginning in CY 2018, the EHR reporting period for a payment adjustment year for eligible hospitals is the entire calendar year that is two years before the payment adjustment year. For example, CY 2018 is the EHR reporting period for the FY 2020 payment adjustment year. The exception to this general rule is for eligible hospitals that successfully demonstrated AIU under the Medicaid EHR Incentive Program for a payment year prior to 2017 and are demonstrating meaningful use for the first time under the Medicaid EHR Incentive Program in the calendar year that is two years before the payment adjustment year. For those eligible hospitals, the same 90-day EHR reporting period used for the Medicaid incentive payment will also apply for purposes of the Medicare payment adjustment year 2 years after the calendar year in which the eligible hospital demonstrates meaningful use. For example, if an eligible hospital has never successfully demonstrated meaningful use in a prior year and demonstrates under the Medicaid EHR Incentive Program that it is a meaningful EHR user for the first time in CY 2018, the EHR reporting period for the Medicaid incentive payments any continuous 90-day period within CY 2018, and the same 90-day period also serves as the EHR reporting period for the FY 2020 payment adjustment year under Medicare. An eligible hospital that successfully demonstrates meaningful use for the relevant period and satisfies all other program requirements will avoid the payment adjustment in the relevant year if the eligible hospital successfully attests by the date specified by CMS.
We have revised the definition of “EHR reporting period for a payment adjustment year” under § 495.4 to reflect these final policies. Table 19 contains a summary of the final policies, although it does not include years beyond 2018.
As follows is a summary of the comments received on the proposals for the EHR reporting period for a payment adjustment year for CAHs (80 FR 16777 through 16779 and 80 FR 20381):
We will also adopt a final policy beginning in 2018 to require CAH (new participants and returning participants) that attest to meaningful use under Medicare to complete a full CY EHR reporting period that is the payment adjustment year. We are adopting a limited exception of a 90-day EHR reporting period within the calendar year that is the payment adjustment year for Medicaid CAH participants demonstrating meaningful use for the first time that previously demonstrated AIU prior to 2017 to allow these providers to earn an incentive payment in the Medicaid program for 2018 without receiving an penalty in the Medicare program.
After consideration of the public comments, we are finalizing the following changes to the EHR reporting period for a payment adjustment year for CAHs as proposed, with a modification for the EHR reporting period in 2017. For the reasons stated in section II.E.2.a. of this final rule with comment period for Medicaid EPs for Stage 3 in 2017, we are finalizing a similar policy for CAHs to establish a 90-day EHR reporting for Stage 3 participants in 2017 for the purposes of avoiding the payment adjustment for FY 2017. For further discussion of the policy related to the EHR reporting period in 2017 we direct readers to section II.B.1.b.(3).iii. of this final rule with comment period.
In CY 2015, the EHR reporting period for a payment adjustment year for CAHs that have not successfully demonstrated meaningful use in a prior year (new participants) is any continuous 90-day period beginning on October 1, 2014 and ending on December 31, 2015. A CAH that successfully demonstrates meaningful use for this period and satisfies all other program requirements will avoid the payment adjustment in FY 2015 if the CAH successfully attests by February 29, 2016.
In CY 2015, the EHR reporting period for a payment adjustment year for CAHs that have successfully demonstrated meaningful use in a prior year (returning participants) is any continuous 90-day period beginning on October 1, 2014 and ending on December 31, 2015. A CAH that successfully demonstrates meaningful use for this period and satisfies all other program requirements will avoid the payment adjustment in FY 2015 if the CAH successfully attests by February 29, 2016.
In CY 2016, the EHR reporting period for a payment adjustment year for CAHs that are new participants is any continuous 90-day period in CY 2016. A CAH that successfully demonstrates meaningful use for this period and satisfies all other program requirements will avoid the payment adjustment in FY 2016 if the CAH successfully attests by February 28, 2017.
In CY 2016, the EHR reporting period for a payment adjustment year for CAHs that are returning participants is the full CY 2016. A CAH that successfully demonstrates meaningful use for this period and satisfies all other program requirements will avoid the payment adjustment in FY 2016 if the CAH successfully attests by February 28, 2017.
In CY 2017, the EHR reporting period for a payment adjustment year for CAHs that are new participants is any continuous 90-day period in CY 2017. A CAH that successfully demonstrates meaningful use for this period and satisfies all other program requirements will avoid the payment adjustment in FY 2017 if the CAH successfully attests by February 28, 2018.
In CY 2017, the EHR reporting period for a payment adjustment year for CAHs that are demonstrating Stage 3 is any continuous 90-day period in CY 2017. A CAH that successfully demonstrates meaningful use for this period and satisfies all other program requirements will avoid the payment adjustment in FY 2017 if the CAH successfully attests by February 28, 2018.
In CY 2017, the EHR reporting period for a payment adjustment year for CAHs that are returning participants and are not demonstrating Stage 3, is the full CY 2017. A CAH that successfully demonstrates meaningful use for this period and satisfies all other program requirements will avoid the payment adjustment in FY 2017 if the CAH successfully attests by February 28, 2018.
Beginning in CY 2018, the EHR reporting period for a payment adjustment year for CAHs is the calendar year that begins on the first day of the second quarter of the federal fiscal year that is the payment adjustment year. For example, in order for a CAH to avoid application of the adjustment to its reasonable costs incurred in a cost reporting period that begins in FY 2018, the CAH must demonstrate it is a meaningful EHR user for an EHR reporting period of the full CY 2018. The exception to this general rule is for CAHs that successfully demonstrated AIU under the Medicaid EHR Incentive Program for a payment year prior to 2017 and are demonstrating meaningful use for the first time under the Medicaid EHR Incentive Program in the calendar year that begins on the first day of the second quarter of the federal fiscal year that is the payment adjustment year. For those CAHs, the same 90-day EHR reporting period used for the Medicaid incentive payment will also apply for purposes of the Medicare payment adjustment year. For example, if a CAH has never successfully demonstrated meaningful use in a prior year and demonstrates under the Medicaid EHR Incentive Program that it is a meaningful EHR user for the first time in CY 2018, the EHR reporting period for the Medicaid incentive payment is any continuous 90-day period within CY 2018, and the same 90-day period also serves as the EHR reporting period for the FY 2018payment adjustment year under Medicare. A CAH that successfully demonstrates meaningful use for the relevant period and satisfies all other program requirements will avoid the payment adjustment in the relevant year if the CAH successfully attests by the date specified by CMS.
We have revised the definition of “EHR reporting period for a payment adjustment year” under § 495.4 to reflect these final policies. Table 20 contains a summary of the final policies, although it does not include years beyond 2018.
As stated previously, sections 1848(a)(7)(B) and 1886(b)(3)(B)(ix)(II) of the Act provide the Secretary with discretionary authority to exempt, on a case by case basis, a provider from the application of the Medicare payment adjustment if the Secretary determines that compliance with the requirements for being a meaningful EHR user would result in a significant hardship. We have established various types of hardship exceptions for which providers may apply as well as deadlines for application. For more information, we refer readers to the Stage 2 final rule at 77 FR 54093 through 54113.
In the EHR Incentive Programs in 2015 through 2017 proposed rule (80 FR 20381), we proposed no changes to the types of hardship exceptions available to EPs, eligible hospitals, and CAHs. Further, we proposed no changes to the existing hardship exception process and timelines under our regulations.
In the Stage 3 proposed rule we proposed no changes to the types of exceptions previously finalized for EPs, eligible hospitals or CAHs (80 FR 16775, 80 FR 16777 and 80 FR 16779), nor did we propose any new types of exceptions for 2017 and subsequent years. Accordingly, we proposed that the exceptions continue as previously finalized. As follows is a summary of the comments received for hardship exceptions:
We are finalizing no changes to the types of hardship exceptions already available to EPs, eligible hospitals, and CAHs, nor do we finalize any new types of hardship exceptions. We are finalizing one procedural change to the hardship exception application deadline for eligible hospitals to July 1 of the year preceding the payment adjustment year to align the application period with EPs in light of the change to align hospitals with the calendar year for the EHR reporting period for a payment adjustment year and the changed attestation deadlines as finalized in section II.E.2.b and II.D of this final rule with comment period. This change is reflected in § 412.64(d)(4).
In the Stage 2 final rule (77 FR 54112 through 54113), we discussed an administrative appeals process for both Stages 1 and 2 of meaningful use. We believe this appeals process is primarily procedural and does not need to be specified in regulation. We developed guidance on the appeals process, which is available on our Web site at
We are finalizing our proposal to maintain this policy as previously adopted.
We did not propose any changes to the existing policies and regulations for MA organizations. Our existing policies and regulations include provisions concerning the EHR incentive payments to qualifying MA organizations and the payment adjustments for 2015 and subsequent MA payment adjustment years. (For more information on MA organization incentive payments, we refer readers to the final rules for Stages 1 and 2 (75 FR 44468 through 44482 and 77 FR 54113 through 54119).)
We did not propose any changes to the hardship exemption policy for MA providers in the proposed regulation. Therefore, the comment is outside the scope of the proposed rule and is not addressed in this final rule with comment period.
Consistent with our approach under both Stage 1 and 2, for Stage 3 we proposed to continue to offer states flexibility under the Medicaid EHR Incentive Program in Stage 3 by adding a new provision at § 495.316(d)(2)(iii) subject to the same conditions and standards as the Stage 2 flexibility policy. We proposed at that under Stage 3 (80 FR 16779), state flexibility would apply only with respect to the public health and clinical data registry reporting objective. We proposed that states could continue to specify the means of transmission of data and otherwise change the public health agency reporting objective as long as the state does not require functionality greater than what is required for Stage 3 and included in the 2015 Edition proposed rule.
Similarly, in the preamble to the EHR Incentive Programs in 2015 through 2017 proposed rule (80 FR 20349), we proposed to continue to offer states flexibility for the public health reporting objective as modified under Stage 2 for 2015 through 2017. We would continue the policy stated in the Stage 2 final rule (77 FR 53979) to allow states to specify the means of transmission of the data or otherwise change the public health measure as long as it does not require EHR functionality that supersedes that which is included in the certification requirements specified under the 2014 Edition certification criteria.
The flexibility to specify transmission standards remains unchanged from the Stage 2 Rule. In the Stage 2 final rule (77 FR 53979), we explained that a state could not require a different standard than the one included in 2014 ONC EHR certification criteria, but in cases where the 2014 ONC EHR certification criteria are silent, such as the means of transmission for a given public health objective, the state may propose changes to public health measures. We maintain this distinction for Stage 3 in relation to the 2015 ONC certification criteria for health IT.
States generally do not have discretion to categorically deny providers from using clinical data registries to meet the public health and clinical data registry reporting objective, so long as the clinical data repositories fall within federal rules and guidance. To address concerns that providers may be discouraged from attesting to public health registries, we reiterate that states can submit for CMS approval revisions to their SMHPs that would require that providers meet certain measures.
We are finalizing the Stage 3 state flexibility provision generally as proposed, with only a minor change to update a cross-reference to the public health and clinical data registry objective.
In the Stage 3 proposed rule (80 FR 16779), we proposed several amendments to the definitions of “EHR Reporting Period” and “EHR reporting period for a payment adjustment year” in § 495.4 that would apply to providers attesting in the Medicaid EHR Incentive Program. While many of the proposed amendments would apply to providers attesting in either the Medicare or Medicaid EHR Incentive Program, we also proposed a limited exception for new meaningful EHR users in the Medicaid program beginning in 2017.
In the EHR Incentive Programs in 2015 through 2017 proposed rule (80 FR 20353 and 20354), we proposed that all providers (EPs, eligible hospitals, and CAHs) would be required to complete an EHR reporting period within January 1 and December 31 of the calendar year in order to fulfill the requirements of the EHR Incentive Programs beginning in calendar year 2015 (except for eligible hospitals and CAHs in 2015, which may begin an EHR reporting period as early as October 1, 2014 and must end by December 31, 2015). We also proposed that for an EHR reporting period in 2015, eligible professionals may select an EHR reporting period of any continuous 90-day period from January 1, 2015 through December 31, 2015; eligible hospitals and CAHs may select an EHR reporting period of any continuous 90-day period from October 1, 2014 through December 31, 2015. These proposed amendments and the final policies adopted are discussed in sections II.B.1.b.(3).(i). and (ii). of this final rule with comment period.
In the Stage 3 proposed rule (80 FR 16739), we proposed that beginning in 2017 and for all EPs, eligible hospitals, and CAHs, the EHR reporting period would be one full calendar year. This proposed amendment is discussed in section II.B.1.b.(3).(iii). of this final rule with comment period, and is finalized with a modification to begin for all providers in 2018 and multiple modifications to the EHR reporting period in 2017. For EPs, eligible hospitals, and CAHs that choose to meet Stage 3 in 2017, the EHR reporting period is any continuous 90-day period within CY 2017. For new participants, the EHR reporting period is any continuous 90-day reporting period within CY 2017. These modifications regarding providers attesting to Stage 3 of meaningful use in 2017 applies to providers attesting to the Medicaid EHR Incentive Program as well.
In the Stage 3 proposed rule (80 FR 16739), we also proposed a limited exception for Medicaid providers demonstrating meaningful use for the first time in 2017 and subsequent years. For that exception, we proposed to maintain the 90-day EHR reporting period for a provider's first payment year based on meaningful use for EPs and eligible hospitals participating in the Medicaid EHR Incentive Program. We proposed that this exception would apply both for purposes of receiving an incentive payment in the Medicaid program and for purposes of avoiding the payment adjustment under the Medicare program for the payment adjustment year that is two years after the calendar year in which the provider first demonstrates meaningful use for an EHR reporting period. As the last year that an eligible professional can begin participation in the Medicaid EHR Incentive Program is 2016, this limited exception would apply only to providers who received an incentive payment for adopt, implement, or upgrade of CEHRT in 2011 through 2016, but did not receive an incentive payment for demonstration of meaningful use until 2017 or after. In this section, we address comments received on this limited exception for new meaningful EHR users in the Medicaid program.
We believe that these changes will allow flexibility for providers who have not demonstrated meaningful use in a previous year and will encourage providers to participate in the program.
In the Stage 3 proposed rule (80 FR 16779), we also proposed to amend § 495.316(c), as well as add a new paragraph § 495.316(f), to formalize the process of how states report to us annually on the providers that have attested to adopt, implement, or upgrade (AIU), or that have attested to meaningful use. Under this proposal, states would follow a structured submission process, in the manner prescribed by CMS, which would include a new annual reporting deadline. We proposed to require states to submit annual reports to CMS within 45 days of the end of the second quarter of each federal fiscal year.
We proposed to regularize the timing of the annual reporting process described in § 495.316 to ensure more timely annual reports and allow for clearer communication to states on when the reports should be submitted to CMS. In addition, CMS and states would be able to more effectively track the progress of states' incentive program implementation and oversight as well as provider progress in achieving meaningful use. Predictable deadlines for annual reporting would permit CMS and the states to more quickly compare and assess overall program impact each year.
In the Stage 3 proposed rule (80 FR 16779), we also noted our intent to consider changes to the data that the annual reporting requirements outlined in § 495.316(d) require states to include in their annual reports. Specifically, we explained we were considering whether to remove the requirement that states report information about practice location for providers that qualify for incentive payments on the basis of having adopted, implemented, or upgraded CEHRT or on the basis of demonstrating they are meaningful users of CEHRT. We stated our belief that this data is useful to both CMS and the states for program implementation purposes, but that the benefits of including it in state reports might be outweighed by the burdens to states of reporting it and requested more information on state burdens and costs associated with complying with this requirement. We solicited comments both on the burdens associated with the requirement to report practice location information for providers that receive incentive payments through the Medicaid EHR Incentive Program, and on the benefits of including this information in state reports.
We proposed to amend § 495.352 to formalize the process of how states submit quarterly progress reports on implementation and oversight activities and to specify the elements that should be included in the quarterly reports. Under this proposal, states would follow a structured submission process, in the manner prescribed by CMS. We proposed that states would report on the following activities: State system implementation dates; provider outreach; auditing; state-specific SMHP tasks; state staffing levels and changes; the number and type of providers that qualified for an incentive payment on the basis of demonstrating that they are meaningful EHR users of CEHRT and the amounts of incentive payments; and the number and type of providers that qualified for an incentive payment on the basis of having adopted, implemented, or upgraded CEHRT and the amounts of incentive payments.
We proposed these changes to the quarterly reporting process described in § 495.352 so that CMS and states can better track state implementation and oversight activity progress in a way that would permit CMS and the states to compare overall programmatic and provider progress. We also expect that streamlined and enhanced quarterly progress reporting would lead to an improvement in overall data quality that would help inform future meaningful use activity across states.
Finally, we proposed to include a deadline for states' quarterly reporting under the proposed amendments to § 495.352, and requested public comment on a deadline of 30 days after the end of each federal fiscal year quarter.
In the Stage 3 proposed rule at (80 FR 16780), we noted that CMS must have accurate and timely data from states regarding both EPs and eligible hospitals that have successfully demonstrated meaningful use for each payment year to ensure that meaningful EHR users in the Medicaid EHR Incentive Program are appropriately exempted from the Medicare payment adjustment for the applicable payment adjustment year. Accordingly, we proposed to add new paragraphs (g) and (h) to § 495.316 to require that states submit reports on a quarterly basis that identify certain providers that attested to meaningful use through the Medicaid EHR Incentive Program for each payment year. Under this proposal, states would submit quarterly reports, in the manner prescribed by CMS, for Medicaid EPs and eligible hospitals that successfully attest to meaningful use for each payment year.
We proposed that states would report quarterly information on each provider that successfully attests to meaningful use, regardless of whether the provider has been paid yet. The report would be required to specify the Medicaid state and payment year. For each EP or eligible hospital listed in the report, the state would also specify the payment year number, the NPI for EPs and the CCN for eligible hospitals, the attestation submission date, the state qualification (as either meaningful use or blank), and the state qualification date (the beginning date of the reporting period in which successful meaningful use attestation was achieved by the EP or eligible hospital). The EP's or eligible hospital's “payment year number” refers to the number of years that the provider has been paid in the EHR Incentive Program; so, for example, this would be “2” for the 2014 payment year if the provider received payments for 2013 and 2014. States would have this data, even for providers that have previously received an incentive payment through the Medicare EHR Incentive Program. If the state is reporting a disqualification, then the state would leave the state qualification field blank. If applicable, in the cases of EPs or eligible hospitals previously identified as meaningful EHR users, the state would be required to specify the state disqualification and state disqualification date (that is, the beginning date of the EHR reporting period during which an EP or eligible hospital was found not to meet the definition of a meaningful EHR user).
We also proposed that states would submit this information beginning with payment year 2013 data. The reports would cover back to the 2013 payment year because that would be the EHR reporting period for the 2015 Medicare payment adjustment year under § 495.4. Providers that successfully attested to meaningful use for 2013 would be exempt from the Medicare payment adjustment in 2015.
We also proposed that states would not be required to report on those EPs who are eligible for the Medicaid EHR Incentive Program on the basis of being a nurse practitioner, certified nurse-midwife, or physician assistant.
In the Stage 3 proposed rule (80 FR 16780), we noted that states are responsible for determining whether and how electronic reporting of CQMs would occur, or whether they wish to allow reporting through attestation. If a state does require electronic reporting, the state is responsible for sharing the details on the process with its provider community. States that wish to establish the method and requirements for electronically reporting would continue to be required to do so through the SMHP submission, subject to our prior approval.
To further our goals of alignment and avoiding duplicative reporting across quality reporting programs, we would recommend that states include a narrative in their SMHP for CY 2017 describing how their proposed meaningful use CQM data submission strategy aligns with their State Medicaid Quality Strategy and report which CEHRT requirements they mandate for eCQM reporting.
For more information on requirements around the State Medicaid Quality Strategy, see
Under the Paperwork Reduction Act of 1995, we are required to provide 60-day notice in the
• The need for the information collection and its usefulness in carrying out the proper functions of our agency.
• The accuracy of our estimate of the information collection burden.
• The quality, utility, and clarity of the information to be collected.
• Recommendations to minimize the information collection burden on the affected public, including automated collection techniques.
The following is a discussion of the requirements contained in the proposed regulations that we believed were subject to PRA and collection of information requirements (ICRs) as a result of this final rule with comment period. This analysis finalizes our projections which were proposed in the March 30, 2015
We solicited public comment on each of these issues for the following sections of this document that contain information collection requirements (ICRs).
This final rule with comment period specifies applicable criteria for demonstrating meaningful use of CEHRT for EHR reporting periods in 2015 through 2017 and for Stage 3 in 2017 and subsequent years. The applicable criteria for demonstrating meaningful use for an EHR reporting period in 2015 through 2017 are based on modifications to the criteria previously set out in Stage 1 and 2 of the EHR Incentive Programs. These changes in the overall burden for providers reporting in 2015 through 2017 are discussed in further detail in the ICR analysis for 2015 through 2017 outlined in section III.B of this final rule with comment period. The ICRs in this section (that is, section III.A. of this final rule with comment period) reflect the provider burden associated with complying with and reporting of Stage 3 requirements beginning in 2017 and each subsequent year.
In § 495.24 (redesignated from § 495.7) we proposed that to successfully demonstrate meaningful use of CEHRT for Stage 3, an EP, eligible hospital, or CAH (collectively referred to as “provider” in this section) must attest, through a secure mechanism in a specified manner, to the following during the EHR reporting period:
• The provider used CEHRT and specified the technology was used.
• The provider satisfied each of the applicable objectives and associated measures in § 495.26.
In § 495.40 (redesignated from § 495.8), we stipulated that providers must also successfully report the clinical quality measures selected by CMS to CMS or the states, as applicable. We estimated that the CEHRT adopted by the provider captures many of the objectives and associated measures and generate automated numerator and denominator information where required, or generate automated summary reports. We noted that we also expect that the provider would enable the functionality required to complete
We proposed that there would be five objectives and ten measures that would require an EP to enter numerators and denominators during attestation. Eligible hospitals and CAHs would have to attest they have met five objectives and ten measures that would require numerators and denominators. For objectives and associated measures requiring a numerator and denominator in the proposed rule, we limited our estimates to actions taken in the presence of certified EHR technology. We did not anticipate a provider would maintain two recordkeeping systems when CEHRT is present. Therefore, we assumed that all patient records that would be counted in the denominator would be kept using certified EHR technology. We expected it would take an individual provider or designee approximately 10 minutes to attest to each meaningful use objective and associated measure that requires a numerator and denominator to be generated. The security risk assessment and its associated measure would not require a numerator and denominator and we would expect it would take an individual provider or designee approximately 6 hours to complete. The clinical decision support and active engagement with a public health agency measures would take an eligible professional, eligible hospital or critical access hospital 1 minute each to report each CDS intervention or registry.
We proposed that EPs would be required to report on a total of 8 objectives and 16 associated measures. For the purpose of the proposed collection of information, we assumed that all eligible providers would comply with the requirements of meaningful use Stage 3. We proposed that eligible hospitals and CAHs would be required to report on a total of 8 objectives and 17 associated measures. We estimated the total annual cost burden for all eligible hospitals and CAHs to attest to EHR technology, meaningful use objectives and associated measures, and electronically submit the clinical quality measures would be $2,135,204 (4,900 eligible hospitals and CAHs × 6 hours 52 minutes × $63.46
After consideration of the public comments received, we are finalizing these burden estimates as proposed but have updated them to reflect policy changes implemented through this final rule with comment period.
In this final rule with comment period, there were five objectives that will require an EP to enter numerators and denominators during attestation. Eligible hospitals and CAHs will have to attest that they have met five objectives that require numerators and denominators. For objectives and associated measures requiring a numerator and denominator, we limit our estimates to actions taken in the presence of certified EHR technology. We do not anticipate a provider will maintain two recordkeeping systems when CEHRT is present. Therefore, we assume that all patient records that will be counted in the denominator will be kept using certified EHR technology. We expect it will take an individual provider or designee approximately 10 minutes to attest to each meaningful use objective and associated measure that requires a numerator and denominator to be generated, as well as each CQM for providers attesting in their first year of the program.
Additionally, providers will be required to report they have completed objectives and associated measures that require a “yes” or “no” response during attestation. For EPs, there are three objectives that require a “yes” or “no” response during attestation. As discussed previously, the associated measures are that EPs are required to conduct a security risk analysis, report to three registries to fulfill the public health objective, and must implement at least five clinical decision support interventions. For eligible hospitals and CAHs, there are three objectives that require a “yes” or “no” response during attestation. The associated measures for eligible hospitals and CAHs require the provider to conduct a security risk analysis, report to four registries to fulfill the public health objective and must implement at least five clinical decision support interventions. We estimate each of these measures would take 1 minute to report.
Providers will also be required to attest that they are protecting electronic health information. We estimate completion of the analysis required to meet successfully the associated measure for this objective will take approximately 6 hours, which is identical to our estimate for the Stage 1 and Stage 2 requirements. This burden estimate assumes that covered entities are already conducting and reviewing these risk analyses under current HIPAA regulations. Therefore, we do not account for the additional burden associated with the conduct or review of such analyses.
Table 21 lists the Stage 3 objectives and associated measures for EPs and eligible hospitals and CAHs. We estimate the objectives and associated measures will take an EP 6 hours 52 minutes to complete, and will take an eligible hospital or CAH 6 hours 52 minutes to complete.
We believe that EPs, eligible hospitals, and CAHs have virtually identical burdens. Eligible hospitals and CAHs are required to report to one additional registry than EPs are required to report. Consequently, we did not prepare lowest and highest burdens. Rather, we computed a burden for EPs and a burden for eligible hospitals and CAHs.
In this final rule with comment period, we estimate that it will take no longer than 6 hours and 52 minutes for an EP to report on each of the applicable objectives and associated measures. The total burden hours for an EP to attest to the criteria previously specified will be 6 hours 52 minutes. We estimate that there could be approximately 609,100 non-hospital-based Medicare and Medicaid EPs in 2017.
We estimate the burden for the approximately 13,635 MA EPs in the MAO burden section. We estimate the total burden associated with these requirements for an EP will be 6 hours 52 minutes. The total estimate annual cost burden for all EPs to attest to EHR technology and meaningful use objectives will be $385,834,395 (506,400 × 6 hours 52 minutes × $92.25 (mean hourly rate for physicians based on May 2013 BLS data)).
Similarly, eligible hospitals and CAHs will attest that they have met the core meaningful use objectives and associated measures, and will electronically submit the clinical quality measures. We estimate that it will take no longer, than 6 hours and 52 minutes to attest that during the EHR reporting period, they used the certified EHR technology, specified the EHR technology used, and satisfied each of the applicable objectives and associated measures. We estimate that there are about 4,900 eligible hospitals and CAHs (3,397 acute care hospitals, 1,395 CAHs, 97 children's hospitals, and 11 cancer hospitals) that may attest to the aforementioned criteria in FY 2017. We estimate the total burden associated with these requirements for an eligible hospital and CAH would be 6 hours 52 minutes. The total estimated annual cost burden for all eligible hospitals and CAHs to attest to EHR technology, meaningful use core set and menu set criteria, and electronically submit the clinical quality measures will be $2,135,204 (4,908 eligible hospitals and CAHs × $63.46 (6 hours 52 minutes × $63.46 (mean hourly rate for lawyers based on May 2013 BLS) data)).
In § 495.40 we proposed that to successfully demonstrate meaningful use of CEHRT for meaningful use in 2015 through 2017, an EP, eligible hospital, or CAH (collectively referred to as “provider” in this section) must attest, through a secure mechanism in a specified manner, to the following during the EHR reporting period: (1) The provider used CEHRT and specified the technology was used; and (2) the provider satisfied each of the applicable objectives and associated measures in § 495.22. In § 495.40, we stipulated that providers must also successfully report the clinical quality measures selected by CMS to CMS or the states, as applicable. We estimated that the CEHRT adopted by the provider captures many of the objectives and associated measures and generate automated numerator and denominator information where required, or generate automated summary reports. We also expected that the provider would enable the functionality required to complete the objectives and associated measures for which they are required to attest.
We proposed that EPs would be required to report on a total of ten objectives and associated measures and eligible hospitals and CAHs would report on a total of nine objectives and associated measures. There are six objectives that will require an EP to enter numerators and denominators during attestation. Eligible hospitals and CAHs will have to attest that they have met six objectives that require numerators and denominators. For objectives and associated measures requiring a numerator and denominator, we limit our estimates to actions taken in the presence of certified EHR technology. We do not anticipate a provider would maintain two recordkeeping systems when CEHRT is present. Therefore, we assumed that all patient records that would be counted in the denominator would be kept using certified EHR technology. We expect it will take an individual provider or designee approximately 10 minutes to attest to each meaningful use objective and associated measure that requires a numerator and denominator to be generated, as well as approximately 1 hour 30 minutes to attest to CQM requirements.
Additionally, providers would be required to report they have completed objectives and associated measures that require a “yes” or “no” response during attestation. For EPs, there are three objectives that would require a “yes” or “no” response during attestation. For eligible hospitals and CAHs, there are 2 objectives and that would require a “yes” or “no” response during attestation. We expect that it would take a provider or their designee 1 minute to attest to each objective that requires a “yes” or “no” response.
Providers would also be required to attest that they are protecting ePHI. We estimate completion of the analysis required to meet successfully the associated measure for this objective would take approximately 6 hours, which is identical to our estimate for the Stage 1 and Stage 2 requirements. This burden estimate assumes that covered entities are already conducting and reviewing these risk analyses under current HIPAA regulations. Therefore, we have not accounted for the additional burden associated with the conduct or review of such analyses.
We estimate the objectives and associated measures would take an EP 6 hours 49 minutes to complete, and would take an eligible hospital or CAH 6 hours 48 minutes to complete.
After consideration of the public comments received, we are finalizing these burden estimates as proposed but have updated them to reflect policy changes implemented through this final rule with comment period. In this final rule with comment period, there are 10 objectives for EPs and 9 objectives for eligible hospitals and CAHs.
Table 22 lists those objectives and associated measures for EPs and eligible hospitals and CAHs. EPs, eligible hospitals, and CAHs have nearly identical reporting burdens. Eligible hospitals and CAHs are required to report to one additional registry than EPs are required to report. However, EPs have an additional objective, Secure Electronic Messaging, which requires a “yes” or “no” response. Consequently, we have not prepared lowest and highest burdens. Rather, we have computed a burden for EPs and a burden for eligible hospitals and CAHs.
We estimate that it will take no longer than 6 hours 49 minutes for an EP to attest to each of the applicable objectives and associated measures. The total burden hours for an EP to attest to the meaningful use objectives and measures and to report CQMs will be 8 hours 19 minutes. We estimate that there could be approximately 595,100 non-hospital-based Medicare EPs in 2015. Based on the historical data, we anticipate approximately 60 percent (357,060) of these EPs may attest to the objectives and measures of meaningful use. In addition, we believe approximately 30,000 Medicaid only EPs, or approximately 51 percent of the Medicaid-only EPs, will successfully demonstrate meaningful use in 2015. The total estimated annual cost burden for all EPs to attest to meaningful use would be $297,076,291 (387,060 × 8 hours 19 minutes × $92.25 (mean hourly rate for physicians based on May 2013
We provide the estimate of the burden for the approximately 13,635 MA Eps in the MA organization burden section. The total annual burden estimates for meaningful use for modifications for 2015 through 2017 are shown in Table 23.
For the purpose of this collection of information, we assumed that all eligible providers will comply with the requirements of Meaningful Use as previously defined if the policies proposed in this rule were not finalized. Therefore, we estimate that the policies contained herein will result in an overall reduction in the reporting burden for providers of 1.45 hours to 1.9 hours for EPs and 2.62 hours for eligible hospitals and CAHs per respondent. While batch reporting for objectives and measures and group reporting for CQMs are available for EPs in the current program; the program is based upon successful individual provider demonstration of meaningful use and so individual totals are used to identify the estimated reduction in provider reporting burden. This reduction of burden is outlined in Table 23.
Using the hourly costs associated with the reporting burden as mentioned previously, this reduction of 1.45 hours to 1.9 hours for EPs and 2.62 hours for eligible hospitals and CAHs represents a per response savings of $133.76 to $175.28 for EPs and $166.27 for eligible hospitals and CAHs. The total cost reduction in cost for providers demonstrating meaningful use is estimated at $48,534,332 at the lowest and $63,359,464 at the highest. These estimates are further outlined in Table 24.
We estimate that the burden will be significantly less for qualifying MA organizations attesting to the meaningful use of their MA EPs, because qualifying MA EPs use the EHR technology in place at a given location or system, so if CEHRT is in place and the qualifying MA organization requires its qualifying MA EPs to use the technology, qualifying MA organizations will be able to determine at a faster rate than individual FFS EPs, that its qualifying MA EPs meaningfully used CEHRT. In other words, qualifying MA organizations can make the determination in masse if the CEHRT is required to be used at its facilities, whereas under FFS, each EP likely must make the determination on an individual basis. We further note that these differences also mean the total reduction in burden for MA organizations resulting from the modifications in this rule will be negligible. We estimate that, on average, it will take an individual 45 minutes to collect information necessary to determine if a given qualifying MA EP has met the meaningful use objectives and measures, and 15 minutes for an individual to make the attestation for each MA EP. Furthermore, the individuals performing the assessment and attesting will not likely be the eligible professional, but non-clinical staff. We believe that the individual gathering the information could be equivalent to a GS 11, step 1 (2015 unadjusted for locality rate), with an hourly rate of approximately $25.00/hour, and the person attesting (and who may bind the qualifying MA organization based on the attestation)
We are revising 42 CFR 495 regarding state reporting requirements to CMS. With respect to the annual reporting requirements in § 495.316 and the quarterly reporting requirements in § 495.352, we do not believe that the amendments to these reporting requirements will increase the burden on states beyond what was previously finalized under OMB control number 0938-1158 following the Stage 2 final rule. The deadlines will be consistent with our past practice, and the changes to the data elements to be reported on are either reduced or similar in burden. Similarly, we do not expect that the amendments regarding the 90-day EHR reporting period for first time meaningful users will impose a burden on states because those amendments would generally maintain the current policy.
However, we are also amending § 495.316 to include a new quarterly reporting requirement. States will report quarterly to CMS regarding the EPs and Medicaid eligible hospitals that have successfully demonstrated meaningful use for each payment year. We need this information to ensure that those EPs who are meaningful EHR users in the Medicaid EHR Incentive Program are appropriately exempted from the Medicare payment adjustment. We cannot accurately exempt these providers using the current data received from states. We expect that it will take a state 20 hours each year to submit this report on a quarterly basis. We believe that the state employee reporting the information could be equivalent to a GS 12, step 1 (2015 unadjusted for locality rate), with an hourly rate of approximately $30.00/hour. This amount is then reduced by the 90 percent federal contribution for administrative services for Medicaid under the EHR Incentive Programs; this equates to approximately $3.00/hour. Therefore, for all state Medicaid agencies to report 4 times per year at 20 hours per report the estimated cost is $13,460 (4560 hours × $3.00/hour).
This final rule with comment period will implement the provisions of the American Recovery and Reinvestment Act (ARRA) of 2009 that provide incentive payments to EPs, eligible hospitals, and CAHs participating in Medicare and Medicaid programs that adopt and meaningfully use CEHRT. This final rule with comment period specifies applicable criteria for demonstrating the Stage 3 requirements for the EHR Incentive Programs. This final rule with comment period also specifies the applicable criteria for an EHR reporting period in 2015 through 2017.
We have examined the impacts of this final rule with comment period as required by Executive Order 12866 on Regulatory Planning and Review (September 30, 1993), Executive Order 13563 on Improving Regulation and Regulatory Review (January 18, 2011), the Regulatory Flexibility Act (RFA) (September 19, 1980, Pub. L. 96-354), section 1102(b) of the Social Security Act, section 202 of the Unfunded Mandates Reform Act of 1995 (March 22, 1995; Pub. L. 104-4), Executive Order 13132 on Federalism (August 4, 1999) and the Congressional Review Act (5 U.S.C. 804(2)).
Executive Orders 12866 and 13563 direct agencies to assess all costs and benefits of available regulatory alternatives and, if regulation is necessary, to select regulatory approaches that maximize net benefits (including potential economic, environmental, public health and safety effects, distributive impacts, and equity). A regulatory impact analysis (RIA) must be prepared for major rules with economically significant effects ($100 million or more in any 1 year). This final rule with comment period is anticipated to have an annual effect on the economy of $100 million or more, making it an economically significant rule under the Executive Order and a major rule under the Congressional Review Act. Accordingly, we have prepared a Regulatory Impact Analysis (RIA) that presents the estimated costs and benefits of this final rule with comment period.
The portion of the final rule related to Stage 3 is one of two coordinated rules related to the EHR Incentive Programs. The other is ONC's 2015 Edition Health Information Technology (Health IT) Certification Criteria, 2015 Edition Base Electronic Health Record (EHR) Definition, and ONC Health IT Certification Program Modifications. Thus, there is an analysis that focuses on the impact associated with Stage 3 requirements for the EHR Incentive Program, the changes in quality measures that would take effect beginning in 2017, and other changes being for the Medicare and Medicaid EHR Incentive Programs.
As we discussed in the Stage 2 final rule (77 FR 54163 through 54291), a number of factors would affect the adoption of EHR systems and demonstration of meaningful use. In this final rule with comment period, we continue to believe that a number of factors would affect the adoption of EHR systems and demonstration of meaningful use. Readers should understand that these forecasts are also subject to substantial uncertainty since meeting the requirements of the program will depend not only on the standards and requirements for 2017 and for eligible hospitals and EPs, but on future rules issued by the Department of Health and Human Services (DHHS).
Based on the Stage 2 final rule, we expect spending under the EHR Incentive Programs for transfer payments to Medicare and Medicaid providers between 2015 and 2017 to be $14.2 billion. However, the policies in this final rule with comment period which are applicable for the EHR Incentive Programs in 2015 through 2017 do not change these estimates over the current period as the proposals in the EHR Incentive Programs in 2015 through 2017 proposed rule applied no changes to the payment of incentives or the application of payment adjustments for 2015 through 2017.
Our analysis of impacts for the policies in this final rule with comment period relate to the reduction in cost associated with provider reporting burden estimates for 2015 through 2017 as affected by the adopted changes to the current program and to the transfer payments for incentives for Medicaid providers and reductions in payments for Medicare providers through payment adjustments for 2018 and subsequent years. In the Stage 3 proposed rule, we noted our expectation that spending under the EHR Incentive Program for transfer payments to Medicare and Medicaid providers between 2017 and 2020 to be $3.7 billion (this estimate includes net payment adjustments for Medicare providers who do not achieve meaningful use in the amount of $0.8 billion).
We stated in the Stage 2 final rule (77 FR 54135 through 54136) that the statute provides Medicare and Medicaid incentive payments for the meaningful use of CEHRT. Additionally, the Medicaid program also provides incentives for the adoption, implementation, and upgrade of certified EHR technology. Beginning in 2015, payment adjustments are incorporated into the Medicare EHR Incentive Program for providers unable to demonstrate meaningful use. The absolute and relative strength of these is unclear. For example, a provider with relatively small Medicare billings will be less affected by payment adjustments than one with relatively large Medicare billings. Another uncertainty arises because there are likely to be “bandwagon” effects as the number of providers using EHRs rises, thereby inducing more participation in the program, as well as greater adoption by entities (for example, clinical laboratories) that are not eligible for incentives or subject to payment adjustments, but do business with EHR adopters. It is impossible to predict exactly if and when such effects may take hold.
All of these factors taken together make it impossible in this final rule with comment period to predict with precision the timing or rates of adoption and successful participation in the program. However, new data is currently available regarding rates of adoption or costs of implementation since the publication of our Stage 1 and Stage 2 final rules. We have included the new data in our estimates, although even these forecasts are still uncertain.
We have also estimated “per entity” costs for EPs, eligible hospitals, and CAHs for implementation/maintenance and reporting requirement costs, not all costs. We believe many adopting entities may achieve dollar savings at least equal to their total costs, and that there may be additional benefits to society. We also believe that implementation costs are significant for each participating entity because providers who were likely to qualify as meaningful users of EHRs were likely to purchase CEHRT. However, we believe that providers who have already purchased CEHRT and participated in Stage 1 or Stage 2 of the EHR Incentive Program will experience significantly lower costs for participation in the program. We continue to believe that the short-term costs of the program may be outweighed by the long-term benefits, including practice efficiencies and improvements in medical outcomes. Although both cost and benefit estimates are highly uncertain, the RIA that we have prepared presents the estimated costs and benefits of this final rule with comment period.
In addition, we include the impact of the EHR Incentive Programs in 2015 through 2017. In relation to the existing program requirements outlined in the Stage 2 final rule (77 FR 53967 through 54162), we do not expect this final rule with comment period to result in more incentives paid or in more providers failing meaningful use and being assessed a payment adjustment. This is due to the nature of the modifications being implemented by this rule, which, while they reduce the reporting burden on providers, do not affect the clinical processes and IT functions required to meet the objectives and measures of the EHR Incentive Programs. The provisions of the modifications portion in this final rule with comment period do not fundamentally change the technology required to support participation in the Medicare and Medicaid EHR Incentive Programs. Under the current program, the requirement to report data on the measures and objectives which have now been identified as redundant to other more advanced measures being retained, or are duplicative of other measures using the same CEHRT function, is essentially requiring providers to report on the same action or process twice. Therefore, it is not the occurrence of the action or process which is reduced by the provisions in this final rule with comment period, but the burden associated with the duplicative and redundant reporting. In addition, the objectives and measures, which are considered topped out, have reached high performance and the statistical evidence demonstrates that the expected result of any provider attesting to the EHR Incentive Programs would be a score near the maximum. However, the analysis of these measures and their identification as topped out also takes into account the statistical likelihood that the functions of measures and the processes behind them would continue even without a requirement to report the results. Therefore, while the provisions result in a reduction in reporting requirements, this does not correlate to a change in the overall achievement of the measures and objective as compared to the current program. Finally, when compared against historical data, the shortened EHR reporting period in 2015 is expected to have a minimal impact on successful demonstration of meaningful
• The shortened EHR reporting period is for 2015 only and not for 2016 or 2017.
• Historical data on attestations shows no strong correlation between a shorter EHR reporting period and the ability of providers to attest for a second year, no correlation for providers returning to attest to a third or fourth year of meaningful use, and providers who would otherwise be in their first year of meaningful use would already have a 90-day EHR reporting period.
• Performance data shows statistically negligible disparity among providers attesting for a 90-day EHR reporting period and those attesting for a full year EHR reporting period on the measures which have been identified as redundant, duplicative, and topped out.
For these reasons, we do not believe the modification provisions in this final rule with comment period will impact the overall estimates for incentive payments, payment adjustments, and the net transfer costs associated with the program. However, these provisions do affect the costs associated with the reporting burden on providers. The impacts directly attributable with the provisions in this final rule with comment period relate to both an hourly reduction per response and an overall reduction in the cost associated with provider reporting. The burden analysis for modifications in this final rule with comment period, as compared to the Stage 2 estimates, reduces the reporting burden for attestation for providers by approximately 1.45 hours to 1.9 hours for EPs and 2.62 hours for eligible hospitals and CAHs per respondent. This burden estimate and analysis of the impact of the policies result in a total cost reduction estimated at $48,534,332 at the lowest and $63,359,464 at the highest. However, we believe the modifications portion of this final rule with comment period will have additional impacts—most notably, cost savings for hospitals and providers that would have additional time to meet the requirements of the program—which cannot be adequately estimated because of the wide variation among provider types, and therefore a designation as an economically significant rule under the Executive Order and a major rule under the Congressional Review Act is still applicable. The burden estimate and analysis of the impact of the policies implemented by the modifications of this final rule with comment period are outlined further in section III. of this final rule with comment period.
The objective of the remainder of this final RIA is to summarize the costs and benefits of the HITECH Act incentive program for the Medicare FFS, Medicaid, and MA programs. We also provide assumptions and a narrative addressing the potential costs to the health care industry for implementation of this technology.
We note that the costs incurred by IT developers for EHR technology development and certification to the 2015 Edition certification criteria for health IT are also in part attributable to the requirements for the use of CEHRT established in this final rule with comment period for Stage 3 of the EHR Incentive Programs. Therefore, to the extent that providers' implementation and adoption costs are attributable to this final rule with comment period, health IT developers' preparation and development costs would also be attributable as these categories of activities may be directly or indirectly incentivized by the requirements to participate in the EHR Incentive Programs. However, other CMS programs (for example PQRS and IQR) do require or promote certification to ONC's criteria-or a professional organization or other such entity could require or promote certification to ONC's criteria.
The Regulatory Flexibility Act (RFA) requires agencies to prepare an Initial Regulatory Flexibility Analysis to describe and analyze the impact of the final rule on small entities unless the Secretary can certify that the regulation will not have a significant impact on a substantial number of small entities. In the healthcare sector, Small Business Administration (SBA) size standards define a small entity as one with between $7.5 to $38.5 million in annual revenues. For the purposes of the RFA, essentially all non-profit organizations are considered small entities, regardless of size. Individuals and states are not included in the definition of a small entity. Since the vast majority of Medicare providers (well over 90 percent) are small entities within the RFA's definitions, it is the normal practice of HHS simply to assume that all affected providers are “small” under the RFA. In this case, most EPs, eligible hospitals, and CAHs are either nonprofit or meet the SBA's size standard for small business. We also believe that the effects of the incentives program on many and probably most of these affected entities would be economically significant. Accordingly, this RIA section, in conjunction with the remainder of the preamble, constitutes the required Final Regulatory Flexibility Analysis (IFRFA). We believe that the adoption and meaningful use of EHRs will have an impact on virtually every EP and eligible hospital, as well as CAHs and some EPs and hospitals affiliated with MA organizations. While the program is voluntary, in the first 5 years it carries substantial positive incentives that make it attractive to virtually all eligible entities. Furthermore, entities that do not demonstrate meaningful use of EHR technology for an applicable EHR reporting period will be subject to significant Medicare payment reductions beginning in 2015. These Medicare payment adjustments are expected to motivate EPs, eligible hospitals, and CAHs to adopt and meaningfully use certified EHR technology.
For some EPs, CAHs, and eligible hospitals, the EHR technology currently implemented could be upgraded to meet the criteria for CEHRT as defined for this program. These costs may be minimal, involving no more than a software upgrade. “Home-grown” EHR systems that might exist may also require an upgrade to meet the certification requirements. We believe many currently used non-certified EHR systems will require significant changes to achieve certification and that EPs, CAHs, and eligible hospitals will have to make process changes to achieve meaningful use.
Data available suggests that more providers have adopted EHR technology since the publication of the Stage 1 final rule. An ONC data brief (No. 16, May 2014) noted that hospital adoption of EHR systems has increased 5 fold since
We estimate that EPs would spend approximately $54,000 to purchase and implement a certified EHR and $10,000 annually for ongoing maintenance according to the Congressional Budget Office (CBO) (75 FR 44546).
In the paper, Evidence on the Costs and Benefits of Health Information Technology, May 2008, in attempting to estimate the total cost of implementing health IT systems in office-based medical practices, the CBO recognized the complicating factors of EHR types, available features and differences in characteristics of the practices that are adopting them. The CBO estimated a cost range of $25,000 to $45,000 per physician. Annual operating and maintenance amount was estimated at 12 to 20 percent of initial costs (that is, $3,000 to $9,000) per physician. For all eligible hospitals, the range is from $1 million to $100 million. Though reports vary widely, we anticipate that the average will be $5 million for eligible hospitals to achieve meaningful use. We estimate $1 million for maintenance, upgrades, and training each year per eligible hospital. However, as stated earlier, many providers have already purchased systems with expenditures focused on maintenance and upgrades. We believe that future retrospective studies on the costs to implement and EHR and the return on investment (ROI) will demonstrate the actual costs incurred by providers participating in the EHR Incentive Programs. The potential costs savings in modifications to the EHR Incentive Programs portion of this final rule with comment period will benefit these providers as a reduction in the overall cost of program participation.
As discussed later in this analysis, we believe that there are many positive effects of adopting EHR on health care providers. We believe that the net effect on some individual providers may be positive. Furthermore, we believe that the provisions in this EHR Incentive Programs in 2015 through 2017 portion of this final rule with comment period will result in an overall reduction in the reporting burden for providers of all types. Accordingly, we believe that the object of the RFA to minimize burden on small entities is met by this final rule with comment period.
Section 1102(b) of the Act requires us to prepare a regulatory impact analysis (RIA) if a rule will have a significant impact on the operations of a substantial number of small rural hospitals. This analysis must conform to the provisions of section 604 of the RFA. For purposes of section 1102(b) of the Act, we define a small rural hospital as a hospital that is located outside of a metropolitan statistical area and has fewer than 100 beds.
The Stage 3 portion of this final rule with comment period will affect the operations of a substantial number of small rural hospitals because they may be subject to adjusted Medicare payments in 2015 if they fail to adopt CEHRT by the applicable EHR reporting period. As stated previously, we have determined that this final rule with comment period will create a significant impact on a substantial number of small entities, and have prepared a Regulatory Flexibility Analysis as required by the RFA and, for small rural hospitals, section 1102(b) of the Act. Furthermore, any impacts that would arise from the implementation of CEHRT in a rural eligible hospital would be positive, with respect to the streamlining of care and the ease of sharing information with other EPs to avoid delays, duplication, or errors. However, the Secretary retains the discretionary statutory authority to make case-by-case exceptions for significant hardships, and has already established certain categories where case-by-case applications may be made such as barriers to Internet connectivity that impact health information exchange.
There is no identifiable disparity among this group and the overall success rates for eligible hospitals and CAHs in meeting the requirements of the program; furthermore, 95 percent of eligible hospitals and CAHs have successfully participated as of January 1, 2015. Finally, on the whole we anticipate an estimated reduction in the reporting burden on eligible hospitals as a group to be less than $1 million. Therefore, we do not believe that the modifications portion of this final rule with comment period will have a significant impact on a substantial number of small entities.
Section 202 of the Unfunded Mandates Reform Act of 1995 (UMRA) requires that agencies assess anticipated costs and benefits before issuing any rule whose mandates will require spending in any 1 year $100 million in 1995 dollars, updated annually for inflation. In 2014, that threshold is approximately $144 million. UMRA does not address the total cost of a rule. Rather, it focuses on certain categories of cost, mainly those “federal mandate” costs resulting from—(1) imposing enforceable duties on state, local, or tribal governments, or on the private sector; or (2) increasing the stringency of conditions in, or decreasing the funding of, state, local, or tribal governments under entitlement programs.
This final rule with comment period imposes no substantial mandates on states. This program is voluntary for states and states offer the incentives at their option. The state role in the incentive program is essentially to administer the Medicaid EHR Incentive Program. While this entails certain procedural responsibilities, these do not involve substantial state expense. In general, each state Medicaid Agency that participates in the incentive program would be required to invest in systems and technology to comply. States would have to identify and educate providers, evaluate their attestations and pay the incentive. However, the federal government would fund 90 percent of the state's related administrative costs, providing controls on the total state outlay. In addition, the changes being made by the modifications portion of this final rule with comment period have very little impact on any state functions.
The investments needed to meet the requirements of the program and obtain incentive funding are voluntary, and hence not “mandates” within the meaning of the statute. However, the potential reductions in Medicare reimbursement beginning with FY 2015
Executive Order 13132 establishes certain requirements that an agency must meet when it promulgates a final rule that imposes substantial direct requirement costs on state and local governments, preempts state law, or otherwise has federalism implications. This final rule with comment period will not have a substantial direct effect on state or local governments, preempt state law, or otherwise have a federalism implication. Importantly, state Medicaid agencies are receiving 100 percent match from the federal government for incentives paid and a 90 percent match for expenses associated with administering the program. As previously stated, we believe that state administrative costs are minimal.
We note that the Stage 3 portion of this final rule with comment period does add a new business requirement for states, because of the existing systems that would need to be modified to track and report on the new requirements of the program for provider attestations. We are providing 90 percent Federal Financial Participation (FFP) to states for modifying their existing EHR Incentive Program systems. We believe the federal share of the 90 percent match will protect the states from burdensome financial outlays and, as noted previously, states offer the Medicaid EHR incentive program at their option.
The modifications portion of this final rule with comment period will not have a substantial direct effect on state or local governments, preempt state law, or otherwise have a Federalism implication.
Based on the actual count of provider's eligible for the program as of December 31, 2014 which were identified through the process of implementing payment adjustments for 2015, we estimated the numbers of EPs and eligible hospitals, including CAHs under Medicare, Medicaid, and MA for 2015 through 2017 and used the updated estimates throughout the analysis. These total potential eligible providers are as follows:
• About 660,000 Medicare FFS EPs (some of whom will also be Medicaid EPs).
About 595,100 non-hospital based Medicare EPs.
• About 58,300 non-Medicare eligible EPs (such as dentists, pediatricians, and eligible non-physicians such as certified nurse-midwives, nurse practitioners, and physicians assistants).
• 4,900 eligible hospitals comprising the following:
++ 3,397 acute care hospitals.
++ 1,395 CAHs.
++ 97 children's hospitals (Medicaid only).
++ 11 cancer hospitals (Medicaid only).
• 16 MA organizations and 13,635 MA EPs
There are no new costs associated with the modifications portion of this final rule with comment period. Furthermore, the estimates for the provisions affecting Medicare and Medicaid EPs, eligible hospitals, and CAHs are somewhat uncertain for the following reasons:
• The program is voluntary although payment adjustments will be imposed on Medicare providers if they are unable to meet the requirements of the program for the applicable EHR reporting period.
• The potential reduction in burden for EPs relate to assumptions of what options for meeting the requirements of the program they would otherwise attest to should the policies in this final rule with comment period not be adopted.
• The net costs and savings for any individual provider may not directly correlate to the total for the organization as larger organizations may employ economies of scale in EHR attestations.
The principal costs of the Stage 3 portion of final rule are the additional expenditures that will be undertaken by eligible entities in order to obtain the Medicaid incentive payments to adopt, implement or upgrade and demonstrate (or both) meaningful use of certified EHR technology, and to avoid the Medicare payment adjustments that will ensue if they fail to do so. The estimates for the provisions affecting Medicare and Medicaid EPs, eligible hospitals, and CAHs are uncertain for the following reasons:
• The program is voluntary although payment adjustments will be imposed on Medicare providers beginning in 2015 if they are unable to demonstrate meaningful use for the applicable EHR reporting period.
• The criteria for the demonstration of meaningful use of CEHRT has been finalized for Stage 1 and Stage 2 and is being finalized for Stage 3, but may change over time.
• The impact of the financial incentives and payment adjustments on the rate of adoption of CEHRT by EPs, eligible hospitals, and CAHs is difficult to predict based on the information we have currently collected.
In the EHR Incentive Programs in 2015 through 2017 proposed rule, we proposed no new policies which would require changes to the development, certification, and implementation of CEHRT or to adoption rates as compared to the policies in the existing program outlined in the Stage 2 final rule (77 FR 54136 through 54146).
As noted at the beginning of this analysis, it is difficult to predict the actual impacts of the policies in this proposed rule with certainty. We believe the assumptions and methods described herein are reasonable for estimating the financial impact of the provisions on providers participating in the Medicare and Medicaid programs, but acknowledge the wide range of possible outcomes.
In brief, the estimates of Medicare EP burden reduction are based on current participation as of January 1, 2015. We estimate that significant cost reductions for Medicare EPs participating in the EHR Incentive Program will result from the policies in this final rule with comment period when compared to the previous requirements for 2015. Our estimates of the reduction in burden cost savings are presented in Table 27. They reflect our assumptions about the proportion of EPs who will demonstrate meaningful use of CEHRT outlined in Table 26 based on historical data.
In brief, the estimates of hospital burden reduction are based on current participation as of January 1, 2015. We estimate that significant cost reductions for Medicare eligible hospitals and CAHs participating in the EHR Incentive Program will result from the policies in this final rule with comment period when compared to the previous requirements for 2015. Our estimates of the reduction in burden cost savings are presented in Table 29. They reflect our assumptions about the proportion of eligible hospitals and CAHs that will demonstrate meaningful use of CEHRT outlined in Table 28 based on historical data.
We estimate that significant cost reductions for Medicaid only EPs participating in the EHR Incentive Program will result from the policies in this final rule with comment period when compared to the previous requirements for 2015. Our estimates of the reduction in burden cost savings are presented in Table 31. They reflect our assumptions about the proportion of Medicaid only EPs who will demonstrate meaningful use of CEHRT outlined in Table 30 based on historical data.
It should be noted that since the Medicaid EHR Incentive Program provides that a Medicaid EP can receive an incentive payment in their first year because he or she has demonstrated meaningful use or because he or she has adopted, implemented, or upgraded CEHRT, these participation rates include only those Medicaid providers who are expected to demonstrate meaningful use. Providers who are dual-eligible have been included in the Medicare EP program estimates based on the total current volume of Medicare EPs who have demonstrated meaningful use in either Medicare or Medicaid as of January 1, 2015.
The burden reduction for Medicaid only eligible hospitals assumes a similar participation rate for the demonstration of meaningful use as is applicable for Medicare eligible hospitals. We estimate that significant cost reductions for Medicaid only eligible hospitals participating in the EHR Incentive Program will result from the policies in this final rule with comment period when compared to the previous requirements for 2015. Our estimates of the reduction in burden cost savings are presented in Table 33. They reflect our assumptions about the proportion of Medicaid only eligible hospitals that will demonstrate meaningful use of CEHRT outlined in Table 32 based on historical data.
In the Stage 2 final rule (77 FR 54136 through 54146), we estimated the impact on healthcare providers using information from four studies. In the absence of any more recent estimates that we are aware of, in this final rule with comment period, we continue to use the same estimates cited in the Stage 2 final rule. We continue to believe that these estimates are reasonably reflective of EHR costs. However, we note, we are unable to delineate all costs due to the great variability in characteristics among the entities that are affected by the final rule; the variability includes, but is not limited to, the size of the practice, extent of use of electronic systems, type of system used, number of staff using the EHR system and the cost for maintaining and upgrading systems or both. Based on these studies and current average costs for available CEHRT products, we continue to estimate for EPs that the average adopt/implement/upgrade cost is $54,000 per physician FTE, while annual maintenance costs average $10,000 per physician FTE.
For all eligible hospitals, we continue to estimate the range is from $1 million to $100 million. Although reports vary widely, we continue to anticipate that the average will be $5 million to achieve meaningful use, because providers who will likely qualify as meaningful users of EHRs will need to purchase certified EHRs. We further acknowledge “certified EHRs” may differ in many important respects from the EHRs currently in use and may differ in the functionalities they contain. We continue to estimate $1 million for maintenance, upgrades, and training each year. Both of these estimates are based on average figures provided in the 2008 CBO report. However, as noted previously, we are unable to delineate all costs due to the great variability in characteristics among the entities that are affected by the final rule; the variability includes, but is not limited to, the size of the hospital, extent of use of electronic systems, type of system used, number of staff using the EHR system and the cost for maintaining and upgrading systems or both.
Industry costs are important, in part, because EHR adoption rates will be a function of these industry costs and the extent to which the costs of “certified EHRs” are higher than the total value of EHR incentive payments available to EPs and eligible hospitals (as well as adjustments, in the case of the Medicare EHR incentive program) and any perceived benefits including societal benefits. Because of the uncertainties surrounding industry cost estimates, we have made various assumptions about adoption rates in the following analysis in order to estimate the budgetary impact on the Medicare and Medicaid programs.
Since the publication of the Stage 1 final rule, there has been little data published regarding the cost of EHR adoption and implementation. A 2011 study (
According to the American Hospital Association 2008 Survey, the range in yearly information technology spending among hospitals ranged from $36,000 to over $32 million. EHR system costs specifically were reported by other experts to run as high as $20 million to $100 million (77 FR 54139). We note that recently about 96 percent of eligible hospitals have received at least one incentive payment under either the Medicare or Medicaid programs. However, as noted previously, we are unable to delineate all costs due to the great variability that are affected by but not limited to the size of the eligible hospital, extent of use of electronic systems, type of system used, number of staff using the EHR system, and the cost for maintaining and upgrading systems or both.
Based on input from a number of internal and external sources, we estimated the numbers of EPs and eligible hospitals, including CAHs under Medicare, Medicaid, and MA expected to be eligible for the program in 2017 and used these estimates for the following analysis of Stage 3 program costs.
• About 675,500 Medicare FFS EPs in 2017 (some of whom will also be Medicaid EPs).
• About 60,600 non-Medicare eligible EPs (such as dentists, pediatricians, and eligible non-physicians such as certified nurse-midwives, nurse practitioners, and physician assistants) could be eligible to receive the Medicaid incentive payments in 2017.
• 4,900 eligible hospitals comprising the following:
++ 3,397 acute care hospitals
++ 1,395 CAHs
++ 97 children's hospitals (Medicaid only)
++ 11 cancer hospitals (Medicaid only)
• All eligible hospitals, except for children's and cancer hospitals, may qualify and apply for both Medicare and Medicaid incentive payments.
• About 16 MA organizations
The estimates for the HITECH Act provisions are based on the economic assumptions underlying the President's FY 2016 Budget. Under the statute, Medicare incentive payments for CEHRT are excluded from the determination of MA capitation benchmarks. We continue to expect a negligible impact on benefit payments to hospitals and EPs from Medicare and Medicaid because of the implementation of EHR technology.
As noted at the beginning of this analysis, it is difficult to predict the actual impacts of the HITECH Act with great certainty. We believe the assumptions and methods described herein are reasonable for estimating the financial impact of the provisions on the Medicare and Medicaid programs, but acknowledge the wide range of possible outcomes.
We began making EHR Incentive payments in 2011. Medicare payments are to be paid for the successful demonstration on meaningful use through CY 2016. Due to the payment lag, some payments may be issued in CY 2017. To avoid the Medicare payment adjustment beginning in 2015, EPs need to successfully demonstrate meaningful use regardless of whether they earn an incentive payment. We estimated the percentage of the remaining EPs who would be meaningful users each calendar year. Table 34 shows the results of these calculations.
Our estimates of the incentive payment costs and payment adjustment savings are presented in Table 35. They reflect actual historical data and our assumptions about the proportion of EPs who will demonstrate meaningful use of CEHRT. Estimated costs are expected to decrease in 2017 through 2020 due to a smaller number of new EPs that would achieve meaningful use and the cessation of the incentive payment program. Payment adjustment receipts represent the estimated amount of money collected due to the payment adjustments for those not achieving meaningful use. Estimated net costs for the Medicare EP portion of the HITECH Act are also shown in Table 35.
In brief, the estimates of hospital adoption were developed by calculating projected incentive payments and then making assumptions about how rapidly hospitals would adopt meaningful use.
Specifically, the first step in preparing estimates of Medicare program costs for eligible hospitals was to determine how many eligible hospitals already received payments under the EHR Incentive program and for what years those payments were received. In order to do this, we used the most recent available data that listed the recipients of incentive payments, and the year and payment amount. This information pertained to eligible hospitals receiving payments through September 2014.
We assume that all eligible hospitals that receive a payment in the first year will receive payments in future years. We also assume the eligible hospitals that have not yet received any incentive payments will eventually achieve meaningful use (either to receive incentive payments or to avoid payment adjustments). We assume that all eligible hospitals would achieve meaningful use by 2018. No new incentive payments would be paid after 2016. However, some incentive payments originating in 2016 would be paid in 2017.
The average incentive payment for each eligible hospital was $1.5 million in the first year. In later years, the amount of the incentive payments drops according to the schedule allowed in law. The average incentive payment for CAHs received in the first year was about $950,000. The average incentive payment received in the second year was about $332,500. The average incentive payment received in the third year was about $475,000. These average amounts were used for these incentive payments in the future. The third year average was also used for the fourth year. These assumptions about the number of hospitals achieving meaningful use in a particular year and the average amount of an incentive payment allows us to calculate the total amount of incentive payments to be made and the amount of payment adjustments for those hospitals who have not achieved meaningful use. The payment incentives available to hospitals under the Medicare and Medicaid EHR Incentive Programs are included in our regulations at 42 CFR part 495. We further estimate that there are 16 MA organizations that might be eligible to participate in the incentive program. Those plans have 32 eligible hospitals. The costs for the MA program have been included in the overall Medicare estimates.
The estimated payments to eligible hospitals were calculated based on the hospitals' qualifying status and individual incentive amounts under the statutory formula. Similarly, the estimated payment adjustments for non-qualifying hospitals were based on the market basket reductions and Medicare revenues. The estimated savings in Medicare eligible hospital benefit expenditures resulting from the use of hospital certified EHR systems were discussed earlier in this section. We assumed no future growth in the total number of hospitals in the U.S. because growth in acute care hospitals has been minimal in recent years. The results are shown in Table 36.
Under section, 4201 of the HITECH Act, states and territories can voluntarily participate in the Medicaid EHR Incentive Program. However, as of the writing of this rule, all states already participate. The payment incentives available to EPs and eligible hospitals under the Medicaid EHR Incentive Program are included in our regulations at 42 CFR part 495. The federal costs for Medicaid incentive payments to providers who can demonstrate meaningful use of EHR technology were estimated similarly to the estimates for Medicare eligible hospitals and EPs. Table 37 shows our estimates for the net Medicaid costs for eligible hospitals and EPs.
It should be noted that since the Medicaid EHR Incentive Program provides that a Medicaid EP can receive an incentive payment in his or her first year because he or she has demonstrated a meaningful use or because he or she has adopted, implemented, or upgraded CEHRT, these participation rates include not only meaningful users but eligible providers implementing CEHRT as well.
Medicaid incentive payments to most eligible hospitals were estimated using the same methodology as described previously for Medicare eligible hospitals and shown in Table 39. Many eligible hospitals may qualify to receive both the Medicare and Medicaid incentive payment. We assume that all eligible hospitals would achieve meaningful use by 2016. However, many of these eligible hospitals would have already received the maximum amount of incentive payments. Table 40 shows our assumptions about the remaining incentive payments to be paid.
As stated previously, the estimated eligible hospital incentive payments were calculated based on the eligible hospitals' qualifying status and individual incentive amounts payable under the statutory formula. The average Medicaid incentive payment in the first year was $1 million. The estimated savings in Medicaid benefit expenditures resulting from the use of CEHRT are discussed in section V.C.4 of this final rule with comment period. Since we use Medicare data and little data existed for children's hospitals, we estimated the Medicaid incentives payable to children's hospitals as an add-on to the base estimate, using data on the number of children's hospitals compared to non-children's hospitals.
In this final rule with comment period, we did not quantify the overall benefits to the industry, nor to eligible hospitals or EPs in the Medicare, Medicaid, or MA programs. Although information on the costs and benefits of adopting systems that specifically meet the requirements for the EHR Incentive Programs (for example, CEHRT) has not yet been collected, and although some studies question the benefits of health information technology, a 2011 study completed by ONC
According to a CBO study, when used effectively, EHRs can enable providers to deliver health care more efficiently.
In the Stage 2 final rule at 77 FR 54144, we discussed research documenting the association of EHRs with improved outcomes among diabetics
In this final rule with comment period, the burden estimate and analysis of the impact of the policies result in a total cost reduction estimated at $48,534,332 at the lowest and $63,359,464 at the highest for an EHR reporting period on an annual basis for 2015 through 2017. For further information on prior estimates of program costs we direct readers to the Stage 2 final rule (77 FR 54145).
The total cost to the Medicare and Medicaid programs between 2017 and 2020 is estimated to be $3.7 billion in transfers.
As stated in the Stage 1 final rule (75 FR 44546), HHS has no discretion to change the incentive payments or payment adjustment reductions specified in the statute for providers that adopt or fail to adopt CEHRT and demonstrate meaningful use of CEHRT. However, we have discretion around how best to meet the HITECH Act requirements for meaningful use for FY 2017 and subsequent years, which we have exercised in this final rule with comment period. Additionally, we have used our discretion to propose the timing of registration, attestation, and payment requirements to allow EPs and eligible organizations as much time as possible in coordination with the anticipated certification of EHR technology to obtain and meaningfully use CEHRT. We recognize that there may be additional costs that result from various discretionary policy choices by providers. However, those costs cannot be estimated as the potential for variance by provider type, organization size, place of service, geographic location, patient population, and the impact of state and local laws is extensive and such variations are not captured in this analysis.
When a rule is considered a significant rule under Executive Order 12866, we are required to develop an accounting statement indicating the classification of the expenditures associated with the provisions of this final rule with comment period. Monetary annualized benefits and non-budgetary costs are presented as discounted flows using 3 percent and 7 percent factors in the following tables. We are not able to explicitly define the universe of those additional costs, nor specify what the high or low range might be to implement EHR technology in this final rule with comment period. We note that federal annualized monetized transfers represent the net total of annual incentive payments in the Medicare and Medicaid EHR Incentive programs less the reductions in Medicare payments to providers failing to demonstrate meaningful use as a result of the related Medicare payment adjustments.
In this final rule with comment period, there is no estimated increase in costs associated with incentive payments or payment adjustments for the Medicare and Medicaid EHR Programs attributable to the modifications to the program proposed in the EHR Incentive Programs in 2015 through 2017 proposed rule.
Expected qualitative benefits include improved quality of care, better health outcomes, reduced errors and the like. Private industry costs would include the impact of EHR activities such as temporary reduced staff productivity related to learning how to use the EHR, the need for additional staff to work with HIT issues, and administrative costs related to reporting. Transfers related to the payment of EHR Incentive Payments for 2017 through 2020 based on the policies in this final rule with comment period and the estimated reduction in Medicare payments through the application of payment adjustments for the same period. We note that this estimate relates only to the policies in this final rule with comment period and does not address subsequent changes pertaining to the MIPS program as established by MACRA which will be further defined in future rulemaking.
Because of the large number of public comments we normally receive on
Administrative practice and procedure, Health facilities, Medicare, Puerto Rico, Reporting and recordkeeping requirements.
Administrative practice and procedure, Electronic health records, Health facilities, Health professions, Health maintenance organizations (HMO), Medicaid, Medicare, Penalties, Privacy, Reporting and recordkeeping requirements.
For the reasons stated in the preamble, the Centers for Medicare & Medicaid Services amends 42 CFR Chapter IV as set forth below:
Secs. 1102 and 1871 of the Social Security Act (42 U.S.C. 1302 and 1395hh), sec. 124 of Pub. L. 106-113 (113 Stat. 1501A-332), sec. 1206 of Pub. L. 113-67, and sec. 112 of Pub. L. 113-93.
Secs. 1102 and 1871 of the Social Security Act (42 U.S.C. 1302 and 1395hh).
The additions and revision read as follows:
(1) For any Federal fiscal year or calendar year before 2018, EHR technology (which could include multiple technologies) certified under the ONC Health IT Certification Program that meets one of the following:
(i) The 2014 Edition Base EHR definition (as defined at 45 CFR 170.102) and has been certified to the certification criteria that are necessary to be a Meaningful EHR User (as defined in this section), including the applicable measure calculation certification criterion at 45 CFR 170.314(g)(1) or (2) for all certification criteria that support a meaningful use objective with a percentage-based measure.
(ii) Certification to—
(A) The following certification criteria:
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(B) Clinical quality measures at—
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(C) Privacy and security at—
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(D) The certification criteria that are necessary to be a Meaningful EHR User (as defined in this section), including the applicable measure calculation certification criterion at 45 CFR 170.314(g)(1) or (2) or 45 CFR 170.315(g)(1) or (2) for all certification criteria that support a meaningful use objective with a percentage-based measure.
(iii) The definition for 2018 subsequent years specified in paragraph (2) of this definition.
(2) For 2018 and subsequent years, EHR technology (which could include multiple technologies) certified under the ONC Health IT Certification Program that meets the 2015 Edition Base EHR definition (as defined at 45 CFR 170.102) and has been certified to the 2015 Edition health IT certification criteria—
(i) At 45 CFR 170.315(a)(12) (family health history) and 45 CFR 170.315(e)(3) (patient health information capture); and
(ii) Necessary to be a Meaningful EHR User (as defined in this section), including the following:
(A) The applicable measure calculation certification criterion at 45 CFR 170.315(g)(1) or (2) for all certification criteria that support a meaningful use objective with a percentage-based measure.
(B) Clinical quality measure certification criteria that support the calculation and reporting of clinical quality measures at 45 CFR 170.315(c)(2) and (3).
(1) * * *
(i) The following are applicable before 2015:
(ii) The following are applicable for 2015, 2016, and 2017:
(A) For the CY 2015 payment year, any continuous 90-day period within CY 2015.
(B) For the CY 2016 payment year:
(
(
(C) For the CY 2017 payment year under the Medicaid EHR Incentive Program:
(
(
(
(iii) The following are applicable beginning with the CY 2018 payment year under the Medicaid EHR Incentive Program:
(A) For the payment year in which the EP is first demonstrating he or she is a meaningful EHR user, any continuous 90-day period within the calendar year.
(B) For the subsequent payment years following the payment year in which the EP first successfully demonstrates he or she is a meaningful EHR user, the calendar year.
(2) * * *
(i) The following are applicable before 2015:
(ii) The following are applicable for 2015, 2016, and 2017:
(A) For the FY 2015 payment year, any continuous 90-day period within the period beginning on October 1, 2014 and ending on December 31, 2015.
(B) For the FY 2016 payment year as follows:
(
(
(C) For the FY 2017 payment year under the Medicaid EHR Incentive Program:
(
(
(
(iii) The following are applicable beginning with the FY 2018 payment year under the Medicaid EHR Incentive Program:
(A) For the payment year in which the eligible hospital or CAH is first demonstrating it is a meaningful EHR user, any continuous 90-day period within the calendar year.
(B) For the subsequent payment years following the payment year in which the eligible hospital or CAH first successfully demonstrates it is a meaningful EHR user, the calendar year.
(1) * * *
(i) The following are applicable before 2015:
(ii) The following are applicable for 2015, 2016, and 2017:
(A) In 2015 as follows:
(
(
(B) In 2016 as follows:
(
(
(C) In 2017 as follows:
(
(
(2) * * *
(i) The following are applicable before 2015:
(ii) The following are applicable for 2015, 2016, and 2017:
(A) In 2015 as follows:
(
(
(B) In 2016 as follows:
(
(
(C) In 2017 as follows:
(
(
(
(iii) The following are applicable beginning in 2018:
(A) Except as provided in paragraph (2)(iii)(B) of this definition, the EHR reporting period is the calendar year that is 2 years before the payment adjustment year.
(B) If an eligible hospital is demonstrating under the Medicaid EHR Incentive Program that it is a meaningful EHR user for the first time in the calendar year that is 2 years before the payment adjustment year, the EHR reporting period for that payment adjustment year is the same continuous 90-day period that is the EHR reporting period for the Medicaid incentive payment within the calendar year that is 2 years before that payment adjustment year.
(3) * * *
(i) The following are applicable before 2015:
(ii) The following are applicable for 2015, 2016, and 2017:
(A) In 2015 as follows:
(1) The EHR reporting period is any continuous 90-day period within the period beginning on October 1, 2014 and ending on December 31, 2015 and applies for the FY 2015 payment adjustment year.
(B) In 2016 as follows:
(
(
(C) In 2017 as follows:
(
(
(
(iii) The following are applicable beginning in 2018:
(A) Except as provided in paragraph (3)(iii)(B) of this definition, the EHR reporting period is the calendar year that begins on the first day of second quarter of the Federal fiscal year that is the payment adjustment year.
(B) If a CAH is demonstrating under the Medicaid EHR Incentive Program that it is a meaningful EHR user for the first time in the calendar year that begins on the first day of the second quarter of the Federal fiscal year that is the payment adjustment year, then any continuous 90-day period within such calendar year. The EHR reporting period for that payment adjustment year is the same continuous 90-day period that is the EHR reporting period for the Medicaid incentive payment within the calendar year that that begins on the first day of the second quarter of the Federal fiscal year that is the payment adjustment year.
The following criteria are applicable before 2015:
(a)
(2) For 2017 only, EPs, eligible hospitals, and CAHs have the option to use the criteria specified for 2018 (as outlined at § 495.24) instead of the criteria specified in this section.
(b)
(2)
(A) Must ensure that the objective in paragraph (e) of this section includes an option for the EP to attest that the objective is not applicable.
(B) Meets the criteria in the applicable objective that would permit the attestation to the exclusion.
(C) Attests.
(ii) An exclusion will reduce (by the number of exclusions applicable) the number of objectives that would otherwise apply in paragraph (e) of this section.
(c)
(2)
(A) Must ensure that the objective in paragraph (e) of this section includes an option for the eligible hospital or CAH to attest that the objective is not applicable.
(B) Meets the criteria in the applicable objective that would permit the attestation to the exclusion.
(C) Attests.
(ii) An exclusion will reduce (by the number of exclusions applicable) the number of objectives that would otherwise apply in paragraph (e) of this section.
(d)
(2) If the objective and associated measure does not reference this paragraph (d) of this section, then the measure must be calculated by reviewing all patient records, not just those maintained using CEHRT.
(e)
(ii)
(B)
(2)
(ii)
(
(
(B)
(C)
(
(2)
(iii)
(
(
(B)
(
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(3)
(ii)
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(
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(C)
(
(
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(iii)
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(B)
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(4)
(ii)
(B)
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(C)
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(iii)
(B)
(C)
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(5)
(ii)
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(B)
(C)
(iii)
(
(
(B)
(6)
(ii)
(B)
(C)
(iii)
(B)
(7)
(ii)
(B)
(C)
(iii)
(A)
(B)
(8)
(A)
(
(
(
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(B)
(
(C)
(ii)
(A)
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(B)
(C)
(9)
(ii)
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(B)
(
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(C)
(10)
(B)
(
(
(
(C)
(
(
(
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(
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(
(
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(D)
(ii)
(B)
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(3)
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(C)
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(D)
The following criteria are optional for EPs, eligible hospitals, and CAHs in 2017 as outlined at § 495.40(a)(2)(i)(E)(
(a)
(2)
(i) Must ensure that the objective in paragraph (d) of this section includes an option to meet 2 out of the 3 associated measures.
(ii) Meets the threshold for 2 out of the 3 measures for that objective.
(iii) Attests to all 3 of the measures for that objective
(3)
(A) Meets the criteria in the applicable objective that would permit the exclusion.
(B) Attests to the exclusion.
(ii) An EP may exclude a measure within an objective which allows for a provider to meet the threshold for 2 of the 3 measures, as outlined in paragraph (a)(2) of this section, in the following manner:
(A)(
(
(B)(
(
(4)
(b)
(2)
(i) Must ensure that the objective in paragraph (d) of this section includes an option to meet 2 out of the 3 associated measures.
(ii) Meets the threshold for 2 out of the 3 measures for that objective.
(iii) Attests to all 3 of the measures for that objective.
(3)
(A) Meets the criteria in the applicable objective that would permit the exclusion.
(B) Attests to the exclusion.
(ii) An eligible hospital or CAH may exclude a measure within an objective which allows for a provider to meet the threshold for 2 of the 3 measures, as outlined in paragraph (b)(2) of this section, in the following manner:
(A)(
(
(B)(
(
(4)
(c)
(2) If the objective and associated measure does not reference this paragraph (c) of this section, then the measure must be calculated by reviewing all patient records, not just those maintained using CEHRT.
(d)
(B)
(ii)
(B)
(B)
(C)
(
(ii)
(B)
(C)
(3)
(B)
(
(C)
(ii)
(B)
(
(4)
(B)
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(
(
(C)
(
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(ii)
(B)
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(
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(5)
(B)
(
(
(
(
(C)
(
(ii)
(B)
(
(
(ii) The provider ensures the patient's health information is available for the patient (or patient-authorized representative) to access using any application of their choice that is configured to meet the technical specifications of the API in the provider's CEHRT.
(
(C)
(6)
(B)
(
(
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(C)
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j. In newly redesignated paragraph (b)(1)(iii), by removing the cross-reference “in § 495.6 and § 495.8 of this subpart” and adding in its place the cross-reference “in § 495.20 or § 495.24 and § 495.40”.
The revisions and additions read as follows:
(a) * * *
(2) * * *
(i) * * *
(B) For calendar years before 2015, satisfied the required objectives and associated measures under § 495.20 for the EP's stage of meaningful use.
(E) For CYs 2015 through 2017, satisfied the required objectives and associated measures under § 495.22(e) for meaningful use.
(F) For CY 2017 only, an EP may satisfy either of the following objectives and measures for meaningful use:
(
(
(b) * * *
(2) * * *
(i) * * *
(B) For fiscal years before 2015, satisfied the required objectives and associated measures under § 495.20 for the eligible hospital or CAH's stage of meaningful use.
(E) For CYs 2015 through 2017, satisfied the required objectives and associated measures under § 495.22(e) for meaningful use.
(F) For CY 2017 only, an eligible hospital or CAH may satisfy either of the following objectives and measures for meaningful use:
(
(
(G) For CY 2018 and subsequent years, satisfied the required objectives and associated measures under § 495.24(d) for meaningful use.
(c) Subject to § 495.332 and § 495.352, the State is required to submit to CMS annual reports, in the manner prescribed by CMS, on the following:
(d) * * *
(2) * * *
(iii) Subject to § 495.332, the State may propose a revised definition for Stage 3 of meaningful use of CEHRT, subject to CMS prior approval, but only with respect to the public health and clinical data registry reporting objective described in § 495.24(d)(8).
(f) Each State must submit to CMS the annual report described in paragraph (c) of this section within 60 days of the end of the second quarter of the Federal fiscal year.
(g) The State must, on a quarterly basis and in the manner prescribed by CMS, submit a report(s) on the following:
(1) The State and payment year to which the quarterly report pertains.
(2) Subject to paragraph (h)(2) of this section, provider-level attestation data for each EP and eligible hospital that attests to demonstrating meaningful use for each payment year beginning with 2013.
(h)(1) Subject to paragraph (h)(2) of this section, the quarterly report described in paragraph (g) of this section must include the following for each EP and eligible hospital:
(i) The payment year number.
(ii) The provider's National Provider Identifier or CCN, as appropriate.
(iii) Attestation submission date.
(iv) The state qualification.
(v) The state qualification date, which is the beginning date of the provider's EHR reporting period for which it demonstrated meaningful use.
(vi) The State disqualification, if applicable.
(vii) The State disqualification date, which is the beginning date of the provider's EHR reporting period to which the provider attested but for which it did not demonstrate meaningful use, if applicable.
(2) The quarterly report described in paragraph (g) of this section is not required to include information on EPs who are eligible for the Medicaid EHR incentive program on the basis of being a nurse practitioner, certified nurse-midwife or physician assistant.
14. Section 495.352 is revised to read as follows:
(a) Beginning with the first quarter of calendar year 2016, each State must submit to HHS on a quarterly basis a progress report, in the manner prescribed by HHS, documenting specific implementation and oversight activities performed during the quarter, including progress in implementing the State's approved Medicaid HIT plan.
(b) The quarterly progress reports must include, but need not be limited to providing, updates on the following:
(1) State system implementation dates.
(2) Provider outreach.
(3) Auditing.
(4) State-specific State Medicaid HIT Plan tasks.
(5) State staffing levels and changes.
(6) The number and type of providers that qualified for an incentive payment on the basis of having adopted, implemented or upgraded CEHRT and the amounts of incentive payments.
(7) The number and type of providers that qualified for an incentive payment on the basis of having demonstrated that they are meaningful users of CEHRT and the amounts of incentive payments.
(c) States must submit the quarterly progress reports described in this section within 30 days after the end of each federal fiscal year quarter.
Employment and Training Administration, Labor.
Final rule.
The Department of Labor is issuing regulations to govern its certification of the employment of nonimmigrant workers in temporary or seasonal agricultural employment under the H-2A program. Specifically, these regulations establish standards and procedures for employers seeking to hire foreign temporary agricultural workers for job opportunities in herding and production of livestock on the range. These regulations are consistent with the Secretary of Labor's statutory responsibility to certify that there are not sufficient able, willing, qualified and available U.S. workers to perform these jobs, and that the employment of foreign workers will not adversely affect the wages and working conditions of workers in the United States similarly employed. Among the issues addressed in these regulations are the qualifying criteria for employing foreign workers in the applicable job opportunities, preparing job orders, program obligations of employers, filing of H-2A applications requesting temporary labor certification for range occupations, recruiting U.S. workers, determining the minimum offered wage rate, and the minimum standards for housing used on the range. The regulations establish a single set of standards and procedures applicable to employers seeking to hire foreign temporary agricultural workers for sheep and goat herding and range production of livestock, given the unique characteristics of these job opportunities in their industry.
For further information, contact William W. Thompson, II, Acting Administrator, Office of Foreign Labor Certification, Employment and Training Administration, U.S. Department of Labor, 200 Constitution Avenue NW., Room C-4312, Washington, DC 20210; Telephone (202) 693-3010 (this is not a toll-free number). Individuals with hearing or speech impairments may access the telephone number above via TTY by calling the toll-free Federal Information Relay Service at 1-800-877-8339.
On April 15, 2015, the Employment and Training Administration (ETA) of the Department of Labor (DOL or Department) issued a notice of proposed rulemaking (NPRM) requesting comments on proposed standards and procedures to govern the certification of nonimmigrant workers in temporary or seasonal agricultural employment under the H-2A program. Temporary Agricultural Employment of H-2A Foreign Workers in the Herding or Production of Livestock on the Open Range in the United States, 80 FR 20300 (2015). Specifically, the NPRM addressed employment in sheep, goat and cattle herding occupations performed on the open range.
The Department received 506 timely comments from a wide variety of sources. Commenters included: Members of Congress; State political officials, including State governors and legislative representatives; State executive agencies; individual ranchers that employ H-2A herders in their operations; national and state-level industry advocacy organizations; worker advocacy organizations; national and state-level agriculture advocacy organizations; wool growers associations; sheep shearing businesses; members of the media; and the Small Business Administration's Office of Advocacy (SBA Office of Advocacy), among others. The vast majority of comments specifically addressed issues contained in ETA's proposed rule. The Department recognizes and appreciates the value of comments, ideas, and suggestions from all those who commented on the proposal, and this Final Rule was developed only after consideration of all the material submitted.
The Immigration and Nationality Act (INA or the Act) establishes the H-2A visa classification for employers to employ foreign workers on a temporary basis to perform agricultural labor or services. INA Section 101(a)(15)(H)(ii)(a), 8 U.S.C. 1101(a)(15)(H)(ii)(a);
(A) There are not sufficient workers who are able, willing, and qualified, and who will be available at the time and place needed to perform the labor or services involved in the petition; and
(B) The employment of the foreign worker(s) in such labor or services will not adversely affect the wages and working conditions of workers in the United States similarly employed.
The Secretary has delegated these responsibilities, through the Assistant Secretary, Employment and Training Administration (ETA), to ETA's Office of Foreign Labor Certification (OFLC). Sec. Order 06-2010, 75 FR 66268 (Oct. 27, 2010). The Secretary has delegated responsibility for enforcement of the worker protections to the Administrator of the Wage and Hour Division (WHD). Sec. Order 01-2014, 79 FR 77527 (Dec. 24, 2014).
Since 1987, OFLC and its predecessor agencies have operated the H-2A program under regulations promulgated under the authority of the Immigration Reform and Control Act of 1986 (IRCA), which amended the INA and established the H-2A program.
This preamble sets out DOL's interpretation of the new regulations added to Subpart B, section by section. Before setting out the section-by-section analysis below, however, we will first acknowledge and respond to comments that did not fit readily into this organizational scheme.
Most of the hundreds of comments we received addressed one or more specific issues in the NPRM, such as the proposed wage methodology, all of which are discussed in greater detail in Sec. IV below. However, within many of those targeted comments were more general remarks on the nature and the scope of the proposed rule, as discussed here. We received several general comments in support of the NPRM and the proposed standards and procedures. Several commenters indicated that new rules were necessary to improve wages and other conditions for workers and to monitor compliance with the regulations. Some commenters noted that the new regulations were long overdue, in particular because foreign workers in herder occupations are grossly underpaid. One commenter noted that although herders' wages should be increased, the upward adjustment should be implemented over a period of time so that employers can adapt to the wage increase.
The vast majority of comments we received were from individuals or organizations that opposed specific aspects of the NPRM's provisions, particularly the wage methodology. Many of the comments were from individual ranchers who stated that their families had been operating their businesses for five or more generations. From a review of these comments, several overarching general themes emerged. Several commenters observed that the current rules “are not broken,” so no fix is required. Dozens of commenters remarked that the proposed wage methodology would result in the loss of livelihood of many individual ranchers, and dozens of others went further to conclude that the proposed wage methodology would put an end to the production of sheep, goat and cattle industries in the United States as a whole. Many commenters noted that satellite industries that provide goods and services to or derive goods and services from sheep, goat and cattle production, including textiles businesses and wool mills; the production of military, sports, and first responder uniforms from sheep wool; meat processing; feed lots; animal transport; veterinarians and vet supplies; and seed stock producers, among others, would be adversely effected by the new regulation. Others noted that in addition to the impact on satellite industries, the communities in which the regulated ranches are located would suffer, because the ranches stimulate the local economy through the purchase of goods, supplies and services locally to sustain their businesses, including banking services, grocers and gas stations, among others. The adverse impact to both the satellite industries and the local communities would include, the comments noted, the loss of jobs to U.S. and foreign workers alike. One comment noted that with increased costs to ranchers, which would result in loss of livestock-based jobs, land grant colleges with agriculture programs would suffer.
We received many comments that addressed the international aspects of the herder occupations and the industries that employ them. One commenter noted that the foreign labor certification program creates goodwill between the United States and the foreign workers' countries of origin, and the new rules would diminish that goodwill. Several comments noted the impact of foreign imports, particularly sheep imports, on the ability of U.S. ranchers to compete in the global marketplace. These comments suggested that if herder wages are increased, the government must also protect the U.S. market from price competition resulting from less expensive foreign imports. Many ranchers remarked that foreign importers would further profit because foreign producers would undercut U.S. meat and wool prices. Commenters also asserted that foreign meat imports are not held to the same food safety standards as U.S. meat producers, which increases the cost of the domestic products.
We also received several dozen comments about the environmental impact that would result if the sheep, goat and cattle industries experience increased costs to employ herders. One commenter noted that grazing livestock producers manage 250 million acres of Western land, including public land under the stewardship of the U.S. Forest Service (USFS or Forest Service) in the U.S. Department of Agriculture and the Bureau of Land Management (BLM) in the U.S. Department of the Interior. Many of these comments noted that the migratory pattern of animal herding is itself a natural resource management activity. Among the natural resource management benefits of controlled animal migration are the improvement of wildlife habitats that promotes animal breeding and sustains migratory fowl; the control of the spread of noxious and invasive weeds; the reduction of the use of herbicides and pesticides; the increased use of sheep “fertilizer” to improve the quality of the land; and the decreased use of machinery for tending the land, thus reducing fuel use and our carbon footprint. Several dozen comments indicated that animal grazing aids in the reduction of undergrowth that feeds wildfires in the West. Thus, these commenters asserted that if sheep, goat and cattle producers' costs are raised, this would result in the reduction of animal grazing overall, which would, in turn, increase wildfires in the Western United States because of the abundance of “fuel” that would otherwise be reduced by grazing. Such fires would, among other things, result in the devastation of sage brush, which is the
Many ranchers noted that, in their view, foreign herders are satisfied with their current wages and working conditions. In support of this conclusion, they indicated that the wages earned are far superior to those wages they might earn for the same work in their countries of origin. Ranchers noted that their foreign workers routinely send funds home, suggesting that the herders have expendable income. They also noted that the same herders return to their U.S. jobs year after year, suggesting that the wages and working conditions are satisfactory to support the retention of foreign herders. Several ranchers noted that herders become “one of the family” and are welcome in the ranch house to take meals with the family, and that employers take good care of herders' health and welfare. To this end, we received several comments inviting us to visit the ranches and the herders so that we could better understand the industry and the way of life. Several ranchers indicated that if there were, in fact, exploitive ranch operations that did not “play by the rules,” DOL should take action against those ranchers but not change the current rules.
We received several comments requesting that we “work closely” with the industry to develop “workable new rules.” Prior to this notice and comment proceeding, we received and considered written input from the industry, as well as employee advocates, in developing the provisions proposed in the NPRM. 80 FR at 20309. We have also reviewed and considered carefully all 506 comments received from the stakeholders affected by this Final Rule, including both industry and employee representatives. We address in more detail below, particularly in the section on the wage methodology adopted in the Final Rule, the concerns raised about the adverse impact of the regulation on ranchers, their local communities, and other industries that serve the ranching industries. As we discuss more fully below, we recognize that after decades of the status quo, in which there was no change to the rules governing these industries, the current modernization effort can have a broad impact, and we have made adjustments to the proposed provisions, as discussed more fully below, with these interests in mind, as well as those of the employees. We thank all commenters for their input, including those that offered their general support for and their opposition to the new regulations, and we have considered all these remarks as we developed the provisions included in this Final Rule.
The NPRM indicated that among the reasons for the current rulemaking was the decision in the
We agree that the
We received two joint comments from worker advocate groups that supported the need for rulemaking, particularly to address the inadequate wage methodology and herder wage stagnation. A relatively brief worker advocate joint submission applauded the proposed rules, asserting that the revisions will “greatly benefit both temporary foreign workers and U.S. workers alike, including long-overdue wage increases and other proposed provisions that seek to address the poor working conditions.”
We received several comments, including from industry associations Mountain Plains Agricultural Services (Mountain Plains) and Western Range Association (Western Range) that address the early history of foreign sheep herders coming into the United States to perform herding work, as early as the 1950s. The NPRM discussed this history in some length. 80 FR at 20301-20302. Based on the history, one commenter noted that early herders from the Basque region in Spain were given special treatment in order to permit their entry into the United States to work when no U.S. workers were available, which gave rise to the establishment of special procedures. Three commenters underscored that Congress recognized the special needs of sheep ranchers in their early enactments in the 1950s. Two commenters indicated, without specific citation, that IRCA intended that DOL grant special procedures to ranchers seeking foreign herders. One commenter asserted that foreign herders should be permitted to stay in the United States longer than typically allowed because of the unique skills of foreign herders. One commenter submitted that the history of special procedures, as reflected in early Congressional action, DOL sub-regulatory action, and subsequent regulations permitting the establishment of special procedures, provides a sound foundation for the continuation of special procedures. Several commenters noted that the process and standards set out in early Departmental guidance and later incorporated into the TEGLs have worked well for decades and that change is unnecessary. These commenters noted that special procedures—separate from the regular H-2A standards—are necessary because of the recognized unique nature of the herding occupation, including that herders tend to the herd all day, every day, and that their remote location makes their work hours difficult to record. Finally, the Worker Advocates' Joint Comment pointed out that even though separate regulatory standards may be required because of the nature of herding work, those variances from the standard H-2A requirements must apply only to herders working on the range and not to livestock workers on the ranch. They further note that the variances must be consistent with the statutory command to protect against adverse effect on U.S. workers' wages and working conditions. As with the proposal in the NPRM, we have taken into account the unique nature of herder work and its long history with respect to the employment of foreign workers as we developed this Final Rule.
We published the NPRM on April 15, 2015 and originally requested that comments be submitted within 30 days, by May 15, 2015. We received 100 comments requesting an extension of the public comment period. A plurality of requests to extend the comment period (48) did not identify the specific time period sought for an extension. However, 38 requests sought an extension of the comment period for 90 days. The remainder of the requests sought additional time variously in a range between 30 and 180 days.
On May 5, 2015, we extended the comment period an additional 15 days, to June 1, 2015. 80 FR 25663. We received a few additional comments (counted in the 100-request total mentioned above) seeking time beyond the new June 1, 2015 deadline. However, because of the
This preamble sets out ETA's interpretation of the new regulations in Subpart B, section by section, and generally follows the outline of the regulations. Within each section of the preamble, the Department has noted and responded to those comments that are addressed to that particular section of the rule. The Department notes that, in the NPRM, we had proposed to place these new rules in a new Subpart C. In order to ensure that there is no confusion regarding the Department's continued authority to enforce requirements relating to herding and range livestock workers pursuant to 29 CFR part 501, we have decided to place the new rules at the end of existing Subpart B, the standard H-2A requirements, rather than in a new Subpart. Therefore, ministerial conforming modifications have been made throughout the regulation to accommodate this non-substantive change. Such minor modifications are not addressed individually below.
As stated in the NPRM, the standard H-2A regulations in existing 20 CFR part 655, subpart B (§§ 655.100—655.185) govern the certification of employers' temporary employment of nonimmigrant workers in temporary or seasonal agricultural employment. Because of the unique nature of the herder occupations, employers who seek to hire temporary agricultural foreign workers to perform herding or production of livestock on the range, as described in § 655.200(b), are subject to certain standards that are different from the regular H-2A standards and procedures. These new regulations, found at §§ 655.200-655.235 (hereinafter generally referred to as the herding and range livestock regulations), are intended as a comprehensive set of regulations governing the certification of the temporary employment of foreign workers in herder or production of livestock occupations on the range.
Prior to this Final Rule, the standards and procedures governing sheep, goat and cattle herders were set separately in two different TEGLs, as noted above. Although there were some differences in the TEGL standards as they applied to the different industries (sheep and goat herding were covered by one TEGL and cattle herding by the second TEGL), the standards and procedures were largely the same. We proposed in the NPRM to set the same certification standards and procedures for employers employing foreign sheep and goat herders as employers employing foreign cattle herders. We received two comments on this issue. The first was included in the Worker Advocates' Joint Comment, which concurred that a single set of rules is needed to protect goat herders, sheep herders, and range production of livestock workers efficiently and effectively. The second comment, submitted by Maltsberger Ranch, opposed applying the same standards to sheep and goat herding, and open range production of livestock.
Maltsberger Ranch indicated that the rules should be different because the animals' “husbandry, needs and handling standards are different, [and an] area's geographic location may dictate the need of different ranching practices. . . . The rule should not be rewritten in a manner that changes the scope of, or redefines the application of special procedures historically granted [to] Range Producers of Livestock.” We are adopting the position taken in the NPRM, which sets common procedures and other standards for sheep and goat herding, and open range production of livestock. The common standards and procedures will improve the requirements' clarity and readability, streamline application processing, and improve compliance, all without hindering variations in employer practices or impairing employee rights or employer obligations. Accordingly, as proposed in the NPRM, the herding and range livestock regulations apply to employers seeking certification of applications to employ foreign herders to tend sheep, goats and cattle on the range.
In order to use the herding and range livestock regulations, an employer's job opportunity must possess all of the characteristics described in this provision. The TEGL for sheep and goat herding occupations and the TEGL for open range production of livestock repeatedly refer to the unique characteristics of these occupations as the bases for the special procedures. The TEGL for sheep and goat herding occupations describes the unique characteristics of herding as “spending extended periods of time with grazing herds of sheep in isolated mountainous terrain; being on call to protect flocks from predators 24 hours a day, 7 days a week . . .” TEGL 32-10, 3. The TEGL for open range livestock production also states that these occupations “generally require workers to live in remote housing of a mobile nature, rather than `a fixed-site farm, ranch or similar establishment.' ” TEGL 15-06, Change 1, Appendix B, I. Both TEGLs require that the Form ETA-790 submitted to the SWA include that the anticipated hours of work are “on call for up to 24 hours per day, 7 days per week.” TEGL 32-10, Attachment A, I(C)(1); TEGL 15-06, Change 1, Attachment A, I(C)(1). Both TEGLs also require that employers provide effective means of communication with workers “due to the remote and unique nature of the work to be performed.” TEGL 32-10, Attachment A, I(C)(4); TEGL 15-06, Change 1, Attachment A, I(C)(4). As discussed more fully in Sec. IV.A.3. of the preamble related to § 655.201, both TEGLs also provide descriptions of job duties that employers may use when submitting their Form ETA-790 to the SWA.
Section 655.200(b) of the NPRM proposed to limit the scope of jobs subject to these rules by requiring that: (1) the work activities involve the herding or production of livestock and any additional duties must be “minor, sporadic, and incidental to the herding or production of livestock”; (2) the “work is performed on the open range requiring the use of mobile housing” for “at least 50 percent of the workdays in the work contract period” and “[a]ny additional work performed at a place other than the range . . . that does not constitute the production of livestock must be minor, sporadic and incidental
In the Final Rule, the Department eliminates the 50 percent mobile housing requirement, and requires that herders spend more than 50 percent of their workdays on the range, which is more consistent with the exemption in the Fair Labor Standards Act (FLSA) for range production of livestock, as discussed below. We have also retained the requirement that the work activities generally require the workers to be on call 24 hours per day, 7 days a week. As discussed in more detail below in Sec. IV.A.3., in which we address § 655.201, “Definition of terms,” we have deleted the definition of “minor, sporadic and incidental” duties and removed the 20 percent cap on such closely and directly related duties.
A number of commenters addressed the requirement that the work be performed on the open range requiring mobile housing for at least 50 percent of the work days in the contract period. Some commenters addressed the 50 percent requirement directly and others provided information regarding the times of year workers typically spend on and off the range or in mobile housing.
Commenters directly addressing the 50 percent range requirement primarily raised concerns with the combined effect of the 50 percent range requirement and the proposed definition of “open range” (which generally included the absence of fencing as a required element of open range, which is discussed further below); they stated that many operations currently using the TEGLs would no longer qualify for the program because of the prevalence of fencing on the range. That is, commenters explained that it is almost impossible to spend at least 50 percent of the contract period away from fences. For example, the Garfield County Farm Bureau (GCFB) commented that the 50 percent range requirement “simply does not work for many of our members.” The GCFB explained that many producers run their operations on private fenced and unfenced parcels, and are only using “large acre non-fenced permits” for late spring and summer, thus not meeting the 50 percent range requirement. Silver Creek Ranch explained that fences are prevalent throughout their herding operations, so to regulate the time herders are in contact with fences or enclosed areas would be impractical and could impair the quality of the care provided to the livestock. The Wyoming Livestock Board explained that many producers graze on crop residue, private leases, vineyards and other parcels near populated areas, and that if “herding can only take place where no fences exist, for at least 50 [percent] of the work time[,] a majority of range sheep operations would not be eligible for H-2A herders.”
Several commenters, including the Idaho Wool Growers Association, stated that the NPRM's dual requirements of no fencing and that the herders must spend half of the year away from headquarters and livestock facilities would disqualify many herders from using these regulations. These commenters primarily discussed the fencing issue and did not elaborate on whether herders typically spend more than 50 percent of the work contract at a fixed site on a ranch or farm. For example, the Texas Sheep & Goat Raisers' Association (TSGRA) stated that “the proposal suggests that no fences would be allowed in connection with sheepherders and, further, half of the herders' year must be away from the ranch headquarters and livestock facilities.” TSGRA further explained that “private grass, supplemental hay and crop aftermath are the available options to maintain year-round feed for the animals and that does not fit the Department's apparent view of grazing out of sight of fencing or facilities.”
Some commenters stated that the 50 percent rule is “unworkable” or an “administrative nightmare” and does not allow for flexibility in cases of bad weather, emergencies, or other circumstances. For example, Henry Etcheverry, a sheep rancher, described the recordkeeping associated with the 50 percent rule as “impossible” and explained that each operation varies and thus requires different times spent in mobile housing or at the ranch. Brian Clark, an employee of the Wyoming State Workforce Agency representing his own views, stated that using percentages to determine how much time is spent on the range could create an “administrative and enforcement nightmare,” does not reflect reality, and does not reflect the FLSA criteria. Peter and Beth Swanson, commercial sheep producers, commented that many of their grazing locations are neither a “ranch site” nor “open range” (as defined in the NPRM) and that time spent on the “open range” depends on range forage availability, which varies due to a number of circumstances, such as rainfall, weather conditions, and land owner decisions. Mountain Valley Livestock stated that time spent in mobile housing versus at headquarters can be completely dependent on the weather.
Mountain Plains and Western Range, in a comment adopted by several other commenters, specifically addressed the 50 percent mobile housing requirement, calling the rule “arbitrary and unworkable.” In their view, a sheepherder spending 182 days of the year in mobile housing but the rest in a bunk house during other livestock production work would not be eligible under either the special procedures or the standard H-2A program. Mountain Plains and Western Range further commented that, as mobile housing was defined in the NPRM, a limited number of range cattle operations in Montana and Texas currently using the special procedures may not be eligible for the new herding and range livestock regulations, as they use non-mobile range housing on the range for livestock workers. However, they acknowledged that virtually all employers use mobile housing except for this small subset.
Mountain Plains and Western Range recommended that instead of the 50 percent range/mobile housing and 20 percent minor, sporadic, and incidental limitations, the Department adopt the FLSA range production exemption from minimum wage and overtime “principally engaged” rule.
The Department received a small number of additional comments specifically addressing the requirement to spend 50 percent of the work contract period in mobile housing; however, none of these comments supported the proposed requirement. As Mountain Plains and Western Range explained, a small number of their members use non-mobile range housing rather than mobile housing and thus would be ineligible to apply under these regulations. The Worker Advocates' Joint Comment commented that the 50 percent mobile housing requirement is unnecessary, and that this requirement could have the unintended effect of inducing employers to house workers in mobile housing when fixed site housing is otherwise available.
Several commenters provided detailed information regarding time typically spent on the ranch versus the range. These comments, considered together, demonstrate that herding and production cycles vary greatly among operations, and a certain amount of flexibility is warranted to allow for differing amounts of time spent at the ranch. However, despite many the commenters expressing concern with a 50 percent range requirement (largely due to the issue of fencing), these comments demonstrate that most operations appear to be spending more than 50 percent of the work contract period on land considered “range,” if fencing is permissible. For example, W.F. Goring & Son commented that they run their sheep on the open range about 80 percent of the time and the remaining 20 percent of the time is “spent on private lambing grounds where our animals are divided into large fenced pastures.” The Siddoway Sheep Company spends approximately two to three months at the ranch for lambing, then spring and fall grazing are conducted on BLM-permitted lands, state lands and private lands, and summer grazing is in the high mountain meadows. Larson Livestock stated that it grazes sheep on the open range for twelve months of the year.
In contrast to the above comments, the Worker Advocates' Joint Comment agreed that the “Department's attempt to specifically delineate the kinds of jobs that fall under [the proposed rule] is long overdue and sorely needed.” However, they expressed concern with the 50 percent threshold, asserting that this provision will adversely impact the wages and working conditions of U.S. workers because it allows too much time off the range and creates a loophole allowing employers to pay the herding and range livestock wage for up to six months of work on the ranch. The advocates explained that “H-2A and comparable U.S. workers, who do not work on the range (ranch hands), would otherwise be classified as `Farmworker, Livestock . . . They would not fall under [these rules] and would be entitled to be paid at the hourly AEWR rate . . . That work, if offered apart from the on the range herding work is more likely to attract U.S. workers.” They recommended that the Department revise the rule to require that 70 percent of the work contract period be spent on the range.
A number of commenters also addressed the requirement that the work activities generally require workers to be on call up to 24 hours per day, 7 days per week. These comments overwhelmingly support the conclusion that these occupations require herders and range livestock production workers to be on call at all times while on the range to protect and manage the herd, one of the unique characteristics of these occupations. The Texas Sheep & Goat Raisers' Association emphasized the on call nature of the job as central to herding, stating, “[s]heep ranching on rangeland throughout the United States has always been an industry that has at its roots sheepherders, which are on call 24 hours a day, 7 days a week, to protect livestock from predation and natural disasters.” The Washington Farm Bureau similarly stated that “the open range sheep and livestock herding industry is unique and requires special treatment” and that herders are constantly on call to protect the herd. However, some commenters stressed that although workers are on call “24/7,” they are not required to work every hour of the day. As Helle Livestock stated, “while herding doesn't require constant attention to the sheep it does require a constant presence.” Southern Cross Ranches commented that “it is imperative for herders to be available on a 24/7 `on call' basis for maintaining herd integrity and predator control” but herders are “not expected to and don't work 24/7.” Mountain Plains and Western Range commented that the term “on call” may be misleading and suggested that instead the Department use the term “available.” Although not specifically commenting on the 24/7 provision, the Worker Advocates' Joint Comment stated that “[w]orkers must also be given time off at least every six months and as required for other H-2A workers, who cannot be required to work more than 6 days per week, while at the ranch.”
As in the TEGLs, these NPRM provisions recognized that herding and range livestock production occupations are unique and distinguishable from other H-2A occupations because they are conducted primarily in remote areas away from headquarters, require workers to be on call 24 hours per day, 7 days a week, and require certain unique job duties. Specifically, the Department included in the NPRM a requirement that at least 50 percent of the work contract period be spent on the range and in mobile housing. The purpose of this provision was to provide a sufficient threshold to confirm the unique, remote characteristics of these occupations, because herding and range livestock regulations are intended only to apply to workers who attend the herd as it grazes on the range, while also allowing for a realistic and workable amount of time at the ranch. The Department concluded that some delineation with respect to ranch versus range time was necessary because it has found in its investigations that some workers are spending extended amounts of time at the ranch while being paid the wage rate intended for range workers under these rules. The Department viewed the 50 percent threshold as a reasonable requirement, as it requires workers to be primarily on the range, is consistent with the FLSA range production of livestock exemption, and allows for flexibility in the cases of emergencies and changing circumstances.
The NPRM further proposed that if an employer violated the 50 percent range requirement, the employer would be in violation of its obligations under this part. 80 FR at 20303. Depending on all the facts and circumstances, the employer would have been responsible for compliance with all of the regular H-2A requirements, including the payment of the highest applicable wage rate for all hours worked, and the Department could have sought other remedies for the violation.
Upon consideration of the all comments received on these issues, the Final Rule removes the requirement that workers be in mobile housing for at least 50 percent of the work contract period. The Department received no comments in support of this provision. We agree with the Worker Advocates' Joint Comment that this requirement is not essential to the 50 percent range requirement to confirm that workers being paid the herding and range livestock worker wage are engaged in work performed on the range, and could have an unintended consequence of employers housing their workers in mobile housing when fixed site housing is otherwise available. Further, the Department did not intend to exclude operations currently using the TEGLs who use non-mobile range housing on the range from using these rules (assuming they are in compliance with the remainder of the requirements under this Subpart), as pointed out by Mountain Plains and Western Range. The issue of non-mobile range housing is addressed in greater detail below, in Sec. IV.E. of this preamble related to the discussion of § 655.230, “Range Housing.” However, we conclude that the need for range housing is relevant to whether a particular area is considered range and have addressed this issue in the definition of “range,” as discussed in greater detail below.
The Final Rule requires that workers spend a majority, meaning “more than 50 percent,” rather than “at least 50 percent” as provided in the NPRM, of the workdays in the work contract period on the range, as range has been defined in the Final Rule. This change is intended to be more consistent with the range production of livestock exemption from minimum wage and overtime under the FLSA. However, the Department concludes that fully adopting the FLSA range production of livestock exemption “principally engaged” rule is inappropriate here, because it would allow these workers to perform duties at the ranch or farm beyond those duties constituting the production of livestock. The Department's consideration of the FLSA exemption, permissible duties and the 20 percent cap are further addressed below in Sec. IV.A.3. of the preamble related to the discussion of § 655.201.
The record demonstrates that a rule requiring a majority of the workdays under the contract to be spent on the range is appropriate and necessary to confirm that occupations under the herding and range livestock regulations, earning the required wage rate, are indeed uniquely remote and thus distinguishable from other H-2A occupations. As discussed above, the use of these special procedures is contingent on these occupations posing unique challenges and circumstances, one of which is the remote nature of the job. We conclude that allowing employers to pay the herding and range livestock wage to workers who are spending more time on the ranch than on the range would be inappropriate and would have an adverse effect on U.S. workers, as this work would otherwise be offered at the standard hourly AEWR for all hours worked and thus be more likely to attract U.S. workers.
The Department concludes that a majority range requirement is sufficient to confirm the unique, remote nature of these occupations and distinguish herders from other H-2A occupations, such as ranch hands, while also allowing for necessary flexibility in modern herding to allow for changing circumstances on the range. Thus, the Department declines to increase the threshold of time required on the range to 70 percent, as suggested by worker advocates. The Department also concludes that a majority range requirement is reasonable and practical. It is consistent with the FLSA range production exemption, as proposed by Mountain Plains and Western Range (a suggestion adopted by several other commenters) and, as discussed above, many comments received on this issue provided evidence that operations currently using the TEGLs are spending more than 50 percent of the contract period on grazing areas considered range, as now defined in the Final Rule. As discussed in detail below, the Department has revised the definition of “open range” to “range” and removed the presence of fencing as an indicator of whether land is “range.” The Department concludes that the revised definition of “range” will address the majority of the comments received regarding the 50 percent range requirement, as they focused largely on the issue of fencing.
Although some commenters expressed concern with setting a certain required percentage of time on the range, we consider the majority range requirement to provide adequate flexibility to address changing circumstances due to weather, forage availability, and other factors. Allowing more than half of the work contract to be spent at locations other than the range while still being paid the herding and range livestock wage would be contrary to the Department's statutory mandate to determine whether U.S. workers are available for the job opportunity, and to provide that there is no adverse effect on similarly employed U.S. workers. Of course, if there are employers who cannot meet the majority range requirement, they may still use the standard H-2A program to obtain workers. Moreover, such employers might be able to use these procedures for some portion of the year that meets the majority range requirement, and use the standard H-2A program for the remainder of the year; this would require filing at least two certification applications.
Additionally, the Final Rule retains the requirement that the work activities generally require the workers to be on call 24 hours per day, 7 days a week. The record fully supports that herding and range livestock production occupations continue to require constant attendance to the herd so that workers are on call 24/7. This is one of the unique characteristics of these occupations that distinguish these jobs from other H-2A occupations, and we conclude that it is appropriate to require that this be a characteristic of such jobs. With respect to the commenters who underscored that “on call” does not mean actively working, the Department agrees that “on call” does not mean working for 24 hours per day, seven days per week, and the current terminology, which has been used consistently in the TEGLs for many years and is used in this final rule, reflects this distinction.
We decline to adopt the Worker Advocates' Joint Comment recommendation to require that workers must be given time off at least every six months and while at the ranch. The NPRM did not include any provisions requiring time off at certain intervals or while on the ranch, and the Department did not seek comment on any issues relating to mandatory time off. Therefore, the public has not had sufficient notice that such a provision was contemplated for the Final Rule and has not had the opportunity to comment on such provisions. Additionally, as discussed above, an essential characteristic of these job opportunities is that they require workers to be on call up to 24 hours per day, 7 days per week. However, the Department understands from its enforcement experience that workers often do receive days off while at the ranch and some comments indicate that some workers receive paid vacation time. We encourage employers to adopt or continue these practices.
As provided in the NPRM and noted above, where the job opportunity does not fall within the scope of herding and range livestock production, the employer must comply with all of the standard H-2A procedures. If an
The TEGL for sheep and goat herding occupations provides a standard description of job duties that employers may use when submitting their Form ETA-790 to the SWA. TEGL 32-10, Attachment A, I(C)(1). That job description includes duties such as: Attending the animals on the range or pasture; using dogs to herd the flock and round up strays; guarding the flock from predatory animals and from eating poisonous plants; examining the animals for signs of illness; administering vaccines, medications and insecticides; and assisting with lambing, docking, and shearing. It also provides that the workers “may perform other farm or ranch chores related to the production or husbandry of sheep and/or goats on an incidental basis.” The TEGL does not define “incidental.” The TEGL also states that any additional duties must be normal and accepted for the occupation.
The TEGL for the open range production of livestock also contains a standard job description listing similar duties related to the animals. TEGL 15-06, Change 1, Attachment A, I(C)(1). It also states that the worker may assist with irrigating, planting, cultivating, and harvesting hay, and that workers must be able to ride and handle horses and maintain their bearings in grazing areas. Finally, it provides that any additional job duties must be normal and accepted for the occupation. The TEGL does not place any limitation on the amount of time workers may perform these duties.
Section 655.201 of the NPRM proposed to define “herding” as the “[a]ctivities associated with the caring, controlling, feeding, gathering, moving, tending, and sorting of livestock on the open range.” 80 FR at 20339. The NPRM proposed to define the “production of livestock” as the “care or husbandry of livestock throughout one or more seasons during the year, including guarding and protecting livestock from predatory animals and poisonous plants; feeding, fattening, and watering livestock, examining livestock to detect diseases, illnesses, or other injuries, administering medical care to sick or injured livestock, applying vaccinations and spraying insecticides on the open range, and assisting with the breeding, birthing, raising, weaning, castration, branding, and general care of livestock.”
Because the proposed definitions of herding, the production of livestock, and minor, sporadic, and incidental work operated together to define the scope of permissible job duties for a worker employed under these regulations, the commenters generally discussed them together; similarly, we are addressing them together. The Final Rule retains the definition of herding as proposed; modifies the definition of the production of livestock to include duties that are closely and directly related to herding or the production of livestock; and eliminates the 20 percent cap on such closely and directly related duties. To provide further guidance, the Final Rule also includes examples of duties that qualify as closely and directly related and duties that do not qualify under these rules.
A substantial number of commenters addressed the proposed intertwined definitions of permissible herder duties. Almost all of the commenters that addressed the proposed 20 percent cap were opposed to it. Some commenters expressed their opposition directly in commenting on the 20 percent cap, while others provided a more generalized opposition to the proposed definitions' limitations on permissible duties.
Mountain Plains and Western Range stated (in a comment adopted by numerous other commenters) that the proposed definitions “are inappropriately restrictive and are not a realistic reflection of the industry's labor needs.” They specifically stated that the 20 percent limit on days spent performing incidental work was “arbitrary” and “unworkable.” They suggested that the Department use “a more holistic and flexible approach” as in the regulations implementing the FLSA's minimum wage and overtime exemption for agricultural employees “principally engaged in the range production of livestock.” 29 U.S.C. 213(a)(6)(E). Those FLSA regulations look to whether the employee's “primary duty” is range work. 29 CFR 780.325(a). Under the FLSA, a worker “who spends more than 50 percent of his time” on the range performing range production duties is exempt from minimum wage and overtime. 29 CFR 780.325(b). Thus, under the FLSA, such an exempt “employee may perform some activities not directly related to the range production of livestock, such as putting up hay or constructing dams or digging irrigation ditches.”
Cunningham Sheep Company and Dufurrena Sheep Company both commented that “[l]imits on incidental work related to herding would unnecessarily burden our operation” because “herders need to remain flexible and be able to perform husbandry-type jobs without unrealistically mandated rules.” Another sheep rancher stated that the definition of incidental work “needs to be more clearly defined and broadened. Fences need to be repaired to hold the sheep in, supplemental feed fed, and a host of associated jobs that do not necessitate the need for additional job descriptions and employees.” Another rancher asserted that, while “H-2A workers should not be diverted to work such as construction,” they should be permitted to perform “related livestock tending duties, such as the building of lambing jugs.” Etchart Livestock similarly stated that incidental work related to sheep production should be allowed, such as “[f]ence repair, corral repair, or other limited tasks,” but did not want a percentage cap; this commenter also stated that if the work does not involve sheep production, it should not be permitted. The Wyoming Farm Bureau Federation stated that the 20 percent “is too low a cap given the nature of the industry.”
Some comments revealed that the ranchers essentially want the workers to be able to perform any chore required (although a number of the examples they gave are animal husbandry duties that fall within the definitions of herding or the production of livestock). One sheep and cattle rancher, Kelly Sewell, noted that workers perform a variety of duties at the ranch base and thus wanted a general agricultural classification because these “valuable employees irrigate crops, fix fences, and many other jobs necessary to run a ranch.” Similarly, Indart Ranch stated that, in “addition to caring for the sheep and husbandry duties, our herders are constantly building and taking down fence, driving pickups and water trucks, fixing and maintaining equipment, amongst many other ranch type duties.” Another sheep rancher commented that, “[a]s long as the workers are working on the ranch . . . there should not be such a thing as a 50-20 rule.” The Rocky Mountain Sheep Marketing Association acknowledged that ranchers sometimes employ extra workers as insurance against an H-2A worker falling ill or going home due to a family need, and stated that under the current regulations “this extra help can be put to productive work on non-herding, necessary work on other aspects of the ranching operation.” The Colorado Wool Growers Association commented that there are many chores associated with maintaining the herd, including “fixing a sheep pasture fence or irrigating a field that is grazed by sheep.” The Association suggested that such activities should not necessitate a separate job or pay rate, but rather that the permissible job duties should include all such chores. CLUB 20 also recommended expanding the job description “to include all chores that are in direct support of maintaining livestock managed in a grazing livestock production system.” Similarly, Mountain Plains and Western Range suggested replacing all of the definitions with a comprehensive “grazing livestock production system” definition.
A number of other comments contained the same theme—that the H-2A workers should be permitted to perform any duty at the ranch, including some activities that would constitute herding or the production of livestock and some that would not. For example, the John Espil Sheep Company comment noted that the livestock workers spend time at the ranch when weaning the calves before they are sold, and that feeding the calves may only take a couple of hours a day. Therefore, they also may perform other duties such as: repairing corrals or the feedlot fence; cleaning the shop, the bunkhouse and the tack room; and harvesting hay for winter feed. The company stated that this is all part of livestock production, and that keeping track of their time hourly or daily would be extremely difficult or impossible, both on the range and at the ranch, because every day is different. Similarly, another sheep rancher, Katie Day, commented that the workers irrigate pastures, harvest livestock feeds, maintain fences, clean corrals, doctor sheep and feed them, and it would be “absurd” to limit how long a job can be performed or to require recordkeeping for the incidental work. Finally, the Garfield County Farm Bureau similarly stated that “[w]hat is defined as incidental work is vital to the day-to-day operations of their ranches. Without the upkeep of fences, pasture irrigation, mitigation of noxious weeds and production of livestock feed, their operations cannot exist. As ranchers, they must be able to perform whatever job needs done at any given time and would expect their employees to do the same. . . In short, there is no such thing as incidental work on a livestock ranch.”
Many employer commenters seemed to object to the 20 percent cap on directly and closely related duties while at the ranch based, at least in part, upon their concerns regarding the associated recordkeeping requirements and, in some cases, a misunderstanding of those requirements. Those specific concerns are addressed in Sec. IV.B.2. of the preamble related to the recordkeeping provision in § 655.210(f).
Numerous employer commenters and their representatives, including American Sheep Industry Association (ASI), Mountain Plains and Western Range, California Wool Growers Association, Colorado Wool Growers Association, Texas Sheep & Goat Raisers Association, Vermillion Ranch and Midland Livestock Company, and John Espil Sheep Company, suggested that the Department adopt a much broader definition of permissible sheepherder duties. They generally labeled their preferred definition as the “Grazing Livestock Management System.” That definition permits “the utilization of herbage or forage on a piece of land via grazing or supplementation” and turns inputs into goods (protein, wool, etc.) through practices that:
Mountain Plains and Western Range stated that this definition would make clear that feedlots and similar operations are not covered, while focusing on the critical component of the job—the grazing of livestock. In a joint comment, Vermillion Ranch and Midland Livestock Company (Vermillion and Midland) stated that it would be “general enough to encompass multiple open range occupations without creating arbitrary line-drawing that is impossible to follow.” They opined that this definition and the FLSA regulatory definitions would be “sufficient to protect the integrity of the special procedure regulations” while not replacing established occupational practices. The Wyoming Wool Growers Association stated that this definition would reflect that herding goes beyond just controlling animal movement and includes animal care and husbandry and natural resource management. The Association commented that the suggested definition of sheepherder duties recognizes the totality of the process. Finally, the California Wool Growers Association stated that this definition would “more accurately
In contrast to most employer commenters, Billie Siddoway, on behalf of the Siddoway Sheep Company, submitted a detailed description of the specific activities performed during various months of the year and did not object to the proposed 20 percent cap. Billie Siddoway stated that if an employee undertakes minor, sporadic or incidental work outside the definition of herding, such as by performing tasks as erecting temporary pens and corrals in anticipation of the lambing season, the employer could track those hours and job duties in order to allow the Department to evaluate compliance with the 20 percent rule. Billie Siddoway requested clarification that the 20 percent limitation applies only to work performed on the ranch (so that, for example, if a pair of workers divide up their chores on the range with one primarily responsible for tending the sheep and the other primarily responsible for caring for the camp and the dogs and horses, there is no need to evaluate that range time).
In further contrast to the vast majority of the employer comments, the Worker Advocates' Joint Comment agreed that the definitions of the terms “herding” and “livestock” are accurate, but stated with respect to the proposed definition of “minor, sporadic, and incidental work” that the 20 percent rule “is a critically important element of the proposed rule.” They emphasized that sheep herders have alleged in litigation that they often are assigned work outside the permissible duties and spend significant time performing duties such as irrigating fields, harvesting crops, and maintaining ranch buildings, vehicles, and equipment. Nonetheless, the workers have been paid the monthly wage required under the TEGL rather than the higher hourly AEWR, which could lead to displacement of domestic workers employed as ranch hands. The Worker Advocates' Joint Comment requested that the Department give more examples of work that would be minor, sporadic and incidental (repairing a fence or corral) as well as examples of work that falls outside the permissible job duties (
The NPRM recognized that employers using these procedures to hire workers for the range production of livestock may, at times, require the workers to bring the herd to the ranch or farm for certain periods to perform work that constitutes the production of livestock, such as lambing or calving, shearing, branding, culling livestock for sale, or tending to a sick animal. The NPRM further recognized that, during such periods at the ranch, the workers could also perform other work that is closely and directly related to herding or the production of livestock. The NPRM proposed to limit to 20 percent the number of ranch days that could be spent performing such directly and closely related work, and it required that the other directly and closely related ranch duties be included in the job order.
The purpose of including the proposed 20 percent cap was to require that workers being paid the herding and range livestock wage not be used as general ranch hands, who are entitled to the standard H-2A hourly AEWR for all hours worked, because these provisions are only intended for workers who attend the herd as it grazes on the range. 80 FR at 20301. The Department determined that some limit on the scope of duties such workers could perform was essential because, in the course of its investigations, it found that some workers are stationed at the ranch for extended portions, if not all, of the job order and are performing general ranch hand work rather than work closely and directly related to the range production of livestock. Therefore, the NPRM identified tilling the soil for hay and constructing an irrigation ditch as examples of work not closely and directly related to herding or the production of livestock. The inspection and repair of the corral was given as an example of work that is closely and directly related. 80 FR at 20303, 20306.
After considering all the comments received, we have decided to remove the 20 percent limitation on the number of ranch days that can be spent on work that is closely and directly related to herding or the production of livestock, because such work is inextricably linked with those primary tasks. Where such work is, indeed, closely and directly related, it comprises an essential part of the work that employees who are engaged in herding and the production of livestock perform. Further, allowing workers to perform work that is closely and directly related to herding and the production of livestock on only one out of every five days at the ranch unnecessarily limits the ranchers' flexibility in dividing tasks among their H-2A workers.
For example, herders may be at the ranch for two months during birthing season. During that time, the workers may remain responsible for caring for the dogs they use on the range to help herd and guard the sheep or goats; they also may remain responsible for the care of the horses they use on the range to pull their camps or to assist with herding. The proposed 20 percent cap on the number of ranch days that a worker could perform such closely and directly related work would have required the employer to divide the animal care sequentially among five herders, so no one worker performed it more than 20 percent of the days. The employer would have violated the cap if it instead had required that one herder do the animal care every day, even if the task only took one or two hours to perform. Smaller ranchers with fewer than five H-2A workers would have found it very difficult to comply with the proposed limitation on the percentage of days such work can be performed at the ranch. When the work is closely and directly related to herding or the production of livestock, there is no need to limit its performance in this way. Therefore, we are including closely and directly related work within the definition of the production of livestock, which provides employers with sufficient flexibility to assign appropriate tasks to workers when they are not on the range. The Final Rule makes conforming changes to delete references to the 20 percent cap in §§ 655.200(b)(1) and (2), 655.210(b), and 655.230(d).
However, we continue to conclude that it is inappropriate to provide employers with the unlimited latitude that some requested by allowing them to require workers employed pursuant to these rules to perform any ranch duties that are necessary to meet the day-to-day needs that arise in ranch operations. Accordingly, the Final Rule does not adopt the revised Grazing Livestock Management System definition of permissible duties, as recommended by a number of employers and their representatives. That definition is overly broad and vague, with undefined terms, such as “management of urban interface,” which make it unsuitable for the Final Rule. That definition would allow ranchers virtually unfettered discretion to assign workers any duties, unrelated to herding and the production of livestock, particularly because it states that the permissible duties “include, but are not limited to” the listed tasks. More specifically, under
For similar reasons, the Department also is not adopting the FLSA's regulatory definition, as some commenters suggested. The FLSA regulation, 29 CFR 780.325, is tied to the FLSA's statutory language, which exempts an employee “principally engaged” in the range production of livestock. Therefore, that regulation allows a tolerance for non-herding work so long as it is less than 50 percent of the work hours. However, such a tolerance would be overbroad in the context of these H-2A rules, which create a special exception from the standard H-2A wage requirements.
Therefore, in order to fulfill our original purpose of providing that workers employed pursuant to the herding and range livestock regulations are not working as general ranch hands when they are not on the range, and to provide the requested guidance and clarity to both workers and the regulated community, the Final Rule includes several additional examples both of duties that qualify as directly and closely related to the production of livestock and duties that do not qualify. The Final Rule identifies the following as examples of work on the ranch that is closely and directly related: repairing fences used to contain the herd; assembling lambing jugs; cleaning out lambing jugs; feeding and caring for the dogs that the workers use on the range to assist with herding or guarding the flock; feeding and caring for the horses that the workers use on the range to help with herding or to move the sheep camps and supplies; and loading animals into livestock trucks for movement to the range or to market. Furthermore, we note that many of the duties that the commenters stated should be permissible (caring for sick animals at the ranch, providing supplemental feed, and assisting with lambing) already are included within the definition of the production of livestock. The Final Rule identifies the following as work that is not closely and directly related: Working at feedlots; planting, irrigating and harvesting crops; operating or repairing heavy equipment; constructing wells or dams; digging irrigation ditches; applying weed control; cutting trees or chopping wood; constructing or repairing the bunkhouse or other ranch buildings; and delivering supplies from the ranch to the herders on the range. Several of these examples are taken from the FLSA regulations implementing the exemption for the range production of livestock, which a number of commenters identified as a model for this rule.
Further, the Final Rule provides employers adequate flexibility in the use of H-2A workers, while still requiring that the work be agricultural and herd-related in nature. Thus, although workers employed pursuant to the herding and range livestock provisions may not engage in work that falls outside the scope of these rules, the Department does not intend to debar an employer who in good faith has H-2A workers perform an insubstantial amount of herding work not listed in the Application. In exercising our enforcement discretion when an employer has had an H-2A worker perform work outside the scope of the activities listed on the job order due to unplanned and uncontrollable events, the Department will consider the employer's explanation, so long as the activities are within the scope of H-2A agriculture, have been occasional or sporadic, and the time spent in total is not substantial. Moreover, the debarment regulations require that the violation be substantial, and that a number of factors must be considered in making that determination, including: An employer's previous history of violations; the number of workers affected; the gravity of the violation; the employer's explanation, if any; its good faith; and its commitment to future compliance. Under these criteria, the good faith assignment of a worker to work not listed in the Application for a small amount of time would not result in debarment. The Department concludes that this improved clarity of the scope of the rules for herding and range livestock workers will lead to improved compliance and more effective enforcement by the Wage and Hour Division. As we explained in the NPRM, 80 FR at 20303, where employers violate this limitation on duties, they may owe back wages and DOL may seek other relief depending upon the precise nature of the violation.
Livestock is not defined in the TEGLs. The NPRM defined livestock as “[a]n animal species or species group such as sheep, cattle, goats, horses, or other domestic hooved animals. In the context of this subpart, livestock refers to those species raised on the open range.” 80 FR at 20339. As explained in the NPRM, the proposed definition of livestock described the type of animals, when managed on the range, covered by these rules. 80 FR at 20303-04. As mentioned above, Mountain Plains and Western Range suggested replacing all of the definitions with a “grazing livestock production system” definition, but this would not address the type of animals covered by these rules. The Worker Advocates' Joint Comment agreed that the definition of the term livestock is accurate. Because the Department received no comments opposing the proposed definition of livestock or otherwise suggesting modification, the Final Rule retains the proposed text without any modification.
The TEGLs set standards for, but do not define, range housing. The NPRM defined “mobile housing” as “[h]ousing meeting the standards articulated under § 655.235 that can be moved from one area to another area on the open range” and explained that this definition “focuses on the movable nature of the housing used on the open range and specifies the provision in the regulation that sets forth the standards such housing must meet.” 80 FR at 20304. The Worker Advocates' Joint Comment agreed with the NPRM definition of range housing. While the Department received comments regarding the standards for such housing and SWA inspection requirements, those comments are discussed in Sec. IV.E. of the preamble related to §§ 655.230 and 655.235. Because we received no comments opposing the definition of range housing or otherwise suggesting modification, the Final Rule reflects the definition proposed in the NPRM, with two modifications. First, we now refer to housing on the range as “range
The TEGL for sheep and goat herding provides that the special procedures were established in recognition of the unique characteristics of sheepherding, which requires “spending extended periods of time grazing herds of sheep in isolated mountainous terrain; being on call to protect flocks from predators 24 hours a day, 7 days a week.” TEGL 32-10, ¶3. The TEGL provides that the SWA may rely on a standard job description of the duties to be performed and this description refers to “sheep and/or goat flock grazing on range or pasture,” but the terms “range” and “pasture” are not further defined.
The TEGL for the open range production of livestock procedures similarly were established in recognition of the “unique characteristics of the open range production of livestock.” TEGL 15-06, Change 1, ¶3. The SWA may rely on a standard description of the job duties for a job opportunity in the open range livestock production industry, which refers to tasks performed “on the open range” and states that the workers also must “occasionally live and work independently or in small groups of workers in isolated areas for extended periods of time.”
The NPRM defined open range as “[u]nenclosed public or private land outside of cities and towns in which sheep, cattle, goats, horses, or other domestic hooved animals, by ownership, custom, license, lease, or permit, are allowed to graze and roam. Animals are not meaningfully enclosed where there are no fences or other barriers protecting them from predators or restricting their freedom of movement; rather a worker must actively herd the animals and direct their movement. Open range may include intermittent fencing or barriers to prevent or discourage animals from entering a particularly dangerous area. These types of barriers prevent access to dangers rather than containing the animals, and therefore supplement rather than replace the worker's efforts.” 80 FR at 20339. The Department specifically sought comment on whether the definition of open range should include a minimum acreage of the land on which the animals roam; under what circumstances (
The Final Rule removes the qualifier “open” and revises the proposed definition, using a multi-factor test based on a modified version of the definition of “range” used in the FLSA range production of livestock exemption. It sets forth the following factors that indicate the range: The land is uncultivated; it involves wide expanses of land, such as thousands of acres; it is located in remote, isolated areas; and range housing is typically required so that the herder can be close to the herd to fulfill the requirement to be constantly ready to attend to the herd. No one factor is controlling and the totality of the circumstances is determinative. The definition also specifies what is not considered range—specifically, that the range does not include feedlots, corrals, or any area where the stock would be near headquarters. The term also does not include any other areas where a herder is not required to constantly be available to attend to the livestock to perform tasks such as ensuring they do not stray off, protecting them from predators, and monitoring their health.
The Department received a substantial number of comments addressing the proposed definition of open range. The comments addressed a number of issues, including: Fencing on the range; the changing nature of the landscape of the West and the feed used for sheep, including crop stubble; the necessity of herders regardless of fences and barriers; “open range” state laws; and the definition of “range” used in the FLSA range production exemption. The comments are addressed below according to the questions presented in the NPRM: (a) Whether the definition of open range should include a minimum acreage of the land on which the animals roam; (b) under what circumstances (
The NPRM requested comments on whether the definition of open range should include a minimum acreage of land. Mountain Plains and Western Range, along with a handful of other commenters, opposed a minimum acreage test. Mountain Plains and Western Range reasoned that an employer may not be aware of the acreage. Commenter Billie Siddoway supported modifying the definition to include “remote areas more than fifty miles from the base ranch that require delivery of water by truck.”
Many commenters explained that livestock grazing varies substantially among operations, depending on the particular ranch owner and/or the geographic location. As indicated by the SBA Office of Advocacy, the practice of herding has changed since the 1950s and herders must graze on lands that are less “open.” Diamond Sheep Company explained that urban sprawl has changed herding patterns, as well as the availability and type of food consumed by sheep. Because the West is no longer an open area, sheepherding in its modern form has changed; according to the Idaho Wool Growers Association and other commenters, it increasingly includes “a mix of native grass on federal, state and/or private leases, hay and alfalfa grazing, crop aftermath grazing, feeding under power lines and in vineyards and even small parcels in residential areas for fuel load management.”
The comments almost unanimously opposed using fencing as a defining factor for “open range.” Commenters indicated that the prohibition on fencing was one of the two most problematic aspects of the NPRM. The comments explained that fencing is common on the range; Mountain Plains and Western Range stated that there is “no such place” that contains such unenclosed land as the Department had described in the NPRM. Stephany Wilkes stated that the idea that grazing only takes place away from fences is “unrealistic, magical thinking.” Mountain Plains conducted a survey of its members and of the 140 employer-members who responded, 45 percent of respondents indicated that their operation would not qualify as “open range” according to the definition in the NPRM. The opposition can generally be described as deriving from the realities of the modern landscape in the West where fences appear for many reasons, including on federal land managed by the Forest Service and the BLM, as well as the proposition that sheepherding requires a herder to be present regardless of whether the area has
The employer comments indicated that fencing may be used on both small and large acreages; the size of fenced land varies, and sheep may be within fences but within thousands of acres of private land. For example, Etchart Livestock, Inc. stated that its private pasture is fenced and varies in size from 4 acres to 4,000 acres. The Washington State Sheep Producers described large bands of sheep that are herded on unfenced open range from early spring to fall and are also herded across 500+ acre rangelands that are fenced for cattle containment, not sheep containment. Rangeland described by D.A. Harral was fenced around the exterior and broken up into 2,000 to 10,000 acre tracts of semi-arid land.
A common theme throughout the comments submitted by ranchers and their associations was that fencing does not replace the need for herders. Julie Hansmire expressed the view that regardless of whether a fence is a quarter of a mile from the sheep or 20 miles, a herder is still required. As explained in the comments, if a fenced area is very large, a herder may keep the sheep in a manageable area, and a herder also keeps the animals moving to graze on different areas for controlled grazing. For example, Hansen Ranch pointed out that its sheep are grazed on Forest Service land to control the noxious weed “Leafy Spurge,” and the sheep herders are needed to keep the sheep grazing on this weed within a fenced area. Many commenters, such as John Parker and the Washington State Sheep Producers, pointed out that sheep cannot be left alone on the range because they may stray from the band of sheep and become lost, or be attacked by predators. Commenters also noted they used temporary fencing as well.
The employer commenters expressed particular concern about predators, explaining that sheep herders are critical to protecting sheep from attack regardless of whether the sheep are in a fenced area. As Pauline Inchauspe described, “[c]oyotes and mountain lions are a constant threat and though the herders are equipped with livestock guardian dogs, there is no substitute for the watchful eye of a sheepherder. Their 24 hour presence is a necessity . . . throughout the entire year.” For example, Detton Fawcett put a herd on private ground with fences and lost 40 percent of his herd over the summer; on another piece of land he lost multiple lambs (stating that losing 50 or more lambs in three weeks is common). Yet, with a herder present, Mr. Fawcett stated that he only loses approximately five percent of the herd.
Commenters also pointed out that the term “open range” refers to state laws that require property owners to build and maintain fences sufficient to keep livestock off their property. For example, William Ashby Maltsberger, a Texas rancher, submitted information on the Texas livestock laws explaining this concept. He pointed out that the NPRM definition of open range would prevent range producers of livestock, who are required by Texas open range law to fence their properties, from using the special procedures. Similarly, Tom Thompson explained that “[o]ur understanding of open range is that if you want to keep other people's livestock off your property you have to put up fences, making fences required in areas where there are other ranchers.”
Both industry and worker advocates suggested using the FLSA range production of livestock exemption definitions in some form for the purposes of the H-2A rule, some suggesting adopting them in full and some emphasizing different portions. Mountain Plains and Western Range and the Worker Advocates' Joint Comment generally encouraged the Department to align the definition of “range” with the FLSA regulations, as discussed further below.
The FLSA range production of livestock exemption regulation defines the term “range” at 29 CFR 780.326(a) and (b). That regulation describes the range generally as land that is not cultivated and typically is not suitable for cultivation because it is rocky, thin, semiarid, or otherwise poor. It is land that produces native forage for animal consumption, and it includes land that is revegetated naturally or artificially to provide a forage cover that is managed like range vegetation. The range need not be open. The regulation provides that many acres of range land are required to graze one animal unit (five sheep or one cow) for 1 month; therefore, by its nature, the range production of livestock is most typically conducted over wide expanses of land, such as thousands of acres.
The FLSA regulation at 29 CFR 780.329 provides that an employee is exempt if his primary duty is the range production of livestock and that this duty necessitates his constant attendance on the range, on a standby basis, for such periods of time so as to make the computation of hours worked extremely difficult. The fact that an employee generally returns to his place of residence at the end of each day does not affect the application of the exemption. However, exempt work must be performed away from the headquarters, which is the place for the transaction of the business of the ranch; the headquarters does not include large acreage, but only the ranchhouse, barns, sheds, pen, bunkhouse, cookhouse, and other buildings in the vicinity. The FLSA exemption does not apply to feed lots or to any area where the stock involved would be near headquarters. Rather, it applies only to those employees principally engaged in activities requiring constant attendance on a standby basis, away from headquarters, such as herding, where the computation of hours worked would be extremely difficult.
Although Mountain Plains and Western Range indicated a preference for eliminating an independent definition of range altogether and instead using the alternative “grazing livestock production system,” (discussed more fully above with regard to the “production of livestock” definition) they alternatively recommended replacing the definition of open range in the NPRM with the FLSA definition of range. Specifically, Mountain Plains and Western Range stated that the use of the phrase “range” as defined in the FLSA is a better fit than “open range,” as nothing is truly “open” land anymore.
The Worker Advocates' Joint Comment emphasized that the rule should specify that the land must be uncultivated so that the H-2A procedures for sheep herders are not more encompassing than the FLSA definition. The Worker Advocates' Joint Comment also supported using a worker's proximity to the ranch as an indication of whether the work is on the open range. Their comment stated that “ranch or farm signifies a place where crops are cultivated or where livestock are enclosed. Proximity to a location where livestock must be enclosed or where land is cultivated is an indication that such a place is not the open range.” They suggested a slight modification to the FLSA definition, stating that work
Other comments echoed similar elements about the topography of range or rangeland, which are factors found in the FLSA definition. For example, Lyle McNeal stated that range has native forages of grasses, forbs, and shrubs and that “range is also defined as uncultivated land, including forest land, which produces forage suitable for livestock grazing.” However, this rancher also noted that herders are needed on other types of land. McNeal further explained that the term “improved range” involves “reseeding and replacing the native range plants with a specific improved forage plant,
The ASI represented that 46 percent of their sheep spend part of the year on federal grazing permits or allotments, but noted that the availability of federal grazing land is on the decline and private grass, supplemental hay, and crop aftermath are the other available grazing options. The Idaho Wool Growers Association identified the primary times crop residue or stored crops (baled hay and corn) are used for feed is during the fall when the sheep are coming down off the mountain, in the winter when native food cannot be found, and in times of drought. The Washington State Sheep Producers indicated that the sheep graze for part of the year on crop aftermath in irrigated crop circles of 100-150 acres in size, and that herders are necessary to move the sheep among the crop circles. The Wyoming Livestock Board stated that “[m]any producers graze also on crop residue, private leases, vineyards and other parcels near fixed ranch sites and populated areas” and that these areas still require managed herding. Eph Jenson Livestock explained that they have been desperate to find feed for the sheep and that allowing sheep to feed on crop residue is an economical means of clearing the field for the farmer. Cunningham Sheep Company stated that crop residue grazing is healthy for the sheep and the agricultural economy because it allows producers to remove residue without burning or using another destruction method.
The distance crop residue grazing takes place from the ranch, and from urban areas, may vary by operation and by geographic location. For example, numerous commenters, including the Utah Farm Bureau Association, the American Farm Bureau and the Sublette County Conservation District, noted that sheep are used for fire prevention close to urban areas, especially in California. Comments indicated that California's sheep industry relies on crop residue grazing near urban areas anywhere from 6 months a year (Roswell Wool) to year-round (California Wool Growers Association). Elgorria Livestock characterized grazing on crop residue as a “large part” of the production cycle in California.
Although not directly discussing the definition of “range,” many commenters, such as the Wyoming Wool Growers Association, noted that mobile housing is necessary for range work because it enables the herder to remain with the herd. As the Colorado Wool Growers Association explained, mobile housing is necessary because “livestock is often grazed far from the nearest town, or the ranch headquarters. It would be illegal to build fixed housing on U.S. Forest Service, Bureau of Land Management grazing allotments, as well as numerous other locations that livestock are grazing. It is not feasible to drive herders back and forth to work every day, leaving sheep unattended and vulnerable to predator attacks, straying too far from water sources, or being exposed to poisonous plants. While a lot of predator attacks happen at night, it is not unusual for predators to attack in broad daylight. This is why there has been the historic recognition of the necessity for mobile housing to keep herders near the sheep.” However, the Wyoming Farm Bureau Federation noted that many livestock workers do not need mobile housing for even 50 percent of the workdays in a contract. Further, as explained by Mountain Plains and Western Range, there are a limited number of employers who use stationary bunkhouses on the range rather than mobile housing at points throughout the “vast areas of land” where cattle are grazing, particularly in Montana and Texas. Finally, the Worker Advocates' Joint Comment indicated that requiring the use of mobile housing would have the unintended effect of inducing employers to house workers in mobile housing when fixed site housing is available; they stated that the nature and location of work should be the focus instead.
Based on the comments received, it is apparent that herding practices have evolved significantly over the last 50 years and the proposed definition of “open range” in the NPRM did not reflect these changes. The Final Rule, therefore, adopts a multi-factor test for defining what constitutes the “range.” As explained below, the Final Rule's definition allows more flexibility than the NPRM and offers more guidance than the TEGLs by drawing on the FLSA regulatory definition suggested by many commenters as a starting point. The definition maintains a nexus to the longstanding purpose of the special procedures, to provide that herders can be available to tend to the flock in remote locations 24 hours a day, 7 days a week. In response to the information received in the comments, the Department will no longer use the term “open range,” will not use a set minimum number of acres in the definition of range, and will not use fencing as a defining feature of the range. We will, however, continue to consider the number of acres as a relevant factor in the determination of range. We address these considerations below.
First, the definition of “open range” in state law has limited use for the purposes of determining special procedures for herders, and the use of the term “open range” in these rules may cause unnecessary confusion in “open range” states. Therefore, as a result of the concerns raised by commenters, the Department no longer uses the NRPM phrase “open range,” and instead the Final Rule defines “range.”
Second, in response to comments, the Department has not included a minimum number of acres in the definition of range. However, the amount of acreage is relevant as a factor in determining whether the area is considered the range, as discussed further below.
Third, the Department understands and appreciates the serious concern raised by commenters regarding the use of fencing as a proxy for open range as proposed. The comments demonstrate that using the NPRM definition is untenable for many ranchers due to the
Rather, based on the comments, when assessing whether the work takes place on the range or off of the range, the Department will consider the following factors that indicate the range: The land is uncultivated; it involves wide expanses of land, such as thousands of acres; it is located in remote, isolated areas; and range housing is typically required so that the herder can be close to the herd to fulfill the requirement to be constantly ready to attend to the herd. No one factor is controlling and the totality of the circumstances is determinative. The question of whether any area on the ranch (beyond the headquarters, discussed below) is considered on the range, and therefore counts toward the 50 percent threshold requirement, or off of the range must be determined by looking at the factors established in this Final Rule. It is worth noting that when we use the term “ranch” as distinguished from the “range” in this Final Rule, we are referring to that portion of the ranch that does not qualify as range after analyzing it under the multi-factor test.
The range specifically does
The work must be performed away from the headquarters used by the employer to qualify as range work. The term “ranch” is distinct from the term “headquarters.” The term headquarters is limited and does not embrace large acreage. The headquarters is the place where the business of the ranch occurs and is often where the owner resides. The term headquarters only includes the ranchhouse, barns, sheds, pen, bunkhouse, cookhouse, and other buildings in the vicinity, meaning that anything beyond this immediate area is not considered the headquarters. Any work performed at or near the headquarters would not qualify as work on the range for purposes of the requirement for herders to spend more than 50 percent of their time on the range.
The Department maintains the requirement that the work must be done away from the headquarters in order to preserve the longstanding purpose of the special procedures—that the unique occupational characteristics require workers to spend extended periods of time in isolated, mountainous, remote areas to be available to attend to the herd's needs on a 24/7 basis, making tracking of the hours worked exceedingly difficult. This situation does not exist when workers are stationed, for example, in a cultivated field
Although the FLSA definition of range provides a useful starting point, the Final Rule does not fully adopt the FLSA definition of range in three key respects. First, for the reasons identified by the Colorado Wool Growers Association and other commenters, range housing typically is necessary for the workers covered under this Rule. The Final Rule contemplates that range housing is almost always a requirement of range work because the workers must be on call 24 hours, 7 days a week to tend to the needs of the animals, and range work cannot take place near the headquarters. Housing with the herd and away from the headquarters is therefore essential. However, the Department does not intend to provide an incentive to use range housing when it is not appropriate, as noted by the Worker Advocates' Joint Comment. Further, the Department acknowledges the comments received about a small subset of workers who use a series of remote, stationary bunkhouses on the range while traveling with the herd, while it is grazing over vast areas of land; this practice would not disqualify their employers from using the these regulations.
The second modification from the FLSA definition is for grazing that occurs on crop residue. Many of the descriptions of the land used for herding submitted by commenters would easily fall within the FLSA range production exemption's regulatory definition of the range as generally uncultivated land and land not suitable for cultivation; however, areas where sheep are grazing on crop residue may not always qualify as “range” under the FLSA definition. Therefore, to accommodate the comments that many sheep are feeding on crop residue during certain months of the year, often on leased lands at a distance from the rancher's property as the herd trails to or from BLM or Forest Service allotments, the Department is establishing the multi-factor test, as well excluding the FLSA regulation's language, “land that is not suitable for cultivation because it is rocky, thin, semiarid, or otherwise poor.” 29 CFR 780.326(b). Allowing for some work on cultivated land, depending on the other factors, is consistent with the purpose of this variance (that the work is unique because it is remote and requires 24/7 availability, which makes the hours difficult to calculate) from the standard H-2A rules. The modern reality of herding, which the commenters indicate occurs on crop residue during certain seasons, does not necessarily disqualify herders who are operating remotely from the ranchers. However, we note that the FLSA regulation provides that “generally” the land is not cultivated and “typically” is not suitable for cultivation; therefore, the deletion of the language is not a significant modification, as the Final Rule still asks whether the land actually is cultivated as an indicator of the range. The Department recognizes that, depending on an analysis of the factors, the test established in the Final Rule may in certain cases encompass more land as “range” than under the FLSA, as indicated in the Worker Advocates' Joint Comment. Additionally, in other cases, an area considered range under the FLSA may not be considered range under the test set forth in the Final Rule, depending on an analysis of the factors.
Third, the Department is intentionally omitting the sentence in the FLSA regulation stating that “[t]he balance of the `headquarters ranch' would be the `range.'” 29 CFR 780.329(b). As discussed above, determining which portions of the balance of the ranch that is away from headquarters are considered on the range, and therefore count toward the 50 percent threshold requirement, or off the range will be assessed using the multi-factor test set forth in the Final Rule.
The Final Rule establishes pre-filing procedures for employers seeking workers to engage in sheep, goat and cattle herding jobs. These provisions assist employers in understanding their pre-filing obligations.
The two TEGLs do not provide a variance from the standard rules for Form ETA-790 filing time frame or location, with one exception. Therefore, under the TEGLs, the standard Form ETA-790 filing requirements in 20 CFR 655.121(a) through (d) apply, except where an agricultural association submits a Form ETA-790 for a “master” job order (
In the NPRM, the Department proposed variances from the job order filing requirements in 20 CFR 655.121(a) through (d) for all range herding and livestock production job orders. Specifically, the NPRM proposed requiring an eligible employer to submit the,
The Department did not receive comments addressing the job order filing requirements proposed in § 655.205, and we therefore adopt the proposed § 655.205, with one minor change. As proposed and adopted, this provision essentially requires that all employers, whether filing as an individual, an association, or and H-2A Labor Contractor (H-2ALC), submit Form ETA-790, directly to NPC together with a completed
Provisions in § 655.210 establish certain content requirements for job orders covering the employment of all herders in range herding and livestock production occupations. Section 655.210(a) reminds employers that if a requirement of the standard H-2A regulations is not addressed in the herding and range livestock regulations (such as workers' compensation, among other requirements), then employer-applicants must comply with the standard regulation. We did not receive any comments from the public on this provision and are adopting it unchanged from the NPRM.
Section 655.210(b) establishes the standards associated with job qualifications and requirements included in the job offer. Many of the standards contained in this provision have been addressed above, in Sec.IV.A.2., related to the nature of herding and range livestock jobs, and in Sec. IV.A.3., related to definitions. As a result, for the reasons discussed above in Sec. IV.A.2., we are adopting the standard unchanged from the NPRM that the job offer must include a statement that the hours of work are “on call for up to 24 hours per day, 7 days per week.” In addition, for the reasons discussed in the same section above (Sec. IV.A.2.), we are clarifying the proposed standard that workers must spend “at least” 50 percent of their workdays during the contract period on the range. Instead, under the Final Rule, the job offer must reflect that workers spend a majority, meaning more than 50 percent, of the workdays during the contract period on the range. Finally, for the reasons discussed above in Sec. IV.A.3. related to definitions, we have decided to eliminate the 20 percent limitation on the number of ranch days that can be spent on work that is closely and directly related to herding or the production of livestock, because such work is inextricably linked with those primary tasks. Where such work is, indeed, closely and directly related, it comprises an essential part of the work that employees who are engaged in herding and the production of livestock perform. The Final Rule requires that all such duties must be specifically disclosed on the job order.
Apart from the issues discussed in the paragraph immediately above and in the prior preamble sections referenced in that paragraph, several issues related to job qualifications and requirements contained in § 655.210(b), including worker experience requirements, are addressed here. Under the H-2A program generally, including under the TEGLs for sheep and goat herding and the range production of livestock, “job offers may not impose on U.S. workers any restrictions or obligations that will not be imposed on the employer's H-2A workers.” 29 CFR 655.122(a). Additionally, each qualification and requirement included in the job offer must be “bona fide and consistent with the normal and accepted qualifications” required by employers not using H-2A workers for those occupations, and the Certifying Officer or the SWA may require supporting documentation to substantiate the appropriateness of any job qualification specified in the job order. 29 CFR 655.122(b).
The TEGLs provide additional information regarding permissible duties, qualifications and requirements. Both TEGLs mandate that the Forms ETA-790 submitted to the SWA provide descriptions of required job duties. TEGL 32-10, Attachment A, I(C)(1); TEGL 15-06, Change 1, Attachment A, I(C)(1). The TEGLs provide that any additional job duties “must be normal
The NPRM similarly provided that the “job offer may also specify that applicants possess up to 6 months of experience in similar occupations involving the herding or production of livestock on the open range and require reference(s) for the employer to verify applicant experience.” 80 FR at 20339. The NPRM further proposed that an employer may specify other appropriate job qualifications and requirements.
The Department received very few comments directly addressing these provisions. Mountain Plains and Western Range commented that “the job qualifications continue over from the TEGLs and are essential for identifying and hiring workers who possess the requisite skills for this special work.” As they explained, “it would be a disaster” to send a new worker to the range with a herd only to have that worker decide they do not in fact enjoy the work or they do not know how to care for and protect the animals. Vermillion and Midland stated that “[e]stablished job descriptions and requirements for various open range livestock occupations should be deemed `bona fide' and `appropriate' under [these provisions] and should not be questioned.”
Although not addressing this provision directly, several commenters discussed the need for skilled herders and the length of time needed to become skilled in this work. For example, Rocky Mountain Sheep Marketing Association commented that their shepherds must be able to manage guard dogs and sheep dogs, horses, and, often, pack mules, “have a thorough grasp of basic veterinary medicine,” and must have the “skills and maturity to protect themselves in remote landscapes,” in addition to many other skills. They further commented that skilled herding is “essential for modern range management.” Peter and Beth Swanson commented that fencing must be done correctly to protect the herd; they stated that herders know what fencing is needed, and how to troubleshoot and correct problems. Mantle Ranch explained that their workers “know how the livestock is handled and where the livestock belong at any given time” and they are “capable of moving, containing, [and] watching over [the herd] for predatory problems, sickness” and the general welfare of the animals. Mantle Ranch further noted that there are many miles of fence and watering facilities that must be “continually monitored, repaired, and updated.” Kelly Ingalls, a sheep ranch manager, stated that “[m]ore animals are saved because of the [H-2A] herder's experience in healing sick and injured animals.”
John & Carolyn Espil stated that “[a] master of sheep husbandry generally has years of experience and an exceptional aptitude for his work.” The Texas Sheep and Goat Raisers' Association similarly commented that it takes years to adequately train a worker, and loss of a seasoned employee could set a business back. Hilger Hereford Ranch commented that a herder with only six months of experience may not understand or be experienced in all of the skills needed, as different tasks and skills are needed throughout the year.
In contrast, the Worker Advocates' Joint Comment opposed the provisions allowing employers to require up to six months of experience and references to verify this experience. They stated that “the experience requirement often serves more as an exclusionary mechanism” rather than a “legitimate job qualification.” As they explained, “experience requirements are often used as a barrier to exclude U.S. workers who may be qualified but do not have experience working with the particular [animal].” Additionally, the “`verifiable' experience requirement is an undue burden on U.S. workers, as employers often require an official reference on the company letterhead of the former employer.” As they explained, “migrant workers often do not maintain records of whom they worked for in the past” and may not have the names, locations or up-to-date contact information for those employers. Furthermore, they stated that verifiable experience requirements are not equally imposed on H-2A foreign workers. Similarly, Brian Clark commented that requiring six months of experience is unnecessary. Mr. Clark stated that three months of experience should be sufficient and that qualified U.S. workers could be found with three months of experience. Additionally, he noted that employers could allow for training in lieu of experience.
As set out in the TEGLs, the provision allowing job offers to require up to six months of experience and verifiable references is due to the unique nature of the work to be performed, which often involves working alone for extended periods of time in remote locations where the herder is responsible for the safety of a herd, which the comments indicate is typically made up of approximately 1,000 ewes. The comments received on the NPRM demonstrate that these occupations require workers with experience in these jobs and the skills necessary to protect the animals and themselves. As explained in the preamble to the NPRM, these skills may include the ability to ride a horse, use a gun to protect the herd from predators, or operate certain motorized vehicles. As noted by Western Range and Mountain Plains, given the remote and unique nature of the work, it would be untenable to hire a worker with little to no occupational experience, who may decide quickly that this work is unsuitable or realize that he or she is unprepared to care for the animals. Additionally, as noted by several commenters, for the safety of the animals and the worker, it is important that workers be able to protect the animals and themselves while on the range. Therefore, the Final Rule retains the provisions from the NPRM allowing job offers to specify that applicants must possess up to six months of experience in similar occupations involving herding or range livestock production,
The Department concludes that “up to six months” is a reasonable and appropriate limitation on the experience requirement. The six-month experience requirement is a longstanding requirement from the TEGLs, based on the unique characteristics of these occupations. As demonstrated by the comments, herding and range livestock production involve changing conditions throughout the year depending on grazing location, weather, predators, animal health, and other evolving circumstances. As these conditions change, different skills may be necessary, as noted by Hilger Hereford Ranch. For some employers, requiring workers to possess up to six months of experience in these occupations is reasonable, as a worker with less experience may have only encountered certain, limited range conditions and may be unprepared for different grazing locations, predator concerns, and weather conditions. Some commenters noted that it may take years of experience to become a skilled herder. The Department concludes that a maximum of six months of experience in similar occupations involving herding or production of livestock on the range, in light of the changing needs and conditions throughout the year, is a normal and accepted job requirement for these unique occupations to ensure that workers are sufficiently experienced in these unique occupations, while preventing unduly burdensome experience requirements that may prevent otherwise qualified U.S. workers from obtaining these positions. However, as underscored by the Worker Advocates' Joint Comment, experience and qualifications requirements must be bona fide and equally required of U.S. and foreign workers. For example, if an employer requires less than six months experience of U.S. workers (for example, three months of experience), at least the same experience requirement must be required of foreign applicants.
Additionally, while employers may require “reference(s) for the employer to verify applicant experience,” such reference requirements must be reasonable and may not be used as a barrier to hiring U.S. workers. Requiring the type of formal, written reference on employer letterhead, as described by the Worker Advocates' Joint Comment, is inappropriate under the Final Rule. Employers who want to verify previous employment must make reasonable efforts to locate and contact the previous employer where an applicant provides basic information such as that required under the TEGLs—the prior employer's name, address and telephone number—or similar information facilitating contact, such as an email address, or social media account. As noted above, any reference requirements for U.S. workers must be no more stringent than those imposed on foreign workers.
The TEGLs required the inclusion of several statements in a job order about the unique aspects of range herder employment, including housing. The TEGLs set forth specific requirements, including an employer's obligation to provide mobile housing for range workers.
In the NPRM, the Department proposed that the employer disclose in the job order seeking workers for range herding positions that mobile housing would be used to satisfy the employer's housing obligation under 20 CFR 655.122(d) (requiring an employer to provide sufficient housing to workers, at no cost to the workers, where their work does not allow them to reasonably return to their residence within the same day). As proposed, the job order would state that mobile housing, meeting the requirements of §§ 655.230 and 655.235, would be provided to workers.
The Department only received a few comments applicable to this requirement. The comments from Mountain Plains and Western Range discussed the use by some employers of fixed-structures in remote areas to temporarily house range workers as they move a herd along its grazing trail. These comments are addressed below in connection with section 655.230. As discussed further in Sec. IV.E. with regard to range housing, the Department's use of the term “mobile housing” was intended to distinguish between permanent, fixed-site housing subject to the standards in 20 CFR 655.122(d) standards and the temporary housing provided workers in different locations, usually in remote areas, as their herds move from one grazing area to another, and does not to preclude the use of alternative housing structures for range workers. The Department has modified the regulation in the Final Rule to enable an employer to accurately indicate the nature of the housing in the job order.
The Department, however, received numerous comments on the use of mobile housing, inspection requirements for such housing, and minimum standards for the mobile housing, including those relating to heating, lighting, cooking, sleeping and personal hygiene while occupying such housing and the provision of food, water, and waste removal to workers while using mobile housing. These comments are discussed below in Sec. IV.E. of the preamble in connection with §§ 655.230 and 655.235.
All H-2A employers, including employers currently utilizing the TEGLs for sheep, goat and cattle herding, must provide to their workers, free of charge, all tools, supplies and equipment required to perform their assigned duties. 20 CFR 655.122(f). The TEGLs further specify that, due to the remote and unique nature of the work to be performed, employers must “specify in the job order and provide at no cost to workers an effective means of communicating with persons capable of responding to the worker's needs in case of emergency.” TEGL 32-10, Attachment A, C(4); TEGL 15-06, Change 1, Attachment A, C(4). As recognized by the TEGLs, communication means are necessary to perform the work and can include, but are not limited to, satellite phones, cell phones, wireless devices, radio transmitters, or other types of electronic communication systems. Except for those requirements that relate to mobile housing standards, the TEGLs do not identify any additional tools, supplies or equipment that must be provided by the employer under 20 CFR 655.122(f).
The NPRM proposed that employers must provide to workers, without charge, all tools, supplies and equipment that are required by law, the employer, or the nature of the work to perform the job safely and effectively. 80 FR at 20340. The NPRM also proposed that employers must disclose in the job order which items it will provide to the worker.
The Department also proposed requiring employers to provide workers, at no cost, an effective means of communicating with persons capable of responding to worker's needs in case of an emergency. 80 FR at 20304-20305. The NPRM provided the same non-exclusive list of acceptable communication devices as in the TEGLs. 80 FR at 20305. Accordingly, the proposed provisions in § 655.210(d) would require employers to specify in the job order the electronic communication devices that will be provided to workers.
Based on the comments received, which we discuss below, the Final Rule retains the NPRM provisions requiring employers to provide, free of charge or deposit charge, all required tools, supplies and equipment and to disclose which items will be provided in the job order, but does not include a list of typically required items in the regulatory text. The Final Rule maintains the requirements that employers must disclose and provide to workers, free of charge or deposit charge, an effective means of communicating with persons capable of responding to the worker's needs in case of an emergency, including, but not limited to, satellite phones, cell phones, wireless devices, radio transmitters, or other types of electronic communication systems. The Final Rule also revises § 655.210(d) to address situations in which workers are stationed in locations where electronic communication devices will not operate effectively. In such cases, the employers must either make arrangements for workers to be located in geographic areas where electronic communication devices can operate effectively on a regular basis, or provide for regular, pre-scheduled, in-person contact. The Final Rule also revises job order disclosure provisions to require the employer to specify the means and frequency with which the employer plans to make contact with the worker when the workers are stationed in locations where electronic communication devices may not operate effectively. Finally, the Department has divided subsection 655.210(d) in the Final Rule into two paragraphs, the first addressing tools, supplies, and equipment generally, and the second specifically addressing communication. We will address each topic separately below.
The Department received a number of comments about the proposal to require employers to provide electronic communication devices to range herders and livestock production workers free of charge or deposit charge. The Worker Advocates' Joint Comment and the Western Watershed Project expressed concern that range herders and livestock production workers often work in remote locations with no means of communication in case of emergency. Western Watershed Project specifically noted that workers are exposed to various hazards in these remote locations, including exposure to disease and attacks from predators. Some employers, and employer associations Mountain Plains and Western Range, also agreed that electronic communication devices can help employers monitor the health and well-being of workers and the herd. One private citizen also suggested that workers should have access to a computer with Skype or similar communication that would allow the workers to contact a trusted person who speaks the workers' language. At least one employer also expressed concern about language barriers.
Only one comment, submitted by the Office of the Governor of Utah, urged the Department to eliminate the requirement that employers provide an electronic form of communication, stating that the Department failed to provide adequate justification for the requirement and asserting that the requirement would create an excessive encumbrance on employers. This comment also suggested that, because “there is no apparent history of safety incidence to cause alarm,” the Department should allow employers to develop their own action plans to provide means of communication to workers during emergencies. Other comments from employers noted that workers often use their employer-provided cell phones to contact their families abroad and suggested that workers should be responsible for the cost of such calls, as well as the cost of providing different devices that the workers may choose that are beyond what is necessary to effectuate emergency contact with the employer and emergency first responders.
We also received comments about workers' access to satellite phones. A comment from the Western Watershed Project urged the Department to require employers to provide workers access to satellite phones where in-person or cell phone contact is not available, as well as working batteries or rechargeable batteries and a solar charger to power the device for the amount of time spent in areas with limited or non-existent communication. This commenter also suggested that employers be required to maintain subscriptions for messaging services in cases of emergency and to provide proof of satellite coverage and appropriate equipment with respect to each worker on an annual basis. Some employer commenters indicated that they currently provide satellite phones to their workers for communication in geographic areas where there is no cellular service coverage and believed this was an effective way of providing contact in the event of an emergency.
The Worker Advocates' Joint Comment urged the Department to require employers to provide workers with a satellite phone for communication at all times. They suggested that, without access to satellite phones, workers who are out on the range with no cellular service coverage will have to depend solely on more frequent contact with the employer as the only means of obtaining aid in the event of an emergency, and that in-person contact with the employer, unless it occurs daily, is not a reliable way of providing access to assistance in cases of emergency. They also stated that the Department's proposal creates a potential conflict of interest for employers in responding to
Comments received from employers and employer associations reflected general agreement that a satellite phone is not an adequate substitute for in-person communication between employers and their workers, and urged the Department to adopt a flexible approach in the Final Rule. Mountain Plains and Western Range acknowledged that electronic communication devices can help employers track the health and well-being of workers, but noted that electronic communication cannot replace face-to-face communication. One employer stated that he had successfully used satellite phones as an effective alternative means of communicating with workers outside cellular service coverage areas, but stressed that employers should be allowed to find solutions that best serve their needs. Other commenters expressed concern about the cost of providing satellite phones and service plans, and one commenter reported that satellite phone service plans would cost $300 to $2,000 per year.
The Department received comments, from workers and employers, agreeing that employers should be required to establish work locations where electronic communication devices will work effectively so that workers' safety and health can be monitored. One commenter stated that it was critical for employers to establish locations where a cell phone, satellite phone, or other device will work, or where workers can stop at a nearby ranch in the event of an emergency. Some employers indicated that they already provide their workers with cell phones with consistent coverage in the areas where workers are stationed, and that they intentionally station workers, as much as possible, in areas that provide cell phone coverage, allowing the workers to regularly contact the employer, as well as family and friends abroad.
The Department also received comments about minimum allowable intervals between contacts initiated by the employer. One commenter, a private citizen, expressed concern that in some cases, it may be over a month before workers have contact with their employer. Comments from Mountain Plains, Western Range, and other trade associations stated that establishing minimum intervals for employer-employee contact is unnecessary and infeasible given the unpredictable nature of the terrain, weather, and cellular telephone signals, and employers currently strive to maintain regular communication with their workers. Several employers pointed out that they have every economic incentive for maintaining regular contact with their workers because they are concerned with both the welfare of the workers and the welfare of the livestock. Other employers commented that they currently have practices in place that provide for regular contact with their workers, including three employers who reported maintaining contact with workers by designating “camp tenders,” who are responsible for resupplying workers' camps and monitoring the health and the well-being of workers and the herd. One employer suggested that employer-employee contact every two to three days should be sufficient. Another employer suggested that as long as workers have the ability to contact the employer at any time, employer initiated contact every ten days is reasonable and sufficient. The employer further explained that some employers arrange for workers to work in pairs during the summer when the workers are in remote areas, and in such cases the employer may only have in-person contact with one of the workers in the working pair. They suggested that, to the extent that minimum contacts are imposed, contact with one member of the working pair of employees in such arrangements should be sufficient. The Worker Advocates' Joint Comment suggested that in-person contact could not be relied upon for emergency purposes unless it is daily. They also stated that, for purposes of defining a reasonable amount of time between in-person visits to deliver necessities (
The Worker Advocates' Joint Comment also emphasized that because workers must rely on their employers for delivery of mail, the Department should promulgate a rule prohibiting employers from opening workers' mail. They also reported that employers sometimes deny workers access to healthcare professionals, and prohibit workers from allowing visitors, using a radio, and possessing reading materials.
Based on the comments received, the Department has decided to maintain the proposed requirement, now located in § 655.210(d)(2), that employers must provide to their workers, free of charge or deposit charge, an effective means of communicating with persons capable of responding to the worker's needs in case of an emergency, including, but not limited to, satellite phones, cell phones, wireless devices, radio transmitters, or other types of electronic communication systems. We found overwhelming agreement among the commenters that this requirement is needed due to the isolated nature of sheep, goat and cattle herding on the range. As the Western Watershed Project comment accurately noted, workers in these occupations often work in remote locations without sufficient access to medical facilities or means of communication in cases of emergency. Without proper communication equipment, range herders and livestock production workers would be unable to seek and obtain assistance in cases of emergency. A majority of employers and employer associations agreed that electronic communication devices can help employers monitor the health and well-being of workers and the herd. Even when working in pairs, a communication device remains necessary because in the event that one worker needs emergency assistance on the range, the second worker would not likely be able to cause EMTs to arrive quickly without a communication device. Furthermore, we interpret the phrase “persons capable of responding to the worker's needs in case of an
After considering all the comments on this subject, the Department also revised and added two subparagraphs in paragraph 655.210(d)(2) to clarify the employer's obligations. First, subparagraph 655.210(d)(2)(i) requires employers to include in the job order a simple statement specifying the type of electronic communication device(s) that the employer will provide, free of charge or deposit charge, to the worker during the entire period of employment. Second, under subparagraph 655.210(d)(2)(ii), the employer must specify in the job order the means and frequency with which the employer plans to make contact with the worker to monitor the worker's well-being if there are periods when the worker is stationed in locations where electronic communication devices may not operate effectively. Subparagraph (ii) also clarifies that such contact must include either (1) arrangements for workers to be located in geographic areas where electronic communication devices can operate effectively on a regular basis, or (2) arrangements for regular, pre-scheduled, in-person visits between workers and the employer, which may include visits between workers and other persons designated by the employer to resupply the workers' camp (
In light of the comments from numerous employers and employer associations about the need for flexibility in determining the best method for providing workers access to emergency services, the Final Rule does not mandate the use of a specific electronic communications device. The Department has also decided not to require employers to provide workers access to satellite phones as a substitute for in-person employer-initiated contacts. Comments received from employers overwhelmingly rejected this approach, citing the costs and reliability of satellite phones, as well as the need for flexibility. The Department, however, clarifies that employers should consider and keep up with advances in technology when selecting appropriate electronic communication devices. A comment from the Western Watershed Project asserted that employers must provide workers with working or rechargeable batteries to power electronic communication devices for the amount of time spent in remote areas. In response, we clarify that the requirement to provide an effective means of electronic communication means that the device must be operable at all times. Therefore, the employer must provide the worker with an adequate power source for the device.
The Department will require the standards set out above without defining “regular” contact or imposing minimum in-person contacts, but, as mentioned above, will require the employer to disclose the frequency of contact in the job order. In the absence of evidence demonstrating pervasive issues with worker access to emergency services, a specific frequency requirement for in-person contacts is unnecessary. This choice strikes a suitable balance between the Department's legitimate interest in protecting H-2A sheep, goat and cattle herders with the employers' need for flexibility in determining the appropriate method for providing workers access to emergency services.
Employers and their associations generally commented that employers provide all the tools, supplies and equipment needed for the job, at no cost to the workers. Some employer commenters listed examples of items that are provided for their herders. For example, F.I.M. Corporation commented that they provide free of charge “clothes, medicine, blankets, rain coats, boots, etc.” Mule Head Growers commented that their herders have ATVs and herding dogs, and that they provide all other supplies requested by the herders. Cindy Siddoway of Siddoway Sheep Company's comment listed the following items as necessary
Employers and their associations commenting on this issue emphasized that required tools, supplies and equipment will vary among ranches due to differing climates, weather conditions, and assigned duties. Items required by the employer on one ranch may be completely unnecessary on another ranch due to the nature of the work. For example, Eph Jensen Livestock commented that “[w]ith the diversity of size, location, and management practices of sheep ranches, it would be impossible to make a checklist of items that need to be provided. This is already monitored by the WHD and penalties are imposed for violations.” The employer further commented that, in its view, the trouble is a lack of practical understanding in DOL investigations, and recommended that in enforcement actions, employers should be allowed the opportunity to explain why certain items were or were not provided.
Due to variety in the items required, several commenters opposed including a list of typically required items in the regulation or in the job order. For example, Billie Siddoway of Siddoway Sheep Company commented that “[b]ecause the provision of equipment varies among ranches and among employees on each ranch, it would be preferable to modify the proposed rule so that an exhaustive list of equipment is not required. Rather, an employer should be able to state generally that the equipment necessary to carry out the job duties will be provided.” Ms. Siddoway further commented that “[i]f the Department deems certain equipment to be significant (
Mountain Plains and Western Range commented that the tools, supplies and equipment required to do the work safely and effectively depends on the time of year or location of the work. They explained that “[t] he items suggested in the NPRM are among those used on the range, binoculars, firearm, boots, rain gear, an ATV or four-wheeler, and/or a horse, but this list should not be considered exhaustive nor mandatory. During different times of the year or in different parts of the West, some or all of these items would be strictly necessary while others would be entirely useless.” Mountain Plains and Western Range further commented that including specific requirements of items to be provided “will not increase job safety or efficiency but would simply provide a ‘gotcha’ opportunity for ambitious plaintiffs lawyers.”
Additionally, some employer commenters noted that items provided should be “within reason” and that the Department's proposal does not take into account personal preferences or other factors. Sheep ranchers John and Carolyn Espil stated that “[i]t is doubtful that the DOL investigators could, in the scope of their investigation, determine whether the charge was for an item requested by the herder for his personal possession or if it was an item that the employer should provide.” They gave the example of “boots” as a required item, stating that the Department gives no variance for price of items, personal preference or frequency of purchase. They commented that they already provide all bedding, clothing and boots within reason, but that the Department's proposal would eliminate all expense for the worker. Eph Jensen Livestock commented that “there has been no accountability placed on the worker for neglect of tools or equipment that employers provide.”
On the other hand, the Worker Advocates’ Joint Comment suggested that the regulation “include an explicit non-exclusive list of such items that are typically required by the nature of the work under [this rule] to avoid employers circumventing this requirement with their own interpretation” of what is required by the job. As they explained, foreign herders and range workers often bring little with them to the United States because they have been assured that “everything will be provided.” The Worker Advocates’ Joint Comment stated that because the TEGLs have never “described the precise items that need to be provided . . . there has never been a consistent understanding among the workers and the industry of what this promise truly encompasses,” so that upon arrival in the United States, foreign workers learn that, while the employer will purchase many of the items needed for the job, the cost of the items is often deducted from the worker's pay. The Worker Advocates' Joint Comment listed several items that they find are required by the nature of the work to perform the job safely and effectively and should be provided free of charge, including binoculars, a rifle/gun, a knife, a trained horse, lighting, bedding, outer wear to protect the worker from the elements, and disposable gloves and disinfectant. They further recommended that, at a minimum, the Final Rule should specify “those categories of items that the Department considers necessary for these jobs, such as ‘bedding’ and ‘outerwear to protect worker from elements.’ ” The Worker Advocates' Joint Comment also supported the NPRM provision requiring employers to list the items that will be provided in the job order, as this will “help employers clarify with the Department the kind of tools that must be provided” free of charge and “the Department can then review whether an employer's job order specifies many of the common items discussed above and require clarification or correction of any deficiencies.” They further recommended that the job order include the list they suggested of specific items and blank lines for any additional items.
As explained in the NPRM, although the H-2A regulations currently require employers to provide, free of charge, all tools, supplies and equipment necessary to complete the duties assigned, Departmental investigations have found instances where employers have failed to supply the necessary tools, supplies and equipment for the job, such as
Based on the comments received, the Final Rule retains the NPRM provisions as proposed, and does not include a specific list of typically required items in the regulations. The Department concludes that it is appropriate to specify in the Final Rule that employers must provide, free of charge or deposit charge, all tools, supplies and equipment required by law, the employer, or the nature of the work to perform the job safely and effectively and to list which items will be provided free of charge or deposit charge in the job order. The comments reflected that although many employers provide all necessary items and provide them free of charge or deposit charge, it is helpful to include in the Final Rule the requirement that the employer must provide all tools, supplies and equipment free of charge, because it provides clarity to workers and employers on the types of items considered required for herding and range production of livestock occupations. If items are only required at certain times of the year, the employer is only required to provide those items during those periods. However, DOL concludes that it is necessary for the employer to disclose that those items will be provided in the job order so that workers are aware of which items will be provided prior to accepting the job. If an employer wishes to further specify in the job order that certain items will be supplied only during specific periods, DOL would not object to this. Additionally, while the standard H-2A regulations require employers to provide, free of charge, all tools, supplies and equipment necessary to complete the duties assigned, the language “by law, by the employer, or by the nature of the work to perform the duties assigned in the job offer safely and effectively” provides additional guidance on the type of items that must be provided free of charge or deposit charge. This provision does not require employers to provide items for the worker's entertainment, such as magazines, CDs and DVDs, or other items that are not required by the job, but employers may choose to do so. As many employers noted, they already supply all items requested by their workers; the Department encourages ranchers to continue to these practices. Some charge the worker for personal items that the workers request, while others do not.
We further conclude that requiring employers to list which items will be provided free of charge or deposit charge in the job order will ensure that workers are aware of what items to expect to be provided, in advance of accepting the job. Additionally, including this list will serve to notify the Department of the types of items required in these occupations, and, as noted by the Worker Advocates' Joint Comment, the Department may review those items and ask for clarification or correction of any deficiencies. In the event of an investigation, the Department may review those items included in the job order; however, the Department is not precluded from determining that additional items not included in the job order were required for a particular worker under the terms of the Final Rule. Additionally, we note that we currently allow, and will continue to allow, an employer in an investigation to provide its explanation of why certain items were or were not provided.
Finally, as noted, we decline to include a list of typically required items in the Final Rule. As demonstrated by the comments received, the tools, supplies and equipment required by employers or by the nature of the work will depend on a number of circumstances, such as the terrain, the season, and the climate. As discussed above, the requirement that employers list in the job order those specific items that will be provided to herders will meet the goal of providing information to workers and to the Department, while avoiding the risk that specifically mandated requirements may become outdated, unnecessary or irrelevant. We note that the term “required” in § 655.210(d)(1) means all tools required by law, by the employer, or by the nature of the work to perform the work safely and effectively. The Department further notes that the preamble discussions here and in the NPRM provide examples of items that may be required by the nature of the work, such as boots, binoculars, a gun, an ATV, or a horse. Additionally, § 655.230 addresses range housing standards, and as fully discussed in preamble Sec. IV.E., certain items are required to be provided to meet those housing standards, such as bedding and heating equipment (or protective clothing where appropriate). As with all required tools, supplies and equipment, these items must be provided to the worker free of charge or deposit charge and listed in the job order.
Currently, as required under the sheep and goat herding TEGL, and pursuant to industry practice for the range production of cattle, H-2A employers employing workers in these range occupations must provide food, free of charge, to their workers.
The Final Rule maintains the requirement that employers must provide either three sufficient meals a day, or furnish free and convenient
Comments received from worker advocates, private citizens, an industry magazine editor, a State government office, employers, and employer associations reflect general agreement that employers should provide range workers with “adequate” meals or “sufficient” provisions of food to prepare healthy, nutritious meals. For instance, in their joint comment, Mountain Plains and Western Range stated that, “[t]he physical demands of the job call for a protein-rich diet for the hearty men that perform this work. . . .” Billie Siddoway of Siddoway Sheep Company, Inc. also stated that “[d]elivering food is a necessary part of range employment because employees do not have ready access to shopping markets.” Other employers agreed that range workers “need and deserve good food” and should be “adequately fed.” One employer, in expressing his support for the proposal to require sufficient and adequate food, opined that “if the workers are happy, well-nourished and content, they will properly care for our animals and properties.”
Commenters disagreed, however, on whether employers are currently providing adequate meals or sufficient food to range workers. Several employers stated that they provide a variety of food, including meat and fresh produce, and accommodate worker preferences for specific foods and quantities. Billie Siddoway of Siddoway Sheep Company, Inc. described their practice of providing hot meals and food to workers as follows:
During the winter lambing season, we employ[] a cook who prepares three hot meals each day. When the [workers] are on the range, they prepare their own meals. On our ranch, each [range worker] provides us with a grocery list. Every eight to ten days, depending on terrain and conditions, we purchase the items on the list and deliver them to the requesting [range worker].
On the other hand, the Worker Advocates' Joint Comment reported instances when food is not delivered to range workers in a timely manner, and provides accounts of workers “being sent by employers to steal fruits and vegetables from the nearby orchards for their own consumption.” A private citizen also recounted instances where employers have forgotten to deliver food supplies to range workers and where employers have supplied food unfit to eat. One other private citizen noted that she visited with range workers who reported going over a month without receiving food from the employer.
The Department also received a number of comments about how and to what extent the Final Rule should specify the employer's food provision obligation. The Worker Advocates' Joint Comment emphasized that range workers need sufficient quantities of food for health maintenance, disease prevention, and preventing vitamin deficiencies. They stated that the terms “sufficient” and “adequate” used in the proposed rule do not provide clear guidance on the amount and kind of food necessary for workers engaged in physically demanding work. Thus, they requested that the Department require in the Final Rule “a daily source of protein and vitamins and minerals” and that employers provide range workers with “fresh food when possible.” They suggested meats, beans, and eggs as permissible sources of protein, and fruits, vegetables, and oils as examples of the remaining vitamins and nutrients. The Worker Advocates' Joint Comment also requested that we set minimum daily calorie requirements, variety recommendations, and food safety standards using federal guidelines, including guidelines from the National Institutes of Health and the U.S. Department of Agriculture. Specifically, they stated employers should provide to each range worker enough food to meet a minimum daily calorie requirement of 3,000 to 4,000 calories (or 21,000 to 32,000 calories per week), and provide range workers with more food during periods when they are engaged in higher levels of activity. One private citizen also suggested that, given the difficulty with refrigeration on the range, the Department should consider requiring employers to provide extra food in order to take spoilage into account.
Comments from employers and employer associations, on the other hand, requested that the Department adopt a flexible, case-by-case approach in defining the employer's food provision obligations. Mountain Plains and Western Range stated that food provision requirements involving calorie counts or menus are unnecessary, arbitrary, and would create “a logistical nightmare” for the Department to enforce and for employers to comply with. They also noted that each worker has his own preference for food, and a “one size fits all” approach mandating a particular diet for range workers would violate those preferences. One employer suggested that imposing calorie requirements and food delivery is beyond the Department's purview. A comment from the Wyoming Farm Bureau Federation suggested that the Department should simply provide clear language about what the employer is not required to provide (
Based on the comments received, the Final Rule retains the proposed standard, now found at paragraph 655.210(e)(1), requiring employers to specify in the job order and to provide to range workers, without charge or deposit charge, either three sufficient meals a day, or free and convenient cooking facilities and adequate provision of food to enable range workers to prepare their own meals. Comments from worker advocates, private citizens, employers, and employer associations revealed general agreement that, given the unique and isolated nature of range herding, employers should be required to provide range workers with adequate and sufficient meals and food.
The Final Rule also revises the proposed regulation by adding a clause at the end of paragraph 655.210(e)(1), stating that to be “sufficient” or “adequate,” meals or food provided by the employer must include a daily source of protein, vitamins, and minerals. The Final Rule reflects a basic nutritional framework and also retains employers' flexibility to accommodate workers' preferences, as well as delivery and storage realities. Such a requirement is appropriate given that range workers are often in isolated locations and entirely dependent upon their employers for adequate food to meet their nutritional needs. This provision also establishes a more objective standard for employers to
Having established the general parameters for minimum food requirements, we conclude that further regulating food provisions by mandating a specific calorie count or specific food delivery intervals is unnecessary. In addition, a one-size-fits-all approach would create significant difficulties given that workers' preferences may vary and food delivery schedules may depend upon the location of work. Nonetheless, we clarify that employers are encouraged to consult and may rely on existing federal guidelines for minimum calorie counts, variety requirements, and/or food safety standards when making decisions about food provision, taking into account the physical conditions and requirements of this work. We further clarify, consistent with the proposal from the Worker Advocates' Joint comment, that acceptable sources of protein include, but are not limited to, meats, beans, and eggs, and acceptable sources of vitamins and minerals include, but are not limited to, fruits, vegetables, and oils. Furthermore, in meeting the food provision requirements under this Final Rule, employers should strive to provide range workers with fresh food when possible.
The TEGLs for employers engaged in sheep, goat and cattle herding require job orders to comply with the standard H-2A requirements, “unless otherwise specified” in the TEGLs. TEGL 32-10, 4; Attachment A, I(B), (C); TEGL 15-06, Change 1, 4; Attachment A, I(B), (C). Both TEGLs provide, with regard to earnings records and statements, that an employer must keep accurate and adequate records with respect to workers' earnings and furnish workers a statement of earnings on or before each pay day (a requirement consistent with the standard H-2A requirement,
The NPRM proposed to limit the special exemption from the standard recordkeeping requirements to the days “when the worker is performing duties on the open range.” 80 FR at 20340. The NPRM also proposed to require employers to keep daily records indicating whether the employee worked on the open range or on the ranch or farm, and to require employers to “keep and maintain records of hours worked and duties performed over the course of the day when the worker is performing work on the ranch or farm.” 80 FR at 20340. Finally, the NPRM proposed to require employers who chose to prorate a worker's wage, based upon the worker's voluntary absence for personal reasons, to keep a record of the reason for the worker's absence.
The NPRM stated that, because the proposal requires a monthly wage, keeping and maintaining records of hours worked was not necessary for days spent on the range. 80 FR at 20305. The daily record of where the work was performed would be sufficient for the Department to assess compliance with the requirement that at least 50 percent of the worker's days be spent on the range. The preamble clarified that, where an employee spends some portion of the day on the range and some portion on the ranch, the day would count as a range day or a ranch day depending upon where the employee spent a majority of the hours worked during the workday. 80 FR at 20306. The NPRM explained that the proposed requirement to keep a record of the hours the employees worked and the duties performed for days spent on the ranch or farm would allow the employer and the Department to determine whether work that did not fall squarely within the definition of the production of livestock satisfied the proposed requirement that it be minor, sporadic, and incidental (
As discussed in Sec. IV.A.3. of the preamble related to § 655.201, the Final Rule eliminates the 20 percent cap on the performance of minor, sporadic, and incidental duties while workers are on the ranch or farm; therefore it also eliminates the requirement to maintain records of hours worked and duties performed while on the ranch or farm. The Final Rule retains the NPRM's other requirements to record whether each day is spent on the range or the ranch and, if the employer chooses to prorate the required wage, to record the reason for the worker's absence.
Many employer commenters objected to the recordkeeping requirements associated with the proposed 20 percent cap on directly and closely related duties while at the ranch. In some cases their concerns were based upon a misunderstanding of those requirements. For example, some commenters thought the proposed rule required them to keep track of the number of hours that workers performed each individual duty while at the ranch, or at least to track the time spent on directly related work versus actual livestock production work, rather than simply to record the total hours worked each ranch day and a description of the duties performed during the day. Thus, one herding employer, Martinez Livestock, stated that requiring the employer to individually itemize each of the incidental chores and the time spent would be time consuming. The Colorado Wool Growers Association commented that the performance of additional related chores should not “require the ranch to keep an onerous set of records, parsing out every single activity.” Another rancher stated that “[k]eeping track of time an employee works in a particular situation or site makes no sense!” Other commenters specifically opposed any additional requirement to keep records of work performed on the range, stating that the added burden would be unnecessary and impractical.
Other commenters addressed the proposed recordkeeping requirements. For example, the American Farm Bureau stated that keeping “hourly records for work performed at the ranch and daily records of the work performed on the range” was burdensome and the Department “has presented no evidence that farmers have been using herding workers on the ranch more than the allowed 20 percent time.” The Utah Farm Bureau Federation and the Michigan Farm Bureau agreed and further concurred with the statement that the proposal would be particularly burdensome for small ranchers; they stated that such family businesses do not have a human resources department for support, and they may not be familiar with the FLSA recordkeeping requirements because one H-2A worker may be their only employee. Another
Many other commenters agreed. For example, John Espil Sheep Company stated that keeping track of their workers' time hourly or daily would be extremely difficult or impossible, both on the range and at the ranch, because every day is different. Another sheep rancher commented that the workers irrigate pastures, harvest livestock feeds, maintain fences, clean corrals, doctor sheep and feed them, and it would be “absurd” to require recordkeeping for this work.
In contrast, Billie Siddoway, on behalf of the Siddoway Sheep Company, stated that it “would not be unreasonable to track the days each employee works on the range or the ranch,” but that it would be onerous to track hours of work and duties performed every day when workers are on the ranch. This commenter suggested that if an employee undertakes minor, sporadic or incidental work outside the definition of herding, “the employer could track those hours and job duties only” in order to allow the Department to evaluate compliance with the 20 percent rule. This commenter further stated that it “would not be unreasonable to track the hours and duties associated with” such incidental tasks as erecting temporary pens and corrals in anticipation of the lambing season, and that limiting the reporting requirement to only incidental work would likely lead to more accurate reporting.
In contrast to the comments by employers or their representatives, the Worker Advocates' Joint Comment suggested that the normal recordkeeping requirements should be extended to these workers, regardless of where the work is performed, so that start and stop times (including for responses to emergencies), total daily hours, and duties would be recorded even for work on the range. They stated that this would allow a more accurate assessment of the appropriate number of hours per workweek to use for the monthly wage computation, and it would allow for enforcement of the hourly AEWR if workers perform duties that fall outside the scope of these regulations, such as if workers are required to repair irrigation ditches or harvest hay. They stated that relieving employers of the standard requirements to maintain “records reflecting daily hours and job duties for open range work incentivizes misclassification.” They also asserted that “[w]ithout recordkeeping requirements, the Department cannot monitor compliance with those requirements,” and that workers “face the daunting task of having to reconstruct covered and uncovered work hours and of having to convince a judge or jury that they are telling the truth” when they seek to recover back wages at the higher hourly AEWR rate. In the alternative, they sought clarification that the exemption from normal recordkeeping applies only when the worker spends an entire day on the range and not when both range and ranch duties are performed during a single day. The Worker Advocates' Joint Comment also noted that any burden from the extra recordkeeping would fall on the employees, not the employers, but that it could involve a simple daily timesheet or calendar that the employer collected each month. Finally, they stated that employers already have timekeeping systems for their other employees, and that the new requirements would add little cost but would provide records important for monitoring and enforcement. The Western Watershed Project concurred that records of actual hours worked should be required.
The Final Rule retains the proposed requirement to track days at the ranch versus days on the range because that is essential to allowing the employer, and the Department if necessary, to assess compliance with the requirement that a majority (more than 50 percent) of the workers' days be spent on the range in order for these rules to apply. Moreover, that requirement imposes only a minimal recordkeeping burden. We understand from the comments that employees generally will work on the range for several months at a time, and then they may be on the ranch for two months, such as for lambing, before again leaving for months on the range. Because the employer simply needs to record (by, for example, checking a box) where the employee worked each day, and because that response will be the same for months at a time, the burden is inconsequential. Moreover, the employer commenters did not object to this aspect of the proposal.
The Final Rule also retains the NPRM's requirement to record the reason for a worker's absence, if the employer chooses to prorate the required wage. The required wage may be prorated only if an employee voluntarily is unavailable for work for personal reasons, such as to return home due to a family member's illness. The notation of the reason for the worker's absence will allow the Department to verify whether any deduction that the employer chooses to make from the worker's required wage was made for appropriate reasons. The need to make such an entry is likely to arise only very rarely and for very few workers; therefore, the burden is minimal. Moreover, employer commenters did not object to this requirement. Accordingly, the Department retains the requirement so that it will have available for later review a contemporaneous explanation for any deductions from the required wage.
The Final Rule eliminates the proposed requirement to maintain records of hours worked and duties performed while on the ranch or farm, because the Final Rule eliminates the proposed 20 percent cap on the performance of minor, sporadic, and incidental duties while workers are on the ranch or farm. The proposed requirement to track duties performed at the ranch was intended to allow the Department to monitor compliance with the 20 percent cap, by preserving a record of the tasks performed each day, so it could be determined whether the tasks were solely those that fell squarely within the definition of the production of livestock or also included some tasks that simply were closely and directly related to herding or the production of livestock. The proposed requirement to track the hours worked while at the ranch was intended to provide the basis for a remedy for a violation when workers exceeded the 20 percent cap. In light of the decision to remove the proposed 20 percent cap from the Final Rule, the associated recordkeeping requirement is no longer necessary for these purposes.
The Department recognizes that records regarding the duties performed and the hours worked would be relevant if the rancher violates the rules by assigning duties to the workers that fall outside the scope of the herding and range livestock regulations during periods when they are not working on the range. Thus if an employer assigned a worker general ranch hand work rather than work that falls within the definition of the production of livestock (which includes all duties that are closely and directly related to the herding or production of livestock), records of the hours worked would be relevant to determining the appropriate
The wage rate required by the standards in § 655.210(g) of this Final Rule is also discussed in Sec. IV.C. of the preamble related to the wage methodology standards in § 655.211, which also governs the applicable wage rate. In addition to the many comments received on the wage methodology, we received a handful of comments on paragraphs 655.210(g) and (h) related to commissions, bonuses, and other incentives, and pay frequency and access.
The TEGLs do not address the issue of whether an employer may pay a wage rate based on commissions, bonuses, or other incentives. Under the standard H-2A rules, at 20 CFR 655.122(l)(1), employers are barred from offering or paying a wage rate based on commissions, bonuses, or other incentives unless the employer guarantees and pays at least the required wage for each pay period. Section 655.210(g)(1) of the proposed rule departed from the standard H-2A requirement, and barred pay rates based on commissions, bonuses, or other incentives entirely. The proposed rule further clarified that all payments must be made free and clear without any authorized deductions. Recognizing that herders are often paid through direct deposit or wire transfer given the remote nature of the work, the preamble further provided that if the employee:
A few employers commented on the prohibition of wage rates based on commissions, bonuses, or other incentives in the NPRM. The joint comment from Vermillion and Midland opposed this requirement. This comment pointed out that a flat prohibition was inconsistent with the rule in the rest of the H-2A program and stated that such payments should be permitted, provided that the employer guaranteed the required wage. Siddoway Sheep recommended that DOL permit employers to withhold a portion of wages as an incentive for the employee to complete the contract period and to discourage workers from leaving to work in other industries. A third employer, Lava Lake Land & Livestock, stated that it was “the American way” to pay for performance and stated that such payments should be permitted if disclosed in the job order and advertised. This employer stated that the required wage should be assessed on an annual basis so that any bonuses could be counted toward compliance with the wage requirement.
We received only a few comments on the issue of pay frequency. Both Edward Tuddenham, an attorney who represents workers, and the Worker Advocates' Joint Comment stated that DOL should require workers to be paid at least twice monthly, consistent with the requirements in the rest of the H-2A program.
Both the Worker Advocates' Joint Comment and the Tuddenham comment further requested that DOL take additional steps to provide workers with “real access to their wages.” These commenters expressed concerns that workers are not provided with the means or time off to go to the bank or check cashing facility and thus are overly dependent on their employers in accessing wages. The Worker Advocates' Joint Comment noted that workers typically either receive wages by direct deposit or have wages sent directly to their families in their home countries. This comment recommended that DOL require by regulation that employers offer the worker the option to receive wages by check, cash, or direct deposit, and asked that DOL require employers to provide workers with physical access to banking facilities. Both comments asked DOL to impose additional regulatory standards, such as requiring by regulation that, if direct deposit is used, all banking information be provided to the worker, and that the worker be provided with the necessary bank cards or other items needed to withdraw these funds.
On the issue of bonuses, commissions, and incentives, we agree that the standard H-2A rule should apply.
We decline to adopt the other recommendations suggested by commenters regarding commissions, bonuses, and incentives. As explained in the preamble to the NPRM, the requirement to pay the required wage necessarily means that payments must be made when due to the worker (in this case, twice monthly, as discussed below). 80 FR at 20306. Authorizing employers to withhold a portion of the workers' pay after work has been performed would be wholly inconsistent with this requirement and with the standard H-2A regulation. The
We agree with the comments recommending that we use the standard H-2A pay frequency, and the Final Rule requires that payments be made at least twice monthly.
On the issue of access to wages, we note that generally payment must be in the form of cash or instrument negotiable at par (
We decline to accept the invitation to develop special rules for the types of payments required to be made to workers in these occupations or to set intervals at which workers must be provided physical access to banking facilities, which would go beyond DOL's obligation to set standards that will protect against adverse effect to U.S. workers. However, given the remoteness of the physical location of work covered by this rule, we encourage employers to continue what appears to be the widespread practice of providing the option for workers to receive payments through wire transfers to a designee or through direct deposit. We further clarify that, because direct deposit may only be used where the worker elects it, an arrangement under which the worker's pay is deposited into a bank account but the worker does not have the information needed to access the bank account, such as the account number, suggests that the worker has not consented to receive payment through direct deposit. Therefore such an arrangement is not permitted.
Under the standard H-2A program, an employer must pay the higher of the hourly Adverse Effect Wage Rate (AEWR), which is based on the combined wage rate for field and livestock workers reported in the Farm Labor Survey (FLS) conducted by the U.S. Department of Agriculture (USDA); the prevailing wage rate or piece rate; the State or federal minimum wage; or an agreed-upon collective bargaining wage rate.
Under the TEGLs, the AEWR for herder occupations is set at the prevailing wage rate of U.S. workers based on surveys conducted by the State Workforce Agencies (SWAs). For these herding occupations, the wage rate from the prevailing wage survey has most often been a monthly wage rate.
The NPRM proposed significant changes to the wage methodology governing H-2A workers engaged in sheep, goat, and cattle herding. As discussed in the NPRM, the dearth of information on the wages of U.S. workers in these occupations has made setting the AEWR based on the SWA surveys unsustainable. 80 FR at 20306-20308. Few employers provide U.S. worker wage information in response to prevailing wage survey requests for these occupations, making it difficult for SWAs to submit statistically valid prevailing wage findings to OFLC. Under the TEGLs, the SWAs use
Because almost every State experienced years in which no wage report could be statistically verified, wage stagnation across these occupations has been the inevitable result in all but two States.
Unlike the requirements in the standard H-2A program, sheep and goat herding employers are required to provide food to the workers free of charge under TEGL 32-10. Although the current cattle production TEGL 15-06, Change 1, does not prohibit employers from deducting the cost of food in accordance with the standard H-2A program regulations, since 2013 employers have been required to provided food free of charge based on the wage surveys from the SWA. Labor Certification Process for the Temporary Employment of Aliens in Agriculture in the United States: Prevailing Wage Rates for Certain Occupations Processed Under H-2A Special Procedures; Correction and Rescission, 78 FR 19019, 19020 (Mar. 28, 2013).
Section 655.211(a) of the NPRM proposed to require employers to
Paragraphs (b) and (c) of § 655.211 set the proposed methodology for establishing the monthly AEWR for these occupations. Due to the challenges in obtaining valid SWA wage results and the resulting wage stagnation from the existing methodology, we proposed to use a different wage source to set the monthly AEWR—the combined hourly wage rate for field and livestock workers from the FLS (“FLS-based AEWR”) used for all other H-2A occupations. In order to derive a monthly wage from this hourly rate, we proposed to use an estimate of 44 hours worked per week, which was a compromise between the pre-NPRM submissions of an attorney representing worker interests, Edward Tuddenham, and the three primary employer associations, Mountain Plains, Western Range, and ASI.
The NPRM further proposed a four-year transition of the new wage rates, with full implementation at the beginning of year five (the NPRM referred to this as a five-year phase-in). In many States in which the current monthly wage rate for sheep and goat herders is $750, the NPRM methodology would result in a required wage rate that triples (or more) the current rate at the end of the transition period.
For the reasons discussed below, and as we proposed in the NPRM, this Final Rule requires covered employers to pay a wage that is the highest of the monthly AEWR, an agreed-upon collective bargaining wage, or the applicable minimum wage imposed by Federal or State law or judicial action. However, based on a review of all the comments on the rulemaking record, and for the reasons set out below, we have concluded that it is more appropriate and consistent with the Department's obligations under the INA to use the current federal minimum wage of $7.25/hour, rather than the FLS-based AEWR, as the basis upon which to set the monthly AEWR for these occupations. In addition, for the reasons discussed below, we have made an upward adjustment of the estimate of hours that herders work in a week, based on a review of data collected from Form ETA-9142A. Accordingly, we will calculate the monthly wage rate as: $7.25/hour multiplied by the revised 48-hour estimate of hours worked per week. Under the Final Rule, the wage rate for these occupations will be adjusted annually based on inflation, and implementation will be transitioned over two years, with full implementation at the beginning of year three. Finally, the Final Rule requires employers to provide three adequate meals without charge to the range workers.
DOL received only a handful of comments on proposed paragraph 655.211(a) of the wage methodology. We received no comments on the requirement that an employer pay the collective bargaining agreement wage only if it is the highest applicable wage, which is consistent with the standard requirement governing the H-2A program, and no commenters objected to the requirement that the employer pay a higher applicable State or Federal minimum wage. In addition, Western Range and Mountain Plains incorporated the requirement to pay a higher applicable State wage into their joint wage proposal, which was supported by the ASI and many individual employers, which is discussed in greater detail below. Therefore, we retain these requirements as proposed in § 655.211(a) with only three clarifying edits. First, the proposed rule stated that the State or Federal minimum wage applied only if the wage was “specific to the occupation(s).” Because that text might be read overly narrowly to exclude workers from a State or Federally required wage if the wage was generally applicable to workers (including herders engaged in the range production of sheep, goats, or cattle), this Final Rule deletes that text from § 655.211(a).
Vermillion and Midland objected to the inclusion of the requirement that a higher wage required by judicial action be paid because that requirement is not included in the standard H-2A regulations, or in the H-2B regulations. In their view, this requirement is unnecessary, would encourage litigation, and creates the possibility of unpredictable wage obligations. This requirement that a higher wage required by judicial action be paid is consistent with ETA's years-long application of the legal settlement from the
We received a comment from one employer objecting to the requirement that the new AEWR rate be paid upon announcement in the
Generally, we received hundreds of comments opposing the use of the FLS as the basis of the wage proposal from individual herding employers; employer associations including Mountain Plains, Western Range, and ASI; State and local government officials, including Governor Mead of Wyoming and Representative Jaggi of the Wyoming House of Representatives; others from Western States with a business interest in the sheep industry, such as accountants for sheep herding employers and wool processors; and SBA Advocacy. These comments primarily provided objections based on the size of the proposed increase, which, as noted previously,
The Colorado Wool Growers Association and others asserted that the wage proposal was “not grounded in the market realities” of the industry. Many employers stated that the wages proposed were too high, given that the result would be payment of higher wages for herders than for other workers in the U.S. economy, including ranch managers, or that the wages paid substantially exceed what H-2A workers would earn for the same work in their home countries. Some commented that because food and housing are paid by the employer, foreign workers are able to send their paychecks in full back to their home countries.
SBA Office of Advocacy reported that, based on its discussions with small livestock and sheep herding operations in California, Colorado, Oregon, Montana, Utah, and Wyoming, every business contacted predicted that it would reduce its operations or close operations within a few years. SBA Office of Advocacy cited a Mountain Plains Survey, in which nearly every one of the association's 214 member respondents commented that it would downsize or shut down operations because of the high wage rates proposed. Individual employers and associations provided similar reports. The following comment from one sheep herding employer, F.I.M. Corporation, is illustrative:
For the period 2006 to 2013 our gross income from sales of wool, lambs, sheep, and hay averaged about $1,100,000 per year. After our operating expenses our net income averaged about 2.5% to 3% of gross or approximately $35,000 per year. This proposed tripling of sheepherder wages will require approximately $250,000 per year in additional wage payments . . . . That much money is simply not available so the Dept of Labor will force FIM Corp and most other sheep producers that employ sheepherders to send the sheepherders home and sell the sheep.
The Texas Sheep and Goat Raisers Association provided estimates based upon the Idaho enterprise sheep budget
Multiple commenters, including Mountain Plains and Western Range, stated that because American wool and lamb represent a small fraction of the world market (less than one percent of wool and meat production worldwide, according to an analysis from Dr. Stephen Bronars submitted with the Mountain Plains and Western Range comment), producers are unable to pass increased labor costs on to consumers. In addition, the Bronars analysis similarly provided that range cattle account for only eight percent of world beef production.
Vermillion and Midland provided an economic analysis of the impact of the
In addition, in opposing the wage increase, the American Farm Bureau Federation (American Farm Bureau) submitted an analysis of the effect of the proposed wage rates based on historic price data from 2000-2014. That comment stated that prices for wool and lamb over the past five years ($1.70/lb for lamb and $1.45/lb for wool) are significantly higher (63 percent for lamb and 113 percent for wool) than averages over the 10 preceding years ($1.04/lb for lamb and $.68/lb for wool). Although the comment acknowledged that a wage increase of the size set out in the proposal was “manageable” at current prices, it provided alternate scenarios to evaluate the ability to absorb the wage increase given average prices for the 2000-2014 period, as well as the lowest prices for the 15-year period ($.80/lb for lamb and $.53/lb for wool). At the 15-year average prices, the comment projected significantly reduced profits in all States if the FLS-based AEWR was paid as compared to the profits that would be achieved with current wage rates; at the lowest prices for this period, the comment forecasted a loss in all States if the full rate proposed in the NPRM was paid compared to a slim profit with current wage rates. Further, the Utah Governor's Office submitted a comment asserting that because prices per lamb have increased from $67.94 in 1994 to $157.15 in 2014 (an inflation-adjusted increase of $48.61 according to the comment) based on analysis from the Iowa State University Extension and Outreach Program, the wage increase proposed could not be absorbed by employers.
Commenters opposing the use of the FLS-based AEWR used varying economic data and budget sources in attempting to demonstrate that the wage increase would force ranches to close and the industry to contract significantly. Overall, DOL received comments reflecting significant variation in estimates of wage costs through the American Farm Bureau, the Wyoming and Idaho budgets provided by commenters, and the estimates of individual commenters. Some provided analysis of wage costs compared with overall revenue to show the impact. Others used “labor costs,” for purposes of comparison, which may include other expenses such as housing or food, making any analysis of the impact of the wage increase necessarily imprecise. Further, while it also opposed the wage increase, the American Farm Bureau comment provided less dire predictions than other commenters or the Wyoming and Idaho analyses.
In addition to economic objections, many of these employers and associations further objected to the wage increase based on their view that the limited number of U.S. workers in these occupations foreclosed the need to provide for any adverse effect. According to Western Range, in 2012 twenty-two U.S. workers applied for 1,000 openings. Western Range stated that only two U.S. workers were “qualified” and were hired, and neither completed the job contract. Mountain Plains stated that in more than 1,000 openings in 2014, only two qualified U.S. workers applied. According to Mountain Plains, one U.S. worker was not interested in the job and the other was hired but quit before completing his contract.
Further, Mountain Plains and Western Range commented that, based on their experiences, higher wages in California have not resulted in increased numbers of U.S. workers applying for jobs in these occupations. According to these associations, since 2011, Mountain Plains has received 18 applications for approximately 400 sheepherder or goat/sheepherder positions in California. No similar data was provided for Western Range. The comment stated that of those 18 prospective workers, 10 were not qualified for the work and the remaining eight withdrew their applications because they were not interested in the job. According to these commenters, in their experience, there are actually fewer applicants in California and fewer U.S. workers who take the jobs advertised there as compared to states like Wyoming or Colorado.
Many employers and associations expressed the view that U.S. workers are unwilling to perform this work due to the remote nature of the work rather than because of low wages, and some expressed disappointment with what they view as the unreliability of the few qualified U.S. workers who apply, stating that they often do not complete the work contract. Other commenters, such as the Utah Farm Bureau Federation, misunderstood the data in the proposal, and stated that the Department “concedes” that there are only 18 U.S. workers in range herding occupations because 18 U.S. workers were included in the 2014 SWA sheep herding surveys and worked in States with a statistically reportable wage. On the other hand, one SWA employee expressed the view that “[q]ualified job seekers often give low wages as one of the reasons they do not apply for these jobs, even though housing and meals are also provided. The number of U.S. job applicants has decreased over the past few years. Increased wages could help to encourage more worker interest in the jobs.” In addition, several employers noted that they have hired U.S. workers, with varying degrees of success. Further, one herding employer admitted that it could not attract U.S. workers because “Americans don't like the conditions or low pay.”
Finally, some commenters also objected to the FLS-based AEWR based on their view that it was inappropriate as a wage source for these occupations.
We received only a few comments in support of the wage proposal in the NPRM, and most of the supportive comments were from individual commenters, including a former SWA employee responsible for surveys from the 1980s until 2005. We also received comments generally supporting the wage proposal from groups such as Public Citizen, a public interest group, and Western Watersheds Project, a project that works to protect and conserve the public lands of the American West. Most group comments, including the comment from Public Citizen, were undetailed and expressed only general support. These commenters asserted that the wage methodology was appropriate and necessary to protect against adverse effect on U.S. workers. Similarly, while he did not comment on the NPRM, Edward Tuddenham, an attorney representing workers, submitted a comment before publication that is part of the administrative record. That comment recommended either that workers be paid for a set estimate of hours multiplied by the FLS-based AEWR rate for time on the range and at the FLS-based AEWR for each hour spent in non-range work, or be paid the FLS-based AEWR for all hours actually worked regardless of location.
The Worker Advocates' Joint Comment was by far the most detailed comment supporting the use of the FLS-based AEWR to set the monthly rate. That comment characterized using the FLS-based AEWR to set the monthly rate as a “practical and commonsense approach.” However, this comment expressed the view that DOL's use of a transition to the FLS-based AEWR in the proposed rule was misguided, and that requiring anything less than immediate implementation would have an adverse effect on U.S. workers performing work as ranch hands, who, like workers covered by this rule, may also perform work that is closely and directly related to the production of livestock.
This comment provided an analysis of purported data flaws in the SWA survey methodology and asked that DOL take into account the “immense losses” from prior SWA survey use to immediately implement the FLS-based AEWR as the base wage source. The comment attributed wage stagnation to DOL's “outdated” methodology and to DOL's settlement of various employer lawsuits over past wage increases, which in the commenters' view has been “strongly pro-employer to the detriment of workers in this area and justifies immediate ameliorative action.”
In support of the view that the FLS-based AEWR should be immediately effective, the Worker Advocates' Joint Comment pointed to several examples of jobs that, in their view, demonstrated that the ranching industry already supports workers earning the full FLS-based AEWR who perform similar work, particularly citing “Sheep, Farmworker General” in Wyoming, “Closed Range Herders” in Texas, and ranch hands performing livestock as well as other tasks. They further cited wage rates paid by employers “in states without large herder populations,” such as for Maine sheep farmers and sheep farm workers in North Dakota (both paid on an hourly basis). Further, they noted that California has a wage rate significantly higher than the current TEGL wages in other States. Finally, the commenters conclude “the sustained scarcity” of U.S. workers in these occupations:
Several of these commenters asked DOL to require payment for all hours worked, or at least for all hours worked when not on the range.
After reviewing all of the comments, we conclude that using the FLS-based AEWR to set the monthly wage for these occupations, which would triple the wage costs of many employers, is likely to result in adverse effect on U.S. workers by causing a substantial number of herding employers to close or significantly downsize their operations—leaving fewer herding jobs available to U.S. workers. Accordingly, we select a different wage source in this Final Rule, as discussed in greater detail below.
In reaching this conclusion, we do not base our analysis on a single comment or set of comments, but on the record as a whole, including data from budget documents submitted, reports from individual employers and associations, and historic pricing data. We recognize limitations on the data provided by employers, their associations, and their other supporters. For example, in some instances, employers used “labor costs” to attempt to demonstrate the impact of a wage increase, although labor costs may include more than just wages. In addition, enterprise budgets, which we examined carefully, typically include a line item for payment to the owner/operator, so that even with reduced or eliminated profits, there is still some payment to the owner. In addition, we cannot assume, as some commenters have done, that all labor in the enterprise budgets is paid at the TEGL wage levels. This is particularly true given that some H-2A employers noted in comments that they pay workers more than the current TEGL wages. We further recognize that only sparse data was provided on the impact of the proposed increase for cattle employers, which comprise a small subset of H-2A herding employers. However, despite these limitations, based on the size of the proposed increase and the data provided, the record provides a reasonable basis to conclude that the proposed wage increase is too great to be borne by the industry, and thus will result in adverse effect on U.S. workers
As discussed further below, this Final Rule imposes a significant wage increase on the industry as compared to the current, stagnated wages required under the TEGLs, albeit of a magnitude lower than the wage originally proposed. However, for several reasons we disagree with worker advocates' comments that setting the wage based on anything other than the Farm Labor Survey is inconsistent with DOL's obligation to protect against adverse effect. First, although we acknowledge that wages under the SWA survey methodology have been stagnant for some time, we are concerned, based on the comments received, that the three-fold wage increase in the proposal would, if implemented, likely result in a significant number of employers choosing to down-size or close their herding operations, resulting in adverse impact on U.S. workers.
We further decline to require payment of the FLS-based AEWR for all hours herders work while at the ranch. We note that this decision is consistent with the FLSA exemption, which permits the exemption to be taken for the entire year provided that the worker is “principally engaged in the range production of livestock.” 29 U.S.C. 213(a)(6)(E). Given the limitation on duties that may be performed by range workers when they are working at the ranch as discussed in Sec. IVA.2., we conclude that this is not likely to have an adverse effect on U.S. workers at the ranch because ranch hands can perform a much broader array of work duties. This is particularly true given that range sheep and goat herders have traditionally been granted certifications for a 364-day period to tend the herd throughout the production cycle, including times at the range and on the ranch. This practice is continued in this Final Rule, which specifically provides that it applies only to workers who spend more than 50 percent of the job order period working on the range, further distinguishing these workers from general ranch hands.
Finally, we decline to adopt Siddoway Sheep's suggestion that DOL conduct a comparison of the wage rate from the FLS with the TEGL wage from a point “when adequate information regarding sheepherders was available” and set the current wage based on that differential. In the absence of underlying records from historic SWA surveys, which are unavailable, we cannot pinpoint the year when adequate information may have been available. However, we reiterate that the TEGL wages have suffered significant stagnation when compared to the FLS-based AEWR for more than 20 years.
We are mindful of our statutory obligation to protect against adverse effect to U.S. workers, even in cases where the number of U.S. workers may be small. As a result, we are not persuaded by employer comments suggesting that U.S. workers will not be qualified or available for this work, regardless of the wage required.
The experience cited by Mountain Plains and Western Range in California (and by employers and others in other States)—that few U.S. workers are available for these jobs—does not undermine this basic economic theory for a number of reasons. First, we note that the Worker Advocates' Joint Comment indicated that some employers are using experience requirements as a basis to require references on letterhead of a previous employer. Such a requirement would be difficult for U.S. workers in many occupations, and this is even more true of U.S. workers seeking work in herding occupations.
Further, that the TEGL wages are higher than those H-2A workers could receive in their home countries should not have any bearing on the wage set by DOL. This will ordinarily be the case with foreign temporary workers. This fact supports, rather than refutes, DOL's obligation to require that wages are set at a rate that will not undercut the wages of U.S. workers, who have different economic incentives than foreign workers and must support themselves in this country, not abroad.
Finally, we have considered the commenters' anecdotal concerns about the unreliability of the domestic workforce. However, even if those concerns had been supported by more substantial evidence, the potential costs that may be incurred as a result of U.S. workers leaving before the end of the job order period are outweighed by the benefit to U.S. workers, and by our statutory responsibility to provide that U.S. workers continue to have access to these jobs.
Where specific wage proposals were made by those opposed to using the FLS-based AEWR as part of the formula to set the base wage, these commenters generally either recommended that DOL not set any wage minimum for these occupations, that DOL continue to use the TEGL methodology, or that DOL adopt one of the two counter-proposals submitted jointly by the three primary employer associations (Mountain Plains, Western Range, and ASI), discussed further below. For example, several ranchers asserted that the federal government should have no role in setting wages for these occupations, but instead wages should be based on the agreement between the worker and employer based on the “market.” Although some comments opposed any increase to current wage rates, many, including ASI and a number of individual employers, acknowledged that it was important for DOL to adopt a methodology to address wage stagnation in these industries.
Mountain Plains and Western Range recommended that DOL either set the monthly AEWR for these occupations based on an inflation-adjusted value from the 1994 sheep TEGL wages cited in the NPRM or based on the current FLSA minimum wage multiplied by a set estimate of hours, recommendations that were endorsed by ASI and a number of individual employers. This comment selected $800/month as the appropriate wage to index, stating that it was the highest wage in the 1994 survey.
For this approach, the associations recommended adjusting the 1994 TEGL wages using a capped version of the Bureau of Labor Statistics' Employment Cost Index for wages and salaries (ECI), with a three year transition followed by full implementation in year four.
As further support for this approach, the associations noted that the wage rate in 2019 under this recommendation, which would be above $1,350 per month, would be consistent with the wage that one of the
The second alternative recommended by these associations, which was also endorsed by ASI and many individual employers, was to use the Federal minimum wage, multiplied by the estimate in the NPRM of 44 hours per week, to establish a monthly required wage. This alternative was also presented with a three-year transition period, with full implementation in year four. As with its first recommendation, if a higher State wage was required, it would apply. This comment states:
If DOL is determined to transition away from a survey-based monthly salary in favor of a monthly salary using the 44-hour week estimate and a base wage rate, Commenters submit that the Federal Minimum Wage of $7.25/hour is a more reasonable starting point than the Farm Labor Survey based AEWRs. . . . Since many of these herds and workers travel across state lines, because food, housing, and clothing are already provided for free, and in order to create a more uniform process, Commenters would propose this single monthly rate in all states, except to the extent that the California or Oregon state statutes or judicial settlements require a higher rate already. While this will place a greater burden on employers in some states more than others, the FLSA wage rate applies uniformly across the nation and serves as a model for this proposal.
As with their first recommendation, the associations cited an affidavit from the
In addition to these two primary recommendations, two commenters suggested that DOL use the California herder wage to set wages in the program. An electric fencing supplier for commercial sheep ranches expressed the view that California's wage “leads the trend” in wages and asked DOL to use California's wage for all employers. The Chairman of ASI's Legislative Action Council similarly stated that Oregon and California wages provided useful “reference” points. The Worker Advocates' Joint Comment similarly used the California wage as evidence that herding employers could remain viable while paying a wage significantly above those currently required under the TEGLs.
Other commenters viewed the California wage rate less favorably. Without offering evidence in support, one individual employer stated that the higher California wage rate had been “detrimental” to the herding industry. Western Range and Mountain Plains asserted, again without evidence to support the assertion, that the California wage rate had forced employers to reduce the size of their businesses, hire fewer U.S. and foreign workers, and ask remaining workers to take on additional duties. These associations stated that proposed wage rates in the NPRM would be even more problematic because workers would be required to be paid significantly more but permitted to perform fewer duties.
We also received several alternate recommendations from individual commenters, which were not supported by other comments. One sheep herding employer stated its operation could afford a wage rate of up to $2,500/month, although no methodology or data was provided in support of the $2,500 figure. Based on the employer's belief that U.S. workers will not apply for herder jobs, another employer recommended that DOL set a higher wage rate for domestic workers as compared to foreign workers, stating that this “would address the Secretary's statutory responsibility to consider the domestic workers without challenging the viability of the businesses offering employment.” Finally, a documentary filmmaker recommended that DOL compare the wage rates in States where large numbers of foreign workers abandon H-2A work with wage rates in States with lower levels of abandonment to determine the appropriate wage.
As discussed above, DOL received a number of comments asking DOL to retain the current TEGL methodology for setting wages or to let the market establish wage rates for these occupations. Neither of these recommendations is viable or consistent with the Department's statutory obligation to protect against adverse effect on U.S. workers. As explained in detail above and in the NPRM, SWA surveys no longer provide sufficient information to permit DOL to use their results to set the AEWR for these occupations, and the persistent lack of wage results has led to wage stagnation that may result in adverse effect to U.S. workers. Nor can the “market” set wages for these workers. The requirement that DOL protect against adverse effect is based on Congressional recognition that bringing in foreign labor has the potential to distort the market for these occupations, and a negotiation between a foreign worker with little bargaining power and a U.S. employer would invariably lead to a wage below what a U.S. worker would accept. For similar reasons, we will not base the wage rate in this Final Rule on whether wages are so low that even foreign workers abandon employment, because such a rate would still be substantially below that which a U.S. worker could be expected to accept. Further, we decline to adopt a two-tiered system by which U.S. workers must be offered a higher wage rate than that offered to foreign workers. To do so would disincentive the hiring of U.S. workers, and would institutionalize a second tier of foreign workers willing to accept wages below that required for U.S. workers, thus creating the adverse effect on U.S. workers we must avoid.
Further, the three primary employer associations have proposed setting the wage based on a methodology that will result in wages significantly above the current TEGL rates. The employer
For several reasons, we decline to adopt the associations' first recommendation to index the 1994 TEGL data. First, this recommendation was based on a mischaracterization of the 1994 TEGL data as the “last year for which such surveys were conducted with statistically valid results.” The NPRM cited the 1994 TEGL data not because it was the last year that the SWA survey produced statistically valid results, but rather because it was the earliest year for which there was documented wage data when we published the NPRM.
In addition, we decline to adopt the alternate recommendations to use the California wage rate to set the national AEWR. We agree, despite differing opinions of some commenters, that the California and Oregon wage rates provide evidence that employers can afford a significantly higher wage rate for these occupations than is currently paid, and can do so without job losses. Despite Mountain Plains and Western Range's assertion that the salary paid by California has led employers to reduce the number of U.S. and H-2A workers employed, this assertion not supported by any evidence. Labor certification data from 2013 and 2014 shows that California remains the second largest user of the herding special procedures. In any event, the California sheep herder wage rate is set through State law, Cal. Labor Code 2695.2(a)(2), and undoubtedly reflects local considerations that may not be appropriately applied across the other States where employing sheep, goat, and cattle herders typically are employed, which generally have lower wage rates than California.
Instead, in view of the necessity to exercise our discretion in setting the wage rate, we view using the current Federal minimum wage rate of $7.25 per hour (which will be adjusted annually based on the ECI), multiplied by an 48 hours per week, to be a more reasonable basis on which to set the AEWR for several reasons.
We are borrowing the current federal minimum wage rate for these occupations as the starting point for part of the new wage methodology, which will be indexed, as discussed below, and we do so with full recognition that workers “principally engaged in the range production of livestock” are not required to be paid the Federal minimum wage under 29 U.S.C. 213(a)(6)(E). We note that, in recommending use of the Federal minimum wage as the starting point for these calculations, the three primary employer associations and many individual commenters have accepted the use of this wage rate as appropriate for calculating the wage rate for these occupations. Further, it is clear from the legislative history that the exemption from the Federal minimum wage for these occupations is based not upon the wage rate itself, but rather on the remoteness of these occupations and the difficulty of tracking hours worked.
Therefore, using the $7.25 per hour rate, multiplied by an approximation of hours to set a monthly salary, is consistent with the exemption or its purposes because it is not an hourly wage that requires hourly recordkeeping. This approach is also consistent with the way Oregon has interpreted its own State laws for these occupations, which requires the State minimum wage to be multiplied by a set number of hours (the equivalent of approximately 40 hours per week) to establish the herder's minimum required salary. Or. Rev. Stat.
In order to prevent wage stagnation from again occurring, we have determined that the new base wage rate should be subject to an adjustment methodology. We agree with those commenters who recommended that we use the ECI for wages and salaries to address the potential for future wage stagnation. Our primary concern in setting the adjustment methodology for these occupations is to confirm that the wages for these occupations will continue to rise apace with wages across the U.S. economy. Although the Department has previously used the Consumer Price Index for All Urban Consumers (CPI-U) in other circumstances where adjustment for inflation is warranted, we conclude that it is reasonable to use the ECI for these occupations, given that housing and food must be provided by the employer under this Final Rule, making the cost of consumer goods less relevant than under circumstances in which workers are paying these costs themselves.
However, we decline to adopt the minimum and maximum ECI calculations provided by Western Range and Mountain Plains, which did not provide any economic rationale for the imposition of a cap, and we will instead use the uncapped ECI to adjust wages, beginning with the rate for calendar year 2017. The 1.5 percent minimum adjustment recommended by the employer associations is illusory, because the ECI has very rarely fallen below 1.5 percent since it was first used in 1981. On the other hand, the ECI has often been above 2.5 percent. Accordingly, the methodology recommended by the employer associations would typically be relevant only in circumstances where the ECI exceeds 2.5 percent. Placing a cap on the ECI-based adjustment has the potential to produce wage stagnation; thus, to protect against adverse effect to U.S. workers, we will not use a capped ECI to adjust wages because herders' wages should not be outpaced by changes to the wages of workers across the U.S. economy in order to avoid adverse effect for U.S. workers.
In order to set the monthly salary, the NPRM proposed a wage based on the estimate that herders work approximately 44 hours per week. This estimate was an average of the 40-hour-per-week estimate suggested by ASI, Western Range, and Mountain Plains, and the 48-hour-per-week calculation submitted by Edward Tuddenham, an attorney representing workers, both of which were submitted before publication of the NPRM. The 40-hour calculation submitted by the employer associations was based on the calculation in the
Employers essentially agreed to the 44-hour estimate from the proposal. Although the pre-NPRM submission from Mountain Plains, Western Range, and ASI used a 40-hour calculation, Western Range and Mountain Plains used DOL's compromise 44-hour calculation in their comment submitted in response to the NPRM, and that proposal was endorsed by ASI and many commenters. We received no other concrete estimate of hours from employers or their representatives, nor did these commenters suggest an alternative data source for an estimation of herders' work hours. Employers generally stated that the exact number of hours varied based on a number of factors, such as seasons and weather. Where they did provide estimates of hours, they were imprecise (for example, stating that herders generally work 4-6 hours per day).
On the other hand, the Worker Advocates' Joint Comment objected to the 44-hour calculation from the proposal. While acknowledging that “a monthly AEWR based on average hourly totals will never be completely accurate,” this comment pointed out that the 40-hour calculation from the
Employers have been exempt from FLSA and H-2A recordkeeping requirements, so we agree with the Worker Advocates' Joint Comment that any estimate of hours worked will necessarily be imprecise. We further agree with the worker advocates that we should not base the hourly projection in any part (as we did in the NPRM) on the 40-hour estimate from the
We concur with the assessment from Edward Tuddenham that the 48-hour estimate from ETA's own data is based on the most comprehensive and detailed data source from which to establish an hourly calculation. Accordingly, we will use that 48-hour calculation, which was also replicated in the submission by the Worker Advocates' Joint Comment, to set the number of hours for the monthly salary formula. Given the challenges with collecting data for these occupations, we conclude that it would be very difficult and resource-intensive for DOL to collect from sources outside ETA data on hours worked. Further, the Colorado study on herder wages, hours and working conditions submitted by worker advocates is informative, but very limited because it is data from a single State and thus not representative of the industry as a whole. Finally, we disagree that employers are likely to under-report hours on the Form ETA-9142A to make the job appear more attractive because employers already advertise in their job orders that herders must be available up to 24 hours per day, 7 days per week.
We recognize that this 48-hour estimate will result in a higher wage than the industry-consensus proposal. However, we conclude that requiring payment for four hours a week in excess of the calculation proposed by the primary employer associations, and supported by many employers, is unlikely to have a substantial effect on the ability of employers to absorb the wage increase required by this Final Rule. Moreover, we conclude that, because it more accurately reflects the likely actual hours worked, it also more accurately reflects the wage that will prevent adverse effects on U.S. workers. Indeed, it would be inconsistent with DOL's obligation to protect against adverse effect to allow employers to pay for fewer hours than is indicated on their own Form ETA-9142A.
In the NPRM, we invited comment on the issue of whether employers should be permitted to deduct some food costs from the required wage rate “in light of the proposed increase in wages,” and, if a food deduction was to be permitted, the appropriate amount of the deduction. 80 FR at 20305. Under the standard H-2A program regulations, employers are permitted to deduct the actual cost of meals up to a rate set each year (which is annually adjusted based on the CPI-U) to offset costs for providing the worker with three meals, unless a higher amount is authorized by the Certifying Officer. 20 CFR 655.173. The maximum standard deduction is currently $11.86 per day ($355.80 for a 30-day month).
Under both of the primary wage recommendations from Mountain Plains and Western Range, employers would be responsible for paying for food, which is consistent with the NPRM, the existing sheep and goat herding TEGL, and the current cattle wage rates. But while neither of these recommendations proposed a food deduction, Mountain Plains and Western Range “encourage[d] the Department to consider permitting one, or at least permitting a deduction reflecting the difference between the more extensive and more expensive food provided to these workers compared to the subsistence and meal charges that the Department uses for other workers.” These commenters stated that both the California State wage and the
In addition, Mountain Plains and Western Range asked DOL to consider the pre-NPRM letter from these associations (and also from ASI) in addition to the two new proposals in its comment. That pre-NPRM letter, included in the administrative record, asked DOL to set the wage rate at the FLSA minimum wage multiplied by 40 hours with a deduction for food based on the USDA “liberal” meal plan for a male, aged 19-50 years, which they stated would “best reflect the protein-rich diet appropriate for active young to middle-aged men working outdoors in high-altitude environments.”
Other employers and associations supported some type of food deduction. For example, the comment from Siddoway Sheep suggested three alternatives for food deductions: (1) Deducting the cost of purchasing food on each employee's grocery list from that employee's wages, (2) a standard ranch-specific deduction based on annualized actual expenditures from the prior three year period,
Vermillion and Midland stated that a food deduction should be permitted for several reasons. The employers cited two legal “precedents” for its position that a food deduction should be allowed, an administrative case
On the other hand, several individual employers opposed a food deduction. For example, one noted that payment of food by the employer is a “longstanding practice of the industry.” Another stated that it would be difficult to calculate the cost of food provided to an individual worker when food is delivered to a sheep camp containing multiple workers. Similarly, the Worker Advocates' Joint Comment stated that food deductions should be permitted only if employers paid the full FLS-based AEWR required by the proposal at the end of the transition period, reasoning that once the wages of these workers were aligned with the wages in the rest of the H-2A program, the workers could afford their own food. This comment recommended that the deduction be limited to the ordinary H-2A wage deduction. The Western Watersheds Project opposed any food deductions.
This Final Rule maintains the current practice under the TEGLs for these industries, and does not permit employers to deduct the cost of food from workers' wages. The decision to use the $7.25 per hour rather than the full FLS-based AEWR, we think it is reasonable to disallow deduction from wages for the costs of providing food to these workers. This is particularly true given that sheep and goat herding employers have continually been required under the TEGLs to provide food without cost to the workers, and cattle herding employers have been required to pay these costs due to the wage finding in the SWA survey since 2013. In addition, as the pre-NPRM comment from ASI, Western Range, and Mountain Plains demonstrates, in adopting a lower base wage rate than the FLS-based AEWR, a food deduction would prevent DOL from fully addressing the wage stagnation in these occupations. Allowing a food deduction would offset a substantial amount of the benefit to the workers of the increase in the wage rate and result in setting effective wages not significantly above the rates required two decades ago.
The legal precedents cited by commenters do not suggest a different result. The administrative case cited by Vermillion and Midland only states that those employers providing meals without charge should be separately surveyed from those that do not, but takes no position on whether a food deduction should or should not be permitted. Further, Section 3(m) of the FLSA applies only where the FLSA applies. Although a few commenters stated that California law permits a food deduction from its sheep herder wage, this is incorrect. California Industrial Welfare Commission (IWC) Order No. 14-2001, Sec. 4(E), 10(F) (amended Jan., 1 2002) expressly bars employers of sheep herders from offsetting the required wage by meals or lodging and incorporates by reference the requirement under the H-2A special procedures for employers to pay for meals.
As discussed above, applying a food deduction would substantially erode the wage increases in this Final Rule after decades of wage stagnation, and is therefore inconsistent with DOL's statutory obligation under the INA. Finally, in response to comments, we clarify that the employer is only required to pay for sufficient and adequate food, and water, as discussed in Sections IV.B. and E. in the preamble related to §§ 655.210(e) and 655.235, and is not required to provide workers with other items, such as tobacco or soda, free of charge, although the employer is free to do so.
Given the size of the wage increase in the NPRM, we proposed a four-year transition with full implementation in year five. 80 FR at 20310. Under the proposal, wages would have been set at 60 percent of the full wage rate in year one, 70 percent in year two, 80 percent in year three, and 90 percent in year four. In proposing this approach in the NPRM, we reasoned that a transition period was needed in order to avoid the unintended consequence of significant job losses that could be prevented by a gradual implementation.
Both the primary Mountain Plains and Western Range recommendations supported a transition, mirroring DOL's concerns in the NPRM about significant job losses if the wage increase were implemented immediately. For each proposal, Mountain Plains and Western Range recommended a three-year transition, with full implementation in year four. For their proposal to use an indexed TEGL wage rate, they proposed to start at 80 percent of the fully adjusted wage; for their proposal to use the FLSA minimum wage, they proposed to start at 75 percent of the adjusted wage. The comment did not provide for any inflation adjustments to the FLSA-based wage until after full implementation, and did not explain the basis of that recommendation. Several individual employers and associations, including the Colorado Wool Growers Association, asked for a longer transition period than proposed if the FLS-based AEWR was used to establish the monthly rate.
Conversely, the Worker Advocates' Joint Comment stated that a transition to a new wage could not be squared with DOL's statutory obligation to protect against adverse effect. This comment asserted that no transition of new wage rates was appropriate given the long history of wage stagnation, which, as discussed above, they attributed to DOL's policy of using SWA survey results and implementation of those results. As discussed above, they cited wage rates for several occupations that do not primarily involve range work, were below the FLS-based AEWR, or were based on sample sizes too small for the SWA to report a wage. They also cited the current California sheep herder wage rate for the proposition that employers could immediately adjust to the full FLS-based AEWR. This comment stated that a transition would cause adverse effect to U.S. workers employed as ranch hands by permitting a much lower wage to be paid for similar work. It further asserted that DOL provided no “empirical support” for the need for a transition in the NPRM, and asked DOL to consider the scope of previous wage stagnation from the SWA surveys as the basis to reject any transition period, or at least in deciding what percentage level to set the wage during a transition period. Several other comments from the Western Watersheds Projects and a few individual commenters stated, without additional elaboration, that the proposed wage rates should apply immediately.
The wage increase under this Final Rule is less than under the proposal, but it remains significant; the final wage rate approximately doubles the current required wage rate for sheep herders in a number of States. For the reasons discussed above, consistent with our decision to use an alternative to the FLS-based AEWR to set the monthly AEWR, we conclude that the data submitted in the Worker Advocates' Joint Comment does not require immediate implementation of the new wage. Although the California wage
In light of the scope of the increase and the economic data provided by commenters, we conclude that a limited transition period to the new wage is necessary. However, we recognize that any transition must not be longer than necessary to prevent adverse effect. As a result, this Final Rule requires a two-year transition (rather than the four years proposed, or the three years recommended by Mountain Plains and Western Range) with full implementation in year three. A transition is particularly needed given that the new wage rate must be paid by all employers one month after publication of the Final Rule, even if the employer is operating under a current certification, as provided in the discussion above related to paragraph 655.211(a). In addition, consistent with the consensus proposal submitted by Mountain Plains and Western Range, we will require the wages to be set at higher percentage levels during the transition years than those proposed, with 80 percent of the full wage rate required in year one and 90 percent in year two. This methodology requires employers to pay more than half of the required increase in in the first year of implementation.
The Western Range and Mountain Plains proposal did not apply any inflation adjustment until after the transition period in their proposal. We conclude that this is inconsistent with DOL's obligation to protect against adverse effect, because it would result in wage rates in future years being lower than if no transition had been applied. Accordingly, after setting the wage rate in year one, we will begin to apply the ECI adjustment in year two so that wages in future years will not be reduced by DOL's decision to apply a transition period.
The TEGLs provide a variance from the geographic scope limitations applicable to
The Department did not receive any comments directly addressing the proposal related to geographic scope limitations for job orders and applications. However, we continue to recognize the transient nature of range herding and livestock production work, as was apparent in other comments received and has been long recognized by the Department. Accordingly, we have adopted this provision in the Final Rule without change.
For master applications, the TEGL covering sheep and goat herding range workers, but not the TEGL for range livestock production workers, allows an association filing as a joint-employer with its members to submit annually a single Form ETA-790 for a master job order directly with the NPC that identifies all included employer-members, dates of work, and work locations and will remain open year-round, unless modifications are required. The employer-members included in the sheep or goat herding master job order are not required to have the same date of need, which is a variance from the date of need requirement in the standard H-2A regulations, at 20 CFR 655.131(b). Because the TEGL covering range workers engaged in livestock production does not include this variance, an agricultural association filing a master application seeking range livestock production workers must submit a new Form ETA-790 to the appropriate SWA in advance of filing each
The Department did not receive comments addressing the filing procedures in proposed § 655.215, and we adopt the provision largely as proposed. Specifically, the Final Rule adopts without change the proposed provisions identifying the forms and documents range employers must submit to the NPC and allowing employer-members with different dates of need to be included in a single master application, regardless of whether the job order and application involves range sheep or goat herding or other range livestock production. The Final Rule also adopts without change the provision allowing annual submission of Form ETA-790 for master application job orders for range sheep and goat herding occupations, unless the job order requires modification. We conclude that these filing procedures
As we have stated above, this section of the Final Rule contains the only variances the Department is making from the general H-2A filing procedures for eligible employers seeking workers in range herding and production of livestock occupations. Unless specifically addressed in these provisions, employers must comply with the processing procedures in the standard H-2A regulations, at 20 CFR 655.130-655.132.
The range livestock production TEGL does not address the period of need an employer must identify on its
The NPRM proposed continuing the TEGLs' distinction between sheep and goat herder employers' period of need and the period of need allowed for the range production of livestock. Thus, the NPRM proposed allowing employers of range sheep and goat herders to identify a period of need of up to 364 days on the
The NPRM sought comment specifically on the issue of the temporary and seasonal nature of herder work, including the amount of time spent on the open range during a year. 80 FR at 20311. We asked about whether the unique characteristics of herding work exist year-round.
Many comments by employers of sheep and goat herders indicate that they use the 364-day maximum period of need permitted under current practice. Several employer comments indicate that they re-employ the same H-2A workers over the years. Mountain Plains and Western Range urged the retention of the 364-day limit on sheep and goat herding, and suggested the extension of the cattle herding limit from 10 to 12 months, because “[a]ll of these animals require year-round care[.]” However, this comment was somewhat vague about any particular seasonal demands of the work:
The general response [to the NPRM questions about the seasonal nature of the work] is that the work is performed on an “as the need arises” basis, and there is no single description of a worker's typical day. The work is defined first and foremost by the needs of the animals in the herder's care. During lambing, kidding, and calving season, the days are longer and the work is focused on the healthy birthing of new animals. Those duties occur at certain times of the year according to the natural cycles of the seasons and the animals. In parts of the West, employers use fixed structures (known as “sheds”) to keep livestock and their offspring safe and healthy during the birthing process. Other ranches perform birthing in open-air pastures. The amount of time spent assisting with this phase depends on the natural conditions of the male and female livestock.
The associations explain that the work is not only performed on an “`as needed” basis, but it is also highly dependent on the weather conditions.
The Worker Advocates' Joint Comment included a brief statement supporting separate certifications for the range production of sheep and goats over the 364-day period of need:
We applaud DOL for requesting comments on whether more than one H-2A labor certification period should be necessary for workers who tend sheep and herd goats. The best way to protect the wages and working conditions of U.S. workers is to have two separate certification periods, one for the birthing period in the spring, which takes place on the ranch, and one for the open range season which lasts from summer through winter. Because the spring birthing period involves no open range tasks, jobs during this season should fall under the normal H-2A regulations, not the proposed special regulations for open range herders.
One of the most informative comments on the nature of herder work and its seasonality was from Siddoway Sheep Company. This comment clearly delineated the seasonal aspects of herder work, at least with respect to this particular ranch. In the winter, the work on the ranch is devoted to lambing (some ranches conduct lambing operations later in the spring, sometimes on the open range, and others conduct it in sheds on or by the base ranch). The Siddoway Ranch conducts lambing in sheds. In January, herders bring the flock closer to the base ranch, and as the herders move down from the winter range, they move into the bunkhouse. Lambing begins in mid-February. Workers are engaged in lambing activities at the base ranch for eight to ten weeks. During the next season—spring grazing—herders move into mobile housing, also called a “sheep camp.” During the spring grazing season, herders move the sheep away from the base ranch toward the summer range, and this period lasts for eight to ten weeks. By the first day of summer, the herders begin to move the sheep to the high mountain meadows for summer grazing. During summer grazing, herders move from the “sheep camps” into outfitter tents. By mid-September, herders begin to move the sheep down from the mountains for fall grazing, and to separate the market sheep from the rest of the herd. The herders move back into the sheep camps. The sheep are bred in October, during the fall grazing period. Once the
We have decided to retain the limitations on period of need contained in the TEGLs and proposed in the NPRM. As a result, § 655.215(b)(2) requires that the period of need for the range production of cattle must be no more than ten months, which is consistent generally with the standard H-2A maximum period of need, and the period of need for range production of sheep and goats must be no longer than 364 days.
We make this decision after considering several factors. First, Section 101(a)(15)(H)(ii)(a) of the INA permits aliens to obtain H-2A visas to come “temporarily to the United States to perform agricultural labor or services . . . of a temporary or seasonal nature.” 8 U.S.C. 1101(a)(15)(H)(ii)(a). Section 101 does not define “temporary” work for purposes of H-2A visas, nor does it indicate how long a position may last and still qualify as “temporary” work. The legislative history of the INA is silent about the expected duration of “temporary” work. Under current regulations issued by the U.S. Citizenship and Immigration Services (USCIS), a component of the Department of Homeland Security (DHS), in order to obtain an H-2A visa, an employer must establish that employment is either seasonal or temporary, which, except in extraordinary circumstances, should last no longer than one year. 8 CFR 214.2(h)(5)(iv)(a). DOL's H-2A regulation on this point is consistent with the DHS regulation. 20 CFR 655.103(d). Therefore, neither the statute nor the agencies' regulations proscribe the 364-day period of need applicable to the range production of sheep and goats.
Second, we have relied for decades on the unique history and experience of sheep herding in the U.S. to support the 364-day period of need for sheep ranchers. This history was discussed in great detail in both the NPRM, 80 FR at 20301-20302, and the TEGL governing sheep and goat production, and we see no reason to rescind our reliance on this aspect of these jobs to shorten the period of need.
Finally, we have reviewed and considered all the comments on this subject, and it is clear that both the ranchers and the herders they employ are well accustomed to the longer period of need for range production of sheep and goats, and that shortening it would be disruptive to the livelihoods of employers and employees alike.
We received several comments on post-certification procedures that were beyond the scope of this rulemaking. First, Mountain Plains and Western Range requested clarification about the post-certification ability of an agricultural association filing a master application to transfer workers between employer-members as needed during the certified period. Similarly, Eph Jensen Livestock, LLC also commented on the value of an association's ability to transfer workers among employer-members on a master application job order. As the Mountain Plains and Western Range comment pointed out, the INA allows a master application certified under the H-2A program to be used for the job opportunities of any of the employer-members that were disclosed in the master job order, and hired workers may be transferred among the employer-members to perform the services for which the certification was granted. 8 U.S.C. 1188(d)(2). This statutory authority, which has not changed, applies to all master applications filed under the H-2A program, not only those for range sheep and goat herders. Although the range sheep and goat herding TEGL included discussion of this INA provision, and explained the Department's expectations where an agricultural association engages in worker transfers, the allowance is not a variance from standard rules. As it is not a variance applicable only to the applications eligible for filing under the herding and range livestock regulations, it is outside the scope of this rulemaking.
The Department also received comments from two employers, Maltsberger Ranch and Cherry Ranch, suggesting changes to H-2A visa duration and the Department's general processing timeline for H-2A applications. McPherrin Damboriena Sheep Co. also expressed the difficulty of aligning visas with actual employment dates. The Department considers these comments beyond the scope of the proposed rule, because they raise issues that cannot be resolved through this regulatory process, which addresses only H-2A range applications, and are therefore not within the scope of this rule.
The TEGLs do not provide variances from the processing procedures in the standard H-2A regulations at 20 CFR 655.140-655.145, except as necessary to accommodate the variances provided for master job orders for range sheep and goat herding occupations, which are submitted annually to the NPC and posted with the SWA year-round, unlike other job orders. Because the Department proposed in the NPRM to shift the timing and location of filing the Form ETA-790 for range occupation job orders from a pre-filing submission to the SWA to concurrent filing to the NPC, we also proposed variations to the standard processing procedures to the extent necessary to reflect the NPC's processing of Forms ETA-790 received with
In addition, the NPRM included a proposed provision intended to clarify how the electronic job registry requirement at 20 CFR 655.144(b) (
The Department did not receive comments addressing these proposed provisions, and we are adopting them unchanged in the Final Rule. These provisions establish a clear, consistent processing framework for applications and job orders for eligible range employers. This section of the Final Rule contains the only variances the Department is making from the general H-2A processing procedures for eligible employers seeking workers in range herding and production of livestock occupations. Unless specifically addressed in these provisions, employers must comply, as they do currently, with the processing procedures in 20 CFR 655.140-655.145.
The TEGL for range livestock production occupations provides no variances from the standard rule's post-acceptance procedures in the standard H-2A regulations, at 20 CFR 655.150-655.158. The TEGL for range sheep and goat herding occupations, however, provides a variance from the newspaper advertisement requirement in the standard H-2A regulations, at 20 CFR 655.151, and clarifies the Department's expectations for an agricultural association's handling of referrals and U.S. applicants responding to master job orders involving multiple employer-members.
In the NPRM, the Department proposed to expand almost all of the range sheep and goat herding TEGL's variances to encompass range livestock production occupations as well. The proposed rule waived the requirement for the placement of an advertisement on two separate days in a newspaper of general circulation as provided in the standard H-2A regulations, at 20 CFR 655.151. The NPRM also included a proposed provision intended to clarify that master application job orders for herding and range livestock employers would be handled in the same way OFLC handles other job orders approved for an association of agricultural employers filing a master application as a joint employer on behalf of its employer-members; the CO would direct the SWAs to keep the job order on its active file until 50 percent of the period of the work contract has elapsed for all employer-members identified on the approved job order. Moreover, the NPRM proposed to expand and codify an association's obligation to accommodate U.S. workers' worksite location preference to all master job orders for range occupations eligible for processing under this rule. Finally, the NPRM included a proposed provision intended to clarify that an association handling the recruitment requirements for its employer-members must maintain a recruitment report containing the information required by 20 CFR 655.156 in a manner that allows the Department to see the recruitment results for each employer-member identified on the H-2A application and approved job order.
We received several comments on these issues. Mountain Plains, Western Range and the SBA Office of Advocacy commented that employers engaged in range herding and livestock production cannot find qualified and available U.S. workers to fill their positions despite employers' efforts. ASI indicated that the labor demographics changed in the 1980s and 1990s, after which time the industry has not been able to find U.S. workers who were interested or had a background in herding. Western Range stated that in 2012 only 22 U.S. workers applied for approximately 1,000 sheepherder positions with its employer-members, and of those 22 applicants, only 2 were considered qualified and ultimately hired. However, Western Range reported that neither of the two U.S. workers hired completed the work contract period. Mountain Plains stated that, in 2014, its employer-members sought to hire workers for more than 1,000 range sheep and goat herding, range livestock production, sheep shearing, and wool grading positions. Of the two qualified U.S. workers who applied, one was not interested in the job and the other was hired but didn't complete the work contract. The Department also received a number of comments from other employers, professional associations, and private citizens generally noting the unavailability of U.S. workers. These comments noted that despite recruitment efforts, U.S. workers are not interested in range herding and production of livestock jobs, and that those who do express initial interest tend to not complete a season. One commenter indicated that U.S. workers are not willing to work more than 40 hours a week. A different commenter indicated that the shortage of both sheep shearers and shepherds is not just limited to the United States, but is worldwide. Another commenter indicated that the domestic labor force is drawn instead to higher paying job sectors, such as oil and gas, where jobs are prevalent in the West. Another employer noted low unemployment rates in her State, and indicated that her business hires interns through a trade association, the Navajo Nation, and from local colleges, but that these workers are available only on an ad hoc basis, and do not provide a stable and consistent labor force. In addition, a number of commenters generally urged the Department to maintain the status quo and keep the existing special procedures for these occupations without change, expressing satisfaction with the existing program variances.
The Department also received a comment from a SWA employee commenting as a private citizen, stating that employers should be required to engage in maximum recruitment efforts and affirmatively request a referral report from the SWA. The commenter also asked the Department to address the commenter's perceived employer preference for foreign workers, the experience requirements in the job order, and the difficulty U.S. workers have to predict their availability a month or two in advance of the employer's start date. The commenter thus raised obligations applicable to all H-2A employers (including the prohibition against preferential treatment of foreign workers and the timing of recruitment in advance of the employer's start date of need). All employers seeking H-2A workers are required to conduct at least the recruitment activity the Department requires, and to cooperate with the SWA referring U.S. applicants. These obligations are not new or specific to these range employers. The commenter did not suggest specific additional recruitment activity or suggest that newspaper advertisements should be retained as a requirement. We note that we address acceptable experience requirements for these range occupations in Section IV.B.2.a. of this preamble.
None of the commenters disagreed with the Department's proposed position that newspaper advertisements are impractical and ineffective recruitment tools for these range occupations. Accordingly, the Final Rule adopts the proposal to expand the current variance to newspaper advertisements to all range occupations eligible for processing under this rule.
After considering all the comments received on this section, we have decided to retain the original § 655.225 as proposed. Because both range herding and livestock production cover multiple areas of intended employment in remote, inaccessible areas within one or more States, and where fewer communities have newspapers, the newspaper advertisement is impractical
The TEGLs require employers to provide free housing to H-2A and corresponding U.S. workers who are not reasonably able to return from their work location to their residence within the same day. Because of the transient nature of the work—going where the herd goes, often in remote areas at some distance from the employer's ranch or farm—the TEGLs recognize that permanent housing is not feasible. Instead, the TEGLs recognize the need for housing that could be moved from one area on the range to another. Under the practice permitted under the TEGLs, most workers were provided a mobile camper that would be towed from one location to another as housing. Tents and other shelters were also used for this purpose, typically where there was no practical alternative given limited accessibility by vehicle because of remoteness and terrain.
In the NPRM, the Department proposed to include in this section the following basic requirements that were established under the TEGLs: (1) Employers subject to this rule may use mobile housing where more permanent housing is not practicable because of the remote and changing location of the employment or its terrain, or the worker is engaged in the production of livestock or activities minor, sporadic, and incidental to herding or production of livestock; (2) OSHA standards for range workers, if promulgated, must be followed; (3) the mobile housing must be inspected by state officials at least every three years, and, if certified as meeting established standards, annually by the employer until the next scheduled state inspection; (4) if a worker is working on or near the employer's ranch, farm, or other central facility (defined as within a reasonable distance for a worker to travel each night), the employer must provide the worker access to a toilet, kitchen, and a cleaning facilities for the worker and his or her clothing, including showers with hot and cold water under pressure; and (5) where a worker is residing temporarily at the employer's fixed-site housing, rather than using his/her mobile housing for this purpose, the fixed-site housing must meet the requirements of 20 CFR 655.122(d) (the housing standards generally applicable to H-2A employment).
The Department explained in the NPRM that since there are no specific OSHA standards for mobile housing on the range, employers were required to follow the requirements established by the TEGLs and that the Department proposed to include these requirements, with some modifications, in this section and section 655.235. The Department invited specific comment on whether an employer should be required to provide a range worker a sleeping facility in fixed-site housing when the worker is working at or nearby the employer's ranch, farm, or some other central location.
A few commenters stated that a range worker's housing should meet the same or similar standards applicable to H-2A workers or other workers engaged in agriculture. Most commenters, however, recognized the unique nature of range employment and addressed various aspects of proposed section 655.230, including inspection of mobile housing, and access to kitchen, toilet, washing, and laundry facilities when a worker is at or nearby an employer's ranch or farm. Worker advocates, employers, and their associations responded to the Department's invitation for comment on whether an employer should be required to provide sleeping accommodations (other than the worker's mobile camp) when a worker is performing work at or near an employer's ranch, farm, or some other central location. Additionally, a few commenters noted that the Department's proposal should be clarified to address temporary bunkhouse-type structures used in remote areas in Texas and Montana, and possibly other areas, to house workers when working in these areas. The comments on these particular issues and the Department's resolution are discussed immediately below by issue.
Several employers and a State agency stated that the current inspection system is working and that there is no need to change the system. They explained that SWA inspection of mobile housing is occurring as often as once or twice a year in some places. One employer, Eph Jensen Livestock, however, noted the application of the standards by inspectors and investigators sometimes varies drastically, and asked the Department to better ensure clarity and consistency in inspections. In contrast, worker advocates asserted that the mobile units used by employers often failed to meet the existing standards. They stated that the Department should better monitor and track mobile housing by requiring annual inspections and instituting a system to track the units inspected, and create an ombudsman position to ensure compliance. They recommended the elimination of the self-inspection process, and stated that if the system was continued there should be more detailed requirements for the self-certification system. In their view, some employers require workers to use uninspected, unsafe units, sometimes in place of those that had been presented for inspection. The worker advocates stated, as a general rule, that the mobile housing is not adequately maintained, especially given the rigors of climate and terrain.
As stated in the preamble to the NPRM, mobile housing must comply with the established standards in order to provide a worker with adequate shelter in circumstances where the climate may be harsh and the terrain is often rough. Regular maintenance and inspection of the mobile units are necessary for a worker's wellbeing. In the Department's view, the proposed inspection system—properly applied—including the denial of certification
No commenters directly opposed the Department's proposal regarding provision of kitchen, toilet, shower, and laundry facilities where a worker is performing work at or near an employer's ranch, farm, or other location where these facilities are already available to other workers. Some commenters stated that they routinely provide these services to the workers. The worker advocates did not oppose the idea that these services must be provided to workers, but, as discussed below, they favored requiring employers to provide fixed-site housing, meeting the usual standards for H-2A housing, for any range worker who was at or nearby a ranch or farm for more than one week.
In responding to the Department's inquiry whether employers should be required to provide living facilities separate from the mobile housing while the herder is working at or near the ranch, several employers and employer associations, including Mountain Plains and Western Range, Lava Lake Land and Livestock, and the Siddoway Sheep Company, voiced strong opposition to the idea. Many stated that such a requirement would be unreasonable because it would require them to construct a structure that would have to meet all the OSHA requirements for fixed-site housing, even though the structure would be used only a few weeks per year. They instead supported the Department's proposal to allow range workers to continue to live in their assigned mobile housing unit when located near a fixed-site ranch location. As mentioned above, however, worker advocates disagreed, asserting that workers should be provided fixed-site housing that meets all the OSHA standards, whenever a worker is at or near the ranch or other location for more than a week. In their view, providing access to running water, toilets, and bathing facilities does not replace an employer's requirement to provide housing meeting the normal standards for H-2A workers.
The Department is adopting its proposal without change. We recognize that there are times when the mobile housing is located at or near the ranch or a central location for certain operations that are a normal part of the herding cycle, such as birthing, shearing, or branding. In such instances, the practice has been for workers to use mobile housing, even where access to fixed housing exists. Under the Final Rule, an employer may continue this practice so long as it provides the workers with access to the other facilities required by this section. However, the Department encourages employers to make appropriate housing available at the ranch, if they have it and if the workers prefer to stay in that housing.
A few commenters, including Mountain Plains and Western Range, the Texas Sheep and Goat Raisers Association, and an employer, William Ashby Maltsberger, expressed concern about the use by employers of remote, but not mobile, housing in their range operations. The commenters stated that these operations, located in Montana and the southern plains states, use strategically located wooden bunkhouses in remote areas as they move herds through their grazing routes. The commenters stated that in light of this practice, it would be inaccurate for these employers to include a statement about “mobile housing” in the job order, as would be required under the Department's proposal. They expressed concerns, too, that unless the Department modified its proposal, these employers could be denied use of range workers under the H-2A program.
The Department's use of the term “mobile housing” in TEGLs and the NPRM was intended to distinguish remote housing provided to workers engaged in range work from fixed-site housing at a ranch or farm. The term's usage was not designed to preclude employers from using remote, but stationary, housing. Accordingly, the title to this section has been changed to “Range Housing,” not “Mobile Housing,” and the regulatory text for §§ 655.230 and 655.235 has been revised to clarify that such housing may be used to house range workers under this rule while they work in remote areas so long as such housing meets all the requirements of this section and the minimum standards established under § 655.235.
The NPRM, in large measure, proposed to codify the minimum standards historically applied by the Department to mobile housing used by sheep, goat, and cattle herders while working on the range. These proposed standards, which closely track the requirements in both TEGLs, were generally consistent with the housing rules for temporary agricultural workers published under 20 CFR part 654, subpart E, as adapted to the unique circumstances of range workers. Providing suitable housing for workers on the range presents unique challenges, given the continuing movement of the range workers as they lead their herd to new grazing areas, often in remote locations at considerable distance from the herd's starting or interim locations, and the relatively small number of workers engaged in this work. In most instances, the housing, which is defined to include tents, moves along with the worker and the herd to the next grazing location. The housing standards, although providing general requirements regarding their physical structure and inspection (see also § 655.230), also specify requirements relating to the provision of facilities (
The term “mobile housing” suggests a structure capable of being transported from one location to another. The housing provided to herders most often
The Department proposed to continue the requirement under both TEGLs that each worker must have his or her own comfortable bed, cot, or bunk, along with a mattress, to sleep. As noted in the NPRM, however, the Department recognizes that where the housing is a one-person unit, occasionally range work requires that two workers must share or use the same bed, because terrain, remote location, or demands of the herd, prevent the employer from bringing a separate housing unit to the site, and the camper is a one-person unit. These situations are intended to be rare and the Department proposed to continue to restrict an employer from requiring workers to share a bed for more than three consecutive days. The Department proposed to continue the requirement that the employer must provide each worker with a separate sleeping bag or other bedding when sharing a bed temporarily.
Worker advocates asserted that the proposed minimum standards too closely mirror the existing housing requirements, which they criticized as outdated, too general, and inadequate to meet the workers' basic needs for shelter, sleeping, cooking, cleaning, and personal hygiene. Worker advocates urged the Department: To forbid the use of kerosene lanterns and other items using combustible fuel; to require newer, safer heating, lighting, cooking and refrigeration facilities, including solar-powered items, LED lights, and battery packs; to require emergency, hand-cranked generators; to require portable camp toilets, and in areas such as corrals, where several individuals may be working, outhouses; and, on at least a monthly basis, to provide each worker the opportunity to take a hot shower and use a washing machine.
The worker advocates took particular issue with the proposed heating standard. Under the NPMR's standard, an employer was not required to provide heating unless the outside temperature remains below 50 degrees for 24 hours. They stated that this standard ignores the wide temperature fluctuations in some locations on the range and exposes range workers to altitude- and cold-related medical conditions, such as frostbite, chilblains, and trench foot. They asserted that the Department should establish a requirement that an employer must equip each housing unit with a heater that can maintain at least a minimum prescribed temperature inside the unit, advocating for heaters capable of keeping the temperature at or above 68 degrees.
In their comments, the worker advocates included a thumbnail sketch of their view of the herders' working and living conditions on the range:
[Herders part] of the year work and live on the valley floor. During the rest of the year they tend sheep in the mountains and deserts. Living alone, they have no contact with other humans for days or weeks. They live in small, dilapidated, one room trailers, called sheep camps, or tents. Most trailers have no form of heating or air conditioning. They become unbearably hot in the summer and intolerably cold during the winter. There are no bathing facilities. There's no running water. No field toilets are provided.
Acknowledging that the workers traverse many different locations in performing their sometime strenuous herding duties, often in remote and rugged areas that require the use of mobile housing, including tents, the employers paint a different picture than the worker advocates. From the employer's perspective, the nature of range work, especially in areas where terrain is mountainous or otherwise not easily accessible, limits their ability to provide housing that exceeds the existing standards. Work is often performed on land managed by federal agencies, including the BLM and the Forest Service, which forbid more permanent housing and regulate such things as waste removal and food storage. At the same time, the employers indicated that where the location of the herders' work permits, workers enjoy conditions better than required by the standards, that the mobile housing meets established certification requirements, and that the herders find their housing suitable and appropriate for their line of work. The employers stated that the workers are resupplied on a regular basis, prefer their mobile housing to alternative structures, and are treated no less well than other employees whose work is essential to an employer's business success. As stated by the Texas Sheep and Goat Association: “The ranchers treat the herders . . . in many cases, as family.” A similar sentiment was expressed by the I & M Sheep Company: “[The H-2A workers] have worked very hard for our family and have become more than just employees to us,” adding that “[w]ithout these individuals, our sheep operation would cease to exist.” To the extent there are problems with compliance, the employers stated that better enforcement, rather than more stringent standards, is the approach that should be taken.
No commenter directly stated that the existing standards, established under the TEGLs, were too stringent; however, as will be discussed, some comments demonstrated that some employers appeared uncertain about some of these requirements. In general, several employers and their associations suggested that the existing standards are just about right, protecting workers' health and safety without imposing excessive or unnecessary costs on employers. As stated by an employer, Theressa Dalling: “The special procedures . . . have worked for [our industry] over the past 35 years. There is no reason to change what has worked.”
Although the worker advocates and employer commenters disagree about the degree to which employers comply with the existing requirements, they agree that some employers fail to comply with the requirements and that compliance can and should be improved. The Department agrees. Compliance can be achieved not only through better enforcement but also through outreach efforts to educate employers and workers about the applicable requirements. In the Department's view, this rulemaking has brought focus to the difficult circumstances under which herders work, the unique features of their employment, and the difficulties confronted by them and their employers, as they perform their work, conduct their business, and attempt to earn a just wage and profit.
Although we conclude that the existing standards, overall, adequately protect the health and safety of the herders, some adjustments and clarifications to the standards are appropriate. These adjustments can be
Both TEGLs and the NPRM stated generally that an employer may satisfy its housing obligations by providing workers use of a mobile unit, camper, or similar mobile vehicle that meets the prescribed standards. The NPRM proposed “Mobile Housing” as this section's title. As discussed in Sec. IV.E.1. of the preamble in connection with § 655.210, the term “mobile housing” fails to include remote fixed-site structures that have been used in Texas, Montana, and other areas to temporarily house range workers. These bunkhouse-type structures are not mobile, but are placed at strategic locations on grazing trails to provide housing for workers as they proceed with a herd along the trail. In the Final Rule, we have revised the title to read “Standards for Range Housing” and made plain that any structure used to temporarily house workers on the range must meet the standards prescribed by §§ 655.230 and 655.235. Further, as discussed below, the Department received several comments that suggest confusion about the use of tents to house workers on the range and how the particular requirements set forth in §§ 655.230 and 655.235 apply to tents. For added clarity, we have revised the regulatory text to specify that tents are structures covered by these sections.
Both TEGLs and the NPRM provide that a housing site must be well drained and without depressions that would allow stagnant water to collect. No comments were received on this point and the Final Rule adopts the proposal without change.
Both TEGLs require employers to provide workers an adequate and convenient supply of water that meets standards established by the State health authority. The TEGLs require that the employer provide an amount sufficient for the normal drinking, cooking, and bathing needs of each worker. The TEGLs also require an employer to provide an adequate supply of potable water, or water that can be easily rendered potable, and to provide individual drinking cups to each worker. In the NPRM, the Department included these requirements. It clarified that the supply of water must be enough for the worker's normal cooking, consumption, cleaning, and laundry needs. Under the proposal, the employer was required to provide the worker with the means to make the water potable. This section overlaps with section 655.210(c), which requires an employer to specify in the job order that it will provide potable water or “water that can be easily rendered potable and the means to do so.”
The preamble to the NPRM explained: “Potable water is water that meets the water quality standards for drinking purposes of either the state or local authority having jurisdiction over supplies of drinking water or the U.S. Environmental Protection Agency's National Primary Drinking Water regulations, 40 CFR part 141.” 80 FR at 20313. The Department explained that this definition mirrors the OSHA field sanitation regulations that define potable water for agricultural establishments, 29 CFR 1928.110.
An adequate and convenient supply of water that meets the standards of the state or local health authority must be provided. Water used for drinking and cooking must be potable or easily rendered potable, and the employer must provide the worker with the means to make the water potable. The amount of water provided must be enough for normal cooking, consumption, cleaning, laundry and bathing needs of each worker; . . . and [i]ndividual drinking cups must be provided.
The Department specifically invited comment on (1) how much of the water should be potable (or easily rendered potable) for cooking and consumption; (2) how much water is sufficient for cleaning, laundry, and bathing requirements; (3) what alternative water supplies may be used when exigent circumstances preclude the employer from transporting water to the worker; and (4) what means are available to make alternate water sources potable for cooking and consumption. 80 FR at 20313.
As discussed further below, we received many comments on whether it was necessary to establish a standard other than to simply require that an employer provide an “[a]dequate and convenient supply of water that meets the standards of the state health authority . . . [in an] amount . . . enough for normal drinking, cooking, and bathing needs of each worker,” as required under the TEGLs. In the Final Rule, the Department, as proposed in the NPRM, specifically requires that the water used for drinking and cooking must be potable or easily rendered potable with the means to make it potable, consistent with the TEGL requirement referring to the State health authority standards.
The Department only received a few comments, discussed below, on the amount of potable water needed for consumption and cooking. The Final Rule requires that employers on a regular basis must supply,
The Department only received a few comments on the amount of non-potable water required to meet the cleaning, laundry, and bathing needs of workers, which are discussed below. The NPRM did not specify an amount of water needed for these purposes, nor preclude an employer in exigent circumstances from requiring that workers rely on alternate sources of water, where available, for these purposes. The Final Rule adopts the approach taken in the proposal.
The Department received several comments on what would constitute an exigent circumstance that would permit
The Department received several comments, which we address below, on the means by which water for drinking and cooking may be rendered potable. The Final Rule does not require that any particular method or device must be used for these purposes. The Final Rule, like the proposal, simply requires that the employer—in those limited circumstances where it is not required to transport potable water for these purposes to a range worker -must provide the means by which the worker may easily render the water potable and clarifies that the employer must provide a worker with the means to test the physical, chemical, and bacteria content of the alternate water sources available so that the worker is able to determine whether it is necessary to treat the water and the most suitable means of making the water potable.
The Department received no comments on its proposal to continue the requirement that an employer must provide individual drinking cups to each worker, and the Department, without further discussion, is including this requirement in the Final Rule.
The worker advocates generally supported the Department's proposal, but suggested that the Department should require employers to provide potable and non-potable water in amounts, prescribed by the Department to meet the workers' minimum daily needs. They stated that employers should be required to deliver this water to the worker and should not be permitted to require a worker to rely on alternative sources of water to meet any of the worker's needs. They asserted that the use of alternate sources of water should be strictly limited to emergency situations such as forest fires or other disasters that temporarily prevent employers from reaching the workers.
Although the employers and their associations generally supported the proposed standard, they strongly opposed any limitation on their use of natural sources of water to satisfy this obligation. They acknowledged that workers should always have enough water for drinking, cooking, bathing, and laundry, but were offended by the suggestion that any legitimate employer would ignore this obligation. They expressed a fear that the Department would “over-regulate” and, in doing so, would significantly impair their ability to successfully operate their businesses.
Mountain Plains and Western Range stated that employers regularly supply their herders with water for drinking, cooking, and bathing unless the herders are working in remote locations that have natural sources of water. Several employers and two state agencies (New Mexico and Utah) explained that workers' needs and the means of providing water vary depending on the season, location, and particular herding operations. Two employers, Henry Etcheverry and Siddoway Sheep Company, described the particular difficulties involved in transporting heavy materials, including water, to herders working in high mountain areas where access is only by horse. Siddoway Sheep Company estimated that it would need an additional eight pack horses per herd to supply workers if natural sources of water could not be used for these purposes.
Mountain Plains and Western Range and two employers, Cindy Siddoway and Henry Etcheverry, explained that there has been no history of workers becoming sick from using natural water sources. Another employer, Sharon O'Toole, noted that range workers are careful with water because it is often not potable in their native countries.
The comments included a variety of cost-effective methods and devices that they stated could be used to make natural sources of water potable, including boiling water, straining melted snow through coffee filters, iodine tablets, ultraviolet purification, bottles, osmosis filters, water purification bottles, and germicidal tablets. One employer, the Siddoway Sheep Company, recommended the use of hand-held bottles designed for water purification, because, its experience has been that workers will risk drinking water without testing or treatment if the only method available leaves an unpleasant taste in the water.
The Department received only a few comments in response to its request for input about the minimum amount of water that should be provided to workers on a daily or weekly basis. Relying on a statement prepared by an expert on the nutritional requirements of rural populations and immigrant workers, the worker advocates asserted that at least 32 gallons of potable water was needed weekly for each worker, for consumption and dishwashing, a daily average of a little more than 4.5 gallons. The only employer to comment directly on this point, Sharon O'Toole, estimated that workers need about 40 gallons per week (5.7 gallons per day) for these purposes. The worker advocates recommended that the employers be required to provide an additional 50 gallons of water (non-potable) for cleaning, bathing and laundry.
The worker advocates submitted short statements from three herders, one of whom stated that about 35 gallons would be the minimum amount of potable water required for each range worker per week (5 gallons per day). One herder stated that his employer had only provided him with a total of 40 gallons of per week (suggesting this amount was intended for the all the worker's drinking, cooking, dishwashing, bathing, and laundry needs). He explained that sometimes he would run out of water before he was resupplied, forcing him to ask other herders, if any were nearby, for water, and that for bathing he had to get water from the sheep's water tank or ponds. Two of the herders said that they were forced to continue wearing dirty clothes if they were not located close to a natural water source.
Worker advocates requested the Department to clarify that separate water supplies should be provided to workers, apart from any supplied for the use of dogs or horses. One commenter, Sims Sheep Co LLC, noted that potable water should be stored in a container appropriate for that purpose. This employer also noted the difficulty of keeping water from freezing, recommending that employers be required to provide containers small enough to be kept inside the worker's housing to prevent the water from freezing.
Mountain States and Western Range requested that the Department not require employers to provide water for
After reviewing and considering all the comments on this provision, we first determined that workers' health and safety are unnecessarily put at risk by requiring an employee, on his or her own, to secure water for essential needs. While working on the range, a worker is always there at the convenience of the employer; thus, it is our view that, at the most fundamental level, it is the responsibility of the employer to ensure the worker's safety while he or she is serving the employer's business interests. The provision of water, no less so than providing a shelter to sleep in, or food to eat, is properly an employer's responsibility where the worker's “residence” is the range, and all his paid and unpaid time there is spent serving the employer's interests. We acknowledge that most employers are responsible and, as such, try to ensure their worker's safety, and that most employers regularly, even in difficult circumstances, extend their best efforts to keep their workers safe. Unfortunately, some employers are not so responsible, and the Department must keep this in mind in setting standards for a workplace, whether it is a factory or the range. Our determination that an employer must provide workers with necessary potable water—the only alternative to leaving the worker to obtain it on his or her own—rests on the need to regulate the actions of noncompliant employers, as well as because the alternative leaves the range workers at too much risk. They work in a place where weather conditions may be severe, temperatures are extreme, drought or near drought conditions may exist, and they are often at considerable distance from their employers and without any ready alternative if their water runs dry.
We next determined that setting a recommended minimum amount of water to satisfy an employer's obligation would benefit both workers and employers. Setting a minimum amount should prompt immediate action by an employer whose practice has been to provide significantly less than this amount, thereby endangering, knowingly or not, the health and safety of its workers. In reviewing the comments, it became clear that many employers, especially in some locations and during certain seasons, have relied on natural sources of water primarily, if not exclusively, to meet or attempt to meet the workers' needs. Thus, having determined that it should be the employer's responsibility to provide the water, not one to be borne by the worker, there was a need, in our view, to establish a ready benchmark to enable these employers to estimate the amount of water they will now have to provide workers, information that it would need to know in order to establish a plan for transporting this water to their workers.
The comments submitted by the worker advocates helped inform the Department about setting the standard at an appropriate amount. Our consideration was guided by a statement included in the worker advocates' comment on this point. The statement was prepared by Sarah A. Quandt, Ph.D., a member of Wake Forest University's Department of Epidemiology and Prevention. She is a recognized expert on issues relating to food and nutrition among rural populations. She has conducted research involving immigrant workers, including crop and construction workers.
The employer's estimate, too, was helpful. Although its recommended weekly amount was about 8 gallons higher (by about one gallon a day) than Dr. Quandt's estimate, the two were close enough to suggest there might be a shared understanding among stakeholders about the amount of water required to meet the essential needs of an in individual engaged in range work. In further considering the issue, the Department consulted two reference guides: The U.S. Army Water Planning Guide, 2008 (Army Water Guide)
Based upon our review of the comments and the authoritative sources noted, we conclude that 4.5 gallons is reasonable as a recommended daily minimum amount of potable water that an employer should provide for each range worker for drinking and cooking. In setting this amount, we have balanced the need to provide workers a sufficient amount of potable water to meet their essential needs and the practical ability of employers to supply the appropriate amount of water without undue burden. Setting the minimum recommended standard at 4.5 gallons per day for drinking and cooking, rather than at the employer's higher estimated level, frees space on an employer's trailer or truck to transport supplies and other items to locations that may be distant from the employer's ranch or farm. Further, we conclude that a more conservative estimate is reasonable for setting this standard. It reduces the initial burden on employers, while providing greater protection to workers than is provided by the existing standard, which does not specify a recommended minimum amount. Some of the employers under this standard
Thus, to meet its obligations, an employer must deliver potable water on a regular basis so that its workers will have the requisite daily amount available during the supply and resupply cycle (except in exigent circumstances where alternative sources may be used to satisfy this requirement). It deserves emphasis that, even if the employer provides the daily recommended minimum amount of potable water, it remains its overriding duty to provide an adequate amount for each worker, based on the needs of a particular worker. This need will vary from individual to individual, and the appropriate amount is affected by many factors, including temperature, humidity, wind, the availability of shade, an individual's weight, and the length and intensity of physical activity. In other words, particularly in a dry or hot climate, employers may well be required to provide more than the 4.5 gallon general minimum.
We have determined not to set a minimum amount of non-potable water that an employer must supply for bathing, washing clothes, or other uses. We have less confidence in estimating an amount for these additional purposes, given that bathing, showering, and laundering practices may vary considerably because they involve matters of personal choice that are affected by the availability of particular facilities. These purposes may require significantly more water than needed for consumption and food preparation and cleanup. Based on day-to-day experience, obtained in providing water for their workers, employers should be able to readily estimate the amount of water actually needed by workers for all their needs, and, where natural water sources are not available, they should be able within a relatively short time to estimate the additional amount of water they will need to provide their workers for bathing and washing their clothes. This approach addresses the concern that if water for laundry is not needed, the employer need not provide water for this purpose. Moreover, this approach allows employers to rely on the worker's use of alternate sources of water for cleaning, bathing and laundry, where such sources are readily available.
The text of the rule also addresses other concerns raised by the commenters, including a clarification that this standard establishes a supply of water strictly for the worker's own use, not a source that may be used to provide water for dog, horses, or the herd. We have also retained and clarified the limited exception under which an employer, for exigent circumstances, may require workers to rely on alternate water sources to provide potable workers to employees. We have been persuaded that requiring potable water to be carried on pack horse would impose an unreasonable burden on employers. The regulatory text has been clarified so that an employer will qualify for this exception only where terrain would prevent delivery of water by motorized vehicle and the employer satisfies the additional conditions described below. In our view, the worker advocates' suggestion that exigent circumstances be limited to emergency situations, such as a forest fire, that would prevent the delivery of supplies to workers, is too restrictive and would impose an unreasonable burden on employers.
We have concluded that the interests of range workers and employers are better served by not providing for a broader exception for exigent circumstances. There will be some occasions, such as a fire or a severe storm, which may temporarily prevent an employer from providing supplies. In those instances, an employer will not be held noncompliant so long as it has been prudent in preparing for such a possibility, such as by providing a reserve supply of water for emergencies, having developed a plan for the extrication of their employees in such circumstances, and having available contact information for government and private agencies that are able to provide rescue services.
As pointed out by commenters, winter conditions may present particular difficulties because freezing temperatures may prevent the easy and immediate consumption of water. Therefore, we have revised the text of the rule to require that wherever and whenever the temperature can reasonably be expected to drop below freezing, the employer must provide containers, appropriate for potable water, that are small enough to be stored in the range housing to prevent freezing.
Regarding the requirement that employers must provide water sufficient for bathing and cleaning, we are clarifying that this water must be clean and free from anything harmful that could be absorbed by the skin or clothing, but the water provided does not need to be potable or easily-rendered potable. For these purposes, an employer may always rely on natural sources of water (springs, streams, fresh snow), when these sources available at the location of the worker's housing. Where the alternate water source is the same source that will be used to water the herd, the herder's dogs and horses, or may collect runoff from areas in which herd excretes, the employer must undertake special precautions to protect the worker's health from risk.
As discussed above, the Final Rule permits an employer, in limited circumstances, to completely rely on natural sources of water to meet the worker's needs, including drinking and cooking. The Final Rule establishes the following conditions to rely on natural sources of water for worker consumption:
• The terrain or weather conditions of the area in which the worker's housing is located prevents the delivery of potable water by a motorized vehicle.
• The employer has identified natural sources of water that are potable or may be easily rendered potable in the area in which the housing will be located and these sources will remain available during the period the worker will be at that location.
• The employer provides the worker with the means to test whether the water is potable and, if not potable, the means to filter out contaminants and treat the water to render it potable.
• The employer must provide this information when it files its
In the Department's view, these conditions carry special importance given the presence of drought and near-drought conditions in parts of the United States, particularly in the Southwest, as well as the significant health risks posed if water sources become contaminated with harmful pathogens because of the presence of nearby herds.
Where the employer seeks to use this exception, it must provide the worker with a device that can test the physical, chemical, and bacteria content of the water and the means to render the water potable. Employers may choose from various approved methods and devices to satisfy this requirement. Potential choices for means to render water potable would include, among others, water purification tablets, portable water purification systems, water
Both TEGLs and the NPRM require that facilities must be provided and maintained for effective disposal of excreta and liquid waste in compliance with state or Federal requirements. Where disposal pits are permitted, the TEGLs and the NPRM state that the pits must be “fly-tight” and maintained in compliance with State and local sanitation requirements.
A few commenters expressed concern about the facilities employers provide to range workers for the disposal of excreta and liquid waste. A few commenters, including worker advocates, stated that employers should be required to provide camp-type portable toilets or outhouses for workers to use on the range. Another commenter stated that employers do not always provide a shovel with which to bury such waste. We have revised the regulation to address this concern.
The rulemaking record does not reflect what particular toilet facilities, if any, are provided workers. The Department would expect that an employer would choose to provide a portable, camp-like toilet for use by its workers. A strictly functional device, shielded from view if the herder is working with others, would appear to be relatively inexpensive and compatible with any State or Federal requirements concerning the disposal of excreta and liquid waste. The Department, however, is less convinced about the suggestion that employers should be required to provide an outhouse, which the Department interprets to mean a permanent or semi-permanent structure constructed of wood or similar material. Obviously, it would be impractical unless workers routinely used the same location to establish a “camp,” and even in these situations, it would entail construction and maintenance costs and would increase, perhaps substantially, an employer's disposal costs. The Department assumes that similar costs would be entailed in the rental, purchase, use, and transportation of a construction-type “porta-john.” Further, the construction of an outhouse would likely be subject to land use restrictions on many parcels of land used for grazing, including Federal lands. Given the absence of information about current employer practices in this area and uncertainty about legal and cost considerations, the Department declines the suggestion to revise the standard to require camp toilets or more substantial structures of this nature, notwithstanding the benefit they would provide for workers.
Both TEGLs and the NPRM required that employers provide structures that are structurally sound, in sanitary condition, and in good repair to protect workers from the elements. Beyond this general duty, the TEGLs also specified a few particular requirements regarding the structure of the housing. The general and particular requirements were included in the NPRM.
Earlier, in the Sec. IV.E.1. of the preamble related to § 655.230, and throughout this section, we discussed various general comments and comments specific to particular requirements. Many of these bear on the structural suitability of a housing unit, but the Department received no comments specifically directed to this subsection and therefore the Final Rule adopts the proposal on this point without change, except to clarify that the requirements relating to housing, including the standard for structure, also apply to tents, except as discussed below.
Some employer comments suggested that there may be some confusion about the application of standards to tents. The proposal did not modify an employer's obligations under the TEGLs to generally apply the same requirements to tents as apply to other range housing. The TEGLs and the NPRM require that an employer may use a tent to house workers only if the terrain or land use regulations prevent the use of more substantial housing and the tent is appropriate for the weather conditions. Further, where tents are used, they are subject to the same requirements that apply to campers or other structures, unless the standards provide otherwise. If it is feasible to provide electricity and mechanical refrigeration at a location, an employer must do so, even if the worker is housed in a tent. While such opportunities will be limited, the obligation remains. If the use of the tent is required by land use restrictions prohibiting more permanent structures, but electric service is available, the employer must provide it. See § 655.235(f). The TEGLs and the NPRM, however, specifically exempted tents from the requirements applicable to other structures—that they have rigid flooring and a second means of egress for escape (unless the tent is large and has rigid walls), see § 655.235(e)(5). Further, the TEGLs and the NPRM prohibited the use of heaters in tents unless the heater was approved for such use and the tent is fireproof. The Final Rule contains these same requirements and exceptions.
Both TEGLs and the NPRM required that stoves or heaters using combustible fuels be safely vented and be shielded by fireproof material. They required that if a heater has automatic controls, it must be of the type that interrupts the fuel supply when the flame fails or a predetermined safe temperature is exceeded.
Neither the TEGLs nor the NPRM, however, required that each housing unit be equipped with a heater or a heating system, nor did either require the employer to ensure that the temperature inside the housing could be maintained at or above a certain level. The NPRM continued the existing standard under which employers could choose not to provide heated units. Under that standard, no heating is required for housing located in mild-climate areas unless the temperature is reasonably expected to drop below 50 degrees and remain continuously below that temperature for 24 hours. To maintain worker safety, however, employers that choose not to provide heating were required to provide the workers with proper protective clothing and bedding.
The worker advocates contended that the Department's proposal ignored the wide temperature fluctuations in some locations where range workers are employed, and that the proposal would continue to expose range workers to altitude- and cold-related conditions that could lead to injury and illness. They asserted that the Department should instead require an employer to provide heating whenever the temperature inside the housing facility falls below a prescribed temperature, advocating in favor of setting this temperature at 68 degrees. The worker advocates also requested the Department to require that any devices that use combustible fuels (which would include those for lighting, heating, and cooking) should have fuel sources stored outside the housing structure. They further requested that the Department require that heating devices should be inspected annually by fire departments or heating specialists. No comments were submitted by employers or their associations on this point. However, as noted throughout this section of the preamble, employers and their associations generally opposed
The worker advocates have presented a persuasive argument that the Department's proposed heating standard does not adequately protect the health and safety of the workers. It is widely known that the hourly temperatures in the mountainous and desert areas in which herding is common can dramatically fluctuate over the course of a day. Even in areas where temperature changes over the course of a day generally fluctuate within a narrower range—areas that could be fairly described as mild and whose usual daily temperature reaches 50 degrees or higher—it is not for uncommon for the temperature to drop below freezing or to feel as if it has when the weather is windy, rainy, or both. In these circumstances, a range worker should be able to obtain a heated shelter from the elements. Accordingly, the Final Rule revises the threshold at which heating must be provided. As revised, an employer must provide heating for a housing unit if the low temperature for any day in the work contract period is reasonably expected to drop below 50 degrees. If the low temperature for any day in which the housing unit is being used is not reasonably expected to drop below 50 degrees Fahrenheit, no separate heating equipment is required as long as proper protective clothing and bedding are made available, free of charge or deposit charge, to the workers.
The Department recognizes that this may require some employers—for the first time—to equip their range housing with heaters. The existing standard is simply inadequate to protect the health and safety of the range workers. The extra clothing and bedding is a poor substitute for a heater on a day when the temperature may remain below 50 degrees.
The Department is unpersuaded by the argument that it should require employers to provide housing units that will maintain a specified inside temperature. The Department has no present information that would allow it to set such a standard, particularly given the wide variety in the design of the housing units used by range workers and the uncertainty that a particular temperature could be achieved without undue expense to employers.
The Department is not convinced that it is necessary to add either a requirement that heating or heating system be inspected annually by a fire department or heating specialist, or a requirement that an employer can only provide a device in which the fuel source is stored outside the housing unit, particularly because the type of device and fuel storage must fit the variety of current and future housing structures. The Final Rule retains the existing requirement under the TEGLs that the units in which workers sleep must be constructed and maintained according to applicable state and local fire and safety laws. Moreover, the housing unit, including any heating equipment, would have to meet whatever inspection requirements are established by the SWA. In our view, this standard adequately ensures the safety of the workers. Accordingly, except for revising the proposed standard to limit the ability of an employer to provide an unheated housing unit, the Final Rule adopts the standard as proposed. Finally, as discussed above in Section IV.B.2.c., heating equipment and, where permitted, protective clothing and bedding, must be listed in the job order along with other required tools, supplies and equipment that will be provided free of charge or deposit charge.
Both TEGLs and the NPRM require that electrical service must be provided if feasible. Both TEGLs and the NPRM required that where electric service is not provided, the employer must provide at least one lantern for each worker. Kerosene lamps were permitted.
The worker advocates, as previously noted, have broadly criticized the Department for not incorporating modern technology in its range housing standards. They have objected to the permitted use of kerosene lamps in the range housing, asserting instead that the Department should require battery or solar-powered devices. Although some employers mentioned that they provided solar power sources for some purposes, none indicated whether they were used to supply power for lighting. As noted throughout this section of the preamble, employers and their associations generally opposed any requirements that would go beyond those required by the TEGLs.
In the Department's view, it is unnecessary and inappropriate to mandate, or categorically forbid, the use of any particular device. Kerosene lanterns have long been used by campers and other outdoors enthusiasts to provide lighting in temporary structures similar to range housing. On the present record, there is nothing that would justify the Department from banning their use. As discussed previously, employers are required to construct and maintain units that comply with applicable state and local fire and safety laws. Where such laws forbid the use of particular kinds of lanterns or impose conditions on their use, an employer would be obliged to follow those laws. Moreover, it is in employers' interest to provide safe lighting options.
There were no comments received on the requirement that an employer must provide at least one lantern for each worker. The Final Rule adopts the proposed lighting standard without change.
Both TEGLs and the NPRM require employers, if feasible, to provide hot and cold water under pressure in range housing. Where not feasible, employers were required to provide movable facilities for bathing, laundry, and hand washing. Only a few concerns were raised in comments on this provision.
Worker advocates requested the Department to provide workers with sun-shower devices when work is being performed in warm climates. They also asserted that employers should be required to provide workers with at least monthly access to facilities where they can have a hot shower and use of a washing machine. A few employers asserted, as discussed in connection with the minimum standard for water, § 655.235(b), that laundry facilities are unnecessary where an employer picks up and launders a worker's dirty clothes and exchanges the laundered clothes for dirty ones when it resupplies the worker. The Department is not persuaded that these suggested changes are necessary.
While the suggested use of a camp-type “sun shower” may be an economical means of allowing a worker to bathe, it is only one of several potential options that may be available to meet the employer's obligation to provide movable facilities for bathing, and there is no basis in the record for the Department to conclude that this device is superior to other methods. Allowing a range worker to obtain a hot shower and access to a washing machine each month could prove costly to an employer. We assume that the employer would have to pay for the services of a substitute worker to watch the herd in the first herder's absence, and the time and distance between the herder's work location and the available facilities might be considerable. Given that under the Final Rule's standard, the workers are provided movable washing and bathing facilities, imposing such a requirement seems unnecessary and, depending upon the time and expenses involved, could impose an unreasonable economic expense on the employer.
With regard to the suggestion that the standard should be revised in recognition that some employers launder their workers' clothes, the Department has determined that the standard should remain unchanged. It is important, in the Department's view, that workers be provided the means—tub, scrub bush, soap, and a line for clothing to dry, and a sufficient amount of water with which to launder all or some of their clothing on an as needed basis. Of course, if an employer chooses to provide laundered clothing regularly, the worker's needs are likely to be minimal.
Both the TEGLs and the NPRM required that employers must provide housing with mechanical refrigeration where feasible. Where mechanical refrigeration is not feasible, the standard provided the employer the choice to either provide a propane or butane-powered refrigerator or provide an alternate means by which food can be used or stored to prevent or avoid spoilage. The TEGLs mentioned salting as method to avoid spoilage. In the NPRM, the Department proposed “dehydration” as another example of an acceptable alternative. The Department invited comment on food preservation options in keeping with food safety and nutrition concerns. These concerns have been addressed in Sec. IV.B.2.d. of this preamble, in connection with § 655.210.
As discussed with regard to the meal requirements established by § 655.210(e), commenters agreed that employers should be required to provide range workers with “adequate” meals or “sufficient” food to prepare healthy, nutritious meals and appropriate means for food storage. Insofar as food storage methods are concerned, commenters disagreed as to whether mechanical refrigeration should be required. The worker advocates suggested that the Department adopt a hierarchy of food storage methods, so that alternatives to refrigeration (
Employer and employer association commenters stated that while refrigeration is provided by some employers in some locations, it cannot be provided in some remote locations (
Mountain Plains, Western Range and some employers, including Siddoway Sheep Company and Henry Etcheverry, read the proposal to require refrigeration units when tents are being used, an undue and likely impossible burden, because an employer's use of tents, in their view, means that the herd is located in an area where the terrain is rugged and supplies and equipment must be transported by pack horses. The Siddoway Sheep Company proposed that the purpose served by refrigeration—to ensure that workers receive nutritious meals—could be achieved by providing the workers with fresh meat and fresh produce for consumption in the short term, supplemented by a variety of canned meats, fruits, and vegetables.
The Department recognizes that range work is performed throughout the year in a wide variety of locations, including some that are remote and not accessible by motorized vehicle. Yet it remains appropriate to establish a minimum standard that is flexible enough to apply to the variety of situations on the range. The historical approach, embodied in the TEGLs and the NPPRM, achieves this purpose. It allows flexibility, while at the same time ensuring that employers provide adequate and sufficient meals to workers, which cannot be met without ensuring that appropriate methods of storage are also provided.
Under the proposal and as adopted in the Final Rule, where mechanical refrigeration is not feasible, an employer may choose among alternative means to eliminate or reduce spoilage of food and thereby meet its obligations under the standard, established in § 655.210, to provide workers with sufficient and adequate meals. While the provision of a butane or propane refrigerator, obviously, would best replicate mechanical refrigeration, we conclude that requiring such use would be impractical in many instances. The Department also recognizes that in some instances, regulations by other government agencies, including those designed to protect people from potentially dangerous encounters with wild animals, will determine appropriate storage methods. Further, as noted below in connection with § 655.235(k), employers are required to provide sealed containers for storing food where there is a risk of contamination of the food by insects, rodents, or other vermin.
Both TEGLs and the NPRM required that if workers were permitted or required to cook in their housing, the employer must provide a space with adequate lighting and ventilation for this purpose. The TEGLs and the NPRM required that the wall surfaces next to the areas for food preparation and cooking must be non-absorbent and easy to clean. They further required that the wall surface next to cooking areas must be made of fire-resistant material. No substantive comments were received on these particular points and the Final Rule adopts the proposal without change.
Both TEGLs and the NPRM required employers to provide clean, durable, and fly-tight containers for each housing unit. If refuse and garbage cannot be buried, the employer was required to collect the garbage twice weekly or more often if necessary. The Department received only a single comment on this standard. The Siddoway Sheep Company stated that the garbage disposal requirements should be clarified because a twice-weekly schedule for removal is impractical in mountain areas, where resupply occurs only once every 8-10 days.
In the discussion above related to § 655.235(b), the Department recognized the impracticality of moving supplies in areas that are not accessible by vehicle. Similar problems are involved with the disposal of refuse and garbage by packhorse or other means. Accordingly, the Final Rule has been revised to provide a limited exception to the general requirement where garbage and other refuse cannot be buried. In those situations, the employer must collect and remove the garbage and other refuse on the return leg of its supply run. The Department reminds employers that other agencies may regulate the storage and disposal of garbage and refuse, and employers are required to comply where such regulations are applicable.
Accordingly, the text has been revised as discussed. Apart from this revision,
Both TEGLs and the NPRM required the employer to provide appropriate materials, including sprays, to combat insects, rodents, and other vermin. The Department received no comment directly on this point and the Final Rule adopts the proposal without change. A private individual, worker advocates, and employers submitted comments on protecting food from insects, rodents, and other wildlife. A private citizen, noting the difficulty of keeping insects away even in private residential areas of the country, recommended that the Department require employers to provide sealed containers to prevent insect contamination. While the Department construes its food storage and insect and rodent control standards to require this practice, the Department has determined that worker health would be better protected by making this requirement explicit. Accordingly, in the Final Rule, the Department has revised the proposal to provide: “Appropriate materials,
The NPRM retained, with minor clarifying edits, the requirement under the TEGLs that each worker have his or her own comfortable bed, cot, or bunk with mattress. The NPRM also continued the existing variance from this requirement for temporary situations of up to three days, in which two workers could share a mobile housing unit with a single bed, provided each worker was provided his or her own sleeping bag or bedding.
Even though the Department's intent was only to maintain the existing standard, many commenters, including Mountain Plains, Western Range, Wyoming Wool Growers, and the Texas Sheep & Goat Raisers Association, perceived the proposal as a new requirement. For example, the Colorado Wool Growers Association stated that this standard would require employers to transport a second mobile unit whenever they have two workers herding the same flock. An employer, Kay and David O. Neves, expressed the concern that the proposed standard would prevent a new herder from living in a two-bed unit with an experienced herder, denying the worker and the employer the benefit of the seasoned worker's experience. Other commenters, including the Texas Sheep & Goat Raisers Association also expressed concern about how the standard should be applied,
The associations and several other commenters stated that the phrase “sleeping facility” was confusing, leaving them guessing whether it refers only to a bed or the entire camp structure. The confusion caused alarm among several commenters who read the proposal to require that they must have two separate mobile housing units whenever two herders would be staying overnight at the same location. Several mentioned that this requirement would force them to purchase new units at a cost of $20,000 per vehicle.
To remedy the concerns noted, Mountain Plains and Western Range suggested that a “sleeping unit” should be defined as “a comfortable bed, cot, or bunk with a clean mattress.” On a separate point, the worker advocates recommended that the Department revise the standard to require that mattresses and pads not sit on the floor of a housing structure and to require that if foam pads are provided, they must be thicker than two inches and covered completely with a washable material. On a related point, the Siddoway Sheep Company requested modification of the sleeping facilities standard to relieve employers of the requirement to provide mattresses or cots when workers are living in tents. It stated that its experience has been that range workers do not use the cots it has provided, preferring instead to use pine boughs.
The Department has determined that its use of the term “sleeping facility” rather than a term such as “sleeping arrangement” or even more simply “a separate bed,” to describe this standard has contributed to unnecessary confusion. “Sleeping facility,” even as defined in the TEGLs and the proposal, carries with it the idea of a physical structure, such as a camper or bunk. As such, the standard can be read to require that whenever an employer assigns a second range worker for longer than three days to work with a another herder, it must provide a separate structure, a separate area within a single structure, or separate bed or cot, or some combination of such requirements, for each worker.
We have revised the requirement to make plain that an employer is not permitted to require workers to use or share a single bed for more than three consecutive days. It should be emphasized that the sleeping standard establishes the general requirement that each worker, on a nightly basis, must be provided his or her own separate bed. The shared sleeping exception is limited to infrequent and temporary (no longer than 3 days) situations where it is impractical to provide a worker with a separate bed, mattress, or cot. The exception cannot be used in other situations to circumvent the requirement of one worker, one bed. Of course, if the camper is designed and certified for occupancy by two people, and has two beds, two workers may occupy it.
In the Final Rule, we have revised the proposed standard to better distinguish the general requirement from the limited three-day exception.
Each worker must be provided housing (including a camper or tent, when permitted or required) that contains, except in a family arrangement, his or her own comfortable bed, cot, or bunk with a clean mattress. An employer may be permitted to require workers to use or share a single bed only where:
• The employer makes the request when filing an application for certification;
• demonstrates to the satisfaction of the CO that it would be impossible or impractical to provide each worker with a separate bed; and
• the employer provides the second worker a sleeping bag or bed roll free of charge or deposit charge.
With regard to the comment that the Department should revise the standard to relieve employers from providing a cot and mattress when workers are staying in tents, the Department disagrees. In doing so, the Department would be removing a basic measure of sleeping comfort. At the same time, it should be clear that the standard does not require a worker to use a mattress and cot if he or she prefers to sleep on pine boughs or some alternative foundation. An employer meets its obligations under the standards by making available the mattress and cot to the worker and allowing him or her to
As a final matter, the Department is not persuaded that it should mandate a specific thickness or covering for a sleeping pad or require an employer to modify its housing to ensure that no worker may be required to sleep on mattresses and pads that sit on the floor of the housing structure. The standard requires that the employer provide a comfortable bed, a standard that admittedly allows room for interpretation, but ensures that a worker must be provided a mattress or its equivalent, which must be clean and which provides some comfort from the alternative of sleeping directly on a hard surface. The rulemaking record does not provide sufficient information that would allow the Department to establish a particular thickness for pads, their covering, or similar particulars for bedding.
The NPRM continued the requirements established under the TEGLs that:
• An employer must provide housing that must be constructed and maintained in compliance with applicable state or local fire and safety laws;
• the storage of flammable or volatile liquids or other materials in living areas is prohibited, except for those needed for current household use;
• the housing provide two safe means by which a worker may escape the unit without difficulty, excepting tents from the requirement of a second means of escape unless they are large and their walls are constructed of rigid material; and
• the employers must provide a first aid kit and provide adequate fire extinguishers in good working condition.
The worker advocates commented on three aspects of the proposal, requesting the Department to require employers: To install smoke detectors in housing and to provide easily accessible fire extinguishers; to require that there be an emergency exit, with egress at rear, of each housing structure; and to include particular items, as identified by the Department, in first aid kits. The worker advocates did not suggest the inclusion of any particular items, but asked the Department to consider the need for items to treat illnesses related to exposure to cold temperatures.
In the Department's view, the proposed standard adequately meets these concerns. The worker advocates have provided no evidence that the standards are inadequate or that workers have been put at risk by the application of the standards. The proposed standard requires compliance with applicable fire and safety laws, including a second means of escape, and requires the unit to have a fire extinguisher in good working condition. The proposed language does not explicitly state that the fire extinguisher must be accessible. We have added this requirement to the standard.
Where state and local authorities have determined that smoke or fire detectors are required for the type of housing provided workers, employers must comply with those requirements. Where such laws do not apply to such housing, without any demonstration that the lack of such devices has caused injury to workers the Department is ill-equipped to mandate their use. Similarly, local and state fire departments, nongovernmental organizations, such as the Red Cross or organizations comprised of camping, hiking, or wilderness exploring enthusiasts, or their worker's compensation insurers, are better suited than the Department, at present, to recommend the items to be included in first aid kits, especially for treating injuries caused by exposure to the elements. However, we would expect that employers in stocking the required first aid kit will take into account the conditions under which range work is performed, including the risks posed by insects, wildlife, and the worker's exposure to extremes of heat, cold, storms, and rugged terrain.
We decline the worker advocates' suggestion that the Department should require employers to provide a hand-cranked generator for emergencies. They have not provided any evidence that would allow the Department to properly consider this request. With regard to their comment on first aid kits, they again have not provided sufficient evidence that would allow the Department to properly consider this request.
The Final Rule adopts the proposal on fire, safety, and first aid without substantive change. The Final Rule makes three minor changes. We have clarified that an employer must comply with both state and local fire and safety laws and that the standards apply to all housing covered by § 655.235, a change, as discussed earlier in connection with § 655.230, to make plain that stationary housing used by some employers on grazing trails must comply with the standards, which were previously referred to “mobile housing.” Finally, we have clarified that employers must ensure the accessibility of fire extinguishers.
Executive Order (E.O.) 13563 directs agencies to: Propose or adopt a regulation only upon a reasoned determination that its benefits justify its costs; tailor the regulation to impose the least burden on society, consistent with achieving the regulatory objectives; and in choosing among alternative regulatory approaches, select those approaches that maximize net benefits. E.O. 13563 recognizes that some benefits are difficult to quantify and provides that, where appropriate and permitted by law, agencies may consider and discuss qualitatively values that are difficult or impossible to quantify, including equity, human dignity, fairness, and distributive impacts.
Under E.O. 12866, the Office of Management and Budget's (OMB's) Office of Information and Regulatory Affairs (OIRA) determines whether a regulatory action is significant and, therefore, subject to the requirements of the E.O. and OMB review. Section 3(f) of E.O. 12866 defines a “significant regulatory action” as any regulatory action that is likely to result in a rule that: (1) Has an annual effect on the economy of $100 million or more or adversely affects in a material way the economy, a sector of the economy, productivity, competition, jobs, the environment, public health or safety, or state, local, or tribal governments or communities (also referred to as “economically significant”); (2) creates serious inconsistency or otherwise interferes with an action taken or planned by another agency; (3) materially alters the budgetary impacts of entitlement grants, user fees, or loan programs, or the rights and obligations of recipients thereof; or (4) raises novel legal or policy issues arising out of legal mandates, the President's priorities, or the principles set forth in the E.O.
OIRA has designated the Final Rule a significant regulatory action under sec. 3(f) of E.O. 12866 but not an economically significant rule. The economic effects of the costs and transfers that would result from the changes in this Final Rule, above and beyond the impacts of the program as it is currently implemented, are not economically significant. The largest impact on employers will result from implementation of the wage setting methodology. The Final Rule will result in average annual transfers from employers to employees due to increased wages of $17.46 million between 2016 and 2025, which includes
In
Through this rulemaking, the Department is complying with an order issued by the district court on remand to remedy the APA violation found by the DC Circuit. The lawsuit, however, is only one of the reasons for the promulgation of this Final Rule. The unique on-call nature (up to 24 hours a day, 7 days a week) of the work activity in isolated areas associated with these occupations, coupled with the sustained scarcity of U.S. workers employed in herding, has made determining an appropriate prevailing wage increasingly difficult under the current methodology for determining wages for these occupations. In these occupations, the prevailing wage serves as the Adverse Effect Wage Rate (AEWR). Few employers provide U.S. worker wage information in response to prevailing wage survey requests for these occupations, making it difficult for State Workforce Agencies (SWAs) to submit statistically valid prevailing wage findings to the OFLC Administrator. For example, based on a review of employer surveys conducted over the last four years by approximately 10 states located in the mountain plains/western regions of the United States, all of the SWAs with reportable wage results under ETA's guidelines reported a combined total of only 30 (2012), 26 (2013), 18 (2014), and 52 (2015) domestic workers performing sheepherding; these numbers are insufficient to report statistically reliable wage results by state. Therefore, through this rulemaking, the Department plans to establish a more effective methodology for determining and adjusting a monthly wage rate for these unique occupations that adequately protects U.S. and H-2A workers in these occupations. In addition, the Department has received complaints concerning housing conditions and has found violations of the housing standards in both complaint and directed (non-complaint) investigations. In addition, several cases have been litigated in which workers' health and safety were at question.
In the Notice of Proposed Rulemaking (NPRM), the Department proposed to set the monthly AEWR for these occupations based on forecasted AEWR values from the Farm Labor Survey conducted by U.S. Department of Agriculture USDA (FLS-based AEWR) multiplied by an estimate of 44 hours per week, with a four-year transition and full implementation in year five (referred to in the NPRM as a five-year
The Department received numerous comments related to the alternatives considered in the NPRM's EO 12866 analysis. Many commenters, including Mountain Plains Agricultural Services and Western Range Association (Mountain Plains and Western Range) and the Texas Sheep & Goat Raisers Association, as well as Brent Espil, Cunningham Sheep Co., and Siddoway Sheep Company, Inc. (individual employers) asserted that the alternatives were not “true” alternatives in that the Department did not consider other ways to determine the AEWR for occupations involving the herding or production of livestock on the range. For this reason, some commenters stated that the Department failed to meet the requirements set forth in the Regulatory Flexibility Act (RFA). They characterized the three alternatives presented by the Department as one alternative with three transition periods methods, and stated that in their view the alternatives therefore do not satisfy the requirements of Section 603(c) of the RFA to describe “any significant alternatives to the proposed rule which accomplish the stated objectives of applicable statutes and which minimize any significant economic impact of the proposed rule on small entities.” The U.S. Small Business Administration (SBA) Office of Advocacy similarly asserted that the Department did not analyze any regulatory alternatives that may minimize the economic impact of the proposed rule on small businesses, and suggested that the Department publish a Supplemental Initial Regulatory Flexibility Analysis (IRFA). The Wyoming Farm Bureau Federation—a trade association—questioned why the Department did not consider longer phase-in alternatives. In the Final Rule, the Department analyzes a different set of alternatives that utilize different wage rate sources, including the Fair Labor Standards Act (FLSA) current minimum wage of $7.25/hour, the 1994 TEGL monthly wage rates indexed by the Employment Cost Index (ECI) for wages and salaries as published by the Bureau of Labor Statistics (BLS), and the FLS-based AEWR.
The Department carefully reviewed the comments related to the proposed wage setting methodology and to the alternatives laid out in the E.O. 12866 analysis and the IRFA. After considering the comments, the Department has decided to set wage the monthly AEWR for range herders of sheep, goats, and other livestock using a formula based on the current FLSA minimum wage of $7.25/hour as a starting point, multiplied by a revised weekly estimate of 48 hours per week, with annual adjustment based on inflation from the ECI for wages and salaries beginning in year two. This base wage source is generally consistent with the second of two alternative proposals set forth by Mountain Plains and Western Range, which was endorsed by the ASI and many individual employers. DOL adopts a weekly hour estimate of 48, which is greater than that proposed by these commenters, and a transition period (two years with full implementation in year three) shorter than that favored by these commenters. As under the proposal, the employer is required to pay an applicable Federal or State minimum wage if higher than the monthly AEWR. As discussed in detail in the preamble, the Department concludes that this wage rate is both necessary to provide a meaningful test of the labor market for available U.S. workers and to protect against adverse effect on workers in the United States similarly employed.
As discussed in the Final Regulatory Flexibility Analysis (FRFA) that follows, in addition to the wage methodology adopted in this Final Rule, the Department considered three alternative methods to set the monthly AEWR: (1) To set the monthly AEWR based on the 1994 TEGL wage adjusted for inflation using the capped ECI,
The selected methodology will most effectively enable the Department to meet its statutory obligations to determine that there are not sufficient workers available to perform the labor or services requested and that the employment of foreign workers will not adversely affect the wages and working conditions of workers in the United States similarly employed before the admission of foreign workers is permitted. The new wage methodology will begin to address immediately and substantially the wage stagnation concerns discussed earlier in the preamble. The transition period recognizes that the full wage increase in a single year could lead to disruptions that could be avoided by the more gradual implementation period. In determining where to set the monthly AEWR so that it will not result in adverse effect, it was appropriate for the Department to consider whether a significantly higher wage could be immediately absorbed by employers or might have the unintended consequence of reducing the availability of jobs for U.S. workers because the wage would result in some employers going out of business or scaling back their operations, as a substantial number of comments demonstrated.
The economic analysis presented below covers employers engaged in the herding or production of livestock on the range. The Department's economic analysis under this Part (III.A) is strictly limited to meeting the requirements under Executive Orders 12866 and 13563. The Department did not use the economic analysis under this Part as a factor or basis for determining the scope or extent of the Department's obligations or responsibilities under the Immigration and Nationality Act, as amended. Nor did the Department use the economic analysis in this Part as a relevant factor relating to any requirement under the Administrative Procedure Act (APA), or any case interpreting the requirements under the APA.
The Department derives its estimates by comparing the baseline, that is, the program benefits and costs under the 2010 Final Rule and TEGLs 32-10 (
The Department has quantified and monetized the impacts of the Final Rule where feasible. Where we were unable to quantify benefits and costs—for example, due to data limitations—we describe them qualitatively and identify which data were not available to quantify the costs. The analysis covers 10 years (2016 through 2025) to ensure it captures all major impacts.
In the remaining sections, the Department first presents an overview of general comments received from the public. We then present a subject-by-subject analysis of the impacts of the Final Rule and a summary of the costs and transfers, including total impacts over the 10-year analysis period.
The NPRM's EO 12866 analysis used an annual growth rate of 2 percent to forecast participation in the H-2A program. Several commenters stated that this growth rate was inaccurate. Carol Martinez, Alex (Buster) Dufurrena, and John and Carolyn Espil, individual employers, stated that the assumed 2-percent annual growth rate of U.S. sheep producers was inaccurate because the proposed rule would put additional financial burdens on producers that would force them to reduce the number of H-2A workers hired or to close. John and Carolyn Espil referenced the BLS Occupational Outlook Handbook (2014-15 Edition), which predicted that farmers, ranchers, and other agricultural managers would experience a loss of 179,000 jobs over the period of 2012-2022, which amounts to a 19 percent reduction. Similarly, the Texas Sheep & Goat Raisers Association and ASI and Public Lands Council stated that after the National Wool Act was phased out by the Federal government in 1993-1995, tens of thousands of sheep ranches went out of business and subsequently, in the late 1990's, linked allied industries also went out of business due to the lack of lamb and wool. Mountain Plains and Western Range stated that the assumed 2-percent employer growth rate “demonstrates how fundamentally wrong DOL's assumptions are.”
The Department had estimated the 2-percent annual growth rate based on historical H-2A program data on labor certifications for sheepherding, goat herding, and range cattle production employers. For the Final Rule, the Department updated its analysis by evaluating the annual change in the number of unique herding employers between FY 2012 and 2014 and found inconsistent results. Between FY 2012 and 2013, we found a decrease in participation of 114 percent, while the FY 2013 and 2014 program data indicate an increase in participation of 11 percent. In light of the comments and this data, in the Final Rule the Department revises the growth rate to be 0 percent, that is, the Department assumes the employer participant population in this H-2A program will neither rise nor fall over the analysis time period.
Several commenters stated that the increased costs associated with the proposed rule, particularly the proposed wage increases, would destroy the industry. Other commenters questioned the accuracy of the economic analysis and opposed some of the conclusions presented in the analysis. For example, Representative Allen Jaggi, an elected official, and Skye Krebs, an individual employer, warned that the proposed rule would force employers out of business because they operate on thin profit margins. The American Farm Bureau Federation used an industry standard range sheep farm budget developed by the University of Utah to analyze the impact of the proposed 2020-2025 forecasted FLS-based AEWR wage, which resulted in $41,325 per year in additional wages. According to the American Farm Bureau, if prices fall to year 2002 conditions—the lowest prices over the period of 2000-2014 ($0.80 per pound for lambs and $0.53 per pound for wool)—employers in each of the 19 states analyzed would be operating at a loss (Alabama, Arizona, Arkansas, California, Colorado, Hawaii, Idaho, Missouri, Montana, New Mexico, Nevada, North Dakota, Oklahoma, Oregon, South Dakota, Texas, Utah, Washington, and Wyoming). They also presented the average prices over the last five years as well as over the preceding 10 years to demonstrate the trend in prices. They noted that the average price received for lamb over the past five years ($1.70 per pound) is 63 percent higher than the price received over the preceding 10 years ($1.04 per pound), while the average price received for wool over the last five years ($1.45 per pound) is 113 percent higher than the prices they received on average over the preceding 10 years ($0.68 per pound). The State of Utah also submitted data pertaining to the average price of lamb over time. The State noted that the average price of lamb increased from $67.94 in 1994 to $157.15 in 2014, which amounts to an increase of $48.61 over a 20-year period after adjusting for inflation. Without acknowledging that worker wages have not similarly been adjusted for inflation, the commenter stated that this small increase in the value of lamb cannot support the proposed tripling in the wage increase and will force producers out of business.
The Utah Farm Bureau Federation, the Texas Sheep & Goat Raisers Association, and Mountain Plains and Western Range analyzed an enterprise budget for an Idaho sheep operation with ewes on the range and selling feeder lambs (Painter, K., Idaho, University of Idaho, 2014), which earned $60 per head in total returns. Using data for the State of Utah, the Utah Farm Bureau estimated that after tripling the wage rate, total returns would decrease 111 percent to negative $6.00 per head, while income above operating costs would decrease 80 percent from $83,000 to less than $17,000. They stated that tripling the hired labor rate reduces total returns from a profit of nearly $90,000 to a loss of approximately $10,200.
The Wyoming Wool Growers Association stated that the Department underestimated the cost associated with the proposed wage increase. They referenced an analysis from the University of Wyoming estimating that the proposed wage increases would increase the annual operating costs by more than 40 percent ($39,600) for a Wyoming range sheep operation with two foreign herders. The analysis also indicated that income above operating costs would fall by 78 percent (to $11,313) under current price conditions. The Texas Sheep & Goat Raisers Association commented that the Department underestimated the cost of the proposed rule, which included the cost of additional wages over the period from 2016 to 2020 ($45 million) and non-wage costs ($5 million per year).
John and Carolyn Espil stated that the Department misrepresented the make-up of the industry as it was presented in the NPRM's Exhibit 2 (The Number and Percentage of H-2A Employers by Occupation and State). They stated that none of the values in the Exhibit reflected the Western Range Association's membership numbers. For example, the Department presented information indicating that Nevada had one employer, while the Western Range Association had 17 members from Nevada as of January 2015. Because of what they perceived as an inaccuracy, they questioned the overall accuracy of the economic analysis. They also disagreed that the proposed rule was not a major rule that required review by Congress under the Small Business Regulatory Enforcement Fairness Act (SBREFA), asserting that it would have an economic impact of at least $100 million and would result in increased costs to consumers, levels of government, and regions due to failed businesses, the loss of stewardship of the land by livestock workers, as well as a loss of 40 percent of the sheep industry. They stated that this would affect competition, employment, investment, productivity, innovation, and the competitiveness of U.S.-based businesses.
Mountain Plains and Western Range, and Vermillion Ranch and Midland Ranch stated that the economic analysis did not take into account the cost of forcing ranches to close or to downsize. The commenters contended that employers would be forced to sell their herds, equipment, and land into a buyer's market. Many other commenters similarly stated that the economic analysis did not estimate the losses associated with the massive sale of livestock. Since 40 percent of the nation's sheep graze on ranges, the commenters asserted that the proposed rule could lead to the sale of breeding ewes for slaughter at undervalued prices because the market would not be able to absorb them. Mountain Plains and Western Range, for example, estimated that the total loss would be $212 million based on the total value of the U.S. sheep supply. They also emphasized that the ranchers could not simply raise prices to cover the increased costs because U.S. producers account for less than seven tenths of one percent of the world's wool production and less than nine tenths of one percent of the world's lamb production.
The commenters focused primarily on the proposed wage increase because labor is such a significant percentage of their operating costs, although the statistics they cited were not uniform. The Utah Farm Bureau Federation referenced an economic analysis conducted by Dr. Julie Shiflett of Juniper Consulting, which stated that hired labor accounts for 40 percent of total operating costs for an average western range sheep operation with two bands of sheep. The Rural Development Office cited the Utah Woolgrowers Association, which also stated that labor costs make up 40 percent of total operating costs in Utah sheep operations.
On the other hand, the Wyoming Livestock Board, the Texas Sheep & Goat Raisers Association, Mountain Plains and Western Range, and ASI and Public Lands Council summarized that current statistics from ASI show that, on average, hired labor costs make up 24 percent of a sheep rancher's total operating costs. The Diamond Sheep Company stated that wage costs represent approximately 20 percent of its operation's annual costs. The commenter noted that, in total, nearly 30 percent of its annual operating costs are labor-related when groceries—which make up approximately five percent—and travel and labor document fees—which make up 2 percent—are included.
Several commenters described the effect the proposed rule's wage increases would have on their operations, with some indicating that the proposal would result in annual operating losses:
• FIM Corp. stated that over the period of 2006-2013, its gross annual income from sales of wool, lambs, sheep, and hay averaged $1.1 million and that after operating expenses are taken out, its net income averaged approximately three percent of gross income. FIM Corp. further stated that the proposed tripling of sheepherder wages would result in approximately $250,000 per year in additional wage payments. The commenter also noted that it employs 11 H-2A sheepherders and seven workers for other ranch work, and stated that it treats them equally; hence, it would apply any wage increase imposed by the Department to all workers, which would cost the commenter's operation between $320,000 and $450,000 per year.
• David and Bonnie Little stated that they typically employ 10 sheepherders and that the proposed wage increase would add an additional $180,000 per year in payroll expenses, which exceeds their average adjusted gross income of $79,000.
• Steve Raftapoulos, an individual employer, stated that the proposed wage increase alone would result in a loss of approximately $120,000 in 2017 and $320,000 by 2020.
• The Siddoway Sheep Company stated that the proposed wage increase would result in increased costs of $98,354 over the first five years of implementation, excluding employer liability for payroll taxes, while using the FLS-based AEWR with no transition would result in increased costs of $138,539 over the first five years of implementation. Siddoway stated that the wage increases should be consistent with average wage growth, and stated (without noting that there has been almost no wage growth for H-2A herders since 1994) that the average wage for U.S. workers increased 3.13 percent in 2011, 3.12 percent in 2012, and 1.28 percent in 2013.
• Eph Jensen Livestock, LLC stated that, in 2014, wages paid to sheepherders accounted for nine percent of the gross revenue and would have accounted for as high as 30 percent if the proposed rule had been fully implemented.
In contrast to the comments from employers, the Worker Advocates' Joint Comment emphasized that the proposed monthly wage was inappropriately low. They criticized the weekly number of hours used to set the proposed monthly wage, presenting data from a survey of 90 H-2A herders indicating that only 7 percent worked less than 60 hours per week, while 62 percent worked more than 81 hours per week, and 35 percent worked more than 91 hours per week. In their view, this study demonstrates that the 44-hour assumption used in the proposal is a significant underestimate of the actual number of hours worked. In support of the view that the FLS-based AEWR should be immediately effective, the Worker Advocates' Joint Comment pointed to several examples of jobs that, in the their view, demonstrated that the ranching industry already supports workers earning the full FLS-based AEWR who perform similar work, particularly citing “Sheep, Farmworker General” in Wyoming, “Closed Range Herders” in Texas, and ranch hands performing livestock as well as other tasks. They further cited wage rates paid by employers “in states without large herder populations,” such as for Maine sheep farmers and sheep farm workers in North Dakota (both paid on an hourly basis). Further, they noted that California, where employers are significant participants in the H-2A program, has a wage rate for herders that is significantly higher than the current TEGL wages in other States.
In response to the comments on potential economic losses to H-2A employers attributable to the proposed
After carefully evaluating all of the available information, we found that the data did not warrant setting wages for these occupations based on the FLS-based AEWR for the reasons discussed in detail in the preamble and summarized below. If the rule would result in a substantial number of range herding employers closing their operations or significantly reducing the number of workers hired, that would result in fewer jobs being available to U.S. workers and would thus be inconsistent with the Department's obligation to protect against adverse effect to U.S. workers.
First, the Department received many comments from employers who have been in the business for many generations asserting that the proposed wage rate would cause many employers to either go out of business entirely or to downsize and greatly reduce the number of workers employed. Commenters provided enterprise budgets for the range sheep production firms in Wyoming, Idaho, and Utah.
The American Farm Bureau, using the average prices for 2000-2014,
Nevertheless, after considering variations from year to year, the data reflect that the increases in the prices of wool and lamb have outpaced the minimal increases in wages, and that based upon the 15-year average prices a substantial increase is wages could be absorbed. Thus, even the three primary employer associations have proposed setting the monthly AEWR based on a methodology that will result in wages significantly above the current TEGL rates, which we view as compelling evidence that the industry will remain viable even where employers pay a significantly higher wage rate to employees in these occupations. This is consistent with the fact that employers in Oregon and California are currently paying substantially higher wages (for example, in California the higher state minimum wage for sheepherders produces a monthly salary for sheepherders of $1,600.34, and effective January 1, 2016 it will increase to $1,777.98). Not only does the industry remain viable at those rates in those States, but California has the second highest number of employers participating in the H-2A sheep and goat herder program.
This evidence is supported by the few comments we received in support of the proposed wage methodology in the NPRM. These commenters stated that wage rates based on the full FLS-based AEWR, as in the proposed rule, are appropriate and necessary to protect against adverse effect on workers in the U.S. similarly employed. The Worker Advocates' Joint Comment provided prevailing wage data for various states based on wage surveys that show that some H-2A workers performing similar duties are paid at wage rates that are comparable to the full AEWR.
However, as discussed in the preamble, DOL found that data did not warrant setting wages for these occupations based on the FLS-based AEWR. The record indicates that the proposed approximate tripling in the wage rates, which would have resulted in higher wage rates than those in California in several states, could not be absorbed without a significant risk of job losses. Based on the comments from ranchers, the Department concludes that at least some sheepherding or goat herding employers would decide to leave the industry if, due to the extra costs, they would be able to earn income outside farming that is significantly higher than their reduced profits or no profit, especially due to the risky and unpredictable nature of agriculture and the fluctuations in prices that they receive with an ever-decreasing share of the world market. Therefore, we conclude that some ranchers would not be able to continue to do business if they had to pay H-2A workers at the FLS-based AEWR, thereby resulting in job losses in the range sheep production industry and related industries.
As noted above, the Department relied on the enterprise budget data submitted by commenters only in conjunction with all the other information in the record in coming to this conclusion, because there are several limitations on that data. First, the enterprise budget data is not available for all range sheep production firms in terms of various operational sizes and geographical areas, which are factors that may significantly affect costs and profitability. Second, budgets are generally constructed to reflect future actions, and it is difficult to accurately predict future commodity prices and yields. High degrees of variability in price and production adversely affect the reliability of the estimates used in the enterprise budgets. Third, it likely that some of the workers included in the enterprise budgets are paid wages above those required by the TEGLs; therefore,
In that regard, the Department did not receive any economic analysis pertaining to range cattle production, which is a much smaller part of the program than the range production of sheep; the limited data received for cattle herding is generally consistent with that received on sheep production. For example, Vermillion Ranch and Midland Ranch, individual employers, provided a link to a study
The Department understands that prices for wool and lamb have varied widely over the past 15 years, and that they are currently at historic highs, so that in determining the appropriate wage rate we cannot consider only what employers presently can pay without resulting in the loss of jobs. Based on the record in the comments as a whole, the Department concludes that some ranchers would not be able to continue to do business if they had to pay H-2A workers at the full FLS-based AEWR, as proposed; thus, there would be a potential for significant job losses in the range sheep, goat and cattle industries and related industries. Therefore, the Department modified the required monthly AEWR in the Final Rule in a manner generally consistent with a suggestion offered by Mountain Plains and Western Range and many other commenters, although modified in a manner suggested in the Worker Advocates' Joint Comment. Thus, the Department has decided to set wage rates for range sheep, goat and other livestock herders based on a formula that uses the current FLSA minimum wage as a starting point and updates it annually for inflation. These rates are in line with those set forth in the second of two alternative proposals by Mountain Plains and Western Range, a proposal that was endorsed by ASI and many individual employers. However, we modify their suggestion by increasing the number of hours in setting the monthly rate to 48 hours per week, and by shortening the transition period before the full monthly AEWR goes into effect. The record, including the comments from the three primary employer associations, demonstrate that such higher wage rates can be absorbed and will not result in significant job losses. In addition, the viability of these higher wage rates is supported by the fact that California has continued to have a vibrant herding industry (it is the second largest user of the H-2A herder program) even in light of the increased wage rates in that state. The Department concludes that the increase in operating costs under the new wage rate initially based on the FLSA should be manageable for ranchers and is the minimum necessary to overcome the decades of wage stagnation and require that the job opportunities are made available to U.S. workers at appropriate wage rates that will not result in adverse effect.
The Department received numerous comments related to the economic impacts of herding on other industries. Many commenters asserted that up- and down-stream businesses in related industries, consumers, as well as local, state, and national economies would be negatively affected by the implementation of the rule.
Several commenters, including ASI and Public Lands Council, the Texas Sheep & Goat Raisers Association, and individual employers, stated that since 38 percent of U.S. sheep are cared for by H-2A workers, if the proposed rule forced ranchers out of business, it could result in up- and down-stream losses. The Texas Sheep & Goat Raisers Association, ASI and Public Lands Council, and the Utah Farm Bureau Federation estimated that, in 2014 dollars, $1.00 of revenue produced by a sheep producer generates $1.71 in backward-linked industries and $0.80 in forward-linked good and services industries, for a total of $3.47 in additional economic impacts generated in the local, rural economy (Shiflett, ASI, Sheep and Lamb Industry Economic Impact Analysis, April 2008, Revised March 2011). They stated that the U.S. sheep industry annually generates approximately $500 million in backward-linked industries through the sale of items such as lambs, wool, and cull breeding stock. The direct and value-added multiplier effects were calculated to be an estimated $486.5 million, which supports an additional $1.2 billion in economic activity for a total of $1.7 billion. The sheep industry also supports forward-linked industries, such as local businesses, through expenditures of sheep-industry generated income on goods and services. Estimates of sales from retail lamb and wool-related products indicate that $785.6 million in production generates an additional $1.9 billion in multiplier effects. The commenters stated that the total economic impact is $2.7 billion. Mountain Plains and Western Range stated that the estimated value of the direct production of sheep cared for by H-2A workers is $275 million, and that revenue created in indirect up- and down-stream businesses is valued at more than $665 million.
The Texas Sheep & Goat Raisers Association and ASI and Public Lands Council further remarked that an estimated loss of $66,167 per rancher would generate approximately $229,320 in backward- and forward-linked businesses, and given that they estimate 598 operations employ herders, rural communities across the West would experience a loss of approximately $137.1 million. The commenters stated that a loss of over $66,000 per sheep rancher would result in 1.67 jobs being lost at the ranch, which would subsequently result in a total loss of 2.62 jobs in the local economy. They estimated that if 598 sheep operations employing herders suffered this loss, the total rural-employment loss would be 1,568 jobs.
Many commenters, including the Texas Sheep & Goat Raisers Association, the Wyoming Livestock Board, the Wyoming Wool Growers Association, the National Lamb Feeders Association, the Garfield County Farm Bureau, and TVB Management Company, discussed the broader impact of the rule. Some
Some commenters from supporting businesses expressed how the proposed rule would affect them. Below are three comments that were typical of the comments provided:
• Oregon Shepherd LLC, which manufactures all-natural wool building insulation, stated that it is a small business with three employees that depends on the U.S. sheep industry for raw materials. It is located in a rural Oregon county with a higher than average unemployment rate.
• Center of the Nation Wool, Inc. is a primary wool supplier to the U.S. textile industry and acts as a wool marketing agent for a large percentage of sheep enterprises, which are mostly small family operations that would be directly affected by the proposed rule. The commenter asserted that the implementation of the proposed rule could lead to a loss of textile jobs and destroy the entire lamb and wool marketing chain.
• Mountain State Rosen, LLC is an integrated lamb packer and processor. It employs over 300 people and has national distribution with annualized sales of $192 million. It is a producer-owned company affiliated with Mountain States Lamb Cooperative, which is comprised of 170 lamb producers located in 17 western states, and 65 percent of the lambs they market through their cooperative come from ranches with H-2A herders. The commenter stated that volume is critical to its business, and the proposed rule would force mass liquidation of western sheep operations, thereby doing significant harm to its business.
The New Mexico Department of Agriculture, the Wyoming Department of Workforce Services, the Wyoming Department of Agriculture, Governor Matthew H. Mead of the State of Wyoming, and John and Carolyn Espil suggested that the Department should perform a full economic analysis on the impacts that the proposed rule would have on local, State, and national economies. ASI and Public Lands Council stated that for some western states (
Other commenters expressed concern that the proposed rule would result in shortages of lamb and wool, because U.S. citizens could not afford or would not be willing to pay higher prices for lamb and wool. A consultant to ASI for military procurement stated that the proposed rule would disrupt the wool industry's ability and requirement (by the Berry Amendment) to support the U.S. Department of Defense (DOD) with wool for garments and blankets. The commenter stated that over 80 percent of the wool required by DOD is grown in the West on lands requiring shepherds. If domestic wool production is reduced by 38 percent, it may be impossible for the national industry to supply DOD. The commenter cited FY 2015 DOD-published accession, retention, and clothing issue rates, which indicate that DOD would spend over $300 million on wool-based garments and blankets in FY 2015. The commenter asserted that this expenditure could support as many as 5,000 manufacturing jobs in the U.S. economy, which may be lost if the proposed rule were implemented.
The Department is unable to accurately quantify the potential indirect economic impacts to related industries in the local and national economies, due to the lack of data and economic models necessary to conduct an appropriate analysis. Therefore, the Department estimated the costs only to the sheep, goat and range cattle production industries that are directed affected by this regulation, both in the NPRM's EO 12866 analysis and IRFA and in the Final Rule's analyses. In the absence of an economic input-output model or comparative general equilibrium model of the economy specifically developed for sheep, goat and range livestock production industries, it is not possible to measure the aggregate indirect economic impact of the Final Rule on other related industries in the economy with any degree of accuracy.
Numerous changes made in the Final Rule make these commenters' concerns about the impact on the broader economy unlikely. These include for example, the adoption of a definition of “range” that deletes the reference to fencing that so many commenters opposed, the adoption of a wage setting methodology that is similar to a suggestion offered by the three primary employer representatives, and the other flexibilities such as the deletion of the proposed 20 percent cap on the days that workers could perform duties at the ranch that are closely and directly relating to herding and/or the production of livestock. The Department concludes that the Final Rule will not likely result in the commenter predictions regarding the impact on the broader economy.
The Department also is responding to a few other specific comments that we received. John and Carolyn Espil stated that the Department misrepresented the make-up of the industry as presented in Exhibit 2 of the NPRM, which showed the number and percentage of H-2A employers by occupation and state derived from H-2A employer applications filed with the Department during FY 2011 and 2012. The Exhibit was not intended to reflect the total number of employers in the industry in Nevada as of January 2015 or the number of members of the Western Range Association. In the Final Rule, the Department has updated the number of H-2A employers by state using H-2A employer applications filed during FY
The Department disagrees with the comment that the proposed rule (or the Final Rule) should be considered a major rule requiring Congressional review under SBREFA. As detailed in the FRFA, the Department does not expect that the impact of the Final Rule will be over $100 million annually, which is the monetary benchmark of significance for a rule to be classified as major under SBREFA. The Department also does not believe that the Final Rule, which was significantly modified from the NPRM in response to the comments, will result in a “major increase in costs or prices” for industries, governments, or consumers, or that it will have a “significant adverse effects” on the economy, such as on competition, employment, productivity or the ability to compete.
The Department's analysis below considers the expected impacts of the following provisions of the Final Rule against the baseline (
For each of these provisions, the Department discusses the relevant costs, benefits, and transfers. In addition, we provide a qualitative assessment of transfer payments associated with the increased wages and protections of U.S. workers. Transfer payments, as defined by OMB Circular A-4, are payments from one group to another that do not affect total resources available to society. Transfer payments are associated with a distributional effect but do not result in additional costs or benefits to society.
The Final Rule codifies certain procedures for employers who apply to the Department to obtain temporary agricultural labor certifications to hire foreign workers to perform herding or the range production of livestock. The Final Rule also clarifies the proportion/type of work that is permitted to be performed by workers at the fixed-site ranch. Any job duties performed at a place other than the range (
This change represents a cost to employers engaged in herding and range livestock production that have had or will have workers at the ranch for more than 50 percent of the contracted workdays or have had workers perform incidental duties at the ranch that are not closely and directly related to herding and/or the production of livestock. These employers will be excluded from applying for workers pursuant to the special procedures unless they commit to complying with the limitations for such workers in the future. The Department is not able to estimate this cost, however, because we do not know how many workers currently spend more than 50 percent of their days working at the farm or ranch, although we believe the number is very small given the commenters' descriptions of the typical herding cycles, which generally involve months spent on the range. Particularly given the Final Rule's revised definition of the term “range,” which no longer includes the word “open” and which deleted the NPRM's proposed limitation to areas that were not fenced, we anticipate employers will be able to satisfy the requirement that at least 50 percent of the job order period be spent on the range. Further, the Final Rule deletes the NPRM's proposed 20 percent cap on the percentage of ranch days that a worker could spend performing closely and directly related work. Therefore, the Department anticipates that it is likely that affected employers will make any necessary adjustments to their practices so that the duties performed by herding and range livestock workers at the employer's fixed-site ranch will be closely and directly related to herding and/or the production of livestock.
As discussed above, the Department received numerous comments related to the proposed methodology for determining worker wages. In particular, employers and their representatives commented on (1) perceived flaws with the Farm Labor Survey (FLS) data, (2) wages not accounting for herder benefits, (3) the effect the proposed wage increases would have on the profitability of operations, and (4) flaws in the reasoning behind the methodology. Worker advocates commented that the proposed wage methodology incorporated a weekly number of hours worked that was too low and that the transition period was inappropriate.
Several commenters stated that it was inappropriate for the Department to determine proposed wages based on semi-annual FLS data produced by USDA's National Agricultural Statistic Service (NASS). For the reasons set forth in the preamble, the Department is not using FLS data in the Final Rule, but rather is relying on the current FLSA minimum wage of $7.25 as the starting point in the wage formula for 2016.
Numerous employer commenters, including Mountain Plains and Western Range and Calvin Roberts, an individual employer, stated that the Department's wage methodology was flawed because it did not account for the other “benefits” employees receive (
The provision of these items does not suggest a different wage is appropriate. As discussed in the preamble, all H-2A employers are required to provide housing free of charge. Furthermore, all H-2A employers are required to provide the tools, supplies, and equipment necessary to perform the job free of charge as well as any job-related transportation. Moreover, sheep and goat herder employers are required under the existing TEGL to provide food free of charge, and livestock herder employers have been required to do so in recent years based on the SWA wage survey. Nonetheless, this economic impact analysis accounts for the cost associated with this requirement for livestock employers below in a separate section.
The Utah Farm Bureau Federation and John and Carolyn Espil stated that the reasoning behind the wage methodology was flawed because the Department's attempt to protect U.S. workers by increasing wages is inappropriate. The commenters remarked that U.S. workers do not want to work in this occupation and are not suited for it. Mountain Plains and Western Range expressed the view that low wages are not the prime deterrent for workers and stated that, in their experience, despite higher wages in California they receive fewer U.S. applicants in sheep herding occupations in that state than in other states.
As discussed above, the Department has decided to set the monthly AEWR for these occupations based on a calculation of $7.25 per hour multiplied by 48 hours per week and adjusted annually for inflation. Because this Final Rule does not use the FLS-based AEWR to set the wage rates, the Department disagrees that meal credits should be included in the new wage formula to offset the wage increase because permitting food deductions under the wage methodology adopted in this Final Rule would erode much of the wage increase; therefore, it would not be sufficient address wage stagnation in these occupations.
As discussed in the preamble, we have elected not to use the FLS-based AEWR to set the monthly AEWR for these occupations because use of this wage source is likely to cause, rather than prevent, adverse effect on U.S. workers. For the reasons discussed above, this decision is not based upon flaws with the FLS as a data source or on commenters' views of the effects of the state law wage rate in California. As explained in the preamble, commenters' observations about California are inconsistent with DOL's experience that California is consistently among the states with the largest number of U.S. sheepherders identified in SWA surveys.
The Department also received many comments in response to the NPRM stating that costs related to the proposed wage increases were underestimated in the economic analysis. Mountain Plans and Western Range Association commented that the proposed wage requirements should be classified as costs rather than transfers. They reasoned that since most of the money earned by H-2A workers is spent in countries like Peru or Mexico, the proposed requirement results in a net loss for the U.S. economy. The Texas Sheep & Goat Raisers Association and Vermillion Ranch and Midland Ranch stated that the Department underestimated the costs of the proposed wage increases, especially for operations with more than three H-2A workers. The commenters estimated their annual costs using an estimate of $13,860 per year for one worker based on the 5-year phase in. Vermillion Ranch, which has 18 workers, would expect to pay $249,480 in additional wages, while Midland Ranch, which has 13 workers, would expect to pay $180,180.
In contrast to the employer comments, the Workers Advocates' Joint Comment stated that the phase-in methodology to the new wage is not justified. They noted that the current wage rates already reflect stagnated wages and asked DOL to consider this history of stagnation in requiring the full FLS-based AEWR to be paid immediately. In the Final Rule the Department does decrease the transition period to two years, and we also increase the number of hours per week on which the monthly AEWR is based.
In the NPRM's EO 12866 analysis assessing the total costs and transfers to society, the proposed wage increases were classified as a transfer. Transfer payments are defined as monetary payments from one group to another that do not affect total resources available to society. However, contrary to the commenters' statements, the proposed wage increases also were classified as additional costs to small H-2A employers in IRFA assessing the impact to H-2A employers (as they are in the analysis in the Final Rule). Wage increases are both transfer payments (to society) and costs (to employers); however, we recognize that foreign employees send at least some of their wages to their families abroad.
The Final Rule changes the methodology for determining the required monthly AEWR for workers engaged in the herding or production of livestock on the range. The Final Rule sets the monthly AEWR for these occupations by multiplying a $7.25 hourly wage rate by 48 hours per week, indexed annually beginning in the second year based on the ECI. The Final Rule uses a two-year transition period (at 80% and 90% of the full rate in 2016 and 2017, respectively) with full implementation in year three (2018).
Exhibit 4 presents the number and percentage of employers engaged in the herding or production of livestock on the range participating in the H-2A program and the state for which they applied for certified H-2A workers. The number of employers is based on the H-2A certification dataset over FY 2013-2014. Note that each employer is counted once for each state for which the employer applied for workers, although due to the itinerant nature of the work, some employers applied for certification covering areas of employment for workers in multiple states. Hence, Exhibit 4 overstates the number of employers participating in the H-2A herder and range livestock program. As Exhibit 4 illustrates, sheepherders and goat herders are most heavily concentrated in Arizona, California, Utah, and Colorado, while range livestock (
To estimate the new monthly AEWR, the Department first calculates the average quarterly wages and salaries ECI for each year from 2012 through 2014. We then take the average year-over-year growth rate and apply the resulting value (2.0 percent) to the initial $7.25 hourly base wage rate used in 2016 and do so each successive year to forecast the hourly base wage rates from 2017 to 2025. The new wage setting methodology will base the calculation on 48 hours per week and includes a two-year transition period. The Department estimates the hourly base wage rate for each year of the analysis period as follows:
Exhibit 6 presents the forecasted ECI-adjusted $7.25 hourly wage rates with the two-year transition period and full implementation in 2018.
To convert this to a monthly wage rate, the Department multiplies the above rates times the estimated 48 hours per week and by 4.333 weeks per month. Exhibit 7 presents the monthly wage rates.
Exhibits 8 and 9 present the wage differential between the monthly AEWR required under this Final Rule and the baseline by state for sheep and goat herders and range livestock production workers, respectively. In the case of California, the monthly AEWR wage is lower than the baseline wage for the first nine years, because state law requires a higher wage. In those years, the workers will continue to receive the baseline wage; therefore, no wage differential results. Similarly, Oregon's state required wage is higher than the rate required under the AEWR calculation of this Final Rule, and it is adjusted annually for inflation using the CPI-U. Accordingly, workers in that state will continue to be paid the state-required rate and employers in Oregon will not be impacted by the wage increase in this Final Rule. Hawaii's current monthly wage of $1,422.52 is based on a 2012 prevailing wage survey conducted by California, and the Final Rule's monthly AEWR is lower than Hawaii's current baseline wage in the first two years. The Department assumes that the workers in Hawaii will continue to receive the baseline wage in those years; therefore, no wage differential results. Additionally, the hourly wage differentials for states that did not have a baseline wage because there were no H-2A workers employed as herders or range livestock workers are denoted as “N/A.” Note that these values are for informational purposes only and were not used in the analysis.
The Department multiplies the average increase in hourly wages per H-2A worker under this wage determination option in 2016 ($1.53) by the estimate of weekly hours (48) and the average duration of need (50 weeks) to obtain the total increase per H-2A worker in 2016 ($3,672). We then multiply the total increase per worker by the number of H-2A certified workers (2,481) to obtain total transfer due to increased wages of $9.11 million in 2016.
The increase in the wage rates for some workers represents an important transfer from agricultural employers to corresponding U.S. workers, not just H-2A workers. As noted previously, the higher wages for workers associated with the Final Rule's methodology for determining the monthly AEWR will result in an improved ability on the part of workers and corresponding U.S. workers and their families to meet their costs of living and spend money in their local communities. On the other hand, higher wages represent an increase in costs of production from the perspective of employers that affects economic profit and creates a disincentive to hire H-2A and corresponding U.S. workers. The Department does not have sufficient information to measure the net effect of these countervailing impacts.
There also may be a transfer of costs from government entities to employers as a result of lower expenditures on unemployment insurance benefits claims. Unemployment insurance benefits replace a maximum of half of prior earnings in most states. However, to the extent that workers who had been laid off and were eligible for unemployment insurance benefits were not willing to accept a job at the current lower wage, and may now be willing to accept the job at the new higher wage, they would not need to seek new or continued unemployment insurance benefits. The Department, however, is not able to quantify these transfer payments.
The Final Rule permits an association of agricultural employers filing as a joint employer to submit a single job order and master
This provision does not represent a change for an association filing a master application as a joint employer with its employer-members for sheepherding or goat herding positions. However, to ensure consistency in the handling of all employers eligible to use these procedures, the Final Rule extends this existing practice to employers in the range herding or production of other livestock.
This change represents a minor cost reduction to employers of H-2A workers in range livestock production occupations that file master applications as joint employers with their employer-members. Due to data limitations regarding the time savings realized by filing a master application relative to separate applications and the extent to which range livestock production employers would file master applications as joint employers with their employer-members, however, the Department is not able to quantify this impact.
The Final Rule extends the waiver of job order filing requirements in 20 CFR 655.121(a) through (d) to employers of H-2A workers in range livestock production occupations. A covered employer will submit its job order,
This provision does not represent a change for an association filing a master application as joint employer with its employer-members for sheepherding or goat herding positions. However, to ensure consistency in the handling of all employers eligible to use these procedures, the Final Rule extends this existing practice to all employers involved in the range herding or production of other livestock.
This change represents a minor cost reduction to employers of H-2A workers in range livestock production occupations who will no longer be required to prepare and send a separate ETA Form 790 submission to the SWA and then communicate directly with the SWA about any concerns the SWA raises with the ETA Form 790. Due to data limitations, however, the Department is not able to quantify the staff time and resource costs saved relative to the baseline in which submission of the form and communication with the SWA is required.
The Final Rule requires that, where a single job order is approved for an association of agricultural employers filing as a joint employer on behalf of its employer-members with different start dates of need, each of the SWAs to which the job order was transmitted by the Contracting Officer (CO) or the SWA having jurisdiction over the location of the association must keep the job order on its active file until 50 percent of the period of the work contract has elapsed for all employer-members identified on the job order, and must refer each qualified U.S. worker who applies (or on whose behalf an application is made) for the job opportunity. The Final Rule also requires that the Department keep the job order posted on the OFLC electronic job registry for the same period.
This change represents a possible cost reduction for an H-2A employer association that files a master application as a joint employer with its employer-members for workers in sheepherding and goat herding occupations. These employers were previously required to accept referrals throughout the work contract period. Under the Final Rule, these employers will only have to accept referrals for 50 percent of the work contract period, resulting in avoided costs of accepting referrals during the second half of the work contract period. Due to data limitations regarding the number of referrals during the second half of the work contract period, however, the Department is not able to quantify this impact.
The Final Rule continues for sheepherding and goat herding occupations and expands to other range livestock production occupations the TEGL practice of granting a waiver of the requirement to place an advertisement on two separate days in a newspaper of general circulation serving the area of intended employment. Because both herding and the range production of livestock cover multiple areas of intended employment in remote, inaccessible areas within one or more states, the newspaper advertisement is impractical and ineffective for recruiting domestic workers for these types of job opportunities.
This change represents a cost reduction to employers of workers in range livestock production occupations. The Department estimates this cost reduction by multiplying the estimated number of applications filed by range livestock production employers each year (107, as determined from a review of 2013 and 2014 applications for labor certification in the herding program) by the average cost of placing a newspaper advertisement ($258.64) and the number
Because these activities require time on the part of a human resources manager on the ranch, we add to the result the incremental cost of preparing the advertisement, which we calculate by multiplying the estimated number of applications filed by range livestock production employers each year (107) by the time required to prepare a newspaper advertisement (0.5 hours), the hourly labor compensation rate of a human resources manager at an agricultural business ($78.48), and the number of advertisements per employer (2).
In total, the cost reduction from not having to place the advertisement and saved labor yield an average annual cost reduction of $0.06 million.
The Department received one comment pertaining to the cost reductions by waiving newspaper advertisements for workers in range livestock production occupations. The Department estimated a labor cost of a human resources (HR) manager to prepare the advertisement. Patrick O'Toole, a private citizen, stated that family members typically serve as the HR managers; hence, they do not receive benefits along with their wages, and they do not spend all of their time acting as the HR manager.
Even if family members serve as the HR managers and are not explicitly compensated for their time and work, it is still considered a cost reduction under the opportunity-cost approach used in the economic analysis for costing purposes. This is similar to the expenditure for family labor in the enterprise budget when family members are not actually paid for their labor. Thus, the Department believes that the inclusion of the labor cost of an HR manager is still reasonable.
The Final Rule requires that eligible U.S. workers who apply for the job opportunities and are hired be placed at the locations nearest to them, absent a request for a different location by the U.S. workers. The Final Rule also requires that associations that fulfill the recruitment requirements for their members maintain a written recruitment report for each individual employer-member identified in the application or job order, including any approved modifications.
The U.S. worker placement requirement represents a minor cost reduction. Because U.S. workers will be placed at locations nearest to them, the Final Rule will yield a decrease in travel costs to arrive at and return from the work site. Due to data limitations regarding travel costs to arrive at and return from the work site for participating U.S. workers, however, the Department is not able to quantify this impact with any certainty.
The recruitment report requirement represents a cost to an association of employers of workers in range livestock occupations. Associations will be required to maintain a written recruitment report for each individual employer-member; however, associations are currently required to document all applications and their disposition, making this a change in the form of the recordkeeping rather than its substance. This will likely lead to a marginal increase in costs for the association to prepare and maintain a more disaggregated recruitment report for each employer-member named on a master application. The Department is not able to quantify this impact with any certainty, however, due to data limitations regarding the time required for associations to prepared and maintain a more disaggregated recruitment report.
In the NPRM, the Department proposed to require that the job offer specify that the employer will provide, without charge or deposit charge, those tools, supplies, and equipment required by law, by the employer, or by the nature of the work to do the job safely and effectively. Because of the isolated nature of these occupations, an effective means of communication between worker and employer—to enable the employer to check the worker's status and the worker to communicate an emergency to persons capable of responding—is required because it is necessary to perform the job safely and effectively. The workers' location may be so remote that electronic communication devices may not work at all times. Therefore, the NPRM proposed to continue the TEGLs' current requirement for the employer to provide an effective means of communicating in an emergency. The Final Rule similarly provides that where the employer will not otherwise make regular contact with the worker (
The Department received several comments on the cost of employer-provided items—including the cost of maintaining regular contact. Sharon O'Toole, an individual employer, stated that it is not necessary to quantify the cost of regular contact between employers and herders, as it has been a common practice for decades to ensure the conditions of herders, sheep, horses, and dogs, which is in an employer's business interest. Contact usually occurs when someone delivers items such as food and water. In contrast, the Wyoming Farm Bureau Federation stated that it is not possible to get a cellular signal in some areas. The commenter noted that a satellite phone plan that allows 10 minutes of usage per month costs at least $300 per year, not including the price of the phone, and that plans can cost as much as $2,000 per year.
The Department understands that there is a range of different ways to establish effective communication between employers and their workers to address the workers' basic needs and to enable contact in an emergency. Employers are not required to provide satellite phones, as they do not always provide reliable service, when other effective means of communication are available. The Department expects that very few employers will have to purchase satellite phone to communicate with their workers.
The Department also received several comments pertaining to the quantification and data sources for other items they stated should be monetized in the economic analysis. For example, Governor Matthew H. Mead of the State of Wyoming remarked that the
Many of these costs, such as the cost of housing and related provisions (utilities/propane), are required by the H-2A program generally; thus those costs are not new or unique under this Final Rule. Other employer business expenses, such as a worker's travel to and from the home country, visa fees, or employer association fees, also are the responsibility of the employer under the standard H-2A regulations. Anything that is newly required by this Final Rule, such as free meals for range livestock workers, is acknowledged and discussed separately.
Finally, many commenters, including Mountain Plains and Western Range, the Washington State Sheep Producers, and John and Carolyn Espil, stated that the Department should monetize the impact caused by the change in the definition of “open range,” which they asserted would exclude approximately 40 percent of employers that currently use the H-2A program. As explained in detail in the preamble, commenters explained that livestock grazing varies substantially, depending on the particular ranch owner and/or the geographic location, and they emphasized that modern grazing contains fencing. Commenters almost unanimously opposed using fencing as a defining factor for “open range.” In response to the comments related to definition of “open range,” the Department decided to use a modified version of the FLSA definition of “range” to provide flexibility and account for the changes in herding practices over time. The Department believes this revised definition of “range” will not impose any additional costs on employers, as most comments indicate that employers assign their H-2A workers to the range for at least the majority of the year.
In the final rule, employers are also required to provide:
• Containers appropriate for storing and using potable water and, in locations subject to freezing temperatures, containers must be small enough to allow storage in the housing unit to prevent freezing;
• facilities, including shovels, for effective disposal of excreta and liquid waste in accordance with the requirements of the state health authority or involved Federal agency; and
• appropriate materials, including sprays, and sealed containers for food storage, to aid housing occupants in combating insects, rodents and other vermin.
The requirement that employers arrange for the workers to be located in a place where the electronic communication device will operate effectively on a regular basis when they are stationed in areas where the devices may not work, or to provide regular in-person contact, represents a possible minor cost to herding or range livestock production employers. This may impose restrictions on land use or require the purchase of particular types of communication devices. The Department cannot, however, predict this impact or quantify it as a cost to employers, but we anticipate that it will be minimal as the current TEGLs contain a similar communication requirement and many employer commenters stated that they are in routine contact with their workers to monitor their health and well-being and that of the herd.
The Department believes that most existing employers already provide to H-2A workers on the range containers for storing and using potable water, shovels for effective disposal of excreta and liquid waste, and insect and rodent control materials such as sprays and sealed containers for food storage in order to satisfy their current requirements under the TEGLs. Even for the small fraction of employers who currently do not provide any such items to H-2A workers on the range, the additional costs would be trivial, at most $50 in 2016.
All H-2A employers must provide either three meals a day or free and convenient kitchen facilities. Currently, as required under the sheepherding and goat herding TEGL and pursuant to practice in the industry for range production of livestock occupations, employers with these range herding occupations must provide food, free of charge, to their workers. The Final Rule adopts this common practice as a requirement for employers engaged in the range production of livestock (who now must provide free food pursuant to the prevailing industry practice) and continues it for employers engaged in sheep or goat herding. The Final Rule also requires employers to disclose it in the job offer. The Final Rule clarifies that the food must be “sufficient” and “adequate” and that it must include a daily source of protein, vitamins and minerals. The employer commenters agreed that the physical demands of the job require a protein-rich diet, and that the workers need and deserve good, nourishing food; they stated that they currently provide such food to their workers, typically in response to the workers' expressed preferences for particular food.
Because this is a current requirement of the sheepherding and goat herding TEGL, this provision does not represent a cost to sheepherding and goat herding employers (the Department concludes that the clarifications requiring that the food be sufficient and adequate, and include a daily source of protein, vitamins and minerals, impose no additional quantifiable cost, particularly given the employers' assertions that they are providing such food now). This provision does, however, represent a cost to other range livestock production employers.
In addition to the cost incurred to purchase food, these range livestock production employers would incur costs to transport the food to the workers. The Department assumes that food would be transported to the workers on a weekly basis along with the potable water. The costs related to transporting food and potable water are accounted for below in the section on costs related to potable water.
The Department received only a handful of comments directly pertaining to the economic analysis of providing meals without charge to workers. However, as discussed in the preamble, some commenters opposed the proposed provision to provide daily meals to workers for free and wanted to be permitted to take a wage credit for the cost of meals, while others thought that providing free food was appropriate. For example, Sharon O'Toole stated that if an employer is not already providing adequate food to employees, then they are in violation of other laws and should not be covered by this rule. She also commented that providing access to expanded cooking facilities is unnecessary because the workers are already provided with hot meals at the ranch.
Vermillion Ranch and Midland Ranch stated that the cost of providing meals increases operating costs substantially when the number of workers hired increases. They said that for Vermillion Ranch, the cost of the meal provision requirement would be $72,954 for 18 workers as opposed to the $12,159 estimated by the Department. The Siddoway Sheep Company stated that during the winter lambing season it employs a cook who prepares the workers three meals each day, and that when workers are on the range, it purchases food every eight to 10 days. The commenter expressed that actual food expenditures, including meat grown on the ranch, average $476 per worker per month. Siddoway provided three alternatives that it supported: (1) Allowing employers to deduct the cost of purchasing the food products on the employee's grocery list; (2) a ranch-specific deduction based on annualized expenditures over a three-year period; and (3) an industry-wide deduction equal to 128 percent of the liberal USDA Food Plan Cost, which is what it estimated it spends on meals. ASI and Public Lands Council, and Mountain Plains and Western Range, also pointed to the USDA liberal meal plan and stated that such a meal plan is more expensive than the subsistence meal charges that the Department uses for workers. For the reasons discussed in the preamble, including the current free food requirements and that the Final Rule uses the FLSA minimum wage rate of $7.25 as the starting point for the wage requirement, we did not permit employers to offset the cost of meals to avoid continued wage stagnation; rather, we have identified it as a cost for range livestock production employers.
The Department received several comments related to the costs of transporting meals and potable water to workers. As summarized below, the commenters (1) stated that the economic analysis did not fully capture the cost, (2) described the amount of water provided and the types of containers typically used at their locations, (3) listed alternative sources of water not specified by the Department, and (4) were generally opposed to employers being required to provide water for laundry.
Several commenters remarked that the Department's economic analysis underestimated the cost to transport meals and potable water; several commenters also provided cost estimates. Eph Jensen Livestock, LLC and Mountain Plains and Western Range stated that the Department did not account for the actual distances traveled between the ranch and camp or how the time needed to travel can vary depending on the type of terrain. Eph Jensen Livestock, LLC, stated that the Department did not account for areas in which vehicle travel is prohibited or impossible. The Wyoming Farm Bureau Federation also commented on the difficulties associated with using a trailer for water. The trailers must often be driven on roads that are two tracks or not maintained. These conditions make it difficult to drive in reverse and drivers occasionally get stuck. In addition, workers' mobile housing units already have a trailer attached. Attaching another trailer would make traveling unsafe, increase traveling time, and result in additional costs. The commenter also noted that some states prohibit the use of triple trailers.
Mountain Plains and Western Range and Sharon O-Toole stated that the estimated costs for providing meals and water did not include the cost of purchasing additional trucks or water trailers. Several commenters stated that in addition to the costs for the truck and trailer, the Department should include the cost to hire a driver with a commercial driver's license. They noted that it recently cost them $45,000 for a cab with 500,000 miles and $8,000 for a used trailer. Sims Sheep Co. LLC stated that trailers and tanks would be more expensive than estimated because they would need to be tailor-made to withstand the weight of the water and poor road/terrain conditions. Paul Nelson stated that it costs $15 for gas each trip, $30 per worker to transport water and other necessities. Cindy Siddoway stated that transportation to mountain camps would require them to purchase eight pack horses, which would cost $9,600 in addition to food and pack saddles. Vermillion Ranch and Midland Ranch stated that the costs of providing sufficient potable water for drinking, cleaning, and laundry using the Department's estimate of $4,910.96 per worker would be $88,397.28 per year and $63,842.28 per year for Vermillion Ranch and Midland Ranch, respectively, given their large number of employees.
Paul Nelson and Cindy Siddoway stated they provide water in five-gallon containers. Donald Watson stated that he provides water in either five-gallon containers, 50-gallon barrels, 400-gallons tanks, or from containers filled by hose, depending on the location. A handful of individual employers warned that large water tanks could restrict workers' access to water during winter months if the water freezes, and that a preferable alternative would be smaller potable water containers that could fit inside the workers' housing units and would thus not be subject to freezing.
Several commenters listed alternative sources of water. The Wyoming Farm Bureau Federation and Sharon O'Toole listed melted snow as an alternative water source, and Cindy Siddoway listed mountain springs and streams as alternative sources. Commenters stated that workers have tools to boil water to
The Department understands that these alternative sources of water would be almost costless relative to the estimated costs of potable water in the economic analysis. However, such alternative sources are not always available, and for health reasons the Department must require that workers have available potable water (or in exigent circumstances the means to make water potable) for consumption, cooking, and dishwashing.
Several commenters opposed the proposed requirement for employers to provide enough water for laundry, stating either that non-potable water sources are often available that are adequate for washing laundry or, more often, that they wash laundry for the workers and deliver it when they bring food to the workers. They stated that this is more cost-effective than transporting water for workers to wash laundry themselves.
A few commenters stated how much water was typically needed in their operations. Sharon O'Toole stated that 40 gallons of potable water per week is enough for a worker to drink and wash. Eph Jensen Livestock, LLC commented that the amount of water needed varies depending on climate.
The Workers Advocates' Joint Comment outlined several suggestions regarding what constitutes an adequate supply of potable water. They stated that the supply of water should be defined as 4 to 4.5 gallons of potable water per day in clean and sealed containers, which amounts to 28 to 31.5 gallons per week. They also noted that the water supply should include an additional 50 gallons per week for cleaning, bathing, and laundry, which is based on comments from range workers. The commenters stated that range workers should be supplied with a means for water purification only in exigent circumstances (
For the reasons discussed in the preamble, in the Final Rule the Department requires employers to provide at least 4.5 gallons of potable water per day, which amounts to at least 31.5 gallons of potable water per worker per week (4.5 x 7). The Department does not specifically define the minimum quantity of water that must be provided for bathing and laundry. The Final Rule also allows the use of alternate sources of water for bathing and laundry where such sources are readily available. Moreover, we note that if employers provide laundry services for workers that likely will substantially minimize their need for water for that purpose. Finally, the Final Rule allows the employer to request a variance from the requirement to provide 4.5 gallons of potable water when workers are located in areas that are not accessible by motorized vehicle; the employer must identify an alternative water supply and disseminate both the means and methods for testing and making potable the water obtained for drinking and cooking from such alternative supplies.
In the NPRM's EO 12866 analysis, the Department estimated that range sheep, goat, and other livestock production employers already must incur the cost under the TEGLs of transporting both food and water for cooking, consumption and bathing to their workers on the range, which must meet state health authority standards. The NPRM proposed to add a requirement for additional water for cleaning and laundry. The Department assumed that the additional water would be transported to the workers on a weekly basis along with the previously required food and potable water. The cost of providing a water supply to workers was estimated as the sum of the cost of the water itself, the cost of purchasing utility trailers to transport the additional water and meals, the cost of mileage for those vehicles, and the wages for the drivers to transport the additional water and meals. The Department noted that because employers are currently required to provide food and water to workers, our cost estimate in the analysis likely was an overestimate.
The Final Rule continues the same general approach, with the modifications discussed above. The Department concludes, given the changes made in the Final Rule, particularly the employers' ability to identify alternative sources of water for bathing and laundry, that the NPRM's general approach remains valid. In addition, because the Final Rule requires only that workers spend the majority of their time on the range, we continue to believe that the estimate likely produces an overestimate because the analysis assumes that the water and food is transported 50 weeks of the year.
The Department estimates the cost of purchasing the water by multiplying the estimated number of employers in each year (485) by the average number of H-2A workers per employer needing potable water on a weekly basis (4.2), the number of gallons of potable water needed per worker on a weekly basis (31.5), the average cost of a gallon of potable water ($0.005), and the average duration of need (50 weeks).
Because the employers must have the means to transport the potable water and food to the workers, the Department estimates the cost of purchasing utility trailers. We assume that 10 percent of agricultural employers do not currently have a trailer sufficient to transport the additional water and food to workers. In the first year of the rule, we include the cost incurred by existing and new H-2A employers to purchase trailers; in future years, we include the cost incurred only by new participants. To calculate the cost for the first year of the Final Rule, we multiply the total number of participants in the program (485) by the assumed percentage of employers that would need to purchase a trailer (10 percent). We then multiply the number of employers needing to purchase a trailer (49) by the average cost of a trailer ($839.34) to estimate the total cost of purchasing utility trailer each year ($40,708).
The Department also estimates the cost of mileage on the employers' vehicles. The mileage reimbursement rate is intended to cover the costs of operating a vehicle for business purposes. The costs encompassed by the standard mileage rate are standard maintenance, repairs, taxes, gas, insurance, and registration fees. Essentially, the standard mileage rate is intended to cover the expenses that an individual would report if using the actual car expenses deduction. While the standard mileage reimbursement rate is simply an estimate and may end up being more or less than actual car expenses, it reflects the full cost of operating a truck for transporting the water and meals. However, the Department assumed that employers already would have a truck for delivering food and water as it is currently required by TEGL and therefore, did not include the cost of purchasing a new truck in this analysis. We estimate this cost by multiplying the estimated number of employers in each year (485) by the average cost per mile of owning and operating an automobile ($0.58), the number of miles driven (roundtrip) to deliver the water and meals (100), and the number of roundtrips expected per year (50).
Because these activities require time on the part of an agricultural worker on the ranch, the Department estimates the cost of transporting the potable water and food to the workers, which we calculate by multiplying the estimated number of employers in each year (485) by the assumed time required to transport the potable water and food (2.86 hours), the hourly labor compensation rate of an agricultural worker ($13.40), and the number of roundtrips per year (50).
This calculation yields an average annual cost of $2.4 million for the cost of the water, utility trailers, vehicle mileage, and labor to deliver the additional water and food.
The Department recognizes that there are times when workers are located at or near the ranch or farm (or a similar central location) for certain operations that are a normal part of the herding cycle, such as birthing (in some cases), shearing, or branding. In such instances, the Final Rule allows workers to continue to use their mobile housing, which may be preferred by workers, even where access to fixed housing exists. However, the Final Rule requires (as the NPRM proposed) in such a situation that workers be granted access to facilities, including toilets and showers with hot and cold water under pressure, as well as cooking and cleaning facilities that satisfy the standard housing requirements if the employer does not provide meals.
The Department received a couple of comments in response to the NPRM pertaining to the cost to provide expanded cooking facilities at a ranch or farm. Sharon O'Toole commented that providing access to expanded cooking facilities is unnecessary because the workers are already provided with hot meals at the ranch. Vermillion Ranch and Midland Ranch objected to the term “ranch” in conjunction with the proposed locations of the expanded cooking facilities.
As the Department stated in its NPRM economic analysis, we do not expect any additional costs for construction or expansion of cooking facilities because existing farm kitchens will be able to increase production to a sufficient extent to provide for the additional workers. As several commenters stated, some employers already provide hot meals to H-2A workers at the ranch. Alternatively, employers need not incur any additional cost to construct or expand cooking facilities as they could simply provide the workers with access to the existing farm kitchen to prepare their own meals.
The requirement to provide access to facilities such as toilets and showers with hot and cold water under pressure, however, will likely impose a cost on herding and range livestock production employers that do not have such facilities for worker use. To estimate the cost of constructing or expanding the cleaning facilities for the first year of the Final Rule, the Department estimates the number of existing H-2A participants that would need to construct/expand cleaning facilities, which we calculate by multiplying the number of existing H-2A participants (485) by the assumed percentage of employers that would need to construct or expand their facilities (20%). We then multiply the number of existing employers that would need to construct/expand facilities (97) by the average cost per square foot to construct or expand cleaning facilities ($270.00) and the assumed size of the cleaning facility (150 sq. ft.).
To calculate the cost for each of the remaining years of the Final Rule, we estimate the average number of employers joining the program that would need to construct such facilities, which we calculate by multiplying the number of participants joining the H-2A program (49) by the assumed percentage of employers that would need to construct or expand their facilities (20%). We then multiply the number of employers joining the H-2A program needing to construct or expand their facilities (10) by the average cost per square foot to construct or expand cleaning facilities ($270.00) and the assumed size of the cleaning facility (150 sq. ft.) to estimate the total cost of constructing or expanding facilities in each remaining year ($0.4 million). Over the 10-year period, this calculation yields an average annual cost of $.75 million to existing and new employers.
In the Final Rule, as specified in § 655.235, the mobile housing unit provided to workers must include operable heating equipment that supplies adequate heat for workers in locations where required for the health and safety of the workers by the climate. Where the climate in which the housing will be used is mild and the low temperature for any day in the work contract period is not reasonably expected to drop below 50 degrees Fahrenheit, no separate heating equipment is required as long as proper protective clothing and bedding are made available, free of charge or deposit charge, to the workers.
The Department acknowledges that this may impose a cost on some employers, but we do not have sufficiently accurate location and temperature available to identify how many workers may require such additional heating units or how many of the mobile housing units already contain built-in heating equipment. The Department evaluated possible portable heating equipment units that are suitable for a housing unit of approximately 150 square feet to determine the range of costs required to purchase heating units. We found 12 different types of portable heating equipment suitable for heating at least 150 square feet, including propane units, kerosene units, and electric units. The propane units range in cost from approximately $69 to $280;
The Department estimates the number of existing H-2A participants that would need to purchase portable heating equipment, which we calculate by multiplying the number of existing H-2A participants (485) by the assumed percentage of employers that would need to purchase portable heating equipment (20%). We then multiply the number of existing employers that would need to purchase portable heating equipment (97) by the average cost of a portable propane heating unit ($150.00). This calculation results in a cost of $14,550 in 2016. The Department added gas costs to employers by assuming that the average price of propane is $3 per gallon and that it would require approximately 323 gallons
To calculate the cost for each of the remaining years of the Final Rule, we estimate the average number of employers joining the program that would need to purchase such equipment, which we calculate by multiplying the number of participants joining the H-2A program (49) by the assumed percentage of employers that would need to purchase portable heating equipment (20%). We then multiply the number of employers joining the H-2A program needing to purchase such equipment (10) by the average purchase cost ($150.00) to estimate the total cost of purchasing portable heating equipment in each remaining year ($1,455). The total cost of providing portable heating equipment and propane is $95,448 in 2017 and thereafter.
The NPRM required that employers generate a daily record of the site of the employee's work, whether it was on the range or on the ranch or farm, and for periods when the worker was on the ranch a record of the hours worked and duties performed. The Department received several comments on the costs of generating daily records of a worker's hours and duties in response to this requirement. Several commenters stated that the Department underestimated the costs associated with the proposed requirement, while one commenter stated that the Department overestimated the costs.
For example, the Wyoming Farm Bureau Federation and Sims Sheep Co. LLC commented that the Department underestimated the costs. The Wyoming Farm Bureau stated that the Department used flawed assumptions in its estimation and remarked, along with John and Carolyn Espil, that most employers do not have an HR manager—often family members are used to perform these tasks. Secondly, the commenter stated that ranch operations do not occur in locations such as offices or manufacturing facilities that are convenient for record keeping. Without access to a clock, it is difficult to track the amount of time spent on activities, which may change unexpectedly (
The Worker Advocates' Joint Comment stated that the Department's methodology for estimating the cost of complying with the proposed record keeping requirement was reasonable; however, they stated the cost may have been overestimated. The commenter noted that operations that employ workers who are not covered by the current herder exemptions are already required to have payroll systems that meet Fair Labor Standards Act (FLSA) requirements, and that it would not require much time to incorporate herder information into those systems. The commenter stated that the benefit of having these records available for monitoring and enforcement outweigh the minor cost of compliance, as the employees generally would bear the responsibility for recording their own time.
The Final Rule modifies the NPRM's proposed recordkeeping requirements by eliminating the requirement to record hours worked when workers are not on the range and by eliminating the requirement to record the duties performed each day when workers are not on the range. The Final Rule retains only the requirement to record daily whether work was performed on the range or at the farm or ranch.
This change represents a minor cost to herding or range livestock production employers who are not already creating and retaining records. Given that the Department received contradictory comments that it had either overestimated or underestimated the costs of the proposed recordkeeping requirement, the Department maintains its average estimate of the time required. The Department estimates the cost by multiplying the time required to prepare and store the records by the average compensation of a human resources manager at an agricultural business. In the first year of the rule, the Department estimates that the average employer will spend approximately 6 minutes each week or approximately 5 hours a year (based on a 50 week average period of need) to prepare and store the records, which amounts to approximately $392.40 ($78.48 x 5) in labor costs per year.
During the first year that this rule would be in effect, herding and range livestock production employers would need to learn about the new requirements. The Department received a couple of comments related to the cost to read and review the proposed rule, which expressed the view that the Department's estimate was too low. For example, Sheep! Magazine commented that it would take longer than two hours to read and review the proposed rule. The commenter stated that the average American cannot read 400 words per minute, especially when reading regulatory language. Vermillion Ranch and Midland Ranch stated that the Department's estimate of the average annual cost ($15.18) to review the NPRM was an underestimate because employers or associations would have to hire counsel and experts to review the NPRM and prepare feedback and guidance. The commenters suggested that it would cost $15,000 per employer.
In response to comments, the Department revised its estimate of time to read and review the Final Rule upward to four hours. While the Department understands that different employers may take more or less time to read and review the rule, it believes that four hours on average is a reasonable estimate of the time needed to learn about the new requirements. The text of the regulation is quite limited in length and scope as it addresses only the subset of requirements for herding and the range production of livestock that are exceptions from the standard H-2A regulations. Further, the Final Rule does not require employers to retain counsel or other advisors to assist them, and the Department will make available compliance assistance materials, including a specific small business compliance guide, that many employers may choose to read in lieu of reading the regulation itself.
This requirement represents a cost to herding and range livestock production employers in the first year of the rule. The Department notes that the cost of reading and reviewing the rule ($313.92) is incurred only in the first year; amortized over the rule's 10-year lifespan, the average annual cost is only $31.39. The Department estimates this cost by multiplying the time required to read and review the new rule (4 hours) by the average compensation of a human resources manager at an agricultural business ($78.48).
Exhibit 10 presents a summary of first-year and average annual costs and transfers by affected entity.
In general, average annual transfers are larger than those in the first year because of the transition period for the monthly wage increases and because the Department adjusted the base wage based upon the wages and salaries ECI over the 10-year analysis period. The average annual transfer from employers to employees due to the revised wage determination methodology for the AEWR amounts to $17.46 million per year. The largest average cost is providing water to workers at $2.36 million per year, followed by the cost of providing meals to workers at $1.78 million per year, the cost of expanding cooking/cleaning facilities at $0.75 million per year, the cost of recordkeeping at $0.19 million per year, the cost of the heating equipment and propane at $0.10 million, and the time required to read and review the Final Rule at $0.02 million per year. Range livestock production employers experience an average annual cost
Exhibit 11 presents a summary of the economic impact analysis of the Final Rule. The monetized net costs and transfers displayed are the yearly summations of the calculations described above. In some cases, the totals for one year are less than the totals of the annual averages described above. The total (undiscounted) costs and transfers of the rule sum to $51.26 million and $174.64 million over the 10-year analysis period, respectively. This amounts to an average annual cost and transfer of $5.13 million and $17.46 million per year, respectively. In total, the 10-year discounted costs of the Final Rule range from $36.87 million to $44.16 million (with 7 and 3 percent discounting, respectively). In total, the 10-year discounted transfers of the Final Rule range from $117.99 million to $146.52 million (with 7 and 3 percent discounting, respectively).
The Department was able to identify cost reductions of the Final Rule due to the elimination of the newspaper advertising requirement, which amount to $0.06 million per year over the 10-year analysis period. The Department also expects there to be cost reductions due to the revised job order submission requirements and the revised master application filing requirements. However, the Department was not able to quantify those cost reductions resulting from the Final Rule.
Due to data limitations, the Department also did not quantify several of the important benefits to society provided by the revised policies. Through this rulemaking the Department is establishing a new methodology for determining a monthly AEWR and clarifying employer obligations for these unique occupations with the aim of protecting the wages and working conditions of U.S. workers and better assessing their availability for these jobs based on appropriate terms and conditions of employment. The higher wages for workers will result in an improved ability on the part of workers and their families to meet their costs of living and spend money in their local communities. Higher wages may also decrease turnover among U.S. workers and thereby decrease the costs of recruitment and retention to employers. Reduced worker turnover is associated with lower costs to employers arising from recruiting and training replacement workers. Because seeking and training new workers is costly, reduced turnover leads to savings for employers. Research indicates that decreased turnover costs partially offset increased labor costs (Reich, Hall, and Jacobs 2003; Fairris, Runstein, Briones, and Goodheart 2005).
This potential retention of U.S. workers may reduce the need to recruit and hire temporary foreign workers to fill these jobs. Furthermore, higher wages may have positive impacts on productivity. Higher wages can boost employee morale, thereby leading to increased effort and greater productivity. For example, Holzer (1990)
In addition, clarifications for such requirements as providing sufficient housing; supplying all tools, supplies, and equipment required, free of charge; establishing effective means of communication in case of emergencies; and providing meals and potable water will better foster the safety and health of both U.S. and H-2A workers as they perform these jobs. Due to data limitations, the Department was not able to quantify or monetize the impact of these protective measures.
The Regulatory Flexibility Act (RFA) at 5 U.S.C. 603 requires agencies to prepare a regulatory flexibility analysis to determine whether a regulation will have a significant economic impact on a substantial number of small entities. Section 605 of the RFA allows an agency to certify a rule in lieu of
Among the reasons for the current rulemaking was the decision of the Court of Appeals for the District of Columbia in the
This section presents an analysis of the significant issues raised by the public comments in response to the initial regulatory flexibility analysis (IRFA) and a summary of the Department's response to those issues. We discuss many of these issues in detail in the preamble and the EO 12866 analysis and, therefore, we incorporate those discussions by reference.
The SBA Office of Advocacy, the Mountain Plains Agricultural Services and Western Range Association (Mountain Plains and Western Range), the Wyoming Wool Growers Association, Vermillion Ranch and Midland Ranch, and others stated that the Department underestimated the cost of the proposed rule for small herding operations because these operations may hire more than three H-2A workers, which is the value the Department used to estimate costs. They emphasized that, for small businesses that hire more than three H-2A workers, the cost of the proposed rule could be higher than the 19 to 24 percent of revenues the Department identified in the IRFA. The commenters referenced a survey by the Colorado Wool Growers Association,
Some commenters provided the number of workers hired on their ranches per year:
• Etchart Livestock, Inc. stated that it employs five to seven foreign workers.
• David and Bonnie Little stated that they employ 10 sheepherders.
• FIM Corp. stated that it employs 11 H-2A sheepherders.
• Julian Land & Livestock stated that it employs 12 to 22 men.
In the Notice of Proposed Rulemaking (NPRM) economic analysis, the Department estimated the average number of H-2A workers per employer as three based on actual H-2A certifications issued during FY 2011 and FY 2012. Based on a review of more recent H-2A certifications issued during FY 2013 and FY 2014, the Department revised the average number H-2A workers per employer to 4.2 in the final regulatory flexibility analysis (FRFA).
The Department received comments on the calculation of the number of affected small entities. The commenters asserted that most or all of the businesses affected by the proposed rule are small entities.
John and Carolyn Espil stated that most or all of the ranches affected by the proposed rule would be small entities. They cited (1) the Nevada Department of Agriculture (NDA), which stated that 82.78 percent of agricultural operations in Nevada are engaged in livestock production and (2) the NDA's Economic Contribution of Agriculture Report, which stated that 82.2 percent of farms and ranches are owned by families or individuals. The commenters also disagreed with the Department's estimate in the IRFA that the average small farm makes $252,050 in annual revenue. The commenters remarked that farms cannot make this much without off-farm income and stated that any other estimates using this annual revenue figure should be considered inaccurate as well. Sharon O'Toole stated that since nearly all of the
Mountain Plains and Western Range and Texas Sheep & Goat Raisers Association cited the ASI, which stated that 99.98 percent of sheep operations in the United States are small businesses. In addition, the commenter noted that nearly all of the members of Mountain Plains and Western Range would meet the statutory definition of a “small business” for an agricultural enterprise. The SBA Office of Advocacy confirmed that approximately 99 percent of U.S. farms in the relevant industries are considered small businesses under the SBA definition. The Siddoway Sheep Company referenced the U.S. Department of Agriculture's most recent census, which stated that 92 percent of sheep and goat operations are family businesses. ASI and Public Lands Council and Patrick O'Toole stated that changes to the H-2A sheepherder program would have a significant negative impact on the 79,500 family farms and ranches that raise sheep in the United States. The Wyoming Livestock Board, the Texas Sheep & Goat Raisers Association, ASI, and the Pilster Ranch stated that 38 percent of sheep production in the United States is under the care of H-2A sheepherders and that the proposed rule would negatively impact the 79,500 family farms in the U.S. sheep industry.
The Department agrees with the commenters that almost all of the H-2A employers affected by the rule are small entities that meet the SBA's small business size standards, which was reflected in the IRFA and is repeated in the FRFA. However, the Department maintains that its estimate of the average revenue of a small entity ($252,050 in 2013 dollars) is consistent with the average revenue from the Idaho farm enterprise budget for range sheep herding submitted by Mountain Plains and Western Range. Please note that in the FRFA, the Department has updated its analysis to 2014 dollars; thus, the revised estimate of the average revenue of a small entity is $256,138 in 2014 dollars.
The Department received several comments stating that the proposed rule would have a significant economic impact on a substantial number of small entities. The Department also received a couple of comments suggesting that the Department publish a Supplemental IRFA for public comment.
The SBA Office of Advocacy, Mountain Plains and Western Range, the Wyoming Wool Growers Association, the Montana Wool Growers Association, John and Carolyn Espil, and Sheep! Magazine concluded that the proposed rule would have a significant economic impact on a substantial number of small entities. The SBA Office of Advocacy stated that the Department's IRFA may have underestimated costs for small businesses and did not analyze any alternatives that may minimize the economic impact on small businesses. The commenter suggested that the Department publish for public comment a Supplemental IRFA analyzing the cost of the proposed rule and alternatives for small businesses that minimize the economic impact.
The Department concluded that the proposed rule would have a significant economic impact on a substantial number of small entities. Therefore, the Department published the IRFA and invited comments on the impact to such small entities. If the small-entity impact estimates in the IRFA underestimated the true costs to the small entities, such as because we were not able to quantify the costs of some of items due to data limitations, we specifically identified those items and invited comments. Very few, if any, responses were received that provided specific information on such costs. Moreover, the IRFA identified two alternatives; we did not identify any less costly alternatives because we concluded, at that time, that such alternatives would not allow the Department to fulfill our dual statutory mandate of determining that no U.S. workers are available for the job and that the employment of foreign workers will not adversely affect the wages and working conditions of workers similarly employed in the United States.
With respect to the “downstream” economic impacts on related industries in the U.S. economy, the Department was unable to quantify such impacts due to a lack of data and statistical input-output models necessary to conduct an accurate analysis. Therefore, such impacts are beyond the scope of this economic analysis.
Based upon the comments received on the NPRM, the Final Rule makes a number of changes to the NPRM, all of which are analyzed below. The Department decided to set the monthly wage rates for range herders of sheep, goats, and other livestock using the current Fair Labor Standards Act (FLSA) minimum wage rate of $7.25 per hour as a starting point, with annual adjustments to account for inflation, and an assumed 48-hour workweek; we also considered and address below alternative wage setting proposals submitted by commenters, including two less costly alternatives.
As discussed in detail in the EO 12866 analysis, the Department received comments related to the alternatives considered in the IRFA. Many commenters asserted that the alternatives were not “true” alternatives in that the Department did not consider other ways to determine the monthly Adverse Effect Wage Rate (AEWR). They commented that the Department only considered alternatives related to the timing of the monthly wage rate increases, and thus they characterized it as one alternative with three transition periods. For this reason, some commenters stated that the Department failed to meet the requirements set forth in Section 603(c) of the RFA to describe “any significant alternatives to the proposed rule which accomplish the stated objectives of applicable statutes and which minimize any significant economic impact of the proposed rule on small entities.”
The Department carefully reviewed the comments related to the proposed wage-setting methodology and to the alternatives laid out in the EO 12866 analysis and the IRFA. After considering the comments, the Department has decided to set the monthly AEWR for range herders of sheep, goats, and other livestock using a formula based on the current FLSA minimum wage as a starting point, with annual adjustment based on inflation. This decision is in line with the second of two alternative proposals set forth by Mountain Plains and Western Range, which was endorsed by the ASI and many individual employers; however, it also was slightly modified consistent with the suggestions in the Worker Advocates' Joint Comment. As discussed in detail in the preamble, the Department concludes that this wage rate is both necessary to provide a meaningful test of the labor market for
The Department has considered three alternatives in addition to the new wage setting methodology in the Final Rule analysis:
(1) To base the monthly AEWR on the 1994 TEGL wage rates ($800, which was approximately the highest 1994 TEGL rate), adjusted to a 2014 monthly wage using the ECI capped at a maximum annual increase of 2.5 percent, the forecasted ECI for wages and salaries values applied to the estimated 2014 monthly wage, and which is introduced over a three-year transition period with full implementation in year four;
(2) to base the monthly AEWR on the current FLSA minimum hourly wage, the forecasted ECI for wages and salaries values applied beginning in year five, a 44-hour workweek, and which is introduced over a three-year transition period with full implementation in year four; and
(3) to base the monthly AEWR on forecasted hourly AEWRs for combined field and livestock workers by state, a 65-hour workweek, with full implementation in year one, and incorporating a monthly food deduction estimate as permitted in the standard H-2A program, which is adjusted by the average CPI-U over 2012 to 2014.
The preamble and the EO 12866 analysis describe in detail the methodology we adopted in the Final Rule and the reasons for its selection over the three alternatives that we considered. The three alternatives that we considered are described in detail below.
Under this alternate wage determination methodology, the Department adjusts the estimated 1994 TEGL wage ($800.00) as recommended by Mountain Plains, Western Range, ASI and others using a capped ECI approach.
• By 1.5 percent if the percentage increase in the wages and salaries ECI during the previous calendar year was less than 1.5 percent;
• By the percentage increase if the percentage increase in the wages and salaries ECI during the previous calendar year was between 1.5 percent and 2.5 percent, inclusive; or
• By 2.5 percent if the percentage increases in the wages and salaries ECI during the previous calendar year was greater than 2.5 percent.
We then apply the growth rate calculated under the Final Rule's source—the average year-to-year-growth rate of the average quarterly wages and salaries ECI for each year from 2012 through 2014 (2.0 percent)—to the 2014-indexed wage ($1,261.84) and forecast the indexed monthly wage required under Alternative 1 for 2016 to 2025. The wage rate determination methodology includes a three-year transition period, with full implementation in year four. The Department estimates the hourly wage rate for each year of the analysis period as follows (Exhibit 13):
Exhibit 14 presents the forecasted ECI-adjusted cap-indexed 1994 TEGL wage with a three-year transition period and full implementation in 2019 under Alternative 1.
Exhibits 15 and 16 present the wage differential between the monthly wage under Alternative 1 and the baseline by state for sheep and goat herders and range livestock production workers, respectively. In the case of California and Oregon, the monthly wage under Alternative 1 is lower than the baseline wage in every year. In the case of Hawaii, where the monthly wage of $1,422.52 is based on a 2012 prevailing wage survey conducted by California, the monthly wage under Alternative 1 is lower than Hawaii's current baseline wage in the first five years. In these instances, the Department assumes that the workers will continue to receive the baseline wage in the applicable year; therefore, no wage differential results. Additionally, the monthly wage differentials for states that did not have a baseline wage because there were no H-2A workers certified are denoted as “N/A.” Note that these values are for informational purposes only and were not used in the analysis.
Under this alternate monthly wage rate determination methodology, which also was generally suggested by Mountain Plains, Western Range, ASI, and other employer commenters, the Department estimates the hourly base wage rate by applying the 2-percent growth rate estimated under the Final Rule's wage methodology, which is the average year-to-year-growth rate of the average quarterly ECI for wages and salaries for each year from 2012 through 2014, to $7.25 for each year beginning in 2020.
To convert the hourly base wage rate to a monthly wage rate, the Department multiplies the hourly wage rate by 44 hours per workweek and 4.333 weeks per month. Exhibit 18 presents the monthly AEWR.
Exhibits 19 and 20 present the wage differential between the monthly wage under Alternative 2 and the baseline by state for sheep and goat herders and range livestock production workers, respectively. In the case of California and Oregon, the monthly wage under Alternative 2 is lower than the baseline wage in every year. In the case of Hawaii, where the monthly wage of $1,422.52 is based on a 2012 prevailing wage survey conducted by California, the monthly wage under Alternative 2 is lower than Hawaii's current baseline wage in the first five years. In these instances, the Department assumes that the workers will continue to receive the baseline wage in the applicable year; therefore, no wage differential results. Additionally, the monthly wage differentials for states that did not have a baseline wage are denoted as “N/A.” Note that these values are for informational purposes only and were not used in the analysis.
Under this alternate wage rate determination methodology, based generally upon the recommendation made in the Joint Workers' Advocate Comment, the Department first calculates the annual percentage change in each state's average FLS-based AEWR for each year from 2013 to 2015. We then take the averages of the resulting two values to estimate the average annual percentage changes by state as shown in Exhibit 21.
Using each state's geometric average annual percent change, we forecast each state's FLS-based AEWR for 2016 to 2025.
As recommended in the Worker Advocates' Joint Comment, this wage rate option does not use a transition period. To convert the hourly FLS-based AEWR to a monthly wage rate, the Department multiplies the hourly wage rate by 65 hours per workweek and 4.333 weeks per month. To account for the food deduction, we convert the 2015 daily food deduction of $11.86 per worker to the monthly food deduction of $359.73 per worker by multiplying the daily food deduction by the number of days per week (7) by the number of weeks per month (4.333).
We subtract the monthly food deduction from the monthly wage. Exhibit 24 presents the monthly wages with the food deductions taken into account.
Exhibits 25 and 26 present the wage differential between the monthly wage under Alternative 3—the forecasted FLS-based AEWR with food deductions taken into account—and the baseline by state for sheep and goat herders and range livestock production workers, respectively. Additionally, the monthly wage differentials for states that did not have a baseline wage because there were no H-2A workers employed as herders or range livestock workers are denoted as “N/A.” Note that these values are for informational purposes only and were not used in the analysis.
As discussed in the preamble and the EO 12866 analysis, the Department concludes that the Final Rule's methodology for setting the monthly AEWR is the most appropriate as it will begin to address immediately and substantially the wage stagnation that has occurred over the past decades. Some transition period is necessary because the comments indicate that requiring the full monthly increase immediately could lead to significant disruptions that might cause job losses due to some employers going out of business or scaling back their operations. Based on all the information in the comments, including balance sheet information from individual
Exhibit 27 presents a summary of average annual transfers over the 10-year analysis period by wage determination methodology. The Department estimates the average annual transfer from all herding and range livestock production employers to workers due to the Final Rule's wage determination methodology, which bases the monthly AEWR on forecasted ECI-adjusted $7.25 base wage, times 48 hours per week with a 2-year transition period, to be $17.46 million per year. This is a decrease relative to the average annual transfer from employers to workers estimated under the NPRM's wage determination methodology, forecasted AEWR values by USDA region incrementally phased in over a 5-year period, of $45.08 million per year. Of the three alternatives, the largest average annual transfer from employers to employees due to Alternative 3's revised wage determination methodology (
As discussed in Section 2 above, the SBA Office of Advocacy submitted substantive comments regarding a number of issues, including the number of H-2A workers per small business, the calculation of the number of affected small entities, and the calculation of the significant impact on a substantial number of small entities. This section summarizes separately the SBA Office of Advocacy's comments and the Department's responses.
The SBA Office of Advocacy commented that the Department underestimated the cost of the proposed rule for small herding operations because these operations may hire more than three H-2A workers, which is the value the Department used to estimate costs. In response to this concern, the Department revised the average number of H-2A workers per employer in the FRFA to 4.2 based on actual H-2A certifications issued during FY 2013 and FY 2014. This figure is consistent with the estimate submitted by the commenters based upon a recent telephone survey conducted by Mountain Plains involving responses from 214 of 275 members.
The SBA Office of Advocacy also commented on the number of small entities affected, noting that approximately 99 percent of sheep operations in the United States are small businesses. The Department agrees that almost all of the H-2A employers affected by the proposed rule are small entities that meet the SBA's small business size standards, which was reflected in the IRFA and is repeated in the FRFA. However, the Department maintains that its estimate of the average revenue of a small entity ($252,050 in 2013 dollars) is consistent with the average revenue from farm enterprise budgets for range sheep herding reported by commenters. Please note that in the FRFA, the Department updates its analysis to 2014 dollars; thus, the revised estimate of the average revenue of a small entity is $256,138.
The SBA Office of Advocacy stated that the proposed rule would have a significant impact on a substantial number of small entities. SBA also commented that the Department's IRFA may have underestimated costs for small businesses and did not analyze any alternatives that may minimize the economic impact on small businesses. SBA suggested that the Department publish for public comment a Supplemental IRFA analyzing the cost of the proposed rule and alternatives for small businesses that minimize the economic impact. The Department concluded that the proposed rule would have a significant impact on a substantial number of small entities. Therefore, the Department published the IRFA and invited comments on the impact to such small entities. If we were not able to quantify certain costs due to data limitations, we identified those items and invited comments. Very few, if any, responses were received that provided specific information on such costs.
The IRFA identified two alternatives for setting the required monthly wage; we did not identify any less costly alternatives in the IRFA because we concluded, at that time, that such alternatives would not allow the Department to fulfill its dual statutory mandate of ensuring that no U.S. workers are available for the job and that the employment of foreign workers will not adversely affect the wages and working conditions of workers similarly employed in the United States. Based upon comments received from the industry, the FRFA identifies two less-costly alternatives to the Final Rule wage methodology and, together with the preamble and EO 12866 analysis, explains why the Department did not find either of those alternatives to be appropriate.
The SBA Office of Advocacy expressed concern about the NPRM's definition of “open range,” noting that 36 percent of respondents to a Mountain Plains survey thought they would not qualify for the program if fences were prohibited. The Final Rule substantially revises the definition of what qualifies as the “range” in recognition of the fact that fences are used in many locations for many purposes, including on Forest Service and BLM lands where animals graze.
The SBA Office of Advocacy also expressed concern that the NPRM relied upon the same hourly wage rate as is paid to regular H-2A field and livestock workers, when herding employers provide housing, food, clothing, tools, paid vacation, etc. Unlike the NPRM, the Final Rule does not base the monthly AEWR on the FLS-based hourly wage. Moreover, we note that all H-2A employers are required to provide free housing and are required to provide the tools, supplies and equipment necessary to perform the job free of charge. The Department does not require herding employers to provide paid vacation, although we support them if they voluntarily choose to do so.
With regard to the concern that small herding operations have a difficult time hiring U.S. workers for this work, we anticipate that updating the required monthly wage rate to overcome the many years of wage stagnation may result in more U.S. workers being interested in this work. California, which has a higher state minimum wage for herders, is consistently among the states with the largest number of U.S. sheepherders identified in SWA surveys.
A small entity is one that is “independently owned and operated and which is not dominant in its field of operation.” The definition of small business varies from industry to industry, to the extent necessary, in order to properly reflect industry size differences. An agency must either use the SBA definition for a small entity or establish an alternative definition for the relevant industries to which a rule applies, which in this case includes Beef Cattle Ranching and Farming (NAICS 112111), Dairy Cattle and Milk Production (NAICS 11212), Sheep and Goat Farming (NAICS 1124), and Other Animal Production (NAICS 1129).
Approximately 99 percent of U.S. farms in the relevant industries have annual revenues of less than $0.75 million and, therefore, fall within the SBA's definition of a small entity. The Department estimates that by 2025, there will be approximately 485 employer applications filed (not necessarily applicants) under the H-2A program for herding and the range production of livestock. The Department considers a rule to have an impact on a “substantial number of small entities” when the total number of small entities impacted by the rule is equal to or great than 15 percent of the relevant universe of small entities affected in a given industry (in this case, the relevant universe is the employers participating in the program). Therefore, the Department concludes the rule will have an impact on a substantial number of small entities as described by the RFA.
The Department has estimated the incremental costs for small businesses from the baseline (
The Department identified the following provisions of the Final Rule to have an impact to industry but was not able to quantify the impacts due to data limitations: proportion/type of work permitted at the ranch (
Under the new wage determination methodology, the use of the forecasted ECI-adjusted $7.25 base wage times 48 hours per week and times 4.333 weeks per month to set the required monthly AEWR, with a two-year transition period, results in an increase of $1.53 in hourly wages (using the assumed 48 hours per week computation) paid to H-2A workers in 2016. The Department multiplies this average hourly wage increase by 48 hours per workweek to obtain a weekly cost per worker of $73.44 ($1.53 × 48) in 2016. The Department then multiplies this weekly cost by 50 weeks, which is the average
To estimate the average annual cost of increased wages paid to H-2A workers under the Final Rule's wage determination methodology, the Department first calculates the average annual assumed hourly wage increase over the period of analysis. Given the average annual assumed hourly wage increase ($2.93), a 48-hour workweek, and an average period of need for workers of 50 weeks, the Department estimates an average annual increased cost of $7,039.20 ($2.93 × 48 × 50) per H-2A worker. For employers hiring the average number of H-2A workers (4.2), this results in an average annual increased cost of $29,564.64 ($7,039.20 × 4.2) paid to workers in wages over the 10-year analysis period.
To estimate the average annual cost of increased wages paid to H-2A workers under the first wage determination methodology alternative—the forecasted ECI-adjusted cap-indexed 1994 TEGL wage with a three-year transition—the Department first calculates the average annual monthly wage increase over the period of analysis. Given the average annual monthly wage increase ($441.66), an average period of need for workers of 11.54 months,
To estimate the average annual cost of increased wages paid to H-2A workers under the second wage determination methodology alternative—the forecasted ECI-adjusted $7.25 wage rate with a three-year transition based on a 44-hour workweek—the Department calculates the average annual hourly wage increase over the period of analysis. Given the average annual hourly wage increase ($2.28), a 44-hour workweek, and an average period of need for workers of 50 weeks, the Department estimates an average annual cost of $5,024.80 ($2.28 × 44 × 50) per H-2A worker. For employers hiring the average number of H-2A workers (4.2), this alternative results in an average annual increased cost of $21,104.16 ($5,024.80 × 4.2) paid to workers in wages.
To estimate the average annual cost of increased wages paid to H-2A workers under the third wage determination methodology alternative—the forecasted State AEWR with food deductions based on a 65-hour workweek—the Department calculates the average annual hourly wage increase over the period of analysis. Given the average annual hourly wage increase ($8.85), a 65-hour workweek, and an average period of need for workers of 50 weeks, the Department estimates an average annual increased cost of $28,772.25 ($8.85 × 65 × 50) per H-2A worker. For employers hiring the average number of H-2A workers (4.2), this results in an average annual increased cost of $120,843.45 ($28,772.25 × 4.2) paid to workers in wages.
Through the Final Rule, the Department will expand to production of livestock occupations on the range the historical practice of waiving the regulatory requirement to place two advertisements in a newspaper serving the area of intended employment for sheepherding and goat herding occupations. This will result in a minor cost reduction. To estimate this cost reduction, the Department multiplies the number of newspaper advertisements required for each range livestock employer application (2) by the average cost of placing a newspaper advertisement ($258.64) to obtain an avoided cost of purchasing advertising space equal to $517(2 × $258.64) per range livestock employer application per year.
Under the Final Rule, the Department will require H-2A employers to provide either three sufficient meals per day or free and convenient kitchen facilities and food provisions to workers. This change represents a cost to range livestock production employers but not to sheepherding or goat herding employers because this is already a requirement under TEGL 32-10. To estimate this cost, the Department multiplies the number of days per week workers receive meals (7) by the average daily cost of meals ($11.86) and the average duration of need in weeks (50) to obtain a cost of $4,151.00 (7 × $11.86 × 50) per range livestock production worker per year.
In addition to the cost to purchase food, range livestock production employers would also incur costs to transport the food to the workers. The Department assumes that food would be transported to the workers on a weekly basis along with the potable water. The costs related to transporting food and potable water are accounted for below in the section on costs related to potable water.
The Final Rule requires that the herding or range livestock production employer provide to the workers adequate provision of potable water (4.5 gallons per day) for drinking and cooking, which is similar to the TEGLs' requirement. The Final Rule continues
As discussed above, in the NPRM the Department assumed that each worker required 28 gallons of water per worker per week. Several commenters stated that this was not a sufficient amount and suggested the Department use an estimate based on 4 to 4.5 gallons of potable water per day in clean and sealed containers. In the Final Rule, the Department revises this assumption to be 4.5 gallons of potable water per day, which amounts to approximately 31.5 gallons of potable water per worker per week (4.5 × 7).
The Department estimates the cost of purchasing the water by multiplying the cost per gallon of potable water ($0.005) by the number of gallons of water per worker per week (31.5) and the average duration of need in weeks (50). This calculation yields a cost of providing potable water equal to $7.88 ($0.005 × 31.5 × 50) per worker per year and $33.08 ($7.88 × 4.2) for employers hiring the average number of 4.2 H-2A workers.
The Department estimates the cost of purchasing a utility trailer to be $839.34.
The Department estimates the cost of vehicle mileage per employer by multiplying the average vehicle mileage cost ($0.58) by the number of miles driven to transport the potable water and meals roundtrip (100) and the average number of roundtrips per year (50).
The Department estimates the labor cost of time to transport the water and meals to workers by multiplying the average number of roundtrips required per employer (50) by the assumed time required to transport the water and meals (2.86 hours) and the hourly compensation of an agricultural worker ($13.40), which amounts to $1,916.20 (50 × 2.86 × $13.40) in labor costs per employer per year.
Finally, the Department sums the cost of purchasing water, the cost of purchasing a trailer to transport the water and meals, the cost of vehicle mileage, and the labor cost of the time required to transport the water and meals to the workers. This requirement will result in a cost of $5,663.42 ($7.88 + $839.34+ $2,900.00 + $1,916.20) per employer hiring only one H-2A worker during the first year of the rule. The average annual cost of this provision for employers hiring only one H-2A worker is $4,908.01 ($7.88 + $83.93 + $2,900.00 + $1,916.20) over the 10-year analysis period. For employers hiring the average number of 4.2 H-2A workers, the first-year cost increases to $5,688.62 ($33.08 + $839.34+ $2,900.00 + $1,916.20) and the average annual cost increases to $4,933.21 ($33.01 + $83.93 + $2,900.00 + $1,916.20).
Where a worker continues to use the mobile housing that was provided by the employer for herding or production of livestock operations on the range while the worker is temporarily stationed at the ranch to perform production of livestock duties (which includes those that are closely and directly related to herding and/or the production of livestock), the Final Rule requires that the employer provide the worker with access to facilities such as toilets and showers with hot and cold water under pressure. To estimate this cost, the Department multiplies the average cost per square foot to construct/expand cleaning facilities ($270.00) by the assumed size of the facility that will be required to be constructed/expanded (150 square feet). This calculation results in a one-time cost of $40,500.00 ($270.00 × 150) for the average employer who must construct such a facility, which amounts to an average annual cost of $4,050.00 over the 10-year analysis period.
In the Final Rule, as specified in § 655.235, the mobile housing unit provided to workers must include operable heating equipment that supplies adequate heat for workers in locations where necessary for the health and safety of workers due to the climate. The Department estimates the average cost per portable gas heating unit is $150.00 and the propane cost to adequately supply heat for workers in locations where the temperature is expected to drop below 50 degrees Fahrenheit is $969.00 per year.
In response to comments, including from small businesses, the Final Rule modifies the NPRM's proposed recordkeeping requirements by eliminating the requirement to record hours worked when workers are not on the range and by eliminating the requirement to record the duties performed each day when workers are not on the range. The Final Rule retains only the requirement to record daily whether work was performed on the range or at the farm or ranch so that the Department can evaluate employers' compliance with the requirement that herding and range livestock workers must spend at least 50 percent of the job order period on the range.
The Department estimates the cost by multiplying the time required to prepare
During the first year that the Final Rule would be in effect, employers involved in the herding or production of livestock on the range would need to learn about the rule provisions and the requirements necessary to remain compliant. In the first year of the rule, the Department estimates that the average small farm will spend approximately 4 hours of staff time to read and review the new rule, which amounts to approximately $313.92 ($78.48 x 4) in labor costs per employer in the first year of the rule. This amounts to an average annual cost of $31.39 ($313.92/10) over the 10-year analysis period.
The Department's calculations indicate that the total average annual cost is $39,955.64 (or 15.6 percent of annual revenues) for the average small entity employing 4.2 workers in sheepherding or goat herding occupations.
For small entities that apply for one worker instead of 4.2—representing the smallest of the small farms that hire workers—the Department estimates that the total average annual cost of the rule is $17,405.00 (or 6.8 percent of annual revenues) for entities employing a worker in a sheepherding or goat herding occupation.
Exhibit 28 presents a summary of the average annual cost per employer. The Department focuses on the average annual cost of the rule rather than costs in the first year because the wage methodology increases the costs of compliance over the analysis time period. The total cost per employer varies depending on whether the employer is a sheepherding or goat herding employer or a range livestock production employer. The Department defines a “significant economic impact” as an impact that amounts to at least three percent of annual revenues. Due primarily to the increase in wages paid to H-2A workers, the proposed rule is expected to have a significant economic impact on affected small entities. The average annual costs reflected in Exhibit 28 are an overestimate for most employers as they would apply only to an employer who must bear all the possible costs, including purchasing a trailer to deliver water, constructing a cleaning facility, and purchasing portable heating equipment. Because those costs apply to only a small percentage of the participating employers, the actual average annual cost for most employers will be substantially less than the cost shown.
The Department has considered three alternatives to the wage methodology contained in the Final Rule, in which the monthly AEWR is based on the current FLSA minimum hourly wage as a starting point (
The Department believes that the option adopted in the Final Rule will most effectively enable the Department to meet its statutory obligations to determine that there are not sufficient workers available to perform the labor or services requested, and that the employment of foreign workers will not adversely affect the wages and working conditions of workers in the United States similarly employed before the admission of foreign workers is permitted, given these occupations and their unique characteristics that have historically resulted in a limited number of U.S. workers interested in performing these jobs. The new wage methodology will begin to address immediately the wage stagnation concerns discussed earlier.
Exhibit 29 presents a summary of the average annual cost per employer for the Final Rule, the NPRM, and the three alternatives. The Final Rule and three alternatives vary only due to their respective revised wage determination methodologies. Note that the average annual cost per employer for the NPRM is in 2013 dollars and did not include annual costs associated with earnings records or heating equipment. In each case, the total cost per employer varies depending on whether the employer is a sheepherding or goat herding employer or a range livestock production employer.
The Department estimated the total cost burden on small entities for each of the alternatives as follows.
The first alternative retains the same features of the 2010 Final Rule, TEGL 32-10, TEGL 15-06, Change 1, and includes the same provisions as the Final Rule except that the wage determination methodology uses the forecasted ECI-adjusted cap-indexed 1994 TEGL wage with a three-year transition period. The Department's calculations indicate that the total average annual cost of this alternative would be $31,797.19 (or 12.4 percent of annual revenues) for the average small entity employing 4.2 workers in sheepherding or goat herding occupations.
For small entities that apply for one worker instead of 4.2—representing the smallest of the small farms that hire workers—the Department estimates that the total average annual cost of this alternative would be $15,462.51 (or 6.0 percent of annual revenues) for entities employing a worker in a sheepherding or goat herding occupation.
The second alternative retains the same features of the 2010 Final Rule, TEGL 32-10, TEGL 15-06, Change 1, and includes the same provisions as the Final Rule except that the wage determination methodology uses a three-year transition period and is based on a 44-hour workweek. The Department's calculations indicate that the total average annual cost of this alternative would be $31,495.16 (or 12.3 percent of annual revenues) for the average small entity employing 4.2 workers in sheepherding or goat herding occupations.
For small entities that apply for one worker instead of 4.2—representing the smallest of the small farms that hire workers—the Department estimates that the total average annual cost of this alternative would be $15,390.60 (or 6.0 percent of annual revenues) for entities employing a worker in a sheepherding or goat herding occupation.
The third alternative retains the same features of the 2010 Final Rule, TEGL 32-10, TEGL 15-06, Change 1, and includes the same provisions as the Final Rule except that the wage determination methodology uses the forecasted state AEWR with food deductions, does not utilize a transition period, and is based on a 65-hour workweek. The Department's calculations indicate that the total average annual cost of this alternative would be $131,234.45 (or 51.2 percent of annual revenues) for the average small entity employing 4.2 workers in sheepherding or goat herding occupations.
For small entities that apply for one worker instead of 4.2—representing the smallest of the small farms that hire workers—the Department estimates that the total average annual cost of this alternative would be $39,138.05 (or 15.3 percent of annual revenues) for entities employing a worker in a sheepherding or goat herding occupation.
This Final Rule will have a significant economic impact on a substantial number of small entities. We recognize the concerns expressed by small businesses and have made every effort to minimize the burden on all users to the extent consistent with DOL's obligations under the INA. The Department's responsibilities under the INA, however, severely constrain our ability to make adjustments to program requirements in an effort to address concerns unique to small business. The Department's mandate under the H-2A program is to set requirements for employers who wish to recruit and hire foreign agricultural workers. Those standards are designed to provide both that foreign workers are hired only if qualified domestic workers are not available and that bringing in H-2A workers will not adversely affect the wages and working conditions of similarly employed domestic workers. These regulations set those standards for range herding occupations. To create different and likely lower standards for small businesses would essentially sanction the very adverse effect that the Department is compelled to prevent. The need for parity among employers regardless of size is illuminated by the fact that Congress within the INA carved out a specific dispensation for small businesses in a specific area of the statute. Section 218(c)(3)(B)(ii) of the INA (8 U.S.C. 1188(c)(3)(B)(ii)) exempts certain small businesses from the application of the 50-percent rule regarding the period that priority hiring rights for U.S. applicants exist. Where Congress has so clearly demonstrated its ability to modify H-2A program requirements to accommodate small businesses, it would be inappropriate and outside of the Secretary's authority for the Department to carve out additional exceptions. Moreover, because commenters indicated that more than 99 percent of sheep operations in the United States qualify as small businesses under the SBA definition, there is no basis for considering special relief for small businesses.
As previously discussed, after considering the comments, DOL determines that it is appropriate and consistent with the Department's obligation to protect against adverse effect to U.S. workers to set the monthly AEWR for these occupations by borrowing the current federal minimum wage of $7.25/hour, multiplied by an estimated 48 hours per week, and adjusted annually based on the ECI. In reaching this result, DOL concludes that the wage source proposed in the NPRM was likely to result in adverse effect to U.S. workers by causing a substantial number of herding employers to close or significantly downsize their operations. In addition to other reasons discussed fully above, we conclude that $7.25/hour is an appropriate starting point to set the monthly rate because the persistent lack of workers in these herding occupations is likely due in part to the reality that U.S. workers can earn at least the federal minimum wage elsewhere. We use the uncapped ECI to adjust wages beginning in year two to require that wages in these occupations continue to rise apace with wages across the U.S. economy and adopt an estimate of 48 hours worked per week, a calculation from data reported on Form ETA-9142A, because it is the most comprehensive and detailed data source from which to establish an hourly calculation. In light of the scope of the increase and the economic data provided by commenters, discussed above, a transition period to the new wage is needed. Recognizing that any transition must not be longer than necessary to prevent adverse effect, we adopt a two-year transition with full implementation in year three. As noted above, the Final Rule does not provide any different wage or implementation period for small businesses, as virtually all employers subject to the Rule are small businesses. However, we believe that the Final Rule's monthly AEWR methodology (which was modeled on one of the methodologies suggested by the three leading industry representatives), together with the other changes made in the Final Rule, such as those relating to the definition of the “range” and the deletion of the 20 percent cap on incidental work at the ranch, will allow small businesses to continue to participate successfully in the program.
In addition to the wage methodology adopted, DOL considered several significant alternative methodologies for setting the monthly AEWR. First, we considered setting the monthly wage rate based on the 1994 TEGL wages adjusted based on the capped ECI, with a three-year transition and full implementation in year four as recommended by Mountain Plains, Western Range, and many others including individual small employers. As discussed further above, we do not adopt this recommendation because it is premised on a misunderstanding of the 1994 data in the NPRM. Further, given the absence of any data to assess an appropriate year and wage rate to index, and what many commenters characterize as the persistent lack of U.S. workers in these occupations for decades, we are concerned that continued reliance on the TEGL wages, even in indexed form, could be inconsistent with DOL's obligation to protect against adverse effect on U.S. workers. In addition, capping the ECI as recommended by commenters would lead to further wage stagnation.
Second, we considered setting the monthly AEWR by borrowing the current federal minimum wage rate of $7.25/hour and multiplying it by 44 hours per week, with a three-year transition and full implementation in year four, using the capped ECI to adjust wages after year four as recommended by Mountain Plains, Western Range and many individual small employers. As discussed fully above, we have adopted the $7.25 rate from this recommendation as the starting point, but have used a 48-hour estimate rather than a 44-hour estimate so that the hourly estimate is based on the most comprehensive data source available. Recognizing that any transition must not be longer than necessary to prevent adverse effect, this Final Rule requires a two-year transition, rather than the three-year transition recommended by these commenters.
Third, we considered setting the monthly wage rate using the FLS-based AEWR, multiplied by a compromise number of weekly hours (65) between the data submitted by workers from the Colorado Legal Services survey, which found that 62 percent of herders worked at least 81 hours per week, and the 48-hour estimate from the Form ETA-9142A data. This option would have been implemented immediately and permitted a food deduction. As discussed above, DOL did not elect to use the FLS-based AEWR to set the monthly wage rate because we conclude that the FLS-based methodology is likely to cause adverse effect to U.S. workers by causing a substantial number of herding employers to close or significantly downsize their operations—leaving fewer herding jobs available to U.S. workers and creating significant economic dislocation. We do not adopt a 65-hour threshold because this Final Rule relies only on the Form ETA-9142A data, the most comprehensive and detailed data source from which to establish an hourly calculation, rather than the calculation based on worker data in a single state. Finally, we do not require immediate implementation because we conclude that a brief transition period is needed for the reasons discussed above.
Executive Order 12875—This Final Rule will not create an unfunded Federal mandate upon any State, local or tribal government.
Title II of the Unfunded Mandates Reform Act of 1995 (2 U.S.C. 1531) directs agencies to assess the effects of Federal regulatory actions on State, local, and Tribal governments, and the private sector. This Final Rule has no Federal mandate, which is defined in 2 U.S.C. 658(6) to include either a “Federal intergovernmental mandate” or a “Federal private sector mandate.” A Federal mandate is any provision in a regulation that imposes an enforceable duty upon State, local, or Tribal governments, or imposes a duty upon the private sector which is not voluntary. A decision by a private entity to obtain an H-2A worker is purely voluntary and is, therefore, excluded from any reporting requirement under the Act.
The SWAs are mandated to perform certain activities for the Federal Government under this program, and are compensated for the resources used in performing these activities.
This Final Rule includes no new mandates for the SWAs in the H-2A application process and does not include any Federal mandate that may result in increased expenditures by State, local, and tribal governments, in the aggregate, of $100 million or more. It also does not result in increased expenditures by the private sector of $100 million or more, because participation in the H-2A program is entirely voluntary. SWA activities under the H-2A program are currently funded by the Department through grants provided under the Wagner-Peyser Act. 29 U.S.C. 49
The Department has determined that this Final Rule will impose a significant economic impact on a substantial number of small entities under the RFA; therefore, the Department will be required to produce a Compliance Guide for Small Entities as mandated by SBREFA. The Department has concluded that this Final Rule is not a major rule requiring review by the Congress under SBREFA because it will not likely result in: (1) An annual effect on the economy of $100 million or more; (2) a major increase in costs or prices for consumers, individual industries, Federal, State or local Government agencies, or geographic regions; or (3) significant adverse effects on competition, employment, investment, productivity, innovation, or on the ability of U.S.-based enterprises to compete with foreign-based enterprises in domestic or export markets.
The Congressional Review Act (5 U.S.C. 801
The Department has reviewed this Final Rule in accordance with E.O. 13132 regarding federalism and has determined that it does not have federalism implications. The Final Rule does not have substantial direct effects on States, on the relationship between the States, or on the distribution of power and responsibilities among the various levels of Government as described by E.O. 13132. Therefore, the Department has determined that this Final Rule will not have a sufficient federalism implication to warrant the preparation of a summary impact statement.
This Final Rule was reviewed under the terms of E.O. 13175 and determined not to have Tribal implications. The Final Rule does not have substantial direct effects on one or more Indian Tribes, on the relationship between the Federal Government and Indian Tribes, or on the distribution of power and responsibilities between the Federal Government and Indian Tribes. As a result, no Tribal summary impact statement has been prepared.
Section 654 of the Treasury and General Government Appropriations Act, enacted as part of the Omnibus Consolidated and Emergency Supplemental Appropriations Act of 1999 (Pub. L. 105-277, 112 Stat. 2681) requires the Department to assess the impact of this NPRM on family well-being. A rule that is determined to have a negative effect on families must be supported with an adequate rationale. The Department has assessed this Final Rule and determines that it will not have a negative effect on families.
This Final Rule is not subject to E.O. 12630, Governmental Actions and Interference with Constitutionally Protected Property Rights, because it does not involve implementation of a policy with takings implications.
This Final Rule has been drafted and reviewed in accordance with E.O. 12988, Civil Justice Reform, and will not unduly burden the Federal court system. The regulation has been written to minimize litigation and provide a clear legal standard for affected conduct, and has been reviewed carefully to eliminate drafting errors and ambiguities.
The Department drafted this Final Rule in plain language.
This Final Rule is not subject to E.O. 13211. It will not have a significant adverse effect on the supply, distribution, or use of energy.
As part of its continuing effort to reduce paperwork and respondent burden, the Department of Labor (the Department) conducts a preclearance consultation process to provide the general public and Federal agencies with an opportunity to comment on proposed and continuing collections of information in accordance with the Paperwork Reduction Act of 1995 (PRA) (44 U.S.C. 3506(c)(2)(A)).
This helps to ensure that the public understands the Department's collection instructions; respondents can provide the requested data and in the desired format, reporting burden (time and financial resources) is minimized, collection instruments are clearly understood, and the Department can properly assess the impact of collection requirements on respondents. Persons are not required to respond to a collection of information unless it displays a currently valid OMB control number as required in 5 CFR 1320.11(l).
The information collected is mandated in this Final Rule at § 655.210(f). The Department did not create a specific form for this new
In accordance with the PRA, 44 U.S.C. 3501, information collection requirements that must be implemented as a result of this regulation must receive approval from the Office of Management and Budget (OMB). Therefore, a clearance package containing the new requirements was submitted to OMB on April 15, 2015 as part of the proposed rule for the hiring of foreign workers in the H-2A program for herding or production of livestock on the open range in the United States under OMB Control Number 1205-0519. The public was given 60 days to comment on this information collection. OMB filed a comment asking the Department to resubmit the information collection at the final rule stage after considering public comments on the NPRM. The Department did resubmit the package prior to publication of this Final Rule. As of publication of this rule, OMB has not approved the information collection under OMB control number 1205-0519. No person is required to respond to a collection of information request unless the collection of the information has a valid OMB control number and expiration date. Therefore, until the Department publishes a
The Department received more than fifty comments about the new recordkeeping requirement as described in the NPRM. Forty seven of the comments opposed the new requirement and four supported the requirement. Many of those who opposed the new requirement misunderstood the requirement and thought that employers would need to keep hourly logs. In actuality, the logs only needed to reflect days on the range; and on those days when an employee worked on the ranch or farm, the employer needed to write down the number of hours worked and a description of the duties performed. The duties did not need to be accounted for by hour and minutes. Those who agreed with the new requirement thought the burden was minimal.
However, in light of these and other comments, and as discussed above in Sec. IV.B.2.e. of the preamble related to § 655.210(f), the Department has decided to change this requirement in the Final Rule. Employers will now only be required to notate whether employees spend days on the ranch or on the range and the reason for any prorated salary paid.
This information collection in this Final Rule creates an associated paperwork burden on the employers that must be assessed under the PRA. Based on the average number of employers filing applications for H-2A workers to perform herding work filed with the Department in 2013 and 2014, the Department estimates that the information collection will affect 485 employers employing foreign sheepherders, goat herders, and other workers engaged in the open range production of livestock. The Department further estimates that it will take each employer, on average, 5 minutes each week to prepare timesheets for its employees, and 1 minute each week to store these timesheets. Thus, the reporting burden for 485 employers is 2,425 minutes (485 employers × 5 minutes) per week, or approximately 40 hours per week. When annualized, the total reporting burden is 2,000 hours per year (40 hours per week × 50 weeks). The total record keeping burden for 485 employers is 485 minutes (485 employers × 1 minute) per week, or 8 hours per week. When annualized, the total recordkeeping burden is 400 hours per year (8 hours per week × 50 weeks). When these two sums are added together, the total employer reporting and recordkeeping burden is 2,400 hours per year.
When estimating the cost burden of paperwork requirements, the Department used the average salary of a Human Resources Manager based on the national cross-industry mean hourly wage rate for a Human Resources Manager ($54.88), from the U.S. Department of Labor, Bureau of Labor Statistics, Occupational Employment Statistics survey wage data,
Total burden cost of this provision is 2,400 hours × $78.48 = $188,352 per year. The total costs other than the time associated with the information collections required under this Final Rule, as defined by the PRA, are zero dollars per employer.
As noted above, this collection of information is subject to the PRA. Accordingly, this information collection in this Final Rule has been submitted to OMB for review under 44 U.S.C. 3507(d) of the PRA. For an additional explanation of how the Department calculated the burden hours and related costs, the PRA package for this information collection (OMB Control Number 1205-0519) can be obtained from the RegInfo.gov Web site at
Administrative practice and procedure, Employment, Employment and training, Enforcement, Foreign workers, Forest and forest products, Fraud, Health professions, Immigration, Labor, Passports and visas, Penalties, Reporting and recordkeeping requirements, Unemployment, Wages, Working conditions.
For the reasons discussed in the preamble, the Department of Labor amends 20 CFR part 655 as follows:
Section 655.0 issued under 8 U.S.C. 1101(a)(15)(E)(iii), 1101(a)(15)(H)(i) and (ii), 1182(m), (n) and (t), 1184(c), (g), and (j), 1188, and 1288(c) and (d); sec. 3(c)(1), Pub. L. 101-238, 103 Stat. 2099, 2102 (8 U.S.C. 1182 note); sec. 221(a), Pub. L. 101-649, 104 Stat. 4978, 5027 (8 U.S.C. 1184 note); sec. 303(a)(8), Pub. L. 102-232, 105 Stat. 1733, 1748 (8 U.S.C. 1101 note); sec. 323(c), Pub. L.103-206, 107 Stat. 2428; sec. 412(e), Pub. L. 105-277, 112 Stat. 2681 (8 U.S.C. 1182 note); sec. 2(d), Pub. L. 106-95, 113 Stat. 1312, 1316 (8 U.S.C. 1182 note); Pub. L. 109-423, 120 Stat. 2900; and 8 CFR 214.2(h)(4)(i).
Subpart B issued under 8 U.S.C. 1101(a)(15)(H)(ii), 1184(c), and 1188; and 8 CFR 214.2(h).
(a)
(b)
(1) The work activities involve the herding or production of livestock (which includes work that is closely and directly related to herding and/or the production of livestock), as defined under § 655.201;
(2) The work is performed on the range for the majority (meaning more than 50 percent) of the workdays in the work contract period. Any additional work performed at a place other than the range must constitute the production of livestock (which includes work that is closely and directly related to herding and/or the production of livestock); and
(3) The work activities generally require the workers to be on call 24 hours per day, 7 days a week.
The following are terms that are not defined in §§ 655.100-655.185 and are specific to applications for labor certifications involving the herding or production of livestock on the range.
The employer whose job opportunity has been determined to qualify for these procedures, whether individual, association, or H-2ALC, is not required to comply with the job order filing requirements in § 655.121(a) through (d). Rather, the employer must submit
(a)
(b)
(c)
(d)
(2) Because of the unique nature of the herding or production of livestock on the range, this equipment must include effective means of communicating with persons capable of responding to the worker's needs in case of an emergency including, but not limited to, satellite phones, cell phones, wireless devices, radio transmitters, or other types of electronic communication systems. The employer must specify in the job order:
(i) The type(s) of electronic communication device(s) and that such device(s) will be provided without charge or deposit charge to the worker during the entire period of employment; and
(ii) If there are periods of time when the workers are stationed in locations where electronic communication devices may not operate effectively, the employer must specify in the job order, the means and frequency with which the employer plans to make contact with the workers to monitor the worker's well-being. This contact must include either arrangements for the workers to be located, on a regular basis, in geographic areas where the electronic communication devices operate effectively, or arrangements for regular, pre-scheduled, in-person visits between the workers and the employer, which may include visits between the workers and other persons designated by the employer to resupply the workers' camp.
(e)
(1) Either three sufficient meals a day, or free and convenient cooking facilities and adequate provision of food to enable the worker to prepare his own meals. To be sufficient or adequate, the meals or food provided must include a daily source of protein, vitamins, and minerals; and
(2) Adequate potable water, or water that can be easily rendered potable and the means to do so. Standards governing the provision of water to range workers are also addressed in § 655.235(e).
(f)
(2) The employer must keep daily records indicating whether the site of the employee's work was on the range or off the range. If the employer prorates a worker's wage pursuant to paragraph (g)(2) of this section because of the worker's voluntary absence for personal reasons, it must also keep a record of the reason for the worker's absence.
(g)
(1) The offered wage shall not be based on commissions, bonuses, or other incentives, unless the employer guarantees a wage that equals or exceeds the monthly AEWR, the agreed-upon collective bargaining wage, or the applicable minimum wage imposed by Federal or State law or judicial action, or any agreed-upon collective bargaining rate, whichever is highest, and must be paid to each worker free and clear without any unauthorized deductions.
(2) The employer may prorate the wage for the initial and final pay periods of the job order period if its pay period does not match the beginning or ending dates of the job order. The employer also may prorate the wage if an employee is voluntarily unavailable to work for personal reasons.
(h)
(a)
(2) If the monthly AEWR established under this section is adjusted during a work contract, and is higher than both the agreed-upon collective bargaining
(b)
(c)
(2) Beginning for calendar year 2017, the monthly AEWR shall be adjusted annually based on the Employment Cost Index for wages and salaries published by the Bureau of Labor Statistics (ECI) for the preceding October—October period.
(d)
(2) For calendar year 2017, the Department shall set the monthly AEWR at 90% of the result of the formula in paragraph (c) of this section.
(3) For calendar year 2018 and beyond, the Department shall set the monthly AEWR at 100% of the result of the formula in paragraph (c) of this section.
(a)
(b)
(1) The
(2) The period of need identified on the
(3) An association of agricultural employers filing as a joint employer may submit a single Form ETA-790 and master
(a)
(b)
(c)
(a) Unless otherwise specified in this section, the requirements for recruiting U.S. workers by the employer and SWA must be satisfied, as specified in §§ 655.150-655.158.
(b)
(c) Any eligible U.S. worker who applies (or on whose behalf an application is made) for the job opportunity and is hired will be placed at the location nearest to him/her absent a request for a different location by the U.S. worker. Employers must make reasonable efforts to accommodate such placement requests by the U.S. worker.
(d) The employer will not be required to place an advertisement in a newspaper of general circulation serving the area of intended employment, as required in § 655.151.
(e) An association that fulfills the recruitment requirements for its members is required to maintain a written recruitment report containing the information required by § 655.156 for each individual employer-member identified in the application or job order, including any approved modifications.
(a) Housing for work performed on the range must meet the minimum standards contained in § 655.235 and § 655.122(d)(2).
(b) The SWA with jurisdiction over the location of the range housing must inspect and certify that such housing used on the range is sufficient to accommodate the number of certified workers and meets all applicable standards contained in § 655.235. The SWA must conduct a housing inspection no less frequently than once every three calendar years after the initial inspection and provide documentation to the employer certifying the housing for a period lasting no more than 36 months. If the SWA determines that an employer's housing cannot be inspected within a 3-year timeframe or, when it is inspected, the housing does not meet all the applicable standards, the CO may deny the H-2A application in full or in part or require additional inspections, to be carried out by the SWA, in order to satisfy the regulatory requirement.
(c)(1) The employer may self-certify its compliance with the standards contained in § 655.235 only when the employer has received a certification from the SWA for the range housing it seeks to use within the past 36 months.
(2) To self-certify the range housing, the employer must submit a copy of the valid SWA housing certification and a written statement, signed and dated by the employer, to the SWA and the CO assuring that the housing is available, sufficient to accommodate the number of workers being requested for temporary labor certification, and meets all the applicable standards for range housing contained in § 655.235.
(d) The use of range housing at a location other than the range, where fixed site employer-provided housing would otherwise be required, is permissible only when the worker occupying the housing is performing work that constitutes the production of livestock (which includes work that is closely and directly related to herding and/or the production of livestock). In such a situation, workers must be granted access to facilities, including but not limited to toilets and showers with hot and cold water under pressure, as well as cooking and cleaning facilities, that would satisfy the requirements contained in § 655.122(d)(1)(i). When such work does not constitute the production of livestock, workers must be housed in housing that meets all the requirements of § 655.122(d).
An employer employing workers under §§ 655.200-655.235 may use a mobile unit, camper, or other similar mobile housing vehicle, tents, and remotely located stationary structures along herding trails, which meet the following standards:
(a)
(b)
(2) The employer must provide each worker at least 4.5 gallons of potable water, per day, for drinking and cooking, delivered on a regular basis, so that the workers will have at least this amount available for their use until this supply is next replenished.
(3) The water provided for use by the workers may not be used to water dogs, horses, or the herd.
(4) In situations where workers are located in areas that are not accessible by motorized vehicle, an employer may request a variance from the requirement that it deliver potable water to workers, provided the following conditions are satisfied:
(i) It seeks the variance at the time it submits its
(ii) It attests that it has identified natural sources of water that are potable or may be easily rendered potable in the area in which the housing will be located, and that these sources will remain available during the period the worker is at that location;
(iii) It attests that it shall provide each worker an effective means to test whether the water is potable and, if not potable, the means to easily render it potable; and
(iv) The CO approves the variance.
(5) Individual drinking cups must be provided; and
(6) Containers appropriate for storing and using potable water must be provided and, in locations subject to freezing temperatures, containers must be small enough to allow storage in the housing unit to prevent freezing.
(c)
(2) If pits are used for disposal by burying of excreta and liquid waste, they must be kept fly-tight when not filled in completely after each use. The maintenance of disposal pits must be in accordance with state and local health and sanitation requirements.
(d)
(2) Housing, other than tents, must have flooring constructed of rigid materials easy to clean and so located as to prevent ground and surface water from entering;
(3) Each housing unit must have at least one window that can be opened or skylight opening directly to the outdoors; and
(4) Tents appropriate to weather conditions may be used only where the terrain and/or land use regulations do not permit the use of other more substantial housing.
(e)
(2) Any stoves or other sources of heat using combustible fuel must be installed and vented in such a manner as to prevent fire hazards and a dangerous concentration of gases. If a solid or liquid fuel stove is used in a room with wooden or other combustible flooring, there must be a concrete slab, insulated metal sheet, or other fireproof material on the floor under each stove, extending at least 18 inches beyond the perimeter of the base of the stove.
(3) Any wall or ceiling within 18 inches of a solid or liquid fuel stove or
(4) When a heating system has automatic controls, the controls must be of the type that cuts off the fuel supply when the flame fails or is interrupted or whenever a predetermined safe temperature or pressure is exceeded.
(5) A heater may be used in a tent if the heater is approved by a testing service and if the tent is fireproof.
(f)
(2) Lanterns, where used, must be provided in a minimum ratio of one per occupant of each unit, including tents.
(g)
(h)
(i)
(2) Wall surfaces next to all food preparation and cooking areas must be of nonabsorbent, easy to clean material. Wall surfaces next to cooking areas must be made of fire-resistant material.
(j)
(2) Provision must be made for collecting or burying refuse, which includes garbage, at least twice a week or more often if necessary, except where the terrain in which the housing is located cannot be accessed by motor vehicle and the refuse cannot be buried, in which case the employer must provide appropriate receptacles for storing the refuse and for removing the trash when the employer next transports supplies to the location.
(k)
(l)
(m)
(2) No flammable or volatile liquid or materials may be stored in or next to rooms used for living purposes, except for those needed for current household use.
(3) Housing units for range use must have a second means of escape through which the worker can exit the unit without difficulty.
(4) Tents are not required to have a second means of escape, except when large tents with walls of rigid material are used.
(5) Adequate, accessible fire extinguishers in good working condition and first aid kits must be provided in the range housing.
Category | Regulatory Information | |
Collection | Federal Register | |
sudoc Class | AE 2.7: GS 4.107: AE 2.106: | |
Publisher | Office of the Federal Register, National Archives and Records Administration |