| Page Range | 56255-56697 | |
| FR Document |
| Page and Subject | |
|---|---|
| 83 FR 56697 - Delegation of Authority Under Section 1244 of the National Defense Authorization Act for Fiscal Year 2019 | |
| 83 FR 56325 - Sunshine Act Meeting | |
| 83 FR 56399 - Sunshine Act Meeting Notice; Meeting No. 18-04 | |
| 83 FR 56365 - Sunshine Act Meetings | |
| 83 FR 56378 - Sunshine Act: Notice of Agency Meeting | |
| 83 FR 56383 - Temporary Emergency Committee of the Board of Governors; Sunshine Act Meeting | |
| 83 FR 56275 - Government in the Sunshine Act Meeting Notice | |
| 83 FR 56322 - Senior Executive Service Performance Review Board; Membership | |
| 83 FR 56255 - Pears Grown in Oregon and Washington; Increased Assessment Rate for Fresh Pears | |
| 83 FR 56365 - Updated Collision Risk Model Priors for Estimating Eagle Fatalities at Wind Energy Facilities | |
| 83 FR 56369 - Notice of Proposed Withdrawal Extension and Opportunity for Public Meeting for the Pelican Island National Wildlife Refuge; Florida | |
| 83 FR 56322 - Clean Air Act Advisory Committee; Notice of Charter Renewal | |
| 83 FR 56364 - Next Generation First Responder (NGFR) | |
| 83 FR 56317 - Notice of Filing; Southern California Edison Company, Appalachian Power Company, Arizona Public Service, Indiana Michigan Power Company, Kentucky Power Company, Pacific Gas and Electric Company, PNM Resources, Public Service Company of Colorado, Puget Sound Energy, San Diego Gas & Electric Company, South Carolina Electric & Gas Company, Southwestern Electric Power Company, Southwestern Public Service Company, Wheeling Power Company | |
| 83 FR 56299 - Sodium Gluconate, Gluconic Acid, and Derivative Products From the People's Republic of China: Antidumping Duty and Countervailing Duty Orders | |
| 83 FR 56315 - Goodyear Lake Hydro, LLC; Notice of Availability of Environmental Assessment | |
| 83 FR 56316 - American Wind Energy Association, The Wind Coalition v. Southwest Power Pool, Inc.; Notice of Complaint | |
| 83 FR 56315 - T.A. Keck, III and H.S. Keck; Notice of Existing Licensee's Failure To File a Notice of Intent To File a Subsequent License Application, and Soliciting Notices of Intent To File a License Application and Pre-Application Documents | |
| 83 FR 56327 - Barriers to Participation in the NIOSH Coal Workers Health Surveillance Program | |
| 83 FR 56274 - Submission for OMB Review; Comment Request | |
| 83 FR 56383 - Notice of Receipt of and Availability for Public Comment on an Application for Wireless Telecommunications Facilities Site; The Presidio of San Francisco, California | |
| 83 FR 56313 - Extension of a Currently Approved Information Collection for the Weatherization Assistance Program | |
| 83 FR 56354 - National Practitioner Data Bank Guidebook | |
| 83 FR 56364 - Minnesota; Amendment No. 1 to Notice of a Major Disaster Declaration | |
| 83 FR 56269 - Suspension of Community Eligibility | |
| 83 FR 56360 - Minnesota; Amendment No. 2 to Notice of a Major Disaster Declaration | |
| 83 FR 56380 - Privacy Act of 1974; System of Records | |
| 83 FR 56300 - Biodiesel From Argentina: Initiation of Changed Circumstances Reviews of the Antidumping and Countervailing Duty Orders | |
| 83 FR 56325 - Agency Information Collection Activities; Submission for OMB Review; Comment Request | |
| 83 FR 56287 - Proposed Information Collection; Comment Request; National Survey of Children's Health | |
| 83 FR 56324 - Next Meeting of the North American Numbering Council | |
| 83 FR 56376 - Notice of Receipt of Complaint; Solicitation of Comments Relating to the Public Interest | |
| 83 FR 56361 - Virginia; Amendment No. 1 to Notice of a Major Disaster Declaration | |
| 83 FR 56361 - Virginia; Major Disaster and Related Determinations | |
| 83 FR 56360 - Commonwealth of the Northern Mariana Islands; Major Disaster and Related Determinations | |
| 83 FR 56359 - Commonwealth of the Northern Mariana Islands; Emergency and Related Determinations | |
| 83 FR 56361 - Wisconsin; Amendment No. 1 to Notice of a Major Disaster Declaration | |
| 83 FR 56328 - Basic Health Program; Final Administrative Order | |
| 83 FR 56314 - Combined Notice of Filings #1 | |
| 83 FR 56316 - Supplemental Notice That Initial Market-Based Rate Filing Includes Request for Blanket Section 204 Authorization: Carson Hybrid Energy Storage LLC | |
| 83 FR 56314 - Combined Notice of Filings #2 | |
| 83 FR 56378 - Request for Information on Update to the 2016 Federal Cybersecurity Research and Development Strategic Plan | |
| 83 FR 56404 - Proposed Collection; Comment Request for Form 4255 | |
| 83 FR 56304 - Takes of Marine Mammals Incidental to Specified Activities; Taking Marine Mammals Incidental to Port of Kalama Expansion Project on the Lower Columbia River | |
| 83 FR 56375 - Notice of Inventory Completion: Historic Westville, Inc., Columbus, GA | |
| 83 FR 56370 - Notice of Inventory Completion: Kansas State Historical Society, Topeka, KS | |
| 83 FR 56258 - Sensient Colors, LLC; Filing of Color Additive Petition | |
| 83 FR 56374 - Notice of Intent To Repatriate Cultural Items: University of California, Davis, Davis, CA | |
| 83 FR 56371 - Notice of Inventory Completion: University of Arkansas Museum Collections, Fayetteville, AR | |
| 83 FR 56353 - Agency Information Collection Activities: Proposed Collection: Public Comment Request; Information Collection Request Title: Maternal and Child Health Bureau Performance Measures for Discretionary Grant Information System (DGIS), OMB No. 0915-0298-Revision | |
| 83 FR 56347 - Drug Development Tool Process Under the 21st Century Cures Act and Prescription Drug User Fee Act VI; Public Meeting; Request for Comments | |
| 83 FR 56319 - Information Collection Request Submitted to OMB for Review and Approval; Comment Request; Renewable Fuel Standard Program | |
| 83 FR 56317 - Information Collection Request Submitted to OMB for Review and Approval; Comment Request; Emission Guidelines for Existing Other Solid Waste Incineration Units (Renewal) | |
| 83 FR 56323 - Information Collection Request Submitted to OMB for Review and Approval; Comment Request; NESHAP for Engine Test Cells/Stands (Renewal) | |
| 83 FR 56321 - Information Collection Request Submitted to OMB for Review and Approval; Comment Request; NSPS for Petroleum Refineries (Renewal) | |
| 83 FR 56323 - Information Collection Request Submitted to OMB for Review and Approval; Comment Request; NESHAP for Primary Lead Smelting (Renewal) | |
| 83 FR 56320 - Information Collection Request Submitted to OMB for Review and Approval; Comment Request; NESHAP for the Secondary Lead Smelter Industry (Renewal) | |
| 83 FR 56318 - Information Collection Request Submitted to OMB for Review and Approval; Comment Request; Acid Rain Program (Renewal) | |
| 83 FR 56259 - Outer Continental Shelf Air Regulations; Consistency Update for Massachusetts | |
| 83 FR 56276 - Notice of Public Meeting of the Georgia Advisory Committee to the U.S. Commission on Civil Rights | |
| 83 FR 56275 - Notice of Public Meeting of the Indiana Advisory Committee to the U.S. Commission on Civil Rights | |
| 83 FR 56276 - Notice of Public Meetings of the Mississippi Advisory Committee to the U.S. Commission on Civil Rights | |
| 83 FR 56312 - Notice of Availability of Government-Owned Inventions; Available for Licensing | |
| 83 FR 56274 - Information Collection Request; Servicing Minor Program Loans | |
| 83 FR 56311 - Department of Defense Military Family Readiness Council; Notice of Federal Advisory Committee Meeting | |
| 83 FR 56302 - National Construction Safety Team Advisory Committee Meeting | |
| 83 FR 56387 - Self-Regulatory Organizations; Nasdaq PHLX LLC; Notice of Filing and Immediate Effectiveness of Proposed Rule Change To Amend the Rule 3400 Series | |
| 83 FR 56384 - Self-Regulatory Organizations; New York Stock Exchange LLC; Notice of Filing and Immediate Effectiveness of Proposed Rule Change To Amend Section 303A.00 of the Manual To Change the Threshold for Qualifying as a Smaller Reporting Company To Qualify for Certain Exemptions From the Compensation Committee Requirements | |
| 83 FR 56385 - Self-Regulatory Organizations; Nasdaq PHLX LLC; Notice of Filing and Immediate Effectiveness of Proposed Rule Change Relating to New Derivative Securities Products | |
| 83 FR 56391 - Stellus Capital Investment Corporation, et al. | |
| 83 FR 56311 - Board of Regents, Uniformed Services University of the Health Sciences; Notice of Federal Advisory Committee Meeting | |
| 83 FR 56313 - Meeting Notice | |
| 83 FR 56359 - North Carolina; Amendment No. 9 to Notice of a Major Disaster Declaration | |
| 83 FR 56362 - Florida; Amendment No. 6 to Notice of a Major Disaster Declaration | |
| 83 FR 56356 - Changes in Flood Hazard Determinations | |
| 83 FR 56362 - Proposed Flood Hazard Determinations | |
| 83 FR 56355 - Center for Scientific Review; Notice of Closed Meetings | |
| 83 FR 56258 - Safety Zone; Allegheny River, Miles 0.0-1.0, Pittsburgh, PA | |
| 83 FR 56354 - National Institute of Mental Health; Notice of Closed Meetings | |
| 83 FR 56354 - National Institute of Allergy and Infectious Diseases; Notice of Closed Meetings | |
| 83 FR 56377 - Polyethylene Terephthalate Resin From Brazil, Indonesia, Korea, Pakistan, and Taiwan; Determinations | |
| 83 FR 56271 - Tankers-Automatic Pilot Systems; Correction | |
| 83 FR 56350 - Agency Information Collection Activities; Proposed Collection; Comment Request; Establishing and Maintaining Lists of U.S. Manufacturers/Processors With Interest in Exporting Center for Food Safety and Applied Nutrition-Regulated Products | |
| 83 FR 56399 - Agency Information Collection Activities: Information Collection Renewal; Comment Request; Leveraged Lending | |
| 83 FR 56402 - Agency Information Collection Activities: Information Collection Renewal; Request for Comment; Identity Theft Red Flags and Address Discrepancies Under the Fair and Accurate Credit Transactions Act of 2003 | |
| 83 FR 56303 - Caribbean Fishery Management Council; Public Meeting | |
| 83 FR 56400 - Agency Information Collection Activities: Information Collection Renewal; Comment Request; Fiduciary Activities | |
| 83 FR 56304 - Proposed Information Collection; Comment Request; Capital Construction Fund Agreement, Certificate Family of Forms and Deposit/Withdrawal Report | |
| 83 FR 56310 - Proposed Information Collection; Comment Request; Application for Appointment in the NOAA Commissioned Officer Corps | |
| 83 FR 56347 - Agency Information Collection Activities; Announcement of Office of Management and Budget Approvals | |
| 83 FR 56349 - Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Surveys and Interviews With Investigational New Drug Sponsors To Assess Current Communication Practices With Food and Drug Administration Review Staff Under the Sixth Authorization of the Prescription Drug User Fee Act | |
| 83 FR 56366 - Endangered Species; Recovery Permit Applications | |
| 83 FR 56666 - De Minimis Exception to the Swap Dealer Definition | |
| 83 FR 56290 - Census Designated Places (CDPs) for the 2020 Census-Final Criteria | |
| 83 FR 56293 - Block Groups for the 2020 Census-Final Criteria | |
| 83 FR 56277 - Census Tracts for the 2020 Census-Final Criteria | |
| 83 FR 56285 - Census County Divisions (CCDs) and Equivalent Entities for the 2020 Census-Final Criteria | |
| 83 FR 56257 - Regulation of NMS Stock Alternative Trading Systems | |
| 83 FR 56272 - Draft Merchant Mariner Medical Manual | |
| 83 FR 56262 - Cyantraniliprole; Pesticide Tolerances | |
| 83 FR 56379 - Exemption; Issuance: Northwest Medical Isotopes, LLC; Medical Radioisotope Production Facility | |
| 83 FR 56640 - Federal Credit Union Bylaws | |
| 83 FR 56406 - Medicare and Medicaid Programs; CY 2019 Home Health Prospective Payment System Rate Update and CY 2020 Case-Mix Adjustment Methodology Refinements; Home Health Value-Based Purchasing Model; Home Health Quality Reporting Requirements; Home Infusion Therapy Requirements; and Training Requirements for Surveyors of National Accrediting Organizations |
Agricultural Marketing Service
Farm Service Agency
Census Bureau
International Trade Administration
National Institute of Standards and Technology
National Oceanic and Atmospheric Administration
Navy Department
Federal Energy Regulatory Commission
Centers for Disease Control and Prevention
Centers for Medicare & Medicaid Services
Food and Drug Administration
Health Resources and Services Administration
National Institutes of Health
Coast Guard
Federal Emergency Management Agency
Fish and Wildlife Service
Land Management Bureau
National Park Service
Comptroller of the Currency
Internal Revenue Service
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 electronic mailing list, go to https://public.govdelivery.com/accounts/USGPOOFR/subscriber/new, enter your e-mail address, then follow the instructions to join, leave, or manage your subscription.
Agricultural Marketing Service, USDA.
Final rule.
This rule implements a recommendation from the Fresh Pear Committee (Committee) to increase the assessment rate established for the 2018-2019 and subsequent fiscal periods. The assessment rate will remain in effect indefinitely unless modified, suspended, or terminated.
Effective December 13, 2018.
Barry Broadbent, Marketing Specialist, or Gary Olson, Regional Director, Northwest Marketing Field Office, Marketing Order and Agreement Division, Specialty Crops Program, AMS, USDA; Telephone: (503) 326-2724, Fax: (503) 326-7440, or Email:
Small businesses may request information on complying with this regulation by contacting Richard Lower, Marketing Order and Agreement Division, Specialty Crops Program, AMS, USDA, 1400 Independence Avenue SW, STOP 0237, Washington, DC 20250-0237; Telephone: (202) 720-2491, Fax: (202) 720-8938, or Email:
This action, pursuant to 5 U.S.C. 553, amends regulations issued to carry out a marketing order as defined in 7 CFR 900.2(j). This rule is issued under Marketing Order No. 927, as amended (7 CFR part 927), regulating the handling of pears grown in Oregon and Washington. Part 927, (referred to as “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 Committee locally administers the Order and is comprised of growers and handlers operating within the area of production, and a public member.
The Department of Agriculture (USDA) is issuing this final rule in conformance with Executive Orders 13563 and 13175. This rule falls within a category of regulatory actions that the Office of Management and Budget (OMB) exempted from Executive Order 12866 review. Additionally, because this rule does not meet the definition of a significant regulatory action, it does not trigger the requirements contained in Executive Order 13771. See OMB's Memorandum titled “Interim Guidance Implementing Section 2 of the Executive Order of January 30, 2017, titled `Reducing Regulation and Controlling Regulatory Costs' ” (February 2, 2017).
This rule has been reviewed under Executive Order 12988, Civil Justice Reform. Under the Order now in effect, Oregon and Washington pear handlers are subject to assessments. Funds to administer the Order are derived from such assessments. The assessment rate established by this rule will be applicable to all assessable pears for the 2018-2019 fiscal period, and continue until amended, suspended, or terminated.
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.
The Order provides authority for the Committee, with the approval of USDA, to formulate an annual budget of expenses and collect assessments from handlers to administer the program. The members are familiar with the Committee's needs and with the costs of goods and services in their local area and are in a position to formulate an appropriate budget and assessment rate. The assessment rate is formulated and discussed in a public meeting where all directly affected persons have an opportunity to participate and provide input.
This rule increases the assessment rate from $0.449 to $0.463 per 44-pound standard box or equivalent of fresh “summer/fall” and “winter” pears handled for the 2018-2019 and subsequent fiscal periods. The higher rate is necessary to fully cover the Committee's 2018-2019 fiscal period budgeted expenditures. The Committee has had to draw from its monetary reserve to partially fund program activities during the last two fiscal periods. Drawing from reserves to fund operations on an on-going basis is not a sustainable strategy. Therefore, increasing the continuing assessment rate will allow the Committee to fully fund budgeted expenses and replenish its financial reserve.
The Committee met on May 31, 2018, and unanimously recommended 2018-2019 fiscal period expenditures of $9,213,133 and an assessment rate of $0.463 per standard box or equivalent of fresh “summer/fall” and “winter” pears handled. In comparison, last year's budgeted expenditures were $9,282,059. The new assessment rate of $0.463 is $0.014 higher than the $0.449 rate previously in effect. The Committee recommended the assessment rate increase because expenditures have exceeded assessment revenue in the previous two fiscal periods.
The major expenditures recommended by the Committee for the 2018-2019 fiscal period include $550,790 for contracted administration by Pear Bureau Northwest, $190,700 for administrative expenses, $771,643 for production research and market development, and $7,700,000 for promotion and paid advertising for both “summer/fall” and “winter” varieties of fresh pears. In comparison, major expenses for the 2017-2018 fiscal period included $512,928 for contracted
The assessment rate recommended by the Committee was derived by considering anticipated expenses, expected shipments, and the amount of funds available in the authorized reserve. Anticipated income derived from handler assessments of $9,260,000 (20 million standard boxes or equivalent at $0.463 per box) should be adequate to cover budgeted expenses of $9,213,133, with any excess funds used to replenish the Committee's monetary reserve. Funds in the reserve (currently $1,096,332) will be kept within the maximum permitted by § 927.42(a) and will not exceed the expenses of approximately one fiscal period.
The assessment rate established in this rule will continue in effect indefinitely unless modified, suspended, or terminated by USDA upon recommendation and information submitted by the Committee or other available information.
Although this assessment rate will be in effect for an indefinite period, the Committee will continue to meet prior to or during each fiscal period to recommend a budget of expenses and consider recommendations for modification of the assessment rate. The dates and times of Committee meetings are available from the Committee or USDA. Committee meetings are open to the public and interested persons may express their views at these meetings. USDA will evaluate Committee recommendations and other available information to determine whether modification of the assessment rate is needed. Further rulemaking would be undertaken as necessary. The Committee's budget for subsequent fiscal periods will be reviewed and, as appropriate, approved by USDA.
Pursuant to 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 rule on small entities. Accordingly, AMS has prepared this final 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 the 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 827 growers of fresh pears in the production area and approximately 38 handlers subject to regulation under the Order. Small agricultural producers are defined by the Small Business Administration (SBA) as those having annual receipts less than $750,000, and small agricultural service firms are defined as those whose annual receipts are less than $7,500,000 (13 CFR 121.201).
According to data from USDA Market News, the industry, and the Committee, for the 2016-17 season, the weighted average f.o.b. price for Oregon-Washington fresh pears was approximately $26.99 per standard 44-pound box. Total shipments for that period were 17,878,219 standard boxes or equivalent. Using the number of handlers, and assuming a normal distribution, the majority of handlers may have average annual receipts of more than $7,500,000 ($26.99 per box times 17,878,219 equals $482,533,130 divided by 38 handlers equals $12,698,240 per handler).
In addition, based on National Agricultural Statistics Service data, the industry produced 441,950 tons of fresh pears in the production area during the 2016-2017 season, with an average grower price of $797 per ton. Based on the average grower price, production, and the total number of Oregon-Washington fresh pear growers, and assuming a normal distribution, the average annual grower revenue is below $750,000 ($797 per ton times 441,950 tons equals $352,234,150 divided by 827 growers equals $425,918 per grower). Thus, the majority of Oregon and Washington fresh pear handlers may be classified as large entities, while the majority of growers may be classified as small entities.
This rule increases the assessment rate collected from handlers for the 2018-2019 and subsequent fiscal periods from $0.449 to $0.463 per standard box or equivalent of Oregon and Washington fresh “summer/fall” and “winter” pears handled. The Committee unanimously recommended 2018-2019 fiscal period expenditures of $9,213,133 and the $0.463 per standard box or equivalent assessment rate. The assessment rate of $0.463 is $0.014 higher than the rate for the 2017-2018 fiscal period. The quantity of assessable fresh “summer/fall” and “winter” pears for the 2018-2019 fiscal period is estimated at 20 million standard boxes or equivalent. Thus, the $0.463 rate should provide $9,260,000 in assessment income. Income derived from handler assessments should be adequate to cover budgeted expenses, with any excess funds used to replenish the Committee's monetary reserve.
The major expenditures recommended by the Committee for the 2018-2019 fiscal period include $550,790 for contracted administration by Pear Bureau Northwest, $190,700 for administrative expenses, $771,643 for production research and market development, and $7,700,000 for promotion and paid advertising for both “summer/fall” pears and “winter” pears. Budgeted expenses for these items in the 2017-2018 fiscal period were $512,928, $232,200, $836,931, and $7,700,000, respectively.
The higher assessment rate is necessary to fully cover the Committee's 2018-2019 fiscal period budgeted expenditures. The Committee has had to draw from its monetary reserve to partially fund program activities during the 2016-2017 and 2017-2018 fiscal periods. Drawing from its financial reserve to fund operations on an on-going basis is not a sustainable strategy. Increasing the continuing assessment rate will allow the Committee to fully fund budgeted expenses and replenish its financial reserve.
Prior to arriving at this budget and assessment rate, the Committee considered maintaining the current assessment rate of $0.449 per standard box or equivalent. However, leaving the assessment unchanged would not have generated sufficient revenue to meet the Committee's 2018-2019 fiscal period budgeted expenses of $9,213,133, and would have required the Committee to continue to deplete its financial reserve. Based on estimated shipments, the recommended assessment rate of $0.463 per standard box or equivalent should provide $9,260,000 in assessment income. The Committee determined assessment revenue should be adequate to cover budgeted expenses for the 2018-2019 fiscal period. Any excess assessment revenue will be allocated to replenish the Committee's monetary reserve. Reserve funds will be kept within the amount authorized in the Order.
A review of historical information and preliminary information pertaining to the upcoming fiscal year indicates that the average grower price for the 2018-2019 season should be approximately $800 per ton of fresh pears. Therefore, the estimated assessment revenue for the 2018-2019 fiscal period as a percentage of total grower revenue is about 2.6 percent.
This action increases the assessment obligation imposed on handlers. While assessments impose some additional costs on handlers, the costs are minimal
In accordance with the Paperwork Reduction Act of 1995 (44 U.S.C. Chapter 35), the Order's information collection requirements have been previously approved by the OMB and assigned OMB No. 0581-0189 Fruit Crops. No changes in those requirements are necessary as a result of this action. Should any changes become necessary, they would be submitted to OMB for approval.
This rule imposes no additional reporting or recordkeeping requirements on either small or large Oregon and Washington fresh pear 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. USDA has not identified any relevant Federal rules that duplicate, overlap, or conflict with this final rule.
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.
A proposed rule concerning this action was published in the
A small business guide on complying with fruit, vegetable, and specialty crop marketing agreements and orders may be viewed at:
After consideration of all relevant material presented, including the information and recommendation submitted by the Committee and other available information, it is hereby found that this rule, will tend to effectuate the declared policy of the Act.
Marketing agreements, Pears, Reporting and recordkeeping requirements.
For the reasons set forth in the preamble, 7 CFR part 927 is amended as follows:
7 U.S.C. 601-674.
On and after July 1, 2018, the following base rates of assessment for fresh pears are established for the Fresh Pear Committee:
(a) $0.463 per 44-pound net weight standard box or container equivalent for any or all varieties or subvarieties of fresh pears classified as “summer/fall”;
(b) $0.463 per 44-pound net weight standard box or container equivalent for any or all varieties or subvarieties of fresh pears classified as “winter”; and
Securities and Exchange Commission.
Final rule; technical correction.
This document makes technical corrections to a rule that was published in the
Effective November 13, 2018.
Tyler Raimo, Senior Special Counsel, at (202) 551-6227; Matthew Cursio, Special Counsel, at (202) 551-5748; Marsha Dixon, Special Counsel, at (202) 551-5782; Jennifer Dodd, Special Counsel, at (202) 551-5653; David Garcia, Special Counsel, at (202) 551-5681; or Megan Mitchell, Special Counsel, at (202) 551-4887; Office of Market Supervision, Division of Trading and Markets, Securities and Exchange Commission, 100 F Street NE, Washington, DC 20549-7010.
We are making a technical amendment to Part III, Item 15.a of Form ATS-N under 17 CFR 249.640.
Brokers, Reporting and recordkeeping requirements, Securities.
For the reasons set out above, title 17, chapter II of the Code of Federal Regulations is amended as follows:
15 U.S.C. 78a
The text of Form ATS-N does not, and this amendment will not, appear in the Code of Federal Regulations.
Food and Drug Administration, HHS.
Notification of petition.
The Food and Drug Administration (FDA or we) is announcing that we have filed a petition, submitted by Sensient Colors, LLC, proposing that the color additive regulations be amended to provide for the safe use of an aqueous extract of butterfly pea flower (
The color additive petition was filed on October 4, 2018.
For access to the docket to read background documents or comments received, go to
Stephen DiFranco, Center for Food Safety and Applied Nutrition, Food and Drug Administration, 5001 Campus Dr., College Park, MD 20740, 240-402-2710.
Under section 721(d)(1) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 379e(d)(1)), we are giving notice that we have filed a color additive petition (CAP 8C0313) submitted by Exponent, Inc. on behalf of Sensient Colors, LLC, 1150 Connecticut Ave. NW, Suite 1100, Washington, DC 20036. The petition proposes to amend the color additive regulations in part 73 (21 CFR part 73), “Listing of Color Additives Exempt From Certification,” to provide for the safe use of an aqueous extract of butterfly pea flower (
The petitioner has claimed that this action is categorically excluded under 21 CFR 25.32(k) because the substance is intended to remain in food through ingestion by consumers and is not intended to replace macronutrients in food. In addition, the petitioner has stated that, to their knowledge, no extraordinary circumstances exist. If FDA determines a categorical exclusion applies, neither an environmental assessment nor an environmental impact statement is required. If FDA determines a categorical exclusion does not apply, we will request an environmental assessment and make it available for public inspection.
Coast Guard, DHS.
Notice of enforcement of regulation.
The Coast Guard will enforce the safety zone for the Pittsburgh Downtown Partnership/Light Up Night Fireworks to provide for the safety of persons, vessels, and the marine environment on the navigable waters of the Allegheny River, miles 0.0 to 1.0, extending the entire width of the river. Our regulation for marine events within the Eighth Coast Guard District identifies the regulated area for this event in Pittsburgh, PA. During the enforcement period, entry into, transiting, or anchoring in the safety zone is prohibited to all vessels not registered with the sponsor as participants or official patrol vessels, unless specifically authorized by the Captain of the Port Marine Safety Unit Pittsburgh (COTP) or a designated representative.
The regulations in 33 CFR 165.801 Table 1, line 37 will be enforced from 9 p.m. through 11:30 p.m. on November 16, 2018.
If you have questions about this notice of enforcement, call or email Petty Officer Jennifer Haggins, Marine Safety Unit Pittsburgh, U.S. Coast Guard; telephone 412-221-0807, email
The Coast Guard will enforce a temporary safety Zone for the Pittsburgh Downtown Partnership/Light Up Night Fireworks in 33 CFR 165.801 Table 1 titled “Sector Ohio Valley Annual and Recurring Safety Zones”, line 37 from 9 p.m. through 11:30 p.m. on November 16, 2018. This action is being taken to provide for the safety of persons, vessels, and the marine environment on the navigable waters of the Allegheny River during this event. Our regulation for marine events within the Eighth Coast Guard District, § 165.801 specifies the location of the regulated area for the Pittsburgh Downtown Partnership/Light Up Night Fireworks. Entry into the safety zone is prohibited unless authorized by the Captain of the Port Marine Safety Unit Pittsburgh (COTP) or a designated representative. Persons or vessels desiring to enter into or passage through the safety zone must request permission from the COTP or a designated representative. They can be reached on VHF FM channel 16. If permission is granted, all persons and vessels shall comply with the instructions of the COTP or designated representative.
In addition to this notice of enforcement in the
Environmental Protection Agency (EPA).
Final rule.
The Environmental Protection Agency (EPA) is updating a portion of the Outer Continental Shelf (OCS) Air Regulations. Requirements applying to OCS sources located within 25 miles of states' seaward boundaries must be updated periodically to remain consistent with the requirements of the corresponding onshore area (COA), as mandated by section 328(a)(1) of the Clean Air Act. The portion of the OCS air regulations that is being updated pertains to the requirements for OCS sources for which Massachusetts is the designated COA. The Commonwealth of Massachusetts' requirements discussed in this document will be incorporated by reference into the Code of Federal Regulations and listed in the appendix to the federal OCS air regulations.
This rule is effective on December 13, 2018. The incorporation by reference of certain publications listed in this rule is approved by the Director of the Federal Register as of December 13, 2018.
EPA has established a docket for this action under Docket Identification No. EPA-R01-OAR-2018-0011. All documents in the docket are listed on the
Eric Wortman, Office of Ecosystem Protection, U.S. Environmental Protection Agency, EPA Region 1, 5 Post Office Square (Mail Code OEP05-2), Boston, MA 02109, (617) 918-1624,
Throughout this document whenever “we,” “us,” or “our” is used, we mean EPA.
On September 4, 1992, the EPA promulgated 40 CFR part 55,
On February 12, 2018 (83 FR 5971), the EPA published a Notice of Proposed Rulemaking (NPRM) proposing to incorporate various Massachusetts air pollution control requirements into 40 CFR part 55. Pursuant to 40 CFR 55.12, consistency reviews will occur (1) at least annually; (2) upon receipt of a Notice of Intent (NOI) under 40 CFR 55.4; or (3) when a state or local agency submits a rule to the EPA to be considered for incorporation by reference in 40 CFR part 55. This action is being taken in response to the submittal of a NOI on December 11, 2017 by Vineyard Wind, LLC.
The EPA reviewed the rules for inclusion in 40 CFR part 55 to ensure that they are rationally related to the attainment or maintenance of federal or state ambient air quality standards and compliance with part C of title I of the CAA, that they are not designed expressly to prevent exploration and development of the OCS, and that they are potentially applicable to OCS sources.
Section 328(a) of the CAA requires that the EPA establish requirements to control air pollution from OCS sources located within 25 miles of states' seaward boundaries that are the same as onshore requirements. To comply with this statutory mandate, the EPA must incorporate applicable onshore rules into 40 CFR part 55 as they exist onshore. This limits the EPA's flexibility in deciding which requirements will be incorporated into 40 CFR part 55 and prevents the EPA from making substantive changes to the requirements it incorporates. As a result, the EPA may be incorporating rules into 40 CFR part 55 that do not conform to all of the EPA's state implementation plan (SIP) guidance or certain requirements of the CAA. Consistency updates may result in the inclusion of state or local rules or regulations into 40 CFR part 55, even though the same rules may ultimately be disapproved for inclusion as part of the SIP. Inclusion in the OCS rule does not imply that a rule meets the requirements of the CAA for SIP approval, nor does it imply that the rule will be approved by the EPA for inclusion in the SIP.
On March 9, 2018, the Commonwealth of Massachusetts amended certain regulatory provisions that pertained to the EPA's February 12, 2018 proposed rulemaking. On May 9, 2018, the EPA reopened the comment period for 30 days and provided notice that the EPA modified the proposed regulatory text for incorporation by reference in this action.
Other specific requirements of the consistency update and the rationale for EPA's proposed action are explained in the February 12, 2018 NPRM and the May 9, 2018 reopening of comment period document and will not be restated here.
In response to the February 12, 2018 NPRM and the May 9, 2018 reopening of the comment period, we received a number of anonymous comments that address subjects outside the scope of our final action, do not explain (or provide a legal basis for) how the final action should differ in any way, and make no specific mention of the final action,
The EPA received one relevant comment from the Commonwealth of Massachusetts that referred specifically to the proposed rulemaking on the consistency update for Massachusetts to the outer continental shelf regulations.
The EPA is taking final action to incorporate the rules potentially applicable to OCS sources for which the Commonwealth of Massachusetts will be the COA. The rules that the EPA is taking final action to incorporate are applicable provisions of (1) 310 CMR 4.00: Timely Action Schedule and Fee Provisions; (2) 310 CMR 6.00: Ambient Air Quality Standards for the Commonwealth of Massachusetts; (3) 310 CMR 7.00: Air Pollution Control; and (4) 310 CMR 8.00: The Prevention and/or Abatement of Air Pollution Episode and Air Pollution Incident Emergencies, as amended through March 9, 2018. The rules that EPA is taking final action to incorporate will replace the rules previously incorporated into 40 CFR part 55 for Massachusetts.
In this rule, the EPA is finalizing regulatory text that includes incorporation by reference. In accordance with requirements of 1 CFR 51.5, the EPA is finalizing the incorporation by reference of the Code of Massachusetts Regulations described in the amendments to 40 CFR part 55 set forth below. The EPA has made, and will continue to make, these documents generally available through
Under the Clean Air Act, the Administrator is required to establish requirements to control air pollution from OCS sources located within 25 miles of states' seaward boundaries that are the same as onshore air pollution control requirements. To comply with this statutory mandate, the EPA must incorporate applicable onshore rules into 40 CFR part 55 as they exist onshore.
• 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);
• This action is not an Executive Order 13771 regulatory action because this action is not significant under Executive Order 12866;
• 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 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, this rule does have tribal implications as specified by Executive Order 13175 (65 FR 67249, November 9, 2000), 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, nor does it impose substantial direct compliance costs on tribal governments or preempt tribal law.
Under the provisions of the Paperwork Reduction Act, 44 U.S.C 3501
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 January 14, 2019. 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. This action may not be challenged later in proceedings to enforce its requirements. (See section 307(b)(2).)
Environmental protection, Administrative practice and procedure, Air pollution control, Carbon monoxide, Incorporation by reference, Intergovernmental relations, Lead, Nitrogen dioxide, Outer continental shelf, Ozone, Particulate matter, Permits, Reporting and recordkeeping requirements, Sulfur oxides, Volatile organic compounds.
Part 55 of chapter I, title 40 of the Code of Federal Regulations is amended as follows:
Section 328 of the Clean Air Act (42 U.S.C. 7401
(e) * * *
(11) * * *
(i) * * *
(A) Commonwealth of Massachusetts Requirements Applicable to OCS Sources, March 9, 2018.
(a) * * *
(1) The following Commonwealth of Massachusetts requirements are applicable to OCS Sources, March 9, 2018, Commonwealth of Massachusetts—Department of Environmental Protection.
The following sections of 310 CMR 4.00, 310 CMR 6.00, 310 CMR 7.00 and 310 CMR 8.00:
Environmental Protection Agency (EPA).
Final rule.
This regulation establishes tolerances for residues of cyantraniliprole in or on multiple commodities which are identified and discussed later in this document. The Interregional Research Project No. 4 (IR-4) and DuPont Crop Protection requested these tolerances under the Federal Food, Drug, and Cosmetic Act (FFDCA).
This regulation is effective November 13, 2018. Objections and requests for hearings must be received on or before January 14, 2019, 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-2017-0694, is available at
Michael Goodis, 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 EPA's tolerance regulations at 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-2017-0694 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 January 14, 2019. 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-2017-0694, 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
In the
These documents referenced summaries of the petitions prepared by DuPont Crop Protection, the registrant, which are available in the docket,
Based upon review of the data supporting the petition, EPA modified some of the tolerance levels to conform to EPA's rounding classes and revised the commodity terminology for two tolerances. These changes are explained in Unit IV.D.
Section 408(b)(2)(A)(i) of FFDCA allows EPA to establish a tolerance (the legal limit for a pesticide chemical residue in or on a food) only if EPA determines that the tolerance is “safe.” Section 408(b)(2)(A)(ii) of FFDCA defines “safe” to mean that “there is a reasonable certainty that no harm will result from aggregate exposure to the pesticide chemical residue, including all anticipated dietary exposures and all other exposures for which there is reliable information.” This includes exposure through drinking water and in residential settings, but does not include occupational exposure. Section 408(b)(2)(C) of FFDCA requires EPA to give special consideration to exposure of infants and children to the pesticide chemical residue in establishing a tolerance and to “ensure that there is a reasonable certainty that no harm will result to infants and children from aggregate exposure to the pesticide chemical residue. . . .”
Consistent with FFDCA section 408(b)(2)(D), and the factors specified in FFDCA section 408(b)(2)(D), 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 cyantraniliprole including exposure resulting from the tolerances established by this action. EPA's assessment of exposures and risks associated with cyantraniliprole follows.
EPA has evaluated the available toxicity data and considered its 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.
In general, cyantraniliprole administration in mammalian test species produces both adverse and adaptive changes in the liver, thyroid gland, and adrenal cortex. With repeated dosing, consistent findings of mild to moderate increases in liver weights across multiple species (rats, mice and dogs) are observed. Dogs appear to be more sensitive than rats and mice; cyantraniliprole produces adverse liver effects (increases in alkaline phosphatase, decreases in cholesterol, and decreases in albumin) in dogs at lower dose levels than in rats. In addition, the liver effects in the dog show progressive severity with increased duration of exposure. The available data also show thyroid hormone homeostasis is altered in rats following exposure to cyantraniliprole after 28 or 90 days; however, cyantraniliprole is not a direct thyroid toxicant.
Cyantraniliprole is classified as “not likely to be carcinogenic to humans” based on the absence of increased tumor incidence in acceptable/guideline carcinogenicity studies in rats and mice, and there are no mutagenicity concerns. There are also no developmental or reproductive toxicity concerns and no offspring susceptibility concerns. Cyantraniliprole does not produce developmental toxicity in either rats or rabbits. The 2-generation reproduction study in rats shows that cyantraniliprole has no adverse effect on any reproductive parameters.
Acute and subchronic neurotoxicity studies reveal no evidence of neurotoxicity. Similarly, cyantraniliprole does not adversely impact the immune system in rats and mice. Based on the results of a 28-day dermal study in rats (as well as the dermal LD
Cyantraniliprole has no significant acute toxicity via the oral, dermal, and inhalation routes of exposure. Cyantraniliprole is not an eye or skin irritant and does not cause skin sensitization.
Specific information on the studies received and the nature of the adverse effects caused by cyantraniliprole as well as the no-observed-adverse-effect-level (NOAEL) and the lowest-observed-adverse-effect-level (LOAEL) from the toxicity studies can be found at
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
A summary of the toxicological endpoints for cyantraniliprole used for human risk assessment is discussed in Unit III.B of the final rule published in the
1.
i.
ii.
iii.
iv.
•
•
•
In addition, the Agency must provide for periodic evaluation of any estimates used. To provide for the periodic evaluation of the estimate of PCT as required by FFDCA section 408(b)(2)(F), EPA may require registrants to submit data on PCT.
The Agency estimated the average PCT for existing uses as follows: Citrus: oranges 62%, grapefruit 87%, and lemons 46%; pome fruit: apples 61% and pears 76%; stone fruits: apricots 53%, cherries 48%, peaches 41%, and plums/prunes 59%; tree nuts: almonds 72%, hazelnuts 65%, pecans 22%, pistachios 49%, and walnuts 53%; bushberries (subgroup 13-07B): blueberries 45%; fruiting vegetables: peppers 45% and tomatoes 54%; cucurbits: cantaloupes 50%, cucumbers 23%, pumpkins 18%, squash 24%, and watermelons 29%; leafy vegetables: celery 70%, lettuce 78%, and spinach 53%;
In most cases, EPA uses available data from United States Department of Agriculture/National Agricultural Statistics Service (USDA/NASS), proprietary market surveys, and California Department of Pesticide Regulation (CDPR) Pesticide Use Reporting (PUR) for the chemical/crop combination for the most recent 10 years. EPA uses an average PCT for chronic dietary risk analysis and a maximum PCT for acute dietary risk analysis. The average PCT figures for each existing use are derived by combining available public and private market survey data for that use, averaging across all observations, and rounding up to the nearest 5%, except for those situations in which the average PCT is less than 1% or less than 2.5%. In those cases, the Agency would use less than 1% or less than 2.5% as the average PCT value, respectively. The maximum PCT figure is the highest observed maximum value reported within the most recent 10 years of available public and private market survey data for the existing use and rounded up to the nearest multiple of 5%, except where the maximum PCT is less than 2.5%, in which case, the Agency uses less than 2.5% as the maximum PCT.
The Agency believes that the three conditions discussed in Unit III.C.1.iv. have been met. With respect to Condition a, PCT estimates are derived from Federal and private market survey data, which are reliable and have a valid basis. The Agency is reasonably certain that the percentage of the food treated is not likely to be an underestimation. As to Conditions b and c, regional consumption information and consumption information for significant subpopulations is taken into account through EPA's computer-based model for evaluating the exposure of significant subpopulations including several regional groups. Use of this consumption information in EPA's risk assessment process ensures that EPA's exposure estimate does not understate exposure for any significant subpopulation group and allows the Agency to be reasonably certain that no regional population is exposed to residue levels higher than those estimated by the Agency. Other than the data available through national food consumption surveys, EPA does not have available reliable information on the regional consumption of food to
2.
Based on the Pesticides in Water Calculator (PWC; version 1.52) and Pesticide Root Zone Model Ground Water (PRZM GW) for ground water and FQPA Index Reservoir Screening Tool (FIRST) for surface water, the estimated drinking water concentrations (EDWCs) of cyantraniliprole for chronic exposures for non-cancer assessments are estimated to be 24 ppb for surface water and 64 ppb for ground water.
Modeled estimates of drinking water concentrations were directly entered into the dietary exposure model. For chronic dietary risk assessment, the water concentration value of 64 ppb was used to assess the contribution to drinking water.
3.
Cyantraniliprole is currently registered for the following uses that could result in residential exposures: Turf grass (including residential, recreational, and golf course turf), ornamentals, and structural buildings (including indoor crack/crevice and outdoor broadcast). EPA assessed residential exposure using the following assumptions: EPA determined that residential exposures may occur by the dermal, oral, and inhalation routes of exposures. However, since dermal hazard has not been identified for cyantraniliprole, the only exposures of concern are handler inhalation (for adults), and post-application incidental oral (for children). Residential handler exposure is expected to be short-term in duration. The turf and ornamental labels indicate that a maximum of two applications are allowed per season. Thus, intermediate-term handler exposures are not likely because of the intermittent nature of applications by homeowners. Post-application incidental oral exposures for children may occur for short- and intermediate-term durations due to the persistence of cyantraniliprole. Further information regarding EPA standard assumptions and generic inputs for residential exposures may be found at
4.
1.
2.
3.
i. The toxicity database for cyantraniliprole is complete.
ii. There is no indication that cyantraniliprole is a neurotoxic chemical and there is no need for a developmental neurotoxicity study or additional UFs to account for neurotoxicity.
iii. There is no evidence that cyantraniliprole results in increased susceptibility in
iv. There are no residual uncertainties identified in the exposure databases. The exposure databases are complete or are estimated based on data that reasonably account for potential exposures. The chronic dietary food exposure assessment was a refined assessment which assumed average field trial residues for all crops (except crop subgroup 1A); PCT when available; empirical processing factors, if available, or default processing factors, as appropriate. The 2012 Residential standard operating procedures (SOPs) were previously used to assess post-application exposure to children including incidental oral exposure, and the residential post-application assessment assumed that maximum application rates are applied and that hand-to-mouth activities occur on the day of application. All of the exposure estimates are based on conservative, health-protective assumptions and are not likely to underestimate risk. EPA made conservative (protective) assumptions in the ground and surface water modeling used to assess exposure to cyantraniliprole in drinking water. EPA used similarly conservative assumptions to assess post application exposure of children as well as
EPA determines whether acute and chronic dietary pesticide exposures are safe by comparing aggregate exposure estimates to the acute PAD (aPAD) and chronic PAD (cPAD). For linear cancer risks, EPA calculates the lifetime probability of acquiring cancer given the estimated aggregate exposure. Short-, intermediate-, and chronic-term risks are evaluated by comparing the estimated aggregate food, water, and residential exposure to the appropriate PODs to ensure that an adequate MOE exists.
1.
2.
3.
Using the exposure assumptions described in this unit for short-term exposures, EPA has concluded the combined short-term food, water, and residential exposures result in an aggregate MOE of 149 for children 1 to 2 years old. For adults, the oral and inhalation routes of exposure are not appropriate to be aggregated since the endpoints of concern are not common. Because EPA's level of concern for cyantraniliprole is a MOE of 100 or below, this MOE is not of concern.
4.
5.
6.
Adequate enforcement methodology (liquid chromatography with tandem mass spectroscopy (LC/MS/MS)) is available to enforce the tolerance expression.
The method may be requested from: Chief, Analytical Chemistry Branch, Environmental Science Center, 701 Mapes Rd., Ft. Meade, MD 20755-5350; telephone number: (410) 305-2905; email address:
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 Nations 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.
There are no established Codex MRLs on the caneberry subgroup 13-07A, soybean, aspirated grain fractions, celtuce, Florence fennel and rice. The U.S. tolerances being established for coffee and
EPA received three comments in response to the Notices of Filing. The first comment indicated IR-4 and Rutgers University are profiteering by registering pesticides. The content of this comment is not material to the safety of the tolerances that are the subject of this action; pesticide registration occurs under the provisions of the Federal Insecticide, Fungicide, and Rodenticide Act. The FFDCA allows any person to file a petition proposing the establishment of a tolerance, and financial benefit from associated registration of pesticides is not a factor EPA considers when determining whether a tolerance is safe.
The second comment stated, in part, that no residues should be allowed. The Agency recognizes that some individuals believe that pesticides should be banned on agricultural crops. However, the existing legal framework provided by section 408 of the Federal Food, Drug and Cosmetic Act (FFDCA) states that tolerances may be set when persons seeking such tolerances or exemptions have demonstrated that the pesticide meets the safety standard imposed by that statute. This citizen's comment appears to be directed at the underlying statute and not EPA's implementation of it; the citizen has made no contention that EPA has acted in violation of the statutory framework.
The last comment expressed concern about pollutant loadings and relatively high costs of regulations. The commenter also mentioned the Shelby Amendment, the Freedom of Information Act and the Intergovernmental Panel on Climate Change. The comment did not raise any issue related to the Agency's safety determination for cyantraniliprole tolerances. The receipt of this comment
EPA modified the proposed tolerance levels for soybean, hulls and soybean, seed to conform to the Agency's rounding classes. The Agency also revised the commodity terminology to use the correct commodity definitions for Florence fennel (Fennel, Florence, fresh leaves and stalk) and Aspirated grain fractions (Grain, aspirated grain fractions).
Therefore, tolerances are established for residues of cyantraniliprole, 3-bromo-1-(3-chloro-2-pyridinyl)-N-[4-cyano-2-methyl-6-[((methylamino)carbonyl]phenyl]-1H-pyrazole-5-carboxamide, in or on Berry, low growing, except strawberry, subgroup 13-07H, except blueberry, lowbush and lingonberry at 0.08 parts per million (ppm);
This action establishes tolerances 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), nor is it considered a regulatory action under Executive Order 13771, entitled “Reducing Regulations and Controlling Regulatory Costs” (82 FR 9339, February 3, 2017). This action does not contain any information collections subject to OMB approval under the Paperwork Reduction Act (PRA) (44 U.S.C. 3501
Since tolerances and exemptions that are established on the basis of a petition under FFDCA section 408(d), such as the tolerances 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.
The additions and revisions read as follows:
(a) * * *
Federal Emergency Management Agency, DHS.
Final rule.
This rule identifies communities where the sale of flood insurance has been authorized under the National Flood Insurance Program (NFIP) that are scheduled for suspension on the effective dates listed within this rule because of noncompliance with the floodplain management requirements of the program. If the Federal Emergency Management Agency (FEMA) receives documentation that the community has adopted the required floodplain management measures prior to the effective suspension date given in this rule, the suspension will not occur and a notice of this will be provided by publication in the
The effective date of each community's scheduled suspension is the third date (“Susp.”) listed in the third column of the following tables.
If you want to determine whether a particular community was suspended on the suspension date or for further information, contact Adrienne L. Sheldon, PE, CFM, Federal Insurance and Mitigation Administration, Federal Emergency Management Agency, 400 C Street SW, Washington, DC 20472, (202) 212-3966.
The NFIP enables property owners to purchase Federal flood insurance that is not otherwise generally available from private insurers. In return, communities agree to adopt and administer local floodplain management measures aimed at protecting lives and new construction from future flooding. Section 1315 of the National Flood Insurance Act of 1968, as amended, 42 U.S.C. 4022, prohibits the sale of NFIP flood insurance unless an appropriate public body adopts adequate floodplain management measures with effective enforcement measures. The communities listed in this document no longer meet that statutory requirement for compliance with program regulations, 44 CFR part 59. Accordingly, the communities will be suspended on the effective date in the third column. As of that date, flood insurance will no longer be available in the community. We recognize that some of these communities may adopt and submit the required documentation of legally enforceable floodplain management measures after this rule is published but prior to the actual suspension date. These communities will not be suspended and will continue to be eligible for the sale of NFIP flood insurance. A notice withdrawing the suspension of such communities will be published in the
In addition, FEMA publishes a Flood Insurance Rate Map (FIRM) that identifies the Special Flood Hazard Areas (SFHAs) in these communities. The date of the FIRM, if one has been published, is indicated in the fourth column of the table. No direct Federal financial assistance (except assistance pursuant to the Robert T. Stafford Disaster Relief and Emergency Assistance Act not in connection with a flood) may be provided for construction or acquisition of buildings in identified SFHAs for communities not participating in the NFIP and identified for more than a year on FEMA's initial FIRM for the community as having flood-prone areas (section 202(a) of the Flood Disaster Protection Act of 1973, 42 U.S.C. 4106(a), as amended). This prohibition against certain types of Federal assistance becomes effective for the communities listed on the date shown in the last column. The Administrator finds that notice and public comment procedures under 5 U.S.C. 553(b), are impracticable and unnecessary because communities listed in this final rule have been adequately notified.
Each community receives 6-month, 90-day, and 30-day notification letters addressed to the Chief Executive Officer stating that the community will be suspended unless the required floodplain management measures are met prior to the effective suspension date. Since these notifications were made, this final rule may take effect within less than 30 days.
Flood insurance, Floodplains.
Accordingly, 44 CFR part 64 is amended as follows:
42 U.S.C. 4001
Coast Guard, DHS.
Final rule; correction.
The Coast Guard is correcting a final rule that appeared in the
Effective December 5, 2018.
You may view comments and related material identified by docket number USCG-2015-0926 using the Federal eRulemaking Portal at
For information about this document or to view material incorporated by reference call or email LCDR Matthew J. Walter, CG-NAV-2, U.S. Coast Guard; telephone 202-372-1565, email
In FR Doc. 2018-24127 appearing on page 55272 in the
Coast Guard, DHS.
Notification of availability and request for comments.
The Coast Guard is seeking public comment regarding the draft Merchant Mariner Medical Manual. The guidance in this Manual should assist medical practitioners, the maritime industry, individual mariners, and Coast Guard personnel in evaluating a mariner applicant's physical and medical status to meet the requirements of the merchant mariner medical certificate. This draft Commandant Instruction Manual incorporates and consolidates prior guidance on the medical evaluation of merchant mariners contained in several Coast Guard documents. The Manual includes guidance on the medical certificate and related processes, including procedures for application, issuance, and cancellation of the medical certificate.
Comments must be submitted to the online docket, via
You may submit comments identified by docket number USCG-2018-0041 using the Federal eRulemaking Portal at
For information about this document call or email Adrienne Buggs, M.D., United States Coast Guard, Office of Merchant Mariner Credentialing; telephone: 202-372-2357, email:
We encourage you to submit comments (or related material) on the draft Merchant Mariner Medical Manual. We will consider all submissions and may adjust our final action based on your comments. If you submit a comment, please include the docket number for this document, 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
The Coast Guard provided guidance on the medical and physical requirements for merchant mariners in the Medical and Physical Evaluation Guidelines for Merchant Mariner Credentials, Navigation and Inspection Circular (NVIC) 04-08, Commandant Publication (COMDTPUB) 16700.4; and in Part A of the Marine Safety Manual, Volume III, Marine Industry Personnel, COMDTINST M16000.8 (Series) [MSM]. In the years since publication of NVIC 04-08, information received from public comment, medical appeals, and federal advisory committee recommendations highlighted the need for additional specificity and clarity in the medical guidance document. It also underscored the potential for confusion caused by having medical evaluation guidance contained in multiple guidance documents. For example, Part A of the MSM, Volume III, which has not been updated since 1999, may contain some information that conflicts with the guidance in NVIC 04-08. In response to these concerns, the Coast Guard began a series of revisions to the medical evaluation guidelines, published as Change 1 to NVIC 04-08, in June 2013, and Change 2 to NVIC 04-08, in April 2016.
In addition to the revisions needed for improved clarity and specificity, the medical guidance also required new policy following publication of the Coast Guard's final rule on the Implementation of the Amendments to the International Convention on Standards for Training, Certification and Watchkeeping for Seafarers, 1978, and Changes to National Endorsements (78 FR 77795, Dec. 24, 2013). Specifically, the Coast Guard needed to develop new guidance to address the medical certificate and related processes required by these regulations. The Coast Guard provided this new guidance through a separate document, titled NVIC 01-14, Guidance on the Issuance of Medical Certificates. With the experience gained since the publication of NVIC 01-14, the Coast Guard has identified areas of the medical certificate policy that are in need of clarification, particularly with respect to some entry-level mariners, and procedures related to mariners who become unfit while in possession of a valid medical certificate. Rather than issuing a change to NVIC 01-14, the Coast Guard will include the revised medical certificate guidance with the medical evaluation guidance in a new policy document called the Merchant Mariner Medical Manual, also known as Commandant Instruction M16721.48.
The draft Merchant Mariner Medical Manual revises, updates and combines the medical evaluation guidance previously published in NVIC 04-08, Part A of the MSM, Volume III, and NVIC 01-14. The Coast Guard developed the draft Manual in consultation with experienced maritime community medical practitioners and industry stakeholders serving on the Merchant Mariner Medical Advisory Committee (MEDMAC) and the
Changes made in this draft Manual seek to improve ease of use, clarify and update prior guidance, and provide more transparency to the regulated community. Major changes include (1) use of a single manual format; (2) clarification of medical certificate requirements for certain entry-level mariners; and (3) the proposed medical certificate cancellation policy.
The Coast Guard began issuing medical certificates in January 2014. The medical certificate is a certificate issued by the Coast Guard under 46 CFR part 10, subpart C, that serves as proof that the seafarer meets the medical and physical standards for merchant mariners. The medical certificate is not a credential (see definitions of medical certificate and credential in 46 CFR 10.107). Prior to the establishment of the medical certificate, a merchant mariner's certification of medical and physical fitness was embedded in the MMC. Under that system, if the Coast Guard received credible information that a mariner no longer met the medical and physical standards, the Coast Guard's only option was to declare the mariner medically incompetent and take suspension and revocation action against the MMC, the mariner's professional credential.
However, not all medical concerns require revocation of the professional credential. In most cases, once it is determined that a medical certificate holder no longer meets the standards for medical certification, it is more appropriate for the agency to take action against the certificate that serves as proof of the mariner's medical fitness. The proposed medical certificate cancellation policy describes the procedures that the Coast Guard would use to cancel a medical certificate if it receives credible information that a medical certificate holder no longer meets the standards for medical fitness. The process involves providing notice to the involved mariner about the information received, and allowing them the opportunity to respond and provide additional information. The proposed policy preserves the mariner's right to reconsideration and appeal under 46 CFR 1.03-15, and, allows the involved mariner to continue to work until final agency action, except in cases where there is evidence of compelling and substantial risk of imminent harm. Furthermore, the policy allows the mariner to retain their MMC, simplifying their return to work when their medical condition improves and allowing them to continue to work in the industry in positions that do not require a medical certificate.
The Coast Guard requests public comment on the draft Medical Manual, with emphasis on its readability, clarity, and ease of use. We welcome suggestions on how the Manual can be improved.
We are particularly interested in whether the draft Manual adequately addresses safety concerns in situations where the Coast Guard receives information indicating that a medical certificate holder has developed a medical condition that poses a significant risk of sudden incapacitation, or is taking a medication that poses a significant risk of impairment.
This document is issued under the authority of 5 U.S.C. 552(a), 46 U.S.C. 7101, and 46 U.S.C. 7302.
The Department of Agriculture will submit the following information collection requirement(s) to OMB for review and clearance under the Paperwork Reduction Act of 1995, Public Law 104-13 on or after the date of publication of this notice. Comments are requested regarding: (1) Whether the 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 burden 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, including through the use of appropriate automated, electronic, mechanical, or other technological collection techniques or other forms of information technology should be addressed to: Desk Officer for Agriculture, Office of Information and Regulatory Affairs, Office of Management and Budget (OMB), New Executive Office Building, Washington, DC; New Executive Office Building, 725 17th Street NW, Washington, DC 20503. Commenters are encouraged to submit their comments to OMB via email to:
Comments regarding these information collections are best assured of having their full effect if received by December 13, 2018. Copies of the submission(s) may be obtained by calling (202) 720-8681.
An agency may not conduct or sponsor a collection of information unless the collection of information displays a currently valid OMB control number and the agency informs potential persons who are to respond to the collection of information that such persons are not required to respond to the collection of information unless it displays a currently valid OMB control number.
Farm Service Agency, USDA.
Notice and request for comments.
In accordance with the Paperwork Reduction Act of 1995, the Farm Service Agency (FSA) is requesting comments from all interested individuals and organizations on an extension of a currently approved information collection to support the Servicing Minor Program Loans.
We will consider comments that we receive by January 14, 2019.
We invite you to submit comments on this notice. In your comments, include the date, volume,
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You may also send comments to the Desk Officer for Agriculture, Office of Information and Regulatory Affairs, Office of Management and Budget, Washington, DC 20503.
Cindy Pawlikowski, (202) 720-0900.
The information collection relates to a program benefit recipient or loan borrower requesting action on security they own, which was purchased with FSA loan funds, improved with FSA loan funds or has otherwise been mortgaged to FSA to secure a Government loan. The information collected is primarily financial data not already on file, such as borrower asset values, current financial information and public use and employment data. There are no changes to the burden hours since the last OMB approval.
For the following estimated total annual burden on respondents, the formula used to calculate the total burden hour is the estimated average time per responses hours multiplied by the estimated total annual responses.
We are requesting comments on all aspects of this information collection to help us:
(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 collection of information including the validity of the methodology and assumptions used;
(3) Evaluate the quality, utility, and clarity of the information technology; and
(4) Minimize the burden of the information collection on those who respond through the use of appropriate automated, electronic, mechanical, or other technological collection techniques or other forms of information technology.
All comments received in response to this notice, including names and addresses where provided, will be made a matter of public record. Comments will be summarized and included in the request for OMB approval of the information collection.
Wednesday, November 14, 2018, 10:00 a.m. ET.
Middle East Broadcasting Networks, Suite D, 7600 Boston Blvd, Springfield, VA 22153.
Notice of meeting of the Broadcasting Board of Governors.
The Broadcasting Board of Governors (Board) will be meeting at the time and location listed above. The Board will vote on a consent agenda consisting of the minutes of its September 5, 2018 meeting, a resolution honoring the 20th anniversary of Radio Free Europe/Radio Liberty broadcasting in the Persian language, and a proposed Board meeting dates in 2019. The Board will receive a report from the Chief Executive Officer and Director of U.S. Agency for Global Media (USAGM).
This meeting will be available for public observation via streamed webcast, both live and on-demand, on the agency's public website at
The public may also attend this meeting in person at the address listed above as seating capacity permits. Members of the public seeking to attend the meeting in person must register at
For more information, please contact USAGM Public Affairs at (202) 203-4400 or by email at
Persons interested in obtaining more information should contact Oanh Tran at (202) 203-4545.
U.S. Commission on Civil Rights.
Announcement of meeting.
Notice is hereby given, pursuant to the provisions of the rules and regulations of the U.S. Commission on Civil Rights (Commission) and the Federal Advisory Committee Act that the Indiana Advisory Committee (Committee) will hold a meeting on Thursday September 27, 2018, from3-4 p.m. EDT for the purpose of discussing a draft op-ed regarding voting rights in the state.
The meeting will be held on Thursday December 6, 2018, from 3-4 p.m. EDT.
Melissa Wojnaroski, DFO, at
This meeting is free and open to the public. Members of the public may join through the above listed toll free call in number. Members of the public will be invited to make a statement as time allows. The conference call operator will ask callers to identify themselves, the organization they are affiliated with (if any), and an email address prior to placing callers into the conference room. Callers can expect to incur regular charges for calls they initiate over wireless lines, according to their wireless plan. The Commission will not refund any incurred charges. Callers will incur no charge for calls they initiate over land-line connections to the toll-free telephone number. Persons with hearing impairments may also follow the proceedings by first calling the Federal Relay Service at 1-800-877-8339 and providing the Service with the conference call number and conference ID number.
Members of the public are also entitled to submit written comments; the comments must be received in the regional office within 30 days following the meeting. Written comments may be mailed to the Regional Programs Unit Office, U.S. Commission on Civil Rights, 230 S Dearborn, Suite 2120, Chicago, IL 60604. They may also be faxed to the Commission at (312) 353-8324, or emailed to Carolyn Allen at
Records generated from this meeting may be inspected and reproduced at the Regional Programs Unit Office, as they become available, both before and after the meeting. Records of the meeting will be available via
U.S. Commission on Civil Rights.
Announcement of meeting.
Notice is hereby given, pursuant to the provisions of the rules and regulations of the U.S. Commission on Civil Rights (Commission) and the Federal Advisory Committee Act that the Mississippi Advisory Committee (Committee) will hold a meeting on Monday December 3, 2018 at 2:30 p.m. Central time. The Committee will review a draft project proposal and discuss next steps in their study of prosecutorial discretion in the state.
The meeting will take place on Monday, December 3, 2018 at 2:30 p.m. Central Time.
Melissa Wojnaroski, DFO, at
Members of the public may listen to this discussion through the above call in number. An open comment period will be provided to allow members of the public to make a statement as time allows. The conference call operator will ask callers to identify themselves, the organization they are affiliated with (if any), and an email address prior to placing callers into the conference room. Callers can expect to incur regular charges for calls they initiate over wireless lines, according to their wireless plan. The Commission will not refund any incurred charges. Callers will incur no charge for calls they initiate over land-line connections to the toll-free telephone number. Persons with hearing impairments may also follow the proceedings by first calling the Federal Relay Service at 1-800-877-8339 and providing the Service with the conference call number and conference ID number.
Members of the public are entitled to submit written comments; the comments must be received in the regional office within 30 days following the meeting. Written comments may be mailed to the Regional Programs Unit, U.S. Commission on Civil Rights, 230 S. Dearborn, Suite 2120, Chicago, IL 60604. They may also be faxed to the Commission at (312) 353-8324, or emailed to Corrine Sanders at
Records generated from this meeting may be inspected and reproduced at the Regional Programs Unit Office, as they become available, both before and after the meeting. Records of the meeting will be available via
U.S. Commission on Civil Rights.
Announcement of meeting.
Notice is hereby given, pursuant to the provisions of the rules and regulations of the U.S. Commission on Civil Rights (Commission) and the Federal Advisory Committee Act that the Georgia Advisory Committee (Committee) will hold a meeting via teleconference on Monday December 17, 2018, at 12:00 p.m. EST for the purpose of reviewing testimony regarding Civil Rights and The Olmstead Act (Disability Rights). The Committee will also discuss next steps in their study of this topic.
The meeting will be held on Monday December 17, 2018, at 12:00 p.m. EST.
Public call information: Dial: 855-719-5012, Conference ID: 6973191.
Melissa Wojnaroski, DFO, at
Members of the public can listen to the discussion. This meeting is available to the public through the above listed toll free number. An open comment period will be provided to allow members of the public to make a statement as time allows. The conference call operator will ask callers to identify themselves, the organization they are affiliated with (if any), and an email address prior to placing callers into the conference room. Callers can expect to incur regular charges for calls they initiate over wireless lines, according to their wireless plan. The Commission will not refund any incurred charges. Callers will incur no charge for calls they initiate over land-line connections to the toll-free telephone number. Persons with hearing impairments may also follow the proceedings by first calling the Federal Relay Service at 1-800-877-8339 and providing the Service with the conference call number and conference ID number.
Members of the public are also entitled to submit written comments; the comments must be received in the regional office within 30 days following the meeting. Written comments may be mailed to the Regional Programs Unit Office, U.S. Commission on Civil Rights, 230 S. Dearborn, Suite 2120, Chicago, IL 60604. They may also be faxed to the Commission at (312) 353-8324, or emailed to Carolyn Allen at
Records generated from this meeting may be inspected and reproduced at the Regional Programs Unit Office, as they become available, both before and after the meeting. Records of the meeting will be available via
Bureau of the Census, Commerce.
Notice of final criteria and program implementation.
Census tracts are relatively permanent small-area geographic divisions of a county or statistically equivalent entity defined for the tabulation and presentation of data from the decennial census and selected other statistical programs. The Census Bureau is publishing this notice in the
This notice's final criteria will be applicable on December 13, 2018.
Requests for additional information on this proposed program should be directed to Vincent Osier at the Geographic Standards, Criteria, and Quality Branch, Geography Division, U.S. Census Bureau, via email at
Census tracts are relatively permanent small-area geographic divisions of a county or statistically equivalent entity
In addition to providing final criteria for census tracts, this notice contains a summary of comments received in response to proposed criteria published in the
In 1905, Dr. Walter Laidlaw originated the concept of permanent, small geographic areas as a framework for studying change from one decennial census to another in neighborhoods within New York City. For the 1910 Census, eight cities—New York, Baltimore, Boston, Chicago, Cleveland, Philadelphia, Pittsburgh, and St. Louis—delineated census tracts (then termed “districts”) for the first time. No additional jurisdictions delineated census tracts until just prior to the 1930 Census, when an additional ten cities chose to do so. The increased interest in census tracts for the 1930 Census is attributed to the promotional efforts of Howard Whipple Green, who was a statistician in Cleveland, Ohio, and later the chairman of the American Statistical Association's Committee on Census Enumeration Areas. For more than twenty-five years, Mr. Green strongly encouraged local citizens, via committees, to establish census tracts
After 1930, the Census Bureau saw the need to standardize the delineation, review, and updating of census tracts and published the first set of census tract criteria in 1934. The goal of the criteria has remained unchanged; they assure comparability and data reliability through the standardization of the population thresholds for census tracts, as well as requiring that tracts' boundaries follow specific types of geographic features that do not change frequently. The Census Bureau began publishing census tract data as part of its standard tabulations beginning with the 1940 Census. Prior to that time, census tract data were published as special tabulations.
For the 1940 Census, the Census Bureau began publishing census block
Starting with the 1960 Census, the Census Bureau assumed a greater role in promoting and coordinating the delineation, review, and update of census tracts. For the 1980 Census, criteria for BNAs were changed to make them more comparable in size and shape to census tracts. For the 1990 Census, all counties contained either census tracts or BNAs.
Census 2000 was the first decade in which census tracts were defined in all counties. In addition, the Census Bureau increased the number of geographic areas whose boundaries could be used as census tract boundaries. It also allowed tribal governments of federally recognized American Indian tribes with a reservation and/or off-reservation trust lands to delineate tracts without regard to state and/or county boundaries, provided the tribe had a 1990 Census population of at least 1,000.
For the 2010 Census, the Census Bureau adopted changes to census tract criteria that recognized their utility as a framework of small geographic areas for presenting and analyzing statistical and other data for a variety of communities, settlement patterns, and landscapes. The Census Bureau augmented its minimum, maximum, and optimum population threshold with housing unit thresholds for use in defining census tracts for seasonal communities that have no or low population on census day (April 1). The Census Bureau formalized criteria for census tracts defined for employment centers, airports, parks, large water bodies, and other special land uses that had been permitted in previous decades, but never specified within the criteria. The Census Bureau also established tribal census tracts as a geographic framework defined within federally recognized American Indian reservations and off-reservation trust lands that is fully separate from the standard census tracts defined within counties.
The
The Census Bureau received comments from 16 individuals or groups of individuals on topics related to (1) use of non-visible political boundaries when defining census tracts; (2) use of employment data to define census tracts encompassing areas with substantial amounts of commercial, industrial, or other non-residential activity for the purpose of transportation planning; (3) maintaining historical comparability; and (4) accounting for statistical data reliability and quality when developing census tract criteria and defining individual census tracts. Commenters represented state and local government agencies, regional planning organizations and councils of governments, state data centers, non-governmental organizations, and academic researchers. Comments received by the Census Bureau are summarized below, as well as the Census Bureau's response to these comments.
The Census Bureau received three comments from individuals in Michigan noting that non-visible minor civil division (MCD) boundaries in Michigan should be permitted to be census tract boundaries for the 2020 Census as was the case in the past. The commenters correctly noted that in Table 1, Acceptable Minor Civil Division and Incorporated Place Boundaries, the proposed criteria were in error with regard to Michigan. The Census Bureau has corrected the table in the final criteria.
The Census Bureau received 14 comments related to defining census tracts encompassing areas with concentrations of employment and jobs or other types of non-residential uses to improve the utility of census tracts for transportation and journey-to-work analysis and planning. Eleven commenters suggested adoption of a minimum threshold of 1,200 workers/jobs (and no maximum or optimum thresholds) to be applied as an alternative to the existing minimum population or housing unit threshold or in combination with population or housing unit thresholds. One commenter supported the use of worker/job counts when defining census tracts, but did not specify a minimum threshold. Two commenters expressed support for modifying criteria for special use census tracts primarily to improve identification of census tracts encompassing areas with concentrations of employment. One commenter noted that applying employment thresholds was not necessary as the sample design for the American Community Survey (which is the source for much of the demographic data used in journey-to-work analysis) focused on residential population concentrations rather than employment concentrations. This commenter suggested that changes to the special use census tract land area criteria could achieve the result desired by commenters proposing employment thresholds and could provide greater flexibility when defining census tracts.
Based on consideration of the comments received on this topic and further discussion with stakeholders in the transportation community, the Census Bureau will change its criteria for defining special use census tracts to no longer specify minimum land area requirements. Special use census tracts should be comparable in land area size to surrounding census tracts to assure data reliability and quality when reporting on workplace-related data and to avoid data disclosure issues. The Census Bureau also recommends that, when defining special use census tracts encompassing employment centers and areas with concentrations of jobs, PSAP participants should strive for a minimum threshold of 1,200 workers/jobs.
One commenter noted the importance of maintaining historical boundaries of census tracts for chronicling change in the sociodemographic characteristics of neighborhoods. The commenter noted that, while adherence to specified population thresholds (particularly the optimum and maximum population thresholds, which factor in decisions to split census tracts) is an important characteristic of census tracts, comparability over time also is a critical characteristic. Further, allowing census tracts to exceed the optimum and maximum thresholds will help mitigate issues related to the large sampling error associated with small geographic areas. The commenter suggested that by leaving census tract boundaries unchanged (
The Census Bureau agrees with the sentiments expressed by this commenter and will continue to allow individual PSAP participants to avoid splitting census tracts if they are more concerned about historical comparability or statistical data reliability or both. We also agree with the suggestion to align block group boundaries with the boundaries of former census tracts in those instances in which census tracts have been merged and will update the final criteria accordingly.
One comment, submitted by a team of researchers, centered around the quality and reliability of statistical data for census tracts and other small geographic areas. Their concern was that the current methodology for updating and defining census tracts, with its focus on maintaining historical comparability as well as adherence to the optimum threshold of 4,000 persons, results in a framework of small geographic areas that may not meet current analytical and policy development needs for statistically reliable data. Similar to the sentiment expressed by the comment discussed above, this group of commenters suggested that in some places and contexts, the population size of census tracts should be allowed to increase beyond the maximum threshold, adding that these larger units would provide higher quality data because they would contain more responses from sample-based surveys. However, in their suggestion regarding adoption of explicit statistical data quality criteria, the commenters are proposing a fundamental change in the process for defining census tracts for data dissemination purposes; that is, if a census tract does not achieve the quality criterion for a given data release, it would be combined with an adjacent tract. The commenters suggest that through this combination, the margins of error on the estimates will be reduced, and data users will be able to obtain a more reliable estimate for a new larger “census tract” (encompassing multiple “sub-tracts”).
While this is an intriguing idea, the Census Bureau cannot implement it at this time. Through the 2020 PSAP, the Census Bureau works with participants to update census tract boundaries prior to the 2020 Census to define a stable geographic framework for tabulating and presenting decennial census and ACS data. As we understand it, the commenters' proposal would result in a framework of “preliminary” census tracts that would be combined, as necessary, to meet statistical data reliability criteria after data have been tabulated, but prior to final release. The Census Bureau needs more time than is available prior to the start of the 2020 PSAP delineation process to research this proposal and consider any potential data tabulation, data disclosure, and analytical implications, particularly if census tracts were combined in different ways depending on the specific mix of variables presented in a particular data tabulation.
1. The primary goal of the census tract is to provide a set of nationally consistent small, statistical geographic units, with stable boundaries, that facilitate analysis of data across time. A century of census tract use, along with ACS and the averaging of sample data for tracts over a five-year span, has shown that continuity and comparability in tracts and their boundaries over time are of considerable importance to data users. Pursuant to this goal, the Census Bureau requests that where a census tract must be updated, for example to meet the minimum or maximum population or housing unit thresholds, that the outer boundaries of the tract not be changed, but rather that a tract be split into two or more tracts, or merged with an adjacent tract. The Census Bureau discourages changes to tract boundaries (that is, “retracting”), except in specified circumstances, which the Census Bureau will review on a case-by-case basis.
2. In order to ensure a minimal level of reliability in sample data and minimize potential disclosures of sensitive information, a census tract should contain at least 1,200 people or at least 480 housing units at minimum, and 8,000 people or 3,200 housing units at maximum. PSAP participants should aim to create census tracts that meet the optimal population of 4,000 or 1,600 housing units and maintain the minimum thresholds unless it is flagged as a special use tract (discussed below), or is coextensive with a county with fewer than 1,200 people. The housing unit criterion is used to accommodate areas that are occupied seasonally and may otherwise show a discrepancy between decennial and ACS figures.
3. The Census Bureau recognizes that there are significant geographic areas that are characterized by unique populations (
4. To facilitate the analysis of data for American Indian tribes, and to recognize their unique governmental status, program participants are encouraged to merge, split, or redefine census tracts to avoid unnecessarily splitting American Indian reservations (AIRs) and off-reservation trust lands (ORTLs). Each contiguous AIR and/or ORTL should be included, along with any necessary territory outside the AIR and/or ORTL, within a single census tract or as few census tracts as possible for the 2020 Census. This is the only situation in which retracting is encouraged (Figure 1).
The criteria herein apply to the United States, including federally recognized AIRs and ORTLs, Puerto Rico, and the Island Areas.
The Census Bureau sets forth the following criteria for use in reviewing, updating, and delineating 2020 Census tracts:
5. Census tracts must not cross county or state boundaries.
This criterion takes precedence over all other criteria or requirements (except for tribal tracts on federally recognized AIRs and/or ORTLs).
6. Census tracts must cover the entire land and water area of a county.
7. Census tracts must comprise a reasonably compact and contiguous land area.
Noncontiguous boundaries are permitted only where a contiguous area or inaccessible area would not meet population or housing unit count requirements for a separate census tract, in which case the noncontiguous or inaccessible area must be combined within an adjacent or proximate tract. For example, an island that does not meet the minimum population threshold for recognition as a separate census tract should be combined with other proximate land to form a single, contiguous census tract. Each case will be reviewed and accepted at the Census Bureau's discretion.
8. Census tract boundaries should follow visible and identifiable features.
To make the location of census tract boundaries less ambiguous, wherever possible, tract boundaries should follow significant, visible, easily identifiable features. The use of visible features facilitates the location and identification of census tract boundaries in the field, both on the ground and in imagery. The selection of permanent physical features also increases the stability of the boundaries over time, as the locations of many visible features in the landscape tend to change infrequently. If census tract boundaries are changed, they should not be moved from a more
The following features are preferred as census tract boundaries for the 2020 Census:
a. State and county boundaries must always be census tract boundaries. This criterion takes precedence over all other boundary criteria or requirements.
b. AIR and ORTL boundaries.
c. Visible, perennial, stable, relatively permanent natural and constructed features, such as roads, shorelines, rivers, perennial streams and canals, railroad tracks, or above-ground high-tension power lines.
d. Boundaries of legal and administrative entities in selected states. Table 1 identifies by state which MCD and incorporated place boundaries may be used as census tract boundaries.
e. Additionally, the following legally defined, administrative boundaries would be permitted as census tract boundaries:
i. Barrio, barrio-pueblo, and sub-barrio boundaries in Puerto Rico;
ii. Census subdistrict and estate boundaries in the U.S. Virgin Islands;
iii. County and island boundaries (both MCD equivalents) in American Samoa;
iv. Election district boundaries in Guam;
v. Municipal district boundaries in the Commonwealth of the Northern Mariana Islands; and,
vi. Alaska Native Regional Corporation boundaries in Alaska, at the discretion of the Census Bureau, insofar as such boundaries are unambiguous for allocating living quarters as part of 2020 Census activities.
f. The boundaries of large parks, forests, airports, penitentiaries/prisons, and/or military installations, provided the boundaries are clearly marked or easily recognized in the field, in imagery, and on the ground.
g. When acceptable visible and governmental boundary features are not available for use as census tract boundaries, the Census Bureau may, at its discretion, approve other nonstandard visible features, such as major ridgelines, above-ground pipelines, intermittent streams, or fence lines. The Census Bureau may also accept, on a case-by-case basis, relatively short stretches of boundaries of selected nonstandard and potentially nonvisible features, such as cadastral and parcel boundaries or the straight-line extensions or other lines-of-sight between acceptable visible features.
The following are the population, housing unit, and area measurement threshold criteria for census tracts (as summarized in Table 2). The same population and housing unit thresholds apply to all types of non-special use census tracts, including census tracts delineated for AIRs and ORTLs, the Island Areas, and encompassing group quarters, military installations, and institutions.
a. 2010 Census population counts should be used in census tract review in most cases. Housing unit counts should be used for census tracts in seasonal communities that have little or no population on Census Day (April 1). Locally produced population and housing unit estimates can be used when reviewing and updating census tracts, especially in areas that have experienced considerable growth since the 2010 Census.
b. The housing unit thresholds are based on a national average of 2.5 persons per household. The Census Bureau recognizes that there are local and regional variations to this average, and will take this into consideration when reviewing all census tract proposals.
c. Any census tract with a population or housing unit count less than the minimum threshold should be merged with an adjacent census tract to form a single tract with at least 1,200 people or at least 480 housing units (Figure 2). The Census Bureau recognizes the complexity that exists between meeting the optimum population or housing unit threshold in a census tract and maintaining census tract comparability over time. For example, if the population or housing unit count based on 2010 Census data was below the minimum thresholds, but significant growth has occurred since 2010 or is expected before 2020 for a census tract, the census tract should not be merged with another census tract. Supporting evidence may be requested by the Census Bureau. However, if the census tract's population does not increase as expected and does not meet either the minimum population or housing unit thresholds for 2020, this may adversely affect the reliability and availability of any sample estimates for that census tract. For this reason, the Census Bureau suggests merging the census tract with another adjacent census tract if there is a possibility that anticipated growth will not be sufficient to meet minimum thresholds. When merging census tracts, the Census Bureau suggests retaining the former census tract boundaries as boundaries for block groups within the newly defined census tract to facilitate historical analysis.
d. For the 2020 Census, the Census Bureau will allow the delineation of special use census tracts, but they are not required. A special use census tract must be designated as a specific use type (
a. A census tract has a basic census tract identifier composed of no more than four digits and may have a two-digit decimal suffix.
b. The range of acceptable basic census tract identifiers for the 2020 Census is from 1 to 9989 (see 6.c. below for exceptions); special use census tracts delineated specifically to complete coverage of large water bodies will be numbered from 9950 to 9989 in each county.
c. Census tracts delineated within or to primarily encompass AIRs and/or ORTLs should be numbered from 9400 to 9499.
d. Census tract identifiers must be unique within each county.
e. Once used, census tract identifiers cannot be reused in a subsequent census to reference a completely different area within a county. If a census tract is split, each portion may keep the same basic 4-digit identifier, but each portion must be given a unique suffix. If a census tract that was suffixed for 2010 Census is split, each portion must be given a new suffix.
f. The range of acceptable census tract suffixes is .01 to .98.
Table 3 provides a summary of the types of census tracts (with their respective population, housing unit, and area measurement thresholds) that the Census Bureau will use for the 2020 Census.
Tribal census tracts are statistical geographic entities defined by the Census Bureau in cooperation with tribal officials to provide meaningful, relevant, and reliable data for small geographic areas within the boundaries of federally recognized AIRs and/or ORTLs. As such, they recognize the unique statistical data needs of federally recognized American Indian tribes. The delineation of tribal census tracts allows for an unambiguous presentation of census tract-level data specific to the federally recognized AIR and/or ORTL without the imposition of state or county boundaries, which might artificially separate American Indian populations located within a single AIR and/or ORTL. To this end, the American
In order to provide meaningful statistical geographic areas within the AIR and/or ORTL, as well as make meaningful and reliable data available for these areas and their populations, tribal census tract geography is maintained separately from standard county-based census tracts. This change was first introduced for the 2010 Census, creating standard, county-based census tracts nationwide and maintaining tribal census tracts as a completely separate set of geography from standard census tracts for both geographic and data presentation purposes. The change eliminated, in part, the reliability and availability data issues for the tribal census tracts and the derived standard census tracts that were present in Census 2000.
As with standard census tracts submitted through this program, the tribal census tracts are submitted to the Census Bureau, and are subject to review to ensure compliance with the published criteria. Detailed criteria pertaining to tribal census tracts will be published in a separate
Bureau of the Census, Commerce.
Notice of final criteria and program implementation.
Census county divisions (CCDs) and equivalent entities are statistical geographic entities established cooperatively by the Census Bureau and officials of state and local governments in 21 states where minor civil divisions (MCDs) either do not exist or have been unsatisfactory for reporting statistical data. The primary goal of the CCD program has been to establish and maintain a set of subcounty units that have stable boundaries and recognizable names. The Census Bureau is publishing this notice in the
This notice's final criteria will be effective on December 13, 2018.
Requests for additional information on this program should be directed to the Geographic Standards, Criteria, and Quality Branch, Geography Division, U.S. Census Bureau, via email at
Census county divisions (CCDs) and equivalent entities are statistical geographic entities established cooperatively by the Census Bureau and officials of state and local governments in 21 states
The Census Bureau is publishing this notice in the
When CCDs were introduced prior to the 1950 Census, few alternatives were available for the provision of statistical data related to relatively stable, subcounty geographic units. Census tracts were defined in only a subset of metropolitan area counties. MCDs existed in all counties, but in some states MCD boundaries changed frequently enough that they were not useful for comparing statistical data from one decade to another.
For much of the period from the 1950 Census through the 1980 Census, county subdivisions (MCDs and CCDs) provided the only subcounty unit of geography at which data users could obtain statistical data for complete coverage of counties nationwide. The introduction of block numbering areas (BNAs) in counties without census tracts for the 1990 Census offered an alternate subcounty entity for which data could be tabulated. For Census 2000, the Census Bureau introduced census tracts nationwide (in many counties, BNAs were simply relabeled as “census tracts”), increasing the dissemination of, and ability to analyze, data at the census tract level, and providing an alternative set of subcounty statistical geographic areas in each county in addition to MCDs and CCDs. Nevertheless, CCDs and MCDs remain useful for presenting subcounty statistics and, in less populous counties containing only one or two census tracts, can provide greater spatial resolution when analyzing the distribution of population and characteristics.
The Census Bureau's proposed criteria for the 2020 Census were unchanged from the final criteria used to delineate CCDs for the 2010 Census. The Census Bureau did not receive any comments in response to the proposed criteria published in the
The criteria outlined herein apply to the United States,
1. The primary goal of the CCD program is to establish and maintain a set of subcounty units that have stable boundaries and recognizable names. The boundaries of CCDs usually coincide with visible features or stable, significant legal boundaries, such as the boundary of an American Indian reservation (AIR), federally managed land, or conjoint incorporated places. CCDs have no legal status as statistical geographic entities and are defined only for the tabulation and presentation of statistical data.
2. A CCD usually represents a single contiguous area consisting of one or more communities, economic centers, or, in some instances, major land uses that are relatively compact in shape.
3. A CCD should have a relationship to existing census tracts, either encompassing one or more census tracts or having two or more CCDs nest within a single census tract. The boundaries of a CCD, or combination of nested CCDs, align with census tract boundaries. Note that a county with a population less than the optimum population for a census tract (less than 4,000 people) may contain more CCDs than census tracts. For example, McCone County, Montana, which has a 2017 estimated population of 1,718, contains only one
4. Since the 1950s, the Census Bureau has worked with state and local officials to replace MCDs with CCDs for the collection, presentation, and analysis of Census Bureau data, particularly in states in which MCDs do not provide governmental services and functions, and in which MCD boundaries tend to change between decennial censuses. For the 2020 Census, CCDs are defined in 21 states: Alabama, Alaska, Arizona, California, Colorado, Delaware, Florida, Georgia, Hawaii, Idaho, Kentucky, Montana, Nevada, New Mexico, Oklahoma, Oregon, South Carolina, Texas, Utah, Washington, and Wyoming. North Dakota adopted CCDs for use in tabulating and presenting data from the 1970 Census. Following the 1970 Census, North Dakota requested that the Census Bureau again use MCDs to tabulate and present statistical data. For the 2010 Census, Tennessee requested that the Census Bureau replace its CCDs with county commissioner districts, a type of legal, administrative MCD.
CCDs should (1) have community orientation, (2) have visible and/or stable boundaries, (3) maintain relationships with census tract boundaries, and (4) have recognizable names.
Each CCD should center on one or more places and encompass additional surrounding territory that together form a cohesive community area. The definition of community should take into account factors, such as production, marketing, consumption, and the integrating factor of local institutions.
The locality on which a CCD is centered usually is an incorporated place or an unincorporated community, which might be identified as a CDP. In some cases, the CCD may center on a major area of significantly different topography, land use, or ownership, such as a large military installation or AIR. A CCD should always comprise a reasonably compact, continuous land area, generally with road access to all areas within the CCD.
To make the location of CCD boundaries less ambiguous, the boundaries should follow, wherever possible, visible and identifiable features. The use of visible features makes it easier to locate and identify CCD boundaries over time, as the locations of most visible features in the landscape change infrequently, making data collection easier and more reliable, while reducing the possibility for data allocation errors. The Census Bureau requires that CCDs follow state and county boundaries, conform to census tract boundaries, and allows CCDs to follow the boundaries of federally recognized AIRs, and federal, state, or locally managed land.
The following features are acceptable:
a. County boundaries (always a CCD boundary);
b. Census tract boundaries, which usually follow visible, perennial, natural, and cultural features, such as roads, rivers, canals, railroads, or above-ground, high-tension power lines;
c. Legally defined, federally recognized AIR boundaries;
d. The boundaries of federal, state, or locally managed land, such as national parks, national monuments, national forests, other types of large parks or forests, airports, marine ports, prisons, military installations, or other large facilities;
e. Conjoint city limits (in certain situations, such as city limits that change infrequently); and,
f. When the above types of features are not available for use as CCD boundaries, the Census Bureau may, at its discretion, approve other nonstandard, visible features, such as ridge lines, above-ground pipelines, streams, or fence lines. The Census Bureau may also accept, on a case-by-case basis, the boundaries of selected nonstandard and potentially nonvisible features, such as the boundaries of cemeteries, golf courses, glaciers, or the straight-line extensions of visible features and other lines-of-sight.
Whenever possible, a CCD should encompass one or more contiguous census tracts, or multiple CCDs should constitute a single census tract. Therefore, CCD boundaries should be consistent with census tract boundaries. Population size is not as important a consideration with CCDs as it is with census tracts. For CCDs that do not meet the thresholds for a census tract, the Census Bureau encourages creating one or more block groups within a census tract that encompass a CCD. Historically, CCDs have ranged from a few hundred people (in selected situations) to more than one million. However, data quality and availability may be factors that local governments and planners should consider in defining statistical geographic areas. As a general rule, period estimates of demographic characteristics of small population areas from the American Community Survey will be subject to higher variances than comparable period estimates for areas with larger populations. In addition, the Census Bureau's disclosure rules may have the effect of restricting the availability and amount of data for areas with small populations.
a. The names of existing CCDs shall not be changed unless a compelling reason is provided, such as when the name from which the CCD was derived has changed, as in the case of Bainbridge Island, Washington, when the name of the city (Winslow) changed;
b. A new CCD usually is named after the largest population center or historically central place within it (
c. Where a CCD contains multiple centers with relatively equal importance, a CCD name may represent the two or three centers (
d. A CCD may be named after the AIR (
e. A CCD may be named after a prominent physical feature (
f. If there is no clear cultural focus or topographic name that can be applied, a CCD name shall consist of the county name and a compass direction to indicate the portion of the county in the CCD or a place name and a compass direction to give the CCD location relative to the place. The directional indicator precedes a county name (
In all cases, the objective is to clearly identify the extent of the CCD by means of an area name since CCD names always should be meaningful to data users. Any name used as a CCD name must also be recognized by the Board on Geographic Names for federal use and appear in the Geographic Names Information System maintained by the U.S. Geological Survey. This includes any individual names combined to make a hyphenated CCD name.
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.
To ensure consideration, written comments must be submitted on or before January 14, 2019.
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 Leah Meyer, U.S. Census Bureau, ADDP, HQ-7H157, 4600 Silver Hill Road, Washington, DC 20233-0001 (301-763-7174 or via email at
Sponsored primarily by the U.S. Department of Health and Human Services' (HHS) Health Resources Services Administration's Maternal and Child Health Bureau (HRSA MCHB), the National Survey of Children's Health (NSCH) is designed to produce data on the physical and emotional health of children under 18 years of age who live in the United States. The United States Department of Agriculture (USDA), Environmental Protection Agency (EPA), and United States Department of Health and Human Services' Center for Disease Control and Prevention, National Center on Birth Defects and Developmental Disabilities (HHS/CDC/NCBDDD) sponsor supplemental questions on the NSCH. The NSCH collects information on factors related to the well-being of children, including access to health care, in-home medical
We have made minor content revisions for the 2019 NSCH. We also plan to monitor the continued effectiveness of unconditional incentives (the relative benefit for reducing survey non-response by providing a $0, $1, $2, or $5 incentive as a token of appreciation) and modifications to data collection strategies based on modeled information about paper or internet response preference. We will test an envelope overprint, a short message and simple image printed to the outside of the invitation envelope, designed to encourage respondents to open and read the invitation and a modified design for the screener invitation letter. We will also conduct a small test of a new screener card, a mechanism to more efficiently screen address eligibility. We will select approximately 184,000 addresses as the 2019 NSCH sample; around 4,000 of those addresses will be randomly assigned to the screener card test. Results from prior year surveys were used to inform the decisions made regarding this 2019 survey project.
Based on the results from prior survey cycles and available funds, an unconditional cash incentive will be included with the initial mailing. Survey research indicates that incentives are a necessary and cost‐effective expense for achieving a response rate that minimizes nonresponse bias
In addition to testing incentives and developing materials, the 2019 NSCH will continue to serve as a platform to evaluate different nonresponse follow-up mailing strategies based on a household's likelihood to respond using a paper questionnaire. We assign a paper-preference probability to every address using American Community Survey (ACS) response mode choices, previous NSCH response mode choices, and small area geographic characteristics. The 30% of addresses with the highest paper-preference probability are assigned to the “High Paper” group and receive a paper questionnaire with the initial invitation. The other 70% of addresses are assigned to the “High Web” group and receive their first paper questionnaires in the second nonresponse follow-up screener invitation.
Since there continues to be a significant potential for cost savings for web data collection over paper data collection, we are working to refine and retest an internet response indicator for future NSCH production cycles based on the results from prior data collection efforts.
In 2019 and beyond, we will continue the use of a pressure-sealed reminder postcard. The reminder postcard will be mailed approximately one week after the initial survey invite mailing and the first nonresponse follow-up. We originally implemented this strategy because the time gap between mailings during the 2016 NSCH proved too long, and a significant dip in response flow was observed between mailings. The pressure-sealed postcard reminder proved effective in 2017 and 2018 at boosting response from the initial mailing and, in 2018, the first nonresponse follow-up. The ability to send reminders enclosed with a pressure-seal system allows us to include login information for the Centurion web instrument as well as specific information about the survey. The postcard also allows us to include a paragraph in Spanish that will direct the respondent to the Spanish web survey or the Telephone Questionnaire Assistance (TQA) line for assistance.
As in prior administration of the NSCH, the 2019 NSCH will have a TQA line available to respondents who experience technical problems with the web instrument, have questions about the survey, or need other forms of assistance. TQA staff will be able to answer respondent questions and concerns, and also collect survey responses over the phone—if the respondent calls in and would like to have interviewer assistance in completing the interview. Also, respondents can submit questions by email. Email Questionnaire Assistance (EQA) agents will monitor the email account inbox and respond promptly.
The 2018 NSCH tested a certified mail sticker, designed to encourage respondents to open the invitation envelope and respond to the NSCH. The sticker significantly increased response, but did not reduce nonresponse bias. The sticker also introduced logistical challenges that make current use as a treatment option untenable. Instead, we will test an envelope overprint, which is a short message on the outside of the envelope that can potentially encourage response and reduce nonresponse bias. Half of addresses (approximately 90,000) will receive the screener invitation in an envelope with the overprint; the other half of addresses will receive our standard white envelope. Packages can also include a modified version of the invitation letter designed to make the text more accessible, such as relocating some necessary information to a text box with a boundary.
In both internet and paper collection modes, the survey design for the 2019 NSCH focuses on first collecting information about the children in the household and basic special health care needs, and then selecting a child from the household for follow-up to collect additional detailed topical information. If there is more than one eligible child in a household, a single child will be selected based on a sampling algorithm that considers the age and number of children as well as the presence of children with special health care needs. We estimate that, from the original 180,000 selected addresses that are assigned to the primary production cycle (excluding the 4,000 addresses
For the 4,000 screener card test addresses, we anticipate that 50% (2,000 addresses) will return the screener card and 10% (400 addresses) will use the web instrument.
Census staff have developed a plan to select a production sample of approximately 184,000 households (addresses) from a Master Address File (MAF)-based sampling frame, with split panels to test mode of administration (
The Tropical Completion Rate is the proportion of topical-eligible houshoulds (i.e., occupied residences with children present) that completed a topical questionnaire. It is equal to I/HCt, where I is the count of completed topicals and HCt is the estimated count of households with children in the sample or S+R+(S+R)/(S+X+R)*e(UR+UO).
The production 2019 NSCH plan for the web push data collection design includes 70% of the estimated 180,000 primary production addresses receiving an initial invite with instructions on how to complete an English or Spanish-language screening questionnaire via the web. Households that decide to complete the web-based survey will be taken through the screening questionnaire to determine if they screen into one of the three topical instruments. Households that list at least one child who is 0 to 17 years old in the screener are directed into a topical questionnaire immediately after the last screener question. If a household in the web push treatment group decides to complete the paper screener, the household may have a chance to receive an additional topical questionnaire incentive.
The production 2019 NSCH plan for the mixed-mode data collection design includes approximately 30% of the 180,000 primary production addresses receiving both an initial invite with a paper screening questionnaire and instructions on how to complete an English or Spanish language screening questionnaire via the web. Households that decide to complete the web-based survey will follow the same screening and topical selection path as the web push. Households that choose to complete the paper screener questionnaire rather than completing the survey on the internet and that have eligible children will be mailed a paper topical questionnaire upon receipt of their completed paper screener at the Census Bureau's National Processing Center. If a household in the mixed-mode group chooses to complete the paper screener instead of completing by internet, then the household may receive an additional topical questionnaire incentive.
Prior to Census administration of the survey, the NSCH was conducted by the Health Services Resources Administration's Maternal and Child Health Bureau and the National Center for Health Statistics. As such, the survey information was sent to respondents under letterhead from the Department of Health and Human Services and the Centers for Disease Control and Prevention, with the Director of NCHS signing the letters to the respondent.
In the 2016 NSCH, we tested both standard contact branding utilized for Census Bureau surveys, which included Census Bureau letterhead and the Census Director's signature, and an alternative sent with HRSA MCHB branding. The first follow-up mailing, sent to non-responding households approximately three-weeks after their initial invitation to respond to the survey by web, was split into two groups. The first group was sent a reminder to participate with their web login and password under standard Census Bureau letterhead. Response was higher from those addresses receiving the standard Census branding.
The “High Web” group will receive two web survey invitation letters requesting their participation in the survey prior to receiving their first paper screener questionnaire in the second follow-up mailing. The “High Paper” group will receive both a web survey invitation letter along with a mailed paper screener questionnaire with the initial invitation and each follow-up mailing. Once a household in the “High Web” group receives a paper screener questionnaire, it will then have the option to either complete the web-based survey or complete the mailed paper screener, similar to the “High Paper” group. If the household chooses to complete the mailed paper questionnaire, then they would then be considered part of the mailout/mailback paper-and-pencil interviewing treatment group. The paper-and-pencil treatment group receives a paper topical questionnaire, if there is at least one eligible child who is 0 to 17 years old listed on the screener. Nonresponse follow-up for the topical questionnaire will include up to one pressure-sealed postcard and up to three mailings including the paper topical questionnaire.
The 2019 NSCH will also include a small screener card test. The screener card is a single-page instrument designed to screen household eligibility
Title 13 U.S.C. Section 8(b);42 U.S.C. 701; 1769d(a)(4)(B); 42 U.S.C. 241; 7 U.S.C. 136r(a); and 15 U.S.C. 2609.
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.
Bureau of the Census, Commerce.
Notice of final criteria and program implementation.
Census designated places (CDPs) are statistical geographic entities representing closely settled, unincorporated communities that are locally recognized and identified by name. They are the statistical equivalents of incorporated places, with the primary differences being the lack of a legally defined boundary and an active, functioning governmental structure, chartered by the state and administered by elected officials. CDPs defined for the 2020 Census will also be used to tabulate American Community Survey, Puerto Rico Community Survey, and Economic Census data after 2020, and potentially data from other Bureau of the Census (Census Bureau) censuses and surveys. The Census Bureau is publishing this notice in the
This notice's final criteria will be applicable on December 13, 2018.
Requests for additional information on this program should be directed to Vincent Osier, Geographic Standards, Criteria, and Quality Branch, Geography Division, U.S. Census Bureau, via email at
Census designated places (CDPs)
The Census Bureau is publishing this notice in the
The CDP concept and delineation criteria have evolved over the past seven decades in response to data user needs for place-level data. This evolution has taken into account differences in the way in which places were perceived, and the propensity for places to incorporate in various states. The result, over time, has been an increase in the number and types of unincorporated communities identified as CDPs. This also results in an increasing consistency in the relationship between the CDP concept and the kinds of places encompassed by the incorporated place category, or a compromise between localized perceptions of place and a concept that would be familiar to data
Although not as numerous as incorporated places or municipalities,
According to the 2010 Census, more than 38.7 million people in the United States, Puerto Rico, and the Island Areas lived in CDPs. The relative importance of CDPs varies from state to state depending on laws governing municipal incorporation and annexation, but also depending on local preferences and attitudes regarding the identification of places.
The Census Bureau's proposed criteria for the 2020 Census were unchanged from the final criteria used to delineate CDPs for the 2010 Census. The Census Bureau did not receive any comments in response to the proposed criteria published in the
The criteria outlined herein apply to the United States, including AIRs and off-reservation trust lands, Puerto Rico, and the Island Areas. In accordance with the final criteria, the Census Bureau may modify and, if necessary, reject any proposals for CDPs that do not meet the established criteria. In addition, the Census Bureau reserves the right to modify the boundaries and attributes of CDPs as needed to maintain geographic relationships before the final tabulation geography is set for the 2020 Census.
The Census Bureau proposes the following criteria and guidelines for use in identifying the areas that will qualify for designation as CDPs for use in tabulating data from the 2020 Census, the American Community Survey, the Puerto Rico Community Survey, the Economic Census, and potentially other Census Bureau censuses and surveys.
1. A CDP constitutes a single, closely settled center of population that is named. To the extent possible, individual unincorporated communities should be identified as separate CDPs. Similarly, a single community should be defined as a single CDP rather than multiple CDPs with each part referencing the community name and a directional term (
Multiple communities may only be combined to form a single CDP when the identities of these communities have become so intertwined that the communities are commonly perceived and referenced as a single place. For example, the communities of Arden and Arcade in California have grown together over time and residents commonly use the place name Arden-Arcade. Further, because of the intertwined identity, residents would have difficulty identifying a boundary between the separate, historical communities of Arden and Arcade. Multiple communities may also be defined as a single CDP when there are no distinguishable or suitable features in the landscape that can be used as a boundary between the communities, even if the two communities still have separate identities. For example, the CDP of Ashton-Sandy Spring in Maryland encompasses two communities that still maintain separate identities in common, daily usage. The two communities, however, have grown together to such an extent that a clear break between the two communities is no longer identifiable in the landscape. In general, when considering whether to combine multiple communities as a single CDP, the following questions should be taken into account:
• Do residents commonly perceive and refer to the communities as a single entity?
• Are there landscape elements, such as signs, that use a hyphenated name for the community?
• Can residents or other knowledgeable individuals identify clear, commonly accepted boundaries for the individual communities?
2. A CDP generally consists of a contiguous cluster of census blocks comprising a single piece of territory and containing a mix of residential, nonresidential, and commercial uses similar to that of an incorporated place of similar size. Some CDPs, however, may be predominantly residential; such places should represent recognizably distinct, locally known communities, but not typical suburban subdivisions. Examples of such predominantly residential communities that can be recognized as CDPs are colonias, small rural communities, and unincorporated resort and retirement communities.
3. A CDP may not be located, either partially or entirely, within an incorporated place or another CDP.
4. A CDP may be located in more than one county but must not cross state boundaries. It is important to note, however, that since county boundaries provide important demarcations for communities, CDPs that cross county lines should be kept to a minimum and identified only when the community clearly sees itself existing on both sides of a county boundary.
5. There are no minimum population or housing unit thresholds for defining CDPs; however, a CDP must contain some population or housing units or
6. CDP boundaries should follow visible features, except in those circumstances when a CDP's boundary is coincident with the nonvisible boundary of a state, county, minor civil division (in the six New England states, Michigan, Minnesota, New Jersey, New York, Pennsylvania, and Wisconsin), or incorporated place. CDP boundaries may follow other nonvisible features in instances where reliance upon visible features would result in overbounding of the CDP in order to include housing units on both sides of a road or street feature. Such boundaries might include parcel boundaries and public land survey system lines; fence lines; national, state, or local park boundaries; ridgelines; or drainage ditches.
7. The CDP name should be one that is recognized and used in daily communication by the residents of the community. Because unincorporated communities generally lack legally defined boundaries, a commonly used community name and the geographic extent of its use by local residents is often the best identifier of the extent of a place, the assumption being that if residents associate with a particular name and use it to identify the place in which they live, then the CDP's boundaries can be mapped based on the use of the name. There should be features in the landscape that use the name, such that a non-resident would have a general sense of the location or extent of the community; for example, signs indicating when one is entering the community; highway exit signs that use the name; or businesses, schools, or other buildings that make use of the name. It should not be a name developed solely for planning or other purposes (including simply to obtain data from the Census Bureau) that is not in regular daily use by the local residents and business establishments.
8. A CDP may not have the same name as an adjacent or nearby incorporated place. If the community does not have a name that distinguishes it from other nearby communities, then the community is not a distinct place. The use of directional terms (“north”, “south”, “east”, “west”, and so forth) to merely differentiate the name of a CDP from a nearby municipality where this name is not in local use is not acceptable. For example, the name “North Laurel” would be permitted if this name were in local use. The name “Laurel North” would not be permitted if it were not in local use. Again, this has much to do with the way in which people typically refer to the places in which they live. It is permissible to change the name of a 2010 CDP for the 2020 Census if the new name provides a better identification of the community.
Bureau of the Census, Commerce.
Notice of final criteria and program implementation.
Block groups are statistical geographic subdivisions of a census tract defined for the tabulation and presentation of data from the decennial census and selected other statistical programs. Block groups also will be used to tabulate and publish estimates from the American Community Survey (ACS) after 2020 and potentially data from other Bureau of the Census (Census Bureau) censuses and surveys. The Census Bureau is publishing this notice in the
This notice's final criteria will be applicable on December 13, 2018.
Requests for additional information on this program should be directed to Vincent Osier at the Geographic Standards, Criteria, and Quality Branch, Geography Division, U.S. Census Bureau, via email at
Block groups are statistical geographic subdivisions of a census tract defined for the tabulation and presentation of data from the decennial census and selected other statistical programs. Block groups also will be used to tabulate and publish estimates from the American Community Survey (ACS)
The Census Bureau is publishing this notice in the
The Census Bureau first delineated block groups as statistical geographic divisions of census tracts for the 1970 Census, comprising contiguous combinations of census blocks for data presentation purposes. At that time, census block groups only existed in urbanized areas in which census blocks were defined. Block groups were defined without regard to political and administrative boundaries, with an average population of 1,000, and to be approximately equal in area.
As use of census block, block group, and census tract data increased among data users, the Census Bureau expanded these programs to cover additional geographic areas while redefining the population threshold criteria to more adequately suit data users' needs. The 1990 Census was the first in which census blocks and block groups were defined throughout the entirety of the United States, Puerto Rico, and the Island Areas. For the 2000 Census, as with census tracts, the Census Bureau increased the number of geographic areas whose boundaries could be used as block group boundaries, and allowed tribal governments of federally recognized American Indian tribes with a reservation and/or off-reservation trust lands to delineate tribal block groups without regard to state and/or county boundaries, provided the tribe had a 1990 Census population of at least 1,000.
For the 2010 Census, the Census Bureau adopted changes to block group criteria that recognized their utility as a framework of small geographic areas and established tribal block groups as a geographic framework for presenting and analyzing statistical and other data for a variety of communities, settlement patterns, and landscapes. The Census Bureau augmented its minimum and maximum population threshold with housing unit thresholds for use in defining block groups for seasonal communities that have no or low population on census day (April 1). In addition, the Census Bureau formalized criteria for block groups defined for employment centers, airports, parks, large water bodies, and other special land uses that had been permitted in previous decades, but never specified within the criteria. The Census Bureau also established tribal block groups as a geographic framework defined within federally recognized American Indian reservations and off-reservation trust lands that is fully separate from the standard block groups defined within counties.
The
The Census Bureau received comments from 16 individuals on one or more topics related to (1) use of non-visible political boundaries when defining block groups, (2) use of employment data to define block groups
The Census Bureau received three comments from individuals in Michigan noting that all minor civil division (MCD) boundaries in Michigan should be permitted to be block group boundaries for the 2020 Census as was the case in the past. The commenters correctly noted that in Table 1, Acceptable Minor Civil Division and Incorporated Place Boundaries, the proposed criteria were in error with regard to Michigan. The Census Bureau has corrected the table in the final criteria.
The Census Bureau received 14 comments related to defining block groups encompassing areas with concentrations of employment and jobs or other types of non-residential uses to improve the utility of block groups for transportation and journey-to-work analysis and planning. Eleven commenters suggested adoption of a minimum threshold of 600 workers/jobs (and no maximum or optimum thresholds) to be applied as an alternative to the existing minimum population or housing unit threshold or in combination with population or housing unit thresholds. One commenter supported the use of worker/job counts when defining block groups, but did not specify a minimum threshold. Two commenters expressed support for modifying criteria for special use block groups primarily to improve identification of block groups encompassing areas with concentrations of employment. One of these commenters noted that applying employment thresholds was not necessary as the sample design for the American Community Survey (which is the source for much of the demographic data used in journey-to-work analysis) focused on residential population concentrations and not employment concentrations. Changes to the special use block group criteria could achieve the result desired by commenters proposing employment thresholds and could also provide greater flexibility when defining block groups.
Based on consideration of the comments received on this topic and further discussion with stakeholders in the transportation community, the Census Bureau will change its criteria for defining special use block groups to no longer specify minimum land area requirements. Special use block groups should be comparable in land area size to surrounding block groups so as to assure data reliability and quality when reporting on workplace-related data and to avoid data disclosure issues. The Census Bureau also recommends that, when defining special use block groups encompassing employment centers and areas with concentrations of jobs, PSAP participants should strive for a minimum threshold of 600 workers/jobs.
One commenter proposed that, when census tracts are merged, an effort should be made to align the boundaries for block groups within the new census tract with the boundaries of the former census tracts that were merged. The commenter noted that this would facilitate historical comparisons of data, particularly when chronicling change in the sociodemographic characteristics of neighborhoods, allowing data users to use block group data to bridge back to previous decades' census tracts.
The Census Bureau agrees with the sentiments expressed by this commenter. We also agree with the suggestion to align block group boundaries with the boundaries of former census tracts in those instances in which census tracts have been merged and will update both the final block group and final census tract criteria accordingly.
1. Block groups are statistical geographic subdivisions of a census tract and are the smallest geographic areas for which the Census Bureau provides sample data, primarily from the ACS 5-year period estimates.
2. Block groups form the geographic framework within which census blocks are numbered.
3. In order to ensure a minimal level of reliability in sample data and minimize potential disclosures of sensitive information, a block group should contain either at least 600 people or at least 240 housing units at minimum, and 3,000 people or 1,200 housing units at maximum. The housing unit criterion is used to accommodate areas that are occupied seasonally and may otherwise show a discrepancy between decennial and ACS figures.
4. The Census Bureau also recognizes that there are significant geographic areas that are characterized by unique populations (
The criteria herein apply to the United States, including federally recognized American Indian reservations (AIRs) and off-reservation trust lands (ORTLs), Puerto Rico, and the Island Areas.
The Census Bureau sets forth the following criteria for use in reviewing, updating, and delineating 2020 Census block groups:
1. Block groups must not cross census tract boundaries.
This criterion takes precedence over all other criteria or requirements. By definition, because census tracts cannot cross county
2. Block groups must cover the entire land and water area of each census tract.
Because census tracts must cover the entire area of a county, by definition, block groups also must cover the entire area of each census tract within each county.
3. A block group must comprise a reasonably compact and contiguous land area.
Noncontiguous boundaries are permitted only where a contiguous area or inaccessible area would not meet population or housing unit count requirements for a separate block group, in which case the noncontiguous or inaccessible area must be combined within an adjacent or proximate block group. For example, an island that does not meet the minimum population threshold for recognition as a separate block group should be combined with other proximate land to form a single block group. Each case will be reviewed and accepted at the Census Bureau's discretion.
4. Block group boundaries should follow visible and identifiable features.
To make the location of block group boundaries less ambiguous, wherever possible, block group boundaries should follow significant, visible, easily identifiable features. The use of visible features facilitates the location and identification of block group boundaries in the field, both on the ground and in imagery. The selection of permanent physical features also increases the stability of the boundaries over time, as the locations of many visible features in the landscape tend to change infrequently. If block group boundaries are changed, they should not be moved from a more significant feature (
The following features are preferred as block group boundaries for the 2020 Census:
a. State, county, and census tract boundaries must always be block group boundaries. This criterion takes precedence over all other boundary criteria or requirements.
b. AIR and ORTL boundaries.
c. Visible, perennial, stable, relatively permanent natural and constructed features, such as roads, shorelines, rivers, perennial streams and canals, railroad tracks, or above-ground high-tension power lines.
d. Boundaries of legal and administrative entities in selected states. Table 1 identifies by state which MCD and incorporated place boundaries may be used as block group boundaries.
e. Additionally, the following legally defined, administrative boundaries are permitted as block group boundaries:
i. Barrio, barrio-pueblo, and subbarrio boundaries in Puerto Rico;
ii. Census subdistrict and estate boundaries in the U.S. Virgin Islands;
iii. County and island boundaries (both MCD equivalents) in American Samoa;
iv. Election district boundaries in Guam;
v. Municipal district boundaries in the Commonwealth of the Northern Mariana Islands; and
vi. Alaska Native Regional corporation boundaries in Alaska, at the discretion of the Census Bureau, insofar as such boundaries are unambiguous for allocating living quarters as part of 2020 Census activities.
f. The boundaries of large parks, forests, airports, penitentiaries/prisons, and/or military installations, provided the boundaries are clearly marked or easily recognized in the field in imagery and on the ground.
g. When acceptable visible and governmental boundary features are not available for use as block group boundaries, the Census Bureau may, at its discretion, approve other nonstandard visible features, such as major ridgelines, above-ground pipelines, intermittent streams, or fence lines. The Census Bureau may also accept, on a case-by-case basis, relatively short stretches of boundaries of selected nonstandard and potentially nonvisible features, such as cadastral and parcel boundaries or the straight-line extensions or other lines-of-sight between acceptable visible features.
The following are the population, housing unit, and area measurement threshold criteria for block groups (as summarized in Table 2). The same population and housing unit thresholds apply to all types of non-special use block groups, including those delineated for AIRs and ORTLs, the Island Areas, and encompassing group quarters, military installations, and institutions.
a. 2010 Census population counts should be used in census block group review in most cases. Housing unit counts should be used for block groups in seasonal communities that have little or no population on Census Day (April 1). Locally produced population and housing unit estimates can be used when reviewing and updating block groups, especially in areas that have experienced considerable growth since the 2010 Census.
b. The housing unit thresholds are based on a national average of 2.5 people per household. The Census Bureau recognizes that there are regional variations to this average, and will take this into consideration when reviewing all census block group proposals.
c. For the 2020 Census, the Census Bureau will allow the delineation of special use census tracts, and special use block groups will be created coextensive with these special use census tracts, but they are not required. A special use census tract, and hence a special use block group, must be designated as a specific use type (
a. A block group encompasses a cluster of census blocks. Each standard block group is identified using a single-digit number that will correspond to the first digit in the number of each census block encompassed by the block group. For example, block group 3 includes all census blocks numbered in the 3000 range within a single census tract.
b. The range of acceptable standard block group numbers is 1 through 9.
c. Block group numbers must be unique within a census tract.
Table 3 provides a summary of the types of block groups (with their respective population, housing unit, and area measurement thresholds) that the Census Bureau will use for the 2020 Census.
Tribal block groups are statistical geographic entities defined by the Census Bureau in cooperation with tribal officials to provide meaningful, relevant, and reliable data for small geographic areas within the boundaries of federally recognized AIRs and/or ORTLs. As such, they recognize the unique statistical data needs of federally recognized American Indian tribes. The delineation of tribal block groups allows for an unambiguous presentation of statistical data specific to the federally recognized AIR and/or ORTL without the imposition of state or county boundaries, which might artificially separate American Indian populations located within a single AIR and/or ORTL. To this end, the American Indian tribal participant may define tribal block groups that cross county or state boundaries, or both. For federally recognized American Indian tribes with AIRs and/or ORTLs that have fewer than 1,200 residents, the Census Bureau will define one tribal census tract and one tribal block group coextensive with the AIR and/or ORTL. Tribal block groups must be delineated to meet all other census block group criteria, and must be identified uniquely so as to clearly distinguish them from county-based block groups. The Census Bureau will address the type of identifiers required for tribal block groups in more detail in a separate
In order to provide meaningful statistical geographic areas within the AIR and/or ORTL, as well as make meaningful and reliable data available for these areas and their populations, tribal block group geography is maintained separately from standard, county-based block groups. This change was first introduced for the 2010 Census, creating standard block groups nationwide and maintaining tribal block groups as a completely separate set of geography from standard block groups for both geographic and data presentation purposes, and eliminates, in part, the reliability and availability data issues for the tribal block groups and the derived standard block groups that were present in Census 2000.
As with standard block groups submitted through this program, the tribal block groups are submitted to the Census Bureau, and are subject to review to ensure compliance with the published criteria. Detailed criteria pertaining to tribal block groups will be published in a separate
Alaska Native Regional Corporation (ANRC)—A corporate geographic area established under the Alaska Native Claims Settlement Act (Pub. L. 92-203, 85 Stat. 688 (1971)) to conduct both the business and nonprofit affairs of Alaska Natives. Twelve ANRCs cover the entire state of Alaska except for the Annette Island Reserve.
Enforcement and Compliance, International Trade Administration, Department of Commerce.
Based on affirmative final determinations by the Department of Commerce (Commerce) and the International Trade Commission (ITC), Commerce is issuing antidumping duty (AD) and countervailing duty (CVD) orders on sodium gluconate, gluconic acid, and derivative products (GNA Products) from the People's Republic of China (China).
Applicable November 13, 2018.
Magd Zalok (AD) at (202) 482-4162 or Robert Galantucci (CVD) at (202) 482-2923, AD/CVD Operations, Office IV, Enforcement and Compliance, U.S. Department of Commerce, 1401 Constitution Avenue NW, Washington, DC 20230.
In accordance with sections 705(d) and 735(d) of the Tariff Act of 1930, as amended (the Act), on September 21, 2018, Commerce published its affirmative final determination of sales at less than fair value (LTFV) and its affirmative final determination that countervailable subsidies are being provided to producers and exporters of GNA Products from China.
The scope of the orders covers all grades of sodium gluconate, gluconic acid, liquid gluconate, and glucono delta lactone (GDL) (collectively GNA Products), regardless of physical form (including, but not limited to substrates; solutions; dry granular form or powders, regardless of particle size; or as a slurry). The scope also includes GNA Products that have been blended or are in solution with other product(s) where the resulting mix contains 35 percent or more of sodium gluconate, gluconic acid, liquid gluconate, and/or GDL by dry weight.
Sodium gluconate has a molecular formula of NaC
The merchandise covered by the scope of the orders is currently classified in the Harmonized Tariff Schedule of the United States (HTSUS) under subheadings 2918.16.1000, 2918.16.5010, and 2932.20.5020. Merchandise covered by the scope may also enter under HTSUS subheadings 2918.16.5050, 3824.99.2890, and 3824.99.9295. Although the HTSUS subheadings and CAS registry numbers are provided for convenience and customs purposes, the written description of the merchandise is dispositive.
In accordance with section 735(d) of the Act, the ITC has notified Commerce of its final determination that an industry in the United States is materially injured within the meaning of section 735(b)(1)(A)(i) of the Act by reason of imports of GNA Products that are sold in the United States at LTFV. Therefore, in accordance with section 735(c)(2) of the Act, we are publishing this antidumping duty order. Because the ITC determined that imports of GNA Products from China are materially injuring a U.S. industry, unliquidated entries of such merchandise from China, entered or withdrawn from warehouse for consumption, are subject to the assessment of antidumping duties.
In accordance with section 736(a)(1) of the Act, Commerce will direct U.S. Customs and Border Protection (CBP) to assess, upon further instruction by Commerce, antidumping duties equal to the amount by which the normal value of the merchandise exceeds the export price (or constructed export price) of the merchandise, for all relevant entries of GNA Products from China. Antidumping duties will be assessed on unliquidated entries of GNA Products from China entered, or withdrawn from warehouse, for consumption on or after July 10, 2018, the date of publication of the
In accordance with section 735(c)(1)(B) of the Act, we will instruct CBP to continue to suspend liquidation on entries of subject merchandise from China. These instructions suspending liquidation will remain in effect until further notice.
We will also instruct CBP to require cash deposits equal to the amount indicated below. Accordingly, effective on the date of publication of the ITC's final affirmative injury determination, CBP will require, at the same time as importers would normally deposit estimated duties on this subject merchandise, a cash deposit equal to the estimated weighted-average dumping margins listed below. Commerce has made no adjustments to the antidumping cash deposit rate because Commerce has made no findings in the countervailing duty investigation that any of the programs are export subsidies.
The weighted-average antidumping duty margin is as follows:
In accordance with section 705(d) of the Act, the ITC notified Commerce of its final determination that the industry in the United States producing GNA Products is materially injured within the meaning of section 705(b)(1)(A)(i) of the Act by reason of subsidized imports of GNA Products from China.
Commerce directed CBP to assess, upon further instruction by Commerce, countervailing duties on unliquidated entries of GNA Products entered, or withdrawn from warehouse, for consumption on or after May 23, 2018, the date of publication of the
In accordance with section 706 of the Act, Commerce will instruct CBP to suspend liquidation on all entries of GNA Products from China, as further described below. These instructions suspending liquidation will remain in effect until further notice. Commerce will also instruct CBP to require cash deposits equal to the amounts as indicated below. Accordingly, effective on the date of publication of the ITC's final affirmative injury determination, CBP will require, at the same time as importers would normally deposit estimated duties on this subject merchandise, a cash deposit equal to the subsidy rates listed below. The all-others rate applies to all producers or exporters not specifically listed below, as appropriate.
This notice constitutes the AD and CVD orders with respect to GNA Products from China pursuant to sections 736(a) and 706(a) of the Act. Interested parties can find an updated list of orders currently in effect by either visiting
These orders are published in accordance with sections 706(a), 736(a), and 19 CFR 351.211(b).
Enforcement and Compliance, International Trade Administration, Department of Commerce.
The Department of Commerce (Commerce) is initiating changed circumstances reviews (CCR) of the antidumping duty (AD) and countervailing duty (CVD) orders on biodiesel from Argentina.
Applicable November 13, 2018.
Kathryn Wallace, AD/CVD Operations, Office VII, Enforcement and Compliance, International Trade Administration, U.S. Department of Commerce, 1401 Constitution Avenue NW, Washington, DC 20230; telephone: (202) 482-6251.
On January 4, 2018, and April 26, 2018, Commerce published the CVD and AD orders on biodiesel from Argentina.
The product covered by the
Pursuant to section 751(b)(1) of the Tariff Act of 1930, as amended (the Act), and 19 CFR 351.216(d), Commerce will conduct a CCR of an AD or CVD order when it receives information concerning, or a request from an interested party which demonstrates, changed circumstances sufficient to warrant such a review. However, section 751(b)(4) of the Act also provides that Commerce may not conduct a CCR of an investigation determination within 24 months of the date of the investigation determination in the absence of “good cause.”
In its request for initiation, the GOA explains that there are changed circumstances sufficient to warrant reconsideration of the AD and CVD final determinations. Regarding changed circumstances, the GOA provided information indicating that, since the
Additionally, the GOA provided two correlating reasons for satisfying the “good cause” requirement pursuant to section 751(b)(4) of the Act. First, the GOA explained that the changes it has made to its export tax system, discussed above, have virtually eliminated the export tax differential among products in the soybean value chain. Specifically, prior to the issuance of the CVD order, in December 2017, products in the soybean value chain (except biodiesel) were subject to an export tax of 27 to 30 percent, while biodiesel was subject to an export tax rate of zero percent.
In considering the GOA's request for a CCR, we note that Commerce has initiated CCRs to address a wide variety of issues, some of which otherwise may or may not be addressed in the context of an annual administrative review.
Therefore, we are initiating CCRs pursuant to sections 751(b)(1) and (4) of the Act and 19 CFR 351.216(c) and (d) to assess the impacts of the GOA's revised export tax regime on the
We intend to publish in the
This notice is published in accordance with section 751(b)(1) and 777(i) of the Act and 19 CFR 351.221(c)(3) of the Act.
The product covered by these orders is biodiesel, which is a fuel comprised of mono-alkyl esters of long chain fatty acids derived from vegetable oils or animal fats, including biologically-based waste oils or greases, and other biologically-based oil or fat sources. These orders cover biodiesel in pure form (B100), as well as fuel mixtures containing at least 99 percent biodiesel by volume (B99). For fuel mixtures containing less than 99 percent biodiesel by volume, only the biodiesel component of the mixture is covered by the scope of these order.
Biodiesel is generally produced to American Society for Testing and Materials International (ASTM) D6751 specifications, but it can also be made to other specifications. Biodiesel commonly has one of the following Chemical Abstracts Service (CAS) numbers, generally depending upon the feedstock used: 67784-80-9 (soybean oil methyl esters); 91051-34-2 (palm oil methyl esters); 91051-32-0 (palm kernel oil methyl esters); 73891-99-3 (rapeseed oil methyl esters); 61788-61-2 (tallow methyl esters); 68990-52-3 (vegetable oil methyl esters); 129828-16-6 (canola oil methyl esters); 67762-26-9 (unsaturated alkylcarboxylic acid methyl ester); or 68937-84-8 (fatty acids, C12-C18, methyl ester).
The B100 product subject to the orders is currently classifiable under subheading 3826.00.1000 of the Harmonized Tariff Schedule of the United States (HTSUS), while the B99 product is currently classifiable under HTSUS subheading 3826.00.3000. Although the HTSUS subheadings, ASTM specifications, and CAS numbers are provided for convenience and customs purposes, the written description of the scope is dispositive.
National Institute of Standards and Technology, Department of Commerce.
Notice of open meeting.
The National Construction Safety Team (NCST) Advisory Committee (Committee) will hold an open meeting via teleconference on Tuesday, November 27, 2018 from 11:00 a.m. to 2:00 p.m. Eastern Time. The primary purpose of this meeting is to finalize the Committee's annual report to Congress. The agenda may change to accommodate Committee business. The final agenda will be posted on the NIST website at
The NCST Advisory Committee will meet on Tuesday, November 27, 2018 from 11:00 a.m. until 2:00 p.m. Eastern Time.
The meeting will be held via teleconference. For instructions on how to participate in the meeting, please see the
Melissa Banner, Administrative Office Assistant, Community Resilience Program, Engineering Laboratory, NIST, 100 Bureau Drive, Mail Stop 8615, Gaithersburg, Maryland 20899-8604. Ms. Banner's email address is
The Committee was established pursuant to Section 11 of the NCST Act (Pub. L. 107-231, codified at 15 U.S.C. 7301
Pursuant to the Federal Advisory Committee Act, as amended, 5 U.S.C. App., notice is hereby given that the NCST Advisory Committee will meet on Tuesday, November 27, 2018 from 11:00 a.m. until 2:00 p.m. Eastern Time. The meeting will be open to the public and will be held via teleconference. There will be no central meeting location. Interested members of the public will be
Individuals and representatives of organizations who would like to offer comments and suggestions related to items on the Committee's agenda for this meeting are invited to request a place on the agenda. Approximately fifteen minutes will be reserved at the beginning of the meeting for public comments. Speaking times will be assigned on a first-come, first-served basis. The amount of time per speaker will be determined by the number of requests received. Questions from the public will not be considered during this period. All those wishing to speak must submit their request by email to the attention of Melissa Banner
Anyone wishing to participate in this meeting must register by 5:00 p.m. Eastern Time, Friday, November 23, 2018. To register please submit your first and last name, email address, and phone number to Melissa Banner at
National Marine Fisheries Service (NMFS), National Oceanic and Atmospheric Administration (NOAA), Commerce.
Notice of a public meeting.
The Caribbean Fishery Management Council will hold its 164th meeting in December to discuss the items contained in the agenda in the
The meetings will be held on December 11-12, 2018, from 9 a.m. to 5 p.m.
The meetings will be held at the Condado Vanderbilt Hotel, Ashford Avenue, 1055, San Juan, Puerto Rico 00907.
Caribbean Fishery Management Council, 270 Muñoz Rivera Avenue, Suite 401, San Juan, Puerto Rico 00918-1903, telephone: (787) 766-5926.
The order of business may be adjusted as necessary to accommodate the completion of agenda items. The meeting will begin on December 11, 2018 at 9 a.m. Other than the start time, interested parties should be aware that discussions may start earlier or later than indicated. In addition, the meeting may be extended from, or completed prior to the date established in this notice.
These meetings are physically accessible to people with disabilities. For more information or request for sign language interpretation and other auxiliary aids, please contact Mr. Miguel A. Rolón, Executive Director, Caribbean Fishery Management Council, 270 Muñoz Rivera Avenue, Suite 401, San Juan, Puerto Rico, 00918-1903, telephone: (787) 766-5926, at least 5 days prior to the meeting date.
National Oceanic and Atmospheric Administration (NOAA), 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.
Written comments must be submitted on or before January 14, 2019.
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 and instructions should be directed to Richard VanGorder, NOAA/NMFS/F/MB5, 1315 East-West Highway, Room 13113, Silver Spring, MD 20910, (301) 427-8784, and
This request is for extension of a currently approved information collection.
Respondents will be commercial fishing industry individuals, partnerships, and corporations which entered into Capital Construction Fund (CCF) agreements with the Secretary of Commerce allowing deferral of Federal taxation on fishing vessel income deposited into the fund for use in the acquisition, construction, or reconstruction of fishing vessels. Deferred taxes are recaptured by reducing an agreement vessel's basis for depreciation by the amount withdrawn from the fund for its acquisition, construction, or reconstruction. The Capital Construction Fund Agreement and Certificate Family of Forms is required pursuant to 50 CFR part 259.2, 50 CFR part 259.9 and Public Law 115-97 (Tax Cuts and Jobs Act of 2017). The deposit/withdrawal information collected from agreement holders is required pursuant to 50 CFR part 259.7 and Public Law 115-97. The information collected from applicants for the CCF Agreement is used to determine their eligibility to participate in the CCF Program. The information collected from agreement holders for the Certificate Family of Forms is used to identify their program eligible vessels, their program projects and to certify the cost of a project at completion. The information collected on the deposit/withdrawal report form is required to ensure that agreement holders are complying with fund deposit/withdrawal requirements established in program regulations and properly accounting for fund activity on their Federal income tax returns. The information collected on the deposit/withdrawal report must also be reported semi-annually to the Secretary of Treasury in accordance with the Tax Reform Act.
The information will be collected on forms submitted electronically, by mail or by fax.
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.
National Marine Fisheries Service (NMFS), National Oceanic and Atmospheric Administration (NOAA), Commerce.
Notice; issuance of an incidental harassment authorization.
In accordance with the regulations implementing the Marine Mammal Protection Act (MMPA) as amended, notification is hereby given that NMFS has issued an Incidental Harassment Authorization (IHA) to the Port of Kalama (POK) for the take of marine mammals, by harassment, incidental to construction activities associated with an expansion project at the Port of Kalama on the Lower Columbia River, Washington.
This Authorization is in effect from October 18, 2018 to October 18, 2019.
Dale Youngkin, Office of Protected Resources, NMFS, (301) 427-8401. Electronic copies of the application and supporting documents, as well as a list of the references cited in this document, may be obtained by visiting the internet at:
The MMPA prohibits the “take” of marine mammals, with certain exceptions. Sections 101(a)(5)(A) and (D) of the MMPA (16 U.S.C. 1361
Authorization for incidental takings shall be granted if NMFS finds that the taking will have a negligible impact on the species or stock(s) and will not have an unmitigable adverse impact on the availability of the species or stock(s) for taking for subsistence uses (where relevant). Further, NMFS must prescribe the permissible methods of taking and other means of effecting the least practicable adverse impact on the affected species or stocks and their habitat, paying particular attention to rookeries, mating grounds, and areas of similar significance, and on the availability of such species or stocks for taking for certain subsistence uses (referred to in shorthand as “mitigation”); and requirements pertaining to the monitoring and reporting of such takings.
The definitions of all applicable MMPA statutory terms cited above are included in the relevant sections below.
On September 28, 2015, we received a request from the POK for authorization of the taking, by Level B harassment only, of marine mammals incidental to the construction associated with the Port of Kalama Expansion Project, which involved construction of the Kalama Marine Manufacturing and Export Facility including a new marine terminal for the export of methanol, and installation of engineered log jams, restoration of riparian wetlands, and the removal of existing wood piles in a side channel as mitigation activities. The specified activity is expected to result in the take of three species of marine mammals (harbor seals, California sea lions, and Steller sea lions). A final version of the application, which we deemed adequate and complete, was submitted on December 10, 2015. We published a notice of a proposed IHA and request for comments on March 21, 2016 (81 FR 715064). After the public comment period and before we issued the final IHA, POK requested that we issue the IHA for 2017 instead of the 2016 work season. We subsequently published the final notice of our issuance of the IHA on December 12, 2016 (81 FR 89436), effective from September 1, 2017-August 31, 2018. In-water work associated with the project was expected to be completed within the one-year timeframe of the IHA.
On June 21, 2018, POK informed NMFS that work relevant to the specified activity considered in the MMPA analysis for the 2017-2018 IHA was postponed and would not be completed. POK requested that the IHA be issued to be effective for the period from 2018—2019. In support of that request, POK submitted an application addendum affirming that no change in the proposed activities is anticipated and that no new information regarding the abundance of marine mammals is available that would change the previous analysis and findings. A notice for the proposed incidental take authorization was published on July 25, 2018 (83 FR 35220), and a corrected notice was published on August 14, 2018 (83 FR 40257). Therefore, comments were received until September 13, 2018. Please refer to the Comments and Responses section below for information on the comments received during the comment periods for the proposed IHA.
The 2017-2018 IHA covered the incidental take of marine mammals due to construction of a marine terminal and dock/pier for the export of methanol, and associated compensatory mitigation activities for the purposes of offsetting habitat effects from the action. The marine terminal will be approximately 45,000 square feet in size, supported by 320 concrete piles (24-inch precast octagonal piles to be driven by impact hammer) and 16 steel piles (12 × 12-inch and 4 × 18-inch anticipated to be driven by vibratory hammer, and impact hammering will only be done to drive/proof if necessary). The compensatory mitigation includes installation of eight engineered log jams (ELJs), which will be anchored by untreated wooden piles driven by impact hammer at low tides (not in water). The compensatory mitigation also includes removal of approximately 157 untreated wooden piles from an old trestle in a nearby backwater area. The piles will be removed either by direct pull or vibratory extraction. Finally, the compensatory mitigation includes wetland restoration and enhancement by removal of invasive species and replacement with native wetland species.
Since no changes have been made to the planned activities reflected in the proposed IHA, NMFS refers the reader to the documents related to the 2017-2018 IHA for more detailed description of the project activities. These previous documents include the
NMFS published a notice of receipt of POK's updated application addendum and proposed IHA in the
As noted in the notice for the proposed IHA, Level A harassment takes proposed for authorization did not rely on calculated takes, and were qualitatively proposed for authorization out of an abundance of caution in the event that some seals may be undetected before entering the Level A harassment zone. Therefore, the amount of Level A harassment takes authorized has not changed as a result of reconsidering the Level A harassment zone and only results in a revision of the Level A harassment monitoring area. Therefore, the requirement for monitoring and shut down distance to avoid Level A harassment take has been revised to 63 m and 26 m to correspond to a two-hour duration for impact driving of concrete piles and vibratory driving of steel piles, respectively.
The Biological Opinion does not identify potential effects of pile driving/in-water construction in regard to any ESA-listed marine mammal species, as none are anticipated to be present in the area of pile driving activities. The Biological Opinion did determine adverse effects to salmon as a result of in-water construction/pile driving but also concluded that the proposed action is not likely to adversely affect southern resident killer whales.
The IHA was issued pursuant to section 101(a)(5)(D) of the MMPA, which requires NMFS to authorize the incidental (but not intentional) take from a specified activity (in this case, in-water construction work associated with the Kalama Manufacturing and Marine Export Facility) in a specified geographic region for a one-year period if the relevant statutory standards are satisfied. The applicant for an IHA describes the specified activity for which the IHA is requested, and need not be a federal action agency. The IHA does not evaluate interrelated and interdependent activities of the specified activity. As Steller sea lions, California sea lions, and harbor seals are the only marine mammal species anticipated to occur in the specified area, these are the appropriate species considered for the IHA.
A description of the marine mammals in the area of the activities is found in the previous documents referenced above, which remain applicable to this IHA as well. In addition, NMFS has reviewed recent Stock Assessment Reports, information on relevant Unusual Mortality Events, and recent scientific literature. Since the submittal of the 2015 IHA application, the USACE has published updated data on pinniped presence at the Bonneville Dam (Tidwell
A description of the potential effects of the specified activities on marine mammals and their habitat is found in the previous documents referenced above, and remain applicable to this proposed IHA. There is no new information on potential effects that would change our analyses or determinations under the 2018-2019 IHA.
A description of the methods and inputs used to estimate take anticipated to occur and, ultimately, the take that was authorized is found in the previous documents referenced above. The methods of estimating take for this IHA are identical to those used in the 2017-2018 IHA, as is the density of marine mammals. The source levels, also remain unchanged from the 2017-2018 IHA, and NMFS's 2016 Technical Guidance for Assessing the Effects of Anthropogenic Sound on Marine Mammal Hearing (NMFS 2016) was used to address new acoustic thresholds in the notice of issuance of the 2017-2018 IHA (see Table 2 for NMFS User Spreadsheet inputs). As stated above, since the submittal of the application for the 2017-2018 IHA (in effect from September 1, 2017 through August 31, 2018), the USACE has published updated data on pinniped presence at the Bonneville Dam, and this data does not suggest a trend that would require a modification to the take estimates or effects analysis. Consequently, the authorized Level B harassment take for this 2018-2019 IHA is identical to the 2017-2018 IHA, as presented in Table 3 below. However, the originally issued IHA did not authorize any Level A harassment take. As harbor seals are smaller and may be more difficult to detect at larger Level A harassment zones, and to account for the potential that they may be unseen or linger longer than expected, a small number of takes by Level A harassment is now authorized. Finally, the pile driving duration informing the calculation of Level A harassment zone sizes has changed from the notice of the proposed IHA as a result of a public comment received. As seals are not transiting to the Bonneville Dam similar to sea lions, and may spend more time in the project vicinity, the duration has been doubled for these species for impact driving of concrete piles and for vibratory driving of steel piles. For impact driving of steel piles, the duration was kept at the original one hour due to the fact that impact driving of these piles would only occur briefly (for proofing) if at all.
At least three observers must be on duty during impact driving at all times. As discussed above, one observer must monitor and implement shutdowns and collect information at each pile driving location at all times. In addition, two shore-based observers are required (one upstream of the project and another downstream of the project), whose primary responsibility shall be to record pinnipeds in the Level B harassment zone and to alert the barge-based observer to the presence of pinnipeds, thus creating a redundant alert system for prevention of injurious interaction as well as increasing the probability of detecting pinnipeds in the disturbance zone. At least three observers must be on duty during vibratory pile driving activity for the first two days, and thereafter on every third day to allow for estimation of Level B harassment takes. Similar to requirements for impact driving, the first observer must be positioned on a work platform or barge where the entirety of the shutdown zone can be monitored. Shore based observers must be positioned to observe the disturbance zone from the bank of the river. Protocols will be implemented to ensure that coordinated communication of sightings occurs between observers in a timely manner.
Pile driving activities may only be conducted during daylight hours. If the shutdown zone is obscured by fog or poor lighting conditions, pile driving will not be initiated until the entire shutdown zone is visible. Work that has been initiated appropriately in conditions of good visibility may continue during poor visibility. The shutdown zone will be monitored for 30 minutes prior to initiating the start of pile driving, during the activity, and for 30 minutes after activities have ceased. If pinnipeds are present within the shutdown zone prior to pile driving, the start will be delayed until the animals leave the shutdown zone of their own volition, or until 15 minutes elapse without re-sighting the animal(s).
Soft start procedures must be implemented at the start of each day's impact pile driving and at any time following cessation of impact driving for a period of thirty minutes or longer. If steel piles require impact installation or proofing, a bubble curtain must be used for sound attenuation. If water velocity is 1.6 ft per second (1.1 miles per hour (mph)) or less for the entire installation period, the pile being driven must be surrounded by a confined or unconfined bubble curtain that will distribute small air bubbles around 100 percent of the pile perimeter for the full depth of the water column. If water velocity is greater than 1.6 feet per second (1.1 mph) at any point during installation, the pile being driven must be surrounded by a confined bubble curtain (
The POK proposes to conduct activities in 2018-2019 that are identical to those covered in the current 2017-2018 IHA. As described above, the number of estimated takes of the same stocks of harbor seals (OR/WA Coast stock), California sea lion (U.S. stock), and Steller sea lion (Eastern DPS) is the same for this IHA as those authorized in the 2017-2018 IHA, which were found to meet the negligible impact and small numbers standards. The authorized take of 1,540 harbor seals; 372 California sea lions, and 372 Steller sea lions represent 6.2 percent, 0.2 percent, and 0.6 percent of these stocks of marine mammals, respectively. We evaluated the impacts of the additional authorization of 10 Level A harassment takes of harbor seal, and find that consideration of impacts to these 10 individuals accruing a small degree of permanent threshold shift (PTS) does not meaningfully change our analysis, nor does it change our findings/determinations. This IHA includes identical required mitigation, monitoring, and reporting measures as the 2017-2018 IHA, and there is no new information suggesting that our prior analyses or findings should change.
Based on the information contained here and in the referenced documents, NMFS has determined the following: (1) The authorized takes will have a negligible impact on the affected marine mammal species or stocks; (2) the required mitigation measures will effect the least practicable impact on marine mammal species or stocks and their habitat; (3) the authorized takes represent small numbers of marine mammals relative to the affected species or stock abundances; and (4) the POK's activities will not have an unmitigable adverse impact on taking for subsistence purposes, as no relevant subsistence uses of marine mammals are implicated by this action.
In compliance with the NEPA of 1969 (42 U.S.C. 4321
Since this IHA covers the same work covered in the 2017-2018 IHA, NMFS has reviewed our previous EA and FONSI, and has determined that our current action is consistent with categories of activities identified in CE B4 of the Companion Manual for NOAA Administrative Order 216-6A, which do not individually or cumulatively have the potential for significant impacts on the quality of the human environment and for which we have not identified any extraordinary circumstances that would preclude this categorical exclusion. Accordingly, NMFS has determined that the issuance of the IHA qualifies to be categorically excluded from further NEPA review. We have reviewed all comments submitted in response to this notice prior to concluding our NEPA process and making our final decision on the 2018-2019 IHA request.
Section 7(a)(2) of the Endangered Species Act of 1973 (ESA: 16 U.S.C. 1531
NMFS has issued an IHA to POK for the incidental take of marine mammals due to in-water construction work associated with the POK Expansion Project for a period of one year, provided the previously mentioned mitigation, monitoring, and reporting requirements are incorporated.
National Oceanic and Atmospheric Administration (NOAA), 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.
Written comments must be submitted on or before January 14, 2019.
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 and instructions should be directed to LT Jared Halonen—Chief, NOAA Corps Recruiting, or LT Ricardo Rodriguez—NOAA Corps Recruiting Officer; OMAO-CPC-OCMD, 8403 Colesville Road, Suite 500, Silver Spring, MD 20910, ((800)-299-6622),
This request is for extension of a currently approved information collection. The NOAA Commissioned Corps is the uniformed component of the National Oceanic and Atmospheric Administration (NOAA), a bureau of the Department of Commerce. Officers serve under Senate-confirmed appointments and Presidential commissions (33 U.S.C. chapter 17, subchapter 1, sections 853 and 854). The NOAA Corps provides a cadre of professionals trained in engineering, earth sciences, oceanography, meteorology, fisheries science, and other related disciplines, who are dedicated to the service of their country and optimization of NOAA's missions to ensure the economic and physical well-being of the Nation.
NOAA Corps officers serve in assignments throughout NOAA, as well as in each of NOAA's Line Offices (National Environmental Satellite, Data, and Information Service, National Ocean Service, National Weather Service, Office of Oceanic and Atmospheric Research and Office of Planning, Programming and Integration).
Persons wishing to be considered for a NOAA Corps Commission must submit a complete application package, including NOAA Form 56-42, at least three letters of recommendation, and official transcripts. A personal interview must also be conducted. Eligibility requirements include a bachelor's degree with at least 48 credit hours of science, engineering or other disciplines related to NOAA's mission, excellent health, and normal color vision with uncorrected visual acuity no worse than 20/400 in each eye (correctable to 20/20).
Applicants must utilize the E-recruit electronic application process (
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
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.
Under Secretary of Defense for Personnel and Readiness, Department of Defense.
Notice of Federal Advisory Committee meeting.
The Department of Defense (DoD) is publishing this notice to announce that the following Federal Advisory Committee meeting of the Department of Defense Military Family Readiness Council will take place.
Open to the public Tuesday, December 11, 2018 from 10:00 a.m. to 12:00 p.m.
The address of the open meeting is the Pentagon, 1155 Defense Pentagon PLC2, Pentagon Library and Conference Center, Room B6, Washington, DC 20301.
William C. Story, (571) 372-5345 (Voice), (571) 372-0884 (Facsimile), OSD Pentagon OUSD P-R Mailbox Family Readiness Council,
This meeting is being held under the provisions of the Federal Advisory Committee Act (FACA) of 1972 (5 U.S.C., Appendix, as amended), the Government in the Sunshine Act of 1976 (5 U.S.C. 552b, as amended), and 41 CFR 102-3.140 and 102-3.150.
Under Secretary of Defense for Personnel and Readiness, Department of Defense (DoD).
Notice of Federal Advisory Committee meeting.
The DoD is publishing this notice to announce that the following Federal Advisory Committee meeting of the Board of Regents (“the Board”), Uniformed Services University of the Health Sciences (USU) will take place.
Tuesday, November 6, 2018, open to the public from 8:00 a.m. to approximately 11:15 a.m. Closed session will occur from approximately 11:20 a.m. to 11:50 a.m.
Uniformed Services University of the Health Sciences, 4301 Jones Bridge Road, Everett Alvarez Jr. Board of Regents Room (D3001), Bethesda, Maryland 20814.
Joshua Barricklow, 301-295-9805 (Voice), 301-295-1960 (Facsimile),
Due to circumstances beyond the control of the Department of Defense (DoD) and the Designated Federal Officer, the Board of Regents, Uniformed Services University of the Health Sciences was unable to provide public notification required by 41 CFR 102-3.150(a) concerning the meeting on November 6, 2018 of the Board of Regents, Uniformed Services University of the Health Sciences. Accordingly, the Advisory Committee Management Officer for the Department of Defense, pursuant to 41 CFR 102-3.150(b), waives the 15-calendar day notification requirement.
This meeting is being held under the provisions of the Federal Advisory Committee Act (FACA) (5 U.S.C., Appendix), the Government in the Sunshine Act (5 U.S.C. 552b), and 41 CFR 102-3.140 and 102-3.150.
Department of the Navy, DoD.
Notice.
The Department of the Navy (DoN) announces the availability of the inventions listed below, assigned to the United States Government, as represented by the Secretary of the Navy, for domestic and foreign licensing by the Department of the Navy.
Requests for copies of the patents cited should be directed to Naval Surface Warfare Center, Crane Div., Code OOL, Bldg. 2, 300 Highway 361, Crane, IN 47522-5001.
Mr. Christopher Monsey, Naval Surface Warfare Center, Crane Div., Code OOL, Bldg. 2, 300 Highway 361, Crane, IN 47522-5001, email
The following patents are available for licensing: Patent No. 10,101125 (Navy Case No. 200366): PRECISION ENGAGEMENT SYSTEM//Patent No. 10,106,880 (Navy Case No. 200332): MODIFYING THE SURFACE CHEMISTRY OF A MATERIAL//Patent No. 10,109,915 (Navy Case No. 103078): PLANAR NEAR-FIELD CALIBRATION OF DIGITAL ARRAYS USING ELEMENT PLANE WAVE SPECTRA//Patent No. 10,091,664 (Navy Case No. 200240): SYSTEM AND METHODS FOR UNOBTRUSIVELY AND RELOCATEABLY EXTENDING COMMUNICATION COVERAGE AND SUPPORTING UNMANNED AERIAL VEHICLE (UAV) ACTIVITIES//Patent No. 10,094,866 (Navy Case No. 103206): PORTABLE MULTI-FUNCTION CABLE TESTER//Patent No. 10,095,193 (Navy Case No. 200284): HIGH SPEED, HIGH VOLTAGE (HV) CAPACITOR SYSTEM (HVCS) CONTROL SYSTEMS AND RELATED METHODS FOR HVCS CHARGE/DISCHARGE UPON ACTIVATION/DEACTIVATION OF A HV MAIN POWER SYSTEM (MPS) OR
35 U.S.C. 207, 37 CFR part 404.
U.S. Election Assistance Commission.
Notice of Public Quarterly Conference Call for EAC Board of Advisors.
Monday, November 26, 2018, 2:00-4:00 p.m. (EDT).
EAC Board of Advisers Quarterly Conference Call.
To listen and monitor the event as an attendee:
1. Go to:
2. Click “Join Now”.
To join the audio conference only:
1. To receive a call back, provide your phone number when you join the event, or
2. call the number below and enter the access code.
(See toll-free dialing restrictions at
For assistance: Contact the host, Mark Abbott at
Bryan Whitener; Telephone: (301) 563-3961.
Members of the public may submit relevant written statements to the Board of Advisors with respect to the meeting no later than 5:00 p.m. EDT on Friday, November 23, 2018. Statements may be sent via email at
This conference call will be open to the public.
Office of Energy Efficiency and Renewable Energy, U.S. Department of Energy.
Notice and request for comments.
The Department of Energy (DOE), pursuant to the Paperwork Reduction Act of 1995), intends to extend for three years, an information collection request with the Office of Management and Budget (OMB). The information collection request, Historic Preservation for Energy Efficiency Programs, was initially approved on December 1, 2010 under OMB Control No. 1910-5155 and expired on September 30, 2015. The reinstatement will allow DOE to continue data collection on the status of the Weatherization Assistance Program (WAP), the State Energy Program (SEP), and the Energy Efficiency and Conservation Block Grant (EECBG) program
Comments regarding this propose information collection must be received on or before January 14, 2019. If you anticipate difficulty in submitting comments within that period, contact the person listed below as soon as possible.
Written comments may be sent to: Christine Askew, EE-5W, U.S. Department of Energy, 1000 Independence Ave. SW, Washington, DC 20585, Email:
Requests for additional information or copies of the information collection instrument and instructions should be directed to: Christine Askew, EE-5W, U.S. Department of Energy, 1000 Independence Ave. SW, Washington, DC 20585-1290, Phone: (202) 586-8224, Fax: (202) 287-1992, Email:
Additional information and reporting guidance concerning the Historic Preservation reporting requirement for the WAP, SEP, and EECBG programs are available for review at:
Program activities will ensure compliance the National Historic Preservation Act (NHPA). Comments are invited on: (a) Whether the extended 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 of the proposed collection of information, including the validity of the methodology and assumptions used; (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. This information collection request contains: (1)
Signed in Washington, DC, on October 30, 2018.
Take notice that the Commission received the following electric corporate filings:
Take notice that the Commission received the following electric rate filings:
The filings are accessible in the Commission's eLibrary system by clicking on the links or querying the docket number.
Any person desiring to intervene or protest in any of the above proceedings must file in accordance with Rules 211 and 214 of the Commission's Regulations (18 CFR 385.211 and 385.214) on or before 5:00 p.m. Eastern time on the specified comment date. Protests may be considered, but intervention is necessary to become a party to the proceeding.
eFiling is encouraged. More detailed information relating to filing requirements, interventions, protests, service, and qualifying facilities filings can be found at:
Take notice that the Commission received the following electric corporate filings:
Take notice that the Commission received the following electric rate filings:
The filings are accessible in the Commission's eLibrary system by clicking on the links or querying the docket number.
Any person desiring to intervene or protest in any of the above proceedings must file in accordance with Rules 211 and 214 of the Commission's Regulations (18 CFR 385.211 and 385.214) on or before 5:00 p.m. Eastern time on the specified comment date. Protests may be considered, but intervention is necessary to become a party to the proceeding.
eFiling is encouraged. More detailed information relating to filing requirements, interventions, protests, service, and qualifying facilities filings can be found at:
In accordance with the National Environmental Policy Act of 1969 and the Federal Energy Regulatory Commission's (Commission) regulations, 18 CFR part 380, the Office of Energy Projects has reviewed the application for a subsequent license for the Colliersville Hydroelectric Project, located on the Susquehanna River, in the Town of Milford, Otsego County, New York, and has prepared an Environmental Assessment (EA) for the project.
The EA contains staff's analysis of the potential environmental impacts of the project and concludes that licensing the project, with appropriate environmental protective measures, 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 website at
You may also register online at
Any comments should be filed within 30 days from the date of this notice.
The Commission strongly encourages electronic filing. Please file comments using the Commission's eFiling system at
For further information, contact Emily Carter at (202) 502-6512 or by email at
The current license for T.A. Keck, III and H.S. Keck's (the Kecks') Blackstone Mill Hydroelectric Project No. 11426 (Blackstone Mill Project) was issued on November 18, 1993, for a term of 30 years, ending October 31, 2023.
The principal project works consist of: (1) A 102-foot-long, approximately 2.5-foot-high dam; (2) a reservoir with a surface area of about 3 acres and a total volume of about 7 acre-feet at the normal water surface elevation of approximately 470 feet mean sea level; (3) a headrace or power canal about 3,200 feet long by 20 feet wide by 5 feet deep; (4) a stone-masonry powerhouse containing two generating units rated at 50 kW and 15 kW for a total installed capacity of 65 kW; (5) an overhead 240-volt transmission line about 60 feet long; and (6) appurtenant equipment and facilities.
At least five years before the expiration of a license for a minor water power project in which sections 14 and 15 of the Federal Power Act were waived, the Commission's regulations require the licensee to file with the Commission a notice of intent (NOI) that contains an unequivocal statement of the licensee's intention to file or not to file an application for a subsequent license, details on the principal project works and installed plant capacity, and other information.
If such a licensee does not inform the Commission that it intends to file an application for, in this case, a subsequent license for the project, the licensee may not file an application for a subsequent license, either individually or in conjunction with an entity or entities that are not currently licensees of the project.
Because the existing license expires on October 31, 2023, the NOI was due to be filed no later than the close of business on October 31, 2018. The Kecks, the existing licensee for the Blackstone Mill Project, failed to file an NOI by this date.
Any party interested in filing a license application for the Blackstone Mill Project No. 11426 must first file a Notice of Intent (NOI)
This notice sets a deadline of 120 days from the date of this notice for interested applicants, other than the existing licensee, to file NOIs, PADs, and requests to use an alternative licensing process.
Applications for a subsequent license from potential (non-licensee) applicants must be filed with the Commission at least 24 months prior to the expiration of the existing license.
Questions concerning this notice should be directed to Andy Bernick at (202) 502-8660 or
This is a supplemental notice in the above-referenced proceeding of Carson Hybrid Energy Storage LLC's application for market-based rate authority, with an accompanying rate tariff, noting that such application includes a request for blanket authorization, under 18 CFR part 34, of future issuances of securities and assumptions of liability.
Any person desiring to intervene or to protest should file with the Federal Energy Regulatory Commission, 888 First Street NE, Washington, DC 20426, in accordance with Rules 211 and 214 of the Commission's Rules of Practice and Procedure (18 CFR 385.211 and 385.214). Anyone filing a motion to intervene or protest must serve a copy of that document on the Applicant.
Notice is hereby given that the deadline for filing protests with regard to the applicant's request for blanket authorization, under 18 CFR part 34, of future issuances of securities and assumptions of liability, is November 26, 2018.
The Commission encourages electronic submission of protests and interventions in lieu of paper, using the FERC Online links at
Persons unable to file electronically should submit an original and 5 copies of the intervention or protest to the Federal Energy Regulatory Commission, 888 First Street NE, Washington, DC 20426.
The filings in the above-referenced proceeding are accessible in the Commission's eLibrary system by clicking on the appropriate link in the above list. They are also available for electronic review in the Commission's Public Reference Room in Washington, DC. There is an eSubscription link on the website that enables subscribers to receive email notification when a document is added to a subscribed docket(s). For assistance with any FERC Online service, please email
Take notice that on November 2, 2018, pursuant to sections 206, 306, and 309 of the Federal Power Act, 16 U.S.C. 824e, 825e, and 825h, and section 206 of the Federal Energy Regulatory Commission's (Commission) Rules of Practice and Procedure, 18 CFR 385.206 (2018), the American Wind Energy Association and The Wind Coalition (collectively, Complainants) filed a formal complaint (complaint) against Southwest Power Pool, Inc.
Complainants certify that a copy of the complaint has been served on the contacts for the Respondent as listed on the Commission's website in the list of Corporate Officials.
Any person desiring to intervene or to protest this filing must file in accordance with Rules 211 and 214 of the Commission's Rules of Practice and Procedure (18 CFR 385.211, 385.214). Protests will be considered by the Commission in determining the appropriate action to be taken, but will not serve to make protestants parties to the proceeding. Any person wishing to become a party must file a notice of intervention or motion to intervene, as appropriate. The Respondent's answer and all interventions, or protests must be filed on or before the comment date. The Respondent's answer, motions to intervene, and protests must be served on the Complainant.
The Commission encourages electronic submission of protests and interventions in lieu of paper using the “eFiling” link at
This filing is accessible on-line at
Take notice that on November 5, 2018, Southern California Edison Company, Appalachian Power Company, Arizona Public Service, Indiana Michigan Power Company, Kentucky Power Company, Pacific Gas and Electric Company, PNM Resources, Public Service Company of Colorado, Puget Sound Energy, San Diego Gas & Electric Company, South Carolina Electric & Gas Company, Southwestern Electric Power Company, Southwestern Public Service Company, and Wheeling Power Company (collectively, the Joint Requesters), filed a request for approval to use Account 439, authorized by the Financial Accounting Standards Board.
Any person desiring to intervene or to protest this filing must file in accordance with Rules 211 and 214 of the Commission's Rules of Practice and Procedure (18 CFR 385.211, 385.214). Protests will be considered by the Commission in determining the appropriate action to be taken, but will not serve to make protestants parties to the proceeding. Any person wishing to become a party must file a notice of intervention or motion to intervene, as appropriate. Such notices, motions, or protests must be filed on or before the comment date. Anyone filing a motion to intervene or protest must serve a copy of that document on the Applicant.
The Commission encourages electronic submission of protests and interventions in lieu of paper using the “eFiling” link at
This filing is accessible on-line at
Environmental Protection Agency (EPA).
Notice.
The Environmental Protection Agency (EPA) has submitted an information collection request (ICR), Emission Guidelines for Existing Other Solid Waste Incineration Units (EPA ICR No. 2164.06, OMB Control No. 2060-0562), to the Office of Management and Budget (OMB), for review and approval in accordance with the Paperwork Reduction Act. This is a proposed extension of the ICR, which is currently approved through November 30, 2018. Public comments were previously requested, via the
Additional comments may be submitted on or before December 13, 2018.
Submit your comments, referencing Docket ID Number EPA-HQ-OECA-2011-0256, to: (1) EPA 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.
Patrick Yellin, Monitoring, Assistance, and Media Programs Division, Office of Compliance, Mail Code 2227A, Environmental Protection Agency, 1200 Pennsylvania Ave. NW, Washington, DC 20460; telephone number: (202) 564-2970; fax number: (202) 564-0050; 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
Environmental Protection Agency (EPA).
Notice.
The Environmental Protection Agency (EPA) has submitted an information collection request (ICR), Acid Rain Program (EPA ICR No. 1633.17, OMB Control No. 2060-0258) to the Office of Management and Budget (OMB) for review and approval in accordance with the Paperwork Reduction Act. This is a proposed extension of the ICR, which is currently approved through November 30, 2018. Public comments were previously requested via the
Additional comments may be submitted on or before December 13, 2018.
Submit your comments, referencing Docket ID Number EPA-HQ-OAR-2009-0022, to (1) EPA 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.
Karen VanSickle, Clean Air Markets Division, Office of Air and Radiation, (6204M), Environmental Protection Agency, 1200 Pennsylvania Ave. NW, Washington, DC 20460; telephone number: 202-343-9220; fax number: 202-343-2361; 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
Environmental Protection Agency (EPA).
Notice.
The Environmental Protection Agency (EPA) has submitted an information collection request (ICR), Renewable Fuel Standard Program (EPA ICR No. 2546.01, OMB Control No. 2060-NEW) to the Office of Management and Budget (OMB) for review and approval in accordance with the Paperwork Reduction Act. This is a request for approval of an ICR that consolidates several existing collections. Public comments were previously requested via the
Additional comments may be submitted on or before December 13, 2018.
Submit your comments, referencing Docket ID No. EPA-HQ-OAR-2017-0599, to (1) EPA 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.
Anne-Marie Pastorkovich, Office of Air and Radiation/Office of Transportation and Air Quality, Environmental Protection Agency, 1200 Pennsylvania Ave. NW, (6405A), Washington, DC 20460; telephone number: 202-343-9623; fax number: 202-343-2800; email address:
Supporting documents, which explain in detail the information that EPA will be collecting, are available in the public docket for this ICR. The docket can be viewed online at
Under the RFS program, a certain volume of renewable fuel is required to replace or reduce the quantity of petroleum-based transportation fuel, heating oil or jet fuel. Obligated parties under the RFS program are refiners or importers of gasoline or diesel fuel. Obligated parties, and exporters of renewable fuel, must meet an annual Renewable Volume Obligation (RVO). Parties meet their RVO by blending renewable fuels into transportation fuel or by obtaining credits called Renewable Identification Numbers (RINs). EPA calculates and establishes RVOs every year through rulemaking, based on the CAA volume requirements and projections of gasoline and diesel production for the coming year. The standards are converted into a percentage and obligated parties must demonstrate compliance annually. RINs are used to demonstrate compliance with the standard and are generated by producers and importers of renewable fuels and traded by various parties. To track compliance with the RFS program, various parties involved with the production and blending of renewable fuels, and who generate, trade or use RINs, must register with EPA and submit various types of compliance
Recordkeeping and reporting are based upon the activity the party engages in under the regulations. A party may be registered in more than one activity. For example, a single party may be both an obligated party and a RIN generator. Such a party would register once, but would submit registration information describing both activities they plan to engage in under the program. The party would then submit reports based upon which activities they actually engaged in during the compliance (calendar) year. Basing the recordkeeping and reporting upon a party's activities ensures that parties must sustain only the recordkeeping and reporting burden necessary to implement the RFS program.
This ICR will supersede and replace several existing ICRs, including: RFS2 Voluntary RIN Quality Assurance Program, OMB Control Number 2060-0688; Cellulosic Production Volume Projections and Efficient Producer Reporting, OMB Control Number 2060-0707; Renewable Fuels Standard Program (RFS2-Supplemental), OMB Control Number 2060-0637; Renewable Fuel Standard (RFS2) Program, OMB Control Number 2060-0640; Regulation of Fuel and Fuel Additives: 2011 Renewable Fuel Standards—Petition for International Aggregate Compliance Approach, OMB Control Number 2060-0655; and Production Outlook Report for Unregistered Renewable Fuels Producers, OMB Control Number 2060-0660.
Environmental Protection Agency (EPA).
Notice.
The Environmental Protection Agency (EPA) has submitted an information collection request (ICR), NESHAP for the Secondary Lead Smelter Industry (EPA ICR No. 1686.11, OMB Control No. 2060-0296), to the Office of Management and Budget (OMB) for review and approval in accordance with the Paperwork Reduction Act. This is a proposed extension of the ICR, which is currently approved through November 30, 2018. Public comments were previously requested, via the
Additional comments may be submitted on or before December 13, 2018.
Submit your comments, referencing Docket ID Number EPA-HQ-OECA-2014-0055, to: (1) EPA 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.
Patrick Yellin, Monitoring, Assistance, and Media Programs Division, Office of Compliance, Mail Code 2227A, Environmental Protection Agency, 1200 Pennsylvania Ave. NW, Washington, DC 20460; telephone number: (202) 564-2970; fax number: (202) 564-0050; 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
Environmental Protection Agency (EPA).
Notice.
The Environmental Protection Agency (EPA) has submitted an information collection request (ICR), NSPS for Petroleum Refineries (EPA ICR No. 1054.13, OMB Control No. 2060-0022), to the Office of Management and Budget (OMB) for review and approval in accordance with the Paperwork Reduction Act. This is a proposed extension of the ICR, which is currently approved through November 30, 2018. Public comments were previously requested, via the
Additional comments may be submitted on or before December 13, 2018.
Submit your comments, referencing Docket ID Number EPA-HQ-OECA-2014-0033, to: (1) EPA 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.
Patrick Yellin, Monitoring, Assistance, and Media Programs Division, Office of Compliance, Mail Code 2227A, Environmental Protection Agency, 1200 Pennsylvania Ave. NW, Washington, DC 20460; telephone number: (202) 564-2970; fax number: (202) 564-0050; 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
In general, all NSPS standards require initial notifications, performance tests, and periodic reports by the owners/operators of the affected facilities. They are also required to maintain records of the occurrence and duration of any startup, shutdown, or malfunction in the operation of an affected facility, or any period during which the monitoring system is inoperative. These notifications, reports, and records are essential in determining compliance with 40 CFR part 60, subpart J.
U.S. Environmental Protection Agency (EPA).
Notice.
Notice is hereby given of the membership of the U.S. Environmental Protection Agency Performance Review Board for 2018.
Debbi Hart, Director, Policy, Planning & Training Division, 3601M, Office of Human Resources, Office of Administration and Resources Management, U.S. Environmental Protection Agency, 1200 Pennsylvania Avenue NW, Washington, DC 20460 (202) 564-2011.
Section 4314(c)(1) through (5) of Title 5, U.S.C., requires each agency to establish in accordance with regulations prescribed by the Office of Personnel Management, one or more SES performance review boards. This board shall review and evaluate the initial appraisal of a senior executive's performance by the supervisor, along with any recommendations to the appointment authority relative to the performance of the senior executive.
Members of the 2018 EPA Performance Review Board are:
Environmental Protection Agency (EPA).
Notice of charter renewal.
Notice is hereby given that the Environmental Protection Agency (EPA) has determined that, in accordance with the provisions of the Federal Advisory Committee Act (FACA), 5 U.S.C. App.2, the Clean Air Act Advisory Committee (CAAAC) is a necessary committee which is in the public interest. Accordingly, the CAAAC is being reinstated for a two-year period. The purpose of the CAAAC is to provide advice and recommendations to the EPA Administrator on policy issues associated with implementation of the Clean Air Act. Inquiries may be directed to Larry Weinstock, CAAAC Designated Federal Officer, U.S. EPA, 1200 Pennsylvania Avenue NW (Mail Code 6103A), Washington, DC 20460, or by email to
Environmental Protection Agency (EPA).
Notice.
The Environmental Protection Agency (EPA) has submitted an information collection request (ICR), NESHAP for Engine Test Cells/Stands (EPA ICR No. 2066.07, OMB Control No. 2060-0483), to the Office of Management and Budget (OMB) for review and approval in accordance with the Paperwork Reduction Act. This is a proposed extension of the ICR, which is currently approved through November 30, 2018. Public comments were previously requested, via the
Additional comments may be submitted on or before December 13, 2018.
Submit your comments, referencing Docket ID Number EPA-HQ-OECA-2014-0091, to: (1) EPA 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.
Patrick Yellin, Monitoring, Assistance, and Media Programs Division, Office of Compliance, Mail Code 2227A, Environmental Protection Agency, 1200 Pennsylvania Ave. NW, Washington, DC 20460; telephone number: (202) 564-2970; fax number: (202) 564-0050; 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
Environmental Protection Agency (EPA).
Notice.
The Environmental Protection Agency has submitted an information collection request (ICR), NESHAP for Primary Lead Smelting (EPA ICR No. 1856.11, OMB Control No. 2060-0414), to the Office of Management and Budget (OMB) for review and approval in accordance with the Paperwork Reduction Act. This is a proposed extension of the ICR, which is currently approved through November 30, 2018. Public comments were previously requested, via the
Additional comments may be submitted on or before December 13, 2018.
Submit your comments, referencing Docket ID Number EPA-HQ-OECA-2014-0068, to: (1) EPA 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.
Patrick Yellin, Monitoring, Assistance, and Media Programs Division, Office of Compliance, Mail Code 2227A, Environmental Protection Agency, 1200 Pennsylvania Ave. NW, Washington, DC 20460; telephone number: (202) 564-2970; fax number: (202) 564-0050; 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
Federal Communications Commission.
Notice.
In this document, the Commission released a public notice announcing the meeting of the North American Numbering Council (NANC). At this meeting, the NANC Working Groups will report on their progress in developing recommendations for the NANC's consideration. In addition, the NANC will continue its discussions on how to modernize and foster more efficient number administration in the United States. The NANC meeting is open to the public. The FCC will accommodate as many attendees as possible; however, admittance will be limited to seating availability.
Tuesday, December 4, 2018, 9:30 a.m.
Requests to make an oral statement or provide written comments to the NANC should be sent to Carmell Weathers, Competition Policy Division, Wireline Competition Bureau, Federal Communications Commission, Portals II, 445 12th Street SW, Room 5-C162, Washington, DC 20554.
Carmell Weathers at (202) 418-2325 or
The Commission will also provide audio coverage of the meeting. Other reasonable accommodations for people with disabilities are available upon request. Request for such accommodations should be submitted via email to
Members of the public may submit comments to the NANC in the FCC's Electronic Comment Filing System, ECFS, at
More information about the NANC is available at
This is a summary of the Commission's document in CC Docket No. 92-237, DA 18-1118 released October 31, 2018. The complete text in this document is available for public inspection and copying during normal business hours in the FCC Reference Information Center, Portals II, 445 12th Street SW, Room CY-A257, Washington, DC 20554. The document may also be purchased from the Commission's duplicating contractor, Best Copy and Printing, Inc., 445 12th Street SW, Room CY-B402, Washington, DC 20554, telephone (800) 378-3160 or (202) 863-2893, facsimile (202) 863-2898, or via the internet at
* The Agenda may be modified at the discretion of the NANC Chairman with the approval of the Designated Federal Officer (DFO).
Thursday, November 15, 2018 at 10:00 a.m.
1050 First Street NE, Washington, DC (12th Floor).
This meeting will be open to the public.
Judith Ingram, Press Officer, Telephone: (202) 694-1220.
Individuals who plan to attend and require special assistance, such as sign language interpretation or other reasonable accommodations, should contact Dayna C. Brown, Secretary and Clerk, at (202) 694-1040, at least 72 hours prior to the meeting date.
Federal Trade Commission (“FTC” or “Commission”).
Notice; request for comments.
The FTC intends to ask the Office of Management and Budget (“OMB”) to extend for an additional three years the current Paperwork Reduction Act (“PRA”) clearance for the information collection requirements in the FTC Red Flags, Card Issuers, and Address Discrepancies Rules
Comments must be submitted by December 13, 2018.
Interested parties may file a comment online or on paper by following the instructions in the Request for Comment part of the
Requests for additional information should be addressed to Mark Eichorn, Assistant Director, Division of Privacy and Identity Protection, Bureau of Consumer Protection, (202) 326-3053, Federal Trade Commission, 600 Pennsylvania Avenue NW, Washington, DC 20580.
The Rules implement sections 114 and 315 of the Fair Credit Reporting Act (“FCRA”), 15 U.S.C. 1681
The Commission received no relevant public comments on the Rules' information collection requirements and FTC staff's associated PRA burden analysis and estimates that appeared in an August 8, 2018
Pursuant to the OMB regulations, 5 CFR part 1320, that implement the PRA,
(1) Whether the disclosure requirements are necessary, including whether the information will be practically useful; (2) the accuracy of our burden estimates, including whether the methodology and assumptions used are valid; (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.
A. Section 114: Red Flags and Card Issuers Rules:
(1) Red Flags:
(2) Card Issuers Rule:
(3) Combined Labor Cost Burden: $65,112,327
B. Section 315—Address Discrepancy Rule:
(1) Estimated Number of Respondents: 121,000
(2) Estimated Hours Burden: 56,467 hours
(3) Estimated Labor Cost Burden: $1,072,873
C. Capital/Non-Labor Costs for Sections 114 and 315.
FTC staff believes that the Rules impose negligible capital or other non-labor costs, as the affected entities are likely to have the necessary supplies and/or equipment already (
You can file a comment online or on paper. For the FTC to consider your comment, we must receive it on or before December 13, 2018. Write “Red Flags Rule, PRA Comment, Project No. P095406” 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 FTC website, at
Postal mail addressed to the Commission is subject to delay due to heightened security screening. As a result, we encourage you to submit your comments online, or to send them to the Commission by courier or overnight service. To make sure that the Commission considers your online comment, you must file it at
If you file your comment on paper, write “Red Flags Rule, PRA Comment, Project No. P095406” 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.
Because your comment will be placed on the publicly accessible FTC website at
Comments containing material for which confidential treatment is requested must be filed in paper form, must be clearly labeled “Confidential,” and must comply with FTC Rule 4.9(c). In particular, the written request for confidential treatment that accompanies the comment must include the factual and legal basis for the request, and must identify the specific portions of the comment to be withheld from the public record.
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 13, 2018. For information on the Commission's privacy policy, including routine uses permitted by the Privacy Act, see
Comments on the information collection requirements subject to review under the PRA should additionally be submitted to OMB. If sent by U.S. mail, they should be addressed to Office of Information and Regulatory Affairs, Office of Management and Budget, Attention: Desk Officer for the Federal Trade Commission, New Executive Office Building, Docket Library, Room 10102, 725 17th Street NW, Washington, DC 20503. Comments sent to OMB by U.S. postal mail, however, are subject to delays due to heightened security precautions. Thus, comments instead can also be sent by email to
Centers for Disease Control and Prevention, HHS.
Request for information.
The Coal Workers' Health Surveillance Program (CWHSP or Program), administered by CDC's National Institute for Occupational Safety and Health (NIOSH), is seeking information from coal miners, miner advocates, unions, industry stakeholders, and other interested parties about barriers to participating in health screening offered by the Program to inform efforts to improve participation.
Comments must be received by January 14, 2019.
Cara N. Halldin, NIOSH Coal Workers' Health Surveillance Program, Respiratory Health Division, 1095 Willowdale Road, MS HG900.2, Morgantown, WV 26505-2888; (304) 285-5754 (this is not a toll-free number);
The NIOSH Coal Workers' Health Surveillance Program was authorized by the Coal Mine Health and Safety Act of 1969, as amended by the Federal Mine Safety and Health Act of 1977 (30 U.S.C. 801
Greater participation in the Program would provide more opportunities for early detection of pneumoconiosis in coal miners, providing those with early disease the ability to take action to reduce the chance for progression to severe lung disease. In order to identify ways to improve participation in the Program, NIOSH is seeking information from all interested parties, especially active coal miners, as well as miner advocates, unions, industry stakeholders, and healthcare providers of screening services for the CWHSP, to learn about the factors that keep miners from participating in the health screening examinations that are available to them.
NIOSH is particularly interested in receiving information about the following questions:
1. Are coal miners aware that periodic health screenings are available, at no cost to them, through the Coal Workers' Health Surveillance Program?
2. Is lack of convenience of the screening—for example, screening locations or hours of availability—a barrier to participation? If yes, please describe those factors that may prevent miners from accessing CWHSP screenings.
3. NIOSH's mobile surveillance unit travels to different locations to provide free black lung screenings, including chest x-rays and spirometry tests.
4. Do coal miners receive encouragement to participate (or discouragement from participating) in the CWHSP screenings from others such as employers, unions, or co-workers? If so, please describe.
5. Are scheduling issues, such as the need to take unpaid time off from work or use vacation hours or non-work hours for health screenings, a barrier to miners' participation in health
6. Does concern about the confidentiality of medical information pose a barrier to participation? If this is a barrier, then please provide recommendations or suggestions for how it can be overcome.
7. Does concern that the early identification of dust-related lung disease might adversely affect a miner's career (
8. Does concern that early identification of dust-related lung disease might affect subsequent eligibility for compensation through Federal or State programs pose a barrier to participation? If this is a barrier, then please describe the specific compensation programs and how eligibility for them can be affected by early detection of dust-related lung disease. Please also provide recommendations or suggestions for how this barrier could be overcome.
9. Does concern that personal finances will require a miner to continue working despite early identification of dust-related lung disease pose a barrier to participation? If this is a barrier, please provide recommendations or suggestions for how it can be overcome.
10. Are there any other barriers to participation that NIOSH should be aware of?
Interested parties may participate in this activity by submitting written views, opinions, recommendations, and data. Comments received, including attachments and other supporting materials, are part of the public record and subject to public disclosure. Do not include any information in your comment or supporting materials that you do not wish to be disclosed. Although your name, contact information, or other information that identifies you in the body of your comments will be on public display, NIOSH will review all submissions and may choose to redact or withhold submissions containing private or proprietary information such as Social Security numbers, medical information, and/or inappropriate language. Comments may be submitted on any topic related to this action. All public comments will be posted in the docket for this action at
Centers for Medicare & Medicaid Services (CMS), HHS.
Notice of Final Administrative Order.
This notice serves to announce that a Final Administrative Order related to the Basic Health Program (BHP) was issued to the States of New York and Minnesota on August 24, 2018.
The Final Administrative Order was effective August 24, 2018.
Christopher Truffer, (410) 786-1264; Meg Barry, (410) 786-1536.
The CMS Administrator issued a Final Administrative Order to set forth the revised payment methodology that applies to the Basic Health Program for 2018
The HHS Revised BHP Payment Methodology modifies the existing methodology for 2018, which is set forth in the payment notice entitled “Basic Health Program; Federal Funding Methodology for Program Years 2017 and 2018” (81 FR 10091, February 29, 2016) (February 2016 Payment Notice). The modification involves the application of a Premium Adjustment Factor (PAF) that considers the premium increases in other states that became effective after the Centers for Medicare & Medicaid Services (CMS), an operating division of the U.S. Department of Health and Human Services (HHS), discontinued payments to issuers for cost-sharing reductions (CSRs) provided to enrollees in qualified health plans (QHPs) offered on health insurance Exchanges.
On July 6, 2018, pursuant to an amended stipulated order issued in
This document does not impose information collection requirements, that is, reporting, recordkeeping, or third-party disclosure requirements. Consequently, review by the Office of Management and Budget under the authority of the Paperwork Reduction Act of 1995 (44 U.S.C. 3501,
We are publishing the Final Administrative Order as an addendum to this Notice.
Food and Drug Administration, HHS.
Notice.
The Food and Drug Administration (FDA) is publishing a list of information collections that have been approved by the Office of Management and Budget (OMB) under the Paperwork Reduction Act of 1995.
Ila S. Mizrachi, Office of Operations, Food and Drug Administration, Three White Flint North, 10A-12M, 11601 Landsdown St., North Bethesda, MD 20852, 301-796-7726,
The following is a list of FDA information collections recently approved by OMB under section 3507 of the Paperwork Reduction Act of 1995 (44 U.S.C. 3507). The OMB control number and expiration date of OMB approval for each information collection are shown in table 1. Copies of the supporting statements for the information collections are available on the internet at
Food and Drug Administration, HHS.
Notice of public meeting; request for comments.
The Food and Drug Administration (FDA or the Agency) is announcing a public meeting entitled “Drug Development Tool Process under the 21st Century Cures Act and PDUFA VI.” This public meeting is intended to fulfill commitments made by FDA under the sixth authorization of the Prescription Drug User Fee Act (PDUFA VI) and the 21st Century Cures Act (Cures Act) by soliciting comments on Drug Development Tool Qualification at FDA related to the qualification process under section 507 of the Federal Food, Drug, and Cosmetic Act (FD&C Act); discussing taxonomy for biomarkers and related concepts used in drug development; and planning activities to define a framework with appropriate standards and scientific approaches to support qualification for a specified context of use.
The public meeting will be held on December 11, 2018, from 9 a.m. to 5 p.m. Submit either electronic or written comments on this public meeting by January 31, 2019. See the
The public meeting will be held at FDA White Oak Campus, 10903 New Hampshire Ave., Bldg. 31, Rm. 1503A (the Great Room), Silver Spring, MD 20993. 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
You may submit comments as follows. Please note that late, untimely filed comments may not be considered. For timely consideration we request that electronic comments be submitted on or before January 31, 2019. The
Submit electronic comments in the following way:
•
• 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:
•
• For written/paper comments submitted to the Dockets Management Staff, 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
Valerie Jimenez, Center for Drug Evaluation and Research, Food and Drug Administration, Hillandale Bldg., Rm. 2156, Silver Spring, MD 20993; 301-796-1345,
The Drug Development Tool (DDT) provisions in section 507 of the FD&C Act (21 U.S.C. 357) were added in December 2016 by section 3011 of the Cures Act (Pub. L. 114-255). FDA's DDT programs include the Animal Model Qualification Program, the Biomarker Qualification Program, and the Clinical Outcome Assessment Qualification Program. These programs are designed to facilitate drug and biological product development by allowing FDA to qualify DDTs based on certain foundational scientific information, thereby minimizing duplication of research and development efforts. FDA committed to meet certain performance goals under PDUFA VI. This reauthorization, part of the FDA Reauthorization Act of 2017 signed by the President on August 18, 2017, includes a number of performance goals and procedures that are documented in the PDUFA VI Commitment Letter, which is available at
FDA is convening a public meeting to discuss and seek public input regarding the DDT qualification pathway for animal models, biomarkers, and clinical outcome assessments. This public meeting will describe the qualification process under section 507 of the FD&C Act and will discuss taxonomy used in drug development, which will include the scientific criteria to determine the acceptance of a qualification submission and essential elements of a full qualification plan. In addition, we will discuss ongoing activities to develop general evidentiary standards to support qualification by the three qualification programs.
Registration is free and based on space availability, with priority given to early registrants. Persons interested in attending this public meeting must register by 11:59 p.m. Eastern Time on Friday, November 30, 2018. Registrants will receive confirmation when they have been accepted. Early registration is recommended because seating is limited; therefore, FDA may limit the number of participants from each organization.
If you need special accommodations due to a disability, please contact
FDA plans to post archived webcasts after the meeting; archived webcasts will be available.
If you have never attended a Connect Pro event before, test your connection at
Food and Drug Administration, HHS.
Notice.
The Food and Drug Administration (FDA) is announcing that a proposed collection of information has been submitted to the Office of Management and Budget (OMB) for review and clearance under the Paperwork Reduction Act of 1995.
Fax written comments on the collection of information by December 13, 2018.
To ensure that comments on the information collection are received, OMB recommends that written comments be faxed to the Office of Information and Regulatory Affairs, OMB, Attn: FDA Desk Officer, Fax: 202-395-7285, or emailed to
Ila S. Mizrachi, Office of Operations, Food and Drug Administration, Three White Flint North, 10A-12M, 11601 Landsdown St., North Bethesda, MD 20852, 301-796-7726,
In compliance with 44 U.S.C. 3507, FDA has submitted the following proposed collection of information to OMB for review and clearance.
In Fiscal Year 2017, FDA published guidance on communications between FDA review staff and drug sponsors during the IND phase of drug development. As part of PDUFA VI, FDA committed to a third-party assessment of current IND-phase communication practices, which should reflect this guidance. The contractor for the assessment of IND communication practices is Eastern Research Group, Inc. (ERG).
Therefore, in accordance with the PDUFA VI Commitment Letter, FDA proposes to have ERG conduct surveys and interviews with sponsors of up to 150 active commercial INDs as follows:
• For each formal meeting between FDA review staff and active commercial IND sponsors during the assessment period, send a survey to the sponsor to solicit specific feedback about communication practices employed for that meeting.
• For each active commercial IND in the assessment, conduct an interview with the sponsor to obtain broader feedback about all communications with FDA review staff during the study period, including telephone and email interactions in addition to meetings.
The purpose of this information collection is to understand active commercial IND sponsor perspectives on communication during drug development with a focus on what is working well, ongoing challenges and pain points, lessons learned, and opportunities for improvement. The contractor will develop anonymized aggregated summaries of survey and interview responses, analyze this information to identify common themes, consider these results along with IND data and feedback from FDA review staff to develop a set of findings and recommendations, and prepare a report to be published on FDA's website. The contractor will keep information collected private; ERG will not disclose personally identifying information to FDA or any other party.
In the
The number of commercial INDs with activity is approximately 4,000 per year. ERG will interview 1 to 3 sponsor representatives at a time for up to 150 INDs during the annual assessment period.
FDA estimates the burden of this collection of information as follows:
FDA estimates that it will take each IND sponsor a maximum of 10 minutes to complete a survey. Up to 150 respondents will take part in the survey, yielding a maximum burden of 25.5 hours. FDA estimates that it will take each IND sponsor up to 90 minutes to respond to requests for interviews and participate in interviews. Up to 450 respondents will take part in interviews, yielding a maximum burden of 675 hours. FDA's burden estimates are based on experience with information collections for similar types of PDUFA-related assessments.
Food and Drug Administration, HHS.
Notice.
The Food and Drug Administration (FDA or Agency) is announcing an opportunity for public comment on the proposed collection of certain information by the Agency. Under the Paperwork Reduction Act of 1995 (PRA), Federal Agencies are required to publish notice in the
Submit either electronic or written comments on the collection of information by January 14, 2019.
You may submit comments as follows. Please note that late, untimely filed comments will not be considered. Electronic comments must be submitted on or before January 14, 2019. The
Submit electronic comments in the following way:
•
• 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:
•
• For written/paper comments submitted to the Dockets Management Staff, 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
Domini Bean, Office of Operations, Food and Drug Administration, Three White Flint North, 10A-12M, 11601 Landsdown St., North Bethesda, MD 20852, 301-796-5733,
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. “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 (44 U.S.C. 3506(c)(2)(A)) requires Federal Agencies to provide a 60-day notice in the
With respect to the following collection of information, FDA invites comments on these topics: (1) Whether the proposed collection of information is necessary for the proper performance of FDA's functions, including whether the information will have practical utility; (2) the accuracy of FDA'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 respondents, including through the use of automated collection techniques, when appropriate, and other forms of information technology.
The United States exports a large volume and variety of foods in international trade. For certain food products, foreign governments may require assurances from the responsible authority of the country of origin of an imported food that the processor of the food is in compliance with applicable country of origin regulatory requirements. Some foreign governments establish additional requirements with which exporters are required to comply and ask for additional assurances from the responsible authority. When requested, FDA may provide this information in the form of lists which are provided to the foreign governments.
For products subject to importing country listing requirements, FDA has historically maintained certain export lists of manufacturers/processors that: (1) Have expressed interest in exporting their products to these countries; (2) are subject to FDA's jurisdiction; and (3) are not the subject of a pending enforcement action (
FDA has generally published guidance documents for these lists under the authority of section 701(h) of the Federal, Food, Drug, and Cosmetic Act (21 U.S.C. 371(h)), which authorizes the Secretary of Health and Human Services (the Secretary) to develop guidance documents with public participation presenting the views of the Secretary on matters under the jurisdiction of FDA.
The guidance documents generally explain what information manufacturers/processors should submit to FDA to be considered for inclusion on the lists and what criteria FDA intends to use to determine eligibility for placement on the lists. The guidance documents also explain how FDA intends to update the lists and communicate any new information to the governments that requested the lists. Finally, the guidance documents note that the information is provided voluntarily by manufacturers/processors with the understanding that it may be posted on FDA's external website and that it will be communicated to, and possibly further disseminated by, the government that requested the list; thus, FDA considers the information on the lists to be information that is not protected from disclosure under 5 U.S.C. 552(b)(4).
Application for inclusion on each list is voluntary. However, some foreign governments may require inclusion on the list for acceptance of imported products. FDA recommends that U.S. manufacturers/processors that want to be placed on the export lists send FDA the following information: (1) Country to which the food manufacturer/processor wants to export product; (2) type of food product facility; (3) the Food Facility Registration number (the information collected by this module is approved under OMB control number 0910-0502), FDA Establishment Identifier number, or Dun & Bradstreet number for the facility; (4) name and address of the firm and the manufacturing plant; (5) name, telephone number, and email address of the contact person; (6) information on the products intended for export; (7) identities of agencies that inspected the plant; (8) date of last inspection, plant number, and copy of last inspection notice; and (9) if other than an FDA inspection, copy of last inspection report. We request that this information be updated every 2 years.
In addition to the information above, some countries may require additional information such as documentation that the firm has been certified by a third-party certification body that it meets the requirements of the importing country. Other information may need to be submitted to be included on the lists depending on the requirements of the importing country. FDA plans to
We use the information submitted by firms to determine their eligibility for placement on the export lists, which may be published on our website. The purpose of the lists is to help CFSAN-regulated industries meet the import requirements of foreign governments.
FDA currently maintains export lists for the European Community and China covered under OMB control numbers 0910-0320 and 0910-0839, respectively. These export lists also serve to assist firms to meet the import requirements of foreign governments. OMB control numbers 0910-0509, 0910-0320, and 0910-0839 are very similar in that they allow FDA to collect information from firms for the purpose of establishing export lists for foreign governments that require these lists before allowing the subject goods to be imported. Thus, with this notice, FDA proposes to consolidate these collections of information for government efficiency and to allow the public to look to one OMB control number for all collections of information for CFSAN export lists. This collection of information is intended to cover all of CFSAN's existing export lists, as well as any additional export lists required by foreign countries.
In 2016, FDA launched the Dairy Listing Module, an electronic registry system (Form FDA 3972) to facilitate applications for inclusion on the dairy export lists. FDA has expanded this system to accommodate applications for inclusion on export lists for CFSAN-regulated products, affording all firms the efficiencies of submitting information electronically. The expanded system is called the Export Listing Module (ELM). The ELM has data fields that allow firms to input the information identified above that FDA recommends providing. In addition, the ELM contains data fields such as “Additional Information” and “Additional Documents” that allow firms to submit any additional data or information (such as third-party certifications) that foreign governments may require. Screenshots of the ELM are available at
FDA estimates the burden of this collection of information as follows:
The information collection reflects an increase in burden by 18,458 hours due to the consolidation of the information collections covered by OMB control numbers 0910-0839 and 0910-0320. Also, our current estimate of the number of foreign countries that may require us to establish lists in the next 3 years and the type of information they may require us to collect in order to maintain such lists has also resulted in an increase. At the same time, we have developed an electronic reporting portal that is expected to reduce the overall reporting time per submission. The portal will enhance the ability of firms to more efficiently request inclusion on export lists.
We base our estimate on the number of manufacturers/processors that have submitted new written requests, biennial updates, and occasional updates over the past 10 years. The estimate of the number of burden hours it will take a manufacturer/processor to gather the information needed to be placed on the list or update its information is based on our experience with manufacturers/processors submitting similar requests. We believe that the information to be submitted will be readily available to manufacturers/processors. This collection is incorporating additional information collected to maintain lists of eligible exporters of CFSAN-regulated products who wish to export to foreign markets, including the European Union, Chile and China under OMB control numbers 0910-0320, “Request for Information from U.S. Processors that Export to the European Community” and 0910-0839, “Establishing and Maintaining Lists of U.S. Manufacturers/Processors with Interest in Exporting CFSAN-Regulated Products to China. ”
We estimate that 1,460 firms will average 30 minutes (0.5 hour) to submit new requests for inclusion on the list, 2,505 firms will average 30 minutes (0.5 hour) to update their information every 2 years, and 300 firms will average 30 minutes (0.5 hour) to occasionally update their information in this system.
Some firms will need to provide documentation that they obtained third-party certification to certify that they have met the requirements of the importing country. Currently, only China has this requirement. Based on our experience with this program, 370 firms will spend about 21 hours to complete the third-party certification for a total of 7,770 burden hours. During the biennial update, we estimate that about half of the 1,110 manufacturers/processors for which the importing country requires third-party certification will be recertified, meaning that 555 manufacturers/processors (1110 manufacturers/processors × 0.5) will get recertified each year. We estimate that it will take each such manufacturer/processor about 21 hours to complete the certification process for a total of 11,655 burden hours (555 manufacturers/processors × 21 hours).
We calculate, therefore, that the total burden for this collection is 21,558 hours.
Health Resources and Services Administration (HRSA), Department of Health and Human Services.
Notice.
In compliance with the requirement of the Paperwork Reduction Act of 1995 for opportunity for public comment on proposed data collection projects, HRSA announces plans to submit an Information Collection Request (ICR), described below, to the Office of Management and Budget (OMB). Prior to submitting the ICR to OMB, HRSA seeks comments from the public regarding the burden estimate, below, or any other aspect of the ICR.
Comments on this ICR must be received no later than January 14, 2019.
Submit your comments to
To request more information on the proposed project or to obtain a copy of the data collection plans and draft instruments, email
When submitting comments or requesting information, please include the information request collection title for reference.
• Trainee Information (Long-term Trainees Only) form:
○ Changes will incorporate options and titles that were omitted from the final submission of the previous OMB package, providing clarification for the reporting of specific descriptive information about Long-term Trainees on the form.
○ Changes will list the following options for “Type”: “Non-Degree Seeking,” “Undergraduate,” “Masters,” “Doctoral,” Post-doctoral,” “Other.”
○ Changes will list the title “Student Status” next to the options for “Part-time student” and “Full-time student.”
• Technical Assistance/Collaboration form:
○ Add a field asking for the “Total number of TA recipients.” This change will allow for better alignment with this data that was previously collected by program, but omitted due to a DGIS paper form error.
○ Add an “Other” category to List B under “Topic of Technical Assistance/Collaboration.” This change would facilitate more accurate data reporting by providing programs an additional category to choose from if their current Technical Assistance activities do not closely align with the existing categories in List B.
HRSA specifically requests comments on (1) the necessity and utility of the proposed information collection for the proper performance of the agency's functions, (2) the accuracy of the estimated burden, (3) ways to enhance the quality, utility, and clarity of the information to be collected, and (4) the use of automated collection techniques or other forms of information technology to minimize the information collection burden.
Health Resources and Services Administration (HRSA), Department of Health and Human Services.
Notice.
HRSA's Division of Practitioner Data Bank (DPDB) announces the release of the revised user National Practitioner Data Bank (NPDB) Guidebook. NPDB is a confidential information clearinghouse created by Congress and intended to facilitate a comprehensive review of the professional credentials of health care practitioners, entities, providers, and suppliers. The NPDB Guidebook is the primary policy document explaining the statutes and regulations behind and operation of the NPDB. It serves as an essential reference for NPDB users, offering reporting and querying examples, explanations, definitions, and frequently asked questions.
David Loewenstein, Director, DPDB, Bureau of Health Workforce, Health Resources and Services Administration, 301-443-2300,
When the NPDB Guidebook was last revised in April 2015, substantial updates altered the regulatory scope, content, and display of the Guidebook. The new Guidebook incorporates information and infographics that augment or further clarify existing Guidebook topics and does not include any significant policy changes. The new NPDB Guidebook is now available at
Pursuant to section 10(d) of the Federal Advisory Committee Act, as amended, notice is hereby given of the following meetings.
The meetings will be closed to the public in accordance with the provisions set forth in sections 552b(c)(4) and 552b(c)(6), Title 5 U.S.C., as amended. The grant applications and the discussions could disclose confidential trade secrets or commercial property such as patentable material, and personal information concerning individuals associated with the grant applications, the disclosure of which would constitute a clearly unwarranted invasion of personal privacy.
Pursuant to section 10(d) of the Federal Advisory Committee Act, as amended, notice is hereby given of the following meetings.
The meetings will be closed to the public in accordance with the provisions set forth in sections 552b(c)(4) and 552b(c)(6), Title 5 U.S.C., as amended. The grant applications and the discussions could disclose confidential trade secrets or commercial property such as patentable material, and personal information concerning individuals associated with the grant applications, the disclosure of which
Pursuant to section 10(d) of the Federal Advisory Committee Act, as amended, notice is hereby given of the following meetings.
The meetings will be closed to the public in accordance with the provisions set forth in sections 552b(c)(4) and 552b(c)(6), Title 5 U.S.C., as amended. The grant applications and the discussions could disclose confidential trade secrets or commercial property such as patentable material, and personal information concerning individuals associated with the grant applications, the disclosure of which would constitute a clearly unwarranted invasion of personal privacy.
Federal Emergency Management Agency, DHS.
Notice.
New or modified Base (1-percent annual chance) Flood Elevations (BFEs), base flood depths, Special Flood Hazard Area (SFHA) boundaries or zone designations, and/or regulatory floodways (hereinafter referred to as flood hazard determinations) as shown on the indicated Letter of Map Revision (LOMR) for each of the communities listed in the table below are finalized. Each LOMR revises the Flood Insurance Rate Maps (FIRMs), and in some cases the Flood Insurance Study (FIS) reports, currently in effect for the listed communities. The flood hazard determinations modified by each LOMR will be used to calculate flood insurance premium rates for new buildings and their contents.
Each LOMR was finalized as in the table below.
Each LOMR is available for inspection at both the respective Community Map Repository address listed in the table below and online through the FEMA Map Service Center at
Rick Sacbibit, Chief, Engineering Services Branch, Federal Insurance and Mitigation Administration, FEMA, 400 C Street SW, Washington, DC 20472, (202) 646-7659, or (email)
The Federal Emergency Management Agency (FEMA) makes the final flood hazard determinations as shown in the LOMRs for each community listed in the table below. Notice of these modified flood hazard determinations has been published in newspapers of local circulation and 90 days have elapsed since that publication. The Deputy Associate Administrator for Insurance and Mitigation has resolved any appeals resulting from this notification.
The modified flood hazard determinations are made pursuant to section 206 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
For rating purposes, the currently effective community number is shown and must be used for all new policies and renewals.
The new or modified flood hazard information is the basis for the floodplain management measures that the community is required either to adopt or to show evidence of being already in effect in order to remain qualified for participation in the National Flood Insurance Program (NFIP).
This new or modified flood hazard information, 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.
This new or modified flood hazard determinations are used to meet the floodplain management requirements of the NFIP and are used to calculate the appropriate flood insurance premium rates for new buildings, and for the contents in those buildings. The changes in flood hazard determinations are in accordance with 44 CFR 65.4.
Interested lessees and owners of real property are encouraged to review the final flood hazard information available at the address cited below for each community or online through the FEMA Map Service Center at
Federal Emergency Management Agency, DHS.
Notice.
This is a notice of the Presidential declaration of an emergency for the Commonwealth of the Northern Mariana Islands (FEMA-3408-EM), dated October 23, 2018, and related determinations.
The declaration was issued October 23, 2018.
Dean Webster, Office of Response and Recovery, Federal Emergency Management Agency, 500 C Street SW, Washington, DC 20472, (202) 646-2833.
Notice is hereby given that, in a letter dated October 23, 2018, the President issued an emergency declaration under the authority of the Robert T. Stafford Disaster Relief and Emergency Assistance Act, 42 U.S.C. 5121-5207 (the Stafford Act), as follows:
I have determined that the emergency conditions in the Commonwealth of the Northern Mariana Islands resulting from Typhoon Yutu beginning on October 24, 2018, and continuing, are of sufficient severity and magnitude to warrant an emergency declaration under the Robert T. Stafford Disaster Relief and Emergency Assistance Act, 42 U.S.C. 5121
You are authorized to provide appropriate assistance for required emergency measures, authorized under Title V of the Stafford Act, to save lives and to protect property and public health and safety, and to lessen or avert the threat of a catastrophe in the designated areas. Specifically, you are authorized to provide assistance for emergency protective measures (Category B), limited to direct Federal assistance, under the Public Assistance program.
Consistent with the requirement that Federal assistance be supplemental, any Federal funds provided under the Stafford Act for Public Assistance will be limited to 75 percent of the total eligible costs. In order to provide Federal assistance, you are hereby authorized to allocate from funds available for these purposes such amounts as you find necessary for Federal emergency assistance and administrative expenses.
Further, you are authorized to make changes to this declaration for the approved assistance to the extent allowable under the Stafford Act.
The Federal Emergency Management Agency (FEMA) hereby gives notice that pursuant to the authority vested in the Administrator, Department of Homeland Security, under Executive Order 12148, as amended, Benigno Bern Ruiz, of FEMA is appointed to act as the Federal Coordinating Officer for this declared emergency.
The following areas of the Commonwealth of the Northern Mariana Islands have been designated as adversely affected by this declared emergency:
Federal Emergency Management Agency, DHS.
Notice.
This notice amends the notice of a major disaster declaration for the State of North Carolina (FEMA-4393-DR), dated September 14, 2018, and related determinations.
This amendment was issued October 25, 2018.
Dean Webster, Office of Response and Recovery, Federal Emergency Management Agency, 500 C Street SW, Washington, DC 20472, (202) 646-2833.
The notice of a major disaster declaration for the State of North Carolina is hereby amended to include the following areas among those areas determined to have been adversely affected by the event declared a major disaster by the President in his declaration of September 14, 2018.
Chatham County for Individual Assistance (already designated for Public Assistance, including direct federal assistance).
Durham and Guilford Counties for Individual Assistance.
Federal Emergency Management Agency, DHS.
Notice.
This is a notice of the Presidential declaration of a major disaster for the Commonwealth of the Northern Mariana Islands (FEMA-4404-DR), dated October 26, 2018, and related determinations.
The declaration was issued October 26, 2018.
Dean Webster, Office of Response and Recovery, Federal Emergency Management Agency, 500 C Street SW, Washington, DC 20472, (202) 646-2833.
Notice is hereby given that, in a letter dated October 26, 2018, the President issued a major disaster declaration under the authority of the Robert T. Stafford Disaster Relief and Emergency Assistance Act, 42 U.S.C. 5121
I have determined that the damage in the Commonwealth of the Northern Mariana Islands resulting from Super Typhoon Yutu beginning on October 24, 2018, and continuing, is of sufficient severity and magnitude to warrant a major disaster declaration under the Robert T. Stafford Disaster Relief and Emergency Assistance Act, 42 U.S.C. 5121
In order to provide Federal assistance, you are hereby authorized to allocate from funds available for these purposes such amounts as you find necessary for Federal disaster assistance and administrative expenses.
You are authorized to provide Individual Assistance and assistance for emergency protective measures (Category B) under the Public Assistance program in the designated areas, Hazard Mitigation throughout the Commonwealth, and any other forms of assistance under the Stafford Act that you deem appropriate subject to completion of Preliminary Damage Assessments (PDAs). Direct Federal assistance is authorized.
Consistent with the requirement that Federal assistance is supplemental, any Federal funds provided under the Stafford Act for Public Assistance, Hazard Mitigation, and Other Needs Assistance will be limited to 75 percent of the total eligible costs. For a period of 30 days, you are authorized to fund assistance for emergency protective measures, including direct Federal assistance, at 100 percent of the total eligible costs.
Further, you are authorized to make changes to this declaration for the approved assistance to the extent allowable under the Stafford Act.
The time period prescribed for the implementation of section 310(a), Priority to Certain Applications for Public Facility and Public Housing Assistance, 42 U.S.C. 5153, shall be for a period not to exceed six months after the date of this declaration.
The Federal Emergency Management Agency (FEMA) hereby gives notice that pursuant to the authority vested in the Administrator, under Executive Order 12148, as amended, Benigno Bern Ruiz, of FEMA is appointed to act as the Federal Coordinating Officer for this major disaster.
The following areas of the Commonwealth of the Northern Mariana Islands have been designated as adversely affected by this major disaster:
The municipalities of Rota, Saipan, Tinian, and the Northern Islands for Individual Assistance.
The municipalities of Rota, Saipan, Tinian, and the Northern Islands for emergency protective measures (Category B), including direct federal assistance, under the Public Assistance program.
All areas within the Commonwealth of the Northern Mariana Islands are eligible for assistance under the Hazard Mitigation Grant Program.
The following Catalog of Federal Domestic Assistance Numbers (CFDA) are to be used for reporting and drawing funds: 97.030, Community Disaster Loans; 97.031, Cora Brown Fund; 97.032, Crisis Counseling; 97.033, Disaster Legal Services; 97.034, Disaster Unemployment Assistance (DUA); 97.046, Fire Management Assistance Grant; 97.048, Disaster Housing Assistance to Individuals and Households In Presidentially Declared Disaster Areas; 97.049, Presidentially Declared Disaster Assistance—Disaster Housing Operations for Individuals and Households; 97.050, Presidentially Declared Disaster Assistance to Individuals and Households—Other Needs; 97.036, Disaster Grants—Public Assistance (Presidentially Declared Disasters); 97.039, Hazard Mitigation Grant.
Federal Emergency Management Agency, DHS.
Notice.
This notice amends the notice of a major disaster declaration for the State of Minnesota (FEMA-4390-DR), dated September 5, 2018, and related determinations.
This amendment was issued November 2, 2018.
Dean Webster, Office of Response and Recovery, Federal Emergency Management Agency, 500 C Street SW, Washington, DC 20472, (202) 646-2833.
The notice of a major disaster declaration for the State of Minnesota is hereby amended to include the following area among those areas determined to have been adversely affected by the event declared a major disaster by the President in his declaration of September 5, 2018.
Kanabec County for Public Assistance program.
The following Catalog of Federal Domestic Assistance Numbers (CFDA) are to be used for reporting and drawing funds: 97.030, Community Disaster Loans; 97.031, Cora Brown Fund; 97.032, Crisis Counseling; 97.033, Disaster Legal Services; 97.034, Disaster Unemployment Assistance (DUA); 97.046, Fire Management Assistance Grant; 97.048, Disaster Housing Assistance to Individuals and Households In Presidentially Declared Disaster Areas; 97.049, Presidentially Declared Disaster Assistance—Disaster Housing Operations for Individuals and Households; 97.050 Presidentially Declared Disaster Assistance to Individuals and Households—Other Needs; 97.036, Disaster Grants—Public Assistance (Presidentially Declared Disasters); 97.039, Hazard Mitigation Grant.
Federal Emergency Management Agency, DHS.
Notice.
This notice amends the notice of a major disaster declaration for the Commonwealth of Virginia (FEMA-4401-DR), dated October 15, 2018, and related determinations.
This amendment was issued October 18, 2018.
Dean Webster, Office of Response and Recovery, Federal Emergency Management Agency, 500 C Street SW, Washington, DC 20472, (202) 646-2833.
The notice of a major disaster declaration for the Commonwealth of Virginia is hereby amended to include the following areas among those areas determined to have been adversely affected by the event declared a major disaster by the President in his declaration of October 15, 2018.
The counties of Charles City, Halifax, King William, and Northumberland and the independent city of Franklin for Public Assistance.
The following Catalog of Federal Domestic Assistance Numbers (CFDA) are to be used for reporting and drawing funds: 97.030, Community Disaster Loans; 97.031, Cora Brown Fund; 97.032, Crisis Counseling; 97.033, Disaster Legal Services; 97.034, Disaster Unemployment Assistance (DUA); 97.046, Fire Management Assistance Grant; 97.048, Disaster Housing Assistance to Individuals and Households In Presidentially Declared Disaster Areas; 97.049, Presidentially Declared Disaster Assistance—Disaster Housing Operations for Individuals and Households; 97.050 Presidentially Declared Disaster Assistance to Individuals and Households—Other Needs; 97.036, Disaster Grants—Public Assistance (Presidentially Declared Disasters); 97.039, Hazard Mitigation Grant.
Federal Emergency Management Agency, DHS.
Notice.
This notice amends the notice of a major disaster declaration for the State of Wisconsin (FEMA-4402-DR), dated October 18, 2018, and related determinations.
This amendment was issued November 1, 2018.
Dean Webster, Office of Response and Recovery, Federal Emergency Management Agency, 500 C Street SW, Washington, DC 20472, (202) 646-2833.
The notice of a major disaster declaration for the State of Wisconsin is hereby amended to include the following area among those areas determined to have been adversely affected by the event declared a major disaster by the President in his declaration of October 18, 2018.
Marquette County for Individual Assistance (already designated for Public Assistance).
The following Catalog of Federal Domestic Assistance Numbers (CFDA) are to be used for reporting and drawing funds: 97.030, Community Disaster Loans; 97.031, Cora Brown Fund; 97.032, Crisis Counseling; 97.033, Disaster Legal Services; 97.034, Disaster Unemployment Assistance (DUA); 97.046, Fire Management Assistance Grant; 97.048, Disaster Housing Assistance to Individuals and Households In Presidentially Declared Disaster Areas; 97.049, Presidentially Declared Disaster Assistance—Disaster Housing Operations for Individuals and Households; 97.050 Presidentially Declared Disaster Assistance to Individuals and Households—Other Needs; 97.036, Disaster Grants—Public Assistance (Presidentially Declared Disasters); 97.039, Hazard Mitigation Grant.
Federal Emergency Management Agency, DHS.
Notice.
This is a notice of the Presidential declaration of a major disaster for the Commonwealth of Virginia (FEMA-4401-DR), dated October 15, 2018, and related determinations.
The declaration was issued October 15, 2018.
Dean Webster, Office of Response and Recovery, Federal Emergency Management Agency, 500 C Street SW, Washington, DC 20472, (202) 646-2833.
Notice is hereby given that, in a letter dated October 15, 2018, the President issued a major disaster declaration under the authority of the Robert T. Stafford Disaster Relief and Emergency Assistance Act, 42 U.S.C. 5121
I have determined that the damage in certain areas of the Commonwealth of Virginia resulting from Hurricane Florence during the period of September 8-21, 2018, is of sufficient severity and magnitude to warrant a major disaster declaration under the Robert T. Stafford Disaster Relief and Emergency Assistance Act, 42 U.S.C. 5121
In order to provide Federal assistance, you are hereby authorized to allocate from funds available for these purposes such amounts as you find necessary for Federal disaster assistance and administrative expenses.
You are authorized to provide Public Assistance in the designated areas and Hazard Mitigation throughout the Commonwealth. Consistent with the requirement that Federal assistance be supplemental, any Federal funds provided under the Stafford Act for Hazard Mitigation will be limited to 75 percent of the total eligible costs. Federal funds provided under the Stafford Act for Public Assistance also will be limited to 75 percent of the total eligible costs, with the exception of projects that meet the eligibility criteria for a higher Federal cost-sharing percentage under the Public Assistance Alternative Procedures Pilot Program for Debris Removal implemented pursuant to section 428 of the Stafford Act.
Further, you are authorized to make changes to this declaration for the approved
The Federal Emergency Management Agency (FEMA) hereby gives notice that pursuant to the authority vested in the Administrator, under Executive Order 12148, as amended, Donald L. Keldsen, of FEMA is appointed to act as the Federal Coordinating Officer for this major disaster.
The following areas of the Commonwealth of Virginia have been designated as adversely affected by this major disaster:
Henry, King and Queen, Lancaster, Nelson, Patrick, Pittsylvania, and Russell Counties and the Independent Cities of Newport News, Richmond, and Williamsburg for Public Assistance.
All areas within the Commonwealth of Virginia are eligible for assistance under the Hazard Mitigation Grant Program.
The following Catalog of Federal Domestic Assistance Numbers (CFDA) are to be used for reporting and drawing funds: 97.030, Community Disaster Loans; 97.031, Cora Brown Fund; 97.032, Crisis Counseling; 97.033, Disaster Legal Services; 97.034, Disaster Unemployment Assistance (DUA); 97.046, Fire Management Assistance Grant; 97.048, Disaster Housing Assistance to Individuals and Households In Presidentially Declared Disaster Areas; 97.049, Presidentially Declared Disaster Assistance—Disaster Housing Operations for Individuals and Households; 97.050, Presidentially Declared Disaster Assistance to Individuals and Households—Other Needs; 97.036, Disaster Grants—Public Assistance (Presidentially Declared Disasters); 97.039, Hazard Mitigation Grant.
Federal Emergency Management Agency, DHS.
Notice.
This notice amends the notice of a major disaster declaration for the State of Florida (FEMA-4399-DR), dated October 11, 2018, and related determinations.
This amendment was issued October 23, 2018.
Dean Webster, Office of Response and Recovery, Federal Emergency Management Agency, 500 C Street SW, Washington, DC 20472, (202) 646-2833.
The notice of a major disaster declaration for the State of Florida is hereby amended to include permanent work under the Public Assistance program for those areas determined to have been adversely affected by the event declared a major disaster by the President in his declaration of October 11, 2018.
Bay, Calhoun, Gadsden, Gulf, Jackson, and Liberty Counties for Public Assistance [Categories C-G] (already designated for Individual Assistance and assistance for debris removal and emergency protective measures [Categories A and B], including direct federal assistance, under the Public Assistance program).
The following Catalog of Federal Domestic Assistance Numbers (CFDA) are to be used for reporting and drawing funds: 97.030, Community Disaster Loans; 97.031, Cora Brown Fund; 97.032, Crisis Counseling; 97.033, Disaster Legal Services; 97.034, Disaster Unemployment Assistance (DUA); 97.046, Fire Management Assistance Grant; 97.048, Disaster Housing Assistance to Individuals and Households In Presidentially Declared Disaster Areas; 97.049, Presidentially Declared Disaster Assistance—Disaster Housing Operations for Individuals and Households; 97.050 Presidentially Declared Disaster Assistance to Individuals and Households—Other Needs; 97.036, Disaster Grants—Public Assistance (Presidentially Declared Disasters); 97.039, Hazard Mitigation Grant.
Federal Emergency Management Agency, DHS.
Notice.
Comments are requested on proposed flood hazard determinations, which may include additions or modifications of any Base Flood Elevation (BFE), base flood depth, Special Flood Hazard Area (SFHA) boundary or zone designation, or regulatory floodway on the Flood Insurance Rate Maps (FIRMs), and where applicable, in the supporting Flood Insurance Study (FIS) reports for the communities listed in the table below. The purpose of this notice is to seek general information and comment regarding the preliminary FIRM, and where applicable, the FIS report that the Federal Emergency Management Agency (FEMA) has provided to the affected communities. 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). In addition, the FIRM and FIS report, once effective, will be used by insurance agents and others to calculate appropriate flood insurance premium rates for new buildings and the contents of those buildings.
Comments are to be submitted on or before February 11, 2019.
The Preliminary FIRM, and where applicable, the FIS report for each community are available for inspection at both the online location
You may submit comments, identified by Docket No. FEMA-B-1860, to Rick Sacbibit, Chief, Engineering Services Branch, Federal Insurance and Mitigation Administration, FEMA, 400 C Street SW, Washington, DC 20472, (202) 646-7659, or (email)
Rick Sacbibit, Chief, Engineering Services Branch, Federal Insurance and Mitigation Administration, FEMA, 400 C Street SW, Washington, DC 20472, (202) 646-7659, or (email)
FEMA proposes to make flood hazard determinations for each community listed below, in accordance with section 110 of the Flood Disaster Protection Act of 1973, 42 U.S.C. 4104, and 44 CFR 67.4(a).
These proposed flood hazard determinations, together with the
The communities affected by the flood hazard determinations are provided in the tables below. Any request for reconsideration of the revised flood hazard information shown on the Preliminary FIRM and FIS report that satisfies the data requirements outlined in 44 CFR 67.6(b) is considered an appeal. Comments unrelated to the flood hazard determinations also will be considered before the FIRM and FIS report become effective.
Use of a Scientific Resolution Panel (SRP) is available to communities in support of the appeal resolution process. SRPs are independent panels of experts in hydrology, hydraulics, and other pertinent sciences established to review conflicting scientific and technical data and provide recommendations for resolution. Use of the SRP only may be exercised after FEMA and local communities have been engaged in a collaborative consultation process for at least 60 days without a mutually acceptable resolution of an appeal. Additional information regarding the SRP process can be found online at
The watersheds and/or communities affected are listed in the tables below. The Preliminary FIRM, and where applicable, FIS report for each community are available for inspection at both the online location
Federal Emergency Management Agency, DHS.
Notice.
This notice amends the notice of a major disaster for the State of Minnesota (FEMA-4390-DR), dated September 5, 2018, and related determinations.
This amendment was issued November 2, 2018.
Dean Webster, Office of Response and Recovery, Federal Emergency Management Agency, 500 C Street SW, Washington, DC 20472, (202) 646-2833.
Notice is hereby given that the incident period for this disaster is now June 15 to July 12, 2018.
The following Catalog of Federal Domestic Assistance Numbers (CFDA) are to be used for reporting and drawing funds: 97.030, Community Disaster Loans; 97.031, Cora Brown Fund; 97.032, Crisis Counseling; 97.033, Disaster Legal Services; 97.034, Disaster Unemployment Assistance (DUA); 97.046, Fire Management Assistance Grant; 97.048, Disaster Housing Assistance to Individuals and Households In Presidentially Declared Disaster Areas; 97.049, Presidentially Declared Disaster Assistance—Disaster Housing Operations for Individuals and Households; 97.050, Presidentially Declared Disaster Assistance to Individuals and Households—Other Needs; 97.036, Disaster Grants—Public Assistance (Presidentially Declared Disasters); 97.039, Hazard Mitigation Grant.
Science and Technology Directorate, Department of Homeland Security.
60-Day notice of information collection; new request for comment.
The Department of Homeland Security (DHS), Science and Technology Directorate (S&T) Next Generation First Responder (NGFR) program seeks to develop and integrate next-generation technologies by testing and evaluating first responder technologies during integration demonstration events. During these events, first responder participants use prototype technologies in a fictional scenario—such as a missing person case, an active shooter event, or a chemical spill—and are asked to share their feedback on how the technology worked in the context of their emergency response to the scenario, including whether the technologies made them more effective, efficient or safe.
The information collected during these events will help provide insight about how to improve technologies for first responders and will help DHS define whether or not the event was successful. Additionally, the feedback and evaluation DHS receives will be used in knowledge products that will then be distributed to other state and local first responder organizations.
Comments are encouraged and accepted until January 14, 2019.
You may submit comments, identified by docket number DHS-2018-0042, at:
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DHS/S&T/NGFR Program Manager: Sridhar Kowdley,
DHS, in accordance with the Paperwork Reduction Act (PRA), 44 U.S.C. 3501
November 19, 2018, 1:30 p.m.—5:10 p.m.
Offices of Baker/McKenzie LLP, 815 Connecticut Avenue NW, Washington, DC 20006.
Meeting of the Board of Directors and Advisory Council, open to the public, portion closed to the public.
Paul Zimmerman, General Counsel, (202) 683-7118.
Fish and Wildlife Service, Interior.
Reopening of the comment period.
The U.S. Fish and Wildlife Service (Service) uses a collision risk model (CRM) to predict the number of golden and bald eagles that may be killed at new wind facilities. The model incorporates existing information on eagle exposure and collision probability in the form of prior distributions (priors). The Service has updated the priors for both species of eagle and, on June 21 of this year, announced the availability of a report of the analysis conducted to generate the new priors (83 FR 28858). The notice solicited public comments on how the Service should use the new bald eagle priors. Today's notice reopens the comment period for 30 days, and provides additional information requested by commenters.
To ensure consideration of written comments, they must be submitted on or before December 13, 2018.
You may submit written comments by one of the following methods:
We will post all comments on
We request that you send comments by only one of the methods described above. We will post all information received on
Ken Richkus, at 703-358-1780 (telephone), or
The U.S. Fish and Wildlife Service (Service) uses a collision risk model (CRM) to predict the number of golden and bald eagles that may be killed at new wind facilities (USFWS 2013; New
The CRM is constructed using a Bayesian framework, and as such incorporates existing information on eagle exposure and collision probability in the form of prior distributions (priors). The priors are formally combined with site-specific data on exposure and the amount of hazardous area and operational time for a site to estimate the expected number of annual eagle collision fatalities.
The Service recently updated the priors for both species of eagle using all available data that meet specific criteria, substantially more data than were available when the original priors were established. We released a report of the analysis undertaken to generate the updated priors and announced the availability of the report in a June 21, 2018,
Because the bald eagle collision prior is based on data from only 14 sites that do not span the range of bald eagle density conditions that exist across the country, the prior may not be as representative as it would be if data from a wider range of location had been available. Given this uncertainty, the Service is considering three alternatives for how to incorporate species-specific priors for bald eagles into the CRM and fatality modeling process:
(1) Use the updated species-specific priors, and use the 80th quantile of the CRM fatality estimates as the initial permitted take number for permits, as is the current practice.
(2) Use the updated species-specific priors, but because the status of bald eagles is secure, adopt a risk-tolerant policy for bald eagles and select a more liberal quantile on the CRM fatality distribution as the initial permitted take number for this species.
(3) Given the limitations in data available to inform the bald eagle priors, initiate an expert elicitation process to further refine the bald eagle priors.
Under any of these scenarios, the Service would use data submitted under permits to make updates to the priors in the future.
Alternative 1 would mean that for a similar level of eagle use observed at a project site, the Service would use higher fatality estimates for bald eagles than for golden eagles. Alternative 2 would be a decision by the Service to be more `risk-tolerant' for bald eagles. This would mean that initial fatality predictions would be lower, however it would also likely mean that more permits would have to be amended to increase the permitted take over time (
Written comments we receive become part of the public record associated with this action. Before including your address, phone number, email address, or other personal identifying information in your comment, you should be aware that the 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. All submissions from organizations or businesses, and from individuals identifying themselves as representatives or officials of organizations or businesses, will be made available for public disclosure in their entirety.
Fish and Wildlife Service, Interior.
Notice of receipt of permit applications; request for comments.
We, the U.S. Fish and Wildlife Service, have received applications for permits to conduct activities intended to enhance the propagation or survival of endangered species under the Endangered Species Act of 1973, as amended. We invite the public and local, State, Tribal, and Federal agencies to comment on these applications. Before issuing any of the requested permits, we will take into consideration any information that we receive during the public comment period.
We must receive written data or comments on the applications by December 13, 2018.
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Karen Marlowe, Permit Coordinator, 404-679-7097 (telephone),
We invite review and comment from local, State, and Federal agencies and the public on applications we have received for permits to conduct certain activities with endangered and threatened species under section 10(a)(1)(A) of the Endangered Species Act of 1973, as amended (ESA; 16 U.S.C. 1531
A recovery permit issued by us under section 10(a)(1)(A) of the ESA authorizes the permittee to conduct activities with endangered or threatened species for scientific purposes that promote recovery or for enhancement of propagation or survival of the species. These activities often include such prohibited actions as capture and collection. Our regulations implementing section 10(a)(1)(A) for these permits are found at 50 CFR 17.22 for endangered wildlife species, 50 CFR 17.32 for threatened wildlife species, 50 CFR 17.62 for endangered plant species, and 50 CFR 17.72 for threatened plant species.
Proposed activities in the following permit requests are for the recovery and enhancement of propagation or survival of the species in the wild. The ESA requires that we invite public comment before issuing these permits. Accordingly, we invite local, State, Tribal, and Federal agencies and the public to submit written data, views, or arguments with respect to these applications. The comments and recommendations that will be most useful and likely to influence agency decisions are those supported by quantitative information or studies.
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.
We publish this notice under section 10(c) of the Endangered Species Act of 1973, as amended (16 U.S.C. 1531
Bureau of Land Management, Interior.
Notice.
The Secretary of the Interior proposes to extend the duration of Public Land Order (PLO) No. 5683 for an additional 40-year term. PLO No. 5683 withdrew 37.50 acres of public land from settlement, sale, location, or entry under the general land laws, including the mining laws, but not from leasing under the mineral leasing laws and reserved under the jurisdiction of the Department of the Interior as part of the Pelican Island National Wildlife Refuge (PINWR), administered by the United States Fish and Wildlife Service (USFWS). This Notice gives an opportunity for the public to comment on the petition/application for the proposed withdrawal extension and to request a public meeting.
For a period until February 11, 2019, all persons who wish to submit comments, suggestions, or objections in connection with the proposed withdrawal extension may do so in writing.
Written comments should be sent to the BLM Southeastern States District Office, Attn: Victoria Craft, 273 Market Street, Flowood, MS 39232 or by email to:
Sally Spencer, phone: 202-912-7700; email:
The withdrawal created by PLO No. 5683 (44 FR 53084, 1979), will expire on September 11, 2019, unless extended. The USFWS has filed a petition/application requesting extension of the withdrawal created by the PLO for an additional 40-year term. The PLO withdrew the following described public land from settlement, sale, location, or entry under the general land laws, including the mining laws, but not from leasing under the mineral leasing laws, and reserved them as part of the PINWR:
The land withdrawn by PLO No. 5683 are located in Indian River County (formerly a portion of Brevard County), Florida.
The purpose of the withdrawal extension is to continue to provide an upland buffer zone between the existing refuge and the adjacent privately held land. The withdrawn land is home to PINWR's Centennial Trail, Boardwalk, and Observation Pavilion, which were developed in recognition of the 2003 Centennial Celebration of the National Wildlife Refuge System, at the home of the first National Wildlife Refuge. The PINWR contains 5,400 acres and is visited by over 100,000 people annually who come to experience nature and learn about the Refuge.
The use of a right-of-way, interagency agreement, or cooperative agreement would not provide adequate protection for the wildlife habitat and unique resource values within the PINWR.
No additional water rights would be needed to fulfill the purpose of the requested withdrawal extension.
There are no suitable alternative sites since the lands described herein contain the natural and biological resources of interest for protection.
All persons who wish to submit comments, suggestions, or objections in connection with the proposed withdrawal extension may present their views in writing to the BLM Eastern States, at the address indicated above. Comments, including names and street addresses of respondents, will be available for public review at the address stated above, during regular business hours, 7:30 a.m. to 4:30 p.m., Monday through Friday, except holidays.
Before including your address, phone number, email address, or other personally identifiable information in your comment, you should be aware that your entire comment—including your personally identifiable information—may be made publicly available at any time. While you can ask the BLM in your comment to withhold your personally identifiable information from public review, we cannot guarantee that we will be able to do so.
Notice is hereby given that an opportunity for a public meeting is afforded in connection with the proposed withdrawal extension. All interested persons who desire a public meeting for the purpose of being heard on the proposed withdrawal extension must submit a written request to the District Manager, BLM Southeastern States District Office at the address provided in the
All statements received will be considered before any recommendation concerning the proposed extension is submitted to the Assistant Secretary—Land and Minerals Management for final action. This withdrawal extension proposal will be processed in accordance with the regulations set forth in 43 CFR 2310.4.
43 CFR 2310.3-1.
National Park Service, Interior.
Notice.
The Kansas State Historical Society has completed an inventory of human remains, in consultation with the appropriate Indian Tribes or Native Hawaiian organizations, and has determined that there is a cultural affiliation between the human remains and present-day Indian Tribes or Native Hawaiian organizations. Lineal descendants or 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 should submit a written request to the Kansas State Historical Society. If no additional requestors come forward, transfer of control of the human remains to the lineal descendants, Indian Tribes, or Native Hawaiian organizations stated in this notice may proceed.
Lineal descendants or 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 should submit a written request with information in support of the request to the Kansas State Historical Society at the address in this notice by December 13, 2018.
Dr. Robert J. Hoard, Kansas State Historical Society, 6425 SW 6th Avenue, Topeka, KS 66615-1099, telephone 785-272-8681, Ext. 269, 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 under the control of the Kansas State Historical Society, Topeka, KS. The human remains were removed from Barber, Cowley, Marion, Rice, and Sumner Counties, KS.
This notice is published as part of the National Park Service's administrative responsibilities under NAGPRA, 25 U.S.C. 3003(d)(3). The determinations in this notice are the sole responsibility of the museum, institution, or Federal agency that has control of the Native American human remains. The National Park Service is not responsible for the determinations in this notice.
A detailed assessment of the human remains was made by the Kansas State Historical Society professional staff in consultation with representatives of the Wichita and Affiliated Tribes (Wichita, Keechi, Waco, and Tawakonie), Oklahoma.
On or before 1985, human remains representing, at minimum, one individual were removed from portions of site 14BA401, the JJ Lemon Ranch site (UBS 2001-22) in Barber County, KS, by an artifact collector in Pratt, KS. In 2001, the collector showed his collection to Kansas State Historical Society staff, who identified and took possession of the human remains—cranial fragments, a mandible fragment with teeth, three vertebrae, and two fragments of a femur—all of which belong to a single, 45-55-year-old male. No known individuals were identified. No associated funerary objects are present.
The site is affiliated with the Middle Ceramic (ca. A.D. 1100-1400) Pratt complex based on diagnostic artifacts observed at the site. The Pratt complex material culture recovered from the site—charred corn cobs, small triangular Washita points, beveled knives, bison scapula hoes, other bone tools, and attributes of ceramic vessel sherds—is representative of the people who are ancestral to the Great Bend aspect and, ultimately, to the Wichita and Affiliated Tribes, as asserted by Brosowske and Bevitt in the volume Kansas Archaeology (Hoard and Banks 2006:180-205), as well as by others. Previously recovered human remains from this site were repatriated to the Wichita and Affiliated Tribes in 1999 (
In 1969, human remains representing, at minimum, one individual was removed from 14SR303, the Buresh site (UBS 2000-12) in Sumner County, KS. Kansas State Historical Society staff excavated the site to save information from the site before it was destroyed by collectors. A human occipital belonging to an adult was recovered from a large basin-shaped feature containing charcoal, tools, and other cultural debris. These human remains were not noted during the excavation, but were found only later, during analysis of the Kansas State Historical Society collections. No known individuals were identified. No associated funerary objects are present.
The site dates to ca. A.D. 1100. The material culture recovered from the site—charred corn cobs, small triangular Washita points, beveled knives, bison scapula hoes, other bone tools, and sherds from globular jars with decorated lips and rims—is consistent with the Washita focus, whose people are considered to be ancestral to the Great Bend aspect and, ultimately, to the Wichita and Affiliated Tribes, as asserted by Brosowske and Bevitt in the volume Kansas Archaeology (Hoard and Banks 2006:180-205), as well as by others.
In 1986, human remains representing, at minimum, one individual were removed from 14MN328, the Mem site (UBS 2001-26) in advance of highway construction. The collections from the site, including ceramic vessel sherds and side-notched arrow pints, are consistent with the Great Bend aspect. Subsequent analysis of collections from the investigations recovered a human deciduous incisor belonging to a single individual. No associated funerary objects are present.
The Great Bend aspect, ca. A.D. 1350-1700, is widely understood to be ancestral to the modern-day Wichita and Affiliated Tribes. This understanding is based on radiocarbon dates, geographic region, material culture, oral tradition, and historical documents such as the entradas of Coronado and Oñate in A.D. 1541 and 1601, respectively, as well as historical continuity into the nineteenth and twentieth centuries. This evidence is strongly asserted in Waldo Wedel's 1959 publication
In 1977, human remains representing, at minimum, one individual were removed from 14RC2, the Major site (UBS 2001-32) in Rice County, KS. A private individual excavated a trash pit at the site, and subsequently donated the collection to the Kansas State
In 1977 and 1978, human remains representing, at minimum, one individual were removed from 14RC8, the Tobias site (UBS 2011-01) in Rice County, KS. Research excavations by the Kansas State Historical Society led to the collection of extensive amounts of cultural material with a clear affiliation to the ancestral Wichita Great Bend aspect. An adult human tooth was recovered from this collection in 2011. No known individuals were identified. No associated funerary objects are present.
In 2005, human remains representing, at minimum, two individuals were removed from 14RC410, the Little River site (UBS 2005-08) in Rice County, KS. Excavations in advance of the construction of a water treatment plant encountered a human burial. Because artifacts consistent with the Great Bend aspect were present at the site, the Wichita and Affiliated Tribes were contacted, and the burial was left in place. During subsequent analysis of the site collection, small, fragmentary remains belonging to two individuals were discovered. No known individuals were identified. No associated funerary objects are present.
Between 1994 and 1996, human remains representing, at minimum, one individual were removed from 14CO1, the Larcom-Haggard site (UBS 2015-08), in Cowley County, KS. Kansas State Historical Society staff excavated this Great Bend aspect site in advance of highway construction. Representatives of the Wichita and Affiliated Tribes were actively consulted during investigations. Subsequent analysis of the materials collected led to the discovery of a single human deciduous incisor. No known individuals were identified. No associated funerary objects are present.
Between 1994 and 1996, human remains representing, at minimum, one individual were removed from 14CO3, the County Club site (UBS 2006-05), in Cowley County, KS. Kansas State Historical Society staff excavated this Great Bend aspect site in advance of highway construction. Representatives of the Wichita and Affiliated Tribes were actively consulted during investigations. Subsequent analysis of the materials collected led to the discovery of a single human deciduous incisor. No known individuals were identified. No associated funerary objects are present.
Between 1994 and 1996, human remains representing, at minimum, one individual were removed from 14CO332, the Havelock site (UBS 2001-20), in Cowley County, KS. Kansas State Historical Society staff excavated this Great Bend aspect site in advance of highway construction. Representatives of the Wichita and Affiliated Tribes were actively consulted during investigations. Subsequent analysis of the materials collected led to the discovery of a single human deciduous incisor. No known individuals were identified. No associated funerary objects are present.
Officials of the Kansas State Historical Society have determined that:
• Pursuant to 25 U.S.C. 3001(9), the human remains described in this notice represent the physical remains of 10 individuals of Native American ancestry.
• Pursuant to 25 U.S.C. 3001(2), there is a relationship of shared group identity that can be reasonably traced between the Native American human remains and the Wichita and Affiliated Tribes (Wichita, Keechi, Waco & Tawakonie), Oklahoma.
Lineal descendants or 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 should submit a written request with information in support of the request to Dr. Robert J. Hoard, Kansas State Historical Society, 6425 SW 6th Avenue, Topeka, KS 66615-1099, telephone 785-272-8681, Ext. 269, email
The Kansas State Historical Society is responsible for notifying the Wichita and Affiliated Tribes (Wichita, Keechi, Waco & Tawakonie), Oklahoma that this notice has been published.
National Park Service, Interior.
Notice.
The University of Arkansas Museum Collections 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 a cultural affiliation between the human remains and associated funerary objects and present-day Indian Tribes or Native Hawaiian organizations. Lineal descendants or 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 the University of Arkansas Museum Collections. If no additional requestors come forward, transfer of control of the human remains and associated funerary objects to the lineal descendants, Indian Tribes, or Native Hawaiian organizations stated in this notice may proceed.
Lineal descendants or 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 the University of Arkansas Museum Collections at the address in this notice by December 13, 2018.
Mary Suter, University of Arkansas Museum Collections, Biomass Building 125, 2435 North Hatch Avenue, Fayetteville, AR 72704, telephone (479) 575-3456, 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 University of Arkansas Museum Collections, Fayetteville, AR. The human remains and associated funerary objects were removed from multiple locations in Arkansas.
This notice is published as part of the National Park Service's administrative
A detailed assessment of the human remains was made by the University of Arkansas Museum Collections professional staff in consultation with representatives of The Quapaw Tribe of Indians.
In 1966, human remains representing, at minimum, one individual were removed from Roland Mound (3AR30) in Arkansas County, AR. The human remains are those of an adult of unknown sex. The human remains were excavated by James A. Scholtz for the University of Arkansas Museum. No known individuals were identified. No associated funerary objects are present.
In 1967, human remains representing, at minimum, two individuals were removed from the Dumond Site (3AR40) in Arkansas County, AR. These remains were excavated by James A. Scholtz for the University of Arkansas Museum. No known individuals were identified. The one associated funerary object, a pottery vessel, is currently missing from the museum's collections.
At an unknown date, human remains representing, at minimum, three individuals were removed from the McDuffie Site (3CG21) in Craighead County, AR. These human remains were donated to the museum by a collector in 1967. No known individuals were identified. No associated funerary objects are present.
In 1929, human remains representing, at minimum, one individual were removed from an unknown site in Conway County, AR. The individual was an adult of unknown sex. Accession records for these remains and associated artifact are incomplete. No known individuals were identified. The one associated funerary object is an engraved long-necked tripod bottle.
In 1933, human remains representing, at minimum, 40 individuals were removed from Togo/Neely's Ferry Site (3CS24) in Cross County, AR. The human remains and associated funerary objects were excavated by the University of Arkansas Museum. No known individuals were identified. The 196 associated funerary objects are: One deer antler tine, one arrow point, one bone awl, two modified gar jaws, one bone bead, 31 shell beads, 13 mammal bone fragments, 32 fish bones, 19 ceramic bottles, 15 ceramic bowls, one lot of charred corn cobs, one stone disc, one ceramic disc, two marine shell ear spools, one effigy bottle, one effigy bowl, one bird effigy bowl, one snake effigy bowl, 19 fish hook fragments, one fired clay object, nine ceramic jars, one deer mandible, one pebble, one shell tempered clay pipe, three deer scapula fragments, one shell ornament, 34 mussel shell fragments, and one pot sherd. An additional three associated funerary objects are currently missing from the museum's collections. They are one shell ear plug, one bone ring, and one gar scale.
In 1933, human remains representing, at minimum, 104 individuals were removed from the Vernon Paul Site (3CS25) in Cross County, AR. These human remains and associated funerary objects were excavated by the University of Arkansas Museum. No known individuals were identified. The 692 associated funerary objects are six deer antler fragments, two arrow points, one sample of ashes, 11 bone awls, five beads, 171 shell beads, 15 animal bone fragments, 44 ceramic bottles, 51 ceramic bowls, 56 fragments of turtle shell, three stone celts, one piece of charcoal, two unmodified cobbles, one cache of charred corn, three ceramic discoidals, one stone discoidal, seven shell ear plugs, 13 effigy bowls, one antler tool, one sample of gravel, one hammer stone, one piece of hematite, 20 ceramic jars, two fish bone needles, one lot pebbles, one bone pin, two pipes, two ceramic cylinders, 151 fragments of a turtle shell rattle, two turtle scapulae, 14 mussel shell fragments, 79 shell-tempered body sherds, and 21 shell tempered rim sherds. One additional associated funerary object is currently missing from the museum's collections. It is one lot of pot sherds.
In 1950, 1967, and another unknown date, human remains representing, at minimum, seven individuals were removed from the Rose Mound Site (3CS27) in Cross County, AR. The human remains removed in 1950 were excavated by the University of Arkansas as part of a Field School. The human remains from 1967 were donated to the University of Arkansas Museum. Human remains from one of the listed individuals were donated to the University of Arkansas at an unknown date and transferred to the control of the University of Arkansas Museum in 2006. No known individuals were identified. The five associated funerary objects are five fragments of copper.
At an unknown date, human remains representing, at minimum, one individual were removed from the Delta Site (3CS69) in Cross County, AR and donated to the University of Arkansas Museum in 1966. No known individuals were identified. No associated funerary objects are present.
In 1967, human remains representing, at minimum, 17 individuals were removed from the Wapanocca Mound Site (3CT9) in Crittenden County, AR. These human remains and associated funerary objects were excavated by the University of Arkansas Museum. No known individuals were identified. The 49 associated funerary objects are: Nine ceramic bottles, 10 ceramic bowls, two effigy bowls, seven ceramic jars, one mano, three mussel shells, seventeen sherds. No known individuals were identified. No associated funerary objects are present.
In 1932 and at an unknown date, human remains representing, at minimum, 37 individuals were removed from the Banks Site (3CT13) in Crittenden County, AR. The human remains removed from the site in 1932 were excavated by the University of Arkansas Museum. In 1960 the University of Arkansas received a donation of additional human remains from this site. No known individuals were identified. The one associated funerary object is a ceramic bottle.
In 1932, human remains representing, at minimum, eight individuals were removed from the Barton Ranch Site (3CT18) in Crittenden County, AR. These human remains and associated funerary objects were excavated by the University of Arkansas Museum. No known individuals were identified. The nine associated funerary objects are three bottles, one bowl, two effigy bowls, and two jars.
In 1932, human remains representing, at minimum, 42 individuals were removed from the Golightly Place Site (3CT19) in Crittenden County, AR. These human remains and associated funerary objects were excavated by the University of Arkansas Museum. No known individuals were identified. The 129 associated funerary objects are: Three deer antler, three arrow points, one sample of ash, three bone awls, 12 ceramic bottles, 17 ceramic bowls, two discoidals, 10 effigy vessels, one hammer stone, eight jars, one lump of tempered clay, 44 pebbles, four mussel shells, 18 fragments of turtle bone and shell, and two pot sherds. An additional two associated funerary objects are currently missing from the museum's collections. They are one ceramic bottle and one ceramic bowl.
At an unknown date, human remains representing, at minimum, one individual were removed from the Belle
In 1967, human remains representing, at minimum, one individual were removed from the Glover Site (3CT37) in Crittenden County, AR. These remains and associated objects were excavated by the University of Arkansas Museum. No known individuals were identified. No associated funerary objects are present.
In 1932, human remains representing, at minimum, three individuals were removed from the Warner Smith Place Site (3CT44) in Crittenden County, AR. These human remains and associated funerary objects were excavated by the University of Arkansas Museum. No known individuals were identified. The two associated funerary objects are one clay pipe and one ceramic bottle.
At an unknown date, human remains representing, at minimum, one individual were removed from the McClure Site (3CW34) in Crawford County, AR, and donated to the University of Arkansas Museum in 1962. No known individuals were identified. No associated funerary objects are present.
At an unknown date, human remains representing, at minimum, three individuals were removed from the Toltec Mounds Site (3LN42) in Lonoke County, AR. These human remains were donated to the University of Arkansas Museum in 1966. No known individuals were identified. No associated funerary objects are present.
In 1932, human remains representing, at minimum, 16 individuals were removed from the Middle Nodena Site (3MS3) in Mississippi County, AR. These human remains and associated funerary objects were excavated by the University of Arkansas Museum. No known individuals were identified. The 22 associated funerary objects are: Seven ceramic bottles, one effigy bottle, seven ceramic bowls, one effigy bowl, two ceramic jars, and four pot sherds.
In 1932, human remains representing, at minimum, 92 individuals were removed from the Upper Nodena Site (3MS4) in Mississippi County, AR. These human remains and associated funerary objects were excavated by the University of Arkansas Museum. No known individuals were identified. The 143 associated funerary objects are: Two arrow points, seven bone awls, 33 shell beads, 25 ceramic bottles, 18 ceramic bowls, eight celts, two ceramic discoidals, three marine shell ear plugs, two effigy bottles, eight effigy bowls, three effigy jars, 11 ceramic jars, one stone pendant, one mussel shell, 18 pot sherds, and one sphere of burned clay.
In 1953, human remains representing, at minimum, 15 individuals were removed from the Gant Site (3MS11) in Mississippi County, AR. These human remains and associated funerary objects were excavated by the University of Arkansas Museum. No known individuals were identified. The six associated funerary objects are: Two ceramic bottles, two ceramic bowls, one ceramic jar, and one pot sherd.
At an unknown date, human remains representing, at minimum, 106 individuals were removed from the Golden Lake Site (3MS60) in Mississippi County, AR. No known individuals were identified. These human remains were donated to the University of Arkansas, Department of Anthropology and entered the University of Arkansas Museum collections in 2006. No known individuals were identified. No associated funerary objects are present.
In 1933, human remains representing, at minimum, four individuals were removed from the Tschudy Lumber Company Site (3PO1) in Poinsett County, AR. These human remains and associated funerary objects were excavated by the University of Arkansas Museum. No known individuals were identified. The 17 associated funerary objects are: Seven pot sherds, nine fire cracked rock pieces, and one ceramic bowl.
In 1933, human remains representing, at minimum, three individuals were removed from the Norris Place Site (3PO3) in Poinsett County, AR. These human remains and associated funerary objects were excavated by the University of Arkansas Museum. No known individuals were identified. The four associated funerary objects are: Two ceramic bowls, one ceramic bottle, and one ceramic jar.
In 1933, human remains representing, at minimum, one individual was removed from the Cart's Camp Site (3PO4) in Poinsett County, AR. These human remains were excavated by the University of Arkansas Museum. No known individuals were identified. No associated funerary objects are present.
At an unknown date, human remains representing, at minimum, one individual were removed from the St. Francis Site in St. Francis County, AR. These human remains were purchased by the University of Arkansas Museum in 1959. No known individuals were identified. No associated funerary objects are present.
In 1961 and at an unknown date, human remains representing, at minimum, three individuals were removed from the Castile Landing Site (3SF12) in St. Francis County, AR. The human remains removed in 1961 were excavated by the University of Arkansas Museum. The human remains of the remaining individuals were donated to the University of Arkansas, Department of Anthropology and entered the University of Arkansas Museum collections in 2006. No known individuals were identified. No associated funerary objects are present.
At an unknown date, human remains representing, at minimum, seven individuals were removed from the Manley Site (3SF25) in St. Francis County, AR. These human remains were donated to the University of Arkansas, Department of Anthropology and entered the University of Arkansas Museum collections in 2006. No known individuals were identified. No associated funerary objects are present.
At an unknown date, human remains representing, at minimum, two individuals were removed from the Hollingsworth Place Site (3WH2) in White County, AR. These human remains were donated to the University of Arkansas Museum in 1964. No known individuals were identified. No associated funerary objects are present.
At an unknown date, human remains representing, at minimum, four individuals were removed from the Charles Figley/Lost Hill Site (3WH34) in White County, AR. These human remains were donated to the University of Arkansas Museum in 1966. No known individuals were identified. No associated funerary objects are present.
At an unknown date, human remains representing, at minimum, one individual were removed from the Churchman Place Site on the Black River in an unknown county in Arkansas. Accession records for this collection are incomplete. No known individuals were identified. No associated funerary objects are present.
At an unknown date, human remains representing, at minimum, one individual were removed from the JB Redmann Site (3PO42) in Poinsett County, AR. Accession records for this collection are incomplete. No known individuals were identified. No associated funerary objects are present.
In 1932, human remains representing, at minimum, two individuals were removed from the Randolph Landing Site in Tipton County, TN. These human remains were excavated by the University of Arkansas Museum. No known individuals were identified. The
In 1933, human remains representing, at minimum, 206 individuals were removed from the Hazel Site (3PO6) in Poinsett County, AR. These human remains and associated funerary objects were excavated by the University of Arkansas Museum. No known individuals were identified. The 1148 associated funerary objects are: One abrader, three antler fragments, one arrow point, two bone awls, one ground stone axe, one raccoon baculum, 30 bone beads, two ceramic beads, four crinoid beads, 435 shell beads, four bird bone fragments, three deer bone fragments, 118 fish bones, four unidentified animal bone fragments, 80 bottles, 84 bowls, one piece of burned clay, one mass of burned clay, wood and animal bone, two pieces of charcoal, one lot of charred plant remains including basketry, one sample of red clay, one sample of white clay, one burned clay hearth, one copper ornament, two pieces of sheet copper, one corn cob, nine daub fragments, three ceramic discoidals, one ear plug, six shell ear plugs, one stone ear plug, two effigy bottles, 12 effigy bowls, one effigy jar, one effigy pipe, five fragments of a shell gorget, 43 jars, one chipped stone knife, one bone needle, one shell pendant, 21 bone pin fragments, two clay pipes, 26 mussel shell pieces, 215 pot sherds, two soil samples, one textile fragment, one piece of copper and textile, three beaver teeth, three turtle shell fragments, and two twigs. An additional 76 associated funerary objects are currently missing from the museum's collections. They are: One antler tine, one lot of charcoal and shell, one bird bill awl, two bone awls, six shell ear plugs, one lot of beads, seven shell beads, two pieces of modified animal bone, eight ceramic bottles, 11 ceramic bowls, one lot of charred wood and grass, one effigy bottle, three effigy bowls, two bone needles, one ceramic sphere, one clay pipe, one piece of sheet copper, 19 mussel shell pieces, one pot sherd, five ceramic vessels, and one sample of soil.
During the Mississippi period (A.D. 950-1541) in the Mississippi valley, distinctive local groups emerge in the archeological record that correspond in geographical extent and cultural cohesiveness to present-day groups that include the Quapaw. Quapaw communities occupied villages located around the confluence of the Arkansas and Mississippi Rivers at the time of late 17th century French exploration. Based on the archeological context for these sites and what is presently known about the peoples who pre-date the historic Quapaw people, the University of Arkansas Museum Collections has determined the human remains and associated funerary objects listed here are culturally affiliated with The Quapaw Tribe of Indians.
Officials of the University of Arkansas Museum have determined that:
• Pursuant to 25 U.S.C. 3001(9), the human remains described in this notice represent the physical remains of 736 individuals of Native American ancestry.
• Pursuant to 25 U.S.C. 3001(3)(A), the 2,426 objects described and included 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.
• Pursuant to 25 U.S.C. 3001(2), there is a relationship of shared group identity that can be reasonably traced between the Native American human remains and associated funerary objects and The Quapaw Tribe of Indians.
Lineal descendants or 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 Suter, University of Arkansas Museum, Biomass Building 125, 2435 N Hatch Ave., Fayetteville, AR 72704, telephone (479) 575-3456, email
The University of Arkansas Museum Collections is responsible for notifying The Quapaw Tribe of Indians that this notice has been published.
National Park Service, Interior.
Notice.
The University of California, Davis, in consultation with the appropriate Indian Tribes or Native Hawaiian organizations, has determined that the cultural items listed in this notice meet the definition of unassociated funerary objects. Lineal descendants or representatives of any Indian Tribe or Native Hawaiian organization not identified in this notice that wish to claim these cultural items should submit a written request to the University of California, Davis. If no additional claimants come forward, transfer of control of the cultural items to the lineal descendants, Indian Tribes, or Native Hawaiian organizations stated in this notice may proceed.
Lineal descendants or representatives of any Indian Tribe or Native Hawaiian organization not identified in this notice that wish to claim these cultural items should submit a written request with information in support of the claim to the University of California, Davis at the address in this notice by December 13, 2018.
Megon Noble, NAGPRA Project Manager, University of California, Davis, 433 Mrak Hall, One Shields Avenue, Davis, CA 95616, telephone (530) 752-8501, email
Notice is here given in accordance with the Native American Graves Protection and Repatriation Act (NAGPRA), 25 U.S.C. 3005, of the intent to repatriate cultural items under the control of the University of California, Davis, Davis, CA, that meet the definition of unassociated funerary objects under 25 U.S.C. 3001.
This notice is published as part of the National Park Service's administrative responsibilities under NAGPRA, 25 U.S.C. 3003(d)(3). The determinations in this notice are the sole responsibility of the museum, institution, or Federal agency that has control of the Native American cultural items. The National Park Service is not responsible for the determinations in this notice.
Sometime before 1904, 13 cultural items were removed from a cremation knoll on Mameluke Hill in El Dorado County, CA. A schoolteacher and her son removed the cultural items from the cremation knoll and gave them to Mr. C. Hart Merriam in 1904. In 1962, C. Hart Merriam's daughter sold the collections accumulated by her father to the University of California, Davis. The 13 unassociated funerary objects are 11 sets of trade beads, one set of barita beads, and one stone amulet.
C. Hart Merriam noted that the cultural items show evidence of burning, and were collected from a cremation knoll. Cremation is the historically documented burial practice of Nisenan peoples. Merriam affiliated the cultural items with the Nisenan. Mameluke Hill is located in the historically documented aboriginal territory of the Nisenan, who are today represented by the Ione Band of Miwok Indians of California; Jackson Band of Miwuk Indians (previously listed as the Jackson Rancheria of Me-Wuk Indians of California); Shingle Springs Band of Miwok Indians, Shingle Springs Rancheria (Verona Tract), California; United Auburn Indian Community of the Auburn Rancheria of California; and the Wilton Rancheria, California, hereafter referred to as “The Tribes.” The glass trade beads date to the historic period.
Officials of the University of California, Davis have determined that:
• Pursuant to 25 U.S.C. 3001(3)(B), the 13 cultural items described above 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 and are believed, by a preponderance of the evidence, to have been removed from a specific burial site of a Native American individual.
• Pursuant to 25 U.S.C. 3001(2), there is a relationship of shared group identity that can be reasonably traced between the unassociated funerary objects and The Tribes.
Lineal descendants or representatives of any Indian Tribe or Native Hawaiian organization not identified in this notice that wish to claim these cultural items should submit a written request with information in support of the claim to Megon Noble, NAGPRA Project Manager, University of California, Davis, 433 Mrak Hall, One Shields Avenue, Davis, CA 95616, telephone (530) 752-8501, email
The University of California, Davis is responsible for notifying The Tribes that this notice has been published.
National Park Service, Interior.
Notice.
Historic Westville, Inc. 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 Historic Westville, Inc. 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 Historic Westville, Inc. at the address in this notice by December 13, 2018.
Terra Martinez, Historic Westville, Inc., 1130 Martin Luther King Jr. Blvd., Columbus, GA 31906, telephone (706) 940-0057, 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 Historic Westville, Inc., Columbus, GA. The human remains and associated funerary objects were removed from unknown parts of northern Georgia and southern Tennessee.
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 museum, institution, or Federal agency that has control of the Native American human remains and associated funerary objects. The National Park Service is not responsible for the determinations in this notice.
A detailed assessment of the human remains was made by the Historic Westville, Inc. professional staff in consultation with representatives of the Absentee-Shawnee Tribe of Indians of Oklahoma; Alabama-Coushatta Tribe of Texas (previously listed as the Alabama-Coushatta Tribes of Texas); Cherokee Nation; Eastern Band of Cherokee Indians; Poarch Band of Creek Indians (previously listed as the Poarch Band of Creek Indians of Alabama); Seminole Tribe of Florida (previously listed as the Seminole Tribe of Florida (Dania, Big Cypress, Brighton, Hollywood & Tampa Reservations)); The Choctaw Nation of Oklahoma; The Muscogee (Creek) Nation; The Seminole Nation of Oklahoma; and the United Keetoowah Band of Cherokee Indians in Oklahoma, hereafter referred to as “The Consulted Tribes.”
In 1985, human remains representing, at minimum, four individuals were donated to Historic Westville, Inc. along with approximately 13,000 other Native American artifacts and reproductions. The collection was donated by Dr. Austin Flint. All attempts by the staff of Historic Westville to reach Dr. Flint or his descendants have been unsuccessful. Documentation of the donation consists of a handwritten inventory done by an appraiser preceding the donation and a signed deed of gift. The collection was re-discovered by current staff in 2016. The four individuals include one subadult of indeterminate sex based on the mandible fragment with unerupted teeth and three individuals of indeterminate
Consulting archeologists identified a percentage of the collection to aid in determining point of origin for the collection. A 5% random sampling of over 1,000 project points revealed that over 80% originated from Georgia and Tennessee. A 20% sampling of pottery sherds also verified that over 80% of the sherds were from Georgia and Tennessee.
Officials of Historic Westville, Inc. have determined that:
• Pursuant to 25 U.S.C. 3001(9), the human remains described in this notice are Native American based on their inclusion in a collection of over 13,000 Native American artifacts.
• Pursuant to 25 U.S.C. 3001(9), the human remains described in this notice represent the physical remains of four individuals of Native American ancestry.
• Pursuant to 25 U.S.C. 3001(3)(A), the 150 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.
• 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.
• According to the final judgement of the Indian Claims Commission or the Court of Federal Claims, the land from which the Native American human remains and associated funerary objects were removed is aboriginal land of the Alabama-Coushatta Tribe of Texas (previously listed as the Alabama-Coushatta Tribes of Texas); Alabama-Quassarte Tribal Town; Catawba Indian Nation (aka Catawba Tribe of South Carolina); Cherokee Nation; Coushatta Tribe of Louisiana; Eastern Band of Cherokee Indians; Eastern Shawnee Tribe of Oklahoma; Mississippi Band of Choctaw Indians; Poarch Band of Creeks (previously listed as the Poarch Band of Creek Indians of Alabama); Sac & Fox Tribe of the Mississippi in Iowa; Seminole Tribe of Florida (previously listed as the Seminole Tribe of Florida (Dania, Big Cypress, Brighton, Hollywood & Tampa Reservation)); Shawnee Tribe; The Chickasaw Nation; The Choctaw Nation of Oklahoma; The Muscogee (Creek) Nation; The Seminole Nation of Oklahoma; Thlopthlocco Tribal Town; and the United Keetoowah Band of Cherokee Indians in Oklahoma, hereafter referred to as “The Tribes.”
• Pursuant to 43 CFR 10.11(c)(1), the disposition of the human remains and associated funerary objects may be to The Tribes.
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 Terra Martinez, Historic Westville, Inc., 1130 Martin Luther King Jr. Blvd., Columbus, GA 31906, telephone (706) 940-0057, email
Historic Westville, Inc. is responsible for notifying The Tribes and The Consulted Tribes that this notice has been published.
U.S. International Trade Commission.
Notice.
Notice is hereby given that the U.S. International Trade Commission has received a complaint entitled
Lisa R. Barton, Secretary to the Commission, U.S. International Trade Commission, 500 E Street SW, Washington, DC 20436, telephone (202) 205-2000. The public version of the complaint can be accessed on the Commission's Electronic Document Information System (EDIS) at
General information concerning the Commission may also be obtained by accessing its internet server at United States International Trade Commission (USITC) at
The Commission has received an amended complaint and a submission pursuant to § 210.8(b) of the Commission's Rules of Practice and Procedure filed on behalf of Juul Labs, Inc., on October 26, 2018. The original complaint was filed on October 3, 2018 and a notice of receipt of complaint; solicitation of comments relating to the public interest was published in the
Proposed respondents, other interested parties, and members of the public are invited to file comments, not to exceed five (5) pages in length, inclusive of attachments, on any public interest issues raised by the complaint or § 210.8(b) filing. Comments should address whether issuance of the relief specifically requested by the complainant in this investigation would affect the public health and welfare in the United States, competitive conditions in the United States economy, the production of like or directly competitive articles in the United States, or United States consumers.
In particular, the Commission is interested in comments that:
(i) explain how the articles potentially subject to the requested remedial orders are used in the United States;
(ii) identify any public health, safety, or welfare concerns in the United States relating to the requested remedial orders;
(iii) identify like or directly competitive articles that complainant, its licensees, or third parties make in the United States which could replace the subject articles if they were to be excluded;
(iv) indicate whether complainant, complainant's licensees, and/or third party suppliers have the capacity to replace the volume of articles potentially subject to the requested exclusion order and/or a cease and desist order within a commercially reasonable time; and
(v) explain how the requested remedial orders would impact United States consumers.
Written submissions on the public interest must be filed no later than by close of business, eight calendar days after the date of publication of this notice in the
Persons filing written submissions must file the original document electronically on or before the deadlines stated above and submit 8 true paper copies to the Office of the Secretary by noon the next day pursuant to § 210.4(f) of the Commission's Rules of Practice and Procedure (19 CFR 210.4(f)). Submissions should refer to the docket number (“Docket No. 3346”) in a prominent place on the cover page and/or the first page. (
Any person desiring to submit a document to the Commission in confidence must request confidential treatment. All such requests should be directed to the Secretary to the Commission and must include a full statement of the reasons why the Commission should grant such treatment.
This action is taken under the authority of section 337 of the Tariff Act of 1930, as amended (19 U.S.C. 1337), and of §§ 201.10 and 210.8(c) of the Commission's Rules of Practice and Procedure (19 CFR 201.10, 210.8(c)).
By order of the Commission.
On the basis of the record
The Commission, pursuant to section 735(b) of the Act (19 U.S.C. 1673d(b)), instituted these investigations effective September 26, 2017, following receipt of petitions filed with the Commission and Commerce by DAK Americas LLC, Charlotte, North Carolina; Indorama Ventures USA, Inc., Decatur, Alabama; M&G Polymers USA, LLC, Houston, Texas; and Nan Ya Plastics Corporation, America, Lake City, South Carolina. The Commission scheduled the final phase of the investigations following notification of preliminary determinations by Commerce that imports of PET resin from Brazil, Indonesia, Korea, Pakistan, and Taiwan were being sold at LTFV within the meaning of section 733(b) of the Act (19 U.S.C. 1673b(b)). Notice of the scheduling of the final phase of the Commission's investigations and of a public hearing to be held in connection therewith was given by posting copies
The Commission made these determinations pursuant to section 735(b) of the Act (19 U.S.C. 1673d(b)). It completed and filed its determinations in these investigations on November 6, 2018. The views of the Commission are contained in USITC Publication 4835 (November 2018), entitled
By order of the Commission.
10:00 a.m., Thursday, November 15, 2018.
Board Room, 7th Floor, Room 7047, 1775 Duke Street (All visitors must use Diagonal Road Entrance), Alexandria, VA 22314-3428.
Open.
1. Share Insurance Fund Quarterly Report.
2. 2019-2020 NCUA Budget.
3. NCUA Rules and Regulations, Fidelity Bonds.
Gerard Poliquin, Secretary of the Board, Telephone: 703-518-6304.
National Coordination Office (NCO) for Networking and Information Technology Research and Development (NITRD); submitted by the National Science Foundation.
Notice of request for information.
Pursuant to the Cybersecurity Enhancement Act of 2014, Federal agencies must update the Federal cybersecurity research and development (R&D) strategic plan every four years. The NITRD NCO seeks public input for the 2019 update of the Federal cybersecurity R&D strategic plan. The updated plan will be used to guide and coordinate federally funded research in cybersecurity, including cybersecurity education and workforce development, and the development of consensus-based standards and best practices in cybersecurity.
To be considered, submissions must be received on or before 11:59 p.m. (ET) on January 15, 2019.
Submissions to this notice may be sent by any of the following methods:
(a)
(b)
(c)
Responses to this RFI may be posted online at
In accordance with FAR 15.202(3), responses to this notice are not offers and cannot be accepted by the Federal Government to form a binding contract. Responders are solely responsible for all expenses associated with responding to this RFI.
Tomas Vagoun at
The Cybersecurity Enhancement Act of 2014 (
The most recent version of the strategic plan was released in February 2016 (
On behalf of Federal agencies and the NITRD Cyber Security and Information Assurance Interagency Working Group, the NCO for NITRD seeks public input on Federal priorities in cybersecurity R&D. Responders should consider a 10-year time frame when characterizing the challenges, prospective research activities, and desired outcomes. Responders are asked to answer one or more of the following questions:
1. What innovative, transformational technologies have the potential to greatly enhance the security, reliability, resiliency, and trustworthiness of the digital infrastructure, and to protect consumer privacy?
2. What progress has been made against the goals of the 2016 Federal Cybersecurity R&D Strategic Plan? Are there mature private-sector solutions that address the deficiencies raised in the 2016 Strategic Plan? What areas of research or topics of the 2016 Strategic Plan no longer need to be prioritized for federally funded basic research?
3. What areas of research or topics of the 2016 Strategic Plan should continue to be a priority for federally funded research and require continued Federal R&D investments?
4. What challenges or objectives not included in the 2016 Strategic Plan should be strategic priorities for federally funded R&D in cybersecurity? Discuss what new capabilities would be desired, what objectives should guide
5. What changes to cybersecurity education and workforce development, at all levels of education, should be considered to prepare students, faculty, and the workforce in the next decade for emerging cybersecurity challenges, such as the implications of artificial intelligence, quantum computing, and the Internet of Things on cybersecurity?
6. What other research and development strategies, plans, or activities, domestic or in other countries, should inform the U.S. Federal cybersecurity R&D strategic plan?
Following the receipt of comments, the NITRD Cyber Security and Information Assurance Interagency Working Group under the National Science and Technology Council will consider the input provided when updating the Federal cybersecurity R&D strategic plan.
Submitted by the National Science Foundation on behalf of the Networking and Information Technology Research and Development (NITRD) National Coordination Office (NCO) on November 7, 2018.
Nuclear Regulatory Commission.
Exemption; issuance.
The U.S. Nuclear Regulatory Commission (NRC) is issuing an exemption to Northwest Medical Isotopes, LLC (NWMI) from the requirement that an application for an NRC license to possess and use special nuclear material for processing and fuel fabrication, scrap recovery or conversion of uranium hexafluoride, or for the conduct of any other activity which the NRC has determined will significantly affect the quality of the environment (and the associated environmental report), be submitted at least 9 months prior to commencement of construction of the plant or facility in which the activity will be conducted.
This exemption is being issued on November 13, 2018.
Please refer to Docket ID NRC-2018-0225 when contacting the NRC about the availability of information regarding this document. You may access publicly-available information related to this document using any of the following methods:
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David Tiktinsky, Office of Nuclear Material Safety and Safeguards, U.S. Nuclear Regulatory Commission, Washington, DC 20555-0001; telephone: 301-415-8740, email:
NWMI is the holder of Construction Permit No. CPMIF-002 (issued on May 9, 2018 (ADAMS Accession No. ML18037A308) under Part 50 of title 10 of the
NWMI submitted an environmental report with its construction permit application, providing environmental information about all of the processes that would occur in both portions of the RPF. In accordance with Section 102(2)(C) of the National Environmental Policy Act of 1969 (NEPA) (42 U.S.C. 4321
The exemption request from NWMI was submitted by letter dated December 18, 2017 (ADAMS Accession No. ML17362A040), as supplemented by a letter dated March 12, 2018 (ADAMS Accession No. ML18088A175). NWMI is requesting an exemption from the requirement that the application (and associated environmental report required by 10 CFR part 51) for 10 CFR part 70 activities be submitted at least 9 months prior to commencement of construction of the 10 CFR part 70 components of the RPF. The activities that will be subject to the 10 CFR part 70 license application are described in the construction permit application that NWMI previously submitted to the NRC under 10 CFR part 50 for an RPF to be constructed in Columbia, Missouri. NWMI Preliminary Safety Analyses Report, Chapter 19, “Environmental Report” Corvallis, OR, Revision 0A
The NRC evaluated the environmental impacts from the 10 CFR part 70 target fabrication activities in the RPF as part of its EIS supporting NWMI's 10 CFR part 50 construction permit application. The exemption would allow NWMI to initiate construction of the 10 CFR part 70 components of the RPF upon the issuance of the 10 CFR part 50 construction permit for the RPF even if the 10 CFR 70.21(f) timing requirement is not met.
Pursuant to 10 CFR 70.17(a), the Commission may, upon application of any interested person or upon its own initiative, grant such exemptions from the requirements of 10 CFR part 70 as it determines are authorized by law and will not endanger life or property or the common defense and security and are otherwise in the public interest.
The applicant has stated that the requested exemption from the requirement to submit an application and associated environmental report at least 9 months prior to the commencement of construction of the RPF, including 10 CFR part 70 components (
The staff evaluated the environmental impacts of the RPF, including the 10 CFR part 70 target fabrication activities as a connected action, in the EIS dated May 31, 2017 (NUREG-2209, “Environmental Impact Statement for the Construction Permit for the Northwest Medical Isotopes Radioisotope Production Facility”, ADAMS Accession No. ML17130A862). The staff concludes, as documented in the EIS, that after weighing the environmental, economic, technical, and other benefits against environmental and other costs, and considering reasonable alternatives, the NRC staff's recommendation, unless safety issues mandate otherwise, is the issuance of a construction permit to NWMI.
The NRC regulation, 10 CFR 70.17, allows the NRC to grant exemptions from the requirements of 10 CFR part 70 provided certain findings are made. Granting the applicant's proposed exemption is not otherwise inconsistent with NRC regulations or other applicable laws. As explained below, the proposed exemption will not endanger life or property, or the common defense and security, and is otherwise in the public interest.
NWMI indicates that it will submit an environmental report with its application for an operating license for the entire RPF which the NRC will be able to review for any significant new information. The NRC will not make a decision on an application to operate the production portion of the facility under 10 CFR part 50 or a license to possess and use special nuclear material for target fabrication under 10 CFR part 70 until after the NRC has completed a NEPA review based on NWMI's proposed application and environmental report, and made the appropriate regulatory findings. Therefore, the exemption is authorized by law.
Construction of the facility has not yet begun. Since the exemption request relates to the timing of when construction may begin, the proposed exemption would not: (a) Impact the probabilities of evaluated accidents; (b) affect margins of safety; (c) affect effectiveness of programs contained in licensing documents; (d) increase effluents; (e) increase occupational radiological exposures; or (f) impact operations or decommissioning activities. The proposed exemption also will not have an impact on common defense and security since the exemption only relates to the timing of construction. NWMI's construction permit does not authorize possession of any nuclear material at the RPF.
Based on its evaluation, the NRC staff has determined that this exemption will not endanger life or property or the common defense and security.
The NRC staff has determined that granting the proposed exemption would allow for efficient construction of the NWMI RPF at an earlier date. The purpose of the NWMI RPF is to produce medical isotopes and help meet the U.S. goal of establishing a domestic supply of Mo-99 as stated in the American Medical Isotopes Production Act, 42 U.S.C. 2065
As required by 10 CFR 51.21, the NRC performed an environmental assessment (EA) that analyzes the environmental impacts of the proposed exemption in accordance with NEPA. Based on that EA, the NRC staff has determined not to prepare an EIS for the proposed exemption, and has issued a finding of no significant impact (FONSI). The EA and FONSI were published in the
Accordingly, the NRC has determined that, pursuant to 10 CFR 70.17, the exemption is authorized by law, will not endanger life or property or the common defense and security, and is otherwise in the public interest. Therefore, the NRC hereby grants NWMI an exemption from the 10 CFR 70.21(f) requirement to submit a 10 CFR part 70 application, and the associated environmental report, 9 months prior to the commencement of construction, to allow NWMI to begin construction of the 10 CFR part 70 portions of the facility along with the rest of the RPF.
For the Nuclear Regulatory Commission.
Occupational Safety and Health Review Commission.
Notice of a modified system of records.
In accordance with the Privacy Act of 1974, the Occupational Safety and Health Review Commission (OSHRC) is revising the notice for Privacy Act system-of-records OSHRC-4.
Comments must be received by OSHRC on or before December 13, 2018.
You may submit comments by any of the following methods:
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•
•
•
Ron Bailey, Attorney-Advisor, Office of the General Counsel, via telephone at (202) 606-5410, or via email at
The Privacy Act of 1974, 5 U.S.C. 552a(e)(4), requires federal agencies such as OSHRC to publish in the
The notice for OSHRC-4, provided below in its entirety, is as follows.
Payroll and Related Records, OSHRC-4.
None.
(1) Paper and electronic files are maintained by the Office of the Executive Director, OSHRC, 1120 20th Street NW, Ninth Floor, Washington, DC 20036-3457; (2) pursuant to an interagency agreement, payroll records are stored electronically by the U.S. Department of Agriculture, National Finance Center (NFC), P.O. Box 60000, New Orleans, LA 70160-0001.
Human Resources Specialist, OSHRC, 1120 20th Street NW, Ninth Floor, Washington, DC 20036-3457; (202) 606-5100.
5 U.S.C. 301, 5516, 5517, 5520; 26 U.S.C. 6011, 6109; 29 U.S.C. 661; 44 U.S.C. 3101.
Records are used by OSHRC and NFC employees to maintain adequate payroll information for OSHRC employees and Commission members.
This system of records covers current and former employees of OSHRC and Commission members.
The records maintained in this system, and the categories of records referenced therein, are as follows. (1) direct deposit records that include the employee's name and signature, address, and telephone number; the type of depositor account selected for direct deposit, and the account and routing numbers; and a voided check; (2) tax records that include the employee's name and signature, social security number, marital status, and home address; the number of allowances for which the employee qualifies; and further information which may be required on state, county, or city withholding certificates; (3) employee retirement estimates that include the employee's name and social security number; (4) records maintained pursuant to the Family Medical Leave Act that include the employee's name, signature, and job description; identity of certain family members and, if a child, date of birth; and medical information pertinent to leave requests; and (5) records necessary for payroll processing by NFC, including those pertaining to time and attendance and leave records, that may include some or all of the information specified above, as well as additional information concerning deductions, salary and benefits.
Information in this system either comes from the individual to whom it applies or is derived from information compiled by OSHRC employees performing administrative duties.
In addition to disclosures generally permitted under 5 U.S.C. 552a(b), all or a portion of the records or information contained in this system of records may be disclosed as a routine use pursuant to 5 U.S.C. 552a(b)(3) under the circumstances or for the purposes described below, to the extent such disclosures are compatible with the purposes for which the information was collected:
(1) To the Department of Justice (DOJ), or to a court or adjudicative body before which OSHRC is authorized to appear, when any of the following entities or individuals—(a) OSHRC, or any of its components; (b) any employee of OSHRC in his or her official capacity; (c) any employee of OSHRC in his or her individual capacity where DOJ (or OSHRC where it is authorized to do so) has agreed to represent the employee; or (d) the United States, where OSHRC determines that litigation is likely to affect OSHRC or any of its components—is a party to litigation or has an interest in such litigation, and OSHRC determines that the use of such records by DOJ, or by a court or other tribunal, or another party before such tribunal, is relevant and necessary to the litigation.
(2) To an appropriate agency, whether federal, state, local, or foreign, charged with investigating or prosecuting a violation or enforcing or implementing a law, rule, regulation, or order, when a record, either on its face or in conjunction with other information, indicates a violation or potential violation of law, which includes civil, criminal or regulatory violations, and such disclosure is proper and consistent with the official duties of the person making the disclosure.
(3) To a federal, state, or local agency maintaining civil, criminal or other relevant enforcement information, such as current licenses, if necessary to obtain information relevant to an OSHRC decision concerning the hiring,
(4) To a federal, state, or local agency, in response to that agency's request for a record, and only to the extent that the information is relevant and necessary to the requesting agency's decision in the matter, if the record is sought in connection with the hiring, appointment, or retention of an employee; the issuance, renewal, suspension, or revocation of a security clearance; the execution of a security or suitability investigation; the letting of a contract; or the issuance of a license, grant or other benefit by the requesting agency.
(5) To an authorized appeal grievance examiner, formal complaints manager, equal employment opportunity investigator, arbitrator, or other duly authorized official engaged in investigation or settlement of a grievance, complaint, or appeal filed by an employee, only to the extent that the information is relevant and necessary to the case or matter.
(6) To OPM in accordance with the agency's responsibilities for evaluation and oversight of federal personnel management.
(7) To officers and employees of a federal agency for the purpose of conducting an audit, but only to the extent that the record is relevant and necessary to this purpose.
(8) To OMB in connection with the review of private relief legislation at any stage of the legislative coordination and clearance process, as set forth in Circular No. A-19.
(9) To a Member of Congress or to a person on his or her staff acting on the Member's behalf when a written request is made on behalf and at the behest of the individual who is the subject of the record.
(10) To the National Archives and Records Administration (NARA) for records management inspections and such other purposes conducted under the authority of 44 U.S.C. 2904 and 2906.
(11) To appropriate agencies, entities, and persons when: (a) OSHRC suspects or has confirmed that there has been a breach of the system of records; (b) OSHRC has determined that as a result of the suspected or confirmed breach there is a risk of harm to individuals, OSHRC, the Federal Government, or national security; and (c) the disclosure made to such agencies, entities, and persons is reasonably necessary to assist in connection with OSHRC's efforts to respond to the suspected or confirmed breach or to prevent, minimize, or remedy such harm.
(12) To NARA, Office of Government Information Services (OGIS), to the extent necessary to fulfill its responsibilities in 5 U.S.C. 552(h), to review administrative agency policies, procedures and compliance with FOIA, and to facilitate OGIS' offering of mediation services to resolve disputes between persons making FOIA requests and administrative agencies.
(13) To another federal agency or federal entity, when OSHRC determines that information from this system of records is reasonably necessary to assist the recipient agency or entity in (a) responding to a suspected or confirmed breach or (b) preventing, minimizing, or remedying the risk of harm to individuals, the recipient agency or entity (including its information systems, programs, and operations), the Federal Government, or national security, resulting from a suspected or confirmed breach.
(14) To the Internal Revenue Service (IRS) for investigation, and to private attorneys, pursuant to a power of attorney.
(15) To the IRS, a copy of an employee's Department of the Treasury Form W-2, Wage and Tax Statement.
(16) To state, city, or other local jurisdictions which are authorized to tax the employee's compensation, a copy of an employee's Form W-2. The record will be provided in accordance with a withholding agreement between the state, city, or other local jurisdiction and the Department of the Treasury pursuant to 5 U.S.C. 5516, 5517, and 5520, or in response to a written request from an appropriate official of the taxing jurisdiction. The request must include a copy of the applicable statute or ordinance authorizing the taxation of compensation and should indicate whether the authority of the jurisdiction to tax the employee is based on place of residence, place of employment, or both.
(17) To a city, copies of executed city tax withholding certifications, pursuant to a withholding agreement between the city and the Department of the Treasury (5 U.S.C. 5520), and in response to written requests from an appropriate city official to OSHRC's Office of the Executive Director.
(18) To NFC to effect issuance of paychecks via electronic fund transfers (EFT) to employees, and distribution of allotments and deductions to financial and other institutions, and for other authorized purposes.
(19) To the Federal Retirement Thrift Investment Board to update Section 401K type records and benefits; to the Social Security Administration to establish social security records and benefits; to the Department of Labor, Office of Worker's Compensation to process compensation claims; to the Department of Defense to adjust military retirement; to health insurance carriers to process insurance claims; and to the Department of Veterans Affairs for the purpose of evaluating veteran's benefits to which the individual may be entitled.
(20) To other federal agencies to effect salary or administrative offsets, or for other purposes connected with the collection of debts owed to the United States, pursuant to sections 5 and 10 of the Debt Collection Act of 1982, as amended by the Debt Collection Improvement Act of 1996.
(21) To other federal, state, local or foreign agencies conducting computer matching programs to help eliminate fraud and abuse and to detect unauthorized overpayments made to individuals. When disclosures are made as part of computer matching programs, OSHRC will comply with the Computer Matching and Privacy Protection Act of 1988, and the Computer Matching and Privacy Protections Amendments of 1990.
(22) To the Office of Child Support Enforcement, Administration for Children and Families, Department of Health and Human Services, the names, social security numbers, home addresses, dates of birth, dates of hire, quarterly earnings, employer identifying information, and state of hire of employees for the purpose of locating individuals to establish paternity, identifying sources of income, and for other child support enforcement actions as required by the Personal Responsibility and Work Opportunity Reconciliation Act of 1996, 42 U.S.C. 653(n).
(23) To “consumer reporting agencies” as defined in the Fair Credit Reporting Act (15 U.S.C. 1681a(f)) or the Federal Claims Collection Act of 1966 (31 U.S.C. 3701(a)(3)) in accordance with 31 U.S.C. 3711(f).
Records are stored on paper in file cabinets at OSHRC's National Office in Washington, DC, and electronically on an access-restricted shared OSHRC drive. Records are also stored electronically on the NFC's personnel/payroll system.
Records are retrieved manually and electronically by name.
Records are retained and disposed of in accordance with NARA's General Records Schedule 2.4.
Paper records are maintained in locked file cabinets, and access is limited to personnel who require access to perform their official functions. Access to electronic records maintained on an OSHRC shared drive is restricted to personnel who require access to perform their official functions.
OSHRC records electronically transmitted to its contractor, NFC, are stored on servers in a secured federal complex with access codes, security codes, and/or security guards. Access to networks and data requires a valid username and password and is further restricted to personnel who have the need to know the information for the performance of their official duties.
Individuals who wish to gain access to their records should notify: Privacy Officer, OSHRC, 1120 20th Street NW, Ninth Floor, Washington, DC 20036-3457. For an explanation on how such requests should be drafted, refer to 29 CFR 2400.6 (procedures for requesting records).
Individuals who wish to contest their records should notify: Privacy Officer, OSHRC, 1120 20th Street NW, Ninth Floor, Washington, DC 20036-3457. For an explanation on the specific procedures for contesting the contents of a record, refer to 29 CFR 2400.8 (Procedures for requesting amendment), and 29 CFR 2400.9 (Procedures for appealing).
Individuals interested in inquiring about their records should notify: Privacy Officer, OSHRC, 1120 20th Street NW, Ninth Floor, Washington, DC 20036-3457. For an explanation on how such requests should be drafted, refer to 29 CFR 2400.5 (notification), and 29 CFR 2400.6 (procedures for requesting records).
None.
April 14, 2006, 71 FR 19556; August 4, 2008, 73 FR 45256; October 5, 2015, 80 FR 60182; and September 28, 2017, 82 FR 45324.
83 FR 55761.
Tuesday, November 13, 2018, at 10:30 a.m.; and Wednesday, November 14, 2018, at 8:30 a.m.
Washington, DC, at U.S. Postal Service Headquarters, 475 L'Enfant Plaza SW, in the Benjamin Franklin Room.
Tuesday, November 13, 2018, at 10:30 a.m.; Wednesday, November 14, 2018, at 8:30 a.m.—Open.
Two agenda items combined and additional information added related to public comment period.
1. Strategic Issues.
2. Financial Matters.
3. Compensation and Personnel Matters.
4. Executive Session—Discussion of prior agenda items and Board governance.
1. Remarks of the Chairman of the Temporary Emergency Committee of the Board.
2. Remarks of the Postmaster General and CEO.
3. Approval of Minutes of Previous Meetings.
4. Committee Reports.
5. FY2018 10K and Financial Statements and Approval of Annual Report and Comprehensive Statement.
6. FY2019 IFP and Financing Resolution.
7. FY2020 Appropriations Request.
8. Quarterly Service Performance Report.
9. Approval of Annual Report and Comprehensive Statement.
10. Draft Agenda for February meetings.
A public comment period will begin immediately following the adjournment of the open session on November 14, 2018. During the public comment period, which shall not exceed 30 minutes, members of the public may comment on any item or subject listed on the agenda for the open session above. Registration of speakers at the public comment period is required. No more than three minutes shall be allotted to each speaker. The time allotted to each speaker will be determined after registration closes. Participation in the public comment period is governed by 39 CFR 232.1(n).
Acting Secretary of the Board, U.S. Postal Service, 475 L'Enfant Plaza SW, Washington, DC 20260-1000. Telephone: (202) 268-4800.
The Presidio Trust.
Public notice.
This notice announces the Presidio Trust's receipt of and availability for public comment on an application from GTE Mobilnet of California d/b/a Verizon Wireless for installation of a wireless telecommunications facilities site (“Project”) in The Presidio of San Francisco. The proposed location of the Project is in the vicinity of 386 Moraga Avenue.
The Project involves (i) installing a new 70-foot monopole to accommodate nine panel antenna panels, and (ii) placing the associated radio equipment on a concrete pad within a 20-foot by 20-foot fenced area. Power and telecommunications service will be brought to the site by underground trench.
Steve Carp, 103 Montgomery Street,
Pursuant to Section 19(b)(1)
The Exchange proposes to amend Section 303A.00 of the NYSE Listed Company Manual (the “Manual”) to change the threshold for listed companies to benefit from the exemptions from the NYSE compensation committee requirements applicable to smaller reporting companies so that all companies that qualify for smaller reporting company status under the revised SEC definition will qualify for those exemptions.
The proposed rule change is available on the Exchange's website 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.
The SEC recently adopted
Smaller reporting companies are entitled to avail themselves of certain exemptions from the NYSE's compensation committee requirements.
The Exchange believes that the proposed rule change is consistent with Section 6(b) of the Act,
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 purposes of the Act. The proposed rule change will not impose any burden competition as its sole purpose is to change the threshold for listed companies to benefit from the exemptions from the NYSE compensation committee requirements applicable to smaller reporting companies so that all companies that qualify for smaller reporting company status under the revised SEC definition will qualify for those exemptions.
No written comments were solicited or received with respect to the proposed rule change.
The Exchange has filed the proposed rule change pursuant to Section 19(b)(3)(A)(iii) of the Act
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 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.
Pursuant to Section 19(b)(1) of the Securities Exchange Act of 1934 (“Act”),
The Exchange proposes to amend Phlx Rule 803 related to derivative
The text of the proposed rule change is available on the Exchange's website 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 aspects of such statements.
The purpose of the proposed rule change is to amend Rule 803 related to derivative securities traded under UTP by removing the requirement in Rule 803(o)(3) for the Exchange to file with the Commission a Form 19b-4(e) for each Derivative Security, and renumbering the remaining rules of Rule 803(o) to maintain an organized rule structure, as described below.
Rule 803(o)(3) sets forth the requirement for Phlx to file with the Commission a Form 19b-4(e) with respect to each Derivative Security that is traded under UTP. However, Phlx believes that it should not be necessary to file a Form 19b-4(e) with the Commission if it begins trading a Derivative Security on a UTP basis, because Rule 19b- 4(e)(1) under the Act refers to the “listing and trading” of a “new derivative securities product.”
The Exchange believes that the requirements of that rule refers [sic] to when an exchange lists and trades a Derivative Security, and not when an exchange seeks only to trade such product on a UTP basis pursuant to Rule 12f-2 under the Act.
Phlx believes that the proposed rule change is consistent with the provisions of Section 6(b)
In addition, the Exchange notes that a substantially identical proposed rule change by NYSE National, Inc. (“NYSE National”) was recently approved by the Commission.
With respect to the renumbering of current Rule 803(o)(4) as Rule 803(o)(3), the Exchange believes that this change is consistent with the Act because they [sic] will allow the Exchange to maintain a clear and organized rule structure, thus preventing investor confusion.
For these reasons, Phlx believes the proposed rule change is consistent with the requirements of Section 6(b)(5) of the Act.
Phlx 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. To the contrary, removing the requirement to file a Form 19b-4(e) will serve to enhance competition by providing for the efficient addition of Derivative Securities for trading under UTP on Phlx. To the extent that a competitor marketplace believes that the proposed rule change places it at a competitive disadvantage, it may file with the Commission a proposed rule change to adopt the same or similar rule.
In addition, the proposal to renumber the current Rules [sic] 803(o)(4) as Rule 803(o)(3) does not impact competition in any respect since it merely maintains a clear and organized rule structure.
No written comments were either solicited or received.
Because the proposed rule change does not: (i) Significantly affect the protection of investors or the public interest; (ii) impose any significant burden on competition; or (iii) become operative prior to 30 days from the date on which it was filed, or such shorter time as the Commission may designate, it has become effective pursuant to Section 19(b)(3)(A) of the Act
The Exchange has asked the Commission to waive the 30-day operative delay so that the proposal may become operative immediately upon filing. Waiving the 30-day delay would permit the Exchange to more efficiently add Derivative Securities to the
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.
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.
Pursuant to Section 19(b)(1) of the Securities Exchange Act of 1934 (“Act”),
The Exchange proposes to amend the Rule 3400 Series concerning the Order Audit Trail System to make conforming and technical changes.
The text of the proposed rule change is available on the Exchange's website 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 aspects of such statements.
The Exchange is proposing to amend the Rule 3400 Series concerning the Order Audit Trail System to: (1) Renumber the Rule 3400 Series to conform it to the numbering convention used by the Nasdaq Stock Market LLC (“Nasdaq”) and FINRA; (2) amend Rule 7410A to expand two existing exemptions and to make technical changes to text under the rule; (3) incorporate by reference FINRA Rules 7430, 7440 and 7450 in Rules 7430A, 7440A and 7450A, respectively, and make conforming changes thereto; and (4) delete Rule 3407.
The Exchange's Rule 3400 Series imposes an obligation on Exchange members to record in electronic form and report to FINRA on a daily basis certain information with respect to orders originated, received, transmitted, modified, canceled, or executed by members in Nasdaq- and Exchange-listed stocks. FINRA's Order Audit Trail System (“OATS”) captures this order information and integrates it with quote and transaction information to create a time-sequenced record of orders, quotes, and transactions. This information is used by FINRA staff to conduct surveillance and investigations of
The Exchange adopted the Rule 3400 Series to copy Nasdaq and FINRA OATS rules, where appropriate. As a general principle, the Exchange endeavors to keep its rules that are corresponding to FINRA rules as closely worded and structured as possible to the FINRA rules on which they are based, including FINRA's OATS rules under the FINRA Rule 7000 Series. In certain instances, the Exchange has not copied a FINRA OATS rule because it is not relevant. For example, the Exchange has not copied FINRA Rule 7410(o)(2), which concerns an exception to the definition of a Reporting Member relating to members operating on equities floors, because the Exchange does not operate an equities floor. Generally, the Exchange also seeks to keep the Rule 3400 Series consistent with Nasdaq's Rule 7400A Series, the substance of which is identical to the related rules of the Exchange. The proposed changes will harmonize Exchange rules with analogous Nasdaq and FINRA rules, which have changed since the Exchange first adopted its rules.
The Exchange is proposing to renumber the Rule 3400 Series to a new Rule 7000A Series, which is identical to how Nasdaq presents its OATS rules. The Exchange does not currently have a Rule 7000A Series and the Exchange is proposing to follow the numbering convention used by FINRA and NASDAQ. As part of this change, the Exchange is also updating cross references in the Rule 7000A Series.
The Exchange is amending renumbered Rule 7410A to make several changes to conform it to the rules of Nasdaq. The Exchange is proposing to add new text noting that the terms under the rule have the same meaning as those defined in the Exchange's By-Laws and rules, unless otherwise noted, which is identical to Nasdaq's Rule 7410A(a). The Exchange is also amending Rule 7410A to make technical changes that harmonize the definitions of “Index Arbitrage Trade,” “Program Trade,” and “Proprietary Trading Firm” with the definitions of those terms in the Nasdaq rules.
The Exchange is also proposing to adopt the same limited exemption from OATS order data recordation requirements for Exchange members that are registered market makers in standardized options on any market. Renumbered Rule 7410A(j) defines the term “Order” as any oral, written, or electronic instruction to effect a transaction in an equity security listed on the Exchange or Nasdaq that is received by a member from another person for handling or execution, or that is originated by a department of a member for execution by the same or another member, other than any such instruction to effect a proprietary transaction originated by a trading desk in the ordinary course of a member's market making activities in an Exchange-listed equity security. The Exchange is proposing to adopt the limited exemption currently available under Nasdaq's analogous definition of “Order,”
The Exchange is proposing to amend Rule 7410A(n)(1) to harmonize the rule with FINRA Rule 7410(o)(1)(A) and Nasdaq Rule 7410A(o)(1)(A). Rule 7410A(n) provides the definition of “Reporting Member Organization,” which means a member organization that receives or originates an order and has an obligation to record and report information under renumbered Rules 7440A and 7450A. The Rule also provides an exception to the general definition if the member organization meets four conditions. The first condition in subparagraph (n)(1), which is the only condition at issue in this proposal, is that currently the member organization engages in a non-discretionary order routing process, pursuant to which it immediately routes, by electronic or other means, all of its orders to a single receiving Reporting Member Organization. On May 12, 2014, FINRA amended FINRA Rule 7410(o)(1)(A) to allow a member to satisfy this condition by permitting a member to alternatively route its orders to two receiving Reporting Members, if two related requirements were met.
The Exchange is proposing to incorporate by reference FINRA Rules 7430, 7440 and 7450 in Rules 7430A, 7440A and 7450A, respectively, and make conforming changes thereto.
With respect to Rule 7440A, the Exchange is proposing to copy Nasdaq Rule 7440A and incorporate by reference FINRA Rule 7440. Current Rule 3404 is meant to copy FINRA Rule 7440; however, FINRA amended FINRA Rule 7440 subsequent to the Exchange adopting Rule 3404 and the Exchange did not update its rule to reflect these changes. Specifically, FINRA amended Rules 7440(a)(2),
(ix),
Current Rule 3405 concerns order data transmission requirements and is meant to copy FINRA Rule 7450. Unlike Nasdaq, which incorporated by reference FINRA Rule 7450 into Nasdaq Rule 7450A, the Exchange instead adopted actual rule text that copied the requirements of FINRA Rule 7450 under Rule 3405. The Exchange is proposing to adopt the approach followed by Nasdaq by incorporating by reference the FINRA rule. Specifically, the Exchange is incorporating by reference FINRA Rule 7450 into Rule 7450A, amending existing paragraphs (a)-(d) to conform them to Nasdaq's Rule 7450A(a)-(d), and deleting paragraphs (e) and (f), which are no longer needed since the Exchange is incorporating by reference FINRA Rule 7450. The Exchange notes that FINRA amended FINRA Rule 7450 subsequent to the Exchange adopting Rule 3405; however, the Exchange did not update its rule to reflect these changes. Specifically, FINRA amended Rule 7450(b),
The Exchange is proposing to delete current Rule 3407, which will be renumbered Rule 7470A and held in reserve. Current Rule 3407 provided an exemption from the order recording and data transmission requirements of current Rules 3404 and 3405, which are OATS rules applicable to manual orders. To qualify for the exemption, a member must have met the following criteria: (1) The member and current control affiliates and associated persons of the member have not been subject within the last five years to any final disciplinary action, and within the last ten years to any disciplinary action involving fraud; (2) the member has annual revenues of less than $2 million; (3) the member does not conduct any market making activities in equity securities listed on the Exchange; (4) the member does not execute principal transactions with its customers (with a limited exception for principal transactions executed pursuant to error corrections); and (5) the member does not conduct clearing or carrying activities for other firms. The exemption was limited to a maximum time of two years although a member was able to request an additional exemption prior to the expiration of a grant of existing exemptive relief. The exemptive authority provided by the rule permitted the Exchange to grant relief to members that meet certain criteria in situations
The Exchange believes that its proposal is consistent with Section 6(b) of the Act,
The Exchange believes that adopting the new limited exception to the definition of “Order” is consistent with the Act because it provides a very narrow exemption from reporting transactions that are done to manage risk and facilitate options market making.
With respect to the proposed technical corrections to the rules, the Exchange believes that these changes are consistent with the Act because they will prevent investor confusion that may be caused by including in the Rules incorrect rule citations, defunct rule text and expired exemptions
The Exchange does not believe that the proposed rule change will impose any burden on competition not necessary or appropriate in furtherance of the purposes of the Act. The proposed rule change aligns the Exchange's rules with those of Nasdaq and FINRA, which will assist FINRA in its oversight work done pursuant to a regulatory services agreement. The proposed changes also provide uniform standards with which market participants must comply. Consequently, the Exchange does not believe that the proposed changes implicate competition at all.
No written comments were either solicited or 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 from the date on which it was filed, or such shorter time as the Commission may designate, it has become effective pursuant to Section 19(b)(3)(A)(iii) of the Act
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.
Securities and Exchange Commission (“Commission”).
Notice.
Notice of application for an order (“Order”) under sections 17(d) and 57(i) of the Investment Company Act of 1940 (the “Act”) and rule 17d-1 under the Act to permit certain joint transactions otherwise prohibited by sections 17(d) and 57(a)(4) of the Act and rule 17d-1 under the Act.
Applicants request an order to permit certain business development companies and certain closed-end management investment companies to co-invest in portfolio companies with each other and with affiliated investment funds and accounts. The Order would supersede the prior order.
Stellus Capital Investment Corporation (the “Company”); Stellus Credit Master Fund I, LLC, Stellus Credit VCOC Fund I, LLC, Stellus Credit Master Fund II, LLC, and Stellus Credit VCOC Fund II, LLC (collectively, “Existing Affiliated Funds”); Stellus Capital SBIC LP, Stellus Capital SBIC GP, LLC, SCIC-Consolidated Blocker, Inc., SCIC-CC Blocker 1, Inc., SCIC-ERC Blocker 1, Inc., SCIC-SKP Blocker 1, Inc., SCIC-APE Blocker 1, Inc., SCIC-HUF Blocker 1, Inc., and SCIC- Hollander Blocker 1, Inc. (collectively, “Existing Wholly-Owned Subsidiaries”); and Stellus Capital Management, LLC (“SCM” and collectively with the Company, the Existing Affiliated Funds and the Existing Wholly-Owned Subsidiaries, the “Applicants”).
The application was filed on December 19, 2017 and amended on September 17, 2018.
An order granting the requested relief will be issued unless the Commission orders a hearing. Interested persons may request a hearing by writing to the Commission's Secretary and serving applicants with a copy of the request, personally or by mail. Hearing requests should be received by the Commission by 5:30 p.m. on December 3, 2018, and should be accompanied by proof of service on applicants, in the form of an affidavit or, for lawyers, a certificate of service. Pursuant to rule 0-5 under the Act, hearing requests should state the nature of the writer's interest, any facts bearing upon the desirability of a hearing on the matter, the reason for the request, and the issues contested. Persons who wish to be notified of a hearing may request notification by writing to the Commission's Secretary.
Secretary, U.S. Securities and Exchange Commission, 100 F St. NE, Washington, DC 20549-1090. Applicants: 4400 Post Oak Parkway, Suite 2200, Houston, TX 77027.
Barbara T. Heussler, Senior Counsel, at (202) 551-6990, or Andrea Ottomanelli Magovern, Branch Chief, at (202) 551-6821 (Chief Counsel's Office, Division of Investment Management).
The following is a summary of the application. The complete application may be obtained via the Commission's website by searching for the file number, or for an applicant using the Company name box, at
1. The Applicants request an Order of the Commission under sections 17(d) and 57(i) of the Act and rule 17d-1 under the Act to permit, subject to the terms and conditions set forth in the application (the “Conditions”), a Regulated Fund
2. The Company is a closed-end management investment company incorporated in Maryland that has elected to be regulated as a BDC under the Act.
3. SCM, a Delaware limited liability company that is registered under the Advisers Act, serves as the investment adviser to the Company pursuant to an investment advisory agreement. SCM also serves as investment adviser to each Existing Affiliated Fund.
4. Applicants represent that each Existing Affiliated Fund is a separate and distinct legal entity and each would be an investment company but for section 3(c)(1), 3(c)(5)(C) or 3(c)(7) of the Act.
5. Applicants state that a Regulated Fund may, from time to time, form one or more Wholly-Owned Investment Subs.
6. Applicants state that SCM is presented with hundreds of investment opportunities each year on behalf of its clients and SCM determines how to allocate those opportunities in a manner that, over time, is fair and equitable to all of its clients. Such investment opportunities may be Potential Co-Investment Transactions.
7. Applicants represent that SCM has established processes for allocating initial investment opportunities, opportunities for subsequent investments in an issuer and dispositions of securities holdings reasonably designed to treat all clients fairly and equitably. Further, Applicants represent that these processes will be extended and modified in a manner reasonably designed to ensure that the additional transactions permitted under the Order will both (i) be fair and equitable to the Regulated Funds and the Affiliated Funds and (ii) comply with the Conditions.
8. If the requested Order is granted, the Adviser will establish, maintain and implement policies and procedures reasonably designed to ensure that when such opportunities arise, the Adviser to the relevant Regulated Funds is promptly notified and receives the same information about the opportunity as any other Adviser considering the opportunity for its clients. In particular, consistent with Condition 1, if a Potential Co-Investment Transaction falls within the then-current Objectives and Strategies
9. The Adviser to each applicable Regulated Fund will then make an independent determination of the appropriateness of the investment for the Regulated Fund in light of the Regulated Fund's then-current circumstances. If the Adviser to a Regulated Fund deems the Regulated Fund's participation in any Potential Co-Investment Transaction to be appropriate, it will formulate a recommendation regarding the proposed order amount for the Regulated Fund.
10. Applicants state that, for each Regulated Fund and Affiliated Fund whose Adviser recommends participating in a Potential Co-Investment Transaction, such Adviser's investment committee will approve an investment amount to be allocated to each Regulated Fund and/or Affiliated Fund participating in the Potential Co-Investment Transaction. Applicants state further that, each proposed order amount may be reviewed and adjusted, in accordance with the Adviser's written allocation policies and procedures, by the Adviser's investment committee.
11. Applicants acknowledge that some of the Affiliated Funds may not be funds advised by an Adviser because they are Stellus Proprietary Accounts. Applicants do not believe these Stellus Proprietary Accounts should raise issues under the Conditions because the allocation policies and procedures of the Advisers provide that investment opportunities are offered to client accounts before they are offered to Stellus Proprietary Accounts.
12. If the aggregate Internal Orders for a Potential Co-Investment Transaction do not exceed the size of the investment opportunity immediately prior to the submission of the orders to the underwriter, broker, dealer or issuer, as applicable (the “External Submission”), then each Internal Order will be fulfilled as placed and to the extent there is excess amount available to invest, a Stellus Proprietary Account shall be permitted to invest. If, on the other hand, the aggregate Internal Orders for a Potential Co-Investment Transaction exceed the size of the investment opportunity immediately prior to the External Submission, then the allocation of the opportunity will be made pro rata on the basis of the size of the Internal Orders and the Stellus Proprietary Accounts shall not be permitted to invest.
13. Applicants state that from time to time the Regulated Funds and Affiliated Funds may have opportunities to make Follow-On Investments
14. Applicants propose that Follow-On Investments would be divided into two categories depending on whether the prior investment was a Co-Investment Transaction or a Pre-Boarding Investment.
15. A Regulated Fund would be permitted to invest in Standard Review Follow-Ons either with the approval of the Required Majority under Condition 8(c) or without Board approval under Condition 8(b) if it is (i) a Pro Rata Follow-On Investment
16. Applicants propose that Dispositions
17. A Regulated Fund may participate in a Standard Review Disposition either with the approval of the Required Majority under Condition 6(d) or without Board approval under Condition 6(c) if (i) the Disposition is a Pro Rata Disposition
18. Applicants represent that under the terms and Conditions of the application, all Regulated Funds and Affiliated Funds participating in a Co-Investment Transaction will invest at the same time, for the same price and with the same terms, conditions, class, registration rights and any other rights, so that none of them receives terms more favorable than any other. However, the settlement date for an Affiliated Fund in a Co-Investment Transaction may occur up to ten business days after the settlement date for the Regulated Fund, and vice versa.
19. Under Condition 15, if an Adviser, its principals, or any person controlling, controlled by, or under common control with the Adviser or its principals, and the Affiliated Funds (collectively, the “Holders”) own in the aggregate more than 25 percent of the outstanding voting shares of a Regulated Fund (the “Shares”), then the Holders will vote such Shares as directed by an independent third party when voting on matters specified in the Condition. Applicants believe that this Condition will ensure that the Independent Directors will act independently in evaluating Co-Investment Transactions, because the ability of an Adviser or its principals to influence the Independent Directors by a suggestion, explicit or implied, that the Independent Directors can be removed will be limited significantly. The Independent Directors shall evaluate and approve any independent party, taking into account its qualifications, reputation for independence, cost to the shareholders, and other factors that they deem relevant.
1. Section 17(d) of the Act and rule 17d-1 under the Act prohibit participation by a registered investment company and an affiliated person in any “joint enterprise or other joint arrangement or profit-sharing plan,” as defined in the rule, without prior approval by the Commission by order upon application. Section 17(d) of the Act and rule 17d-1 under the Act are applicable to Regulated Funds that are registered closed-end investment companies.
2. Similarly, with regard to BDCs, section 57(a)(4) of the Act generally prohibits certain persons specified in section 57(b) from participating in joint transactions with the BDC or a company controlled by the BDC in contravention of rules as prescribed by the Commission. Section 57(i) of the Act provides that, until the Commission prescribes rules under section 57(a)(4), the Commission's rules under section 17(d) of the Act applicable to registered closed-end investment companies will be deemed to apply to transactions subject to section 57(a)(4). Because the Commission has not adopted any rules under section 57(a)(4), rule 17d-1 also applies to joint transactions with Regulated Funds that are BDCs.
3. Co-Investment Transactions are prohibited by either or both of rule 17d-1 and section 57(a)(4) without a prior exemptive order of the Commission to the extent that the Affiliated Funds and the Regulated Funds participating in such transactions fall within the category of persons described by rule 17d-1 and/or section 57(b), as applicable, vis-à-vis each participating Regulated Fund. Each of the participating Regulated Funds and Affiliated Funds may be deemed to be affiliated persons vis-à-vis a Regulated Fund within the meaning of section 2(a)(3) by reason of common control because (i) the Adviser manages each of the Affiliated Funds and may be deemed to control any Future Regulated Fund and any Future Affiliated Fund, and (ii) the Adviser manages the Company pursuant to its investment advisory agreement. Thus, each of the Affiliated Funds could be deemed to be a person related to the Company in a manner described by section 57(b) and related to Future Regulated Funds in a manner described by rule 17d-1; and therefore the prohibitions of rule 17d-1 and section 57(a)(4) would apply respectively to prohibit the Affiliated Funds from participating in Co-Investment Transactions with the Regulated Funds. In addition, because the Stellus Proprietary Accounts are controlled by SCM and, therefore, may be under common control with the Company, any future Advisers, and any Future Regulated Funds, the Stellus Proprietary Accounts could be deemed to be persons related to the Regulated Funds (or a company controlled by the Regulated Funds) in a manner described by section 57(b) and also prohibited
4. In passing upon applications under rule 17d-1, the Commission considers whether the company's participation in the joint transaction is consistent with the provisions, policies, and purposes of the Act and the extent to which such participation is on a basis different from or less advantageous than that of other participants.
5. Applicants state that in the absence of the requested relief, in many circumstances the Regulated Funds would be limited in their ability to participate in attractive and appropriate investment opportunities. Applicants state that, as required by rule 17d-1(b), the Conditions ensure that the terms on which Co-Investment Transactions may be made will be consistent with the participation of the Regulated Funds being on a basis that it is neither different from nor less advantageous than other participants, thus protecting the equity holders of any participant from being disadvantaged. Applicants further state that the Conditions ensure that all Co-Investment Transactions are reasonable and fair to the Regulated Funds and their shareholders and do not involve overreaching by any person concerned, including the Advisers. Applicants state that the Regulated Funds' participation in the Co-Investment Transactions in accordance with the Conditions will be consistent with the provisions, policies, and purposes of the Act and would be done in a manner that is not different from, or less advantageous than, that of other participants.
Applicants agree that the Order will be subject to the following Conditions:
1.
(a) The Advisers will establish, maintain and implement policies and procedures reasonably designed to ensure that each Adviser is promptly notified of all Potential Co-Investment Transactions that fall within the then-current Objectives and Strategies and Board-Established Criteria of any Regulated Fund the Adviser manages.
(b) When an Adviser to a Regulated Fund is notified of a Potential Co-Investment Transaction under Condition 1(a), the Adviser will make an independent determination of the appropriateness of the investment for the Regulated Fund in light of the Regulated Fund's then-current circumstances.
2.
(a) If the Adviser deems a Regulated Fund's participation in any Potential Co-Investment Transaction to be appropriate for the Regulated Fund, it will then determine an appropriate level of investment for the Regulated Fund.
(b) If the aggregate amount recommended by the Advisers to be invested in the Potential Co-Investment Transaction by the participating Regulated Funds and any participating Affiliated Funds, collectively, exceeds the amount of the investment opportunity, the investment opportunity will be allocated among them pro rata based on the size of the Internal Orders, as described in section III.A.1.b. of the application. Each Adviser to a participating Regulated Fund will promptly notify and provide the Eligible Directors with information concerning the Affiliated Funds' and Regulated Funds' order sizes to assist the Eligible Directors with their review of the applicable Regulated Fund's investments for compliance with these Conditions.
(c) After making the determinations required in Condition 1(b) above, each Adviser to a participating Regulated Fund will distribute written information concerning the Potential Co-Investment Transaction (including the amount proposed to be invested by each participating Regulated Fund and each participating Affiliated Fund) to the Eligible Directors of its participating Regulated Fund(s) for their consideration. A Regulated Fund will enter into a Co-Investment Transaction with one or more other Regulated Funds or Affiliated Funds only if, prior to the Regulated Fund's participation in the Potential Co-Investment Transaction, a Required Majority concludes that:
(i) The terms of the transaction, including the consideration to be paid, are reasonable and fair to the Regulated Fund and its equity holders and do not involve overreaching in respect of the Regulated Fund or its equity holders on the part of any person concerned;
(ii) the transaction is consistent with:
(A) The interests of the Regulated Fund's equity holders; and
(B) the Regulated Fund's then-current Objectives and Strategies;
(iii) the investment by any other Regulated Fund(s) or Affiliated Fund(s) would not disadvantage the Regulated Fund, and participation by the Regulated Fund would not be on a basis different from, or less advantageous than, that of any other Regulated Fund(s) or Affiliated Fund(s) participating in the transaction; provided that the Required Majority shall not be prohibited from reaching the conclusions required by this Condition 2(c)(iii) if:
(A) The settlement date for another Regulated Fund or an Affiliated Fund in a Co-Investment Transaction is later than the settlement date for the Regulated Fund by no more than ten business days or earlier than the settlement date for the Regulated Fund by no more than ten business days, in either case, so long as: (x) The date on which the commitment of the Affiliated Funds and Regulated Funds is made is the same; and (y) the earliest settlement date and the latest settlement date of any Affiliated Fund or Regulated Fund participating in the transaction will occur within ten business days of each other; or
(B) any other Regulated Fund or Affiliated Fund, but not the Regulated Fund itself, gains the right to nominate a director for election to a portfolio company's board of directors, the right to have a board observer or any similar right to participate in the governance or management of the portfolio company so long as: (x) The Eligible Directors will have the right to ratify the selection of such director or board observer, if any; (y) the Adviser agrees to, and does, provide periodic reports to the Regulated Fund's Board with respect to the actions of such director or the information received by such board observer or obtained through the exercise of any similar right to participate in the governance or management of the portfolio company; and (z) any fees or other compensation that any other Regulated Fund or Affiliated Fund or any affiliated person of any other Regulated Fund or Affiliated Fund receives in connection with the right of one or more Regulated Funds or Affiliated Funds to nominate a director or appoint a board observer or otherwise to participate in the governance or management of the portfolio company will be shared proportionately among any participating Affiliated Funds (who may, in turn, share their portion with their affiliated persons) and any participating Regulated Fund(s) in accordance with the amount of each such party's investment; and
(iv) the proposed investment by the Regulated Fund will not involve compensation, remuneration or a direct or indirect
3.
4.
5.
6.
(a)
(i) The Adviser to such Regulated Fund or Affiliated Fund
(ii) the Adviser to each Regulated Fund that holds an investment in the issuer will formulate a recommendation as to participation by such Regulated Fund in the Disposition.
(b)
(c)
(i)(A) The participation of each Regulated Fund and Affiliated Fund in such Disposition is proportionate to its then-current holding of the security (or securities) of the issuer that is (or are) the subject of the Disposition;
(ii) each security is a Tradable Security and (A) the Disposition is not to the issuer or any affiliated person of the issuer; and (B) the security is sold for cash in a transaction in which the only term negotiated by or on behalf of the participating Regulated Funds and Affiliated Funds is price.
(d)
7.
(a)
(i) The Adviser to such Regulated Fund or Affiliated Fund will notify each Regulated Fund that holds an investment in the issuer of the proposed Disposition at the earliest practical time;
(ii) the Adviser to each Regulated Fund that holds an investment in the issuer will formulate a recommendation as to participation by such Regulated Fund in the Disposition; and
(iii) the Advisers will provide to the Board of each Regulated Fund that holds an investment in the issuer all information relating to the existing investments in the issuer of the Regulated Funds and Affiliated Funds, including the terms of such investments and how they were made, that is necessary for the Required Majority to make the findings required by this Condition.
(b)
(i) The Disposition complies with Condition 2(c)(i), (ii), (iii)(A), and (iv); and
(ii) the making and holding of the Pre-Boarding Investments were not prohibited by section 57 or rule 17d-1, as applicable, and records the basis for the finding in the Board minutes.
(c)
(i)
(ii)
(iii)
(iv)
(v)
8.
(a)
(i) The Adviser to each such Regulated Fund or Affiliated Fund will notify each Regulated Fund that holds securities of the portfolio company of the proposed transaction at the earliest practical time; and
(ii) the Adviser to each Regulated Fund that holds an investment in the issuer will formulate a recommendation as to the proposed participation, including the amount of the proposed investment, by such Regulated Fund.
(b)
(i)(A) The proposed participation of each Regulated Fund and each Affiliated Fund in such investment is proportionate to its outstanding investments in the issuer or the security at issue, as appropriate,
(ii) it is a Non-Negotiated Follow-On Investment.
(c)
(d)
(i) The amount of the opportunity proposed to be made available to any Regulated Fund is not based on the Regulated Funds' and the Affiliated Funds' outstanding investments in the issuer or the security at issue, as appropriate, immediately preceding the Follow-On Investment; and
(ii) the aggregate amount recommended by the Advisers to be invested in the Follow-On Investment by the participating Regulated Funds and any participating Affiliated Funds, collectively, exceeds the amount of the investment opportunity, then the Follow-On Investment opportunity will be allocated among them
(e)
9.
(a)
(i) The Adviser to each such Regulated Fund or Affiliated Fund will notify each Regulated Fund that holds securities of the portfolio company of the proposed transaction at the earliest practical time;
(ii) the Adviser to each Regulated Fund that holds an investment in the issuer will formulate a recommendation as to the proposed participation, including the amount of the proposed investment, by such Regulated Fund; and
(iii) the Advisers will provide to the Board of each Regulated Fund that holds an investment in the issuer all information relating to the existing investments in the issuer of the Regulated Funds and Affiliated Funds, including the terms of such investments and how they were made, that is necessary for the Required Majority to make the findings required by this Condition.
(b)
(c)
(i)
(ii)
(iii)
(iv)
(d)
(i) The amount of the opportunity proposed to be made available to any Regulated Fund is not based on the Regulated Funds' and the Affiliated Funds' outstanding investments in the issuer or the security at issue, as appropriate, immediately preceding the Follow-On Investment; and
(ii) the aggregate amount recommended by the Advisers to be invested in the Follow-On Investment by the participating Regulated Funds and any participating Affiliated Funds, collectively, exceeds the amount of the investment opportunity,
(e)
10.
(a) Each Adviser to a Regulated Fund will present to the Board of each Regulated Fund, on a quarterly basis, and at such other times as the Board may request, (i) a record of all investments in Potential Co-Investment Transactions made by any of the other Regulated Funds or any of the Affiliated Funds during the preceding quarter that fell within the Regulated Fund's then-current Objectives and Strategies and Board-Established Criteria that were not made available to the Regulated Fund, and an explanation of why such investment opportunities were not made available to the Regulated Fund; (ii) a record of all Follow-On Investments in and Dispositions of investments in any issuer in which the Regulated Fund holds any investments by any Affiliated Fund or other Regulated Fund during the prior quarter; and (iii) all information concerning Potential Co-Investment Transactions and Co-Investment Transactions, including investments made by other Regulated Funds or Affiliated Funds that the Regulated Fund considered but declined to participate in, so that the Independent Directors, may determine whether all Potential Co-Investment Transactions and Co-Investment Transactions during the preceding quarter, including those investments that the Regulated Fund considered but declined to participate in, comply with the Conditions.
(b) All information presented to the Regulated Fund's Board pursuant to this Condition will be kept for the life of the Regulated Fund and at least two years thereafter, and will be subject to examination by the Commission and its staff.
(c) Each Regulated Fund's chief compliance officer, as defined in rule 38a-1(a)(4), will prepare an annual report for its Board each year that evaluates (and documents the basis of that evaluation) the Regulated Fund's compliance with the terms and Conditions of the application and the procedures established to achieve such compliance.
(d) The Independent Directors will consider at least annually whether continued participation in new and existing Co-Investment Transactions is in the Regulated Fund's best interests.
11.
12.
13.
14.
15.
16.
For the Commission, by the Division of Investment Management, under delegated authority.
The TVA Board of Directors will hold a public meeting on November 14, 2018, in the Bancorp South Conference Center, 387 East Main Street, Tupelo, Mississippi. The meeting will be called to order at 9:30 a.m. CT to consider the agenda items listed below. TVA management will answer questions from the news media following the Board meeting.
On November 13, the public may comment on any agenda item or subject at a board-hosted
Status: Open.
For more information: Please call TVA Media Relations at (865) 632-6000, Knoxville, Tennessee. People who plan to attend the meeting and have special needs should call (865) 632-6000. Anyone who wishes to comment on any of the agenda in writing may send their comments to: TVA Board of Directors, Board Agenda Comments, 400 West Summit Hill Drive, Knoxville, Tennessee 37902.
Office of the Comptroller of the Currency (OCC), Treasury.
Notice and request for comment.
The OCC, 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 a continuing information collection as required by the Paperwork Reduction Act of 1995 (PRA).
In accordance with the requirements of the PRA, the OCC may not conduct or sponsor, and respondents are not required to respond to, an information collection unless it displays a currently valid Office of Management and Budget (OMB) control number.
The OCC is soliciting comment concerning the renewal of its information collection titled “Leveraged Lending.”
Comments must be received by January 14, 2019.
Commenters are encouraged to submit comments by email, if possible. You may submit comments by any of the following methods:
•
•
•
You may review comments and other related materials that pertain to this information collection beginning on the date of publication of the second notice for this collection
•
• For assistance in navigating
•
Shaquita Merritt, Clearance Officer, (202) 649-5490 or, for persons who are deaf or hearing impaired, TTY, (202) 649-5597, Chief Counsel's Office, Office of the Comptroller of the Currency, 400 7th Street SW, Washington, DC 20219.
Under the PRA (44 U.S.C. 3501-3520), federal agencies must obtain approval from OMB for each collection of information they conduct or sponsor. “Collection of information” is defined in 44 U.S.C. 3502(3) and 5 CFR 1320.3(c) to include Agency recommendations, 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 title 44 (44 U.S.C. 3506(c)(2)(A)) requires federal agencies to provide a 60-day notice in the
The final guidance recommends that financial institutions consider developing: (i) Underwriting policies for leveraged lending, including stress-testing procedures for leveraged credits; (ii) risk management policies, including stress-testing procedures for pipeline exposures; and, (iii) policies and procedures for incorporating the results of leveraged credit and pipeline stress tests into the firm's overall stress-testing framework. While not requirements, these recommended policies qualify as “collections of information” as defined in the PRA.
Respondents are financial institutions with leveraged lending activities as defined in the guidance that may develop policies recommended in the guidance.
Comments submitted in response to this notice will be summarized, included in the request for OMB approval, and become a matter of public record. Comments are invited on:
(a) Whether the information collections are necessary for the proper performance of the OCC's functions, including whether the information has practical utility;
(b) The accuracy of the OCC's estimates of the burden of the information collections, including the validity of the methodology and assumptions used;
(c) Ways to enhance the quality, utility, and clarity of the information to be collected;
(d) Ways to minimize the burden of information collections on respondents, including through the use of automated collection techniques or other forms of information technology; and
(e) Estimates of capital or startup costs and costs of operation, maintenance, and purchase of services to provide information.
Office of the Comptroller of the Currency (OCC), Treasury.
Notice and request for comment.
The OCC, 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 a continuing information collection as required by the Paperwork Reduction Act of 1995 (PRA).
An agency may not conduct or sponsor, and a respondent is not required to respond to, an information collection unless it displays a currently valid OMB control number.
The OCC is soliciting comment concerning the renewal of its information collection titled, “Fiduciary Activities.”
You should submit written comments by January 14, 2019.
Commenters are encouraged to submit comments by email, if possible. You may submit comments by any of the following methods:
•
•
•
•
You may review comments and other related materials that pertain to this information collection beginning on the date of publication of the second notice
•
• For assistance in navigating
•
Shaquita Merritt, Clearance Officer, (202) 649-5490 or, for persons who are deaf or hard of hearing, TTY, (202) 649-5597, Chief Counsel's Office, Office of the Comptroller of the Currency, 400 7th Street SW, Washington, DC 20219.
Under the PRA (44 U.S.C. 3501-3520), federal agencies must obtain approval from OMB for each collection of information they conduct or sponsor. “Collection of information” is defined in 44 U.S.C. 3502(3) and 5 CFR 1320.3(c) to include agency requests and requirements that members of the public submit reports, keep records, or provide information to a third party. Section 3506(c)(2)(A) of part 44 (44 U.S.C. 3506(c)(2)(A)) requires federal agencies to provide a 60-day notice in the
Twelve CFR 9.8 and 150.410-150.430 require that national banks and FSAs document the establishment and termination of each fiduciary account and maintain adequate records. Records must be retained for a period of three years from the later of the termination of the account or the termination of any litigation. The records must be separate and distinct from other records of the institution.
Twelve CFR 9.9 and 12 CFR 150.480 require national banks and FSAs to note the results of any audit conducted (including significant actions taken as a result of the audit) in the minutes of the board of directors. National banks and FSAs that adopt a continuous audit system must note the results of all discrete audits performed since the last audit report (including significant actions taken as a result of the audits) in the minutes of the board of directors at least once during each calendar year.
Twelve CFR 9.17(a) and 150.530 require that a national bank or FSA seeking to surrender its fiduciary powers file with the OCC a certified copy of the resolution of its board of directors evidencing that intent.
Twelve CFR 9.18(b)(1) (and 12 CFR 150.260 by cross-reference) require national banks and FSAs to establish and maintain each CIF in accordance with a written plan approved by the board of directors or a committee authorized by the board. The plan must include provisions relating to:
• Investment powers and policies with respect to the fund;
• Allocation of income, profits, and losses;
• Fees and expenses that will be charged to the fund and to participating accounts;
• Terms and conditions regarding admission and withdrawal of participating accounts;
• Audits of participating accounts;
• Basis and method of valuing assets in the fund;
• Expected frequency for income distribution to participating accounts;
• Minimum frequency for valuation of fund assets;
• Amount of time following a valuation date during which the valuation must be made;
• Bases upon which the institution may terminate the fund; and
• Any other matters necessary to define clearly the rights of participating accounts.
Twelve CFR 9.18(b)(1) (and 150.260 by cross-reference) require that a national bank or FSA make a copy of any CIF plan available for public inspection at its main office and provide a copy of the plan to any person who requests it.
Twelve CFR 9.18(b)(4)(iii)(E) (and 150.260 by cross-reference) require that national banks and FSAs adopt portfolio and issuer qualitative standards and concentration restrictions for short-term investment funds (STIFs), a type of CIF.
Twelve CFR 9.18(b)(4)(iii)(F) (and 150.260 by cross-reference) require that national banks and FSAs adopt liquidity standards and include provisions that address contingency funding needs for STIFs.
Twelve CFR 9.18(b)(4)(iii)(G) (and 150.260 by cross-reference) require that national banks and FSAs adopt shadow pricing procedures for STIFs that calculate the extent of difference, if any, of the mark-to-market net asset value per participating interest from the STIF's amortized cost per participating interest, and to take certain actions if that difference exceeds $0.005 per participating interest.
Twelve CFR 9.18(b)(4)(iii)(H) (and 150.260 by cross-reference) require that national banks and FSAs adopt, for STIFs, procedures for stress testing the STIF's ability to maintain a stable net asset value per participating interest and provide for reporting the results.
Twelve CFR 9.18(b)(4)(iii)(I) (and 150.260 by cross-reference) require that national banks and FSAs adopt, for STIFs, procedures that require a national bank or FSA to disclose to the OCC and to STIF participants within five business days after each calendar month-end the following information about the fund: Total assets under
Twelve CFR 9.18(b)(4)(iii)(J) (and 150.260 by cross-reference) require that national banks and FSAs adopt, for STIFs, procedures that require a national bank or FSA that manages a STIF to notify the OCC prior to or within one business day thereafter of certain events.
Twelve CFR 9.18(b)(4)(iii)(K) (and 150.260 by cross-reference) require that national banks and FSAs adopt, for STIFs, certain procedures in the event that the STIF has repriced its net asset value below $0.995 per participating interest.
Twelve CFR 9.18(b)(4)(iii)(L) (and 150.260 by cross-reference) require that national banks and FSAs adopt, for STIFs, procedures for initiating liquidation of a STIF upon the suspension or limitation of withdrawals as a result of redemptions.
Twelve CFR 9.18(b)(6)(ii) (and 150.260 by cross-reference) require, for CIFs, that national banks and FSAs, at least once during each 12-month period, prepare a financial report of the fund based on the audit required by 12 CFR 9.18(b)(6)(i). The report must disclose the fund's fees and expenses in a manner consistent with applicable state law in the state in which the national bank or FSA maintains the fund and must contain:
• A list of investments in the fund showing the cost and current market value of each investment;
• A statement covering the period after the previous report showing the following (organized by type of investment):
○ A summary of purchases (with costs);
○ A summary of sales (with profit or loss and any investment change);
○ Income and disbursements; and
○ An appropriate notation of any investments in default.
Twelve CFR 9.18(b)(6)(iv) (and 150.260 by cross-reference) require that a national bank or FSA managing a CIF provide a copy of the financial report, or provide notice that a copy of the report is available upon request without charge, to each person who ordinarily would receive a regular periodic accounting with respect to each participating account. The national bank or FSA may provide a copy to prospective customers. In addition, the national bank or FSA must provide a copy of the report upon request to any person for a reasonable charge.
Twelve CFR 9.18(c)(5) (and 150.260 by cross-reference) require that, for special exemption CIFs, national banks and FSAs must submit to the OCC a written plan that sets forth:
• The reason the proposed fund requires a special exemption;
• The provisions of the fund that are inconsistent with 12 CFR 9.18(a) and (b);
• The provisions of 12 CFR 9.18(b) for which the national bank or FSA seeks an exemption; and
• The manner in which the proposed fund addresses the rights and interests of participating accounts.
Comments submitted in response to this notice will be summarized, included in the request for OMB approval, and become a matter of public record. Comments are invited on:
(a) Whether the collection of information is necessary for the proper performance of the functions of the OCC, including whether the information has practical utility;
(b) The accuracy of the OCC's estimate of the burden of the collection of information;
(c) Ways to enhance the quality, utility, and clarity of the information to be collected;
(d) Ways to minimize the burden of the collection on respondents, including through the use of automated collection techniques or other forms of information technology; and
(e) Estimates of capital or start-up costs and costs of operation, maintenance, and purchase of services to provide information.
Office of the Comptroller of the Currency (OCC), Treasury.
Notice and request for comment.
The OCC, 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 a continuing information collection as required by the Paperwork Reduction Act of 1995 (PRA).
An agency may not conduct or sponsor, and a respondent is not required to respond to, an information collection unless it displays a currently valid OMB control number.
The OCC is soliciting comment concerning the renewal of its information collection titled, “Identity Theft Red Flags and Address Discrepancies under the Fair and Accurate Credit Transactions Act of 2003.”
Comments must be received by January 14, 2019.
Commenters are encouraged to submit comments by email, if possible. You may submit comments by any of the following methods:
•
•
•
•
You may review comments and other related materials that pertain to this information collection beginning on the date of publication of the second notice for this collection
•
• For assistance in navigating
•
Shaquita Merritt, Clearance Officer, (202) 649-5490 or, for persons who are deaf or hearing impaired, TTY, (202) 649-5597, Chief Counsel's Office, Office of the Comptroller of the Currency, 400 7th Street SW, Washington, DC 20219.
Under the PRA (44 U.S.C. 3501-3520), federal agencies must obtain approval from OMB for each collection of information they conduct or sponsor. “Collection of information” is defined in 44 U.S.C. 3502(3) and 5 CFR 1320.3(c) to include agency requests and requirements that members of the public submit reports, keep records, or provide information to a third party. Section 3506(c)(2)(A) of part 44 (44 U.S.C. 3506(c)(2)(A)) requires federal agencies to provide a 60-day notice in the
• Guidelines for financial institutions and creditors regarding identity theft with respect to their account holders and customers; (in developing the guidelines, the Agencies are required to identify patterns, practices, and specific forms of activity that indicate the possible existence of identity theft; the guidelines must be updated as often as necessary and must be consistent with the policies and procedures required under section 326 of the USA PATRIOT Act, (31 U.S.C. 5318(l));
• Regulations that require each financial institution and each creditor to establish reasonable policies and procedures for implementing the guidelines in order to identify possible risks to account holders or customers or to the safety and soundness of the institution or creditor; and
• Regulations generally requiring credit and debit card issuers to assess the validity of change of address requests under certain circumstances.
Section 315 of the FACT Act also amended section 605 of FCRA to require the Agencies to issue regulations providing guidance regarding what reasonable policies and procedures a user of consumer reports must have in place and employ when a user receives a notice of address discrepancy from a consumer reporting agency (CRA). These regulations are required to describe reasonable policies and procedures for users of consumer reports to:
• Enable a user to form a reasonable belief that it knows the identity of the person for whom it has obtained a consumer report; and
• Reconcile the address of the consumer with the CRA, if the user establishes a continuing relationship with the consumer and regularly and, in the ordinary course of business, furnishes information to the CRA.
As required by section 114 of the FACT Act, appendix J to 12 CFR part 41 contains guidelines for financial institutions and creditors to use in identifying patterns, practices, and specific forms of activity that may indicate the existence of identity theft. In addition, 12 CFR 41.90 requires each financial institution or creditor that is a national bank, federal savings association, federal branch or agency of a foreign bank, and any of their operating subsidiaries that are not functionally regulated, to establish an Identity Theft Prevention Program (Program) designed to detect, prevent, and mitigate identity theft in connection with accounts. Pursuant to § 41.91, credit card and debit card issuers must implement reasonable policies and procedures to assess the validity of a request for a change of address under certain circumstances.
Section 41.90 requires each OCC-regulated financial institution or creditor that offers or maintains one or more covered accounts to develop and implement a Program. In developing a Program, financial institutions and creditors are required to consider the guidelines in appendix J and include the suggested provisions, as appropriate. The initial Program must be approved by the institution's board of directors or by an appropriate committee thereof. The board, an appropriate committee thereof, or a designated employee at the level of senior management must be involved in the oversight of the Program. In addition, staff members must be trained to carry out the Program. Pursuant to § 41.91, each credit and debit card issuer is required to establish and implement policies and procedures to assess the validity of a change of address request if it is followed by a request for an additional or replacement card. Before issuing the additional or replacement card, the card issuer must notify the cardholder of the request and provide the cardholder a reasonable means to report incorrect address changes or use another means to assess the validity of the change of address.
As required by section 315 of the FACT Act, § 1022.82
Section 1022.82 requires each user of consumer reports to develop and implement reasonable policies and procedures designed to enable the user to form a reasonable belief that a consumer report relates to the consumer about whom it requested the report when it receives a notice of address discrepancy from a CRA. A user of consumer reports also must develop and implement reasonable policies and procedures for furnishing a customer address that the user has reasonably confirmed to be accurate to the CRA from which it receives a notice of address discrepancy when the user can: (1) Form a reasonable belief that the consumer report relates to the consumer about whom the user has requested the report; (2) establish a continuing relationship with the consumer; and (3) establish that it regularly and in the ordinary course of business furnishes information to the CRA from which it received the notice of address discrepancy.
Comments submitted in response to this notice will be summarized, included in the request for OMB approval, and become a matter of public record. Comments are invited on:
(a) Whether the collection of information is necessary for the proper performance of the functions of the OCC, including whether the information has practical utility;
(b) The accuracy of the OCC's estimate of the burden of the collection of information;
(c) Ways to enhance the quality, utility, and clarity of the information to be collected;
(d) Ways to minimize the burden of the collection on respondents, including through the use of automated collection techniques or other forms of information technology; and
(e) Estimates of capital or start-up costs and costs of operation, maintenance, and purchase of services to provide information.
Internal Revenue Service (IRS), Treasury.
Notice and request for comments.
The Internal Revenue Service (IRS), 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 information collections, as required by the Paperwork Reduction Act of 1995. The IRS is soliciting comments concerning Recapture of Investment Credit.
Written comments should be received on or before January 14, 2019 to be assured of consideration.
Direct all written comments to Laurie Brimmer, Internal Revenue Service, Room 6526, 1111 Constitution Avenue NW, Washington, DC 20224.
Requests for additional information or copies of the form and instructions should be directed to Martha R. Brinson, at (202) 317-5753, or at Internal Revenue Service, Room 6526, 1111 Constitution Avenue NW, Washington, DC 20224, or through the internet at
The following paragraph applies to all of the collections of information covered by this notice:
An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless the collection of information displays a valid OMB control number. Books or records relating to a collection of information must be retained as long as their contents may become material in the administration of any internal revenue law. Generally, tax returns and tax return information are confidential, as required by 26 U.S.C. 6103.
Centers for Medicare & Medicaid Services (CMS), HHS.
Final rule with comment period.
This final rule with comment period updates the home health prospective payment system (HH PPS) payment rates, including the national, standardized 60-day episode payment rates, the national per-visit rates, and the non-routine medical supply (NRS) conversion factor, effective for home health episodes of care ending on or after January 1, 2019. This rule also: Updates the HH PPS case-mix weights for calendar year (CY) 2019 using the most current, complete data available at the time of rulemaking; discusses our efforts to monitor the potential impacts of the rebasing adjustments that were implemented in CYs 2014 through 2017; finalizes a rebasing of the HH market basket (which includes a decrease in the labor-related share); finalizes the methodology used to determine rural add-on payments for CYs 2019 through 2022, as required by section 50208 of the Bipartisan Budget Act of 2018 (Pub. L. 115-123) hereinafter referred to as the “BBA of 2018”; finalizes regulations text changes regarding certifying and recertifying patient eligibility for Medicare home health services; and finalizes the definition of “remote patient monitoring” and the recognition of the costs associated with it as allowable administrative costs.
This rule also summarizes the case-mix methodology refinements for home health services beginning on or after January 1, 2020, which includes the elimination of therapy thresholds for payment and a change in the unit of payment from a 60-day episode to a 30-day period, as mandated by section 51001 of the Bipartisan Budget Act of 2018. This rule also finalizes changes to the Home Health Value-Based Purchasing (HHVBP) Model. In addition, with respect to the Home Health Quality Reporting Program, this rule discusses the Meaningful Measures Initiative; finalizes the removal of seven measures to further the priorities of this initiative; discusses social risk factors and provides an update on implementation efforts for certain provisions of the IMPACT Act; and finalizes a regulatory text change regarding OASIS data.
For the home infusion therapy benefit, this rule finalizes health and safety standards that home infusion therapy suppliers must meet; finalizes an approval and oversight process for accrediting organizations (AOs) that accredit home infusion therapy suppliers; finalizes the implementation of temporary transitional payments for home infusion therapy services for CYs 2019 and 2020; and responds to the comments received regarding payment for home infusion therapy services for CY 2021 and subsequent years.
Lastly, in this rule, we are finalizing only one of the two new requirements we proposed to implement in the regulations for the oversight of AOs that accredit Medicare-certified providers and suppliers. More specifically, for reasons set out more fully in the section X. of this final rule with comment period, we have decided not to finalize our proposal to require that all surveyors for AOs that accredit Medicare-certified providers and suppliers take the same relevant and program-specific CMS online surveyor training that the State Agency surveyors are required to take.
However, we are finalizing our proposal to require that each AO must provide a written statement with their application to CMS, stating that if one of its fully accredited providers or suppliers, in good-standing, provides written notification that they wish to voluntarily withdraw from the AO's CMS-approved accreditation program, the AO must continue the provider or supplier's current accreditation until the effective date of withdrawal identified by the facility or the expiration date of the term of accreditation, whichever comes first.
In commenting, please refer to file code CMS-1689-FC. Because of staff and resource limitations, we cannot accept comments by facsimile (FAX) transmission.
Comments, including mass comment submissions, must be submitted in one of the following three ways (please choose only one of the ways listed):
1.
2.
Please allow sufficient time for mailed comments to be received before the close of the comment period.
3.
For information on viewing public comments, see the beginning of the
For general information about the Home Health Prospective Payment System (HH PPS), send your inquiry via email to:
For general information about home infusion payment, send your inquiry via email to:
For information about the Home Health Value-Based Purchasing (HHVBP) Model, send your inquiry via email to:
For information about the Home Health Quality Reporting Program (HH QRP) contact: Joan Proctor, (410) 786-0949.
For information about home infusion therapy health and safety standards, contact: CAPT Jacqueline Leach, (410) 786-4282 or Sonia Swancy, (410) 786-8445.
For information about health infusion therapy accreditation and oversight, contact: Caroline Gallaher (410) 786-8705.
This final rule with comment period updates the payment rates for home health agencies (HHAs) for calendar year (CY) 2019, as required under section 1895(b) of the Social Security Act (the Act). This rule also updates the case-mix weights under sections 1895(b)(4)(A)(i) and (b)(4)(B) of the Act for CY 2019. For home health services beginning on or after January 1, 2020, this rule finalizes case-mix methodology refinements, which eliminate the use of therapy thresholds for case-mix adjustment purposes; and changes the unit of payment from a 60-day episode of care to a 30-day period of care, as mandated by section 51001 of the Bipartisan Budget Act of 2018 (hereinafter referred to as the “BBA of 2018”). This final rule with comment period also: Finalizes the methodology used to determine rural add-on payments for CYs 2019 through 2022, as required by section 50208 of the BBA of 2018; finalizes regulations text changes regarding certifying and recertifying patient eligibility for Medicare home health services under sections 1814(a) and 1835(a) of the Act; and finalizes our proposal on how to define “remote patient monitoring” under the Medicare home health benefit and include the costs of such monitoring as an allowable administrative costs. Lastly, this rule finalizes changes to the Home Health Value Based Purchasing (HHVBP) Model under the authority of section 1115A of the Act, and the Home Health Quality Reporting Program (HH QRP) requirements under the authority of section 1895(b)(3)(B)(v) of the Act.
This final rule with comment period establishes a transitional payment for home infusion therapy services for CYs 2019 and 2020, as required by section 50401 of the BBA of 2018. In addition, this rule finalizes health and safety standards for home infusion therapy and an accreditation and oversight process for qualified home infusion therapy suppliers.
This final rule with comment period implements health and safety standards for qualified home infusion therapy suppliers as required by section 5012 of the 21st Century Cures Act. These standards provide a foundation for ensuring patient safety and quality care by establishing requirements for the plan of care to be initiated and updated by a physician; 7-day-a-week, 24-hour-a-day access to services and remote monitoring; and patient education and training regarding their home infusion therapy care.
This final rule with comment period also implements regulations for the approval and oversight of AOs that accredit home infusion therapy suppliers.
In the CY 2015 HH PPS final rule (79 FR 66072), we finalized our proposal to recalibrate the case-mix weights every year with the most current and complete data available at the time of rulemaking. In section III.B. of this rule, we are recalibrating the HH PPS case-mix weights, using the most current cost and utilization data available, in a budget-neutral manner. In section III.C. of this rule, we are finalizing the rebasing of the home health market basket and updates to the payment rates under the HH PPS by the home health payment update percentage of 2.2 percent (using the 2016-based Home Health Agency (HHA) market basket update of 3.0 percent, minus 0.8 percentage point for multifactor productivity) as required by section 1895(b)(3)(B)(vi)(I) of the Act. Also in section III.C. of this final rule with comment period, we are finalizing a reduction in the labor-related share from 78.5 to 76.1 percent of total costs on account of the rebasing of the home health market basket. Lastly, in section III.C. of this rule, we update the CY 2019 home health wage index using FY 2015 hospital cost report data. In section III.D. of this final rule with comment period, we are finalizing a methodology for applying rural add-on payments for CYs 2019 through 2022, as required by section 50208 of the BBA of 2018. In section III.E. of this rule, we are finalizing a reduction to the fixed-dollar loss ratio from 0.55 to 0.51 for CY 2019 in order to increase outlier payments as a percentage of total payments so that this percentage is closer to, but no more than, 2.5 percent.
In section III.F. of this rule, we are finalizing case-mix methodology refinements and a change in the unit of payment from a 60-day episode of care to a 30-day period of care effective January 1, 2020 and in a budget neutral manner, as required by section 51001 of the BBA of 2018. The “Patient-Driven Groupings Model”, or PDGM, relies more heavily on clinical characteristics and other patient information to place patients into meaningful payment categories and eliminates the use of therapy service thresholds, as required by section 51001(a)(3) of the BBA of 2018, that are currently used to case-mix adjust payments under the HH PPS.
In section III.G. of this rule, we are finalizing regulation text changes at 42 CFR 424.22(b)(2) to eliminate the requirement that the certifying physician must estimate how much longer skilled services will be needed as part of the recertification statement. In addition, in section III.G of this rule, consistent with section 51002 of the BBA of 2018, we are finalizing a proposal to align the regulations text at § 424.22(c) with current subregulatory guidance to allow medical record documentation from the HHA to be used to support the basis for certification and/or recertification of home health eligibility, if certain requirements are met.
In section III.H. of this rule, we are finalizing our proposal to define “remote patient monitoring” under the Medicare home health benefit and changes to the regulations at § 409.46 to include costs of remote patient monitoring as allowable administrative costs.
In section IV. of this final rule with comment period, we are finalizing changes to the Home Health Value Based Purchasing (HHVBP) Model implemented January 1, 2016. Specifically, we are finalizing, beginning with performance year (PY) 4, the following policy changes: removal of two Outcome and Assessment Information Set (OASIS) based measures, Influenza Immunization Received for Current Flu Season and Pneumococcal Polysaccharide Vaccine Ever Received, from the set of applicable measures; replacement of three OASIS-based measures (Improvement in Ambulation-Locomotion, Improvement in Bed Transferring, and Improvement in Bathing) with two new composite measures on total normalized composite change in self-care and mobility; changes to how we calculate the Total Performance Scores by changing the weighting methodology for the OASIS-based, claims-based, and HHCAHPS measures; and a change to the scoring methodology by reducing the maximum amount of improvement points an HHA can earn, from 10 points to 9 points. We are also providing an update on the progress towards developing public reporting of performance under the HHVBP Model and providing a summary of public comments received in response to our solicitation of feedback on what information we should consider making publicly available in the future.
In section V. of this final rule with comment period, we are finalizing updates to our the Home Health (HH) Quality Reporting Program (QRP) by adopting eight measure removal factors, removing seven measures, and updating our regulations to clarify that not all OASIS data are required for the HH QRP. We are also providing an update on the implementation of certain provisions of the IMPACT Act, and are finalizing our proposal to increase the number of years of data used to calculate the Medicare Spending per Beneficiary measure for purposes of display from 1 year to 2 years.
In section VI.A. of this final rule with comment period, we discuss general background of home infusion therapy services and how this relates to the implementation of the new home infusion benefit. In section VI.B. of this final rule with comment period, we have finalized the addition of a new subpart I under the regulations at 42 CFR part 486 to incorporate health and safety requirements for home infusion therapy suppliers. These regulations provide a framework for CMS to approve home infusion therapy accreditation organizations. Subpart I includes General Provisions (Scope and Purpose, and Definitions) and Standards for Home Infusion Therapy (Plan of Care and Required Services). Section VI.D. of this final rule with comment period provides information on temporary transitional payments for home infusion therapy services for CYs 2019 and 2020 as mandated by section 50401 of the BBA of 2018, and responds to the comments received regarding issues such as the regulatory definition of “Infusion Drug Administration Calendar Day.”
In section VI.C. of this final rule with comment period, we discuss the requirements set forth in section 1861(iii)(3)(D)(III) of the Act, which mandates that suppliers of home infusion therapy receive accreditation from a CMS-approved accrediting organization (AO) in order to receive Medicare payment. The Secretary must designate AOs to accredit suppliers furnishing home infusion therapy not later than January 1, 2021. Qualified home infusion therapy suppliers are required to receive accreditation before receiving Medicare payment for services provided to Medicare beneficiaries.
Until now, no regulations have addressed the following elements of CMS' approval and oversight of the AOs that accredit suppliers of home infusion therapy: (1) The required components to be included in a home infusion therapy AO's initial or renewal accreditation program application; (2) regulations related to CMS' review and approval of the home infusion therapy AOs application for approval of its accreditation program; and (3) the
In this final rule with comment period, we are not finalizing our proposal to modify 42 CFR 488.5 by adding a requirement that all surveyors, that work for AOs that accredit Medicare certified providers and suppliers, must complete the relevant program specific CMS online trainings.
However, in this final rule with comment period, we are finalizing the proposed requirement to be added at § 488.5 which requires the AOs for Medicare certified providers and suppliers to provide a written statement with their application stating that if a fully accredited facility deemed to be in good-standing provides written notification that they wish to voluntarily withdraw from the AO's CMS-approved accreditation program, the AO must continue the facility's current accreditation until the effective date of withdrawal identified by the facility or the expiration date of the term of accreditation, whichever comes first.
In the CY 2019 HH PPS proposed rule, we stated that regulatory reform and reducing regulatory burden are high priorities for us. To reduce the regulatory burden on the healthcare industry, lower health care costs, and enhance patient care, in October 2017, we launched the Meaningful Measures Initiative.
The Meaningful Measures Framework has the following objectives:
• Address high-impact measure areas that safeguard public health;
• Patient-centered and meaningful to patients;
• Outcome-based where possible;
• Fulfill each program's statutory requirements;
• Minimize the level of burden for health care providers (for example, through a preference for EHR-based measures where possible, such as electronic clinical quality measures);
• Provide significant opportunity for improvement;
• Address measure needs for population based payment through alternative payment models; and
• Align across programs and/or with other payers.
In order to achieve these objectives, stated in the proposed rule that we had identified 19 Meaningful Measures areas and mapped them to six overarching quality priorities as shown in Table 2:
By including Meaningful Measures in our programs, we stated our belief that we can also address the following cross-cutting measure criteria:
• Eliminating disparities;
• Tracking measurable outcomes and impact;
• Safeguarding public health;
• Achieving cost savings;
• Improving access for rural communities; and
• Reducing burden.
We also stated the we believe that the Meaningful Measures Initiative will improve outcomes for patients, their families, and health care providers while reducing burden and costs for clinicians and providers and promoting operational efficiencies.
The Balanced Budget Act of 1997 (BBA) (Pub. L. 105-33, enacted August 5, 1997), significantly changed the way Medicare pays for Medicare home health services. Section 4603 of the BBA mandated the development of the HH PPS. Until the implementation of the HH PPS on October 1, 2000, HHAs received payment under a retrospective reimbursement system.
Section 4603(a) of the BBA mandated the development of a HH PPS for all Medicare-covered home health services provided under a plan of care (POC) that were paid on a reasonable cost basis by adding section 1895 of the Act, entitled “Prospective Payment For Home Health Services.” Section 1895(b)(1) of the Act requires the Secretary to establish a HH PPS for all costs of home health services paid under Medicare. Section 1895(b)(2) of the Act requires that, in defining a prospective payment amount, the Secretary will consider an appropriate unit of service and the number, type, and duration of visits provided within that unit, potential changes in the mix of services provided within that unit and their cost, and a general system design that provides for continued access to quality services.
Section 1895(b)(3)(A) of the Act requires the following: (1) The computation of a standard prospective payment amount that includes all costs for HH services covered and paid for on a reasonable cost basis, and that such amounts be initially based on the most recent audited cost report data available to the Secretary (as of the effective date
Section 1895(b)(3)(B) of the Act requires the standard prospective payment amounts be annually updated by the home health applicable percentage increase. Section 1895(b)(4) of the Act governs the payment computation. Sections 1895(b)(4)(A)(i) and (b)(4)(A)(ii) of the Act require the standard prospective payment amount to be adjusted for case-mix and geographic differences in wage levels. Section 1895(b)(4)(B) of the Act requires the establishment of an appropriate case-mix change adjustment factor for significant variation in costs among different units of services.
Similarly, section 1895(b)(4)(C) of the Act requires the establishment of wage adjustment factors that reflect the relative level of wages, and wage-related costs applicable to home health services furnished in a geographic area compared to the applicable national average level. Under section 1895(b)(4)(C) of the Act, the wage-adjustment factors used by the Secretary may be the factors used under section 1886(d)(3)(E) of the Act.
Section 1895(b)(5) of the Act gives the Secretary the option to make additions or adjustments to the payment amount otherwise paid in the case of outliers due to unusual variations in the type or amount of medically necessary care. Section 3131(b)(2) of the Affordable Care Act revised section 1895(b)(5) of the Act so that total outlier payments in a given year would not exceed 2.5 percent of total payments projected or estimated. The provision also made permanent a 10 percent agency-level outlier payment cap.
In accordance with the statute, as amended by the BBA, we published a final rule in the July 3, 2000
Section 5201(c) of the Deficit Reduction Act of 2005 (DRA) (Pub. L. 109-171, enacted February 8, 2006) added new section 1895(b)(3)(B)(v) to the Act, requiring HHAs to submit data for purposes of measuring health care quality, and linking the quality data submission to the annual applicable payment percentage increase. This data submission requirement is applicable for CY 2007 and each subsequent year. If an HHA does not submit quality data, the home health market basket percentage increase is reduced by 2 percentage points. In the November 9, 2006
The Affordable Care Act made additional changes to the HH PPS. One of the changes in section 3131 of the Affordable Care Act is the amendment to section 421(a) of the Medicare Prescription Drug, Improvement, and Modernization Act of 2003 (MMA) (Pub. L. 108-173, enacted on December 8, 2003) as amended by section 5201(b) of the DRA. Section 421(a) of the MMA, as amended by section 3131 of the Affordable Care Act, requires that the Secretary increase, by 3 percent, the payment amount otherwise made under section 1895 of the Act, for HH services furnished in a rural area (as defined in section 1886(d)(2)(D) of the Act) with respect to episodes and visits ending on or after April 1, 2010, and before January 1, 2016.
Section 210 of the Medicare Access and CHIP Reauthorization Act of 2015 (Pub. L. 114-10) (MACRA) amended section 421(a) of the MMA to extend the 3 percent rural add-on payment for home health services provided in a rural area (as defined in section 1886(d)(2)(D) of the Act) through January 1, 2018. In addition, section 411(d) of MACRA amended section 1895(b)(3)(B) of the Act such that CY 2018 home health payments be updated by a 1 percent market basket increase. Section 50208(a)(1) of the BBA of 2018 again extended the 3 percent rural add-on through the end of 2018. In addition, this section of the BBA of 2018 made some important changes to the rural add-on for CYs 2019 through 2022, to be discussed later in this final rule with comment period.
Generally, Medicare currently makes payment under the HH PPS on the basis of a national, standardized 60-day episode payment rate that is adjusted for the applicable case-mix and wage index. The national, standardized 60-day episode rate includes the six home health disciplines (skilled nursing, home health aide, physical therapy, speech-language pathology, occupational therapy, and medical social services). Payment for non-routine supplies (NRS) is not part of the national, standardized 60-day episode rate, but is computed by multiplying the relative weight for a particular NRS severity level by the NRS conversion factor. Payment for durable medical equipment covered under the HH benefit is made outside the HH PPS payment system. To adjust for case-mix, the HH PPS uses a 153-category case-mix classification system to assign patients to a home health resource group (HHRG). The clinical severity level, functional severity level, and service utilization are computed from responses to selected data elements in the OASIS assessment instrument and are used to place the patient in a particular HHRG. Each HHRG has an associated case-mix weight which is used in calculating the payment for an episode. Therapy service use is measured by the number of therapy visits provided during the episode and can be categorized into nine visit level categories (or thresholds): 0 to 5; 6; 7 to 9; 10; 11 to 13; 14 to 15; 16 to 17; 18 to 19; and 20 or more visits.
For episodes with four or fewer visits, Medicare pays national per-visit rates based on the discipline(s) providing the services. An episode consisting of four or fewer visits within a 60-day period receives what is referred to as a low-utilization payment adjustment (LUPA). Medicare also adjusts the national standardized 60-day episode payment rate for certain intervening events that are subject to a partial episode payment adjustment (PEP adjustment). For certain cases that exceed a specific cost threshold, an outlier adjustment may also be available.
As required by section 1895(b)(3)(B) of the Act, we have historically updated the HH PPS rates annually in the
To account for the changes in case-mix that were not related to an underlying change in patient health status, we implemented a reduction, over 4 years, to the national, standardized 60-day episode payment rates. That reduction was to be 2.75 percent per year for 3 years beginning in CY 2008 and 2.71 percent for the fourth year in CY 2011. In the CY 2011 HH PPS final rule (76 FR 68532), we updated our analyses of case-mix change and finalized a reduction of 3.79 percent, instead of 2.71 percent, for CY 2011 and deferred finalizing a payment reduction for CY 2012 until further study of the case-mix change data and methodology was completed.
In the CY 2012 HH PPS final rule (76 FR 68526), we updated the 60-day national episode rates and the national per-visit rates. In addition, as discussed in the CY 2012 HH PPS final rule (76 FR 68528), our analysis indicated that there was a 22.59 percent increase in overall case-mix from 2000 to 2009 and that only 15.76 percent of that overall observed case-mix percentage increase was due to real case-mix change. As a result of our analysis, we identified a 19.03 percent nominal increase in case-mix. At that time, to fully account for the 19.03 percent nominal case-mix growth identified from 2000 to 2009, we finalized a 3.79 percent payment reduction in CY 2012 and a 1.32 percent payment reduction for CY 2013.
In the CY 2013 HH PPS final rule (77 FR 67078), we implemented the 1.32 percent reduction to the payment rates for CY 2013 finalized the previous year, to account for nominal case-mix growth from 2000 through 2010. When taking into account the total measure of case-mix change (23.90 percent) and the 15.97 percent of total case-mix change estimated as real from 2000 to 2010, we obtained a final nominal case-mix change measure of 20.08 percent from 2000 to 2010 (0.2390 * (1−0.1597) = 0.2008). To fully account for the remainder of the 20.08 percent increase in nominal case-mix beyond that which was accounted for in previous payment reductions, we estimated that the percentage reduction to the national, standardized 60-day episode rates for nominal case-mix change would be 2.18 percent. Although we considered proposing a 2.18 percent reduction to account for the remaining increase in measured nominal case-mix, we finalized the 1.32 percent payment reduction to the national, standardized 60-day episode rates in the CY 2012 HH PPS final rule (76 FR 68532). Section 3131(a) of the Affordable Care Act added new section 1895(b)(3)(A)(iii) to the Act, which required that, beginning in CY 2014, we apply an adjustment to the national, standardized 60-day episode rate and other amounts that reflect factors such as changes in the number of visits in an episode, the mix of services in an episode, the level of intensity of services in an episode, the average cost of providing care per episode, and other relevant factors. Additionally, we were required to phase in any adjustment over a 4-year period in equal increments, not to exceed 3.5 percent of the payment amount (or amounts) as of the date of enactment of the Affordable Care Act in 2010, and fully implement the rebasing adjustments by CY 2017. Therefore, in the CY 2014 HH PPS final rule (78 FR 72256) for each year, CY 2014 through CY 2017, we finalized a fixed-dollar reduction to the national, standardized 60-day episode payment rate of $80.95 per year, increases to the national per-visit payment rates per year, and a decrease to the NRS conversion factor of 2.82 percent per year. We also finalized three separate LUPA add-on factors for skilled nursing, physical therapy, and speech-language pathology and removed 170 diagnosis codes from assignment to diagnosis groups in the HH PPS Grouper. In the CY 2015 HH PPS final rule (79 FR 66032), we implemented the second year of the 4-year phase-in of the rebasing adjustments to the HH PPS payment rates and made changes to the HH PPS case-mix weights. In addition, we simplified the face-to-face encounter regulatory requirements and the therapy reassessment timeframes.
In the CY 2016 HH PPS final rule (80 FR 68624), we implemented the third year of the 4-year phase-in of the rebasing adjustments to the national, standardized 60-day episode payment amount, the national per-visit rates and the NRS conversion factor (as discussed previously). In the CY 2016 HH PPS final rule, we also recalibrated the HH PPS case-mix weights, using the most current cost and utilization data available, in a budget-neutral manner and finalized reductions to the national, standardized 60-day episode payment rate in CY 2016, CY 2017, and CY 2018 of 0.97 percent in each year to account for estimated case-mix growth unrelated to increases in patient acuity (that is, nominal case-mix growth) between CY 2012 and CY 2014. Finally, section 421(a) of the MMA, as amended by section 210 of the MACRA, extended the payment increase of 3 percent for HH services provided in rural areas (as defined in section 1886(d)(2)(D) of the Act) to episodes or visits ending before January 1, 2018.
In the CY 2017 HH PPS final rule (81 FR 76702), we implemented the last year of the 4-year phase-in of the rebasing adjustments to the national, standardized 60-day episode payment amount, the national per-visit rates and the NRS conversion factor (as outlined previously). We also finalized changes to the methodology used to calculate outlier payments under the authority of section 1895(b)(5) of the Act. Lastly, in accordance with section 1834(s) of the Act, as added by section 504(a) of the Consolidated Appropriations Act, 2016 (Pub. L. 114-113, enacted December 18, 2015), we implemented changes in payment for furnishing Negative Pressure Wound Therapy (NPWT) using a disposable device for patients under a home health plan of care for which payment would otherwise be made under section 1895(b) of the Act.
Section 5012 of the 21st Century Cures Act (“the Cures Act”) (Pub. L. 114-255), which amended sections 1861(s)(2) and 1861(iii) of the Act, established a new Medicare home infusion therapy benefit. The Medicare home infusion therapy benefit covers the professional services, including nursing services furnished in accordance with the plan of care, patient training and education (not otherwise covered under the durable medical equipment benefit), remote monitoring, and monitoring services for the provision of home infusion therapy and home infusion drugs furnished by a qualified home infusion therapy supplier. This benefit will ensure consistency in coverage for home infusion benefits for all Medicare beneficiaries. Section 50401 of the BBA of 2018 amended section 1834(u) of the
Home infusion therapy is a treatment option for patients with a wide range of acute and chronic conditions, ranging from bacterial infections to more complex conditions such as late-stage heart failure and immune deficiencies. Home infusion therapy affords a patient independence and better quality of life, because it is provided in the comfort of the patient's home at a time that best fits his or her needs. This is significant, because generally patients can return to their daily activities after they receive their infusion treatments and, in many cases, they can continue their activities while receiving their treatments. In addition, home infusion therapy can provide improved safety and better outcomes. The home has been shown to be a safe setting for patients to receive infusion therapy.
Souayah, N., Hasan, A., Khan, H., et al. (2011). The safety profile of home infusion of intravenous immunoglobulin in patients with neuroimmunologic disorders. Journal of Clinical Neuromuscular Disease, 12(supp 4), S1-10. doi: 10.1097/CND.0b013e3182212589.
Infusion therapy typically means that a drug is administered intravenously, but the term may also refer to situations where drugs are provided through other non-oral routes, such as intramuscular injections and epidural routes (into the membranes surrounding the spinal cord). Diseases that may require infusion therapy include infections that are unresponsive to oral antibiotics, cancer and cancer-related pain, dehydration, and gastrointestinal diseases or disorders which prevent normal functioning of the gastrointestinal system. Other conditions treated with specialty infusion therapies may include some forms of cancers, congestive heart failure, Crohn's Disease, hemophilia, hepatitis, immune deficiencies, multiple sclerosis and rheumatoid arthritis. Infusion therapy originates with a prescription order from a physician or another qualified prescriber who is overseeing the care of the patient. The prescription order is sent to a home infusion therapy supplier, which is a state-licensed pharmacy, physician, or other provider of services or suppliers licensed by the state.
A 2010 Government Accountability Office (GAO) report (10-426) found that most health insurers rely on credentialing, accreditation, or both to help ensure that plan members receive quality home infusion services from their network suppliers.
Sections 1861(iii)(3)(D)(III) and 1834(u)(5) of the Act, as amended by section 5012 of the Cures Act requires that, in order to participate in Medicare, home infusion therapy suppliers must select a CMS-approved AO and undergo an accreditation review process to demonstrate that the home infusion therapy program meets the accreditation organization's standards. Section 1861(iii) of the Act, as amended by section 5012 of the Cures Act, sets forth standards in three areas: (1) Ensuring that all patients have a plan of care established and updated by a physician that sets out the care and prescribed infusion therapy necessary to meet the patient-specific needs; (2) having procedures to ensure that remote monitoring services associated with administering infusion drugs in a patient's home are provided; and (3) having procedures to ensure that patients receive education and training on the effective use of medications and equipment in the home.
In the July 12, 2018
In the CY 2019 proposed rule (83 FR 32348), we provided a summary of analysis on fiscal (FY) 2016 HHA cost report data and how such data, if used, would impact our estimate of the percentage difference between Medicare payments and HHA costs. In addition, we presented information on Medicare home health utilization statistics and trends that included HHA claims data through CY 2017. We will continue monitoring the impacts due to the rebasing adjustments and other policy changes and will provide the industry with periodic updates on our analysis in rulemaking and/or announcements on the HHA Center web page at:
In the CY 2015 HH PPS final rule (79 FR 66072), we finalized a policy to annually recalibrate the HH PPS case-mix weights—adjusting the weights relative to one another—using the most current, complete data available. To recalibrate the HH PPS case-mix weights for CY 2019, we will use the same methodology finalized in the CY 2008
To generate the final CY 2019 HH PPS case-mix weights, we used CY 2017 home health claims data (as of June 30, 2018) with linked OASIS data. These data are the most current and complete data available at this time. We noted in the proposed rule that we would use CY 2017 home health claims data (as of June 30, 2018 or later) with linked OASIS data to generate the CY 2019 HH PPS case-mix weights for this final rule with comment period. The process we used to calculate the HH PPS case-mix weights is outlined in this section.
In updating the four-equation model for CY 2019, using 2017 home health claims data (the last update to the four-equation model for CY 2018 used CY 2016 home health claims data), there were few changes to the point values for the variables in the four-equation model. These relatively minor changes reflect the change in the relationship between the grouper variables and resource use between CY 2016 and CY 2017. The final CY 2019 four-equation model resulted in 119 point-giving variables being used in the model (as compared to the 119 variables for the CY 2018 recalibration, which can be found in Table 2 of the CY 2018 HH PPS final rule (82 FR 51684)). There were 9 variables that were added to the model due to the presence of additional resources associated with those variables and 9 variables that were dropped from the model due to the absence of additional resources associated with those variables. Of the variables that were in both the four-equation model for CY 2019 and the four-equation model for CY 2018, the points for 7 variables increased in the CY 2019 four-equation model and the points for 68 variables decreased in the CY 2019 4-equation model. There were 35 variables with the same point values.
• Step 1: First and second episodes, 0-13 therapy visits.
• Step 2.1: First and second episodes, 14-19 therapy visits.
• Step 2.2: Third episodes and beyond, 14-19 therapy visits.
• Step 3: Third episodes and beyond, 0-13 therapy visits.
• Step 4: Episodes with 20+ therapy visits.
Then, we divide the distribution of the clinical score for episodes within a step such that a third of episodes are classified as low clinical score, a third of episodes are classified as medium clinical score, and a third of episodes are classified as high clinical score. The same approach is then done looking at the functional score. It was not always possible to evenly divide the episodes within each step into thirds due to many episodes being clustered around one particular score.
Also, we looked at the average resource use associated with each clinical and functional score and used that as a guide for setting our thresholds. We grouped scores with similar average resource use within the same level (even if it meant that more or less than a third of episodes were placed within a level). The new thresholds, based off the final CY 2019 four-equation model points are shown in Table 4.
To ensure the changes to the HH PPS case-mix weights are implemented in a budget neutral manner, we then apply a case-mix budget neutrality factor to the CY 2019 national, standardized 60-day episode payment rate (see section III.C.3. of this final rule with comment period). The case-mix budget neutrality factor is calculated as the ratio of total payments when the CY 2019 HH PPS case-mix weights (developed using CY 2017 home health claims data) are applied to CY 2017 utilization (claims) data to total payments when CY 2018 HH PPS case-mix weights (developed using CY 2016 home health claims data) are applied to CY 2017 utilization data. This produces a case-mix budget neutrality factor for CY 2019 of 1.0169.
The following is a summary of the comments received and our responses to comments on the CY 2019 HH PPS case-mix weights.
Section 1895(b)(3)(B) of the Act requires that the standard prospective payment amounts for CY 2019 be increased by a factor equal to the applicable home health market basket update for those HHAs that submit quality data as required by the Secretary. Effective for cost reporting periods beginning on or after July 1, 1980, we developed and adopted an HHA input price index (that is, the home health “market basket”). Although “market basket” technically describes the mix of goods and services used to produce home health care, this term is also commonly used to denote the input price index derived from that market basket. Accordingly, the term “home health market basket” used in this document refers to the HHA input price index.
The percentage change in the home health market basket reflects the average change in the price of goods and services purchased by HHAs in providing an efficient level of home health care services. We first used the home health market basket to adjust HHA cost limits by an amount that reflected the average increase in the prices of the goods and services used to furnish reasonable cost home health care. This approach linked the increase in the cost limits to the efficient utilization of resources. For a greater discussion on the home health market basket, see the notice with comment period published in the February 15, 1980
The home health market basket is a fixed-weight, Laspeyres-type price index. A Laspeyres-type price index measures the change in price, over time, of the same mix of goods and services purchased in the base period. Any changes in the quantity or mix of goods and services (that is, intensity) purchased over time are not measured.
The index itself is constructed in three steps. First, a base period is selected (in this final rule with comment period, we are using 2016 as the base period) and total base period expenditures are estimated for a set of mutually exclusive and exhaustive spending categories, with the proportion of total costs that each category represents being calculated. These proportions are called “cost weights” or “expenditure weights.” Second, each expenditure category is matched to an appropriate price or wage variable, referred to as a “price proxy.” In almost every instance, these price proxies are derived from publicly available statistical series that are published on a consistent schedule (preferably at least on a quarterly basis). Finally, the expenditure weight for each cost category is multiplied by the level of its respective price proxy. The sum of these products (that is, the expenditure weights multiplied by their price index levels) for all cost categories yields the composite index level of the market basket in a given period. Repeating this step for other periods produces a series of market basket levels over time. Dividing an index level for a given period by an index level for an earlier period produces a rate of growth in the input price index over that timeframe.
As noted previously, the market basket is described as a fixed-weight index because it represents the change in price over time of a constant mix (quantity and intensity) of goods and services needed to provide HHA services. The effects on total expenditures resulting from changes in the mix of goods and services purchased subsequent to the base period are not measured. For example, a HHA hiring more nurses to accommodate the needs of patients would increase the volume of goods and services purchased by the HHA, but would not be factored into the price change measured by a fixed-weight home health market basket. Only when the index is rebased would changes in the quantity and intensity be captured, with those changes being reflected in the cost weights. Therefore, we rebase the market basket periodically so that the cost weights reflect recent changes in the mix of goods and services that HHAs purchase (HHA inputs) to furnish inpatient care between base periods.
We believe that it is desirable to rebase the home health market basket periodically so that the cost category weights reflect changes in the mix of goods and services that HHAs purchase in furnishing home health care. We based the cost category weights in the current home health market basket on CY 2010 data. We proposed to rebase and revise the home health market basket to reflect 2016 Medicare cost report (MCR) data, the latest available and most complete data on the actual structure of HHA costs.
The terms “rebasing” and “revising,” while often used interchangeably, denote different activities. The term “rebasing” means moving the base year for the structure of costs of an input price index (that is, in this exercise, we moved the base year cost structure from CY 2010 to CY 2016) without making any other major changes to the methodology. The term “revising” means changing data sources, cost
For this rebasing and revising, we rebased the detailed wages and salaries and benefits cost weights to reflect 2016 BLS Occupational Employment Statistics (OES) data for HHAs. The 2010-based home health market basket used 2010 BLS OES data for HHAs. We also proposed to break out the All Other (residual) cost category weight into more detailed cost categories, based on the 2007 Benchmark U.S. Department of Commerce, Bureau of Economic Analysis (BEA) Input-Output (I-O) Table for HHAs. The 2010-based home health market basket used the 2002 I-O data. Finally, due to its small weight, we proposed to eliminate the cost category `Postage' and include these expenses in the `All Other Services' cost weight.
The major cost weights for this revised and rebased home health market basket are derived from the Medicare cost reports (MCR; CMS Form 1728-94) data for freestanding HHAs whose cost reporting period began on or after October 1, 2015 and before October 1, 2016. Of the 2016 Medicare cost reports for freestanding HHAs, approximately 84 percent of the reports had a begin date on January 1, 2016, approximately 6 percent had a begin date on July 1, 2016, and approximately 4 percent had a begin date on October 1, 2015. Using this methodology allowed our sample to include HHAs with varying cost report years including, but not limited to, the Federal fiscal or calendar year. We referred to the market basket as a calendar year market basket because the base period for all price proxies and weights are set to CY 2016.
We maintained our policy of using data from freestanding HHAs (77 FR 67081), which account for over 90 percent of HHAs (82 FR 35383), because we have determined that they better reflect HHAs' actual cost structure. Expense data for hospital-based HHAs can be affected by the allocation of overhead costs over the entire institution.
We derived eight major expense categories (Wages and Salaries, Benefits, Contract Labor, Transportation, Professional Liability Insurance (PLI), Fixed Capital, Movable Capital, and a residual “All Other”) from the 2016 Medicare HHA cost reports. Due to its small weight, we eliminated the cost category `Postage' and included these expenses in the “All Other (residual)” cost weight. These major expense categories are based on those cost centers that are reimbursable under the HHA PPS, specifically Skilled Nursing Care, Physical Therapy, Occupational Therapy, Speech Pathology, Medical Social Services, Home Health Aide, and Supplies. These are the same cost centers that were used in the 2014 base payment rebasing (78 FR 72276), which are described in the Abt Associates Inc. June 2013, Technical Paper, “Analyses In Support of Rebasing and Updating Medicare Home Health Payment Rates” (
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As prescription drugs and DME are not payable under the HH PPS, we maintained our policy to exclude those items from the home health market basket. Totals within each of the major cost categories were edited to remove reports where the data were deemed unreasonable (for example, when total costs were not greater than zero). We then determined the proportion of total Medicare allowable costs that each category represents. For all of the major cost categories except the “residual” All Other cost weight, we then removed those providers whose derived cost weights fall in the top and bottom 5 percent of provider-specific cost weights to ensure the removal of outliers. After the outliers were removed, we summed the costs for each category across all remaining providers. Then, we divided this by the sum of total Medicare allowable costs across all remaining
Table 7 shows the major cost categories and their respective cost weights as derived from the Medicare cost reports for this final rule with comment period.
The decrease in the wages and salaries cost weight of 1.2 percentage points and the decrease in the benefits cost weight of 1.3 percentage points is attributable to both employed compensation and direct patient care contract labor costs as reported on the MCR data. Our analysis of the MCR data shows that the decrease in the compensation cost weight of 2.4 percentage points (calculated by combining wages and salaries and benefits) from 2010 to 2016 occurred among for-profit, nonprofit, and government providers and among providers serving only rural beneficiaries, only urban beneficiaries, or both rural and urban beneficiaries.
Over the 2010 to 2016 time period, the average number of FTEs per provider decreased considerably. This corresponds with the HHA claims analysis published on page 35279 of the CY 2018 proposed rule (
The direct patient care contract labor costs are contract labor costs for skilled nursing, physical therapy, occupational therapy, speech therapy, and home health aide cost centers. We allocated these direct patient care contract labor costs to the Wages and Salaries and Benefits cost categories based on each provider's relative proportions of both employee wages and salaries and employee benefits costs. For example, the direct patient care contract labor costs that are allocated to wages and salaries is equal to: (1) The employee wages and salaries costs as a percent of the sum of employee wages and salaries costs and employee benefits costs times; and (2) direct patient care contract labor costs. Nondirect patient care contract labor costs (such as contract labor costs reported in the Administrative and General cost center of the MCR) are captured in the “All Other” residual cost weight and later disaggregated into more detail as described later in this section. This is a similar methodology that was implemented for the 2010-based home health market basket.
We further divided the “All Other” residual cost weight estimated from the 2016 Medicare cost report data into more detailed cost categories. To divide this cost weight we used the 2007 Benchmark I-O “Use Tables/Before Redefinitions/Purchaser Value” for NAICS 621600, Home Health Agencies, published by the BEA. These data are publicly available at
Using this methodology, we derived nine detailed cost categories from the 2016-based home health market basket “All Other” residual cost weight (19.0 percent). These categories are: (1) Operations and Maintenance; (2) Administrative Support; (3) Financial Services; (4) Medical Supplies; (5) Rubber and Plastics; (6) Telephone; (7) Professional Fees; (8) Other Products; and (9) Other Services. The 2010-based home health market basket included a
Table 8 lists the final 2016-based home health market basket cost categories, cost weights, and price proxies.
We received no comments on the derivation of the 2016-based Home Health market basket cost categories and weights and therefore are finalizing the categories and weights without modification.
After we computed the CY 2016 cost category weights for the rebased home health market basket, we selected the most appropriate wage and price indexes to proxy the rate of change for each expenditure category. With the exception of the price index for Professional Liability Insurance costs, the price proxies are based on Bureau of Labor Statistics (BLS) data and are grouped into one of the following BLS categories:
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We evaluated the price proxies using the criteria of reliability, timeliness, availability, and relevance. Reliability indicates that the index is based on valid statistical methods and has low sampling variability. Widely accepted statistical methods ensure that the data were collected and aggregated in way that can be replicated. Low sampling variability is desirable because it indicates that sample reflects the typical members of the population. (Sampling variability is variation that occurs by chance because a sample was surveyed rather than the entire population.) Timeliness implies that the proxy is published regularly, preferably at least once a quarter. The market baskets are
As part of the revising and rebasing of the home health market basket, we proposed to rebase the home health blended Wages and Salaries index and the home health blended Benefits index. We proposed to use these blended indexes as price proxies for the Wages and Salaries and the Benefits portions of the proposed 2016-based home health market basket, as we did in the 2010-based home health market basket. A more detailed discussion is provided in this rule.
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We proposed to continue to use the National Industry-Specific Occupational Employment and Wage estimates for North American Industrial Classification System (NAICS) 621600, Home Health Care Services, published by the BLS Office of Occupational Employment Statistics (OES) as the data source for the cost shares of the home health blended wage and benefits proxy. This is the same data source that was used for the 2010-based HHA blended wage and benefit proxies; however, we proposed to use the May 2016 estimates in place of the May 2010 estimates. Detailed information on the methodology for the national industry-specific occupational employment and wage estimates survey can be found at
The needed data on HHA expenditures for the six occupational subcategories (Health-Related Professional and Technical, Non Health-Related Professional and Technical, Management, Administrative, Health and Social Assistance Service, and Other Service Workers) for the wages and salaries component were tabulated from the May 2016 OES data for NAICS 621600, Home Health Care Services. Table 9 compares the 2016 occupational assignments to the 2010 occupational assignments of the six CMS designated subcategories. If an OES occupational classification does not exist in the 2010 or 2016 data we use “n/a.”
Total expenditures by occupation were calculated by taking the OES number of employees multiplied by the OES annual average salary for each subcategory, and then calculating the proportion of total wage costs that each
A comparison of the yearly changes from CY 2016 to CY 2019 for the 2010-based home health Wages and Salaries blend and the 2016-based home health Wages and Salaries blend is shown in Table 11. The annual increases in the two price proxies are the same when rounded to one decimal place.
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There is no available data source that exists for benefit expenditures by occupation for the home health industry. Thus, to construct weights for the home health benefits blend we calculated the ratio of benefits to wages and salaries for CY 2016 for the six ECI series we used in the blended ‘wages and salaries’ and ‘benefits’ indexes. To derive the relevant benefits weight, we applied the benefit-to-wage ratios to each of the six occupational subcategories from the 2016 OES wage and salary weights, and normalized. For example, the ratio of benefits to wages from the 2016 home health wages and salaries blend and the benefits blend for the management category is 0.984. We applied this ratio to the 2016 OES weight for wages and salaries for management, 7.6 percent, and then normalized those weights relative to the other 5 benefit occupational categories to obtain a benefit weight for management of 7.3 percent.
A comparison of the yearly changes from CY 2016 to CY 2019 for the 2010-based home health Benefits blend and the 2016-based home health Benefits blend is shown in Table 13. The annual increases in the two price proxies are the same when rounded to one decimal place.
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To accurately reflect the price changes associated with physician PLI, each year we collect PLI premium data for physicians from a representative sample of commercial carriers and publically available rate filings as maintained by each State's Association of Insurance Commissioners. As we require for our other price proxies, the PLI price proxy is intended to reflect the pure price change associated with this particular cost category. Thus, the level of liability coverage is held constant from year to year. To accomplish this, we obtain premium information from a sample of commercial carriers for a fixed level of coverage, currently $1 million per occurrence and a $3 million annual limit. This information is collected for every State by physician specialty and risk class. Finally, the State-level, physician-specialty data are aggregated to compute a national total, using counts of physicians by State and specialty as provided in the American Medical Association (AMA) publication,
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After consideration of public comments, we are finalizing the proposed 2016-based home health market basket without modification. A comparison of the yearly changes from CY 2014 to CY 2021 for the 2010-based home health market basket and the final 2016-based home health market basket is shown in Table 14.
Table 14 shows that the forecasted rate of growth for CY 2019 for the 2016-based home health market basket is 3.0 percent, the same rate of growth as estimated using the 2010-based home health market basket; other forecasted years also show a similar increase. Similarly, the historical estimates of the growth in the 2016-based and 2010-based home health market basket are the same except for CY 2015 where the
The growth rates in Table 14 are based upon IHS Global Inc.'s (IGI) 3rd quarter 2018 forecast. IGI is a nationally recognized economic and financial forecasting firm that contracts with CMS to forecast the components of the market baskets. We noted in the proposed rule that if more recent data were subsequently available (for example, a more recent estimate of the market basket), we would use such data to determine the market basket increases in the final rule. In that proposed rule the forecasted rate of growth for CY 2019, based on IGI's 1st quarter 2018 forecast, for the 2016-based home health market basket was 2.8 percent (83 FR 32368).
The 2016-based HHA market basket, along with its predecessors such as the 2010-based HHA market basket, are fixed-weight indices that are intended to measure the input prices used in providing home health care services. The market basket by definition is a price index rather than a cost index and, therefore, only accounts for changes in prices, holding quantities constant. In order to reflect the changes in the mix of input costs over time, CMS rebases the market basket periodically to ensure that the index is reflecting the most up to date relative cost shares for specific categories of expenses. We have found that the relative cost shares for each category do not change substantially from year to year.
The current CY 2019 market basket update factor of 3.0 percent reflects the projected price growth in the input costs to provide home health services. This forecast is based on the IHS Global Inc. (IGI) third quarter 2018 forecast. IGI is a nationally recognized economic and financial forecasting firm that contracts with CMS to forecast the components of the market baskets.
We also note that according to the Medicare Payment Advisory Committee, Medicare home health revenue has greatly exceeded Medicare home health costs since PPS implementation, with the most recent Medicare margins for 2016 estimated to be 15.5 percent (
Effective for CY 2019, we revised the labor-related share to reflect the 2016-based home health market basket Compensation (Wages and Salaries plus Benefits) cost weight. The current labor-related share is based on the Compensation cost weight of the 2010-based home health market basket. Based on the 2016-based home health market basket, the labor-related share would be 76.1 percent and the non-labor-related share would be 23.9 percent. The labor-related share for the 2010-based home health market basket was 78.535 percent and the non-labor-related share was 21.465 percent. As explained earlier, the decrease in the compensation cost weight of 2.4 percentage points is attributable to both employed compensation (wages and salaries and benefits for employees) and direct patient care contract labor costs as reported in the MCR data. Table 15 details the components of the labor-related share for the 2010-based and 2016-based home health market baskets.
There are no changes to the labor-related share in this final rule with comment period compared to the labor related share in the proposed rule (83 FR 32368).
We implemented the revision to the labor-related share of 76.1 percent in a budget neutral manner. This proposal would be consistent with our policy of implementing the annual recalibration of the case-mix weights and update of the home health wage index in a budget neutral manner.
In the CY 2015 HHA PPS final rule (79 FR 38384 through 38384), we finalized our methodology for calculating and applying the MFP adjustment. As we explained in that rule, section 1895(b)(3)(B)(vi) of the Act, requires that, in CY 2015 (and in subsequent calendar years, except CY 2018 (under section 411(c) of the Medicare Access and CHIP Reauthorization Act of 2015 (MACRA) (Pub. L. 114-10, enacted April 16, 2015)), the market basket percentage under the HHA prospective payment system as described in section 1895(b)(3)(B) of the Act be annually adjusted by changes in economy-wide productivity. Section 1886(b)(3)(B)(xi)(II) of the Act defines the productivity adjustment to be equal to the 10-year moving average of change in annual economy-wide private nonfarm business multifactor productivity (MFP) (as projected by the Secretary for the 10-year period ending with the applicable fiscal year, calendar year, cost reporting period, or other annual period) (the “MFP adjustment”). The Bureau of Labor Statistics (BLS) is the agency that publishes the official measure of private nonfarm business MFP. Please see
Based on IHS Global Inc.'s (IGI's) 3rd quarter 2018 forecast with history through the 2nd quarter of 2018, the projected MFP adjustment (the 10-year moving average of MFP for the period ending December 31, 2019) for CY 2019 is 0.8 percent.
We noted in the proposed rule that if more recent data were subsequently available (for example, a more recent estimate of the MFP adjustment), we would use such data to determine the MFP adjustment in the final rule. For comparison purposes, the proposed MFP adjustment for CY 2019 was 0.7 percent (83 FR 32368), and was based on IGI's 1st quarter 2018 forecast.
Using IGI's third quarter 2018 forecast, the MFP adjustment for CY 2019 is projected to be 0.8 percent. In accordance with section 1895(b)(3)(B)(iii) of the Act, we proposed to base the CY 2019 market basket update, which is used to determine the applicable percentage increase for HHA payments, on the most recent estimate of the 2016-based home health market basket. Based on IGI's third quarter 2018 forecast with history through the second quarter of 2018, the projected increase of the 2016-based home health market basket for CY 2019 is 3.0 percent. We then reduce this percentage increase by the current estimate of the MFP adjustment for CY 2019 of 0.8 percentage point in accordance with 1895(b)(3)(B)(vi) of the Act. Therefore, the current estimate of the CY 2019 HHA payment update is 2.2 percent (3.0 percent market basket update, less 0.8 percentage point MFP adjustment).
Section 1895(b)(3)(B)(v) of the Act requires that the home health update be decreased by 2 percentage points for those HHAs that do not submit quality data as required by the Secretary. For HHAs that do not submit the required quality data for CY 2019, the home health payment update would be 0.2 percent (2.2 percent minus 2 percentage points).
Based on IGI's third quarter 2018 forecast, we are finalizing the CY 2019 HHA payment update at 2.2 percent (3.0 percent market basket update, less 0.8 percentage point MFP adjustment).
Sections 1895(b)(4)(A)(ii) and (b)(4)(C) of the Act require the Secretary to provide appropriate adjustments to the proportion of the payment amount under the HH PPS that account for area wage differences, using adjustment factors that reflect the relative level of wages and wage-related costs applicable to the furnishing of HH services. Since the inception of the HH PPS, we have used inpatient hospital wage data in developing a wage index to be applied to HH payments. We proposed to continue this practice for CY 2019, as we continue to believe that, in the absence of HH-specific wage data that accounts for area differences, using inpatient hospital wage data is appropriate and reasonable for the HH PPS. Specifically, we proposed to continue to use the pre-floor, pre-reclassified hospital wage index as the wage adjustment to the labor portion of the HH PPS rates. For CY 2019, the updated wage data are for hospital cost reporting periods beginning on or after October 1, 2014, and before October 1, 2015 (FY 2015 cost report data). We apply the appropriate wage index value to the labor portion of the HH PPS rates based on the site of service for the beneficiary (defined by section 1861(m) of the Act as the beneficiary's place of residence).
To address those geographic areas in which there are no inpatient hospitals, and thus, no hospital wage data on which to base the calculation of the CY 2019 HH PPS wage index, we proposed to continue to use the same methodology discussed in the CY 2007 HH PPS final rule (71 FR 65884) to address those geographic areas in which there are no inpatient hospitals. For rural areas that do not have inpatient hospitals, we proposed to use the average wage index from all contiguous Core Based Statistical Areas (CBSAs) as a reasonable proxy. Currently, the only rural area without a hospital from which hospital wage data could be derived is Puerto Rico. However, for rural Puerto Rico, we do not apply this methodology due to the distinct economic circumstances that exist there (for example, due to the close proximity to one another of almost all of Puerto Rico's various urban and non-urban areas, this methodology would produce a wage index for rural Puerto Rico that is higher than that in half of its urban areas). Instead, we proposed to continue to use the most recent wage index previously available for that area. For urban areas without inpatient hospitals, we use the average wage index of all urban areas within the state as a reasonable proxy for the wage index for that CBSA. For CY 2019, the only urban area without inpatient hospital wage data is Hinesville, GA (CBSA 25980).
On February 28, 2013, OMB issued Bulletin No. 13-01, announcing revisions to the delineations of MSAs, Micropolitan Statistical Areas, and CBSAs, and guidance on uses of the delineation of these areas. In the CY 2015 HH PPS final rule (79 FR 66085 through 66087), we adopted the OMB's new area delineations using a 1-year transition. On August 15, 2017, OMB issued Bulletin No. 17-01 in which it announced that one Micropolitan Statistical Area, Twin Falls, Idaho, now qualifies as a Metropolitan Statistical Area.
The following is a summary of the comments received on the proposed CY 2019 home health wage index and our responses:
The Medicare HH PPS has been in effect since October 1, 2000. As set forth in the July 3, 2000 final rule (65 FR 41128), the base unit of payment under the Medicare HH PPS is a national, standardized 60-day episode payment rate. As set forth in § 484.220, we adjust the national, standardized 60-day episode payment rate by a case-mix relative weight and a wage index value based on the site of service for the beneficiary.
To provide appropriate adjustments to the proportion of the payment amount under the HH PPS to account for area wage differences, we apply the appropriate wage index value to the labor portion of the HH PPS rates. The labor-related share of the case-mix adjusted 60-day episode is 76.1 percent and the non-labor-related share is 23.9 percent for CY 2019. The CY 2019 HH PPS rates use the same case-mix methodology as set forth in the CY 2008 HH PPS final rule with comment period (72 FR 49762) and is adjusted as described in section III.B of this final rule with comment period. The following are the steps we take to compute the case-mix and wage-adjusted 60-day episode rate for CY 2019:
• Multiply the national 60-day episode rate by the patient's applicable case-mix weight.
• Divide the case-mix adjusted amount into a labor (76.1 percent) and a non-labor portion (23.9 percent).
• Multiply the labor portion by the applicable wage index based on the site of service of the beneficiary.
• Add the wage-adjusted portion to the non-labor portion, yielding the case-mix and wage adjusted 60-day episode rate, subject to any additional applicable adjustments.
In accordance with section 1895(b)(3)(B) of the Act, we proposed the annual update of the HH PPS rates. Section 484.225 sets forth the specific annual percentage update methodology. In accordance with § 484.225(i), for a HHA that does not submit HH quality data, as specified by the Secretary, the unadjusted national prospective 60-day episode rate is equal to the rate for the previous calendar year increased by the applicable HH market basket index amount minus 2 percentage points. Any reduction of the percentage change would apply only to the calendar year involved and would not be considered in computing the prospective payment amount for a subsequent calendar year.
Medicare pays the national, standardized 60-day case-mix and wage-adjusted episode payment on a split percentage payment approach. The split percentage payment approach includes an initial percentage payment and a final percentage payment as set forth in § 484.205(b)(1) and (b)(2). We may base the initial percentage payment on the submission of a request for anticipated payment (RAP) and the final percentage payment on the submission of the claim for the episode, as discussed in § 409.43. The claim for the episode that the HHA submits for the final percentage payment determines the total payment amount for the episode and whether we make an applicable adjustment to the 60-day case-mix and wage-adjusted episode payment. The end date of the 60-day episode as reported on the claim determines which calendar year rates Medicare will use to pay the claim.
We may also adjust the 60-day case-mix and wage-adjusted episode payment based on the information submitted on the claim to reflect the following:
• A low-utilization payment adjustment (LUPA) is provided on a per-visit basis as set forth in §§ 484.205(c) and 484.230.
• A partial episode payment (PEP) adjustment as set forth in §§ 484.205(d) and 484.235.
• An outlier payment as set forth in §§ 484.205(e) and 484.240.
Section 1895(b)(3)(A)(i) of the Act requires that the 60-day episode base rate and other applicable amounts be standardized in a manner that eliminates the effects of variations in relative case-mix and area wage adjustments among different home health agencies in a budget neutral manner. To determine the CY 2019 national, standardized 60-day episode payment rate, we apply a wage index
To calculate the wage index budget neutrality factor, we simulated total payments for non-LUPA episodes using the CY 2019 wage index (including the application of the labor-related share of 76.1 percent and the non-labor-related share of 23.9 percent) applied to CY 2017 utilization (claims) data and compared it to our simulation of total payments for non-LUPA episodes using the CY 2018 wage index (including the application of the current labor-related share of 78.535 percent and the non-labor-related of 21.465) applied to CY 2017 utilization (claims) data. By dividing the total payments for non-LUPA episodes using the CY 2019 wage index by the total payments for non-LUPA episodes using the CY 2018 wage index, we obtain a wage index budget neutrality factor of 0.9985. We will apply the wage index budget neutrality factor of 0.9985 to the calculation of the CY 2019 national, standardized 60-day episode payment rate.
As discussed in section III.B. of this final rule with comment period, to ensure the changes to the case-mix weights are implemented in a budget neutral manner, we proposed to apply a case-mix weight budget neutrality factor to the CY 2019 national, standardized 60-day episode payment rate. The case-mix weight budget neutrality factor is calculated as the ratio of total payments when CY 2019 case-mix weights are applied to CY 2017 utilization (claims) data to total payments when CY 2018 case-mix weights are applied to CY 2017 utilization data. The case-mix budget neutrality factor for CY 2019 is 1.0169 as described in section III.B. of this final rule with comment period. Next, we apply the payment rates by the CY 2019 home health payment update percentage of 2.2 percent as described in section III.C.2. of this final rule with comment period. The CY 2019 national, standardized 60-day episode payment rate is calculated in Table 16.
The CY 2019 national, standardized 60-day episode payment rate for an HHA that does not submit the required quality data is updated by the CY 2019 home health payment update of 2.2 percent minus 2 percentage points and is shown in Table 17.
The national per-visit rates are used to pay LUPAs (episodes with four or fewer visits) and are also used to compute imputed costs in outlier calculations. The per-visit rates are paid by type of visit or HH discipline. The six HH disciplines are as follows:
• Home health aide (HH aide).
• Medical Social Services (MSS).
• Occupational therapy (OT).
• Physical therapy (PT).
• Skilled nursing (SN).
• Speech-language pathology (SLP).
To calculate the CY 2019 national per-visit rates, we started with the CY 2018 national per-visit rates. Then we applied a wage index budget neutrality factor to ensure budget neutrality for LUPA per-visit payments. We calculated the wage index budget neutrality factor by simulating total payments for LUPA episodes using the CY 2019 wage index and comparing it to simulated total payments for LUPA episodes using the CY 2018 wage index. By dividing the total payments for LUPA episodes using the CY 2019 wage index by the total payments for LUPA episodes using the CY 2018 wage index, we obtained a wage index budget neutrality factor of 0.9996. We apply the wage index budget neutrality factor of 0.9996 in order to
The LUPA per-visit rates are not calculated using case-mix weights. Therefore, no case-mix weights budget neutrality factor is needed to ensure budget neutrality for LUPA payments. Lastly, the per-visit rates for each discipline are updated by the CY 2019 home health payment update percentage of 2.2 percent. The national per-visit rates are adjusted by the wage index based on the site of service of the beneficiary. The per-visit payments for LUPAs are separate from the LUPA add-on payment amount, which is paid for episodes that occur as the only episode or initial episode in a sequence of adjacent episodes. The CY 2019 national per-visit rates for HHAs that submit the required quality data are updated by the CY 2019 HH payment update percentage of 2.2 percent and are shown in Table 18.
The CY 2019 per-visit payment rates for HHAs that do not submit the required quality data are updated by the CY 2019 HH payment update percentage of 2.2 percent minus 2 percentage points and are shown in Table 19.
LUPA episodes that occur as the only episode or as an initial episode in a sequence of adjacent episodes are adjusted by applying an additional amount to the LUPA payment before adjusting for area wage differences. In the CY 2014 HH PPS final rule (78 FR 72305), we changed the methodology for calculating the LUPA add-on amount by finalizing the use of three LUPA add-on factors: 1.8451 for SN; 1.6700 for PT; and 1.6266 for SLP. We multiply the per-visit payment amount for the first SN, PT, or SLP visit in LUPA episodes that occur as the only episode or an initial episode in a sequence of adjacent episodes by the appropriate factor to determine the LUPA add-on payment amount. For example, in the case of HHAs that do submit the required quality data, for LUPA episodes that occur as the only episode or an initial episode in a sequence of adjacent episodes, if the first skilled visit is SN, the payment for that visit will be $270.27 (1.8451 multiplied by $146.48), subject to area wage adjustment.
All medical supplies (routine and non-routine) must be provided by the HHA while the patient is under a home health plan of care. Examples of supplies that can be considered non-routine include dressings for wound care, I.V. supplies, ostomy supplies, catheters, and catheter supplies. Payments for NRS are computed by multiplying the relative weight for a particular severity level by the NRS conversion factor. To determine the CY 2019 NRS conversion factor, we updated the CY 2018 NRS conversion
Using the CY 2019 NRS conversion factor, the payment amounts for the six severity levels are shown in Table 21.
For HHAs that do not submit the required quality data, we updated the CY 2018 NRS conversion factor ($53.03) by the CY 2019 home health payment update percentage of 2.2 percent minus 2 percentage points. The CY 2019 NRS conversion factor for HHAs that do not submit quality data is shown in Table 22.
The payment amounts for the various severity levels based on the updated conversion factor for HHAs that do not submit quality data are calculated in Table 23.
The following is a summary of the public comments received on the CY 2019 Annual Payment Update and our responses.
Over the 2011 to 2018 time period, the home health market basket update and home health payment rates have been reduced to reflect other statutorily required adjustments (such as the MFP adjustment (required by section 1895(b)(3)(B)(vi) of the Social Security Act), and rebasing adjustments to the national, standardized 60-day episode payment rates (required under section 3131(a) of the Patient Protection and Affordable Care Act of 2010 (Pub. L. 111-148), as amended by the Health Care and Education Reconciliation Act of 2010 (Pub. L. 111-152)). In some years, this has resulted in the 60-day episode payment rates being less than in prior years. The rationale and methodology regarding these other adjustments, along with CMS response to comments, can be found in prior CY HH PPS proposed and final rules.
We would note, however, that since PPS implementation and particularly over the 2011 to 2016 time period, according to MedPAC, freestanding home health agency margins have averaged roughly 14 percent. Furthermore, as shown in the 2016-based home health market basket, approximately 76 percent of home health costs are compensation costs; therefore, we disagree with the commenter's claims that they are unable to attract and retain medically trained personnel due to insufficient payment updates.
Section 421(a) of the MMA required, for HH services furnished in a rural area (as defined in section 1886(d)(2)(D) of the Act), for episodes or visits ending on or after April 1, 2004, and before April 1, 2005, that the Secretary increase the payment amount that otherwise would have been made under section 1895 of the Act for the services by 5 percent.
Section 5201 of the DRA amended section 421(a) of the MMA. The amended section 421(a) of the MMA required, for HH services furnished in a rural area (as defined in section 1886(d)(2)(D) of the Act), on or after January 1, 2006, and before January 1, 2007, that the Secretary increase the payment amount otherwise made under section 1895 of the Act for those services by 5 percent.
Section 3131(c) of the Affordable Care Act amended section 421(a) of the MMA to provide an increase of 3 percent of the payment amount otherwise made under section 1895 of the Act for HH services furnished in a rural area (as defined in section 1886(d)(2)(D) of the Act), for episodes and visits ending on or after April 1, 2010, and before January 1, 2016.
Section 210 of the MACRA amended section 421(a) of the MMA to extend the rural add-on by providing an increase of 3 percent of the payment amount otherwise made under section 1895 of the Act for HH services provided in a rural area (as defined in section 1886(d)(2)(D) of the Act), for episodes and visits ending before January 1, 2018.
Section 50208(a) of the Bipartisan Budget Act of 2018 amended section 421(a) of the MMA to extend the rural add-on by providing an increase of 3 percent of the payment amount otherwise made under section 1895 of the Act for HH services provided in a rural area (as defined in section 1886(d)(2)(D) of the Act), for episodes and visits ending before January 1, 2019.
Section 50208(a)(1)(D) of the BBA of 2018 adds a new subsection (b) to section 421 of the MMA to provide rural add-on payments for episodes and visits ending during CYs 2019 through 2022. It also mandates implementation of a new methodology for applying those payments. Unlike previous rural add-ons, which were applied to all rural areas uniformly, the extension provides varying add-on amounts depending on the rural county (or equivalent area) classification by classifying each rural county (or equivalent area) into one of three distinct categories: (1) Rural counties and equivalent areas in the highest quartile of all counties and equivalent areas based on the number of Medicare home health episodes furnished per 100 individuals who are entitled to, or enrolled for, benefits under part A of Medicare or enrolled for benefits under part B of Medicare only, but not enrolled in a Medicare Advantage plan under part C of Medicare (the “High utilization” category); (2) rural counties and equivalent areas with a population density of 6 individuals or fewer per square mile of land area and are not included in the “High utilization” category (the “Low population density” category); and (3) rural counties and equivalent areas not in either the “High utilization” or “Low population density” categories (the “All other” category).
The proposed rule outlined how we categorized rural counties (or equivalent areas) into the three distinct categories outlined in section 50208 of the BBA of 2018 based on CY 2015 claims data and 2015 data from the Medicare Beneficiary Summary File, as well as 2010 Census data. The rural add-on percentages and duration of rural add-on payments outlined in law are shown in Table 25. The HH Pricer module, located within CMS' claims processing system, will increase the base payment rates provided in Tables 16 through 23 by the appropriate rural add-on percentage prior to applying any case-mix and wage index adjustments.
The proposed rule further described the provisions of section 50208(a)(2) of the Bipartisan Budget Act of 2018, which amended section 1895(c) of the Act by adding a new requirement set out at section 1895(c)(3) of the Act. This requirement states that no claim for home health services may be paid unless “in the case of home health services furnished on or after January 1, 2019, the claim contains the code for the county (or equivalent area) in which the home health service was furnished.” This information will be necessary in order to calculate the rural add-on payments. We proposed that HHAs enter the FIPS state and county code, rather than the SSA state and county code, on the claim.
The data used to categorize each county or equivalent area is available in the Downloads section associated with the publication of the proposed rule at:
The following is a summary of the public comments received on the proposal for Rural Add-on Payments for CYs 2019 through 2022 and our responses:
Section 1895(b)(5) of the Act allows for the provision of an addition or adjustment to the home health payment amount otherwise made in the case of outliers because of unusual variations in the type or amount of medically necessary care. Under the HH PPS, outlier payments are made for episodes whose estimated costs exceed a threshold amount for each Home Health Resource Group (HHRG). The episode's estimated cost was established as the sum of the national wage-adjusted per-visit payment amounts delivered during the episode. The outlier threshold for each case-mix group or Partial Episode Payment (PEP) adjustment is defined as the 60-day episode payment or PEP adjustment for that group plus a fixed-dollar loss (FDL) amount. For the purposes of the HH PPS, the FDL amount is calculated by multiplying the HH FDL ratio by a case's wage-adjusted national, standardized 60-day episode payment rate, which yields an FDL dollar amount for the case. The outlier threshold amount is the sum of the wage and case-mix adjusted PPS episode amount and wage-adjusted FDL amount. The outlier payment is defined to be a proportion of the wage-adjusted estimated cost beyond the wage-adjusted threshold. The proportion of additional costs over the outlier threshold amount paid as outlier payments is referred to as the loss-sharing ratio.
As we noted in the CY 2011 HH PPS final rule (75 FR 70397 through 70399), section 3131(b)(1) of the Affordable Care Act amended section 1895(b)(3)(C) of the Act, and required the Secretary to reduce the HH PPS payment rates such that aggregate HH PPS payments were reduced by 5 percent. In addition, section 3131(b)(2) of the Affordable Care Act amended section 1895(b)(5) of the Act by redesignating the existing language as section 1895(b)(5)(A) of the Act, and revising the language to state that the total amount of the additional payments or payment adjustments for outlier episodes could not exceed 2.5 percent of the estimated total HH PPS payments for that year. Section 3131(b)(2)(C) of the Affordable Care Act also added section 1895(b)(5)(B) of the Act which capped outlier payments as a percent of total payments for each HHA at 10 percent.
As such, beginning in CY 2011, we reduce payment rates by 5 percent and target up to 2.5 percent of total estimated HH PPS payments to be paid as outliers. To do so, we first returned the 2.5 percent held for the target CY 2010 outlier pool to the national, standardized 60-day episode rates, the national per visit rates, the LUPA add-on payment amount, and the NRS conversion factor for CY 2010. We then reduced the rates by 5 percent as required by section 1895(b)(3)(C) of the Act, as amended by section 3131(b)(1) of the Affordable Care Act. For CY 2011 and subsequent calendar years we target up to 2.5 percent of estimated total payments to be paid as outlier
In the CY 2017 HH PPS proposed and final rules (81 FR 43737 through 43742 and 81 FR 76702), we described our concerns regarding patterns observed in home health outlier episodes. Specifically, we noted that the methodology for calculating home health outlier payments may have created a financial incentive for providers to increase the number of visits during an episode of care in order to surpass the outlier threshold; and simultaneously created a disincentive for providers to treat medically complex beneficiaries who require fewer but longer visits. Given these concerns, in the CY 2017 HH PPS final rule (81 FR 76702), we finalized changes to the methodology used to calculate outlier payments, using a cost-per-unit approach rather than a cost-per-visit approach. This change in methodology allows for more accurate payment for outlier episodes, accounting for both the number of visits during an episode of care and also the length of the visits provided. Using this approach, we now convert the national per-visit rates into per 15-minute unit rates. These per 15-minute unit rates are used to calculate the estimated cost of an episode to determine whether the claim will receive an outlier payment and the amount of payment for an episode of care. In conjunction with our finalized policy to change to a cost-per-unit approach to estimate episode costs and determine whether an outlier episode should receive outlier payments, in the CY 2017 HH PPS final rule we also finalized the implementation of a cap on the amount of time per day that would be counted toward the estimation of an episode's costs for outlier calculation purposes (81 FR 76725). Specifically, we limit the amount of time per day (summed across the six disciplines of care) to 8 hours (32 units) per day when estimating the cost of an episode for outlier calculation purposes.
We plan to publish the cost-per-unit amounts for CY 2019 in the rate update change request, which is issued after the publication of the CY 2019 HH PPS final rule. We note that in the CY 2017 HH PPS final rule (81 FR 76724), we stated that we did not plan to re-estimate the average minutes per visit by discipline every year. Additionally, we noted that the per-unit rates used to estimate an episode's cost will be updated by the home health update percentage each year, meaning we would start with the national per- visit amounts for the same calendar year when calculating the cost-per-unit used to determine the cost of an episode of care (81 FR 76727). We note that we will continue to monitor the visit length by discipline as more recent data become available, and we may propose to update the rates as needed in the future.
For a given level of outlier payments, there is a trade-off between the values selected for the FDL ratio and the loss-sharing ratio. A high FDL ratio reduces the number of episodes that can receive outlier payments, but makes it possible to select a higher loss-sharing ratio, and therefore, increase outlier payments for qualifying outlier episodes. Alternatively, a lower FDL ratio means that more episodes can qualify for outlier payments, but outlier payments per episode must then be lower.
The FDL ratio and the loss-sharing ratio must be selected so that the estimated total outlier payments do not exceed the 2.5 percent aggregate level (as required by section 1895(b)(5)(A) of the Act). Historically, we have used a value of 0.80 for the loss-sharing ratio which, we believe, preserves incentives for agencies to attempt to provide care efficiently for outlier cases. With a loss-sharing ratio of 0.80, Medicare pays 80 percent of the additional estimated costs above the outlier threshold amount.
Simulations based on CY 2015 claims data (as of June 30, 2016) completed for the CY 2017 HH PPS final rule showed that outlier payments were estimated to represent approximately 2.84 percent of total HH PPS payments in CY 2017, and as such, we raised the FDL ratio from 0.45 to 0.55. We stated that raising the FDL ratio to 0.55, while maintaining a loss-sharing ratio of 0.80, struck an effective balance of compensating for high-cost episodes while still meeting the statutory requirement to target up to, but no more than, 2.5 percent of total payments as outlier payments (81 FR 76726). The national, standardized 60-day episode payment amount is multiplied by the FDL ratio. That amount is wage-adjusted to derive the wage-adjusted FDL amount, which is added to the case-mix and wage-adjusted 60-day episode payment amount to determine the outlier threshold amount that costs have to exceed before Medicare would pay 80 percent of the additional estimated costs.
In the CY 2019 proposed rule, we simulated payments using preliminary CY 2017 claims data (as of March 2, 2018) and the CY 2018 HH PPS payment rates (82 FR 51676), and estimated that outlier payments in CY 2018 would comprise 2.30 percent of total payments and approximately 2.32 percent of total HH PPS payments in CY 2019. Our simulations showed that the FDL ratio would need to be changed from 0.55 to 0.51 to pay up to, but no more than, 2.5 percent of total payments as outlier payments in CY 2019.
Given the statutory requirement that total outlier payments not exceed 2.5 percent of the total payments estimated to be made based under the HH PPS, in the CY 2019 proposed rule, we proposed to lower the FDL ratio for CY 2019 from 0.55 to 0.51 to better approximate the 2.5 percent statutory maximum. However, we noted that we were not proposing a change to the loss-sharing ratio (0.80) for the HH PPS to remain consistent with payment for high-cost outliers in other Medicare payment systems (for example, IRF PPS, IPPS, etc.).
Using updated CY 2017 claims data (as of June 30, 2018) and the final CY 2019 payment rates presented in section III.C of this final rule with comment period, we estimate that outlier payments would continue to constitute approximately 2.47 percent of total HH PPS payments in CY 2019 under the current outlier methodology. Given the statutory requirement to target up to, but no more than, 2.5 percent of total payments as outlier payments, we believe that modifying the FDL ratio from 0.55 to 0.51 with a loss-sharing ratio of 0.80 is appropriate given the percentage of outlier payments projected for CY 2019.
In the CY 2019 HH PPS proposed rule, we also described clinical examples of how care for a patient with ALS could qualify for an additional outlier payment, which would serve to offset unusually high costs associated with providing home health to a patient with unusual variations in the amount of medically necessary care. (83 FR 32340).
The following is a summary of the comments received on outlier payments under the HH PPS and our responses.
To better align payment with patient care needs and better ensure that clinically complex and ill beneficiaries have adequate access to home health care, we proposed case-mix methodology refinements through the
Costs during an episode/period of care are estimated based on the concept of resource use, which measures the costs associated with visits performed during a home health episode/period. For the current HH PPS case-mix weights, we use Wage Weighted Minutes of Care (WWMC), which uses data from the Bureau of Labor Statistics (BLS) reflecting the Home Health Care Service Industry. For the PDGM, we proposed shifting to a Cost-Per-Minute plus Non-Routine Supplies (CPM + NRS) approach, which uses information from the Medicare Cost Report. The CPM + NRS approach incorporates a wider variety of costs (such as transportation) compared to the BLS estimates and the costs are available for individual HHA providers while the BLS costs are aggregated for the Home Health Care Service industry.
Similar to the current payment system, we proposed that 30-day periods under the PDGM would be classified as “early” or “late” depending on when they occur within a sequence of 30-day periods. Under the current HH PPS, the first two 60-day episodes of a sequence of adjacent 60-day episodes are considered early, while the third 60-day episode of that sequence and any subsequent episodes are considered late. Under the PDGM, we proposed that the first 30-day period would be classified as early and all subsequent 30-day periods in the sequence (second or later) would be classified as late. We proposed to adopt this episode timing classification for 30-day periods with the implementation of the PDGM. Similar to the current payment system, we proposed that a 30-day period could not be considered early unless there was a gap of more than 60 days between the end of one period and the start of another. The comprehensive assessment would still be completed within 5 days of the start of care date and completed no less frequently than during the last 5 days of every 60 days beginning with the start of care date, as currently required by § 484.55, “Condition of participation: Comprehensive assessment of patients.”
Under the PDGM, we proposed that each 30-day period would also be classified into one of two admission source categories—community or institutional—depending on what healthcare setting was utilized in the 14 days prior to home health. The 30-day period would be categorized as institutional if an acute or post-acute care stay occurred within the prior 14 days to the start of the 30-day period of care. The 30-day period would be categorized as community if there was no acute or post-acute care stay in the 14 days prior to the start of the 30-day period of care.
We proposed further grouping 30-day periods into one of six clinical groups based on the principal diagnosis. The principal diagnosis reported would provide information to describe the primary reason for which patients were receiving home health services under the Medicare home health benefit. The proposed six clinical groups, were as follows:
• Musculoskeletal Rehabilitation.
• Neuro/Stroke Rehabilitation.
• Wounds- Post-Op Wound Aftercare and Skin/Non-Surgical Wound Care.
• Complex Nursing Interventions.
• Behavioral Health Care.
• Medication Management, Teaching and Assessment (MMTA).
Under the PDGM, we proposed that each 30-day period would be placed into one of three functional impairment levels. The level would indicate if, on average, given the HHA's responses on certain functional OASIS questions, a 30-day period was predicted to have higher costs or lower costs. For each of the six clinical groups, we proposed that total periods would be further classified into one of three functional impairment levels with roughly 33 percent of total 30-day periods for all HHAs in each level. We determined how many periods of care would be in each functional impairment level based on the relative number of periods in a potential impairment level, and on the clustering of summed functional scores. The functional impairment level assignment under the PDGM is very similar to the functional level assignment in the current payment system.
Finally, we proposed that 30-day periods would receive a comorbidity adjustment category based on the presence of secondary diagnoses. We proposed that, depending on a patient's secondary diagnoses, a 30-day period may receive “no” comorbidity adjustment, a “low” comorbidity adjustment, or a “high” comorbidity adjustment. For low-utilization payment adjustments (LUPAs) under the PDGM, we proposed that the LUPA threshold would vary for a 30-day period under the PDGM depending on the PDGM payment group to which it was assigned. For each payment group, we proposed to use the 10th percentile value of visits to create a payment group specific LUPA threshold with a minimum threshold of at least 2 visits for each group.
The proposed rule further outlined the data file construction process for the PDGM-related analyses, including the claims data used, how the data were cleaned, how OASIS data were matched to claims data, how measures of resource use were constructed, and the total number of 30-day periods used for constructing the PDGM case-mix weights in the proposed rule (82 FR 35297 through 35298).
The following is a summary of general comments received on the proposals and our responses.
On February 1, 2018, CMS convened another TEP to gather perspectives and identify and prioritize recommendations from industry leaders, clinicians, patient representatives, and researchers with experience with home health care and/or experience in home health agency management regarding the case-mix adjustment methodology refinements described in the CY 2018 HH PPS proposed rule (82 FR 35270), and alternative case-mix models submitted during 2017 as comments to the CY 2018 HH PPS proposed rule. During the TEP, there was a description and solicitation of feedback on the components of the proposed case-mix methodology refinement, such as resource use, 30-day periods, clinical groups, functional levels, comorbidity groups, and other variables used to group periods into respective case-mix groups. Also discussed were the comments received from the CY 2018 HH PPS proposed rule, the creation of case-mix weights, and an open discussion to solicit feedback and recommendations for next steps. This TEP satisfied the requirement set forth in section 51001(b)(1) of the BBA of 2018, which requires that at least one session of such a TEP be held between January 1, 2018 and December 31, 2018. In addition, section 51001(b)(3) of the BBA of 2018 requires the Secretary to issue a report to the Committee on Ways and Means and Committee on Energy and Commerce of the House of Representatives and the Committee on Finance of the Senate on the recommendations from the TEP members, no later than April 1, 2019. This report has already been completed and is available on the CMS HHA Center web page at:
We believe that the proposed PDGM could assist with meeting the IMPACT Act requirement that the Secretary of Health and Human Services develop a technical prototype for a unified post-acute care (PAC) prospective payment system (PAC PPS). We believe many aspects of the PDGM could be used in a unified PAC PPS prototype so that payments under such a prototype would be based according to individual characteristics, as specified by the IMPACT Act. We do not believe that the PDGM will disrupt the HHVBP Model or the Home Health star ratings. The PDGM is a case-mix adjustment model intended to pay for services more accurately and we believe the HHVBP Model and the Home Health star ratings can continue unchanged when HHA periods of care are paid according to the case-mix adjustments of the PDGM. We do not believe the implementation of the PDGM will eliminate the rationale behind the proposed Review Choice Demonstration for Home Health Services. The PDGM is a case-mix adjustment model with the goal of better aligning home health payments with patient care needs and the cost of care, while the proposed Review Choice Demonstration for Home Health Services would be a demonstration aimed at assisting in the development of improved procedures to identify, investigate, and prosecute potential Medicare fraud occurring among HHAs providing services to Medicare beneficiaries.
With regards to inaccurate assignments to payment classifications under the PDGM, corrections to payment classifications on claims will not require appealing the initial determination. Because the assignment of the payment classification will be performed by the claims system based on data reported by the HHA on the claim or the corresponding patient assessment, the provider could correct this information to change the assignment. The HHA could submit a correction OASIS assessment and subsequently adjust their claim after the corrected assessment is accepted, or simply correct the payment-related items on the claim (occurrence code, diagnosis code, etc.) and submit the adjusted claim.
To construct the case-mix weights for the PDGM proposal, the costs of providing care needed to be determined. A Wage-Weighted Minutes of Care (WWMC) approach is used in the current payment system based on data from the BLS. However, we proposed to adopt a Cost-per-Minute plus Non-Routine Supplies (CPM+NRS) approach, which uses information from HHA Medicare cost reports and home health claims. Under the proposed PDGM, we group periods of care into their case-mix groups taking into account admission source, timing, clinical group, functional level, and comorbidity adjustment. From there, the average resource use for each case-mix group dictates the group's case-mix weight. We proposed that resource use is the estimated cost of visits recorded on the home health claim plus the cost of NRS recorded on the claims. The cost of NRS is generated by taking NRS charges on claims and converting them to costs using a NRS cost to charge ratio that is specific to each HHA. When NRS is factored into the average resource use, NRS costs are reflected in the average resource use that establishes the case-mix weights. Similar to the current system, NRS would still be paid prospectively under the PDGM, but the PDGM eliminates the separate case-mix adjustment model for NRS. See the proposed rule for more detail on the steps used to generate the measure of resource use under the proposedCPM+NRS approach (83 FR 32385 through 32388).
The following is a summary of the public comments received on the “Methodology Used to Calculate the Cost of Care” proposal and our responses.
In response to comments regarding the accuracy of HHA Medicare cost report data, as we indicated in the proposed rule, we applied the trimming methodology described in detail in the “Analyses in Support of Rebasing & Updating Medicare Home Health Payment Rates” Report available at:
As always, we encourage providers to fill out the Medicare cost reports as accurately as possible. We remind the industry again that each home health cost report is required to be certified by the Officer or Director the home health agency. We also welcome suggestions for improving compliance and accuracy on cost reports within the current cost reporting forms. We will explore whether it is feasible to provide some sort of national, mandatory training on completing the Medicare HHA cost report form and whether and to what extent CMS can conduct more desk reviews and audits of Medicare HHA cost reports in the future.
With regards to the case-mix weights rewarding inefficient providers with high costs or facility-based HHAs, each HHA's costs impact only a portion of the calculation of the weights and costs are blended together across all HHAs. To put it simply, the payment regression was estimated using 8,521,924 30-day periods from 10,522 providers. On average, each provider contributed 841 30-day periods to the payment regression, which is only 0.010 percent of all 30-day periods. Therefore, including or excluding any single HHA on average would not dramatically impact the results of the payment regression. Additionally, in the PDGM, we estimate the payment regression using provider-level fixed effects; therefore we are looking at the within provider variation in resource use. That is, we may find there are two HHAs with different cost structures (for example, HHA “A”) has costs that are on average 1.5 times as high as HHA “B”) but both HHAs can still have similar patterns in resource use across their 30-day periods. Since the PDGM is controlling for the variation in the general costs for HHAs with high and lower costs, including those that have variation in costs due to being facility-based versus freestanding, we do not agree that using the CPM+NRS approach in estimating resource use introduces a bias that favors inefficient or facility-based HHAs.
As noted by the commenters, in the CY 2008 HH PPS proposed rule we stated that because the market for most NRS is national, we proposed not to have a geographic adjustment to the conversion factor (72 FR 25430). More accurately, because the NRS conversion factor reflected supplies and not wage and wage-related costs, we did not subject NRS payments to the geographic wage adjustment process. However, we
(1) From the cost reports, obtain total costs for each of the six home health disciplines for each HHA.
(2) From the cost reports, obtain the number of visits by each of the six home health disciplines for each HHA.
(3) Calculate discipline-specific cost per visit values by dividing total costs [1] by number of visits [2] for each discipline for each HHA. For HHAs that do not have a cost report available (or a cost report that was trimmed from the sample), imputed values are used as follows:
• A state-level mean is used if the HHA was not hospital-based. The state-level mean is computed using all non-hospital based HHAs in each state.
• An urban nationwide mean is used for all hospital-based HHAs located in a Core-based Statistical Area (CBSA). The urban nation-wide mean is computed using all hospital-based HHAs located in any CBSA.
• A rural nationwide mean is used for all hospital-based HHAs not in a CBSA. The rural nation-wide mean is computed using all hospital-based HHAs not in a CBSA.
(4) From the home health claims data, obtain the average number of minutes of care provided by each discipline across all episodes for a HHA.
(5) From the home health claims data, obtain the average number of visits provided by each discipline across all episodes for each HHA.
(6) Calculate a ratio of average visits to average minutes by discipline by dividing average visits provided [5] by average minutes of care [4] by discipline for each HHA.
(7) Calculate costs per minute by multiplying the HHA's cost per visit [3] by the ratio of average visits to average minutes [6] by discipline for each HHA.
(8) Obtain 30-day period costs by multiplying costs per minute [7] by the total number of minutes of care provided during a 30-day period by discipline. Then, sum these costs across the disciplines for each period.
NRS costs are added to the resource use calculated in [8] in the following way:
(9) From the cost reports, determine the NRS cost-to-charge ratio for each HHA. Imputation for missing or trimmed values is done in the same manner as it was done for cost per visit (see [3] as previously indicated).
(10) From the home health claims data, obtain NRS charges for each period.
(11) Obtain NRS costs for each period by multiplying charges from the home health claims data [10] by the cost-to-charge ratio from the cost reports [9] for each HHA.
Resource use is then obtained by:
(12) Summing costs from [8] with NRS costs from [11] for each 30-day period.
Currently, HHAs are paid for each 60-day episode of home health care provided. By examining the resources used within a 60-day episode of care, we identified differences in resources used between the first 30-day period within a 60-day episode and the second 30-day period within a 60-day episode. Episodes have more visits, on average, during the first 30 days compared to the last 30 days. Costs are much higher earlier in the episode and lesser later on, therefore, dividing a single 60-day episode into two 30-day periods more accurately apportions payments. In addition, with the removal of therapy thresholds from the case-mix adjustment methodology under the HH PPS, a shorter period of care reduces the variation and improves the accuracy of the case-mix weights generated under the PDGM.
Section 1895(b)(2)(B) of the Act, as added by section 51001(a)(1) of the BBA of 2018, requires the Secretary to apply a 30-day unit of service for purposes of implementing the HH PPS, effective January 1, 2020. We note that we interpret the term “unit of service” to be synonymous with “unit of payment” and will henceforth refer to “unit of payment” in this final rule with comment period with regards to payment under the HH PPS. Therefore, in accordance with section 1895(b)(2)(B) of the Act, we proposed changing the unit of payment from a 60-day episode of care to 30-day unit of payment, effective January 1, 2020.
We also note that not all home health requirements have a 60-day timeframe. For example, OASIS reporting regulations require the OASIS to be completed within 5 days and transmitted within 30 days of completing the assessment of the beneficiary. In addition, physical, occupational, and speech therapists must provide the needed therapy service and functionally reassess the patient at least every 30 calendar days. Home health is not the only care setting where billing and certifications are not done in the same timeframe. For example, hospices must certify and recertify patients every 60-90 days and they bill on a monthly basis. Previous to the inception of the HH PPS, HHAs also billed on a monthly basis even though the plan of care and certifications were completed every 60 days.
Just like in the current system, under the PDGM, before a provider submits a final claim, the HHA will need to have a completed OASIS assessment, signed certification, orders, and plan of care. Our expectation is that the HHA will obtain the signed physician certification and plan of care timely. As we have reiterated in previous rulemaking and in sub-regulatory guidance, the certification must be complete prior to when an HHA bills Medicare for payment; however, physicians should complete the certification when the plan of care is established, or as soon as possible thereafter. This is longstanding CMS policy as referenced in Pub 100-01, Medicare General Information, Eligibility, and Entitlement Manual, chapter 4, section 30.1.
For implementation purposes, the 30-day payment amount would be paid for home health services that start on or after January 1, 2020. More specifically, for 60-day episodes that begin on or before December 31, 2019 and end on or after January 1, 2020 (episodes that would span the January 1, 2020 implementation date), payment made under the Medicare HH PPS would be the CY 2020 national, standardized 60-day episode payment amount. For home health periods of care that begin on or after January 1, 2020, the unit of payment would now be a 30-day period and payment made under the Medicare HH PPS would be the CY 2020 national, standardized prospective 30-day payment amount. For home health periods of care that begin on or after December 2, 2020 through December 31, 2020 and end on or after January 1, 2021, the HHA would be paid the CY 2021 national, standardized prospective 30-day payment amount.
As we have stated, the requirements for when to update the comprehensive assessment remain unchanged. For example, if the HHA does not need to update the comprehensive assessment prior to recertifying the patient (for which the comprehensive assessment would be completed within the last 5 days of every 60 days beginning with the start of care date), then responses from the start of care OASIS would be used for determining the functional impairment level for both the first and second 30-day periods. The follow-up OASIS completed near the time of recertification would be used for the third and fourth 30-day periods of care. If, for example, the HHA needs to complete a resumption of care OASIS within 48 hours of the patient returning to home health after being transferred and admitted to the hospital for 24 hours or more and this occurs during the first 30-day period of care, then the responses for functional items from the resumption of care assessment would be used to determine the functional impairment level for the second 30-day period of care.
With regards to diagnosis codes, the PDGM uses the diagnoses from the home health claim to group a 30-day home health period of care into a clinical group and to determine if there is a comorbidity adjustment. If a home health patient has any changes in diagnoses (either the principal or secondary), this would be reflected on the home health claim and the case-mix weight could change accordingly. However, we would expect that the HHA clinical documentation would also reflect these changes and any communication/coordination with the certifying physician would also be documented. The home health CoPs at § 484.60(c) require that the HHA must promptly alert the relevant physician(s) to any changes in the patient's condition or needs that suggest that outcomes are not being achieved and/or that the plan of care should be altered.
Section 1895(b)(3)(A)(iv) of the Act, requires CMS to calculate a 30-day payment amount for CY 2020 in a budget neutral manner such that estimated aggregate expenditures under the HH PPS during CY 2020 are equal to the estimated aggregate expenditures that otherwise would have been made under the HH PPS during CY 2020 in the absence of the change to a 30-day unit of payment. As also required by 1895(b)(3)(A)(iv) of the Act, to calculate a 30-day payment amount in a budget- neutral manner, we are required to make assumptions about, and take into account behavior changes that could occur as a result of the implementation of the 30-day unit of payment and case-mix adjustment factors in CY 2020. We are also required to calculate a budget-neutral 30-day payment amount before the provisions of section 1895(b)(3)(B) of the Act are applied, that is, before application of the home health applicable percentage increase, the adjustment for case-mix changes, the adjustment if quality data is not reported, and the productivity adjustment.
To calculate the 30-day budget-neutral payment amount, we proposed three assumptions about behavior change that could occur in CY 2020 as a result of the implementation of the 30-day unit of payment and the implementation of the PDGM case-mix adjustment methodology:
• Clinical Group Coding: This is based on the principal diagnosis code for the patient as reported by the HHA on the home health claim. Our proposed assumption was that HHAs will change their documentation and coding practices and put the highest paying diagnosis code as the principal diagnosis code in order to have a 30-day period be placed into a higher-paying clinical group.
• Comorbidity Coding: The PDGM further adjusts payments based on patients' secondary diagnoses as reported by the HHA on the home health claim. OASIS only allows HHAs to designate 1 principal diagnosis and 5 secondary diagnoses while the home health claim allows HHAs to designate 1 principal diagnosis and 24 secondary diagnoses. Our proposed assumption was that by taking into account additional ICD-10-CM diagnosis codes listed on the home health claim (beyond the 6 allowed on the OASIS), more 30-day periods of care will receive a comorbidity adjustment
• LUPA Threshold: Under the proposed PDGM, our proposed assumption was that for one-third of LUPAs that are 1 to 2 visits away from the LUPA threshold HHAs will provide 1 to 2 extra visits to receive a full 30-day payment.
If no behavioral assumptions were made, we estimated that the 30-day payment amount needed to achieve budget neutrality would be $1,873.91. The clinical group and comorbidity coding assumptions would result in the need to decrease the budget-neutral 30-day payment amount to $1,786.54 (a 4.66 percent decrease from $1,873.91). Adding the LUPA assumption would require us to further decrease that amount to $1,753.68 (a 6.42 percent decrease from $1,873.91). Because we proposed to implement the 30-day unit of payment and the PDGM for CY 2020, we would propose the actual 30-day payment amount in the CY 2020 HH PPS proposed rule calculated using CY 2018 home health utilization data and we would calculate this amount before application of the proposed home health update percentage required for CY 2020 (as required by section 1895(b)(3)(B)(i) of the Act). In the proposed rule, we noted that we are also required under section 1895(b)(3)(D)(i) of the Act, as added by section 51001(a)(2)(B) of the BBA of 2018, to analyze data for CYs 2020 through 2026, after implementation of the 30-day unit of payment and new case-mix adjustment methodology, to annually determine the impact of differences between assumed behavior changes and actual behavior changes on estimated aggregate expenditures. We interpret actual behavior change to encompass both behavior changes that were previously outlined, as assumed by CMS when determining the budget-neutral 30-day payment amount for CY 2020, and other behavior changes not identified at the time the 30-day payment amount for CY 2020 is determined.
We solicited comments on the proposed behavior change assumptions previously outlined to be used in determining the 30-day payment amount for CY 2020.
The following is a summary of the public comments received on the “30-day Unit of Payment” proposals and our responses.
While certain commenters seem to assume that CMS can precisely identify those agencies practicing abusive coding, we do not agree that agency specific case-mix levels can precisely distinguish the agencies that engage in abusive coding from all others. System wide, case-mix levels have risen over time throughout the country, while patient characteristics data indicate little real change in patient severity over time. That is, the main issue is not the level of case-mix billed by any specific HHA over a period of time, but the amount of change in the billed case-mix weights not attributable to underlying changes in actual patient severity. Therefore, while commenters provided specific suggestions for targeted efforts, we are unable to implement such actions for the reasons described. We note that we have taken various measures to reduce payment vulnerabilities and the federal government has launched actions to directly identify fraudulent and abusive activities. Commenters should be aware of tip lines available that can help support investigative efforts of the federal government. The Office of the Inspector General, Department of Health and Human Services website at:
Finally, we remind commenters that section 1895(b)(3)(A)(iv) of the Act requires that in calculating a 30-day budget-neutral payment amount, we are required to make assumptions about behavior changes that could occur as a result of the implementation of the 30-day unit of payment and a change to the case-mix adjustment methodology; therefore, we do not have the discretion to apply different policies. Likewise, we are required to analyze data for CYs 2020 through 2026, after implementation of the 30-day unit of payment and the alternate case-mix adjustment methodology, to annually determine the impact of the differences between assumed behavioral changes and actual behavioral changes on estimated aggregate expenditures and adjust the payment amount either upwards or downwards accordingly.
With regards to our assumption that HHAs would code the highest-paying diagnosis code as primary for the clinical grouping assignment, this assumption was based on decades of past experience under the case-mix system for the HH PPS and other case-mix systems for other payment systems, such as the implementation of the diagnosis-related groups (DRGs) and the Medicare Severity (MS)-DRGs under the inpatient prospective payment system. In the FY 2008 IPPS final rule (72 FR 47176), we noted that case-mix refinements can lead to substantial unwarranted increase in payments. To address this issue when CMS transitioned from DRGs to MS-DRGs, MedPAC recommended that the Secretary project the likely effect of reporting improvements on total payments and make an offsetting adjustment to the national average base payment amounts (72 FR 47176). In the FY 2008 IPPS final rule (72 FR 47181), we summarized instances where case-mix increases resulted from documentation and coding-induced changes for the first year of the IRF PPS and in Maryland hospitals' transition to APR DRGs (estimated at around 5 percent in both instances). Therefore, we estimated that a total adjustment of 4.8 percent would be necessary to maintain budget neutrality for the transition to the MS-DRGs (72 FR 47178).
In both the FY 2010 and FY 2011 IPPS final rules, subsequent analysis of claims data, using FYs 2008 and 2009 claims, supported the prospective payment adjustments to account for the documentation and coding effects (74 FR 43770 and 75 FR 50356). Specifically, we stated that based on our retrospective evaluation of claims, our actuaries determined that the implementation of the MS-DRG system resulted in a 2.5 percent change and a 5.4 percent change in case-mix not due to actual changes in patient characteristics, but due to documentation and coding changes for discharges occurring during FYs 2008 and 2009, respectively. We stated that the coding assumption is appropriate because, in the absence of such adjustments, the effect of the documentation and coding changes resulting from the adoption of the MS-DRGs results in inappropriately high payments because that portion of the increase in aggregate payments is not due to an increase in patient severity of illness (and costs).
With regards to experience under the HH PPS, we note that effective for CY 2008, CMS finalized changes to the HH PPS case-mix model to reflect different resource costs for early home health episodes versus later home health episodes and expanded the case-mix variables and therapy thresholds included in the payment model (72 FR 49764). These changes resulted in the 153 home health resource groups (HHRGs) currently used to case-mix adjust payment in the HH PPS. Since the CY 2008 proposed rule, we have stated in HH PPS rulemaking that we would continue to monitor case-mix
Our analysis shows that only about a third of 30-day periods move into a different clinical group as a result of the clinical group coding assumption, meaning that the reported secondary diagnosis(es) would place a period of care into a higher case-mix group under the PDGM if reported as the principal diagnosis. Clinically, there are circumstances in which it would be appropriate to report a higher paying code as the principal diagnosis. For example, if medical documentation notes that a patient was recently hospitalized for exacerbation of congestive heart failure (which, if reported as the principal diagnosis, would group a period of care into the clinical group, MMTA) and there is expected teaching by the HHA associated with the recent exacerbation, but the patient also has a stage 2 pressure ulcer (which, if reported as the principal diagnosis, would group a period of care into the clinical group, Wounds) that requires wound care, we believe it would be appropriate to report the pressure ulcer as the principal diagnosis as the pressure ulcer would likely take priority as the primary reason for home health care in terms of increased resource utilization. However, the teaching associated with the exacerbation of heart failure would be a secondary reason, but still an important additional reason for home health care, and congestive heart failure would be reported as an additional diagnosis on the home health claim. In the current HH PPS, the assignment of points as part of the clinical level in the case-mix methodology is dependent upon the reporting of diagnoses. However, the points assigned are not generally dependent on whether the diagnosis is reported as the primary diagnosis or other diagnosis, except for a few exceptions. This means, that for most of the clinical point assignments, the ordering of the diagnosis does not matter as much as whether the diagnosis is present or not. For example, if a cancer diagnosis is reported, there are the same number of associated clinical points regardless of whether the cancer diagnosis is reported as a principal diagnosis or as a secondary diagnosis. However, under the PDGM, the ordering of diagnoses is important in determining the clinical group and the comorbidity adjustment, so we do expect that HHAs will improve the ordering of diagnosis codes to ensure that the home health period of care is representative of patient characteristics and paid accordingly. Furthermore, the implementation of ICD-10-CM has expanded the diagnosis code set significantly, making it possible for HHAs to more accurately and specifically code conditions present in the home health patient population.
With regards to the comorbidity coding assumption, using the home health claim for the comorbidity adjustment as opposed to OASIS provides more opportunity to report all comorbid conditions that may affect the home health plan of care. The OASIS item set only allows HHAs to designate up to 5 secondary diagnoses, while the home health claim (837I institutional claim format-electronic version of the paper UB-04) allows HHAs to report up to 24 secondary diagnoses. Additionally, because ICD-10 coding guidelines require reporting of all secondary diagnoses that affect the plan of care, we would expect that more secondary diagnoses would be reported on the home health claim given the increased number of secondary diagnosis fields on the home health claim compared to the OASIS item set. Therefore, we assume that by taking into account additional ICD-10-CM diagnosis codes listed on the home health claim, more 30-day periods of care will receive a comorbidity adjustment than periods otherwise would have received if we only used the OASIS diagnosis codes for payment. Furthermore, because the comorbidity adjustment in the PDGM can increase payment by up to 20 percent, we assume that HHAs will ensure that secondary diagnoses affecting the home health plan of care would be reported to more accurately identify the conditions affecting resource use.
Regarding the LUPA threshold assumption, as noted in the FY 2001 HH PPS final rule, the episode file showed that approximately 16 percent of episodes would have received a LUPA (65 FR 41162). However, currently, only about 7 percent of all 60-day episodes receive a LUPA. In other words, it appears HHAs changed practice patterns such that more than half of 60-day episodes that would have been LUPAs upon implementation of the HH PPS are now non-LUPAs. Current data for CY 2017 suggest that what would be about one-third of the LUPA episodes with visits near the LUPA threshold would move up to become non-LUPA episodes as we currently see clustering of episodes at and around the current LUPA threshold of 5 visits. Under the current 60-day episode structure, there is a natural breaking point in the distribution of episodes between those with 4 or fewer visits (LUPAs) and those with 5 or more visits (non-LUPAs). The distribution around this breaking point of episodes as a percent of total episodes has remained fairly constant over the last few years. In particular, the episodes with 2, 3, or 4 visits are similar, with each comprising about 2.4 percent of total episodes. Likewise, the
We disagree with those commenters who state that the behavioral assumptions basically construct a completely new payment system that is predicated on gaming of the system. The goal of the proposed PDGM is to more accurately pay for home health services based on patient characteristics. As previously noted, section 1895(b)(3)(A)(iv) of the Act requires that behavioral assumptions be made in calculating the payment amount for CY 2020 so that the estimated aggregate amount of expenditures under the HH PPS in CY 2020 is equal to the estimate aggregate amount of expenditures in CY 2020 that otherwise would have been made under the HH PPS if the change to a 30-day unit of payment had not been enacted. Furthermore, we remind commenters that the law requires that CMS analyze data for CYs 2020 through 2026, after implementation of the 30-day unit of payment and the alternate case-mix adjustment methodology, to annually determine the impact of the differences between assumed and actual behavioral changes on estimated aggregate expenditures and adjust the payment amount either upwards or downwards accordingly. As such, we do not believe the law provides the latitude to test behavioral assumptions prior to implementation of the 30-day unit of payment and the PDGM for CY 2020 given these requirements, in law, to make behavioral assumptions in calculating a 30-day budget-neutral payment amount for CY 2020 and to determine the impact on estimated aggregate expenditures of differences between the assumed and actual behavior changes once the data for CYs 2020 through 2026 become available to determine whether temporary and permanent adjustments are needed.
We believe that, as described in the CY 2019 HH PPS proposed rule and throughout this final rule with comment period, we have provided sufficient detail for these behavioral assumptions as well as referenced past rules in which nominal case-mix change has been evaluated. The reconciliation process involving temporary and permanent adjustments required by law should assure HHAs that any over or underestimate of the payment amount will be adjusted accordingly. However, to support HHAs in evaluating the effects of the proposed PDGM, CMS provides, upon request, a Home Health Claims-OASIS Limited Data Set (LDS) to accompany the proposed and final rules. The Home Health Claims-OASIS LDS file can be requested by following the instructions on the following CMS website:
In accordance with the BBA of 2018, we will annually determine the impact of differences between assumed behavior changes and actual behavior changes on estimated aggregate expenditures for CYs 2020 through 2026. We interpret actual behavior change to encompass both behavior changes that were previously outlined, as assumed by CMS when determining the budget-neutral 30-day payment amount for CY 2020, and other behavior changes not identified at the time the 30-day payment amount for CY 2020 is determined.
In the CY 2015 HH PPS final rule (79 FR 66072), we finalized our proposal to recalibrate the case-mix weights every year with more current data. Therefore, we refer commenters to previous HH PPS rules (for example, CY 2016 HH PPS final rule, (80 FR 68629)), where we recalibrate case-mix weights to account for nominal case-mix change. We anticipate a similar methodology when making any required permanent and temporary adjustments to payments, as required under sections 1895(b)(3)(D)(ii) and (iii) of the Act, to address the impact of the assumed versus actual behavioral change after implementation of the PDGM and the 30-day budget-neutral payment amount. Section 1895(b)(3)(D)(ii) of the Act requires notice and comment rulemaking for any permanent adjustments. Section 1895(b)(3)(D)(iii) of the Act similarly requires notice and comment rulemaking for any temporary adjustments. As a result, any reconciliation methodology for permanent and/or temporary adjustments would be subject to rulemaking, with the opportunity for the public to provide comments prior to the finalization of any policies. The data from CYs 2020 through 2026 will be available to determine whether temporary adjustments and/or permanent adjustments (increase or decrease) are needed no earlier than in years 2022 through 2028 rulemaking.
We believe that the temporary and prospective adjustments outlined in the statute are not meant to act as a cap on overall home health expenditures. CMS is required by section of 1895(b)(3)(A)(iv) of the Act to calculate a 30-day payment amount for CY 2020 in a budget neutral manner so that estimated aggregate expenditures under the HH PPS during CY 2020 made under the new 30-day unit of payment would be equal to the estimated aggregate expenditures that otherwise would have been made in the absence of the 30-day unit of payment. Likewise, any permanent or temporary adjustments made, as required by the BBA of 2018, would be made to address the impact of differences between assumed and actual behavior changes on estimated aggregate expenditures with respect to years beginning with 2020 and ending with 2026. Any adjustment to the payment amount resulting from differences between assumed versus actual behavior changes would not be related to increases in the number of beneficiaries utilizing Medicare home health services. The purpose of the required behavioral assumptions is to calculate the 30-day budget-neutral payment amount and not to limit payment for home health services or access to needed care.
We disagree with comments that state that the behavioral assumptions made under the PDGM are already accounted for in the current HH PPS case-mix system given the assumptions made under the proposed PDGM are based on a shorter unit of payment, 30 days as opposed to the current 60 days. As described throughout this final rule with comment period and the proposed rule, the variation in resource utilization is most notable in the first versus second and subsequent 30-day periods of care. Consequently, the behavioral assumptions are based on the 30-day unit of payment and the unique case-mix variables that are present under the PDGM, but not under the current HH PPS case-mix system.
Therefore, past analysis confirms that there are noted changes in provider behavior resulting from the presence of thresholds that affect payment. As such, we believe that the presence of thresholds, regardless of whether they are therapy or LUPA thresholds, provides the incentive for providers to
We acknowledge that there have been previous phase-ins of other payment adjustments to account for nominal case mix growth. We remind commenters that the statute requires that in calculating the 30-day budget-neutral payment amount, for home health units of service furnished that end during the 12-month period beginning January 1, 2020, the Secretary shall make assumptions about behavior changes that could occur as a result of the implementation of a 30-day unit of payment and the alternate case-mix adjustment methodology. Therefore, we do not have the discretion to implement a different policy. However, because the statute requires that we must analyze data for CYs 2020 through 2026 after implementation of the 30-day unit of payment and new case-mix adjustment methodology to annually determine the impact of differences between assumed behavior changes and actual behavior changes on estimated aggregate expenditures, and to make payment amount adjustments accordingly, we believe there is already a mechanism in place to assure HHAs that payment amount will be adjusted to accurately account for actual behavior.
We remind commenters that the 30-day unit of payment and the PDGM will not be implemented until CY 2020 and CMS will analyze claims data from CY 2018 to determine any changes to the payment amount for CY 2020 and will propose the amount in the CY 2020 HH PPS proposed rule. Finally, we are required to make the adjustments at a later date when we have actual data. Therefore, we can ensure that the 30-day payment amounts are set at the level they would have been had changes in case mix due to behavior adjustments been known. Therefore, we do not believe it is necessary to phase-in the impacts of the behavioral assumptions. By providing updated analysis and payment rates in the CY 2020 HH PPS proposed rule, this will allow stakeholders additional opportunity to comment on the behavioral assumption impacts. While many commenters wanted CMS to delay implementation of the behavioral assumption impacts until actual data are available, CMS is required under section 1895(b)(3)(A)(iv) of the Act to take into account behavior changes that could occur as a result of the implementation of a 30-day unit of payment and the case-mix adjustment factors that are implemented in CY 2020 when calculating the 30-day budget neutral payment amount for CY 2020. Deferring until actual data are available would delay implementation of the behavioral assumption impacts until CY 2022, which would not meet the requirements of the statute. Data from CY 2020 to 2026 will be available to determine whether temporary or permanent adjustments to the payment amounts are needed.
CMS does not intend to prescribe how home health agencies provide care to their patients. As reiterated throughout this section, services provided, including the disciplines providing the care and the frequency of those services, are done so in accordance with an individualized plan of care, established and periodically reviewed by the certifying physician. We recognize that some beneficiaries may benefit from the frontloading of visits and there has been research to indicate that the frontloading of skilled visits is beneficial to some patients and may reduce hospitalization.
In the current HH PPS, there is a split percentage payment approach to the 60-day episode. The first bill, a Request for Anticipated Payment (RAP), is submitted at the beginning of the initial episode for 60 percent of the anticipated final claim payment amount. The second, final bill is submitted at the end of the 60-day episode for the remaining 40 percent. For all subsequent episodes for beneficiaries who receive continuous home health care, the episodes are paid at a 50/50 percentage payment split.
The BBA of 2018 requires a change to the unit of payment from a 60-day episode to a 30-day period of care, effective January 1, 2020. As described in the CY 2018 HH PPS proposed rule (82 FR 35270) and in the CY 2019 HH PPS proposed rule (83 FR 32391), we believe that as a result of the reduced timeframe for the unit of payment, that a split percentage approach to payment may not be needed for HHAs to maintain adequate cash flow. Currently, about 5 percent of requests for anticipated payment are not submitted until the end of a 60-day episode of care and the median length of days for RAP submission is 12 days from the start of the 60-day episode. As such, we are reevaluating the necessity of RAPs for existing and newly-certified HHAs versus the risks they pose to the Medicare program.
In the CY 2019 HH PPS proposed rule, we described in detail, potential program integrity vulnerabilities as they relate to RAP payments (83 FR 32391). We stated that given the program integrity concerns and the reduced timeframe for the unit of payment (30 days rather than 60 days), we proposed not to allow newly-enrolled HHAs, that is HHAs certified for participation in Medicare effective on or after January 1, 2019, to receive RAP payments beginning in CY 2020. We proposed that HHAs, that are certified for participation in Medicare effective on or after January 1, 2019, would still be required to submit a “no pay” RAP at the beginning of care in order to establish the home health period of care, as well as every 30-days thereafter.
We proposed that existing HHAs, that is HHAs certified for participation in Medicare with effective dates prior to January 1, 2019, would continue to receive RAP payments upon implementation of the 30-day unit of payment and the proposed PDGM case-mix adjustment methodology in CY 2020.
We solicited comments as to whether the split payment approach would still be needed for HHAs to maintain adequate cash flow if the unit of payment changes from 60-day episodes to 30-day periods of care under our proposal. In addition, we solicited comments on ways to phase-out the split percentage payment approach in the future. Specifically, we solicited comments on reducing the percentage of the upfront payment over a period of time. We also solicited comments on requiring for HHAs to submit a notice of admission within 5 days of the start of care to alert the claims processing system that a beneficiary is under a home health period of care, if in the future the split percentage approach was eliminated. to assure being established as the primary HHA for the beneficiary and so that the claims processing system is alerted that a beneficiary is under a HH period of care to enforce the consolidating billing edits required by law.
The following is a summary of the public comments received on the “Split Percentage Payment Approach for a 30-day Unit of Payment” proposal and our responses:
We acknowledge and appreciate the concerns commenters have with regards to abuse of the RAP policy by certain HHAs. We plan to continue to closely monitor RAP submissions, service utilization, payment, and quality trends which may change as a result of implementing of the PDGM and a 30-day unit of payment. If changes in practice and/or coding patterns or RAPs submissions arise, we may take further action, which may include administrative action against providers as appropriate and/or proposing changes in policy. We will also continue to work with the HHS Office of Inspector General in case any cases of provider abuse are identified.
We would like to reiterate that in the CY 2019 HH PPS proposed rule, we proposed existing HHAs, that is HHAs that are certified for participation in Medicare with effective dates prior to January 1, 2019, would continue to receive RAP payments upon implementation of the PDGM in CY 2020. Only newly-enrolled HHAs, that is HHAs certified for participation in Medicare effective on or after January 1, 2019, would not receive RAP payments beginning in CY 2020.
In the CY 2019 HH PPS proposed rule, we described analysis showing the impact of timing on home health resource use and proposed to classify the 30-day periods under the proposed PDGM as “early” or “late” depending on when they occur within a sequence of 30-day periods. For the purposes of defining “early” and “late” periods for the PDGM, we proposed that only the first 30-day period in a sequence of periods be defined as “early” and all other subsequent 30-day periods would be considered “late”. Additionally, we proposed that the definition of a “home health sequence” (as currently described in § 484.230) would remain unchanged relative to the current system; that is, 30-day periods are considered to be in the same sequence as long as no more than 60 days pass between the end of one period and the start of the next, which is consistent with the definition of a “home health spell of illness” described at section 1861(tt)(2) of the Act. We further noted that because section 1861(tt)(2) of the Act is a definition related to eligibility for home health services as described at section 1812(a)(3) of the Act, it does not affect or restrict our ability to implement a 30-day unit of payment.
We solicited public comments on the timing categories under the proposed PDGM and the associated regulations text changes discussed in section III.F.13 of the proposed rule. The following is a summary of the public comments received and our responses:
Additionally, in our CY 2008 HH PPS final rule, we implemented an “early” and “late” distinction in the HH PPS in which the late episode groupings were weighted more heavily than those episodes designated as early due to heavier resource use during later episodes (72 FR 49770). At that time, commenters expressed concerns that this heavier weighting for later episodes could lead to gaming by providers, with patients on service longer than would be appropriate, and that providers may not discharge patients when merited. During our analysis in support of subsequent refinements to the HH PPS in 2015, as described in the CY 2015 HH PPS proposed rule (79 FR 38366), we analyzed the utilization patterns observed in the CY 2013 claims data and observed that the resource use for later episodes had indeed shifted such that later episodes had less resource use than earlier periods, which was the opposite of the pattern observed prior to CY 2008. Furthermore, in its 2016 Report to Congress, MedPAC noted that, between 2002 and 2014, a pattern in home health emerged where the number of episodes of care provided to home health beneficiaries trended upwards, with the average number of episodes per user increasing by 18 percent, rising from 1.6 to 1.9 episodes per user.
Moreover, the public comments we received in response to both the CY 2018 and CY 2019 HH PPS proposed rules presented conflicting predictions regarding anticipated provider behavior in response to the implementation of the PDGM. Several commenters stated that they expected providers to discharge patients after the first 30-days of care given that the case-mix weights are, on average, higher for the first 30-days of care. Other commenters expressed
In the CY 2019 HH PPS proposed rule, we described analysis showing the impact of the source of admission on home health resource use and proposed to establish two admission source categories for grouping 30-day periods of care under the PDGM—institutional and community—as determined by the healthcare setting utilized in the 14 days prior to home health admission (83 FR 32340). We proposed that 30-day periods for beneficiaries with any inpatient acute care hospitalizations, skilled nursing facility (SNF) stays, inpatient rehabilitation facility (IRF) stays, or long term care hospital (LTCH) stays within the 14 days prior to a home health admission would be designated as institutional admissions. We also proposed that the institutional admission source category would also include patients that had an acute care hospital stay during a previous 30-day period of care and within 14 days prior to the subsequent, contiguous 30-day period of care and for which the patient was not discharged from home health and readmitted (that is, the admission date and from date for the subsequent 30-day period of care do not match) as we acknowledge that HHAs have discretion as to whether they discharge the patient due to a hospitalization and then readmit the patient after hospital discharge. However, we also proposed that we would not categorize PAC stays (SNF, IRF, LTCH stays) that occur during a previous 30-day period and within 14 days of a subsequent, contiguous 30-day period of care (that is, the admission date and from date for the subsequent 30-day period of care do not match) as institutional, as we would expect the HHA to discharge the patient if the patient required PAC in a different setting and then readmitted the patient, if necessary, after discharge from such setting. If the patient was discharged and then readmitted to home health, the admission date and “from” date on the 30-day claim would match and the claims processing system will look for an acute or a PAC stay within 14 days of the home health admission date. We proposed that this admission source designation process would be applicable to institutional stays both paid by Medicare or another payer. All other 30-day periods would be designated as community admissions. For the purposes of a RAP, we proposed that we would only adjust the final home health claim submitted for source of admission. Additionally, we also proposed that HHAs would only indicate the proposed admission source occurrence codes on the final claim and not on any RAPs submitted. The proposed admission source category was discussed in detail in the proposed rule.
We solicited public comments on the admission source component of the proposed PDGM. The following is a summary of the public comments and our responses:
While we recognize that there is more recent use of Ambulatory Surgery Centers (ASCs) for certain joint replacement surgeries, we do not have sufficient data at this time to determine the impact on home health resource use for beneficiaries coming from an ASC facility after these types of surgeries. As mentioned previously, we will only include those stays that are considered institutional stays in other Medicare settings and where “institutional” refers to discharges from acute-care hospitals, IRFs, LTCHs, IPFs, and SNFs. Therefore, a discharge from an ASC does not meet the definition of “institutional”. Likewise, discharge from hospice care would not be considered an institutional discharge, nor would we expect large enough numbers of beneficiaries discharging from hospice to home health to warrant such an inclusion.
However, we note that as we receive and evaluate new data related to the provision of Medicare home health care under the PDGM, we will continue to assess the payment levels for admission source within a home health period and give consideration to any cost differentiation evidenced by the resources required by those home health patients with a preceding outpatient event.
Moreover, we proposed that newly-created occurrence codes would also be established, allowing HHAs to manually indicate on Medicare home health claims that an institutional admission had occurred prior to the processing of an acute/post-acute Medicare claim, if any, by Medicare systems in order to receive the higher payment associated with the institutional admission source sooner (83 FR 35312). However, the usage of the occurrence codes is limited to situations in which the HHA has information about the acute or PAC stay. We also noted that the use of these occurrence codes would not be limited to home health beneficiaries for whom the acute/post-acute claims were paid by Medicare. HHAs would also use the occurrence codes for beneficiaries with acute/post-acute care stays paid by other payers, such as the Veterans Administration (VA).
If a HHA does not include the occurrence code on the HH claim indicating that a home health patient had a previous institutional stay, processed either by Medicare or other institutions such as the VA, such an admission will be categorized as “community” and paid accordingly. However, if later a Medicare acute/post-acute claim for an institutional stay occurring within 14 days of the home health admission is submitted within the timely filing deadline and processed by the Medicare systems, the HH claim would be automatically adjusted and re-categorized as an institutional admission and appropriate payment modifications would be made. If there was a non-Medicare institutional stay occurring within 14 days of the home health admission but the HHA was not aware of such a stay, upon learning of such a stay, the HHA would be able to resubmit the HH claim that included an occurrence code, subject to the timely filing deadline, and payment adjustments would be made accordingly.
Again, however, we note that the Medicare claims processing system will check for the presence of an acute/post-acute Medicare claim for an institutional stay occurring within 14 days of the home health admission on an ongoing basis and automatically assign the home health claim as “community” or “institutional” appropriately. As a result, with respect to a HH claim with a Medicare institutional stay occurring within 14 days of home health admission, we will not require the submission of an occurrence code in order to appropriately categorize the HH claim to the applicable admission source. With respect to a HH claim with a non-Medicare institutional stay occurring with 14 days of home health admission, a HHA would need to submit an occurrence code on the HH claim in order to have the HH claim categorized as “institutional” and paid the associated higher amount.
Additionally, we plan to provide education and training regarding all aspects of the admission source process and to develop materials for guidance on claims adjustments, for resolution of claims processing issues, for defining timely filing windows, and for appropriate usage of occurrence codes through such resources as the Medicare Learning Network. We will also update guidance in the Medicare Claims Processing Manual as well as the Medicare Benefit Policy Manual as appropriate with detailed procedures. We will also work with the MACs to address any concerns regarding the processing of home health claims as well as develop training materials to facilitate all aspects of the transition to the PDGM, including the unique aspects of the admission source categories.
With regards to the length of time for resubmission of home health claims that reflect a non-Medicare institutional claim, all appropriate Medicare rules regarding timely filing of claims will still apply. Procedures required for the resubmission of home health claims will apply uniformly for those claims that require editing due to the need to add or remove occurrence codes. Details regarding the timely filing guidelines for the Medicare program are available in the Medicare Claims Processing Manual, Chapter 1—General Billing Requirements, which is available at the following website:
Additionally, we reiterate that the HHA is not dependent on the institutional provider's “correct” submission of the institutional claim for appropriate admission source categorization, as HHAs will have the
In the CY 2019 HH PPS proposed rule (83 FR 32340), we proposed grouping 30-day periods of care into six clinical groups: Musculoskeletal Rehabilitation, Neuro/Stroke Rehabilitation, Wounds— Post-Op Wound Aftercare and Skin/Non-Surgical Wound Care, Behavioral Health Care (including Substance Use Disorder), Complex Nursing Interventions, and Medication Management, Teaching, and Assessment (MMTA). We stated that by placing periods of care into clinical groups reflecting the primary reason the patient is receiving home health, as determined by the principal diagnosis on the claim, we would capture the most common types of care provided and more accurately align payments with the cost of providing care (that is, resource use).
In response to comments on the CY 2018 HH PPS proposed rule (82 FR 35317) and a Technical Expert Panel (TEP) held in February 2018, we conducted further analysis on the division of the MMTA clinical group into subgroups. We conducted a thorough review of all the diagnosis codes grouped into the MMTA group and we grouped codes into MMTA subgroups based on feedback from public comments, which mainly focused on cardiac, oncology, infectious, and respiratory diagnoses. We created the additional subgroups (Surgical Aftercare, Cardiac/Circulatory, Endocrine, GI/GU, Infectious Diseases/Neoplasms/Blood Forming Diseases, Respiratory, and Other) based on data that showed above-average resource use for the codes in those groups, and then combined certain groups that had a minimal number of codes.
Similar to the initial Home Health Groupings Model (HHGM) analysis conducted in 2016 that was discussed in the CY 2018 HH PPS proposed rule, results showed that the change in case-mix weights, as well as impacts to the other case-mix variables (admission source/timing, comorbidity adjustment) was minimal for the 30-day periods assigned to these subgroups compared to the case-mix weights without the subgroups. We showed that overall, using the MMTA subgroup model would result in more payment groups but no significant differences in case-mix weights across those groups. For that reason, in the CY 2019 HH PPS proposed rule, we proposed to retain the six clinical groups as shown in Table 26, and not divide the MMTA clinical group into subgroups. A complete list of ICD-10-CM codes and their assigned clinical groupings is posted on the CMS HHA Center web page (
The following is a summary of the public comments received on the proposed clinical groups under the PDGM and our responses:
Therefore, we will create 7 additional clinical groups to replace the comprehensive MMTA group. These subgroups were selected based on public comments in response to the CY 2018 HH PPS proposed rule and these comments mainly focused on cardiac, oncology, infectious disease, and respiratory diagnoses.
• MMTA—Surgical Aftercare
• MMTA—Cardiac/Circulatory
• MMTA—Endocrine
• MMTA—GI/GU
• MMTA—Infectious Disease/Neoplasms/Blood-forming Diseases
• MMTA—Respiratory
• MMTA—Other
The addition of these 7 new groups generated a new table of case-mix weights for the model. The PDGM will now contain 432 case-mix groups. We agree with commenters that greater specificity in the MMTA clinical group will help distinguish differences in care and allow for greater transparency in resource use. We also believe that with the elimination of therapy thresholds, having more discrete subgroups within this clinical group may result in more variation in resource use over time.
In addition to coding guidelines, we also looked at clinical practice guidelines and the interventions and skilled care involved in managing the diagnosis at home. We believe these guidelines provide valuable information for establishing a plan of care and support home health resource use. For instance, an infection of an amputation stump may only require treatment with antibiotics, whereas management of necrotic tissue always involves debridement and subsequent wound care in order to allow wound healing to take place. Thus, necrosis of an amputation stump clearly denotes wound care. For a period to be grouped into the wound category, the diagnosis on the claim must reflect a break in skin integrity for which clinical practice guidelines involve wound care necessitating skilled nursing services. A diagnosis simply indicating infection may or may not necessitate wound care.
We also expect that whenever possible, the most specific code that describes a medical disease, condition, or injury should be documented. For instance many codes contain the word “unspecified.” Generally, “unspecified” codes are used when there is lack of information about location or severity of medical conditions in the medical record. However, we would expect a provider to use a precise code whenever more specific codes are available. Furthermore, if additional information regarding the diagnosis is needed, we would expect the HHA to follow-up with the referring provider in order to ensure the care plan is sufficient in meeting the needs of the patient. We believe that a vague principal diagnosis does not clearly identify the primary reason for home health, and subsequently leads to ambiguous resource use. For example, T14.90 “Injury, unspecified”, lacks clarity regarding the type and extent of injury and therefore, fails to indicate and support the needed resources. Additionally, the ICD-10-CM code set includes laterality. We believe a home health clinician should not report an “unspecified” code if that clinician can identify the side or site of a condition. For example, a home health clinician should be able to state whether a fracture of the arm is the right or left arm.
Similarly, many of the codes that indicate pain or contractures as the primary diagnosis, for example M54.5, Low back pain or M62.422, Contracture of muscle, right hand, although site specific, do not indicate the cause of the pain or contracture. We would expect a more definitive diagnosis indicating the cause of the pain or contracture, as the reason for the skilled care, in order to appropriately group the home health period.
We also believe that the majority of the R codes (codes that describe signs and symptoms, as opposed to diagnoses) are not appropriate as principal diagnosis codes for grouping home health periods into clinical groups. While we recognize that the coding guidelines allow for the reporting of signs, symptoms, and less well-defined conditions, HHAs are required to establish an individualized plan of care in accordance with the home health CoPs at § 484.60. The plan of care must specify the services necessary to meet the patient-specific needs as identified during the comprehensive assessment. This includes identification of the responsible discipline(s), and anticipated measurable outcomes as a result of implementing and coordinating the plan of care. We believe that the use of symptoms, signs, and abnormal clinical and laboratory findings would make it difficult to meet the requirements of an individualized plan of care. Likewise, we believe that clinically it is important for home health clinicians to have a clearer understanding of the patients' diagnoses in order to safely and effectively furnish home health services. Interventions and treatment aimed at mitigating signs and symptoms of a condition may vary depending on the cause. For example, if a patient has been referred to home health with a diagnosis of “other abnormalities of gait and mobility” (R26.89), we believe it is important for the home health clinician to know what is precipitating the abnormality. For instance, a plan of care for a gait abnormality related to a neurological diagnosis is likely to be different from a plan of care for a gait abnormality due to a fracture or injury. Anecdotally, we have heard that the home health referral may be non-specific or that the physician may be in the process of determining a more definitive diagnosis. However, with respect to patient safety and quality of care, we believe it is important for a clinician to investigate the cause of the signs and/or symptoms for which the referral was made. This may involve calling the referring physician to gather more information regarding the gait abnormality. We note that HHAs are required under the home health CoPs at § 484.60 to participate in care coordination to assure the identification of patient needs and factors that could affect patient safety and treatment efficacy. Coding guidelines are clear that R codes are to be used when no more specific diagnosis can be made even after all the facts bearing on the case have been investigated. Therefore, these codes
Another commonly reported diagnosis, M62.81, “Muscle weakness, generalized” is extremely vague. Generalized muscle weakness, while obviously a common condition among recently hospitalized patients does not clearly support a rationale for skilled services and does not lend itself to a comprehensive plan of care. In § 409.44(c)(1)(ii) we state that “the patient's clinical record must include documentation describing how the course of therapy treatment for the patient's illness or injury is in accordance with accepted professional standards of clinical practice.” If there is not an identified cause of muscle weakness, then it would be questionable as to whether the course of therapy treatment would be in accordance with accepted professional standards of clinical practice. Additionally, in the 2008 HH PPS final rule, we identified “muscle weakness (generalized)” as a nonspecific condition that represents general symptomatic complaints in the elderly population. We stated that inclusion of this code “would threaten to move the case-mix model away from a foundation of reliable and meaningful diagnosis codes that are appropriate for home care” (72 FR 49774). Specifically, the 2008 HH PPS final rule stipulated that the case-mix system avoid, to the fullest extent possible, non-specific or ambiguous ICD-9-CM codes, codes that represent general symptomatic complaints in the elderly population, and codes that lack consensus for clear diagnostic criteria within the medical community. We believe that diagnostic approaches to determining the cause of muscle weakness, polyneuropathy, and other vague conditions, combined with the expanded ICD-10 list, ensure that codes exist that more clearly describe a patient's need for home health. With respect to commenter rationale for coding “Muscle weakness, generalized” in response to severe deconditioning and weakness due to extended hospitalization, we believe a more appropriate code would be one of the muscle wasting and atrophy codes as grouped into the musculoskeletal group. Muscle wasting and atrophy would indicate the reason for the generalized muscle weakness and provide more clarity for the necessity of skilled services.
Using these guidelines, we worked with certified coders to review all of the codes submitted with commenter feedback. We included the new codes added with respect to Fiscal Year 2018 (for use beginning October 1, 2017) and with respect to Fiscal Year 2019 (for use beginning October 1, 2018) and grouped the MMTA diagnosis codes into the appropriate sub-groups. We remind commenters that the ICD 10-CM code list is updated each fiscal year with an effective date of October 1st. Because of an annual October effective date for updated ICD 10-CM codes, the HH PPS is subject to two Grouper releases, one in October and one in January, to ensure that claims are submitted with the most current code set available. Additionally, we re-grouped many of the codes submitted by commenters based on feedback we received and changed the clinical grouping of many additional codes based on commenter rationale. For example, we agree with commenters regarding many of the S and T codes where the fracture and/or injury is unspecified, but the site is specified. We maintain that the site of injury and/or fracture should be identified; however, we believe that, as the treatment or intervention would likely not change based on the exact type of injury or fracture, many of these codes are appropriate to group the period into a clinical group. These codes were changed to either the musculoskeletal group or the wounds group. We also agreed with commenters regarding some of the combination diagnosis/symptom codes. For example, we re-grouped I13.2, Hypertensive heart and chronic kidney disease with heart failure and with stage 5 chronic kidney disease, or end stage renal disease into MMTA- Cardiac/Circulatory, as despite the likelihood that the patient is covered under the End Stage Renal Disease (ESRD) benefit, the patient may also be receiving home health services for hypertension. We also agree that Z46.6, Encounter for fitting and adjustment of urinary device should be grouped into the Complex Nursing Interventions group.
Regarding A41.0, Sepsis due to Staphylococcus aureus and A40.0, Sepsis due to streptococcus, group A, as guidelines state that a sepsis diagnosis should be assigned the appropriate code for the underlying systemic infection, these codes will be classified under MMTA—Infectious Disease/Neoplasms/Blood-forming Diseases. With regards to Z45.2, Encounter for adjustment and management of VAD, per coding guidelines, Z45.2 can be reported as the principal diagnosis and will remain in the Complex Nursing Interventions group. However, we recognize that coding guidelines indicate that if treatment is directed at current, acute disease, then the disease diagnosis code should be reported first, followed by the Z aftercare codes. Therefore, in a case where the patient is receiving an IV antibiotic for sepsis, as the HHA is required to code sepsis as the primary diagnosis, the Z code must be listed as the first secondary diagnosis code listed on the claim in order to group the period into the Complex Nursing Interventions group.
Ultimately we believe that precise coding allows for more meaningful analysis of home health resource use and ensures that patients are receiving appropriate home health services as identified on an individualized plan of care. We thank the commenters for their in-depth review and suggested changes to the ICD-10-CM code assignments for the clinical groups under the PDGM. We note that we did regroup additional codes to the ones identified in this section, based on the reasons previously discussed, and we encourage HHAs to continue to review the list of diagnosis codes in the PDGM Grouper Tool posted with the final rule on the HHA Center web page (
Under the PDGM, case-mix assignment is based, in part, on certain items in patient assessments completed by home health agencies and the diagnoses reported on the home health claim. Thus, if the average case-mix weight of Medicare home health patients increases over time, the extent to which case-mix increases reflect real changes in patient characteristics versus nominal case-mix changes attributable to changes in coding practices (more commonly referred to as “up-coding”) has been examined. CMS examines the proportion of total case-mix change that is nominal versus real across all HHAs on an annual basis as this has important implications for determining home health payment rates that are accurate and reasonable. We do not determine nominal case-mix changes on a case-by-case basis.
Ultimately, case-mix adjustment takes into account the resource use of different groups of home health patients, and although not the sole determinant, diagnosis has always been a factor. Highlighting the principal diagnosis in the case-mix model helps to define the primary reason for home health, but does not in any way dictate what services should be included in the plan of care. Therefore, if the primary reason for home health care is for maintenance purposes with the primary need being therapy, this would be indicated on the plan of care and the patient would likely be grouped into one of the therapy groups.
The home health benefit is a bundled payment. It allows home health agencies the discretion to allocate resources based on their knowledge of the patient and the services needed to meet the goals of the individualized home health plan of care. This would mean that the HHA would consider the most appropriate and efficient use of home health services based on patient needs. Therefore, therapy may be an important service in any of the clinical groups; however, it may not necessarily be the primary reason for home health care, which is what the clinical group is intended to capture. Similarly, we expect that skilled nursing, home health aide, and medical social services would likely be included in the care plan for patients in the rehabilitation clinical groups.
While implementing the use of safeguards to ensure comprehensive evaluation of therapy needs is out of scope for this rule, we note that the home health CoPs establish the health and safety standards for care given to Medicare home health beneficiaries. As such, the CoPs would include such safeguards such as the type and frequency of patient assessments. Finally, section 1895(b)(4)(B)(ii) of the Act, as added by section 51001 of the BBA of 2018 requires elimination of therapy thresholds as part of the case-mix adjustment methodology, effective for January 1, 2020.
As part of the overall case-mix adjustment under the PDGM, we proposed in the CY 2019 HH PPS proposed rule to include a functional impairment adjustment to account for the resource costs associated with providing home health care to those patients with functional impairments. Research has shown a relationship exists between functional status, rates of hospital readmission, and the overall costs of health care services.
Including functional status in the case-mix adjustment methodology allows for higher payment for those patients with higher service needs. As functional status is commonly used for risk adjustment in various payment systems, including in the current HH PPS, we proposed that the PDGM would also adjust payments based on responses to selected functional OASIS items that have demonstrated higher resource use. Generally, worsening functional status is associated with higher resource use, indicating that the responses to functional OASIS items may be useful as adjustors to construct case-mix weights for an alternative case-mix adjustment methodology.
Each proposed OASIS item included in the PDGM has a positive relationship with resource use, meaning as functional status declines (as measured by a higher response category), home health periods have more resource use, on average. In the CY 2019 HH PPS proposed rule, we proposed that the following OASIS items would be included as part of the functional impairment level adjustment under the PDGM:
• M1800: Grooming.
• M1810: Current Ability to Dress Upper Body.
• M1820: Current Ability to Dress Lower Body.
• M1830: Bathing.
• M1840: Toilet Transferring.
• M1850: Transferring.
• M1860: Ambulation/Locomotion.
• M1033 Risk of Hospitalization (at least four responses checked, excluding responses #8, #9, and #10).
Under the PDGM, a home health period of care receives points based on each of the responses associated with
As noted in section III.F.6 of this final rule with comment period, we are subdividing the MMTA clinical group into seven sub-groups (MMTA-aftercare; cardiac/circulatory; endocrine; gastrointestinal/genitourinary; infectious disease/neoplasms/blood-forming diseases; respiratory; and other) to more accurately capture unique patient characteristics associated with patients receiving home health services for medication management, teaching, and assessment. As such, we recalculated the functional points and the thresholds for the functional impairment levels by clinical group. This also resulted in a few minor changes to the functional thresholds compared to the thresholds in the CY 2019 HH PPS proposed rule (Table 42, 83 FR 32406). The updated OASIS points table for the functional items and the table of functional impairment level thresholds for by clinical group are found in Tables 28 and 29.
In the CY 2019 HH PPS proposed rule, we solicited comments on the proposed functional OASIS items, the associated points, and the thresholds by clinical group used to group patients into three functional impairment levels under the PDGM, as previously outlined. The majority of comments received were very similar to those received on the alternate case-mix adjustment methodology (HHGM), in the CY 2018 HH PPS proposed rule. The comments received are summarized in this section.
We disagree that the functional impairment level case-mix payment adjustment is inadequate and that the PDGM would inhibit access to care for those with patients with complex and/or chronic care needs and high functional impairments. The absence of discipline-related therapy thresholds allows for a more equitable distribution of services based on patient needs, including needs for chronically ill patients. We note that the PDGM is structured to capture patient characteristics, including functional impairment status, similar to the functional case-mix adjustment in the current HH PPS. As HHA-reported OASIS information determines the payment amounts for each of the functional levels, accurate reporting on the OASIS by HHAs will help to ensure that the case-mix adjustment is in alignment with the actual level of functional impairment.
We also disagree with the comment that the PDGM favors only those home health patients who are expected to improve, does not take into account patients with longer term maintenance therapy needs, and is counter to the provisions of the Jimmo Settlement Agreement. We remind commenters that the structure of the home health benefit requires a multidisciplinary approach, and the PDGM promotes the provision of not only therapy services, but skilled nursing, home health aide, and medical social services as well. The clinical groups, as well as the functional impairment level case-mix adjustment, account for the full range of services available under the Medicare home health benefit. We believe that the functional impairment level adjustment compensates for the resource needs of those with functional impairment and ongoing therapy needs, and therefore does not endorse one type of patient over another. There has never been an expectation that only patients who demonstrate the ability to improve are eligible for the Medicare home health benefit. We have educated the MACs extensively to ensure that any medical review of claims for cognitively or functionally impaired patients who are receiving maintenance therapy to prevent further deterioration, are doing
We believe adding a more robust and granular functional impairment level adjustment should preserve, and potentially increase access to therapy services for vulnerable patients who may not otherwise have received needed therapy services, including those with complex and/or chronic care needs. As such, we would expect continued admissions of these patient populations with therapy visits provided in accordance with physician orders as documented on the plan of care, including the frequency and duration of these orders. We remind HHAs that the PDGM case-mix adjusters work in tandem to reflect a patient's resource needs. The overall payment for a home health period of care under the PDGM is determined by the cumulative effect of all of the variables used in the case-mix adjustments. Ultimately, the goal of the PDGM is to provide more accurate payment based on the identified resource use of different patient groups.
The PDGM is not limiting or prohibiting the provision of therapy services or the number of home health periods of care, nor is there a reduction to the overall base rate of home health payment. The commenters imply that HHAs would “cherry pick” the type of patients to admit primarily based on Medicare payment under the PDGM and that care decisions, including the number of therapy visits, are determined solely on profitability of patients. As such, any potential access issues would be the result of a change in HHA behavior in response to the removal of therapy thresholds to maximize margins of a bundled payment rather than the result of a case-mix adjustment model that seeks to more accurately pay for home health services. Manipulating visit patterns, including the type and number of visits provided, and/or admitting only certain patient populations to maximize payment is counter to the purpose of a prospective payment system and the intent of a patient-driven Medicare home health benefit. Furthermore, this could result in a violation of the home health CoPs and may signal program integrity issues. We will continue to monitor the impact of all of the case-mix adjustments in the PDGM to determine if any changes to utilization are occurring, especially as they relate to the provision of therapy. This may involve, but is not limited to, comparative analysis of utilization patterns prior to and after the implementation of the PDGM and could result in additional enforcement actions as a result of any program integrity concerns. Likewise, the BBA of 2018 requires that we calculate the 30-day budget-neutral payment amount based on assumed behavior changes resulting from the implementation of a 30-day unit of payment and the PDGM. The law also requires that we annually analyze the impact of differences between the assumed and actual behavioral changes on estimated aggregate expenditures for CYs 2020 through 2026 and to make any payment amount adjustments, either upwards or downwards, accordingly.
We agree with commenters that the role of the physical, occupational, and speech language pathology therapists is important in quality outcomes and the prevention of adverse events, such as falls and emergency room visits, and that these disciplines are important in helping patients remain in their own homes. However, we note that the goal of the PDGM is to provide appropriate payment based on the identified resource use of different patient groups; not to encourage, discourage, value, devalue, or promote one type of skilled care over another.
We do not expect HHAs to make personnel decisions solely based on a change to the HH PPS case-mix methodology as the requirements for providing home health services have not been changed. Under the Medicare home health benefit, skilled professional services include skilled nursing services, physical therapy, speech-language pathology services, and occupational therapy, as specified in § 409.44, and dependent services include home health aide services and medical social work services, as specified in § 409.45. Skilled professionals who provide services to HHA patients directly or under arrangement must participate in the coordination of care. Additionally, we note that the home health CoPs at § 484.60 require that each patient receive an individualized written plan of care that must specify the care and services necessary to meet the patient-specific needs as identified in the comprehensive assessment, including identification of the responsible discipline(s).
Concerns regarding HHAs changing the way they provide services to eligible beneficiaries, specifically therapy services, should be mitigated by the more granular functional impairment level adjustment (for example, functional thresholds which vary between each of the clinical groups). The functional impairment level case-mix adjustment is reflective of the resource costs associated with the reported OASIS items and therefore ensures greater payment accuracy based on patient characteristics. We believe that this approach will help to maintain and could potentially increase access to needed therapy services. We remind HHAs that the provision of home health services should be based on patient characteristics and identified care needs. This could include those patients with complex and/or chronic care needs, or those patients requiring home health services over a longer period of time or for which there is no measureable or expected improvement.
Finally, we believe that the PDGM is in alignment with the tenants of the CMS Triple Aim to provide better care for individuals; promote better health outcomes for populations; and lower health care costs. The PDGM does so by taking a patient-driven approach over a volume-based approach by using patient characteristics, rather than arbitrary thresholds of visits that do not necessarily equate to better outcomes or
The new home health CoPs are more detailed in the expectations of the provision of needed home health services. Specifically, the CoPs at § 484.60 require that patients are accepted for treatment on the reasonable expectation that an HHA can meet the patient's medical, nursing, rehabilitative, and social needs in his or her place of residence. Services are required to be identified in an individualized written plan of care, including any revisions or additions. The individualized plan of care must specify the care and services necessary to meet the patient-specific needs as identified in the comprehensive assessment, including identification of the responsible discipline(s), and the measurable outcomes that the HHA anticipates will occur as a result of implementing and coordinating the plan of care.
It is difficult to proactively determine that care is “inadequate” or “of poor quality” given that we do not know the type, frequency or quality of services until after those services are provided. The volume of services provided does not necessarily equate with higher quality of care.
We believe that the home health CoPs provide the requirements to promote and ensure quality home health care. However, as we indicated in the CY 2019 HH PPS proposed rule, we will continue to analyze utilization trends, including therapy visits as reported on home health claims, to identify any issues that may warrant any quality or program integrity intervention.
We believe that the structure of the PDGM is more patient-driven than the current case-mix system and more accurately represents the patient characteristics that will correspond to an appropriate individualized care plan to provide those needed services. We believe that the PDGM will allow for more tailored, appropriate quality of care and removes the financial incentive to focus on the volume of care and not patient needs. By keeping patient characteristics at the center of the case-mix adjustment methodology, we believe that patient needs will be more accurately addressed and that this has the potential to result in care plan goal achievement and desired patient outcomes.
Additionally, the Medicare home health benefit requires a multidisciplinary approach to care and the expectation is that HHAs provide the full range of services under the benefit to all eligible beneficiaries, and not solely therapy services. As such, developing a business model designed to target only those patients requiring therapy in order to maximize Medicare payment is counter to the requirements under the benefit. It also places the HHA at financial risk if payment is reliant only on a specific patient population. For those HHAs who do provide the full range of services and do not target only those patients for whom they can maximize payment based on therapy thresholds, we believe that the functional impairment level adjustment provides sufficient additional payment across all clinical groups. This would include those patients who are receiving home health services primarily for other skilled needs but who may also require therapy services as part of their home health plan of care. The PDGM is clinically-based, meaning it relies more heavily on patient characteristics to place home health periods of care into clinically meaningful payment categories. These patient characteristics also help home health clinicians differentiate between the services needed by home health patients. We believe that a patient-driven approach to case-mix adjusting payment better clarifies the services provided under the Medicare home health benefit. Therefore, we believe this patient-driven approach better promotes efficiencies in the provision of care based on actual patient needs and will make it easier for HHAs to manage revenues and costs.
Finally, to support HHAs in evaluating the effects of the proposed PDGM, CMS is providing, upon request, a Home Health Claims-OASIS Limited Data Set (LDS).
When we re-examined the OASIS caregiver items for possible inclusion in the functional impairment level case-mix adjustment in the PDGM, we found inverse patterns in resource use (82 FR 35319). We examined OASIS items associated with types and sources of caregiver assistance and frequency of ADL/IADL assistance. These items assess the ability and willingness of non-agency caregivers (such as family members, friends, or privately paid caregivers) to provide categories of assistance needed by the patient, including ADL/IADL assistance, medication administration, and management of equipment. As responses to these items generally are not based on direct observation by the clinician conducting the assessment,
Finally, we continue to believe that including this kind of variable in the case-mix system raises significant policy concerns. We maintain that a case-mix adjustment should not discourage assistance from family members of home care patients, nor should it make patients believe there is some financial stake in how they report their familial supports during their convalescence. We have concerns that adjusting payment in response to the absence of a caregiver would introduce negative incentives with adverse effects on home health Medicare beneficiaries.
As discussed previously, the OASIS cognitive items are not used for a payment adjustment under the current HH PPS, but most of the proposed functional items are. As commenters have stated, there is potentially more HHA focus on the OASIS payment items, which could explain why the functional items show a positive relationship to resource use while the cognitive items do not. As many commenters have stated and as supported in the research, there is a relationship between cognition and functional status. As such, we believe that the functional items included in the functional impairment level case-mix adjustment provide a reasonable proxy for cognitive status given their interrelatedness. Because of the negative relationship between the OASIS cognitive items and resource use, we decided not to include the items as part of the functional adjustment in the PDGM but will continue to analyze their inclusion once the PDGM is implemented.
Similarly, we also examined pain and dyspnea OASIS items for inclusion in the case-mix adjustment methodology including OASIS items M1242, Pain and M1400, Shortness of Breath. While M1242, Pain, is used in the current HH PPS, this was shown to have only a minimal relationship with resource use in the current payment model. Additionally, we believe that this one item alone may not be robust enough to fully capture the pain presentation of the patient and its impact on resource utilization and therefore it was dropped from consideration. While M1400, Shortness of Breath, is also used in the current HH PPS, it too shows minimal impact on resource use. We did not include M1400 in the PDGM case-mix adjustment methodology because we believe the more granular ICD-10 codes that describe respiratory conditions, more accurately capture this patient characteristic. Again, we refer commenters to the more detailed discussion on why certain OASIS items were included or excluded from the model, the “Overview of the Home Health Groupings Model Technical Report”
The PDGM has other case-mix adjustments in addition to the functional impairment level to adjust payment for those patients requiring multiple therapy disciplines or those chronically ill patients with significant functional impairment. We believe that also accounting for timing, source of admission, clinical group (meaning the primary reason the patient requires home health services), and the presence of comorbidities will provide the necessary adjustments to payment to ensure that care needs are met based on actual patient characteristics.
To address comments about evidence regarding “too much” therapy, we remind commenters that analysis has repeatedly shown that the current HH PPS therapy thresholds promote the provision of care based on increased payment associated with each of these thresholds as opposed to actual patient needs. In the CY 2018 HH PPS proposed rule, analysis of home health claims shows that the average episode payment by the number of therapy visits for episodes with at least one therapy visit increases sharply just over payment thresholds at 6, 7, and 16 (82 FR 35276).
Furthermore, CMS analysis demonstrates that the average share of therapy visits across all 60-day episodes of care increased from 9 percent of all visits in 1997, prior to the implementation of the HH PPS (see 64 FR 58151), to 39 percent of all visits in 2015 (82 FR 35276). We note that the therapy thresholds have been widely criticized by MedPAC who has recommended the removal of therapy thresholds for the past 5 years, as their analysis has repeatedly shown that Medicare payments for home health services have substantially exceeded costs. Additionally, the Senate Committee on Finance conducted an investigation and issued a report on therapy practices of four of the largest publically-traded home health agencies where three out of the four companies investigated encouraged therapists to target the most profitable number of therapy visits, even when patient need alone may not have justified such patterns. The Senate investigation also highlighted the abrupt and dramatic responses the home health industry has taken to maximize payment under the therapy threshold models (both the original 10-visit threshold model and under the revised thresholds implemented in the CY 2008 HH PPS final rule (72 FR 49762)). The report noted that, under the current HH PPS, HHAs have broad discretion over the number of therapy visits provided, and therefore have control of the single-largest variable in determining reimbursement and overall margins. The report recommended that CMS closely examine a future payment approach that focuses on patient wellbeing and health characteristics, rather than the numerical utilization measures.
We agree that most patients would prefer to receive services in their own home whenever feasible and the Medicare home health benefit affords a comprehensive range of services for eligible beneficiaries. However, we are cognizant that payment may affect practice patterns and our analysis has shown that visits vary in response to financial incentives. While the goal of the PDGM case-mix adjustments is to align payment with actual patient characteristics, we are aware that practice patterns may shift upon implementation of a new case-mix methodology. Our goal is to protect patient choice and preferences as well as promote the provision of high quality, appropriate home care. As we have reiterated throughout this final rule with comment period, upon implementation of the PDGM, we will continue to examine the impact of all OASIS items on resource costs. Likewise, we will also examine any changes in the number of therapy visits provided that could indicate HHAs stinting on needed therapy services to determine whether any impacts warrant additional refinements to the case-mix adjustments under the PDGM.
We note that the goal of the PDGM is to provide appropriate payment based on the identified resource use of different patient groups; not to encourage, discourage, value, devalue, or promote one type of skilled care over another. Because there are no service utilization thresholds in the PDGM, we expect that HHAs will respond by adapting a business model based on more patient-centered care as opposed to payment-driven care.
The proposed PDGM groups home health periods based on the primary reason for home health care (principal diagnosis), functional level, admission source, and timing. To further account for differences in resource use based on patient characteristics, we proposed to use the presence of home health specific comorbidities as part of the overall case-mix adjustment under the PDGM. The home health-specific comorbidity list is based on the principles of patient assessment by body systems and their associated diseases, conditions, and injuries to develop larger categories of conditions that identified clinically relevant relationships associated with increased resource use. These broad, body system-based categories we proposed to use to group comorbidities within the PDGM included the following:
• Heart Disease.
• Respiratory Disease.
• Circulatory Disease and Blood Disorders.
• Cerebral Vascular Disease.
• Gastrointestinal Disease.
• Neurological Disease and Associated Conditions.
• Endocrine Disease.
• Neoplasms.
• Genitourinary and Renal Disease.
• Skin Disease.
• Musculoskeletal Disease or Injury.
• Behavioral Health (including Substance Use Disorders).
• Infectious Disease.
These broader categories were further refined into comorbidity subcategories to more accurately capture differences in resource use. All of the comorbidity diagnoses grouped into these comorbidity categories and subcategories are posted on the Home Health Agency web page and listed in the HHGM technical report, “Medicare Home Health Prospective Payment System: Case-Mix Methodology Refinements Overview of the Home Health Groupings Model”, at the following link:
We originally proposed in the CY 2018 HH PPS proposed rule that if a period had at least one secondary diagnosis reported on the home health claim that fell into one of the proposed body-system based subcategories listed in that rule, the period would receive a comorbidity adjustment to account for higher costs associated with the comorbidity (82 FR 35309). A period would receive only one comorbidity adjustment regardless of the number of secondary diagnoses reported on the home health claim that fell into one of the subcategories. We received comments supporting the inclusion of a comorbidity adjustment, but the
Taking these comments into consideration, CMS conducted additional analysis on the effect of comorbidities on resource utilization during a home health period of care. The goal of our analyses was to identify those clinically and statistically significant comorbidities and interactions that could be used to further case-mix adjust a 30-day home health period of care. In the CY 2019 HH PPS proposed rule, we described the methodology used to identify, group, and appropriately weight comorbidity subgroups and interactions between subgroups (83 FR 32375). As a result of these analyses, we identified that there were certain individual comorbidity subgroups and interactions of the comorbidity subgroups (for example, having diagnoses associated with two of the comorbidity subgroups) which could be used as part of the comorbidity case-mix adjustment in the PDGM. This meant that patients with certain comorbidities and interactions of certain comorbid conditions have home health periods of care with higher resource use than home health periods of care without those comorbidities or interactions. Specifically, we identified individual comorbidity subgroups that were statistically and clinically significant for case-mix adjustment and these are identified in Table 30. From the individual comorbidity subgroups, we then identified a subset of statistically and clinically significant comorbidity interactions for case-mix adjustment and these are identified in Table 31.
In the CY 2019 HH PPS proposed rule, we proposed three mutually exclusive levels of comorbidity case-mix adjustment that depend on the presence of certain secondary diagnoses codes: No Comorbidity Adjustment, Low Comorbidity Adjustment, and High Comorbidity adjustment. We proposed that home health 30-day periods of care can receive a comorbidity payment adjustment under the following circumstances:
•
•
A 30-day period would receive no comorbidity adjustment if no secondary diagnoses exist or none meet the criteria. A 30-day period of care can receive only one comorbidity adjustment—low or high—regardless of the number of subgroups or subgroup interactions. We proposed that the low comorbidity adjustment amount would be the same across the individual subgroups and the high comorbidity adjustment would be the same across the subgroup interactions. Table 46 in the CY 2019 HH PPS proposed rule showed the average resource use by comorbidity adjustment (83 FR 32411).
With dividing the MMTA clinical group into subgroups as finalized in section III.E.6 of this final rule with comment period, we note that the number of comorbidity subgroups in both the low and high comorbidity adjustment is higher than as described in the CY 2019 HH PPS proposed rule. This more recent analysis of CY 2017 home health claims results in 13 comorbidity subgroups which would receive the low comorbidity adjustment and 34 comorbidity subgroup interactions which would receive the high comorbidity adjustment (see Tables 30 and 31).
We solicited comments on the comorbidity case-mix adjustment in the PDGM, which includes three comorbidity levels: No Comorbidity, Low Comorbidity, and High Comorbidity Adjustment. We also invited comment on the payments associated with the Low and High Comorbidity Adjustment to account for increased resource utilization resulting from the presence of certain comorbidities and comorbidity interactions. These comments are summarized in this section along with our responses.
We agree that continued monitoring is needed to understand how the PDGM, including the comorbidity adjustment, affects home health patients and providers and inform future refinements. While we are aware of the prevalence of comorbidities in the Medicare home health population, we note that the average number of comorbidities in the aggregate becomes the standard within that population for the purpose of payment. For example, if the Medicare home health patient population has an average of three comorbidities then this is already factored into the base rate given that this rate represents the average home health payment for the average patient. The case-mix adjustment process recognizes increased resource use beyond the average. If the “average” patient under home health is multi-morbid, then additional resource use is not evident as the data reflects this average.
As noted in the CY 2019 HH PPS proposed rule, the comorbidity subgroups were selected through a stepwise process that identified clinically and statistically meaningful diagnosis-based comorbidity groups that were associated with higher resource use than the average or that would be indicated by examining clinical and functional groups, admission source, and timing characteristics. As such, the comorbidity subgroups were meant to identify only those cases when resource use was higher than the median when accounting for other attributions of the patient. A similar process was used to identify the comorbidity subgroup interactions that would result in a high comorbidity adjustment. We agree that social determinants of health is an important consideration in providing effective patient-centered health care, and we thank the commenter for raising this point. However, the comorbidity adjustment in the PDGM is meant to capture clinical conditions that are present that affect resource utilization under a home health plan of care.
We anticipate that we would annually recalibrate the PDGM case-mix weights, which would include the comorbidity adjustment. This would be similar to the annual recalibration of case mix weights under the current HH PPS. Therefore, this could mean additions or subtractions of comorbidity subgroups and/or comorbidity subgroup interactions in the low and/or high comorbidity adjustment groups in the future. We will continue to analyze and monitor reported secondary diagnoses to inform the need for any future refinements to the comorbidity adjustment under the PDGM.
We disagree with commenters who stated that not enough periods of care would receive the comorbidity adjustment. To better ensure that reported conditions represented an actual impact on resource use, the proposed comorbidities include those conditions that represent more than 0.1 percent of periods and have at least as high as the median resource use as they indicate a direct relationship between the comorbidity and resource utilization. Under the PDGM, this approach increases the 30-day periods of care that would receive a comorbidity adjustment compared to the approach proposed in the CY 2018 HH PPS proposed rule. Under the proposed PDGM, almost 40 percent of home health periods of care would receive a low or high comorbidity adjustment compared to approximately 15 percent of home health periods under the HHGM. We believe a more granular approach to the comorbidity adjustment more accurately represents patient characteristics and more accurately aligns payments with the cost of providing care. Again, we remind commenters that the comorbidity adjustment is just one of the case-mix variables in the PDGM made in addition to the base payment and adjustments made for clinical and functional status, admission source, and timing. These variables work in tandem to account for the complexity of patient care needs and to make payment for home health services accordingly. Similarly, the HH PPS is a bundled payment to cover all home health services, including ancillary services such as home health aides. HHAs are expected to provide the services, including the disciplines responsible for providing those services, in accordance with the home health plan of care.
We disagree that this approach to a comorbidity adjustment exposes HHAs to additional risk. In the CY 2001 HH PPS final rule, commenters stated that patients with multiple diagnoses should be credited with additional points in their clinical dimension measurement given the impact of comorbidities on resource use (65 FR 41153). We stated that time constraints and the data available during the development of the HH PPS was not robust enough for the inclusion of a comorbidity variable as part of the HH PPS case-mix adjustment (65 FR 41153). We also reiterated that we would consider comorbidities for future case-mix analyses and that such an effort would be significantly aided by complete four-digit and 5-digit diagnosis coding on the OASIS record. In the CY 2008 HH PPS final rule (72 FR 49772), we added secondary diagnoses and their interactions with the principal diagnosis as part of the clinical dimension in the overall case-mix adjustment. However, analysis since that time has shown that nominal case-mix growth became an ongoing issue resulting from the incentive in the current HH PPS to code only those conditions associated with clinical points even though the data did not show an associated increase in resource utilization. For CY 2018, there was a 0.97 percent reduction to the national, standardized 60-day payment rate to account for nominal case-mix growth between CY 2012 and CY 2014. Therefore, during the development of the PDGM, we sought to mitigate nominal case-mix growth and looked at different ways to account for comorbidities in the overall case-mix adjustment. The description of the initial comorbidity analysis for an alternate case-mix methodology is included in the technical report, “Overview of the Home Health Groupings Model” found on the HHA Center web page.
Currently, a 60-day episode with four or fewer visits is paid the national per visit amount by discipline, adjusted by the appropriate wage index based on the site of service of the beneficiary, instead of the full 60-day episode payment amount. Such payment adjustments are called Low Utilization Payment Adjustments (LUPAs). While the proposed PDGM system in the CY 2019 HH PPS proposed rule would still include LUPA payments, the approach to calculating the LUPA thresholds needed to change due to the proposed change in the unit of payment to 30-day periods of care from 60-day episodes. We note that in the current payment system, approximately 8 percent of episodes are LUPAs. Under the PDGM, the 30-day periods of care have substantially more periods with four or fewer visits than 60-day episodes. Therefore, to create LUPA thresholds under the PDGM, in the CY 2019 proposed rule (82 FR 32411), we proposed to set the LUPA threshold at the 10th percentile value of visits or 2 visits, whichever is higher, for each payment group in order to target approximately the same percentage of LUPAs. This resulted in approximately 7.1 percent of 30-day periods that would be LUPAs (assuming no behavior change) under the PDGM. We also proposed that the LUPA thresholds for each PDGM payment group would be re-evaluated every year based on the most current utilization data available.
We received several comments on the LUPA threshold methodology proposed for the PDGM and these are summarized in this section with our responses:
Section 1895(b)(4)(B) requires the Secretary to establish appropriate case mix adjustment factors for home health services in a manner that explains a significant amount of the variation in cost among different units of services. In the CY 2019 HH PPS proposed rule (83 FR 32415), we proposed an alternative case-mix adjustment methodology to better align payment with patient care needs. The proposed alternative case-mix adjustment methodology places patients into meaningful payment categories based on patient characteristics (principal diagnosis, functional level, comorbid conditions, referral source and timing). As outlined in previous sections of this final rule with comment period, we are finalizing this alternative case-mix adjustment methodology, called the PDGM. This new methodology results in 432 unique case-mix groups. These 432 unique case-mix payment groups are called Home Health Resource Groups (HHRGs).
To generate PDGM case-mix weights, we utilized a data file based on home health 30-day periods of care, as reported in Medicare home health claims linked to OASIS assessment data to obtain patient characteristics. The claims data provides visit-level data and data on whether non-routine supplies (NRS) was provided during the period and the total charges for NRS. We determined the case-mix weight for each
After best fitting the model on CY 2017 home health data, we used the estimated coefficients of the model to predict the expected average resource use of each 30-day period based on the five PDGM categories. In order to normalize the results, we divided the regression predicted resource use of each 30-day period by the overall average resource use used to estimate the model in order to calculate the case mix weight of all periods within a particular payment group, where each payment group is defined as the unique combination of the subgroups within the five PDGM categories (admission source, timing of the 30-day period, clinical grouping, functional impairment level, and comorbidity adjustment). The case-mix weight is then used to adjust the base payment rate to determine each period's payment. Table 48 shows the coefficients of the payment regression used to generate the weights, and the coefficients divided by average resource use. Information can be found in section III.F.6 of this rule for the clinical groups, section III.F.7 of this rule for the functional impairment levels, section III.F.5 for admission source, section III.F.4 for timing, and section III.F.8 for the comorbidity adjustment.
Table 34 presents the case-mix weight for each Home Health Resource Group (HHRG) in the regression model. LUPA episodes, outlier episodes, and episodes with PEP adjustments were excluded. Weights are determined by first calculating the predicted resource use for episodes with a particular combination of admission source, episode timing, clinical grouping, functional impairment level, and comorbidity adjustment. This
Similar to the annual recalibration of the case-mix weights under the current HH PPS, we proposed to annually recalibrate the PDGM case-mix weights. We note that this includes a re-calculation of the proposed PDGM case-mix weights for CY 2020 in the CY 2020 HH PPS proposed rule using CY 2018 home health claims data linked with OASIS assessment data since we will implement the PDGM for 30-day periods of care beginning on or after January 1, 2020.
In conjunction with the implementation of the PDGM, in the CY 2019 HH PPS proposed rule (83 FR 32420) we proposed to revise the frequency with which we update the HH PPS Grouper software used to assign the appropriate HIPPS code used for case-mix adjustment onto the claim. Since CY 2004 when the HH PPS moved from a fiscal year to a calendar year basis, we have updated the Grouper software twice a year. We provide an
We solicited public comments on the proposed PDGM case-mix weights, case-mix weight methodology and proposed annual recalibration of the case-mix weights, updates to the HH PPS Grouper software, and the associated regulations text changes in section III.F.13 of this proposed rule. The following is a summary of the public comments on the case mix weight methodology under PDGM and the updates to the HH PPS Grouper Software and our responses:
Currently, LUPA episodes qualify for an add-on payment when the episode is the first or only episode in a sequence of adjacent episodes. As stated in the CY 2008 HH PPS final rule, LUPA add-on payments are made because the national per-visit payment rates do not adequately account for the front-loading of costs for the first LUPA episode of care as the average visit lengths in these initial LUPAs are 16 to 18 percent higher than the average visit lengths in initial non-LUPA episodes (72 FR 49848). LUPA episodes that occur as the only episode or as an initial episode in a sequence of adjacent episodes are adjusted by applying an additional amount to the LUPA payment before adjusting for area wage differences. Under the PDGM, we proposed that the LUPA add-on factors will remain the same as the current payment system, described in the CY 2019 HH PPS proposed rule (83 FR 32372). We proposed to multiply the per-visit payment amount for the first SN, PT, or SLP visit in LUPA 30-day periods that occur as the only 30-day period or an initial 30-day period in a sequence of adjacent periods of care by the appropriate factor (1.8451 for SN, 1.6700 for PT, and 1.6266 for SLP) to
The current partial episode payment (PEP) adjustment is a proportion of the episode payment and is based on the span of days including the start-of-care date (the date of the first billable service) through and including the last billable service date under the original plan of care before an intervening event in a home health beneficiary's care defined as:
• A beneficiary elected transfer, or
• A discharge and return to home health that would warrant, for purposes of payment, a new OASIS assessment, physician certification of eligibility, and a new plan of care.
For 30-day periods of care, we proposed that the process for partial payment adjustments would remain the same as the existing policies pertaining to partial episode payments. When a new 30-day period begins due to the intervening event of a beneficiary elected transfer or there was a discharge and return to home health during the 30-day period, we proposed that the original 30-day period would be proportionally adjusted to reflect the length of time the beneficiary remained under the agency's care prior to the intervening event. The proportional payment is the partial payment adjustment. The partial payment adjustment would be calculated by using the span of days (first billable service date through and including the last billable service date) under the original plan of care as a proportion of 30. The proportion would then be multiplied by the original case-mix and wage index to produce the 30-day payment.
We solicited public comments on the LUPA add-on payments and partial payment adjustments proposed for the PDGM and the associated changes in the regulations text. The following is a summary of the public comments and our responses:
As described in section III.E. of the CY 2019 HH PPS proposed rule (83 FR 32375), section 1895(b)(5) of the Act allows for the provision of an addition or adjustment to the home health payment amount in the case of outliers because of unusual variations in the type or amount of medically necessary care. The history of and current methodology for payment of high-cost outliers under the HH PPS is described in detail in section III.E. of the CY 2019 HH PPS proposed rule (83 FR 32375). We proposed that we would maintain the current methodology for payment of high-cost outliers upon implementation of the PGDM and that we would calculate payment for high-cost outliers based upon 30-day periods of care.
As discussed in the CY 2019 HH PPS proposed rule (83 FR 32421), we updated our outlier estimates for this final rule with comment period. Simulating payments using preliminary CY 2017 claims data and the CY 2019 payment rates, we estimated that outlier payments under the PGDM with 30-day periods of care would comprise approximately 4.77 percent of total HH PPS payments in CY 2019. Given the statutory requirement that estimated total outlier payments do not exceed the 2.5 percent of total payments (as required by section 1895(b)(5)(A) of the Act), we estimated that the FDL ratio under the PGDM would need to change to 0.71 to maintain compliance with statute. However, given the implementation of the PGDM for 30-day periods of care beginning on or after January 1, 2020, we will update our estimate of outlier payments as a percent of total HH PPS payments using the most current and complete utilization data available at the time of CY 2020 rate setting and would propose a change in the FDL ratio for CY 2020, if needed.
We solicited public comments on maintaining the current outlier payment methodology for the PGDM and the associated changes in the regulations text. The following is a summary of the public comments and our responses:
Regarding the 8-hour limit on the amount of time per day counted toward the estimation of a period's costs, as noted in the CY2017 HH PPS final rule (81 FR 76729), where a patient is eligible for coverage of home health services, Medicare statute limits the amount of part-time or intermittent
An ALS beneficiary may be assessed by a physician in the community and subsequently be deemed to require home health services for skilled nursing, physical therapy, occupational therapy, and a home health aide. The beneficiary could receive skilled nursing twice a week for 45 minutes to assess dyspnea when transferring to a bedside commode, stage two pressure ulcer of the sacrum, and pain status. In addition, a home health aide could provide services for three hours in the morning and three hours on Monday, Wednesday and Friday and two and a half hours in the morning and two and half hours in the afternoon on Tuesday and Thursdays to assist with bathing, dressing and transferring. Physical therapy services twice a week for 45 minutes could be provided for adaptive transfer techniques, and occupational therapy services could be supplied twice a week for 45 minutes for assessment and teaching of assistive devices for activities of daily living to prevent or slow deterioration of the beneficiary's condition. Because of the patient's condition, the first 30-day period of care would be placed into the community early, neuro rehabilitation, high functional impairment, and low comorbidity group (1BC21). For the purposes of this example, we assume that services are rendered per week for a total of 4 weeks per 30-day period of care.
For the first 30-day period of this clinical scenario under the PDGM, the preceding calculation illustrates how HHAs would be paid by Medicare for providing care to patients with higher resource use in their homes.
For the second 30-day period under the PDGM, the ALS beneficiary continues to require the home health services of skilled nursing, physical therapy, occupational therapy and a nurse's aide. The beneficiary continues to receive skilled nursing twice a week to assess dyspnea when transferring to a bedside commode, stage two pressure ulcer at the sacrum, and pain status. A home health aide could provide services for three hours in the morning and three hours on Monday, Wednesday, and Friday and two and a half hours in the morning and two and half hours in the afternoon on Tuesday and Thursdays to assist with bathing, dressing, and transferring. Physical therapy services twice a week for 45 minutes could be provided for adaptive transfer techniques, and occupational therapy services could be supplied twice a week for 45 minutes for assessment and teaching of assistive devices for activities of daily living to prevent or slow deterioration of the beneficiary's condition. Given the beneficiary's condition the second 30-day period of care would fall into the community late, neuro rehabilitation, high functional impairment, and low comorbidity group (3BC21).
For the second 30-day period of this clinical scenario, the previous calculation demonstrates how outlier payments could be made for patients with chronic, complex conditions under the PDGM. We note that this example is presented for illustrative purposes only, and is not intended to suggest that all diagnoses of ALS should receive the grouping assignment or number of periods described here. The CMS Grouper would assign these groups based on information in the OASIS. In general, we expect that outlier payments for unusually high cost periods in PDGM will be comparable to those under the current system, but there may be a small increase or decrease in rates depending on each beneficiary's specific situation. We reiterate that outlier payments could provide payment to HHAs for those patients with higher resource use and that the patient's condition does not need to improve for home health services to be covered by Medicare. We appreciate the feedback we have received from the public on the outlier policy under the HH PPS and look forward to ongoing collaboration with stakeholders on any further refinements that may be warranted, including the proposed outlier methodology under the PDGM.
We are finalizing a number of revisions to the regulations to implement the PDGM for periods of care beginning on or after January 1, 2020, as outlined in sections through III.F.1 through III.F.12 of this final rule with comment period. We are finalizing to make conforming changes in § 409.43 and part 484 Subpart E to revise the unit of service from a 60-day episode to a 30-day period. In addition, we are finalizing to restructure § 484.205. These revisions would be effective on January 1, 2020. Specifically, we are- doing the following:
• Revising § 409.43, which outlines plan of care requirements. We are revising several paragraphs to phase out the unit of service from a 60-day episode for claims beginning on or before December 31, 2019, and to implement a 30-day period as the new unit of service for claims beginning on or after January 1, 2020 under the PDGM. We are moving and revising paragraph (c)(2) to § 484.205 as paragraph (c)(2) aligns more closely with the regulations addressing the basis of payment.
• Revising the definitions of rural area and urban area in § 484.202 to remove “with respect to home health episodes ending on or after January 1, 2006” from each definition as this verbiage is no longer necessary.
• Restructuring § 484.205 to provide more logical organization and revise to account for the change in the unit of payment under the HH PPS for CY 2020. The PDGM uses 30-day periods rather than the 60-day episode used in the current payment system. Therefore, we are to revising § 484.205 to remove references to “60-day episode” and to refer more generally to the “national, standardized prospective payment”. We are also revising § 484.205 as follows:
++ Adding paragraphs to paragraph (b) to define the unit of payment.
++ Moving language which addresses the requirement for OASIS submission from § 484.210 and inserting it into § 484.205 as new paragraph (c).
++ Moving paragraph (c)(2) from § 409.43 to § 484.205 as new paragraph (g) in order to better align with the regulations detailing the basis of payment.
++ Adding paragraph (h) to discuss split percentage payments under the current model and the PDGM.
We are not changing the requirements or policies relating to durable medical equipment or furnishing negative pressure wound therapy using a disposable device.
• Removing § 484.210 which discusses data used for the calculation of the national prospective 60-day episode payment as we believe that this information is duplicative and already incorporated in other sections of part 484, subpart E.
• Revising the section heading of § 484.215 from “Initial establishment of the calculation of the national 60-day episode payment” to “Initial establishment of the calculation of the national, standardized prospective 60-day episode payment and 30-day payment rates.” Also, we are adding paragraph (f) to this section to describe when the national, standardized prospective 30-day payment rate applies.
• Revising the section heading of § 484.220 from “Calculation of the adjusted national prospective 60-day episode payment rate for case-mix and area wage levels” to “Calculation of the case-mix and wage area adjusted prospective payment rates.” We are removing the reference to “national 60-day episode payment rate” and replacing it with “national, standardized prospective payment”.
• Revising the section heading in § 484.225 from “Annual update of the unadjusted national prospective 60-day
• Revising the section heading of § 484.230 from “Methodology used for the calculation of low-utilization payment adjustment” to “Low utilization payment adjustment”. Also, we are designating the current text to paragraph (a) and inserting language such that paragraph (a) applies to claims beginning on or before December 31, 2019, using the current payment system. We are adding paragraph (b) to describe how low utilization payment adjustments are determined for claims beginning on or after January 1, 2020, using the PDGM.
• Revising the section heading of § 484.235 from “Methodology used for the calculation of partial episode payment adjustments” to “Partial payment adjustments”. We are removing paragraphs (a), (b), and (c). We are removing paragraphs (1), (2), and (3) which describe partial payment adjustments from paragraph (d) in § 484.205 and incorporating them into § 484.235. We are adding paragraph (a) to describe partial payment adjustments under the current system, that is, for claims beginning on or before December 31, 2019, and paragraph (b) to describe partial payment adjustments under the PDGM, that is, for claims beginning on or after January 1, 2020.
• Revising the section heading for § 484.240 from “Methodology used for the calculation of the outlier payment” to “Outlier payments.” In addition, we are removing language at paragraph (b) and appending it to paragraph (a). We are adding language to revised paragraph (a) such that paragraph (a) will apply to payments under the current system, that is, for claims beginning on or before December 31, 2019. We are revising paragraph (b) to describe payments under the PDGM, that is, for claims beginning on or after January 1, 2020. In paragraph (c), we are replacing the “estimated” cost with “imputed” cost. Lastly, we are revising paragraph (d) to reflect the per-15 minute unit approach to imputing the cost for each claim.
We did not receive any comments on the corresponding regulations text changes regarding the PDGM; therefore, we are finalizing regulations text changes as proposed without modification.
Section 51002 of the BBA of 2018 amended sections 1814(a) and 1835(a) of the Act to provide that, effective for physician certifications and recertifications made on or after January 1, 2019, in addition to using the documentation in the medical record of the certifying physician or of the acute or post-acute care facility (where home health services were furnished to an individual who was directly admitted to the HHA from such facility), the Secretary may use documentation in the medical record of the HHA as supporting material, as appropriate to the case involved. We believe the BBA of 2018 provisions are consistent with our existing policy in this area, which is currently reflected in sub-regulatory guidance in the Medicare Benefit Policy Manual (Pub. 100-02, chapter 7, section 30.5.1.2),
In the CY 2019 HH PPS proposed rule, we proposed to amend the regulations text at § 424.22(c) to align the regulations text with current sub-regulatory guidance that allows medical record documentation from the HHA to be used to support the basis for certification and/or recertification of home health eligibility, if the following requirements are met:
• The documentation from the HHA can be corroborated by other medical record entries in the certifying physician's and/or the acute/post-acute care facility's medical record for the patient, thereby creating a clinically consistent picture that the patient is eligible for Medicare home health services as specified in § 424.22(a)(1) and (b).
• The certifying physician signs and dates the HHA documentation demonstrating that the documentation from the HHA was considered when certifying patient eligibility for Medicare home health services. HHA documentation can include, but is not limited to, the patient's plan of care required in accordance with § 409.43 and/or the initial and/or comprehensive assessment of the patient required in accordance with § 484.55.
HHAs have the discretion to determine the type and format of any documentation used to support home health eligibility. Anecdotally, we have received reports from HHAs that they typically include this supporting information on the plan of care. In accordance with § 409.43(c)(3), the plan of care must be signed by the physician before the HHA submits its final claim for payment. In the CY 2019 HH PPS proposed rule, we stated that because existing sub-regulatory guidance allows HHA-generated documentation to be used as supporting material for the physician's determination of eligibility for home health services, we expect that most HHAs already have a process in place to provide this information to the certifying physician or the acute/post-acute care facility. We solicited comments on the proposal to amend the regulations at § 424.22(c) to align the regulations text with current sub-regulatory guidance to allow medical record documentation from the HHA to be used to support the basis for certification and/or recertification of home health eligibility under certain conditions and the comments received are summarized in this final rule with comment period.
In the CY 2018 HH PPS proposed rule (82 FR 35378), we invited public comments about improvements that can be made to the health care delivery system that reduce unnecessary burdens for clinicians, other providers, and patients and their families. Specifically, we asked the public to submit their ideas for regulatory, sub-regulatory, policy, practice, and procedural changes to reduce burdens for hospitals, physicians, and patients, improve the quality of care, decrease costs, and ensure that patients and their providers and physicians are making the best health care choices possible.
Several commenters requested that CMS consider eliminating the requirement that the certifying physician include an estimate of how much longer skilled services will be required at each home health recertification, as set forth at § 424.22(b)(2) and in sub- regulatory guidance in the Medicare Benefit Policy Manual (Chapter 7, Section 30.5.2). Commenters stated that this estimate is duplicative of the Home Health CoP requirements for the content of the home health plan of care, set out at § 484.60(a)(2).
We determined that the estimate of how much longer skilled care will be required at each recertification is not currently used for quality, payment, or program integrity purposes. Given this consideration and the existing home health CoP requirements for the content of the home health plan of care, in the CY 2019 HH PPS proposed rule we proposed to eliminate the regulatory requirement, as set forth at § 424.22(b)(2), that the certifying physician, as part of the recertification statement, provide an estimate of how much longer skilled services will be required (83 FR 32424). All other recertification content requirements under § 424.22(b)(2) would remain unchanged. We noted that the elimination of this recertification requirement would result in a reduction of burden for certifying physicians by reducing the amount of time physicians spend on the recertification process, resulting in an overall cost savings of $14.2 million. We provide a description of this burden reduction in section X.C.1.c. of this final rule with comment period.
We solicited comments regarding the proposed elimination of the requirement that the certifying physician include an estimate of how much longer skilled services will be required at each home health recertification, as well as the corresponding regulations text changes at § 424.22(b)(2).
In the CY 2019 HH PPS proposed rule (83 FR 32425), we acknowledged the potential benefit of the use of remote patient monitoring to augment the home health plan of care. We discussed how remote patient monitoring could enable the HHA to more quickly identify any changes in the patient's clinical condition, prompting physician review of, and potential changes to, the plan of care. For example, in cases where the home health patient is admitted for skilled observation and assessment of the patient's condition due to a reasonable potential for complications or an acute episode, remote patient monitoring could augment home health visits until the patient's clinical condition stabilized. Fluctuating or abnormal vital signs could be monitored between visits, potentially leading to quicker interventions and updates to the treatment plan. Additionally, we discussed findings of our literature review that revealed that remote patient monitoring may improve patients' ability to maintain independence, improving their quality of life. Particularly for patients with chronic obstructive pulmonary disease (COPD) and congestive heart failure (CHF), research indicates that remote patient monitoring has been successful in reducing readmissions and long-term acute care utilization.
We explained that although section 1895(e)(1)(A) of the Act prohibits payment for services furnished via a telecommunications system if such services substitute for in-person home health services ordered as part of a plan of care, the statute does not define the term “telecommunications system” as it relates to the provision of home health care. While a service using a form of telecommunications, remote patient monitoring is not considered a Medicare telehealth service as defined under section 1834(m) of the Act. Additionally, there is no direct interaction between the patient and the practitioner. Remote monitoring, rather uses digital technology to relay information captured by the patient to the practitioner for review, and to potentially prompt changes to the plan of care. We explained that for these reasons it would not be subject to the telehealth restrictions on originating site and interactive telecommunications systems technology under section 1834(m) of the Act.
Therefore, because the statute does not define the term “telecommunications system” as it relates to the provision of home health care, we proposed to define remote patient monitoring in regulation under the Medicare home health benefit as “the collection of physiologic data (for example, ECG, blood pressure, glucose monitoring) digitally stored and/or transmitted by the patient and/or caregiver to the HHA.” This definition aligns with the description for CPT code 99091, which allows physicians and other healthcare professionals to bill for the collection and interpretation of physiologic data digitally stored and/or transmitted by the patient and/or caregiver to the physician or other qualified health care professional (82 CFR 53013). We recognized that HHAs cannot bill for this code (CPT code 99091); however, we believe the code's description accurately describes remote monitoring services. We also noted that CPT code 99091 includes the interpretation of the physiologic data, whereas the HHA would only be responsible for the collection of the data.
Currently home health costs associated with remote patient monitoring are reported on line 23.20 on Worksheet A as direct costs associated with telemedicine. For 2016, approximately 3 percent of HHAs reported telemedicine costs that accounted for roughly 1 percent of their total agency costs on the HHA cost report. However, these costs are not allocated to the costs per visit. Allowing HHAs to report the costs of remote patient monitoring on the HHA cost report as part of their operating expenses, which are factored into the costs per visit, would have important implications for assessing home health costs relevant to payment, including HHA Medicare margin calculations. Therefore, we proposed to amend the regulations at 42 CFR 409.46 to include the costs of remote patient monitoring as an allowable administrative cost (that is, operating expense), if remote patient monitoring is used by the HHA to augment the care planning process.
We solicited comments on the proposed regulatory definition of remote patient monitoring under the HH PPS to describe telecommunication services used to augment the plan of care during a home health episode. Additionally, we welcomed comments regarding additional utilization of telecommunications technologies for consideration in future rulemaking. We also solicited comments on the proposed changes to the regulations at 42 CFR 409.46, to include the costs of remote patient monitoring as allowable administrative costs (that is, operating expenses) on the HHA cost report. The following is a summary of the public comments received and our responses.
Additionally, we are finalizing our proposal to amend the regulations at 42 CFR 409.46 to include the costs of remote patient monitoring as an allowable administrative cost (that is, operating expense), if remote patient monitoring is used by the HHA to augment the care planning process.
As authorized by section 1115A of the Act and finalized in the CY 2016 HH PPS final rule (80 FR 68624), we began testing the HHVBP Model on January 1, 2016. The HHVBP Model has an overall purpose of improving the quality and delivery of home health care services to Medicare beneficiaries. The specific goals of the Model are to: (1) Provide incentives for better quality care with greater efficiency; (2) study new potential quality and efficiency measures for appropriateness in the home health setting; and (3) enhance the current public reporting process.
Using the randomized selection methodology finalized in the CY 2016 HH PPS final rule, we selected nine states for inclusion in the HHVBP Model, representing each geographic area across the nation. All Medicare-certified Home Health Agencies (HHAs) providing services in Arizona, Florida, Iowa, Maryland, Massachusetts, Nebraska, North Carolina, Tennessee, and Washington (competing HHAs) are required to compete in the Model. Requiring all Medicare-certified HHAs providing services in the selected states to participate in the Model ensures that: (1) There is no selection bias; (2) participating HHAs are representative of HHAs nationally; and (3) there is sufficient participation to generate meaningful results.
As finalized in the CY 2016 HH PPS final rule, the HHVBP Model uses the waiver authority under section 1115A(d)(1) of the Act to adjust Medicare payment rates under section 1895(b) of the Act beginning in CY 2018 based on the competing HHAs' performance on applicable measures. Payment adjustments will be increased incrementally over the course of the HHVBP Model in the following manner: (1) A maximum payment adjustment of 3 percent (upward or downward) in CY 2018; (2) a maximum payment adjustment of 5 percent (upward or downward) in CY 2019; (3) a maximum payment adjustment of 6 percent (upward or downward) in CY 2020; (4) a maximum payment adjustment of 7 percent (upward or downward) in CY 2021; and (5) a maximum payment adjustment of 8 percent (upward or downward) in CY 2022. Payment adjustments are based on each HHA's Total Performance Score (TPS) in a given performance year (PY) comprised of: (1) A set of measures already reported via the Outcome and Assessment Information Set (OASIS) and completed Home Health Consumer Assessment of Healthcare Providers and Systems (HHCAHPS) surveys for all patients serviced by the HHA and select claims data elements; and (2) three New Measures for which points are achieved for reporting data.
For CY 2019 (83 FR 32426), we proposed to remove five measures and add two new proposed composite measures to the applicable measure set for the HHVBP model, revise our weighting methodology for the measures, and rescore the maximum number of improvement points.
In the CY 2016 HH PPS final rule, we finalized a set of quality measures in Figure 4a: Final PY1 Measures and Figure 4b: Final PY1 New Measures (80 FR 68671 through 68673) for the HHVBP Model to be used in PY1, referred to as the starter set. We also stated that this set of measures will be subject to change or retirement during subsequent model years and revised through the rulemaking process (80 FR 68669).
The measures were selected for the Model using the following guiding principles: (1) Use a broad measure set that captures the complexity of the services HHAs provide; (2) incorporate flexibility for future inclusion of the Improving Medicare Post-Acute Care Transformation Act of 2014 (IMPACT) measures that cut across post-acute care settings; (3) develop `second generation' (of the HHVBP Model) measures of patient outcomes, health and functional status, shared decision making, and patient activation; (4) include a balance of process, outcome and patient experience measures; (5) advance the ability to measure cost and value; (6) add measures for appropriateness or overuse; and (7) promote infrastructure investments. This set of quality measures encompasses the multiple National Quality Strategy (NQS) domains
In the CY 2017 HH PPS final rule, we removed four measures from the measure set for PY1 and subsequent performance years: (1) Care Management: Types and Sources of Assistance; (2) Prior Functioning ADL/IADL; (3) Influenza Vaccine Data Collection Period: Does this episode of care include any dates on or between October 1 and March 31?; and (4) Reason Pneumococcal Vaccine Not Received, for the reasons discussed in that final rule (81 FR 76743 through 76747).
In the CY 2018 HH PPS final rule, we removed the OASIS-based measure, Drug Education on All Medications Provided to Patient/Caregiver during All Episodes of Care, from the set of applicable measures beginning with PY3 for the reasons discussed in that final rule (82 FR 51703 through 51704).
For PY4 and subsequent performance years, we proposed (83 FR 32426 through 32427) to remove two OASIS-based process measures, Influenza Immunization Received for Current Flu
We also adopted the Pneumococcal Polysaccharide Vaccine Ever Received measure beginning PY1 of the model. This process measure reports the percentage of HH episodes during which patients were determined to have ever received the Pneumococcal Polysaccharide Vaccine. The measure is based on guidelines previously issued by the Advisory Committee on Immunization Practices (ACIP),
We invited public comment on our proposal to remove these two OASIS-based measures, Influenza Immunization Received for Current Flu Season and Pneumococcal Polysaccharide Vaccine Ever Received, from the set of applicable measures for PY4 and subsequent performance years.
The following is a summary of the public comments received on these proposals and our responses:
With respect to the commenter's concern that removal of the “Influenza” measure from the HHVBP model's applicable measure set would result in the vaccine not being given, we note that while the purpose of including these measures may be to drive certain outcomes or processes, such as administering a vaccine, removing the measure from the HHVBP Model's applicable measure set does not mean that HHAs will avoid providing appropriate care when needed. Moreover, although the “Influenza” measure was removed from the Quality of Patient Care Star Rating effective April 2018, HHAs will continue to report the measure in the HH QRP and it will continue to be displayed on Home Health Compare (HHC). As discussed in the proposed rule, we proposed to remove this measure from the HHVBP model's applicable measure set in response to concerns that it may not fully capture HHA performance in the administration of the influenza vaccine. However, we believe that HHAs will continue to have an incentive to provide the vaccine where appropriate.
With respect to the removal of the Pneumococcal Polysaccharide Vaccine Ever Received measure, we note that CMS is finalizing in this final rule with comment period the removal of this measure for purposes of the HH QRP beginning with the CY 2021 HH QRP and will publicly report the measure on HHC until January 2021. As we discuss in response to comments in section V. of this final rule with comment period, while we understand that assessing and appropriately vaccinating patients are important components of the care
As previously noted, one of the goals of the HHVBP Model is to study new potential quality and efficiency measures for appropriateness in the home health setting. In the CY 2018 HH PPS Final Rule, we solicited comment on additional quality measures for future consideration in the HHVBP model, specifically a Total Change in ADL/IADL Peformance by HHA Patients Measure, a Composite Functional Decline Measure, and behavioral health measures (82 FR 51706 through 51711). For the reasons discussed in the proposed rule (83 FR 32427 through 32429), we proposed to replace three individual OASIS measures (Improvement in Bathing, Improvement in Bed Transferring, and Improvement in Ambulation-Locomotion) with two composite measures: Total Normalized Composite Change in Self-Care and Total Normalized Composite Change in Mobility. As we discussed in the CY 2019 HH PPS proposed rule, these proposed measures use several of the same ADLs as the composite measures discussed in the CY 2018 HH PPS final rule (82 FR 51707). Our contractor convened a TEP in November 2017, which supported the use of two composite measures in place of the three individual measures because HHA performance on the three individual measures would be combined with HHA performance on six additional ADL measures to create a more comprehensive assessment of HHA performance across a broader range of patient ADL outcomes. The TEP also noted that HHA performance is currently measured based on any change in improvement in patient status, while the composite measures would report the magnitude of patient change (either improvement or decline) across six self-care and three mobility patient outcomes.
We indicated in the proposed rule that there are currently three ADL improvement measures in the HHVBP Model (Improvement in Bathing, Improvement in Bed Transferring, and Improvement in Ambulation-Locomotion). The maximum cumulative score across all three measures is 30. Because we proposed to replace these three measures with the two composite measures, we also proposed that each of the two composite measures would have a maximum score of 15 points, to ensure that the relative weighting of ADL-based measures would stay the same. That is, there would still be a maximum of 30 points available for ADL-related measures.
We stated that the proposed Total Normalized Composite Change in Self-Care and Total Normalized Composite Change in Mobility measures would represent a new direction in how quality of patient care is measured in home health. We stated that both of these proposed composite measures combine several existing and endorsed HH QRP outcome measures into focused composite measures to enhance quality reporting. These proposed composite measures fit within the
The proposed Total Normalized Composite Change in Self-Care measure computes the magnitude of change, either positive or negative, based on a normalized amount of possible change on each of six OASIS-based quality outcomes. These six outcomes are as follows:
The proposed Total Normalized Composite Change in Mobility measure computes the magnitude of change, either positive or negative, based on the normalized amount of possible change on each of three OASIS-based quality outcomes. These three outcomes are as follows:
The magnitude of possible change for these OASIS items varies based on the number of response options. For example, M1800 (grooming) has four behaviorally-benchmarked response options (0 = most independent; 3 = least independent) while M1830 (bathing) has seven behaviorally-benchmarked response options (0 = most independent; 6 = least independent). The maximum possible change for a patient on item M1800 is 3, while the maximum possible change for a patient on item M1830 is 6. We indicated that both proposed composite measures would be computed and normalized at the episode level, then aggregated to the HHA level using the following steps:
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We created two prediction models for the proposed Total Normalized Composite Change in Self-Care (TNC_SC) and Total Normalized Composite Change in Mobility (TNC_MOB) measures using information from OASIS items and patient clinical condition categories (see Table 37 for details on the number of OASIS items and OASIS clinical categories used in the prediction models). We computed multiple ordinary least squares (OLS) analyses beginning with risk factors that were available from OASIS D items and patient condition groupings. Any single OASIS D item might have more than one risk factor because we create dichotomous risk factors for each response option on scaled (from dependence to independence) OASIS items. Those risk factors that were statistically significant at p<0.0001 level were kept in the prediction model. These two versions (CY 2014 and CY 2015) of the prediction models were done as “proof of concept.” We proposed that the actual prediction models for the composite measures, if finalized, would use episodes of care that ended in CY 2017, which we proposed would be the baseline year for the quality outcome measures used to compute the two proposed composite measures, as listed previously. The baseline year for these two composite measures would be CY 2017.
The following table (Table 37) provides an overview of results from the CY 2014 and CY 2015 prediction models for each proposed measure with estimated R-squared values comparing observed vs. predicted episode-level performance. This same information was included in Table 50 of the CY 2019 HH PPS proposed rule (83 FR 32428 through 32429).
Table 37 presents the following summary information for the prediction models for the two proposed composite measures.
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The prediction models are applied at the episode level to create a specific predicted value for the composite measure for each episode of care. These episode level predicted values are averaged to compute a national predicted value and an HHA predicted value. The episode level observed values are averaged to compute the HHA observed value. The HHA TNC_SC and TNC_MOB observed scores are risk adjusted based on the following formula:
We explained in the proposed rule that HHAs are not allowed to skip any of the OASIS items that are used to compute these proposed composite measures or the risk factors that comprise the prediction models for the two proposed composite measures. The OASIS items typically do not include “not available (NA)” or “unknown (UK)” response options, and per HHQRP requirements,
We invited public comment on our proposals to replace three OASIS-based measures, Improvement in Ambulation-Locomotion, Improvement in Bed Transferring, and Improvement in Bathing, with two proposed composite measures, Total Normalized Composite Change in Self-Care and Total Normalized Composite Change in Mobility, for PY4 and subsequent performance years.
Finally, while not all of the OASIS items that comprise the Total Normalized Composite Change in Self Care composite measure are currently included in the measure set for the HHVBP Model, the composite measure would use data on these OASIS items that are already collected from the participating HHAs. All HHAs must report such data in order to meet the requirements for certification as an HHA, per the Medicare Conditions of Participation (CoP) requirements at § 484.55(c)(2). The individual OASIS items included in the Self-Care and Mobility composite measures focus on areas that target broad clinical goals related to therapy provided in the home setting: Improvement in ability to conduct activities of daily living for oneself (that is, dressing and bathing) and improvement in mobility (that is, ability to transfer). While not all of the individual OASIS items that comprise the composite measures are currently included in the HHVBP Model measure set, they reflect activities and goals that are consistent with the goals of the HHVBP Model: To encourage HHAs to improve the quality of care for beneficiaries. We expect that HHAs already focus on improvement in such areas not just because such items are included in the OASIS or are required
Table 38 reflects our finalized polices to remove the Influenza Immunization Received for Current Flu Season and Pneumococcal Polysaccharide Vaccine Ever Received measures and to replace the Improvement in Ambulation-Locomotion, Improvement in Bed Transferring, and Improvement in Bathing measures with the new Total Normalized Composite Change in Self-Care and Total Normalized Composite Change in Mobility measures. Table 38 identifies the applicable measures set for PY4 and each subsequent performance year until such time that another set of applicable measures, or changes to this measure set, are proposed and finalized in future rulemaking.
In the CY 2016 HH PPS final rule, we finalized weighting measures within each of the HHVBP Model's four classifications (Clinical Quality of Care, Care Coordination and Efficiency, Person and Caregiver-Centered Experience, and New Measures) the same for the purposes of payment adjustment. We finalized weighting each individual measure equally because we did not want any one measure within a classification to be more important than another measure, to encourage HHAs to approach quality improvement initiatives more broadly, and to address concerns where HHAs may be providing services to beneficiaries with different needs. Under this approach, a measure's weight remains the same even if some of the measures within a classification group have no available data. We stated that in subsequent years of the Model, we would monitor the impact of equally weighting the individual measures and may consider changes to the weighting methodology after analysis and in rulemaking (80 FR 68679).
For PY4 and subsequent performance years, we proposed to revise how we weight the individual measures and amend § 484.320(c) accordingly (83 FR 32431). Specifically, we proposed to change our methodology for calculating the Total Performance Score (TPS) by weighting the measure categories so that the OASIS-based measure category and the claims-based measure category would each count for 35 percent and the HHCAHPS measure category would count for 30 percent of the 90 percent of the TPS that is based on performance of the Clinical Quality of Care, Care Coordination and Efficiency, and Person and Caregiver-Centered Experience measures. We noted that these measures and their proposed revised weights would continue to account for the 90 percent of the TPS that is based on the Clinical Quality of Care, Care Coordination and Efficiency, and Person and Caregiver-Centered Experience measures. Data reporting for each New Measure would continue to have equal weight and account for the 10 percent of the TPS that is based on the New Measures collected as part of the Model. As discussed further in the proposed rule and in this final rule with comment period, we stated that we believe that this proposed reweighting, to allow more weight for the claims-based measures, would better support improvement in those measures.
We explained in the proposed rule that weights would also be adjusted under our proposal for HHAs that are missing entire measure categories. For example, if an HHA is missing all HHCAHPS measures, the OASIS and claims-based measure categories would both have the same weight (50 percent each). We stated that we believe that this approach would also increase the weight given to the claims-based measures, and as a result give HHAs more incentive to focus on improving them. Additionally, if measures within a category are missing, the weights of the remaining measures within that measure category would be adjusted proportionally, while the weight of the category as a whole would remain consistent. We also proposed that the weight of the Acute Care Hospitalization: Unplanned Hospitalization during first 60 days of Home Health claims-based measure would be increased so that it has three times the weight of the Emergency Department Use without Hospitalization claims-based measure, based on our understanding that HHAs may have more control over the Acute Care Hospitalization: Unplanned Hospitalization during first 60 days of Home Health claims-based measure. In addition, because inpatient hospitalizations generally cost more than ED visits, we stated that we believe improvement in the Acute Care Hospitalization: Unplanned Hospitalization during first 60 days of Home Health claims-based measure may have a greater impact on Medicare expenditures.
We proposed to reweight the measures based on our ongoing monitoring and analysis of claims and OASIS-based measures, which shows that there has been a steady improvement in OASIS-based measures, while improvement in claims-based measures has been relatively flat. For example, Figures 1 and 2 (which were included as Figures 5 and 6 in the proposed rule) show the change in average performance for the claims-based and OASIS-based performance measures used in the Model. For both figures, we report the trends observed in Model and non-Model states. In both Model and non-Model states, there has been a slight increase (indicating worse performance) in the Acute Care Hospitalization: Unplanned Hospitalization during first 60 days of Home Health measure. For all OASIS-based measures, except the Improvement in Management of Oral Medications measure and the Discharge to Community measure, there has been substantial improvement in both Model and non-Model states. Given these results, we stated that we believe that increasing the weight given to the claims-based measures, and the Acute Care Hospitalization: Unplanned Hospitalization during first 60 days of Home Health measure in particular, may give HHAs greater incentive to focus on quality improvement in the claims-based measures. Increasing the weight of the claims-based measures was also supported by our contractor's TEP.
Table 52 of the proposed rule (83 FR 32434) showed the current weighting and the proposed revised weighting for each measure based on our proposal to change the weighting methodology from weighting each individual measure equally to weighting the OASIS, claims-based, and HHCAHPS measure categories at 35-percent, 35-percent and 30-percent, respectively. Table 52 of the proposed rule also showed the proposed weighting methodology based on various scoring scenarios. This same information is presented in Table 39 of this final rule with comment period. For example, for HHAs that are exempt from their beneficiaries completing HHCAHPS surveys, the total weight given to OASIS-based measures scores would be 50 percent, with all OASIS-based measures (other than the two composite measures) accounting for an equal proportion of that 50 percent, and the total weight given to the claims-based measures scores would be 50 percent, with the Acute Care Hospitalization: Unplanned Hospitalizations measure accounting for 37.50 percent and the ED Use without Hospitalization measure accounting for 12.50 percent. The OASIS- and claims-based measure categories would have equal weights in this scenario because the weight for each remaining category when one category is missing is based on the relative weight of the category when all three are present. Because both the OASIS- and claims-based categories would have a weight of 35% when HHCAHPS data is reported, each would have a 50% weight if HHCAHPS data is not available. However, if no claims-based measure data is available, the OASIS-based measures would have a higher weight than the HHCAHPS category, because their weights when all three categories are available are 35% and 30%, respectively. Finally, both Table 52 of the proposed rule and Table 39 of this final rule with comment period show the change in the number of HHAs, by size, that would qualify for a TPS and payment adjustment under the current and proposed reweighting methodologies, using CY 2016 data. We noted in the proposed rule that Table 52 only reflects the proposed changes to the weighting methodology, and not the other proposed changes to the HHVBP model for CY 2019 which, if finalized, would change the proposed weights as set forth in Table 52 (and Table 39 of this final rule with comment period). We referred readers to Table 65 of the proposed rule (83 FR 32506) which reflected the weighting that would apply if all of our proposed changes, including the proposed changes to the applicable measure set, were adopted for CY 2019. We indicated that as reflected in that table, the two proposed composite measures, if finalized, would have weights of 7.5 percent when all three measure categories are reported. For purposes of this final rule with comment period, we refer readers to Table 50 of this final rule with comment period, which reflects the weighting that will apply beginning in CY 2019 based on all of our finalized proposals, including the finalized reweighting and our finalized changes to the applicable measure set. As reflected in Table 50 of this final rule with comment period, the two finalized composite measures will have weights of 7.5 percent when all three measure categories are reported.
We invited public comments on the proposal to reweight the measures within the Clinical Quality of Care, Care Coordination and Efficiency, and Person
The following is a summary of the public comments received on this proposal and our responses:
With regard to the commenter's suggestion to reweight the claims-based measures to 60 percent, we are concerned that such an approach would encourage HHAs to focus on the claims-based measures (and particularly the Unplanned Hospitalization measure) at the expense of other quality improvement efforts, such as patient experience and mobility improvement, which are assessed through HHCAHPS and the OASIS measures. We are attempting to balance encouraging HHAs to focus on measures that may more heavily impact Medicare expenditures (such as the claims-based measures) with ensuring that HHAs focus on quality improvement across various focus areas, including those which are not directly measured through the claims-based measures, such as patient experience and mobility. As such, we do not believe we should increase the weight for claims-based measures above what we have proposed when HHCAHPS data are not available; rather, we believe a more gradual approach is appropriate for increasing HHAs' focus on claims-based measures. In addition, we continue to believe that OASIS-based measures provide important information about quality of care and want to continue to encourage HHAs to further improve on such measures. Finally, with regard to MedPAC's suggestion to weight the HHCAHPS higher than the OASIS-based measures, we agree with MedPAC that measuring patient experience during home health episodes is important. As discussed in this section, while we proposed to weight the HHCAHPS category less than the other two categories, the overall change in the weight for the HHCAHPS is not significant. As Table 50 reflects, HHCAHPS were reduced from 31.25 percent to 30.00 percent for the category and from 6.25 percent to 6.00 percent for each individual HHCAHPS measure under our proposal. A greater reduction actually occurs for the OASIS-based measures (as shown in Table 50, total weight for OASIS measures goes from 56.25 percent to 35.00 percent for the category and 6.25 percent to 5.00 percent for individual OASIS measures, other than the two new composite measures). This is because under current policy each HHCAHPS, OASIS-based, and claims-based measure is weighted equally and because the number of measures in each category differs. We believe the proposed reweighting balances our interest in encouraging focus on claims-based measures as well as on the patient experience and OASIS-based measures.
In the CY 2016 HH PPS final rule, we finalized that an HHA could earn 0 to 10 points based on how much its performance in the performance period improved from its performance on each measure in the Clinical Quality of Care, Care Coordination and Efficiency, and Person and Caregiver-Centered Experience classifications during the baseline period. We noted, in response to public comment about our scoring methodology for improvement points, that we will monitor and evaluate the impact of awarding an equal amount of points for both achievement and improvement and may consider changes to the weight of the improvement score relative to the achievement score in future years through rulemaking (80 FR 68682).
We proposed to reduce the maximum amount of improvement points, from 10 points to 9 points, for PY4 and subsequent performance years for all measures except for the Total Normalized Composite Change in Self-Care and Total Normalized Composite Change in Mobility measures, for which we proposed the maximum improvement points would be 13.5 (83 FR 32435). The maximum score of 13.5 represents 90 percent of the maximum 15 points that could be earned for each of the two composite measures. The HHVBP Model focuses on having all HHAs provide high quality care and we stated in the proposed rule that we believe that awarding more points for achievement than for improvement beginning with PY4 of the model would support this goal. We stated that we expect that at this point several years into participation in the Model, participating HHAs have had enough
We also stated in the proposed rule that this proposal would be consistent with public comments from prior rulemaking, and suggestions provided by our contractor's TEP. As summarized in the CY 2016 HH PPS final rule, we received comments encouraging us to focus on rewarding the achievement of specified quality scores, and reduce the emphasis on improvement scores after the initial 3 years of the HHVBP Model. Some commenters suggested measuring performance primarily based on achievement of specified quality scores with a declining emphasis over time on improvement versus achievement (80 FR 68682).
The TEP also agreed with reducing the maximum number of improvement points, which they believed would better encourage HHAs to pursue improved health outcomes for beneficiaries. We noted in the proposed rule that for the Hospital Value-Based Purchasing (HVBP) Program, CMS finalized a scoring methodology where hospitals could earn a maximum of 9 improvement points if their improvement score falls between the improvement threshold and the benchmark (76 FR 26515). We proposed that HHVBP would employ a similar scoring methodology where HHAs could earn a maximum of 9 improvement points.
We proposed that an HHA would earn 0-9 points based on how much its performance during the performance period improved from its performance on each measure in the Clinical Quality of Care, Care Coordination and Efficiency, and Person and Caregiver-Centered Experience classifications during the baseline period. We stated that a unique improvement range for each measure would be established for each HHA that defines the difference between the HHA's baseline period score and the same state level benchmark for the measure used in the achievement scoring calculation, according to the proposed improvement formula. If an HHA's performance on the measure during the performance period was—
• Equal to or higher than the benchmark score, the HHA could receive an improvement score of 9 points, or 13.5 points for the Total Normalized Composite Change in Self-Care and Total Normalized Composite Change in Mobility measures (an HHA with performance equal to or higher than the benchmark score could still receive the maximum of 10 points for achievement (or 15 points, for the composite measures));
• Greater than its baseline period score but below the benchmark (within the improvement range), the HHA could receive an improvement score of 0-9 based on the formula and as illustrated in the examples (except for the Total Normalized Composite Change in Self-Care and Total Normalized Composite Change in Mobility measures, for which the maximum improvement score would be 13.5, as noted previously);
• Equal to or lower than its baseline period score on the measure, the HHA could receive zero points for improvement.
We also presented examples of how the proposed changes to the performance scoring methodology would be applied in the context of the measures in the Clinical Quality of Care, Care Coordination and Efficiency, and Person and Caregiver Centered Experience classifications (83 FR 32426 through 32438). We invited public comment on the proposal to reduce the maximum amount of improvement points, from 10 points to 9 points for PY 4 and subsequent performance years. The following is a summary of the public comments received on this proposal and our responses:
For illustrative purposes we present the following examples of how the changes to the performance scoring
Figure 3 also shows the scoring for HHA ‘B.’ HHA B's performance on this measure went from 52.168 (which was below the achievement threshold) in the baseline period to 76.765 (which is above the achievement threshold) in the performance period. Applying the achievement scale, HHA B will earn 1.067 points for achievement, calculated as follows: 9 * (76.765 − 75.358)/(97.676 − 75.358) + 0.5 = 1.067.
In Figure 4, HHA ‘C’ yielded a decline in performance on the improvement in pain measure, falling from 70.266 to 58.487. HHA C's performance during the performance period was lower than the achievement threshold of 75.358 and, as a result, the HHA will receive zero points based on achievement. It will also receive zero points for improvement, because its performance during the performance period was lower than its performance during the baseline period.
We will monitor and evaluate the impact of reducing the maximum improvement points to 9 and will consider whether to propose more changes to the weight of the improvement score relative to the achievement score in future years through rulemaking.
In the CY 2016 HH PPS final rule (80 FR 68658), we stated that one of the three goals of the HHVBP Model is to enhance the current public reporting processes. We reiterated this goal and continued discussing the public display of HHAs' Total Performance Scores (TPSs) in the CY 2017 HH PPS final rule (81 FR 76751 through 76752). We believe that publicly reporting a participating HHA's TPS will encourage providers and patients to use this information when selecting an HHA to provide quality care. We stated in the proposed rule that we were encouraged by the previous stakeholder comments and support for public reporting that could assist patients, physicians, discharge planners, and other referral sources to choose higher-performing HHAs.
In the CY 2017 HH PPS final rule, we noted that a commenter suggested that we not consider public display until after the Model was evaluated. Another commenter favored the public display of the TPS, but recommended that CMS use a transparent process and involve stakeholders in deciding what will be reported, and provide a review period with a process for review and appeal before reporting.
As discussed in the CY 2017 HH PPS final rule, we are considering public reporting for the HHVBP Model after allowing analysis of at least eight quarters of performance data for the Model and the opportunity to compare how these results align with other publicly reported quality data (81 FR 76751). While we did not make a specific proposal in the CY 2019 HH PPS proposed rule, we solicited further public comment on what information, specifically from the CY 2017 Annual Total Performance Score and Payment Adjustment Reports and subsequent annual reports, should be made publicly available. We noted that HHAs have the opportunity to review and appeal their Annual Total Performance Score and Payment Adjustment Reports as outlined in the appeals process finalized in the CY 2017 HH PPS final rule (81 FR 76747 through 76750). Examples of the information included in the Annual Total Performance Score and Payment Adjustment Report include the agency: name, address, TPS, payment adjustment percentage, performance information for each measure used in the Model (for example, quality measure scores, achievement, and improvement points), state and cohort information, and percentile ranking. We stated that based on the public comments received, we will consider what information, specifically from the annual reports, we may consider proposing for public reporting in future rulemaking.
We received a number of out-of-scope comments on policy areas not addressed by our proposals, including requests for us to expand the HHVBP Model to a national program. We thank the commenters for their input and would address any future changes through rulemaking.
Section 1895(b)(3)(B)(v)(II) of the (the Act) requires that for 2007 and subsequent years, each HHA submit to the Secretary in a form and manner, and at a time, specified by the Secretary, such data that the Secretary determines are appropriate for the measurement of health care quality. To the extent that an HHA does not submit data with respect to a year in accordance with this clause, the Secretary is directed to reduce the HH market basket percentage increase applicable to the HHA for such year by 2 percentage points. As provided at section 1895(b)(3)(B)(vi) of the Act, depending on the market basket percentage increase applicable for a particular year, for 2015 and each subsequent year (except 2018), the reduction of that increase by 2 percentage points for failure to comply with the requirements of the HH QRP and further reduction of the increase by the productivity adjustment described in section 1886(b)(3)(B)(xi)(II) of the Act may result in the home health market basket percentage increase being less than 0.0 percent for a year, and may result in payment rates under the Home Health PPS for a year being less than payment rates for the preceding year.
For more information on the policies we have adopted for the HH QRP, we refer readers to the CY 2007 HH PPS final rule (71 FR 65888 through 65891), the CY 2008 HH PPS final rule (72 FR 49861 through 49864), the CY 2009 HH PPS update notice (73 FR 65356), the CY 2010 HH PPS final rule (74 FR 58096 through 58098), the CY 2011 HH PPS final rule (75 FR 70400 through 70407), the CY 2012 HH PPS final rule (76 FR 68574), the CY 2013 HH PPS final rule (77 FR 67092), the CY 2014 HH PPS final rule (78 FR 72297), the CY 2015 HH PPS final rule (79 FR 66073 through 66074), the CY 2016 HH PPS final rule (80 FR 68690 through 68695), the CY 2017 HH PPS final rule (81 FR 76752), and the CY 2018 HH PPS final rule (82 FR 51711 through 51712).
Although we have historically used the preamble to the HH PPS proposed and final rules each year to remind stakeholders of all previously finalized program requirements, we have concluded that repeating the same discussion each year is not necessary for every requirement, especially if we have codified it in our regulations. Accordingly, the following discussion is limited as much as possible to a discussion of our proposals, the comments we received on those proposals and our responses to those comments, and policies we are finalizing for future years of the HH QRP after consideration of the comments. We intend to use this approach in our rulemakings for the HH QRP going forward.
For a detailed discussion of the considerations we historically use for measure selection for the HH QRP quality, resource use, and others measures, we refer readers to the CY 2016 HH PPS final rule (80 FR 68695 through 68696).
We interpret the comment regarding the applicability of quality measures across the post-acute care settings to mean that we should take into consideration the appropriateness of measures that would be used in both institutional and home-based settings. While we believe there can be overlap in patient populations across the four post-acute care (PAC) providers for which we are required to adopt measures that meet requirements under section 1899B of the Act, we recognize that each PAC provider setting also has unique attributes, and we take these differences into consideration during our measure development and maintenance work.
With regard to the comment that we should consider the adoption of measures that take into account patients who may not have goals for improvement, we agree that not all patients may have goals associated with improvement and we are interested in the utilization of such measures that address this population in the HH QRP and in post-acute care in general. Further, we agree that such measures should be tested to ensure their reliability and validity in the home setting.
In the CY 2018 HH PPS final rule (82 FR 51713 through 51714) we discussed the importance of improving beneficiary outcomes including reducing health disparities. We also discussed our commitment to ensuring that medically complex patients, as well as those with social risk factors, receive excellent care. We discussed how studies show that social risk factors, such as being
In the CY 2018/FY 2018 proposed rules for our quality reporting and value-based purchasing programs, we solicited feedback on which social risk factors provide the most valuable information to stakeholders and the methodology for illuminating differences in outcomes rates among patient groups within a provider that will also allow for a comparison of those differences, or disparities, across providers.
Feedback we received across our quality reporting programs included encouraging CMS to explore whether factors could be used to stratify or risk adjust the measures (beyond dual eligibility), to consider the full range of differences in patient backgrounds that might affect outcomes, to explore risk adjustment approaches, and to offer careful consideration of what type of information display will be most useful to the public.
We also sought public comment on confidential reporting and future public reporting of some of our measures stratified by patient dual eligibility. In general, commenters noted that stratified measures could serve as tools for hospitals to identify gaps in outcomes for different groups of patients, improve the quality of health care for all patients, and empower consumers to make informed decisions about health care. Commenters encouraged us to stratify measures by other social risk factors such as age, income, and educational attainment. With regard to value-based purchasing programs, commenters also cautioned CMS to balance fair and equitable payment while avoiding payment penalties that mask health disparities or discouraging the provision of care to more medically complex patients. Commenters also noted that value-based payment program measure selection, domain weighting, performance scoring, and payment methodology must account for social risk.
As a next step, we are considering options to improve health disparities among patient groups within and across hospitals by increasing the transparency of disparities as shown by quality measures. We also are considering how this work applies to other CMS quality programs in the future. We refer readers to the FY 2018 IPPS/LTCH PPS final rule (82 FR 38403 through 38409) for more details, where we discuss the potential stratification of certain Hospital IQR Program outcome measures. Furthermore, we continue to consider options to address equity and disparities in our value-based purchasing programs.
We plan to continue working with ASPE, the public, and other key stakeholders on this important issue to identify policy solutions that achieve the goals of attaining health equity for all beneficiaries and minimizing unintended consequences.
As a part of our Meaningful Measures Initiative, discussed in section I.D.1 of this final rule with comment period and in the CY 2019 HH PPS proposed rule (83 FR 32440 through 32441), we strive to put patients first, ensuring that they,
Specifically, we stated our belief that the goals of the HH QRP and the measures used in the program overlap with the Meaningful Measures Initiative priorities, including making care safer, strengthening person and family engagement, promoting coordination of care, promoting effective prevention and treatment, and making care affordable.
We also stated that we had evaluated the appropriateness and completeness of the HH QRP's current measure removal factors. In the CY 2017 HH PPS final rule (81 FR 76754 through 76755), we noted that we had adopted a process for retaining, removing, and replacing previously adopted HH QRP measures. To be consistent with other established quality reporting programs, in the CY 2019 HH PPS proposed rule (83 FR 32440 through 32441), we proposed to replace the six criteria used when considering a quality measure for removal, finalized in the CY 2017 HH PPS final rule (81 FR 76754 through 76755), with the following seven measure removal factors, finalized for the LTCH QRP in the FY 2013 IPPS/LTCH PPS final rule (77 FR 53614 through 53615), for the SNF QRP in the FY 2016 SNF PPS final rule (80 FR 46431 through 46432), and for the IRF QRP in the CY 2013 OPPS/ASC final rule (77 FR 68502 through 68503), for use in the HH QRP:
• Factor 1. Measure performance among HHAs is so high and unvarying that meaningful distinctions in improvements in performance can no longer be made.
• Factor 2. Performance or improvement on a measure does not result in better patient outcomes.
• Factor 3. A measure does not align with current clinical guidelines or practice.
• Factor 4. A more broadly applicable measure (across settings, populations, or conditions) for the particular topic is available.
• Factor 5. A measure that is more proximal in time to desired patient outcomes for the particular topic is available.
• Factor 6. A measure that is more strongly associated with desired patient outcomes for the particular topic is available.
• Factor 7. Collection or public reporting of a measure leads to negative unintended consequences other than patient harm.
As we stated in the proposed rule, we believe these measure removal factors are substantively consistent with the criteria we previously adopted (but noted that we would be changing the terminology to call them “factors”) and appropriate for use in the HH QRP. However, we stated that even if one or more of the measure removal factors applies, we might nonetheless choose to retain the measure for certain specified reasons. We stated that examples of such instances could include when a particular measure addresses a gap in quality that is so significant that removing the measure could result in poor quality, or in the event that a given measure is statutorily required. Furthermore, we noted that consistent with other quality reporting programs, we would apply these factors on a case-by-case basis.
We finalized in the CY 2017 HH PPS final rule (81 FR 76755) that removal of a HH QRP measure would take place through notice and comment rulemaking, unless we determined that a measure is causing concern for patient safety. Specifically, in the case of a HH QRP measure for which there is a reason to believe that the continued collection raised possible safety concerns, we stated that we would promptly remove the measure and publish the justification for the removal in the
In the CY 2019 HH PPS proposed rule (83 FR 32440 through 32441), we also proposed to adopt an additional factor to consider when evaluating potential measures for removal from the HH QRP measure set:
• Factor 8. The costs associated with a measure outweigh the benefit of its continued use in the program.
As we discussed in the CY 2019 HH PPS proposed rule (83 FR 32344 through 32345, 32440 through 32441), with respect to our new Meaningful Measures Initiative, we are engaging in efforts to ensure that the HH QRP measure set continues to promote improved health outcomes for beneficiaries while minimizing the overall costs associated with the program. We stated our belief that these costs are multifaceted and include not only the burden associated with reporting, but also the costs associated with implementing and maintaining the program. We also stated that we had identified several different types of costs, including, but not limited to the following:
• Provider and clinician information collection burden and burden associated with the submitting/reporting of quality measures to CMS.
• The provider and clinician cost associated with complying with other HH programmatic requirements.
• The provider and clinician cost associated with participating in multiple quality programs, and tracking multiple similar or duplicative measures within or across those programs.
• The cost to CMS associated with the program oversight of the measure, including measure maintenance and public display.
• The provider and clinician cost associated with compliance with other federal and state regulations (if applicable).
For example, we stated that it may be of limited benefit to retain or maintain a measure which our analyses show no longer meaningfully supports program objectives (for example, informing beneficiary choice). It may also be costly for HHAs to track confidential feedback, preview reports, and publicly reported information on a measure where we use the measure in more than one program. We may also have to expend resources to maintain the specifications for the measure, including the tools needed to collect, validate, analyze, and publicly report the measure data.
When these costs outweigh the evidence supporting the continued use of a measure in the HH QRP, we stated our belief that it may be appropriate to remove the measure from the program. Although we recognize that one of the main goals of the HH QRP is to improve beneficiary outcomes by incentivizing health care providers to focus on specific care issues and making public data related to those issues, we also
We proposed that we would remove measures based on Factor 8 on a case-by-case basis. For example, we may decide to retain a measure that is burdensome for HHAs to report if we conclude that the benefit to beneficiaries is so high that it justifies the reporting burden. We stated that our goal is to move the HH QRP program forward in the least burdensome manner possible, while maintaining a parsimonious set of meaningful quality measures and continuing to incentivize improvement in the quality of care provided to patients.
We invited public comment on our proposals to replace the six criteria used when considering a quality measure for removal with the seven measure removal factors currently adopted in the LTCH QRP, IRF QRP, and SNF QRP. We also invited public comment on our proposal to adopt new measure removal Factor 8: The costs associated with a measure outweigh the benefit of its continued use in the program.
The HH QRP currently has 30
To address the Meaningful Measures Initiative discussed in the CY 2019 HH PPS proposed rule in the CY 2019 HH PPS proposed rule (83 FR 32442 through 32446) we proposed to remove seven measures from the HH QRP beginning with the CY 2021 HH QRP. We received a few general comments on the proposed removal of these measures.
We remind HHAs that the removal of a measure from the HH QRP does not prevent HHAs from continuing to incorporate the quality process addressed by that measure in their own quality monitoring activities, and we would encourage HHAs to do so.
In the CY 2019 HH PPS proposed rule (83 FR 32442), we proposed to remove the Depression Assessment Conducted Measure from the HH QRP beginning with the CY 2021 HH QRP under Factor 1: Measure performance among HHAs is so high and unvarying that meaningful distinctions in improvements in performance can no longer be made.
In the CY 2010 HH PPS final rule (74 FR 58096 through 58098), we adopted the Depression Assessment Conducted Measure beginning with the CY 2010 HH QRP. Depression in the elderly is associated with disability, impaired well-being, service utilization,
We stated in the CY 2019 HH PPS proposed rule that in our evaluation of the Depression Assessment Conducted Measure, we found that HHA performance is very high and that meaningful distinctions in improvements in performance cannot be made. The mean and median agency performance scores for this measure in 2017 (96.8 percent and 99.2 percent, respectively) when compared to the mean and median agency performance scores for this measure in 2010 (88.0 percent and 96.6 percent, respectively) indicate that an overwhelming majority of patients are screened for depression in the HH setting. Further, these performance scores demonstrate the improvement in measure performance since its adoption in the HH QRP. In addition, in 2017 the 75th percentile measure score (100 percent) and the 90th percentile measure score (100 percent) are statistically indistinguishable from each other, meaning that the measure scores do not meaningfully distinguish scores between HHAs. Further, the Truncated Coefficient of Variation (TCV)
For these reasons, we proposed to remove the Depression Assessment Conducted Measure from the HH QRP beginning with the CY 2021 HH QRP under our Factor 1: Measure performance among HHAs is so high and unvarying that meaningful distinctions in improvements in performance can no longer be made.
We stated in the proposed rule that if we finalized this proposal, HHAs would no longer be required to submit OASIS Item M1730, Depression Screening at SOC/ROC for the purposes of this measure beginning January 1, 2020. HHAs would, however, continue to submit data on M1730 at the time point of SOC/ROC as a risk adjuster for several other OASIS-based outcome measures currently adopted for the HH QRP.
We invited public comment on this proposal.
In the CY 2019 HH PPS proposed rule (83 FR 32442 through 32443), we proposed to remove the Diabetic Foot Care and Patient/Caregiver Education Implemented during All Episodes of Care Measure from the HH QRP beginning with the CY 2021 HH QRP under our proposed Factor 1: Measure performance among HHAs is so high and unvarying that meaningful distinctions in improvements in performance can no longer be made.
In the CY 2010 HH PPS final rule (74 FR 58096 through 58098), we adopted the Diabetic Foot Care and Patient/Caregiver Education Implemented during All Episodes of Care Measure beginning with the CY 2010 HH QRP. This process measure reports the percentage of HH quality episodes in which diabetic foot care and patient/caregiver education were included in the physician-ordered plan of care and implemented (at the time of or at any time since the most recent SOC/ROC assessment). The measure numerator is calculated using OASIS Item M2401 row a, Intervention Synopsis: Diabetic foot care.
We stated in the CY 2019 HH PPS proposed rule (83 FR 32443) that in our evaluation of the Diabetic Foot Care and Patient/Caregiver Education Implemented during All Episodes of Care Measure, we found that HHA performance is very high and that meaningful distinctions in improvements in performance cannot be made. The mean and median agency performance scores for this measure in 2017 (97.0 percent and 99.2 percent, respectively) when compared to the mean and median agency performance score for this measure in 2010 (86.2 percent and 91.7 percent, respectively), indicate that an overwhelming majority of HH episodes for patients with diabetes included education on foot care. Further, these scores demonstrate the improvement in measure performance since the Diabetic Foot Care and Patient/Caregiver Education Implemented during All Episodes of Care Measure's adoption in the HH QRP. In addition, in 2017, the 75th percentile measure score (100 percent) and the 90th percentile score (100 percent) are statistically indistinguishable from each other, meaning that the measure scores do not meaningfully distinguish between HHAs. Further, the TCV for this measure is 0.03, suggesting that it is not useful to draw distinctions between individual agency performance scores for this measure.
For these reasons, we proposed to remove the Diabetic Foot Care and Patient/Caregiver Education Implemented during All Episodes of Care Measure from the HH QRP beginning with CY 2021 HH QRP under our proposed Factor 1: Measure performance among HHAs is so high and unvarying that meaningful distinctions in improvements in performance can no longer be made.
We stated in the proposed rule that if we finalized this proposal, HHAs would no longer be required to submit OASIS Item M2401 row a, Intervention Synopsis: Diabetic foot care at the time point of Transfer to an Inpatient Facility (TOC) and Discharge from Agency—Not to an Inpatient Facility (Discharge) for the purposes of the HH QRP beginning January 1, 2020. HHAs may enter an equal sign (=) for M2401, row a, at the time point of TOC and Discharge on or after January 1, 2020. We also stated that if we finalized this proposal, data for this measure would be publicly reported on HH Compare until January 2021.
We invited public comment on this proposal.
In the CY 2019 HH PPS proposed rule (83 FR 32443), we proposed to remove the Multifactor Fall Risk Assessment Conducted For All Patients Who Can Ambulate (NQF #0537) Measure from the HH QRP beginning with the CY 2021 HH QRP, under our proposed Factor 1: Measure performance among HHAs is so high and unvarying that meaningful distinctions in improvements in performance can no longer be made.
In CY 2010 HH PPS final rule (74 FR 58096 through 58098), we adopted the Multifactor Fall Risk Assessment Conducted For All Patients Who Can Ambulate (NQF #0537) Measure
We stated in the proposed rule (83 FR 32443) that in our evaluation of the Multifactor Fall Risk Assessment Conducted For All Patients Who Can Ambulate (NQF #0537) Measure, we found that HHA performance is very high and that meaningful distinctions in improvements in performance cannot be made. The mean and median agency performance scores for this measure in 2017 (99.3 percent and 100.0 percent, respectively) when compared to the mean and median agency performance score for this measure in 2010 (94.8 percent and 98.9 percent, respectively), indicate that an overwhelming majority of patients in an HHA have had a multifactor fall risk assessment at SOC/ROC and demonstrates the improvement in measure performance since its adoption. In addition, in 2017, the 75th percentile measure score (100 percent) and the 90th percentile measure score (100 percent) are statistically indistinguishable from each other, meaning that the measure scores do not meaningfully distinguish between HHAs. Further, the TCV for this measure is 0.01, suggesting that it is not useful to draw distinctions between individual agency performance scores for this measure.
For these reasons, we proposed to remove the Multifactor Fall Risk Assessment Conducted For All Patients Who Can Ambulate (NQF #0537) Measure from the HH QRP beginning with the CY 2021 HH QRP, under our proposed Factor 1: Measure performance among HHAs is so high and unvarying that meaningful distinctions in improvements in performance can no longer be made.
We stated in the proposed rule that if we finalized this proposal, HHAs would no longer be required to submit OASIS Item M1910, Falls Risk Assessment at SOC/ROC beginning January 1, 2020. HHAs may enter an equal sign (=) for M1910 at the time point of SOC and ROC beginning January 1, 2020. We also stated that if we finalized this proposal, data for this measure would be publicly reported on HH Compare until January 2021.
We invited public comment on this proposal.
In the CY 2019 HH PPS proposed rule (83 FR 32443 through 32444), we proposed to remove the Pneumococcal Polysaccharide Vaccine (PPV) Ever Received Measure from the HH QRP beginning with the CY 2021 HH QRP, under our proposed Factor 3: A measure does not align with current clinical guidelines or practice.
In the CY 2010 HH PPS final rule (74 FR 58096 through 58098), we adopted the Pneumococcal Polysaccharide Vaccine Ever Received Measure beginning with CY 2010 HH QRP. This process measure reports the percentage of HH quality episodes during which patients were determined to have ever received the Pneumococcal Polysaccharide Vaccine. The measure is calculated using OASIS Items M1051, Pneumococcal Vaccine and M1056, Reason Pneumococcal Vaccine not received.
At the time that this measure was adopted in the HH QRP, the Advisory Committee on Immunization Practices (ACIP),
Since this measure was added to the HH QRP, the ACIP has updated its pneumococcal vaccination recommendations.
We stated in the proposed rule that the specifications for the Pneumococcal Polysaccharide Vaccine Ever Received Measure do not fully reflect the current ACIP guidelines. Therefore, we believe that the Pneumococcal Polysaccharide Vaccine Ever Received Measure no longer aligns with the current clinical guidelines or practice. For this reason, we proposed to remove the Pneumococcal Polysaccharide Vaccine Ever Received Measure from the HH QRP beginning with the CY 2021 HH QRP under our proposed Factor 3: A measure does not align with current clinical guidelines or practice.
We stated in the proposed rule (83 FR 32444) that if we finalized this proposal, HHAs would no longer be required to submit OASIS Items M1051, Pneumococcal Vaccine and M1056, Reason Pneumococcal Vaccine not received at the time point of TOC and Discharge for the purposes of the HH QRP beginning January 1, 2020. HHAs may enter an equal sign (=) for Items M1051 and M1056 at the time point of TOC and Discharge on or after January 1, 2020. We also stated that if we finalized this proposal, data for this measure would be publicly reported on HH Compare until January 2021.
We invited public comment on this proposal.
In the CY 2019 HH PPS proposed rule (83 FR 32444 through 32445), we proposed to remove the Improvement in the Status of Surgical Wounds Measure from the HH QRP beginning with the CY 2021 HH QRP under our proposed Factor 4: A more broadly applicable measure (across settings, populations, or conditions) for the particular topic is available.
In the CY 2008 HH PPS final rule (72 FR 49861 through 49863), we adopted the Improvement in the Status of Surgical Wounds Measure for the HH QRP beginning with the CY 2008 program year. This risk-adjusted outcome measure reports the percentage of HH episodes of care during which the patient demonstrates an improvement in the condition of skin integrity related to the surgical wounds. This measure is solely calculated using OASIS Items M1340, Does this patient have a Surgical Wound? and M1342, Status of Most Problematic Surgical Wound that is Observable.
We stated in the proposed rule (83 FR 32444) that the Improvement in the
In contrast, the Percent of Residents or Patients with Pressure Ulcers That Are New or Worsened (Short Stay) Measure (NQF #0678)
Therefore, we proposed to remove the Improvement in the Status of Surgical Wounds Measure from the HH QRP beginning with the CY 2021 HH QRP under our proposed Factor 4: A more broadly applicable measure (across settings, populations, or conditions) for the particular topic is available.
We stated in the proposed rule that if we finalized this proposal, HHAs would no longer be required to submit OASIS Items M1340, Does this patient have a Surgical Wound and M1342, Status of Most Problematic Surgical Wound that is Observable, at the time points of SOC/ROC and Discharge for the purposes of this measure beginning with January 1, 2020 episodes of care. However, HHAs would still be required to submit data on Items M1340 and M1342 at the time point of SOC/ROC as risk adjusters for several other OASIS-based outcome measures currently adopted for the HH QRP,
We invited public comment on this proposal.
In the CY 2019 HH PPS proposed rule (83 FR 32445), we proposed to remove the Emergency Department (ED) Use without Hospital Readmission during the First 30 Days of HH (NQF #2505) Measure from the HH QRP beginning with the CY 2021 HH QRP, under our proposed Factor 4: A more broadly applicable measure (across settings, populations, or conditions) for the particular topic is available.
In the CY 2014 HH PPS final rule (78 FR 72297 through 72301), we adopted the claims-based ED Use without Hospital Readmission during the first 30 days of HH (NQF #2505) Measure beginning with CY 2014 HH QRP. The particular topic for this measure is ED utilization, as it estimates the risk-standardized rate of ED use without acute care hospital admission during the 30 days following the start of the HH stay for patients with an acute inpatient hospitalization in the 5 days before the start of their HH stay. The ED Use without Hospital Readmission during the First 30 Days of HH (NQF #2505) Measure is limited to Medicare FFS patients with a prior, proximal inpatient stay. Recent analyses from 2016 and 2017 show that this measure annually captured approximately 2.5 million (25.1 percent in 2016 and 25.1 percent in 2017) of Medicare FFS HH stays and was reportable for less than two-thirds of the HHAs (62.1 percent in 2016 and 62.6 percent in 2017).
We stated in the proposed rule (83 FR 32444) that the ED Use without Hospitalization During the First 60 Days of HH (NQF #0173) Measure also addresses the topic of ED utilization during a HH stay. This measure reports the percentage of Medicare FFS HH stays in which patients used the ED but were not admitted to the hospital during the 60 days following the start of the HH stay. The ED Use without Hospitalization during the First 60 days of HH (NQF #0173) Measure includes Medicare FFS patients irrespective of whether or not they had an acute inpatient hospitalization in the 5 days prior to the start of the HH stay and spans the first 60 days of a HH episode. Recent analyses using 2016 and 2017 data show this measure annually captures approximately 8.3 million stays (81.9 percent in 2016 and 81.8 percent in 2017) and is reportable by a greater number of HHAs (88.8 percent in 2016 and 88.1 percent in 2017) than the ED Use without Hospital Readmission During the First 30 Days of HH (NQF #2505) Measure.
We stated in the proposed rule (83 FR 32445) that the ED Use without Hospital Readmission During the First 30 Days of HH (NQF #2505) Measure addresses outcomes of Medicare FFS patients for a 30-day interval after the start of their HH care, regardless of the length of their HH stay. The more broadly applicable ED Use without Hospitalization during the First 60 days of HH (NQF #0173)
For these reasons, we proposed to remove the ED Use without Hospital Readmission During the First 30 Days of HH (NQF #2505) Measure from the HH QRP beginning with the CY 2021 HH QRP under our proposed Factor 4: A more broadly applicable measure (across settings, populations, or conditions) for the particular topic is available. We stated in the proposed rule that if we finalized this proposal, data for this measure would be reported on HH Compare until January 2020.
We invited public comment on this proposal.
In the CY 2019 HH PPS proposed rule (83 FR 32445 through 32446), we proposed to remove the Rehospitalization during the First 30 Days of HH (NQF #2380) Measure from the HH QRP beginning with the CY 2021 HH QRP, under our proposed Factor 4: A more broadly applicable measure (across settings, populations, or conditions) for the particular topic is available.
In the CY 2014 HH PPS final rule (78 FR 72297 through 72301), we adopted the claims-based Rehospitalization during the first 30 Days of HH Measure beginning with the CY 2014 HH QRP. The measure was NQF-endorsed (NQF #2380) in December 2014. The Rehospitalization during the first 30 Days of HH (NQF #2380) Measure addresses the particular topic of acute care hospital utilization during a HH stay. This measure estimates the risk-standardized rate of unplanned, all-cause hospital readmissions for patients who had an acute inpatient hospitalization in the 5 days before the start of their HH stay and were admitted to an acute care hospital during the 30 days following the start of the HH stay (78 FR 72297 through 72301). The Rehospitalization During the First 30 Days of HH (NQF #2380) Measure only includes Medicare FFS patients. Recent analyses from 2016 and 2017 show that this measure annually captured approximately 2.5 million (25.1 percent in 2016 and 25.1 percent in 2017) of Medicare FFS HH stays and was reportable for less than two-thirds of the HHAs (62.1 percent in 2016 and 62.6 percent in 2017).
In the CY 2013 HH PPS final rule (77 FR 67093 through 67094), we finalized the claims-based Acute Care Hospitalization Measure. The measure's title was later updated to Acute Care Hospitalization During the First 60 Days of HH (NQF #0171) to improve clarity.
We stated in the proposed rule (83 FR 32446) that the Rehospitalization during the First 30 Days of HH (NQF #2380) Measure addresses outcomes of Medicare FFS patients for a 30-day interval after the start of their HH care, regardless of the length of their HH stay. In contrast, the Acute Care Hospitalization During the First 60 Days of HH (NQF #0171) Measure is broader because it addresses these same outcomes for a greater number of Medicare FFS patients during the first 60 Days of a HH stay, which includes the 30-day interval of the Rehospitalization during the First 30 Days of HH (NQF #2380) Measure. The measure specifications for both measures are otherwise harmonized along several measure dimensions, including data source, population, denominator exclusions, numerator, and risk adjustment methodology. As a result, removing the Rehospitalization during the First 30 Days of HH (NQF #2380) Measure in favor of the Acute Care Hospitalization during the First 60 Days of HH (NQF #0171) Measure will not result in a loss of the ability to measure the topic of acute care hospital utilization across the HH setting.
For these reasons, we proposed to remove the Rehospitalization during the First 30 Days of HH (NQF #2380) Measure from the HH QRP beginning with the CY 2021 HH QRP under our proposed Factor 4: A more broadly applicable measure (across settings, populations, or conditions) for particular topic is available. We stated in the proposed rule that if we finalized this proposal, data for this measure would be publicly reported on HH Compare until January 2020.
We invited public comment on this proposal.
In the CY 2018 HH PPS final rule (82 FR 51731), we stated that we intended to specify two measures that will satisfy
We stated in the proposed rule that as a result of the input provided during a public comment period between November 10, 2016 and December 11, 2016, input provided by a technical expert panel (TEP) convened by our contractor, and pilot measure testing conducted in 2017, we are engaging in continued development work on these two measures, including supplementary measure testing and providing the public with an opportunity for comment in 2018. Further, we reconvened a TEP for these measures in April 2018. We now intend to specify the measures under section 1899B(c)(1)(E) of the Act no later than January 1, 2020, and intend to proposed to adopt the measures beginning with the CY 2022 HH QRP, with data collection at the time point of SOC, ROC and Discharge beginning with January 1, 2021. For more information on the pilot testing, we refer readers to:
Our home health regulations, codified at § 484.250(a), require HHAs to submit OASIS assessments and Home Health Care Consumer Assessment of Healthcare Providers and Systems Survey® (HHCAHPS) data to meet the quality reporting requirements of section 1895(b)(3)(B)(v) of the Act. In the CY 2019 HH PPS proposed rule (83 FR 32446), we proposed to revise § 484.250(a) to clarify that not all OASIS data described in § 484.55(b) and (d) are needed for purposes of complying with the requirements of the HH QRP. OASIS data items may be submitted for other established purposes unrelated to the HH QRP, including payment, survey, the HH VBP Model, or care planning. Any OASIS data that are not submitted for the purposes of the HH QRP are not used for purposes of HH QRP compliance.
We invited public comment on our proposal to revise our regulations at § 484.250(a) to clarify that not all OASIS data described in § 484.55(b) and (d) are needed for purposes of complying with the requirements of the HH QRP.
Section 1899B(g) of the Act requires that data and information regarding PAC provider performance on quality measures and resource use and other measures be made publicly available beginning not later than 2 years after the applicable specified `application date'. In the CY 2018 HH PPS final rule (82 FR 51740 through 51741), we finalized that we will publicly display the Medicare Spending Per Beneficiary (MSPB)-PAC HH QRP beginning in CY 2019 based on 1 year of claims data on discharges from CY 2017.
In the CY 2019 HH PPS proposed rule (83 FR 32446), we proposed to increase the number of years of data used to calculate the MSPB-PAC HH QRP for purposes of display from 1 year to 2 years. Under this proposal, data on this measure would be publicly reported in CY 2019, or as soon thereafter as operationally feasible, based on discharges from CY 2016 and CY 2017. We also stated that increasing the measure calculation and public display periods from 1 to 2 years of data would increase the number of HHAs with enough data adequate for public reporting for the MSPB-PAC HH QRP measure from 90.7 percent (based on August 1, 2014-July 31, 2015 Medicare FFS claims data) to 94.9 percent (based on August 1, 2014-July 31, 2016 Medicare FFS claims data). We further stated that increasing the measure public display periods to 2 years would align with the public display periods of these measures in the IRF QRP, LTCH QRP, and SNF QRP.
We invited public comment on our proposal to increase the number of years of data used to calculate the MSPB-PAC HH QRP for purposes of display from 1 year to 2 years.
We disagree with the recommendation to use 2 years of data for low-volume HHAs but 1 year of data for larger HHAs because HHA performance may no longer be comparable using different time periods for data collection. Finally, there is no
In the CY 2019 HH PPS proposed rule (83 FR 32446), we did not propose changes to the Home Health Care Consumer Assessment of Healthcare Providers and Systems® (HHCAHPS) Survey requirements for CY 2019. Therefore, HHCAHPS Survey requirements are as codified in § 484.250 and the HHCAHPS survey vendors' data submission deadlines are as posted on HHCAHPS website at
In this section of the rule, we discuss the new home infusion therapy benefit that was established in section 5012 of the 21st Century Cures Act. This benefit covers the professional services, including nursing services, patient training and education, and monitoring services associated with administering infusion drugs by an item of durable medical equipment (DME) in a patient's home. This final rule with comment period will establish health and safety standards for home infusion therapy and provide consistency in coverage for home infusion therapy services. In addition, this final rule with comment period establishes regulations for the approval and oversight of accrediting organizations that provide accreditation to home infusion therapy suppliers. This rule also provides information on the implementation of the home infusion therapy services temporary transitional payments for CYs 2019 and 2020, as mandated by section 50401 of the BBA of 2018, and finalizes a regulatory definition of “Infusion Drug Administration Calendar Day.”
Infusion drugs and administration services can be furnished in multiple health care settings, including inpatient hospitals, skilled nursing facilities (SNFs), hospital outpatient departments (HOPDs), physicians' offices, and in the home. Traditional Fee-for-Service (FFS) Medicare provides coverage for infusion drugs, equipment, supplies, and administration services. However, Medicare coverage requirements and payment vary for each of these settings. Infusion drugs, equipment, supplies, and administration are all covered by Medicare in the inpatient hospital, SNFs, HOPDs, and physicians' offices.
Generally, Medicare payment under Part A for the drugs, equipment, supplies, and services are bundled, meaning a single payment is made on the basis of expected costs for clinically-defined episodes of care. For example, if a beneficiary is receiving an infusion drug during an inpatient hospital stay, the Part A payment for the drug, supplies, equipment, and drug administration is included in the diagnosis-related group (DRG) payment to the hospital under the Medicare inpatient prospective payment system. Beneficiaries are liable for the Medicare inpatient hospital deductible.
Similarly, if a beneficiary is receiving an infusion drug while in a SNF under a Part A stay, the payment for the drug, supplies, equipment, and drug administration are included in the SNF prospective payment system payment. After 20 days of SNF care, there is a daily beneficiary cost-sharing amount through day 100 when the beneficiary becomes responsible for all costs for each day after day 100 of the benefit period.
Under Medicare Part B, certain items and services are paid separately while other items and services may be packaged into a single payment together. For example, in an HOPD and in a physician's office, the drug is paid separately, generally at the average sales price (ASP) plus 6 percent. There is also a separate payment for drug administration in which the payment for infusion supplies and equipment is packaged in the payment for administration. The separate payment for infusion drug administration in an HOPD and in a physician's office generally includes a base payment amount for the first hour and a payment add-on that is a different amount for each additional hour of administration. The beneficiary is responsible for the 20 percent coinsurance under Medicare Part B.
Medicare FFS covers outpatient infusion drugs under Part B, “incident to” a physician's services, provided the drugs are not usually self- administered by the patient. Drugs that are “not usually self-administered,” are defined in our manual according to how the Medicare population as a whole uses the drug, not how an individual patient or physician may choose to use a particular drug. For the purpose of this exclusion, the term “usually” means more than 50 percent of the time for all Medicare beneficiaries who use the drug. The term “by the patient” means Medicare beneficiaries as a collective whole. Therefore, if a drug is self-administered by more than 50 percent of Medicare beneficiaries, the drug is excluded from Part B coverage. This determination is made on a drug-by-drug basis, not on a beneficiary-by-beneficiary basis.
Home infusion therapy involves the intravenous or subcutaneous administration of drugs or biologicals to an individual at home. Certain drugs can be infused in the home, but the nature of the home setting presents different challenges than the settings previously described. The components needed to perform home infusion include the drug (for example, antibiotics, immune globulin), equipment (for example, a pump), and supplies (for example, tubing and catheters). Likewise, nursing services are necessary to train and educate the patient and caregivers on the safe administration of infusion drugs in the home. Visiting nurses often play a large role in home infusion. Nurses typically train the patient or caregiver to self-administer the drug, educate on side effects and goals of therapy, and visit periodically to assess the infusion site and provide dressing changes. Depending on patient acuity or the complexity of the drug administration, certain infusions may require more nursing time, especially those that require special handling or pre-or post-infusion protocols. The home infusion process typically requires coordination among multiple entities, including patients, physicians, hospital discharge planners, health plans, home infusion pharmacies, and, if applicable, home health agencies. With regard to payment for home infusion therapy under traditional Medicare, drugs are generally covered under Part B or Part D. Certain infusion pumps, supplies (including home infusion drugs), and nursing are covered in some circumstances through the Part B durable medical equipment (DME) benefit, the Medicare home health benefit, or some combination of these benefits.
Medicare Part B covers a limited number of home infusion drugs through the DME benefit if: (1) The drug is necessary for the effective use of an external or implantable infusion pump classified as DME and determined to be reasonable and necessary for administration of the drug; and (2) the drug being used with the pump is itself reasonable and necessary for the treatment of an illness or injury. Only certain types of infusion pumps are covered under the DME benefit. The Medicare
Section 5012 of the 21st Century Cures Act (Pub. L. 114-255) (Cures Act) creates a separate Medicare Part B benefit category under section 1861(s)(2)(GG) of the Act for coverage of home infusion therapy-associated professional services for certain drugs and biologicals administered intravenously, or subcutaneously through a pump that is an item of DME, effective January 1, 2021. The infusion pump and supplies (including home infusion drugs) will continue to be covered under the DME benefit. Section 1861(iii)(2) of the Act defines home infusion therapy to include the following items and services: The professional services (including nursing services), furnished in accordance with the plan, training and education (not otherwise included in the payment for the DME), remote monitoring, and other monitoring services for the provision of home infusion therapy furnished by a qualified home infusion therapy supplier in the patient's home. Section 1861(iii)(3)(B) of the Act defines the patient's home to mean a place of residence used as the home of an individual as defined for purposes of section 1861(n) of the Act. As outlined in section 1861(iii)(1) of the Act, to be eligible to receive home infusion therapy services under the home infusion therapy benefit, the patient must be under the care of an applicable provider (defined in section 1861(iii)(3)(A) of the Act as a physician, nurse practitioner, or physician's assistant), and the patient must be under a physician-established plan of care that prescribes the type, amount, and duration of infusion therapy services that are to be furnished. The plan of care must be periodically reviewed by the physician in coordination with the furnishing of home infusion drugs (as defined in section 1861(iii)(3)(C) of the Act). Section 1861(iii)(3)(C) of the Act defines a “home infusion drug” under the home infusion therapy benefit as a drug or biological administered intravenously, or subcutaneously for an administration period of 15 minutes or more, in the patient's home, through a pump that is an item of DME as defined under section 1861(n) of the Act. This definition does not include insulin pump systems or any self-administered drug or biological on a self-administered drug exclusion list.
Section 1861(iii)(3)(D)(i) of the Act defines a qualified home infusion therapy supplier as a pharmacy, physician, or other provider of services or supplier licensed by the state in which supplies or services are furnished. The provision specifies qualified home infusion therapy suppliers must furnish infusion therapy to individuals with acute or chronic conditions requiring administration of home infusion drugs; ensure the safe and effective provision and administration of home infusion therapy on a 7-day-a-week, 24-hour-a-day basis; be accredited by an organization designated by the Secretary; and meet other such requirements as the Secretary deems appropriate, taking into account the standards of care for home infusion therapy established by Medicare Advantage (MA) plans under part C and in the private sector. The supplier may subcontract with a pharmacy, physician, other qualified supplier or provider of medical services, in order to meet these requirements.
Section 1834(u)(1) of the Act requires the Secretary to implement a payment system under which, beginning January 1, 2021, a single payment is made to a home infusion therapy supplier for the items and services (professional services, including nursing services; training and education; remote monitoring, and other monitoring services). The single payment must take into account, as appropriate, types of infusion therapy, including variations in utilization of services by therapy type. In addition, the single payment amount is required to be adjusted to reflect geographic wage index and other costs that may vary by region, patient acuity, and complexity of drug administration. The single payment may be adjusted to reflect outlier situations, and other factors as deemed appropriate by the Secretary, which are required to be done in a budget neutral manner. Section 1834(u)(3) of the Act specifies that annual updates to the single payment are required to be made beginning January 1, 2022, by increasing the single payment amount by the percent increase in the CPI for all urban consumers for the 12-month period ending with June of the preceding year, reduced by the multi-factor productivity adjustment. The unit of single payment for each infusion drug administration calendar day, including the required adjustments and the annual update, cannot exceed the amount determined under the fee schedule under section 1848 of the Act for infusion therapy services if furnished in a physician's office, and the single payment amount cannot reflect more than 5 hours of infusion for a particular therapy per calendar day. Section 1834(u)(4) of the Act also allows the Secretary discretion, as appropriate, to consider prior authorization requirements for home infusion therapy services. Finally, section 5012(c)(3) of the 21st Century Cures Act amended section 1861(m) of the Act to exclude home infusion therapy from the HH PPS beginning on January 1, 2021.
Section 5012 of the Cures Act requires that, to receive payment under the Medicare home infusion therapy benefit, home infusion therapy suppliers must select a CMS-approved accreditation organization (AO) and undergo an accreditation review process to demonstrate that the home infusion therapy supplier meets the AO's standards. Section 1861(iii) of the Act,
The Journal of Infusion Nursing standards of practice specifically address patient education, and state that it is the clinician's role to educate the patient, caregiver, and/or surrogate about the prescribed infusion therapy and plan of care including, but not limited to, purpose and expected outcome(s) and/or goals of treatment, infusion therapy administration; infusion device-related care; potential complications; or adverse effects associated with treatment. (Infusion Therapy Standards of Practice, 2015).
Currently, standards for home infusion therapy have been established by the current AOs; however, they are not necessarily consistent. In order to assure consistency in the areas identified in the Act, we are establishing basic standards that all AOs will be required to meet or exceed. We proposed universal standards for Medicare-participating qualified home infusion therapy suppliers to ensure the quality and safety of home infusion therapy services for all beneficiaries that these suppliers serve.
In preparation for developing these standards and to gain a clear understanding of the current home infusion therapy supplier private sector climate, we reviewed the requirements established by section 5012 of the 21st Cures Act, performed an extensive review of the standards from all six AOs that accredit home infusion suppliers (The Joint Commission, Accreditation Commission for Health Care, Compliance Team, Community Health Accreditation Partner, Healthcare Quality Association on Accreditation, and National Association of Boards of Pharmacy), and reviewed various other government and industry publications listed in this final rule with comment period. In addition to the standards, we reviewed the following documents related to coverage:
• Government Accountability Office-10-426 report, which describes the state of coverage of home infusion therapy components under Medicare fee-for-service prior to the enactment of the Cures Act (GAO, 2010).
• Medicare and Home Infusion white paper written by the National Home Infusion Association (NHIA), which provided an overview of Medicare coverage provided for Home Infusion Therapy services prior to the enactment of the Cures Act, as well as results of a study conducted by Avalere Health on the potential savings that could result from Medicare coverage of infusion therapy provided in the home (National Home Infusion Therapy Association, NDS).
• American Society of Health System Pharmacists Guidelines on Home Infusion Pharmacy Services, which provided an in-depth overview of specialized, complex pharmaceuticals, best practices on providing home infusion therapy in the home or alternative site settings, and the plans to execute and manage the therapy (American Society of Health-System Pharmacists. ASHP guidelines on Home Infusion Pharmacy Service, 2014).
• The requirements of numerous Medicare Advantage plans, Medicare FFS, and private insurance plans.
Upon review of these materials, we believe that there is a sufficient private-sector framework already in place to address many of the areas that will typically be included in the establishment of basic health and safety standards for home infusion therapy. For example, existing AO standards include requirements related to plan of care, monitoring, patient assessment, quality improvement, and infection control. While the exact content of the AO standards vary, we believe that the standards are adequate to ensure patient health and safety. The AO representing the largest number of home infusion therapy suppliers requires that home infusion pharmacies provide certain services to ensure safe and appropriate therapy, in compliance with nationally recognized standards of practice. Patient training and education activities, as part of their required admission procedures, include the use of medical and disposable equipment, medication storage, emergency procedures, vascular access device management, recognition of a drug reaction, and when to report any adverse drug event. As such, we concluded that it was appropriate to propose requirements for only those elements specifically identified in section 1861(iii) of the Act. Through the CMS accreditation organization process, we would monitor home infusion therapy suppliers to assure that services are provided in a safe and effective manner, and would consider future rulemaking to address any areas that may need improvement in the future. We solicited public comment on this approach and invited comments related to the home infusion therapy standards.
We propose to add a new 42 CFR part 486, subpart I, to incorporate the home infusion therapy supplier requirements. The proposed regulations would provide a framework for CMS to approve home infusion therapy accreditation organizations and give them the authority to approve Medicare certification for home infusion therapy suppliers. Final subpart I would include General Provisions (Basis and Scope, and Definitions) and Standards for Home Infusion Therapy (Plan of Care and Required Services).
We proposed to set forth the basis and scope of part 486 at § 486.500. Part 486 is based on sections 1861(iii)(2)(D) of the Act, which establishes the requirements that a home infusion therapy supplier must meet in order to participate in the Medicare program. These proposed provisions serve as the basis for survey activities for the purposes of determining whether a home infusion therapy supplier meets the requirements for participation in Medicare. Section 1834(u) of the Act serves as the basis for the establishment of a prospective payment system for home infusion therapy covered under Medicare. In addition, section 1834(u)(5) of the Act establishes the factors for the Secretary to designate organizations to accredit suppliers furnishing home infusion therapy and requires that organizations be designated not later than January 1, 2021.
At proposed § 486.505, we define certain terms that would be used in the home infusion therapy requirements. We define the terms “applicable provider”, “home”, “home infusion drug”, and “qualified home infusion therapy supplier” in accordance with the definitions set forth in section 1861(iii) of the Act. Furthermore, section 1861(iii) of the Act includes a definition of the term “home infusion therapy” that is the basis of the health and safety requirements set forth in this final rule with comment period. In accordance with the Act, we proposed the following definitions:
• “Applicable provider” would mean a physician, a nurse practitioner, and a physician assistant.
• “Home” would mean a place of residence used as the home of an individual, including an institution that is used as a home. However, an institution that is used as a home may not be a hospital, CAH, or SNF as defined in sections 1861(e), 1861(mm)(1), and 1819 of the Act, respectively.
• “Home infusion drug” would mean a parenteral drug or biological administered intravenously, or subcutaneously for an administration period of 15 minutes or more, in the home of an individual through a pump that is an item of durable medical equipment. The term does not include insulin pump systems or a self-administered drug or biological on a self-administered drug exclusion list.
• “Qualified home infusion therapy supplier” would mean a supplier of home infusion therapy that meets all of the following criteria which are set forth at section 1861(iii)(3)(D)(i) of the Act: (1) Furnishes infusion therapy to individuals with acute or chronic conditions requiring administration of home infusion drugs; (2) ensures the safe and effective provision and administration of home infusion therapy on a 7-day-a-week, 24-hour-a-day basis; (3) is accredited by an organization designated by the Secretary in accordance with section 1834(u)(5) of the Act; and (4) meets such other requirements as the Secretary determines appropriate.
Proposed subpart I, as required by section 5012 of the Cures Act, would specify that the qualified home infusion therapy supplier ensure that all patients have a plan of care established by a physician.
Proposed § 486.520(a), requires that all patients must be under the care of an “applicable provider” as defined at § 486.505. Proposed § 486.520(b) requires that the qualified home infusion therapy supplier ensure that all patients must have a plan of care established by a physician that prescribes the type, amount, and duration of home infusion therapy services that are furnished. The plan of care would also include the specific medication, the prescribed dosage and frequency as well as the professional services to be utilized for treatment. In addition, the plan of care would specify the care and services necessary to meet the patient-specific needs.
We also proposed, at § 486.520(c), that the qualified home infusion therapy supplier must ensure that the plan of care for each patient is periodically reviewed by the physician. We did not propose to establish a specific timeframe for review requirements, but the expectation is that the physician is active in the patient's care and can make appropriate decisions related to the course of therapy if changes are necessary in regards to the progress of the patient and goal achievement with the infusion therapy.
Section 1861(iii)(2)(D)(II) of the Act specifically mandates that qualified home infusion therapy suppliers ensure the safe and effective provision and administration of home infusion therapy on a 7-day-a-week, 24-hour-a-day basis. Infusion drugs are administered directly into a vein or under the skin, eliciting a more rapid clinical response than with oral medications. Consequently, an adverse effect or a medication error could result in a quicker and/or more severe complication. Therefore, at § 486.525(a), we proposed to require the provision of professional services, including nursing services, furnished in accordance with the plan of care. We proposed to require that home infusion therapy suppliers ensure that professional services are available on a 7-day-a-week, 24-hour-a-day basis in order to ensure that patients have access to expert clinical knowledge and advice in the event of an urgent or emergent infusion-related situation. This requirement is imperative, as the success of home infusion therapy is often dependent upon the professional services being available during all hours and days of the week that allows for the patient to safely and effectively manage all aspects of treatment.
At § 486.525(b), we proposed to require patient training and education, not otherwise paid for as durable medical equipment, and as described in 42 CFR 424.57(c)(12). This requirement is consistent with section 1861(iii)(2)(B) of the Act. In addition, the patient training and education requirements are consistent with standards that are already in place, as established by the current AOs of home infusion therapy suppliers. This is a best practice, as home infusion therapy may entail the use of equipment and supplies with which patients' may not be comfortable or familiar.
At § 486.525(c), we proposed to require qualified home infusion therapy suppliers to provide remote monitoring and monitoring services for the provision of home infusion therapy services and home infusion drugs furnished by a qualified home infusion therapy supplier. This proposed requirement is also consistent with section 1861(iii)(2)(B) of the Act. Monitoring the patient receiving infusion therapy in their home is an important standard of practice that is an integral part of providing medical care to patients in their home.
Section 1861(iii)(3)(D)(III) of the Act, as added by section 5012(b) of the Cures Act, requires that a home infusion therapy supplier be accredited by an AO designated by the Secretary in accordance with section 1834(u)(5) of the Act. Section 1834(u)(5)(A) of the Act identifies factors for designating AOs and modifying the list of designated AOs. These statutory factors are: (1) The ability of the organization to conduct timely reviews of accreditation applications; (2) the ability of the organization take into account the capacities of suppliers located in a rural area (as defined in section 1886(d)(2)(D) of the Act); (3) whether the organization has established reasonable fees to be charged to suppliers applying for accreditation; and, (4) such other factors as the Secretary determines appropriate.
Section 1834(u)(5)(B) of the Act requires the Secretary to designate AOs to accredit home infusion therapy suppliers furnishing home infusion therapy not later than January 1, 2021. In the proposed rule we stated that, there are six AOs that are currently providing accreditation to home infusion therapy suppliers, which are: (1) The Joint Commission (TJC); (2) Accreditation Commission for Health Care (ACHC); (3) Compliance Team (TCT); (4) Community Health Accreditation Partner (CHAP); (5) Healthcare Quality Association on Accreditation; and (6) National Association of Boards of Pharmacy. However, since the publication of the proposed rule, we have learned that there are two additional organizations that provide accreditation to home infusion therapy suppliers. These organizations are: (1) The Centers for Pharmacy Practice Accreditation (CPPA) and (2) URAC.
Five of these AOs are providing accreditation to home infusion therapy suppliers as part of the overall accreditation of home health agencies. The remaining AOs are pharmacy associations that have home infusion therapy accreditation programs that have not been approved by Medicare.
We proposed to publish a solicitation notice in the
Section 1861(iii)(3)(D) of the Act requires “qualified home infusion therapy suppliers” to be accredited by a CMS-approved AO. We proposed that, in order for the home infusion therapy suppliers accredited by the eight AOs that currently provide non-Medicare
We proposed that the home infusion therapy accreditation program be a separate and distinct accreditation program from the HHA AO's home health accreditation program. This would mean that AOs currently surveying HHAs would have a separate accreditation program with separate survey processes and standards for the accreditation of home infusion therapy suppliers. In addition, we proposed to require that the applications submitted by all HHA and pharmacy AOs that currently provide accreditation to home infusion therapy suppliers meet the application requirements set forth in the proposed home infusion therapy AO approval and oversight regulations at § 488.1010 and meet or exceed the substantive home infusion therapy health and safety standards proposed to be set out at 42 CFR part 485, subpart I.
Section 1834(u)(5)(C)(ii) of the Act states that in the case where the Secretary removes a home infusion therapy AO from the list of designated home infusion therapy AOs, any home infusion therapy supplier that is accredited by the home infusion therapy AO during the period beginning on the date on which the home infusion therapy AO is designated as an CMS-approved home infusion therapy AO and ending on the date on which the home infusion therapy AO is removed from such list, shall be considered to have been accredited by an home infusion therapy AO designated by the Secretary for the remaining period such accreditation is in effect. Under section 1834(u)(5)(D) of the Act, in the case of a home infusion therapy supplier that is accredited before January 1, 2021 by a home infusion therapy AO designated by the Secretary as of January 1, 2019, such home infusion therapy supplier shall be considered to be accredited by a home infusion therapy AO designated by the Secretary as of January 1, 2023, for the remaining period such accreditation is in effect. Home infusion therapy suppliers are required to receive accreditation before receiving Medicare payment for services provided to Medicare beneficiaries.
Section 1861(iii)(3)(D) of the Act defines “qualified home infusion therapy suppliers” as being accredited by a CMS-approved AO. In the proposed rule, we proposed to establish regulations for the approval and oversight of AOs that accredit home infusion therapy suppliers to address the following: (1) The required components to be included in a home infusion therapy AO's initial or renewal application for CMS approval of the AO's home infusion therapy accreditation program; (2) the procedure for CMS' review and approval of a home infusion therapy AOs application for CMS approval of its home infusion therapy accreditation program; and (3) the process for ongoing monitoring and oversight of the CMS-approved home infusion therapy AOs.
Upon receipt of an application from a home infusion therapy AO seeking CMS approval of its home infusion therapy accreditation program, CMS will determine its completeness in accordance with the requirements set forth at § 488.1010(a). Once CMS has determined that an application is complete, CMS will then review it to determine whether the application meets the requirements set forth at § 488.1000 to § 488.1050 and whether the AOs accreditation standards meet or exceed the Medicare home infusion therapy health and safety accreditation requirements set forth at proposed § 486.500 to § 486.525. CMS will also assess whether the AO accredits only those home infusion therapy suppliers that provide all services required by the Medicare home infusion therapy health and safety and payment regulations. Pursuant to § 488.1010(d), CMS must complete the application review process and issue a decision within 210 days from the date that CMS determines that the application is complete. In accordance with § 488.1020(b), CMS will publish a final notice in the
Upon receipt of an application, CMS will determine its completeness in accordance with the requirements set forth at § 488.1010(a). Once CMS has determined that the application is complete, CMS will review it to determine whether the application meets the requirements set forth at § 488.1000 to § 488.1050 and whether the AOs accreditation standards meet or exceed the Medicare home infusion therapy health and safety accreditation requirements set forth at proposed § 486.500 to § 486.525. CMS will also assess whether the AO accredits only those home infusion therapy suppliers that provide all services required by the Medicare home infusion therapy health and safety and payment regulations. Pursuant to § 488.1010(d), CMS must complete the application review process and issue a decision within 210 days from the date CMS determines that the application is complete. In accordance with § 488.1020(b), CMS will publish a final notice in the
If the NABP were to submit an application to CMS for approval of a home infusion therapy accreditation program, we would be required to give the same consideration to that
It is interesting to point out that these same commenters strongly advocated for CMS to “grandfather” in the existing eight home infusion therapy AOs which were recognized in the proposed rule. These commenter's argued that for CMS to do otherwise would be to defeat Congress's clear direction and understanding that the accreditation program be functional by January 1, 2019, and would severely disrupt care for patients. As the NAPB is one of eight existing home infusion therapy accrediting organizations, it would seem that these commenters have on one hand, advocated that the NABP should “grandfathered” in as one of the eight existing home infusion therapy AOs, while also advocating for their exclusion as a home infusion therapy AO. These arguments conflict with one another.
Several commenters suggested that the accreditation of home infusion therapy suppliers should be allowed as part of an HHA AO's overall accreditation and not require a totally separate accreditation as long as the accreditation organization meets all the CMS mandated home infusion therapy accreditation health and safety standards. Some of these commenters stated the belief that requiring AOs with existing home infusion therapy accreditation programs to submit a home infusion therapy accreditation program that is separate and distinct from their HHA accreditation program could affect the quality of care provided by these AOs and that such a policy would further fragment care delivery.
Another commenter suggested that CMS should permit a separate home infusion therapy accreditation module, approved by CMS, under an existing accreditation program because CMS has already done considerable review of the existing HHA accreditation programs and could benefit from working with the AOs to build on already existing standards to establish a standard set of standards that could be included for all accreditation organizations rather than developing a totally separate, free-standing home infusion therapy accreditation program.
Several commenters stated the belief that the requirement for a distinct, freestanding accreditation program for home infusion therapy suppliers would place additional burden on home care programs that currently provide home infusion therapy services as well as on accrediting organizations (AOs). One of these commenters expressed the concern that a totally separate accreditation program for HIT only would involve excessive cost and personnel time for agencies and CMS.
Second, given that our review of the commenter's HHA accreditation program standards occurred prior to the passage of the statutory mandate for CMS to designate AOs to accredit home infusion therapy suppliers our review of AOs' HHA programs focus on and assess the AO's HHA accreditation program standards and adherence to the CMS Home Health Conditions of Participation. Therefore, the reliance on our previous review of the HHA accreditation program standards and survey processes would not be sufficient to ensure that a HHA AO's home infusion therapy accreditation program would meet or exceed Medicare home infusion therapy health and safety standards that we are finalizing in this rule.
In addition, in this rule, we have proposed to establish new home infusion therapy health and safety accreditation standards that each home infusion therapy AO must incorporate into their home infusion therapy accreditation standards. When we reviewed the HHA AOs previous application, this review would have occurred prior to the publication of the CY 2019 Home Health proposed rule. Therefore, the HHA AOs could not yet have incorporated the new home infusion therapy health and safety standards into the accreditation standards they submitted with their applications. The establishment of the Medicare home infusion therapy health and safety accreditation standards will require that the existing home HHA/home infusion therapy AOs revise their home infusion therapy accreditation standards to ensure that they meet or exceed these new home infusion therapy health and safety standards. Therefore, we must require that each of the existing HHA/home infusion therapy AOs submit for our review, a new application seeking approval for a separate and distinct accreditation program for home infusion therapy suppliers, to ensure that the accreditation standards used meet or exceed the Medicare home infusion therapy health and safety standards.
Moreover, the statutory requirement of section 1834(u)(5) of the Act
As stated in the proposed rule, we plan to publish a solicitation notice seeking national AOs to accredit home infusion therapy suppliers shortly after publication of the final rule. In addition, § 488.1010(d) requires CMS to complete its review of an application submitted by a home infusion therapy AO within 210 calendar days from the date that CMS determines that an application is complete. If we publish the solicitation notice by December 31, 2018 and receive applications from prospective home infusion therapy AOs during the first 5 months of 2019, we would be required to complete our review of these applications and issue our decisions by December 31, 2019, which is 1 full year before the January 1, 2021 deadline. Assuming we publish the solicitation notice by December 31, 2018, and considering that we must complete review of the application within 210 days, there would be a 16-month period in which prospective home infusion therapy AOs could submit their application for CMS review and obtain approval by the January 1, 2021 deadline specified in section 1834(u)(5)(B) of the Act.
The existing AOs that have been providing accreditation of home infusion therapy suppliers already have established home infusion therapy accreditation programs and accreditation standards. A number of commenters have stated that their respective home infusion therapy standards already meet or exceed the CMS proposed home infusion therapy accreditation health and safety standards and therefore believe that they should not be required to submit an application to CMS for approval. However, if this is the case, we believe that it should not take these AOs long to prepare the information and documentation required to apply for CMS approval of their home infusion therapy accreditation programs.
Likewise, we do not believe that it would take a long period of time for the HHA AOs that accredit home infusion therapy suppliers to prepare and submit their applications for CMS approval of a separate and distinct home infusion therapy accreditation program. It is our understanding from the comments received that these AOs have home infusion therapy accreditation standards that already meet or exceed the CMS proposed home infusion therapy accreditation health and safety standards; however, these home infusion therapy accreditation standards are integrated into the AO's HHA accreditation program. We believe that it would be an uncomplicated matter for these HHA AOs to segregate their home infusion therapy accreditation program into an individual accreditation program. As these AOs have previously established one or more accreditation programs and survey processes in the past, and have prepared and submitted one or more applications to CMS for approval of these accreditation programs, we believe that it would take these AOs less time and effort to do so for a separate and distinct home infusion therapy accreditation program.
Section 1834(u)(5)(D) titled “
We proposed to establish new regulations in a new subpart L in 42 CFR part 488 that would govern CMS' approval and oversight of AOs that accredit home infusion therapy suppliers. We believe these new regulations would provide CMS with reasonable assurance that the home infusion therapy AO's accreditation program requirements are consistent with the appropriate Medicare accreditation program requirements. Further, we believe that these proposed regulations would provide CMS with a way to provide oversight for AOs that accredit home infusion therapy suppliers, and provide CMS with authority over the home infusion therapy suppliers.
We proposed to implement a comprehensive, consistent and standardized set of AO oversight regulations for accreditors of home infusion therapy suppliers. It is our intention to provide home infusion therapy AOs with the flexibility to innovate within the framework of these regulations while assuring that their accreditation standards meet or exceed the appropriate Medicare requirements, and their survey processes are comparable to those of Medicare. “Flexibility to innovate” means that AOs retain the freedom to develop their own accreditation standards and survey processes, so long as the AO ensures that they meet the health and safety standards (contained in 42 CFR part 486, subpart B) and the AO meets the requirements of the AO approval and oversight regulations.
The proposed regulations would reflect requirements similar to those in place for the oversight of national AOs for Medicare-certified providers and suppliers which are codified at 42 CFR 488.1 through 488.13 and 42 CFR part 489, but would be modified, as appropriate, to be applicable for accreditors of home infusion therapy suppliers. We believe that it is important to have AO approval and oversight regulations that are as consistent as possible across all AOs and to treat all AOs in a similar manner.
In formulating our approach to implementing the statutory requirements related to accreditation organizations, we had considered using the regulations at 42 CFR 488.1 to 488.13 for the approval and oversight of AOs that accredit home infusion therapy suppliers. However, we decided not to do so because we believe that Congress, by setting out separate accreditation organization approval standards for home infusion therapy suppliers at 1834(u)(5)(A) of the Act, intended approval for this accreditation program to be a discrete process. We believe that having a separate set of approval regulations applicable only to home infusion therapy suppliers will best reflect Congress's intent.
Only limited portions of the regulations at §§ 488.1 through 488.13 will apply to AOs that accredit home infusion therapy suppliers. For example, § 488.6, regarding accredited provider entities' participation in Medicaid, will not apply to home infusion therapy because home infusion therapy suppliers is not a benefit specified in our Medicaid regulations.
Section 488.7, titled “Release and use of accreditation surveys” and § 488.8 titled “Ongoing review of accrediting organizations” will have parallel provisions applicable to AOs that accredit home infusion therapy suppliers (§ 488.1025). However, § 488.9 titled “Validation surveys” will not have a parallel provision applicable to
Section 488.10, titled “State survey agency review: Statutory provisions”, § 488.11 titled “State survey agency functions” and § 488.12 titled “Effect of survey agency certification” will also not have parallel provisions applicable to home infusion therapy AOs. This is because, as stated previously, the SA does not perform validation surveys for AOs that accredit home infusion therapy providers. Section 488.13, titled “Loss of accreditation” provides that “if an accrediting organization notifies CMS that it is terminating a provider or supplier due to non-compliance with its CMS-approved accreditation requirements, the SA will conduct a full review in a timely manner.” This section will also not have parallel provisions applicable to AOs that accredit home infusion therapy suppliers because this regulation section requires use of the SA.
Section 488.14 titled, “Effect of QIO review” provides that “when a QIO is conducting review activities under section 1154 of the Act and part 466 of this chapter, its activities are in lieu of the utilization review and evaluation activities required of health care institutions under sections 1861(e)(6), and 1861(k) of the Act.” This section will not have parallel provisions applicable to AOs for home infusion therapy suppliers because it is only applicable only to hospitals.
Finally, § 488.18, titled “Documentation of findings” states that “the findings of the State agency with respect to each of the conditions of participation, requirements (for SNFs and NFs), or conditions for coverage must be adequately documented.” As noted previously, we will not be including a parallel provision applicable to AOs that accredit home infusion therapy suppliers because it involves the activities of the SAs, which will not be involved in the home infusion therapy supplier accreditation process.
In conclusion, a majority of sections contained in §§ 488.1 through 488.13 do not apply to home infusion therapy AOs and home infusion therapy suppliers. Therefore, we have created a separate set of regulations that are specifically applicable to home infusion therapy AOs.
We sought comment on our decision not to use the existing regulation at §§ 488.1 through 488.13. We did not receive any comments on this topic.
Our conventional validation process involves the participation of the CMS Regional Offices (ROs) to request the State Survey Agency to conduct an onsite validation (follow-up) survey within 60 days of an AO's onsite survey. The purpose of a validation survey is to evaluate the ability of that AO's survey process to identify serious, condition level deficiencies.
We did not propose to establish a validation program requirement for home infusion therapy AOs and suppliers due to a number of resource constraints. Several factors limit our ability to establish and implement a validation program for home infusion therapy AOs. First, as mentioned previously, the SAs are not available to perform validation surveys for home infusion therapy AOs. This is because, pursuant to section 1864(a) of the Act, the SA, enters into an agreement with the Secretary to provides services to only a limited number of healthcare provider types (that is, hospitals, skilled nursing facilities, home health agencies, hospice programs, rural health clinics, critical access hospitals, comprehensive outpatient rehabilitation facilities, laboratories, clinics, rehabilitation agencies, public health agencies, or ambulatory surgical centers.
We sought public comment on the decision not to propose a validation process at this time.
Even though we would not have a formal validation process in place, we would be able to monitor the performance of the home infusion therapy AOs as part of the ongoing AO oversight process provided for in the home infusion therapy AO approval and oversight regulations at §§ 488.1010 through 488.1050. For example, under proposed § 488.1030 we would have the ability to carry out performance reviews to evaluate the performance of each CMS-approved home infusion therapy accreditation program on an ongoing basis; comparability reviews to assess the equivalency of a home infusion therapy AO's CMS-approved program requirements with the comparable Medicare home infusion therapy accreditation requirements after CMS imposes new or revised Medicare accreditation requirements; and standards reviews when a home infusion therapy accrediting organization proposes to adopt new or revised accreditation standards. We may also perform CMS-approved
In addition, proposed § 488.1035 would require the home infusion therapy AOs to submit information to CMS which would help us monitor the AO's performance. This information would also help to ensure that the home infusion therapy suppliers accredited by the AO provide care that meets the health and safety standards contained in 42 CFR part 486, subpart B. This information includes the following:
• Copies of all home infusion therapy supplier accreditation surveys, together with any survey-related information.
• Notice of all accreditation decisions.
• Notice of all complaints related to the AO's accredited suppliers.
• Information about all home infusion therapy accredited suppliers against which the home infusion therapy accreditation organization has taken remedial or adverse action, including revocation, withdrawal, or revision of the providers or suppliers accreditation.
• Annual basis, summary data specified by CMS that relate to the past year's accreditation activities and trends.
• Notice of any changes in the home infusion therapy accrediting organization's accreditation standards or requirements or survey process.
We proposed to establish regulations for the approval and oversight of AOs for home infusion therapy suppliers. We also proposed the health and safety standards which home infusion therapy suppliers must meet, and which the home infusion AOs must meet or exceed in their accreditation standards. These health and safety standards are being set forth in this final rule with comment period at 42 CFR part 486, subpart I. The AOs that currently accredit home infusion therapy suppliers have not heretofore been governed by any CMS regulations related to home infusion therapy accreditation or health and safety standards. These AOs have each created their own set of accreditations standards. These accreditation standards vary from AO to AO.
Section 1834(u)(5)(C) of the Act requires home infusion therapy suppliers to be accredited in order to receive payment for the services they provide. We proposed to require that the home infusion therapy accreditation program submitted to CMS for approval by each of the AOs that currently accredit home infusion therapy suppliers be separate and distinct accreditation programs that are not part of the AOs home health accreditation program. We proposed to further require that the AOs home infusion therapy accreditation standards meet or exceed the health and safety standards for home infusion therapy suppliers. Finally, we would require that the application meet the requirements of proposed 42 CFR 488.1010.
As noted previously, we proposed to create a new set of regulations titled, “Approval and Oversight of Home Infusion Therapy Supplier Accrediting Organizations” at 42 CFR part 488, subpart L. These proposed regulations would set forth the application and reapplication procedures for national AOs seeking approval or re-approval of authority to accredit home infusion therapy suppliers; ongoing CMS oversight processes for approved AOs that accredit home infusion therapy suppliers; and, appeal procedures for AOs that accredit home infusion therapy suppliers. In this section of the final rule, we describe our regulatory provisions.
The following sections discuss the regulations, in their order.
We proposed at § 488.1000 to set forth the statutory authority related to this set of regulations. Sections 1834(u)(5) and 1861(iii) of the Act would be the statutory basis for these regulations. These sections of the Act provide the Secretary with the authority necessary to carry out the administration of the Medicare program. Section 1861 of the Act defines services, supplier types and benefits, and over whom Medicare may have authority. Section 1861(d) defines the term “supplier.” Section 1834(u)(5) of the Act governs accreditation of home infusion therapy suppliers.
Section 1861(iii)(3)(D)(i)(III) of the Act requires that home infusion therapy suppliers be accredited by an organization designated under section 1834(u)(5) of the Act. Section 1834(u)(5) of the Act requires that the Secretary establish factors in designating accrediting organizations and designate accrediting organizations to accredit suppliers furnishing home infusion therapy by January 1, 2021.
Proposed § 488.1000(a) would set forth the statutory authority for the accreditation of home infusion therapy suppliers by the home infusion therapy AOs. Title 42 CFR 488.1000(b) would set forth the scope of the regulation, which is the application and reapplication procedures for national AOs seeking approval or re-approval of authority to accredit home infusion therapy suppliers; ongoing CMS oversight processes for approved of home infusion therapy AOs; and, appeal procedures for AOs of home infusion therapy suppliers.
We proposed the following definitions:
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Proposed § 488.1010 would contain application and re-application procedures for all national AOs seeking CMS-approval of an accreditation program for home infusion therapy suppliers. Proposed § 488.1010(a) would provide a comprehensive listing of the information, supporting documentation, certifications, written statements and other data that prospective AOs for home infusion therapy suppliers would be required to include in their application for approval to accredit home infusion therapy suppliers. The proposed requirements under this section would apply to both initial applications for CMS-approval as well as applications for re-approval of an
Proposed § 488.1010(a)(1) requires AOs for home infusion therapy suppliers seeking initial or renewed CMS-approval of their home infusion therapy accreditation program to demonstrate that they meet the definition of a “national accrediting organization.” Section 1865 of the Act requires that accrediting organizations be national in scope.
Proposed § 488.1010(a)(2) requires AOs to specifically identify the Medicare supplier type for which they are requesting CMS-approval or reapproval.
Proposed § 488.1010(a)(3) requires AOs to demonstrate their ability to take into account the capacities of home infusion therapy suppliers in rural areas (as defined in section 1834(u)(5)(A)(ii) of the Act.
Proposed § 488.1010(a)(4) requires the home infusion therapy AO to provide information that documents their knowledge, expertise, and experience in the healthcare field for which they offer accreditation and for which they are requesting approval.
Proposed § 488.1010(a)(5) requires the AO to submit a detailed crosswalk (in table format) that identifies, for each of the applicable Medicare health and safety requirements, the exact language of the accrediting organization's comparable accreditation requirements and standards. This proposed requirement would allow CMS to evaluate whether the accreditation program standards meet or exceed the applicable Medicare requirements.
Proposed § 488.1010(a)(6) requires each AO for home infusion therapy suppliers to provide a detailed description of its survey process. This requirement is intended to allow CMS to gain a better understanding of an AO's survey process and ensure that its survey and enforcement processes are comparable to Medicare's health and safety standards (contained in 42 CFR part 486, subpart I).
Proposed § 488.1010(a)(7)(ii) requires home infusion therapy AOs that use offsite audits, or other evaluation strategies to evaluate the quality of services provided by a home infusion therapy supplier, to follow up these offsite audits with periodic onsite visits. We believe that it is very important for the AOs that accredit home infusion therapy suppliers to follow-up off-site survey reviews with periodic on-site visits to ensure that the home infusion therapy supplier is complying with all accreditation standards and meeting all health and safety regulations.
We proposed at § 488.1010(a)(8), to require an AO for home infusion therapy suppliers to provide a description of the criteria for determining the size and composition of the onsite survey or offsite audit teams or teams used for other accreditation evaluation strategies.
We proposed at § 488.1010(a)(9) to require that an AO for home infusion therapy suppliers provide CMS with information regarding the overall adequacy of the number of surveyors, auditors, and other staff available to perform all survey related activities. Under this section, the home infusion therapy AO would also be required to provide an explanation as to how it will maintain an adequate number of trained surveyors on staff. The home infusion therapy AO must also describe its ability to increase the size of survey, audit, and other survey program staff to match growth in the number of accredited home infusion therapy suppliers while maintaining re-accreditation intervals for existing accredited home infusion therapy suppliers.
We proposed at § 488.1010(a)(10) to require that an AO for home infusion therapy suppliers provide CMS with detailed information about the individuals who perform survey activities, including onsite surveys, offsite audits and other review processes, for the purpose of ensuring accredited home infusion therapy suppliers maintain adherence to the accreditation program requirements.
Proposed § 488.1010(a)(11) requires each AO for home infusion therapy suppliers to describe the content, frequency and types of in-service training provided to survey and audit personnel.
We proposed at § 488.1010(a)(12) to require AOs for home infusion therapy suppliers to provide documentation which describes the evaluation systems used to monitor the performance of individual surveyors, survey teams, and staff that perform audit activities. This requirement will provide CMS with insight into how each home infusion therapy AO measures the performance of their surveyors, survey teams and staff that perform audit activities.
We proposed at § 488.1010(a)(13) to require the AO for home infusion therapy suppliers to provide the organization's policies and procedures for avoiding and handling conflicts of interest, including the appearance of conflicts of interest, involving individuals who conduct surveys, audits or participate in accreditation decisions.
Proposed § 488.1010(a)(14) requires the AO for home infusion therapy suppliers to provide CMS with documentation of its policies and procedures for handling disputes filed by a home infusion therapy supplier regarding survey or audit findings, or an adverse decision.
We proposed at § 488.1010(a)(15) requires that home infusion therapy AOs provide CMS with copies of the policies and procedures to be used when an accredited home infusion therapy supplier either—(1) removes or ceases furnishing services for which they are accredited; or (2) adds home infusion therapy services for which they are not accredited.
We proposed at § 488.1010(a)(16) to require the home infusion therapy AOs to provide CMS with the organization's policies and procedures for responding to and investigating complaints and grievances against accredited suppliers.
We proposed at § 488.1010(a)(17) to require that the home infusion therapy AOs furnish a description of the AO's accreditation status decision-making process.
We proposed at § 488.1010(a)(18) to require a home infusion therapy AOs to provide CMS with a list of all home infusion therapy suppliers currently accredited by that home infusion therapy AO.
We proposed at § 488.1010(a)(19) to require that the home infusion therapy AOs provide CMS with a schedule of all survey activity (including but not limited to onsite surveys, offsite audits and other types if survey strategies), expected to be conducted by the home infusion therapy AO during the 6-month period following submission of the application.
We proposed at § 488.1010(a)(20) to require that the home infusion therapy AO submit a written statement or document that demonstrates the organization's ability to furnish CMS with the electronic data the home infusion therapy AO must report to CMS as required by proposed § 488.1035.
We proposed at § 488.1010(a)(21) to require that the home infusion therapy AO provide a description of the organization's data management and analysis system with respect to its surveys and accreditation decisions.
We proposed at § 488.1010(a)(22) to require the home infusion therapy AO to furnish the three most recent annual
We proposed at § 488.1010(a)(23) to require the home infusion therapy AOs to provide a written statement, in which the home infusion therapy AO acknowledges, as a condition for approval, that the organization agrees to the items set forth in § 488.1010(a)(23)(i) through (vi).
Proposed § 488.1010(a)(23)(i) requires the home infusion therapy AO to provide a written statement acknowledging that, as a condition for approval, that if the home infusion therapy AO decides to voluntarily terminate its accreditation program, the home infusion therapy AO must provide written notification to CMS and all home infusion therapy suppliers accredited by that AO. This written notice must be provided at least 180 calendar days in advance of the effective date of the home infusion therapy AOs decision to voluntarily terminate its CMS-approved accreditation program.
Proposed § 488.1010(a)(24) requires the home infusion therapy AOs to provide CMS with a listing of the organization's fees for home infusion therapy accreditation. The home infusion therapy AO must notify CMS of any plans for reducing the burden and cost of accreditation to small or rural home infusion therapy suppliers. While CMS does not undertake to set or regulate the fees charges by a home infusion therapy AO, we do review fees charged by AOs to determine whether they are reasonable as directed by sections 1834(u)(5)(A)(iii) of the Act.
Proposed § 488.1010(b) requires home infusion therapy AOs to agree to submit any additional information, documentation, or attestations, including items not previously listed that CMS may deem necessary to make a determination for approval or denial of the home infusion therapy AO's application. Should we require this additional information, we would notify the home infusion therapy AO of the request and provide the home infusion therapy AO with a reasonable timeframe to submit the requested information.
We proposed at § 488.1010(c) to allow a home infusion therapy AO to withdraw its initial application for CMS's approval of its home infusion therapy accreditation program at any time before we publish the final
Proposed § 488.1010(d) requires CMS to complete its review of an application submitted by a home infusion therapy AO within 210 calendar days from the date that CMS determines that the application is complete. We proposed that to determine completeness, each application would be assigned to a technical review team upon receipt by CMS.
We sought public comment on the application requirements set forth in § 488.1010. We further sought comments on the burden related to the requirements of the application procedure. We received the following public comments:
We agree with these commenters that the 90 day notice period may not be a sufficient period of time in which an otherwise compliant home infusion therapy provider could seek out another CMS-approved home infusion therapy AO, file the required application, and complete the accreditation process. Therefore, we have decided to increase the notice requirement specified in § 488.1010(a)(23)(i) from 90 days to 180 days as requested.
It is important to note that § 488.1010(a)(23) requires the home infusion therapy AOs to provide a written statement in their application to CMS, in which the home infusion therapy AO acknowledges, as a condition for approval, that the organization agrees to the items set forth in § 488.1010(a)(23)(i) through (vi). However, the actual requirement that the home infusion therapy AO provide notice is set forth at § 488.1045(a). Since we will be increasing the notice requirement that is to be included in the statement that is to be provided in the application submitted by the home infusion therapy AO as a condition for approval as required by § 488.1010(a)(23)(i), we must also make a corresponding change to the notice requirement in § 488.1045(a).
Proposed § 488.1015(a) requires that except as provided in paragraph (b), a home infusion therapy AO whose request for CMS' approval or re-approval of a home infusion therapy accreditation program was denied, or an organization that has voluntarily withdrawn an initial application, could resubmit its application if the organization had: (1) Revised its accreditation program to address the issues related to the denial of its previous request or its voluntary withdrawal; and (2) resubmitted the application in its entirety.
Proposed § 488.1015(b) provides that a home infusion therapy AO that has requested reconsideration of an application denial by CMS could not submit a new application until the pending reconsideration was administratively final. This proposed provision would ensure that review of accreditation matters on reconsideration are pending before only one administrative agency and one administrative level at a time.
We sought public comments on the requirements of § 488.1015. We did not receive any comments regarding § 488.1015.
Proposed § 488.1020(a) requires CMS to publish a notice in the
Section 488.1020(b) requires that when CMS approves or re-approves an application for approval of a home infusion therapy AO's accreditation program, a final notice will be published in the
If CMS makes a decision to disapprove a home infusion therapy AOs application, our final notice would state the deficiencies found in the application and the reason why the AOs accreditation program did not met or exceeded Medicare accreditation program requirements. However, an AO has the option of voluntarily withdrawing its application at any time up until the publication of the final notice.
We proposed at § 488.1020(b)(2) that if CMS did not approve a home infusion therapy AO's application for approval of its home infusion therapy accreditation program, the final notice would explain how the home infusion therapy AO failed to meet Medicare home infusion therapy accreditation program requirements. This notice would indicate the effective date of the decision.
We sought comment on the requirements of § 488.1020, including on the appropriate term for approval of an AO. We did not receive any comments regarding § 488.1020.
Proposed § 488.1025 requires a home infusion therapy AO to include, in its accreditation agreement with each home infusion therapy supplier, an acknowledgement that the home infusion therapy supplier agrees to release to CMS a copy of its most current accreditation survey and any information related to the survey that CMS may require, including the home infusion therapy supplier's corrective action plans. Proposed § 488.1025(a) provides that CMS may determine that a home infusion therapy supplier does not meet the applicable Medicare conditions or requirements on the basis of its own investigation of the accreditation survey or any other information related to the survey.
Proposed § 488.1025(b) prohibits CMS from disclosing home infusion therapy survey reports or survey related information according to section 1865(b) of the Act. However, CMS would be permitted to publicly disclose an accreditation survey and information related to the survey, upon written request, to the extent that the accreditation survey and survey information is related to an enforcement action taken by CMS.
CMS would use the home infusion therapy supplier accreditation survey information for purposes such as: (1) Confirmation of the home infusion therapy supplier's eligibility for Medicare participation; (2) to review and approve the home infusion therapy AO's recommendations regarding accreditation; (3) to review the home infusion therapy AO's investigations of complaints; and (4) to review the corrective action taken by the AO when deficiencies are found on survey.
We sought public comments on the requirements of § 488.1025. We did not receive any comments regarding § 488.1025.
Proposed § 488.1030 clarifies that a formal accreditation program review could be opened on an ongoing basis. Specifically, this proposed section would describe standardized requirements related to the ongoing federal review of home infusion therapy AOs and their approved accreditation programs. This proposed section would clarify that CMS oversight of accreditation programs is consistent across home infusion therapy AOs. We are committed to treating all home infusion therapy AOs subject to our oversight in the same manner. Under proposed § 488.1030, we could conduct the following three types of reviews of an AO's home infusion therapy accreditation programs: (1) Performance review; (2) comparability review; and (3) CMS-approved accreditation program review.
Proposed § 488.1030(a) allows CMS to perform a performance review, in which we would evaluate the performance of each CMS-approved home infusion
Proposed § 488.1030(b) allows CMS to perform a comparability review to assess the equivalency of a home infusion therapy AO's CMS-approved home infusion therapy accreditation program requirements with comparable Medicare home infusion therapy accreditation requirements. Proposed § 488.1030(b)(1) allows CMS to perform a comparability review when CMS imposes new or revised Medicare accreditation requirements. When this occurs, proposed § 488.1030(b)(1) requires CMS to provide written notice to the home infusion therapy AOs when changes have been made to the Medicare home infusion therapy accreditation requirements. Proposed § 488.1030(b)(2) requires the home infusion therapy accrediting organization to make revision to its home infusion therapy accreditation standards or survey process so as to incorporate the new or revised Medicare accreditation requirements.
Proposed § 488.1030(b)(3) would further require that the written notice sent by CMS to the home infusion therapy AO specify a deadline (not less than 30 days) by which the home infusion therapy AO must prepare and submit their home infusion therapy accreditation program requirement revisions and the timeframe for implementation. Proposed § 488.1030(b)(4) would allow a home infusion therapy AO to submit a written request for an extension of the submission deadline as long as this request was submitted prior to the original deadline.
Proposed at § 488.1030(b)(5) requires that, after completing the comparability review, CMS would provide written notification to the home infusion therapy AO, specifying whether or not their revised home infusion therapy accreditation program standards continued to meet or exceed all applicable Medicare requirements. We propose at § 488.1030(b)(6) that if, no later than 60 days after receipt of the home infusion therapy AO's accreditation standard changes, CMS did not provide the written notice to the home infusion therapy AO, then the revised home infusion therapy program accreditation standards would be deemed to meet or exceed all applicable Medicare requirement and the accreditation program will have continued CMS-approval without further review or consideration.
Proposed § 488.1030(b)(7) provide that if a home infusion therapy AO was required to submit a new application because CMS imposed new regulations or made significant substantive revisions to the existing regulations, CMS would provide notice of the decision to approve or disapprove the application within the time period specified in proposed § 488.1010(d).
We proposed at § 488.1030(b)(8) that if a home infusion therapy AO failed to submit its changes within the required timeframe, or failed to implement the changes that had been determined by CMS to be comparable, CMS could open an accreditation program review in accordance with § 488.1030(d).
When a home infusion therapy AO proposes to adopt new home infusion therapy accreditation standards or changes, in its survey process, we proposed at § 488.1030(c)(1) to require the home infusion therapy AO to provide notice to CMS no less than 60 days prior to the planned implementation date of the changes. Proposed § 488.1030(c)(2) prohibits the home infusion therapy AO from implementing these changes before receiving CMS' approval except as provided in proposed § 488.1030(c)(4). Proposed § 488.1030(c)(3) requires that this written notice contain a detailed description of the changes to be made to the organization's home infusion therapy accreditation standards, including a detailed crosswalk (in table format) that states the exact language of the revised accreditation requirements and the corresponding Medicare requirements for each. The requirements of proposed §§ 488.1030(c)(2) and 488.10(c)(3) ensures that the home infusion therapy AO provides CMS with advance notice of any changes to their home infusion therapy accreditation requirements and survey processes. This notice would allow CMS time to review these changes to ensure that the revised home infusion therapy accreditation standards and survey processes continue to meet or exceed all applicable Medicare home infusion therapy requirements and continue to be comparable to all applicable Medicare home infusion therapy survey processes, and provide a response to the home infusion therapy AO. This proposed section would also prohibit home infusion therapy AOs from implementing any of the changes in their home infusion therapy accreditation requirements and survey processes, until CMS approval has been received.
Proposed § 488.1030(c)(4) requires CMS to provide written notice to the home infusion therapy accrediting organization indicating whether the home infusion therapy accreditation program, including the revisions, continued or does not continue to meet or exceed all applicable Medicare home infusion therapy requirements. If CMS found that the accrediting organization's home infusion therapy accreditation program, including the revisions did not continue to meet or exceed all applicable Medicare home infusion therapy requirements. CMS would have to state the reasons for these findings.
Section 488.1030(c)(5) requires CMS to provide this written notice to the home infusion therapy AO by the 60th calendar day following receipt of the home infusion therapy AO's written changes as to whether the home infusion therapy AO's revised home infusion therapy accreditation program standards and survey processes have been be deemed to meet or exceed all applicable Medicare home infusion therapy requirements and have continued CMS approval without further review or consideration. This proposed section would further specify that if CMS failed to provide the required written notice to the home infusion therapy AO by the 60-day deadline, the home infusion therapy AO's revised accreditation program standards would be deemed to meet or exceed all applicable Medicare requirements and have continued CMS approval without further review or consideration.
Proposed § 488.1030(c)(5) permits CMS to open an accreditation program review, in accordance with § 488.1030(d), if a home infusion therapy AO implemented changes to their home infusion therapy accreditation requirements or survey process that were not determined nor deemed by CMS to be comparable to the applicable Medicare requirements.
We proposed at § 488.1030(d) to permit CMS to initiate an accreditation program review when a comparability or performance review reveals evidence that a home infusion therapy AO's CMS-approved home infusion therapy accreditation program is in substantial non-compliance with the requirements of the home infusion therapy health and safety regulations contained in 42 CFR part 486, subpart B. Proposed § 488.1030(d)(1) requires CMS to provide written notice to the home infusion therapy AO when a home infusion therapy accreditation program review is initiated. Proposed § 488.1030(d)(1)(i) through (iv) set forth the requirements for this written notice,
At § 488.1030(d)(2), we proposed that CMS reviews and approves the home infusion therapy AO's plan of correction for acceptability within 30 days after receipt. Proposed § 488.1030(d)(3) provides that CMS monitors the implementation of the home infusion therapy accrediting organization's plan of correction for a period not to exceed 180 days from the date of approval. During the 180-day review period, CMS monitors implementation of the accepted plan of correction as well as progress towards correction of identified issues and areas of non-compliance that triggered the accreditation program review.
We proposed at § 488.1030(d)(4) to authorize CMS to place the home infusion therapy AO's CMS-approved accreditation program on probation for a subsequent period of up to 180 calendar days, if necessary. The additional period of time may be necessary if CMS determines, as a result of the home infusion therapy accreditation program review or a review of an application for renewal of an existing CMS-approved accreditation program, that the home infusion therapy AO has failed to meet any of the requirements of proposed § 488.1010, or has made significant progress correcting identified issues or areas of non-compliance, but requires additional time to complete full implementation of corrective actions or demonstrate sustained compliance. If a home infusion therapy AO's term of approval expires before the 180-day period is completed, the probationary period would be deemed to end upon the day of expiration of the home infusion therapy AO's term of approval. In the case of a renewal application where we have placed the home infusion therapy accreditation program on probation, we proposed that any approval of the applications must be conditional while the program remains on probation.
If we place a home infusion therapy AO's accreditation program on probation, proposed § 488.1030(d)(4)(i) requires CMS to issue a written determination to the home infusion therapy AO, within 60 calendar days after the end of any probationary period. The written determination must state whether or not the CMS-approved home infusion therapy accreditation program continued to meet the requirements of this section and the reasons for the determination.
If we determined that withdrawal of approval from a CMS-approved accreditation program was necessary, proposed § 488.1030(d)(4)(ii) requires CMS to send written notice to the home infusion therapy AO which contained the following information: (1) Notice of CMS' removal of approval of the home infusion therapy AOs accreditation program; (2) the reason(s) for the removal; and (3) the effective date of the removal determined in accordance with § 488.1030(d)(4)(ii).
If CMS withdrew the approval of a home infusion therapy AO accreditation program, § 488.1030(d)(4)(iii) requires CMS to publish a notice of its decision to withdraw approval of the accreditation program in the
Proposed § 488.1030(e) allows CMS to immediately withdraw the CMS approval of an home infusion therapy AO's home infusion therapy accreditation program, if at any time CMS makes a determination that the continued approval of that home infusion therapy accreditation program poses an immediate jeopardy to the patients of the entities accredited under the program; or the continued approval otherwise constitutes a significant hazard to the public health.
We proposed at § 488.1030(f) to mandate that any home infusion therapy AO whose CMS approval of its home infusion therapy accreditation program has been withdrawn must notify, in writing, each of its accredited home infusion therapy suppliers of the withdrawal of CMS approval and the implications for the home infusion therapy suppliers' payment status no later than 30 calendar days after the notice is published in the
We sought public comments on the requirements and the burden associated with the requirements of § 488.1030.
We did not receive any comments related to the burden associated with requirements § 488.1030. However, we did receive the following comment related to the requirements of § 488.1030:
Also, many AOs have accreditation programs for numerous types of providers and suppliers. If CMS were to use varying standards for different types of providers and suppliers, it would make it difficult for these AOs with multiple accreditation programs to administer these programs in a smooth
Proposed § 488.1035 requires a home infusion therapy AO to provide certain information to CMS and carry out certain activities on an ongoing basis. More specifically § 488.1035(a) requires the home infusion therapy AO to provide CMS with all of the following in written format (either electronic or hard copy):
• Copies of all home infusion therapy accreditation surveys, together with any survey-related information that CMS may require (including corrective action plans and summaries of findings with respect to unmet CMS requirements);
• Notice of all home infusion therapy accreditation decisions.
• Notice of all complaints related to home infusion therapy suppliers.
• Information about all home infusion therapy accredited suppliers against which the home infusion therapy AO has taken remedial or adverse action, including revocation, withdrawal, or revision of the home infusion therapy supplier's accreditation.
• Summary data specified by CMS that relate to the past year's home infusion therapy accreditation activities and trends which is to be provided on an annual basis.
• Notice of any changes in its home infusion therapy accreditation standards or requirements or survey process.
Proposed § 488.1035(b) requires a home infusion therapy AO to submit an acknowledgment of receipt of CMS' notification of a change in CMS requirements within 30 days from the date of the notice. Section 488.1035(c) requires that a home infusion therapy AO permit its surveyors to serve as witnesses if CMS takes an adverse action based on accreditation findings.
Proposed § 488.1035(d) requires that within 2 business days of identifying a deficiency of an accredited home infusion therapy supplier that poses immediate jeopardy to a beneficiary or to the general public, the home infusion therapy AO must provide CMS with written notice of the deficiency and any adverse action implemented by the home infusion therapy AO. Section 488.1035(e) requires that within 10 calendar days after our notice to a CMS-approved home infusion therapy AO that CMS intends to withdraw approval of the home infusion therapy AO, the home infusion therapy AO must provide written notice of the withdrawal to all of the organization's accredited home infusion therapy suppliers.
We sought public comment on the requirements and the burden associated with § 488.1035. We received no comments in regards to requirements and the burden associated with § 488.1035.
We proposed at § 488.1040(a) and (b) to permit CMS to conduct an onsite inspection of the home infusion therapy AOs operations and offices at any time to verify the organization's representations and to assess the organization's compliance with its own policies and procedures. Activities to be performed by CMS staff during the onsite inspections may include, but are not limited to: (1) Interviews with various home infusion therapy AO staff; (2) review of documents, and survey files, audit tools and related records; (3) observation of meetings concerning the accreditation process; (4) auditing meetings concerning the accreditation process; (5) observation of in-progress surveys and audits; (6) evaluation of the home infusion therapy AO's survey results and accreditation decision-making process.
CMS would perform onsite visits to a home infusion therapy AOs offices only for specific reasons. For example, when an AO had filed an initial or renewal application for approval of its home infusion therapy accreditation program, CMS would perform an onsite visit to the AOs offices as part of the application review process. If CMS has opened a program review and put the home infusion therapy AO on probation for a 180 day period, we would perform an onsite visit to the AOs offices to check of the AOs progress in implementing the plan of correction.
If CMS decides to perform on onsite visit to the home infusion therapy AOs offices, we would notify the AO. We would coordinate with the AO staff to schedule the onsite visit at mutually agreed upon date and time.
The intended purpose of this proposed section is to provide CMS with an opportunity to observe, first hand, the daily operations of home infusion therapy AOs and to ensure that the home infusion therapy accreditation program is fully implemented and operational as presented in the written application. Onsite inspections would strengthen our continuing oversight of the home infusion therapy AO performance because they provide an opportunity for us to corroborate the verbal and written information submitted to CMS by the home infusion therapy AO in their initial and renewal applications. In addition, onsite inspections would allow CMS to assess the home infusion therapy AO's compliance with its own policies and procedures.
We sought public comments on the requirements of and the burden related to § 488.1040. However, we received no comments in regards to requirements and the burden associated with § 488.1040.
The proposed provisions related to the voluntary and involuntary termination of CMS approval of a home infusion therapy AO's accreditation program are set out at § 488.1045. Proposed § 488.1045(a) addresses voluntary termination of a home infusion therapy AO's accreditation program by the home infusion therapy AO. A home infusion therapy AO that decides to voluntarily terminate its CMS-approved accreditation program must provide written notice to CMS and each of its accredited home infusion therapy suppliers at least 180 days in advance of the effective date of the termination. This written notice must state the implications for the home infusion therapy supplier's payment should there be a lapse in their accreditation status.
Proposed § 488.1045(b) addresses CMS' involuntary termination of a home infusion therapy AO's CMS-approved accreditation program. Once CMS publishes the notice in the
Proposed § 488.1045(c) addresses the requirements that would apply to both voluntary and involuntary terminations of CMS approval of the home infusion therapy AO. Proposed § 488.1045(c)(1) provides that the accreditation status of affected home infusion therapy suppliers will be considered to remain in effect until their current term of accreditation expired. In the case where a home infusion therapy AO has been removed as a CMS-approved AO, any home infusion therapy supplier that is accredited by the organization during the period beginning on the date the organization was approved by CMS until the date the organization was removed, shall be considered accredited for its remaining accreditation period.
Proposed § 488.1045(c)(2) provides that for any home infusion therapy supplier, whose home infusion therapy AO's CMS approval has been voluntarily or involuntarily terminated by CMS, and who wishes to continue to receive reimbursement from Medicare, must provide written notice to CMS at least 60-calendar days prior to its accreditation expiration date which states that the home infusion therapy supplier has submitted an application for accreditation under another CMS-approved home infusion therapy accreditation program. This proposed section further states that failure to comply with this 60-calendar day requirement prior to expiration of their current accreditation status could result in a suspension of payment.
Proposed § 488.1045(c)(3) requires that the terminated home infusion therapy AO must provide a second written notification to all accredited suppliers 10 calendar days prior to the organization's accreditation program effective date of termination.
The proposed notice provisions at § 488.1045(c)(2) and (3) could help prevent home infusion therapy suppliers from suffering financial hardship that could result from a denial of payment of Medicare claims if their home infusion therapy accreditation lapses as a result of the voluntary or involuntary termination of a CMS-approved home infusion therapy AO program.
We proposed at § 488.1045(d), that if a home infusion therapy supplier requests a voluntary withdrawal from accreditation, it will not be possible for the withdrawal to become effective until the home infusion therapy AO completes three required steps. First, the AO would have to contact the home infusion therapy supplier to seek written confirmation that the home infusion therapy supplier intended to voluntarily withdraw from the accreditation program. Second, the home infusion therapy AO would have to advise home infusion therapy supplier, in writing, of the statutory requirement at section 1861(iii)(3)(D)(i)(III) of the Act for requiring accreditation for all home infusion therapy suppliers. Third, the home infusion therapy AO would have to advise the home infusion therapy supplier of the possible payment consequence for a lapse in accreditation status. Section 488.1045(d)(3) requires the home infusion therapy AO to submit their final notice of the voluntary withdrawal of accreditation by the home infusion therapy supplier 5 business days after the request for voluntary withdrawal was ultimately processed and effective.
We believe that it is important that the home infusion therapy seek confirmation that the home infusion therapy supplier has indeed requested a voluntary termination of their accreditation. This confirmation would prevent the erroneous termination of the accreditation of a home infusion therapy supplier that did not request it or had subsequently withdrawn their request for voluntary termination.
We believe that it is also important for the home infusion therapy AO to provide the required written notice to the home infusion therapy supplier that requests a voluntary withdrawal from accreditation, so that the home infusion therapy supplier has been fully informed of the requirements for accreditation according to section 1861(iii)(3)(D)(i)(III) of the Act and the payment consequences of being unaccredited. If there is a lapse in the accreditation status of the home infusion therapy supplier, they would not be eligible to receive payment from Medicare for services furnished to Medicare beneficiaries. A home infusion therapy infusion therapy supplier that is unaware of this payment consequence could suffer financial hardship due to furnishing services to Medicare beneficiaries for which they cannot be reimbursed after a lapse in accreditation.
We solicited public comments on the requirements of and the burden related to § 488.1045.
In support of this contention that the previous requirements would be too burdensome, the commenter stated the belief that the home infusion therapy supplier would be responsible for knowing the CMS rules of coverage. AO's should provide this information to the supplier in the form of the AO's accreditation process and/or procedures. The AO should not have the burden of producing documentation that they informed the supplier at 3 separate times of what could happen if they withdrew their accreditation.
Similarly, we believe that this task can be accomplished by the AO sending one single correspondence to the home infusion therapy supplier and simple follow-up monitoring to ensure that the
Several commenters have urged CMS to amend the notice requirement of proposed § 488.1045(c)(2). These commenters have requested that CMS decrease the minimum time period by which affected home infusion therapy suppliers must provide their written notice to CMS informing us that they have filed an application with another home infusion therapy AO from 60 days to 5 days prior to the effective date of the termination of the home infusion therapy suppliers current term of accreditation. These commenters stated the belief that the change to a 5 day notice requirement will ensure that the second AO termination notice to providers can be acted upon if, for any reason, the original termination notice was missed.
In the case of an involuntary termination of an AOs CMS approval, § 488.1045(b) as finalized requires that CMS publish a notice in the
In addition to the notices required by the regulatory provisions previously referenced, CMS will take all appropriate steps to ensure that the affected home infusion therapy suppliers are given timely notice about the termination of their home infusion therapy AO's CMS-approved home infusion therapy accreditation program. Some possible methods CMS would use to make this information available to these affected home infusion therapy suppliers include, but are not limited to posting of information on the Quality, Safety and Oversight Group (QSOG) web page, notification sent via email and email blasts, information published in the Medicare Learning Network newsletter, Medicare payment manual bulletin, newsletter and in Medicare Learning Network publications, and discussion during Open Door Forums.
We believe that the requirement that affected home infusion therapy suppliers provide CMS with written notice that they have filed an application for accreditation with another CMS-approved home infusion therapy AO at least 60 days prior to the expiration of their current term of accreditation is an essential requirement for several reasons. First, it ensures CMS that all home infusion therapy suppliers affected by a voluntary or involuntary termination of a particular AO's CMS-approved accreditation program have indeed filed applications with other CMS-approved home infusion therapy AOs in a timely manner.
Second, the required 60 day written notice to be provided by these affected home infusion therapy suppliers informs CMS that they have already filed an application and initiated the accreditation process with another CMS-approved home infusion therapy AO. This in turn, will trigger the CMS payment system not to continuing paying these home infusion therapy suppliers until their new accreditation information is received.
The requirement that written notice be submitted by all affected home infusion therapy suppliers at least 60 days prior to the expiration of their current terms of accreditation provides CMS with assurances that the accreditation process for each these affected home infusion therapy suppliers has already been initiated, is either substantially completed or will be completed prior to the expiration of the affected home infusion therapy suppliers current term of accreditation and that CMS can be assured that they are not going to be paying claims submitted by non-accredited home infusion therapy supplier.
The accreditation process takes several months, at a minimum. If CMS were to allow these home infusion therapy suppliers to wait until 5 days prior to the expiration date of their current term of accreditation to notify CMS that they have initiated the accreditation process (filed an application) with another AO, CMS would have no assurance that the
We proposed at § 488.1050 to set forth the appeal process through which a home infusion therapy AO may request reconsideration of an unfavorable decision made by CMS. Proposed at § 488.1050(b)(1), the home infusion therapy AO will have to submit a written request for reconsideration within 30 calendar days of the receipt of the CMS notification of an adverse determination or non-renewal. Proposed § 488.1050(b)(2) requires the home infusion therapy AOs to submit a written request for reconsideration which specifies the findings or issues with which the home infusion therapy AO disagreed and the reasons for the disagreement. Proposed § 488.1050(b)(3) allows a home infusion therapy AO to withdraw their request for reconsideration at any time before the administrative law judge issues a decision.
We proposed at § 488.1050(c)(1) to establish requirements for CMS when a request for reconsideration has been received from a home infusion therapy AO. Specifically, CMS would be required to provide the home infusion therapy AO with: The opportunity for an administrative hearing with a hearing officer appointed by the Administrator of CMS; the opportunity to present, in writing and in person, evidence or documentation to refute CMS' notice of denial, termination of approval, or non-renewal of CMS approval and designation. Proposed § 488.1050(c)(2) requires CMS to send the home infusion therapy AO written notice of the time and place of the informal hearing at least 10 business days before the scheduled hearing date.
We proposed at § 488.1050(d)(1) to establish rules for the administrative hearing such as who may attend the hearing on behalf of each party, including but not limited to legal counsel, technical advisors, and non-technical witnesses that have personal knowledge of the facts of the case. This proposed section would also specify the type of evidence that may be introduced at the hearing. Specifically, we would specify and clarify, at proposed § 488.1050(d)(4), that the hearing officer would not have the authority to compel by subpoena the production of witnesses, papers, or other evidence. Proposed § 488.1050(d)(5) provides that the legal conclusions of the hearing officer within 45 calendar days after the close of the hearing. Proposed § 488.1050(d)(6) requires the hearing officer to present his or her findings and recommendations in a written report that includes separately numbered findings of fact. According to proposed § 488.1050(d)(7), the decision of the hearing officer would be final.
We sought public comments on the requirements of § 488.1050. We received no comments on the requirements of § 488.1050.
In the CY 2019 HH PPS proposed rule (83 FR 32340) we discussed the implementation of the home infusion therapy services temporary transitional payment under paragraph (7) of section 1834(u) of the Act, as added by section 50401 of the BBA of 2018 (Pub. L. 115-123). This section provided for a temporary transitional payment for administration of home infusion drugs for 2019 and 2020. These services must be furnished by an eligible home infusion supplier in the individual's home to an individual who is under the care of an applicable provider and where there is a plan of care established and periodically reviewed by a physician prescribing the type, amount, and duration of infusion therapy services. Section 1834(u)(7)(F) of the Act defines eligible home infusion suppliers as suppliers that are enrolled in Medicare as pharmacies that furnish external infusion pumps and external infusion pump supplies, and that maintain all pharmacy licensure requirements in the State in which the applicable infusion drugs are administered. This means that existing DME suppliers that are enrolled in Medicare as pharmacies that provide external infusion pumps and supplies are considered eligible home infusion suppliers. Section 1834(u)(7)(A)(iii) of the Act defines the term “transitional home infusion drug” using the same definition as “home infusion drug” under section 1861(iii)(3)(C) of the Act, which is a drug or biological administered intravenously, or subcutaneously for an administration period of 15 minutes or more, in the home of an individual through a pump that is an item of DME. Additionally, section 1834(u)(7)(C) of the Act specifies the HCPCS codes for the drugs and biologicals covered under the Local Coverage Determinations (LCDs) for External Infusion Pumps, and identifies three payment categories for which a single payment amount will be established for home infusion therapy services furnished on each infusion drug administration calendar day. Payment category 1 includes antifungals and antivirals, uninterrupted long-term infusions, pain management, inotropic, and chelation drugs. Payment category 2 includes subcutaneous immunotherapy infusions. Payment category 3 includes certain chemotherapy drugs. The payment category for subsequent transitional home infusion drug additions to the LCDs and compounded infusion drugs not otherwise classified, as identified by HCPCS codes J7799 and J7999, will be determined by the Medicare administrative contractors.
As set out at new section 1834(u)(7)(D) of the Act, each payment category will be paid amounts equal to amounts for statutorily specified codes for which payment is made under the Physician Fee Schedule for each infusion drug administration calendar day in the individual's home for drugs assigned to such category. No geographic adjustment applies to the payments. In accordance with section 1834(u)(7)(E)(ii) of the Act, in the case that two (or more) home infusion drugs or biologicals from two different payment categories are administered to an individual concurrently on a single infusion drug administration calendar day, one payment for the highest payment category would be made.
In the CY 2019 HH PPS proposed rule, we outlined the billing procedure for the temporary transitional payment. We created a new HCPCS G-code for each of the three payment categories. We stated that the eligible home infusion supplier will submit, in line-item detail on the claim, a G-code for each infusion drug administration
In general, section 1834(u)(7) specifies, in detail, the requirements of the temporary transitional payment for home infusion therapy services, and in most instances, we generally do not have the discretion to apply different policies. However, we proposed a regulatory definition of “infusion drug administration calendar day” to specify in more detail, the policy in the statute as to when Medicare should make a single payment for home infusion therapy services. As required by section 1834(u)(1)(A)(ii) of the Act, a unit of single payment under the home infusion therapy benefit payment system is for each infusion drug administration calendar day in the individual's home. Section 1834(u)(7)(E)(i) clarifies that an infusion drug administration calendar day in the individual's home refers to payment only for the date on which professional services (as described in section 1861(iii)(2)(A)) were furnished to administer such drugs to such individual. Therefore, we proposed to define in regulation that “infusion drug administration calendar day” refers to payment for the day on which home infusion therapy services are furnished by skilled professional(s) in the individual's home on the day of infusion drug administration. As we stated in the proposed rule, we believe this to mean skilled services as set out at 42 CFR. 409.32. This regulation states that the skilled services furnished on such day must be so inherently complex that they can only be safely and effectively furnished by, or under the supervision of, professional or technical personnel.
The following is a summary of the public comments received on the “Proposed Temporary Transitional Payment for Home Infusion Therapy Services for CYs 2019 and 2020” and our responses.
However, in accordance with section 1861(iii)(1) of the Act, the term “home infusion therapy” means the items and services furnished by a qualified home infusion therapy supplier, which are furnished in the individual's home. Likewise, section 1834(u)(7)(B)(iv) establishes a single payment amount for each infusion drug administration calendar day in the individual's home. Additionally, section 1834(u)(7)(E)(i) of the Act states that payment to an eligible home infusion supplier or qualified home infusion therapy supplier for an infusion drug administration calendar day in the individual's home refers to payment only for the date on which professional services, as described in section 1861(iii)(2) of the Act, were furnished to administer such drugs to such individual. This includes all such drugs administered to such individual on such day. We believe the BBA of 2018 includes this clarification of “infusion drug administration calendar day” in order to establish clear parameters so as to explicitly pay for services that occur in the patient's home when the drug is being administered. Our interpretation of the phrase “only for the date on which professional services, as described in section 1861(iii)(2) of the Act, were furnished” is that mere infusion without any professional services furnished cannot trigger a home infusion therapy services payment for any day the drug is infused by the DME pump. Thus, we believe that the language in the statute clearly delineates a subset of days on which professional services are provided in the patient's home in order for payment to occur.
Additionally, section 1834(u)(7)(A)(i) of the Act states that payment to an eligible home infusion supplier is for items and services furnished in coordination with the furnishing of transitional home infusion drugs. The language does not indicate that payment is for the furnishing of the home infusion drug, but for the services provided together and in cooperation
Furthermore, we note that the payment for an infusion drug administration calendar day is a single payment amount covering: professional services, including nursing services, furnished in accordance with a plan of care; training and education (not otherwise paid for as durable medical equipment); remote monitoring; and monitoring services furnished by a qualified home infusion therapy supplier. Therefore, at § 486.525, we have mirrored the language in section 1861(iii)(2)(A) of the Act that requires the provision of professional services, including nursing services, furnished by the home infusion therapy supplier in accordance with the plan of care. Since the Medicare payment is a single payment amount, we do not believe it is necessary to define “professional services” in regulation. By specifically enumerating a specific list of services we would risk inadvertently excluding services that may be necessary for the care of a specific patient as part of the required services under the home infusion therapy benefit.
Section 1861(iii)(1)(B) requires the individual to be under a plan of care, established by a physician, prescribing the type, amount, and duration of home infusion therapy services that are to be furnished. Thus, it is the individual's physician who is responsible for establishing the type and scope of professional services needed in the home in order to ensure home infusion therapy is successful. In the proposed rule, we did state that the services on this day must meet the criteria for skilled services as set out at § 409.32. This criteria states that to be considered a skilled service, the service must be so inherently complex that it can be safely and effectively performed only by, or under the supervision of, professional or technical personnel. Although this is a requirement for coverage of post-hospital SNF care, the definition of skilled services is not specific to skilled nursing services in a SNF. Section 409.42(c)(1) under the home health benefit also references § 409.32 as the criteria for intermittent skilled nursing services. Additionally, although both benefits require “skilled services” in reference to nursing, the definition is not exclusive to nursing services.
Finally, section 1834(u)(7)(D) of the Act sets the temporary transitional payment equal to 4 units at the amounts determined under the physician fee schedule (that is, equivalent to 4 hours of infusion in a physician's office). Payment for an infusion drug administered in a physician's office or outpatient center is made based on the occurrence of the professional services furnished during the visit. The professional services necessary for the infusion drug administration at these sites of care are factored into the payment for the visit, not separately payable. As such, it is not necessary to define the professional services required for infusion drug administration in a physician's office or outpatient center because payment is not dependent upon the individual services furnished, but rather the occurrence of the visit and the professional services furnished at the time. Likewise, the home infusion therapy services temporary transitional payment includes payment for any professional services furnished in the patient's home to administer the infusion drug.
It is unclear why the commenter states that the home infusion supplier would be required to assume responsibility for visits which may be unrelated to the patient's infusion therapy. We recognize that currently home infusion suppliers may contract with HHAs to furnish the nursing services; however, it is incumbent upon the home infusion supplier to negotiate appropriate contract terms in order to only assume responsibility for services related to home infusion therapy.
We also note that section VI.C.2.f. of the proposed rule discusses the
The payment for professional services and training and education (not otherwise paid for under the Medicare Part B DME benefit), remote monitoring and monitoring services is only made when a skilled professional is physically present in a patient's home on a day of drug administration. This does not mean that that the external infusion pump, drug, and related supplies are not covered on days when there is not a skilled professional in the home. The home infusion therapy services temporary transitional payment is a separately paid amount from the external infusion pump, drug, and related supplies.
Additionally, we state in the proposed rule that the professional services covered under this benefit are not intended to provide on-going nursing supervision throughout each infusion. We do not expect a nurse to be present for every infusion, or to stay for the duration of each infusion once the patient and/or caregiver has been taught to operate the pump. In section VI.C.2.d. of the proposed rule, we outline the training and education services that we believe the home infusion therapy payment would cover. We state that these would include a limited amount of teaching and training on the provision of home infusion drugs that is not already covered under the DME benefit.
Furthermore, section 1861(iii)(2)(B) includes the provision of monitoring and remote monitoring as part of the home infusion therapy benefit. In the proposed rule, we indicated that we understand that some home infusion therapy patients may require daily monitoring, but generally do not need to be seen by a practitioner daily. In section VI.C.2.d. of the proposed rule, we state our belief that monitoring and remote monitoring can enable daily contact with, or assessment of certain patients without necessitating a visit.
Considering that we do not expect a visit to be made for each infusion drug administration, we also do not believe the supplier should be paid every day that the medication is infused regardless of whether or not direct care services are furnished. We should also emphasize that the patient is responsible for 20 percent coinsurance for every home infusion therapy services payment in addition to the 20 percent coinsurance charged for the DME infusion pump supplies and the drug. Therefore, we believe tying the payment to a visit in the beneficiary's home would ensure that the beneficiary is receiving direct care services for which he/she is paying 20 percent coinsurance. We state in the proposed rule that we generally anticipate that a home infusion therapy supplier would provide a visit approximately two times a week for the first week and then weekly thereafter over the course of infusion therapy depending on the drug and patient. Therefore, the proposed definition of infusion drug administration calendar day would result in payment only for these days when a visit occurs. Likewise, the beneficiary would be responsible for the 20 percent coinsurance amount only on these days. Section 1834(u)(7) requires that the temporary transitional home infusion therapy services payment be equal to 4 units at the amounts determined under the physician fee schedule (that is, the equivalent of 4 hours of infusion in a physician's office). This amount would range from $141 to $240 (using CY 2018 fee schedule amounts). If payment were to be made every day an infusion occurred, regardless of whether a visit was made, the beneficiary would be responsible for the home infusion therapy services coinsurance amount each and every day the infusion
We also do not anticipate that this requirement would lead to any additional home visits than are currently provided by home infusion suppliers. As many commenters pointed out, visits are often provided weekly, which aligns with what we stated in the proposed rule. Furthermore, we consider this benefit to be an additional payment for the direct care services associated in coordination with the furnishing of home infusion drugs.
Upon the expiration of the home infusion therapy services temporary transitional payment, we will be fully implementing the home infusion therapy services payment system under section 1834(u)(1) of the Act, as added by section 5012 of the 21st Century Cures Act (Pub. L. 114-255). In the CY 2019 HH PPS proposed rule (83 FR 32340), we discussed the provisions of the law, and in anticipation of future rulemaking, solicited comments regarding the payment system for home infusion therapy services beginning in CY 2021. We discussed the relationship between the new home infusion therapy benefit and the existing Medicare DME and home health benefits; the definition of infusion drug administration day; payment basis, limitation on payment, required and discretionary adjustments, and billing procedures; the professional/nursing services and monitoring related to the administration of home infusion drugs; and the role of prior authorization. Specifically, we requested comments on retaining the definition of “infusion drug administration calendar day”, as proposed in section IV.C.2. of the proposed rule for the full implementation of the home infusion therapy services benefit, and invited comments on any additional interpretations of professional, nursing, training and education, and monitoring services that may be considered under the scope of the home infusion therapy benefit. We solicited comments on ways to account for therapy type and complexity of administration, as well as ways to capture patient acuity, and requested feedback on situations that may incur an outlier payment and potential designs for an outlier payment calculation. And finally, we invited comments on the unit of single payment; limitations on payment; prior authorization; and required and discretionary adjustments, and solicited any additional suggestions as to how qualified home infusion therapy suppliers should bill and be paid for services under the home infusion therapy benefit, including whether it is reasonable to require two separate claims submissions to account for different components of home infusion therapy.
As there is overlap between the provisions of the home infusion therapy services temporary transitional payment and the full home infusion therapy benefit to be implemented in 2021, many of the proposed rule comments we received pertained to both. However, while we did not include proposals regarding payment for home infusion therapy services for CY 2021 and beyond, we did receive several comments related specifically to implementation of the full benefit. These comments included suggestions regarding billing, payment basis and adjustments, prior authorization, and
We did receive several technical comments regarding certain provisions that are addressed in the responses in this section of this final rule with comment period.
We appreciate commenter feedback and will take all comments under consideration while implementing the permanent home infusion therapy services benefit. We encourage commenters to submit additional comments regarding the full implementation of the benefit to the home infusion policy mailbox at
To participate in the Medicare program, Medicare-certified providers and suppliers of health care services, must be substantially in compliance with specified statutory requirements of the Act, as well as any additional regulatory requirements related to the health and safety of patients specified by the Secretary of the Department of Health and Human Services (HHS). Medicare certified providers and suppliers are enrolled in the Medicare program by entering into an agreement with Medicare. They include hospitals, skilled nursing facilities, home health agencies, hospice programs, rural health clinics, critical access hospitals, comprehensive outpatient rehabilitation facilities, laboratories, clinics, rehabilitation agencies, public health agencies, and ambulatory surgical centers. These health and safety requirements are generally called conditions of participation (CoPs) for most providers, requirements for skilled nursing facilities (SNFs), conditions for coverage (CfCs) for ambulatory surgical centers (ASCs) and other suppliers, and conditions for certification for rural health clinics (RHCs). A Medicare-certified provider or supplier that does not substantially comply with the applicable health and safety requirements risks having its participation in the Medicare program terminated.
In accordance with section 1864 of the Act, state health departments or similar agencies, under an agreement with CMS, survey health care providers and suppliers to ascertain compliance with the applicable CoPs, CfCs, conditions of certification, or requirements, and certify their findings to us. Based on these State Survey Agency (SA) certifications, we determine whether the provider or
Section 1865(a) of the Act allows most health care facilities to demonstrate compliance with Medicare CoPs, requirements, CfCs, or conditions for certification through accreditation by a CMS-approved program of a national accreditation body. If an AO is recognized by the Secretary as having standards for accreditation that meet or exceed Medicare requirements, any provider or supplier accredited by the AO's CMS-approved accreditation program may be deemed by us to meet the Medicare conditions or requirements.
We are responsible for the review, approval and subsequent oversight of national AOs' Medicare accreditation programs, and for ensuring providers or suppliers accredited by the AO meet the quality and patient safety standards required by the Medicare CoPs, requirements, CfCs, and conditions for certification. Any national AO seeking approval of an accreditation program in accordance with section 1865(a) of the Act must apply for and be approved by CMS for a period not to exceed 6 years.
The AO must reapply for renewed CMS approval of an accreditation program before the date its approval period expires. This allows providers or suppliers accredited under the program to continue to be deemed to be in compliance with the applicable Medicare CoPs, requirements, CfCs, and conditions for certification. Regulations implementing these provisions are found at 42 CFR 488.1 through 488.9.
We believe that it is necessary to revise the regulations for Medicare-certified providers and providers to add two new requirements for the AOs that accredit certified providers and providers. First, we proposed at § 488.5 to require AOs for Medicare-certified providers and suppliers to include a written statement in their application which states that if a fully accredited and deemed facility in good standing provides written notification that they wish to voluntarily withdraw from the AO's CMS-approved accreditation program, the AO must continue the facility's current accreditation until the effective date of withdrawal identified by the facility or the expiration date of the term of accreditation, whichever comes first. We also proposed to modify the AO oversight regulations at § 488.5 by adding new requirements for training for AO surveyors.
We proposed adding a new provision to the approval and oversight regulations for AOs that accredit Medicare certified providers and suppliers at § 488.5(a)(17)(iii), which would require that, with an initial or renewal application for CMS-approval of a Medicare certified provider or supplier accreditation program, an AO must include a written statement agreeing that when a fully accredited, deemed provider or supplier in good standing notifies its AO that it wishes to voluntarily withdraw from the AO's accreditation program, the AO would honor the provider's or supplier's current term of accreditation until the effective date of withdrawal identified by the facility, or the expiration date of the term of accreditation, whichever comes first. We made this proposal because we have received numerous complaints from accredited and deemed facilities in good standing with their then-current AO stating that once they provide notification to the AO of their intent to voluntarily withdrawal their accreditation business from that AO, the AO frequently terminated their accreditation immediately, without regard to their current accreditation status, up to date payment of fees, contract status, or the facility's requested effective date of withdrawal. We do not believe it is reasonable for AOs to penalize facilities because they choose to terminate the services of an AO.
Providers and suppliers may be left without an accreditation status that would allow them to continue to participate in Medicare.
The commenter also stated that this proposal would allow facilities to circumvent the mechanisms AOs for Medicare certified providers and suppliers have had in place for ongoing review of accredited facilities. The commenter believes that the rule, as written, would require this AO to maintain a facility's accreditation status regardless of the commenter AO's
It is our position that if an accredited provider or supplier has paid the agreed upon accreditation fees, successfully gone through the survey process, and is in good standing with their AO, but has, for whatever reason, decided to switch accreditation to another AO or to submit to a survey by a state agency, there is no justifiable reason for the current AO to cancel that provider/suppliers accreditation prior to the expiration date.
CMS has seen cases in which shortly after an AOs has been informed by one of its accredited providers/suppliers in good standing that said provide/supplier wishes to withdraw their accreditation business from that AO and become accredited by another AO (or obtain state certification), the current AO terminates that provider/suppliers accreditation, regardless of how much time remains on that provider's or supplier's existing term of accreditation. We believe that these instances of early termination of the accreditation of a provider/suppliers in good standing, with no performance or complaint issues who has recently informed their AO that they were switching to another AO are either retaliatory in nature, or done because these providers were no longer considered a viable source of revenue. We agree that it is unreasonable for AOs to penalize facilities who choose to terminate the services of that AO, and as such, support this proposal.
We proposed to add a new requirement at § 488.5(a)(7) which imposes a new training requirement for surveyors of AO that accredit Medicare-certified provider and supplier types by amending the provision at § 488.5(a)(7). We proposed that all AO surveyors be required to complete the relevant program-specific CMS online trainings initially, and thereafter, consistent with requirements established by CMS for state surveyors. CMS provides a wide variety of comprehensive trainings through an on-demand integrated surveyor training website. These online trainings are available and can be accessed by state and federal surveyors and the public, free of charge, 24 hours a day, 365 days a year. These online trainings are currently publically available for the SA surveyors.
As part of our oversight of the AOs performance, CMS has contracted with the SAs to perform validation surveys on a sample of providers and suppliers (such as hospitals, critical access hospital, ambulatory surgical centers, and home health agencies) accredited by the AOs that accredit Medicare certified providers and suppliers. Validation surveys must be performed by the SA within 60 days of the survey performed by the AO. As a validation survey is performed within 60 days of the AO survey, we believe that the conditions at the hospital or other facility being surveyed will be similar at the time of the validation survey.
The purpose of a validation survey is to compare the survey findings of the AO to the survey findings of the SA to see if there are any disparities. The amount of disparities found in the AO's survey is called the “disparity rate” and is tracked by CMS as an indication of the quality of the surveys performed by the AO.
CMS has determined that many of the AOs' disparity rates have been consistently high. This means that the AOs have consistently failed to find the same condition level deficiencies in the care provided by the hospital or other providers surveyed that were found by the SA during the validation survey.
At the time of the writing of the proposed rule, we believed that the disparity in findings made by the AO surveyors and those of the SA surveyors could largely be attributed the difference in the training and education provided to the AO surveyors. Each AO is responsible for providing training and education to their surveyors. In the proposed rule, we stated that because each AO is an independent entity, the surveyor training and education provided by each AO to its surveyor's varies and is not consistent. We further stated that CMS provides comprehensive online training to the SA surveyor staff on the CMS Surveyor Training website
In the proposed rule, we stated that it was our belief that the AO's disparity rate would be decreased if all surveyors took the same training. We further stated the belief that completion of the same surveyor training by both SA and AO surveyors would increase the consistency between the results of the surveys performed by the SAs and AOs and have a positive impact on the historically high disparity rate. Therefore, we proposed that all AO surveyors be required to take the CMS online surveyor training offered on the CMS website. We further proposed to require each AO to provide CMS with documentation which provides proof that each surveyors had completed the CMS online surveyor training. Finally, we proposed that if the AO fails to provide this documentation, CMS could place the AO on an accreditation program review pursuant to § 488.8(c). We received a number of comments in response to this proposals.
In support of the request to decrease the number of validation surveys to be performed if this requirement for surveyor training is finalized, a commenter pointed out that there are other administrative reviews including the RAC, Pre Claim Review, Probe & Educate, and routine MAC ADR probes that could assess an AOs compliance and performance. Another commenter stated that while there are ample enforcement tools, CMS has not clearly targeted these efforts to bad actors and high-value HHAs have had to divert resources from direct care to administrative functions. This commenter suggestion that audit frequency should be determined using current data along with Program for Evaluating Payment Patterns Electronic Report (PEPPER) reports to identify underperforming and/or noncompliant agencies and that audits should be limited to topics within statutory and regulatory parameters.
• A commenter recommended that CMS make the online surveyor trainings available but not mandatory for all AO surveyor so that each AO could then evaluate its own training and education materials and make an independent decision regarding how best to use the CMS training tools.
• A commenter stated that they support the CMS aim of reducing disparity rates, but that they cannot support the proposal as written due to its vagueness.
• Another commenter stated that the proposed rule offers little guidance on CMS implementation of this new requirement. Another commenter expressed concern regarding how this requirement would be fully operationalized.
• A commenter noted that the proposed rule does not specify the CMS online training courses for which it expects completion. Another commenter expressed the concern that it is unclear from the text of this rule, how often surveyors would be required to participate in the training.
• Several commenters stated the belief that there are ambiguities in the proposal that essentially create further opportunity for non-uniformity in surveyor training across the industry. Any non-uniformity in training could reduce the meaningfulness of any presumed links between surveyor training mandates and disparity rates that CMS hopes to identify and impact.
• Another commenter requested more clarity concerning training requirements including course enrollment expectations, frequency of course completion, and clarification regarding whether CMS intends to implement a reporting mechanism for AOs to validate surveyor course completion. This commenter expressed concern that, while the proposed rule proposed completion of “relevant program specific CMS online trainings established for state surveyor,” the variety of online training programs offered and the lack of specificity over the precise training modules required per program could create confusion over which precise training elements would be required for full rule compliance.
• Another commenter expressed doubt that a mandatory requirement for AO surveyors to take CMS online surveyor training would improve AO the disparity rates, and that reviewing online training does not guarantee surveyors will retain and then apply all the information from the trainings during their surveys.
• Several commenters strongly suggested that CMS needs to establish a measurable correlation between the proposal and the expected outcome before CMS proposes to require AOs to implement any costly program.
• Several commenters suggested that if CMS has questions and concerns with the current surveyor education provided by AOs, it seems like this would be an issue to be addressed when reevaluating that AO's own accreditation from CMS.
• A commenter also made the suggestion that CMS should also evaluate the length of surveys and determine whether it would make sense to have a minimum (or standard) length for all individuals surveying for a specific provider or supplier type. Or have a minimum (or standard) number of surveyors participating in each survey. This commenter stated the belief that there could be a number of factors involved in the disparity rate.
• Several commenters stated that they do not agree with CMS' assumptions that inconsistent training between SA surveyors and AO surveyors is the reason for high disparity rates. One of these commenters stated that they fail to see the correlation between different AO surveyor training programs and disparity rates when the disparity rate is a comparison of an SA survey result against an AO survey result and not a comparison between AOs.
• Another commenter recognizes that disparity rates are a constant challenge for CMS and AOs, and that root-cause factors driving high disparity rates are complex and multi-faceted. Yet another of these commenters stated that while surveyor training may be a factor that influences disparity rates, it is unclear whether mandating that AOs to require that surveyors complete CMS training modules will actually reduce the disparity rate. The hypothesis that mandating additional AO surveyor training will lower disparity rates is untested and unproven, and the basis for the hypothesis is unclear.
• Several commenters expressed the belief that unknown or alternative factors may truly drive high disparity rates and that there are multiple explanations as to why the disparity rate could be elevated that are not related to surveyor training. For example, according to these commenters, it is possible that there could be variance or issues with the validation surveyors. Reviewing online training does not guarantee surveyors will retain and then apply all the information from the trainings during their surveys.
• A number of commenters raised the following points in objection to our proposal that AO surveys complete CMS-provided mandatory surveyor training:
++ CMS reviews and approves all AO training, verifying its adequacy.
++ State agency surveyors are not required to have actual experience in the health care field for which they survey. This commenter stated that at least one accreditor requires a minimum of 5 years' experience in the same field that they will survey, thus making them a subject matter expert.
++ State agencies send multiple surveyors for multiple days, where AOs
++ State agencies cite the same deficiencies multiple times. AOs normally do not.
++ There is not an appeal process for the AO in regard to a validation survey. When a validation survey comes back with deficiencies that the AO did not cite and does not agree with, CMS only accepts the state validation surveyors' deficiencies as accurate.
• Several commenters expressed concern that this new requirement would place significant new burden on AOs.
A commenter recommended that CMS delay implementation of the current proposal, and instead bring together accreditation organizations and providers and suppliers to more fully explore how to improve disparity rates between AO and validation surveys. Several other commenters encouraged CMS to engage the AOs directly in both the initiative to reduce disparity rates and on any initiatives that may impact AO accreditation program operations.
This section addressed two requests for information (RFI).
In the CY 2019 HH PPS proposed rule (83 FR 32471 through 32473), we included a Request for Information (RFI) related to promoting interoperability and electronic health care information exchange. We received approximately 28 timely pieces of correspondence on this RFI. We appreciate the input provided by commenters.
In the CY 2019 HH PPS proposed rule (83 FR 32473 and 32474), we included a Request for Information (RFI) related to price transparency and improving beneficiary access to home health agency charge information. We received approximately 15 timely pieces of correspondence on this RFI. We appreciate the input provided by commenters.
Under the Paperwork Reduction Act of 1995, we are required to provide 30-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.
To derive average costs, we used data from the U.S. Bureau of Labor Statistics' May 2017 National Occupational Employment and Wage Estimates for all salary estimates (
This final rule with comment period makes reference to associated information collections that are not discussed in the regulation text contained in this document. These final changes are associated with the information collection request (ICR)—Outcome and Assessment Information Set (OASIS) OASIS-C2/ICD-10 (CMS-10545), approved under OMB control number 0938-1279. We note that on March 12, 2018 (83 FR 10730) we published a notice in the
We believe that the burden associated with the OASIS is the time and effort associated with data collection and reporting. As of April 1, 2018, there are approximately 11,623 HHAs reporting OASIS data to CMS.
In section V.E.1. of this final rule with comment period, we are removing the Depression Assessment Conducted Measure from the HH QRP under measure removal Factor 1: Measure performance among HHAs is so high and unvarying that meaningful distinctions in improvements in performance can no longer be made. Removing this measure will not impact our collection of information because OASIS Item M1730, which is used to calculate this measure, is also used as a risk adjuster to calculate other OASIS-based outcome measures currently adopted for the HH QRP.
In section V.E.2. of this final rule with comment period, we are removing the Diabetic Foot Care and Patient/Caregiver Education Implemented during All Episodes of Care Measure from the HH QRP under measure removal Factor 1: Measure performance among HHAs is so high and unvarying that meaningful distinctions in improvements in performance can no longer be made. This measure is calculated using OASIS Item M2401, row a at the time point of Transfer to an Inpatient Facility (TOC) and Discharge from Agency—Not to an Inpatient Facility (Discharge). Specifically, we are removing this one data element at the TOC and Discharge time points.
In section V.E.3. of this final rule with comment period, we are removing the Multifactor Fall Risk Assessment Conducted For All Patients Who Can Ambulate (NQF #0537) Measure from the HH QRP under measure removal Factor 1: Measure performance among HHAs is so high and unvarying that meaningful distinctions in improvements in performance can no longer be made. This measure is calculated using OASIS Item M1910 at the time point of SOC/ROC. Specifically, we are removing this one data element at the SOC/ROC time point.
In section V.E.4. of this final rule with comment period, we are removing the Pneumococcal Polysaccharide Vaccine Ever Received Measure from the HH QRP, under measure removal Factor 3: A measure does not align with current clinical guidelines or practice. This measure is calculated using OASIS Items M1051 and M1056 at the time points of TOC and Discharge. Specifically, we are removing these two data elements at the TOC and Discharge time points.
In section V.E.5. of this final rule with comment period, we are removing the Improvement in the Status of Surgical Wounds Measure from the HH QRP under measure removal Factor 4: A more broadly applicable measure (across settings, populations, or conditions) for the particular topic is available. Removing this measure will not impact our collection of information because OASIS Items M1340 and M1342 are used as risk adjusters to calculate other OASIS-based outcome measures currently adopted for the HH QRP and OASIS Items M1340 and M1342 are also used for the Potentially Avoidable Events measure Discharged to the Community Needing Wound Care or Medication Assistance that is used by HH surveyors during the survey process.
In sections V.E.6. and V.E.7. of this final rule with comment period, we are removing the Emergency Department Use without Hospital Readmission during the First 30 Days of HH (NQF #2505) Measure and the Rehospitalization during the First 30
In summary, we are finalizing the net reduction of 1 data element at SOC, 1 data element at ROC, 3 data elements at TOC and 3 data elements at Discharge associated with OASIS item collection as a result of the measure removals from the HH QRP.
The OASIS instrument is used for meeting the home health Conditions of Participation, requirements under the HH QRP, and for payment purposes under the HH PPS. As outlined in section III.F. of this final rule with comment period, to calculate the case-mix adjusted payment amount for the PDGM, we are finalizing our proposal to add collection of two current OASIS items (10 data elements) at the follow-up (FU) time point:
• M1033: Risk for Hospitalization (9 data elements)
• M1800: Grooming (1 data element).
As outlined in section III.F of this final rule with comment period, several OASIS items will not be needed in case-mix adjusting the period payment for the PDGM; therefore, 19 current OASIS items (48 data elements) are optional at the FU time point:
Therefore, we are finalizing the net reduction of 38 data elements at FU associated with OASIS item collection as a result of the implementation of the PDGM for CY 2020.
In summary, as a net result of the policies we are finalizing in this final rule with comment period, we will be removing 1 data element at SOC, 1 data element at ROC, 38 data elements at FU, 3 data elements at TOC and 3 data elements at Discharge associated with OASIS item collection as a result of the measure removals from the HH QRP and the implementation of the PDGM starting January 1, 2020.
We assume that each data element requires 0.3 minutes of clinician time to complete. Therefore, we estimate that there is a reduction in clinician burden per OASIS assessment of 0.3 minutes at SOC, 0.3 minutes at ROC, 11.4 minutes at FU, 0.9 minutes at TOC and 0.9 minutes at Discharge.
The OASIS is completed by RNs or physical therapists (PTs), or very occasionally by occupational therapists (OT) or speech language pathologists (SLP/ST). Data from 2016 show that the SOC/ROC OASIS is completed by RNs (approximately 87 percent of the time), PTs (approximately 12.7 percent of the time), and other therapists, including OTs and SLP/STs (approximately 0.3 percent of the time). We estimated a weighted clinician average hourly wage of $70.75, inclusive of fringe benefits, using the hourly wage data in Table 41. Individual providers determine the staffing resources necessary.
Table 43 shows the total number of assessments submitted in CY 2017 and estimated burden at each time point.
Based on the data in Table 43 for the 11,623 active Medicare-certified HHAs in April 2018, we estimate the total average decrease in cost associated with changes with OASIS item collection at $5,148.94 per HHA annually, or $59,846,101.27 for all HHAs annually. This corresponds to an estimated reduction in clinician burden associated with changes to collection of information associated with the OASIS of 72.8 hours per HHA annually, or
At § 486.520, Plan of Care, we propose that all patients must have a plan of care established by a physician that prescribes the type, amount, and duration of infusion therapy services that are to be furnished. This requirement directly implements section 5012 of the 21st Century Cures Act. Accredited home infusion therapy suppliers are already required by their accrediting bodies to provide all care in accordance with a plan of care that specifies the type, amount, and duration of infusion therapy services to be furnished to each patient; therefore this requirement will not impose a burden upon accredited agencies. Furthermore, all existing home infusion therapy suppliers are already accredited due to existing payment requirements established by private insurers and Medicare Advantage plans. In accordance with the implementing regulations of the PRA at 5 CFR 1320.3(b)(3), this requirement exists even in the absence of a federal requirement; therefore, the associated burden is not subject to the PRA. We did not receive any comments from the public, either in agreement or opposition, regarding our estimation of burden for information collection requirements in relation to the implementation of the home infusion therapy standards as delineated by section 5012 of the 21st Century Cures Act; therefore, we are finalizing this estimate without modification.
We did not receive any comments from the public, either in agreement or opposition, regarding our estimation of burden for information collection requirements in relation to the implementation of the home infusion therapy standards as delineated by section 5012 of the 21st Century Cures Act; therefore, we are finalizing this estimate without modification.
We are finalizing establish a new set of regulations related to the approval and oversight of accrediting organizations that accredit home infusion therapy suppliers. If finalized, these new regulatory requirements will impose burden on those new AOs that seek approval of their Home Infusion Therapy accreditation program. This burden will include, but is not limited to the time and costs associated with the following activities: (1) Preparation and filing of an initial application seeking CMS approval of the AOs home infusion therapy accreditation program; (2) participation in the application review process (that is, meetings, provide additional information and materials that may be required, participate in a site visit, etc.); (3) seeking new accreditation clients; (4) performing on-site surveys, off-site survey audits or the performance of other types of survey activities; (5) participation in CMS ongoing accreditation program review activities; (6) performance of periodic re-accreditation activities; (7) investigation of complaints and performing complaint surveys; (8) administration of the appeals process for providers that have been denied accreditation; (9) staff training, in-services and continuing education; and (10) ensuring that surveyor staff have the proper education, training, and credentials.
The following is a discussion of the potential ICR burdens associated with the home infusion therapy supplier accreditation oversight regulations and well as any PRA exceptions that may apply.
We believe that the information collection burden associated with the preparation and submission of an initial or renewal application for approval and designation as a home infusion therapy AO and the participation in other accreditation related activities does not meet the definition of “collection of information” as defined in 5 CFR 1320.3(c) because it is “not imposed on 10 or more persons.” This information collection burden will be imposed only on those national AOs that accredit home infusion therapy suppliers.
At this time, there are five CMS-approved HHA AOs that provide home infusion therapy accreditation as part of the deeming accreditation of home health agencies. These HHA AOs are The Joint Commission (TJC), the Accreditation Commission for Health Care (ACHC), The Compliance Team (TCT), the Community Health Accreditation Partner (CHAP), and the Healthcare Quality Association on Accreditation.
There are three pharmacy association AOs that provide non-CMS approved home infusion therapy accreditation. These non-CMS approved Home infusion AOs are the National Association of Boards of Pharmacy, the Centers for Pharmacy Practice Accreditation (CPPA) and URAC).
In this final rule with comment period, we have to require that these AO must apply for CMS approval of a home infusion therapy accreditation that is separate and distinct from its home health accreditation program. When we do solicit AOs to accredit home infusion therapy suppliers, we do not anticipate receiving more than the six applications which will be submitted by the existing AOs seeking approval of a home infusion therapy accreditation program, because this is a specialized area of accreditation.
It is possible that the number of AOs that we designate to accredit home infusion therapy suppliers may increase to 10 or more in the future, when we begin accepting applications for home infusion therapy AOs. However, we do not anticipate that the number of AOs that will accredit home infusion therapy suppliers will increase to 10 or more in the foreseeable future.
Should the number of AOs that accredit home infusion therapy suppliers rise to 10 or more, we will prepare and submit an information collection request (ICR) for the burden associated with the accreditation process, as well as obtain OMB approval, prior to accepting additional applications.
We did not receive comments on these information collection requirements.
We are modifying the AO approval and oversight regulations for Medicare certified providers and suppliers by adding a new requirement. Section 488.5(a)(17)(iii) will require that the AOs for Medicare certified providers and suppliers include a written statement in their application for CMS approval agreeing that if a fully accredited and deemed facility in good standing provides written notification that they wish to voluntarily withdraw from the accrediting organization's CMS-approved accreditation program, the accrediting organization must continue the facility's current accreditation in full force and effect until the effective date of withdrawal identified by the facility or the expiration date of the term of accreditation, whichever comes first.
An AO would prepare this written statement as part of the preparation of the initial or renewal applications they submit to CMS seeking initial and renewal approval of the CMS approval
We believe that it would take no more than 15 minutes for the AO to add this statement to the written document containing all the statements and affirmations that AO must submits as a condition of approval. We believe that this task would be performed by an administrative assistant. According to the U.S. Bureau of Labor Statistics, the mean hourly wage for an executive administrative assistant is $28.56 (
We had also proposed to add a new requirement at § 488.5(a)(7) to require surveyors for AOs that accredit non-certified providers and suppliers to take the CMS online surveyor training. However, after consideration of the public comments received regarding this proposal, we have decided not to finalize the proposal.
We have submitted a copy of this final rule with comment period to OMB for its review of the rule's information collection and recordkeeping requirements. The requirements are not effective until they have been approved by OMB.
We invite public comments on these information collection requirements. If you wish to comment, please identify the rule (CMS-1689-F) and, where applicable, the ICR's CFR citation, CMS ID number, and OMB control number.
To obtain copies of a supporting statement and any related forms for the collection(s) summarized in this notice, you may make your request using one of following:
1. Access CMS' website 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.
See this rule's
Section 1895(b)(1) of the Act requires the Secretary to establish a HH PPS for all costs of home health services paid under Medicare. In addition, section 1895(b) of the Act requires: (1) The computation of a standard prospective payment amount include all costs for home health services covered and paid for on a reasonable cost basis and that such amounts be initially based on the most recent audited cost report data available to the Secretary; (2) the prospective payment amount under the HH PPS to be an appropriate unit of service based on the number, type, and duration of visits provided within that unit; and (3) the standardized prospective payment amount be adjusted to account for the effects of case-mix and wage levels among HHAs. Section 1895(b)(3)(B) of the Act addresses the annual update to the standard prospective payment amounts by the HH applicable percentage increase. Section 1895(b)(4) of the Act governs the payment computation. Sections 1895(b)(4)(A)(i) and (b)(4)(A)(ii) of the Act require the standard prospective payment amount to be adjusted for case-mix and geographic differences in wage levels. Section 1895(b)(4)(B) of the Act requires the establishment of appropriate case-mix adjustment factors for significant variation in costs among different units of services. Lastly, section 1895(b)(4)(C) of the Act requires the establishment of wage adjustment factors that reflect the relative level of wages, and wage related costs applicable to home health services furnished in a geographic area compared to the applicable national average level.
Section 1895(b)(3)(B)(iv) of the Act provides the Secretary with the authority to implement adjustments to the standard prospective payment amount (or amounts) for health services paid under Medicare. In addition, section 1895(b) of the Act requires: (1) The computation of a standard prospective payment amount include all costs for home health services covered and paid for on a reasonable cost basis and that such amounts be initially based on the most recent audited cost report data available to the Secretary; (2) the prospective payment amount under the HH PPS to be an appropriate unit of service based on the number, type, and duration of visits provided within that unit; and (3) the standardized prospective payment amount be adjusted to account for the effects of case-mix and wage levels among HHAs. Section 1895(b)(3)(B) of the Act addresses the annual update to the standard prospective payment amounts by the HH applicable percentage increase. Section 1895(b)(4) of the Act governs the payment computation. Sections 1895(b)(4)(A)(i) and (b)(4)(A)(ii) of the Act require the standard prospective payment amount to be adjusted for case-mix and geographic differences in wage levels. Section 1895(b)(4)(B) of the Act requires the establishment of appropriate case-mix adjustment factors for significant variation in costs among different units of services. Lastly, section 1895(b)(4)(C) of the Act requires the establishment of wage adjustment factors that reflect the relative level of wages, and wage-related costs applicable to home health services furnished in a geographic area compared to the applicable national average level.
Section 1895(b)(3)(B)(iv) of the Act provides the Secretary with the authority to implement adjustments to the standard prospective payment amount (or amounts) for subsequent years to eliminate the effect of changes in aggregate payments during a previous year or years that were the result of changes in the coding or classification of different units of services that do not reflect real changes in case-mix. Section 1895(b)(5) of the Act provides the Secretary with the option to make changes to the payment amount otherwise paid in the case of outliers because of unusual variations in the type or amount of medically necessary care. Section 1895(b)(3)(B)(v) of the Act requires HHAs to submit data for purposes of measuring health care quality, and links the quality data submission to the annual applicable percentage increase. Section 50208 of the BBA of 2018 (Pub. L. 115-123) requires the Secretary to implement a new methodology used to determine rural add-on payments for CYs 2019 through 2022.
Section 1895(b)(2) of the Act and section 1895(b)(3)(A) of the Act, as amended by section 51001(a)(1) and 51001(a)(2) of the BBA of 2018 respectively, require the Secretary to implement a 30-day unit of service, effective for CY 2020, and calculate a 30-day payment amount for CY 2020 in a budget neutral manner, respectively. In addition, section 1895(b)(4)(B) of the Act, as amended by section 51001(a)(3) of the BBA of 2018, requires the Secretary to eliminate the use of the
Finally, the HHVBP Model applies a payment adjustment based on an HHA's performance on quality measures to test the effects on quality and expenditures.
Section 1861(iii) of the Act, as added by the Cures Act, sets forth three elements for home infusion therapy suppliers in three areas: (1) Ensuring that all patients have a plan of care established and updated by a physician that sets out the care and prescribed infusion therapy necessary to meet the patient-specific needs, (2) having procedures to ensure that remote monitoring services associated with administering infusion drugs in a patient's home are provided, and (3) having procedures to ensure that patients receive education and training on the effective use of medications and equipment in the home. These provisions serve as the basis for suppliers to participate in Medicare.
Section 1834(u) of the Act serves as the basis for the establishment of a prospective payment system for home infusion therapy covered under Medicare. Section 1834(u)(7) of the Act, as added by BBA of 2018 requires the Secretary to provide a temporary transitional payment to eligible home infusion therapy suppliers for items and services associated with the furnishing of transitional home infusion drugs for CYs 2019 and 2020. Under this payment methodology (as described in section VI.D. of this final rule with comment period), the Secretary will establish three payment categories at amounts equal to the amounts determined under the Physician Fee Schedule established under section 1848 of the Act for services furnished during CY 2019 for codes and units of such codes, determined without application of the geographic adjustment.
Section 1834(u)(5)(B) of the Act requires the Secretary to designate organizations to accredit qualified home infusion therapy suppliers furnishing home infusion therapy no later than January 1, 2021. Qualified home infusion therapy suppliers must furnish infusion therapy to individuals with acute or chronic conditions requiring administration of home infusion drugs; ensure the safe and effective provision and administration of home infusion therapy on a 7-day-a-week, 24-hour-a-day basis; be accredited by an accrediting organization designated and approved by the Secretary; and meet other such requirements as the Secretary deems appropriate.
We have examined the impacts of this rule 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), the Congressional Review Act (5 U.S.C. 804(2)), and Executive Order 13771 on Reducing Regulation and Controlling Regulatory Costs (January 30, 2017).
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). Section 3(f) of Executive Order 12866 defines a “significant regulatory action” as an action that is likely to result in a rule: (1) Having an annual effect on the economy of $100 million or more in any 1 year, or adversely and materially affecting 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) creating a serious inconsistency or otherwise interfering with an action taken or planned by another agency; (3) materially altering the budgetary impacts of entitlement grants, user fees, or loan programs or the rights and obligations of recipients thereof; or (4) raising novel legal or policy issues arising out of legal mandates, the President's priorities, or the principles set forth in the Executive Order.
A regulatory impact analysis (RIA) must be prepared for major rules with economically significant effects ($100 million or more in any 1 year). The net transfer impact related to the changes in payments under the HH PPS for CY 2019 is estimated to be $420 million (2.2 percent). The net transfer impact in CY 2020 related to the change in the unit of payment under the PDGM is estimated to be $0 million as section 51001(a) of the BBA of 2018 requires such change to be implemented in a budget-neutral manner. The net transfer impact in CY 2019 related to the Temporary Transitional Payment for Home Infusion Therapy is estimated to be $48 million. The savings impacts related to the HHVBP model as a whole are estimated at $378 million for CYs 2018 through 2022. Due to the modifications to OASIS item collection as a result of the changes to the HH QRP and the changes to the HH PPS (PDGM), both effective on and after January 1, 2020, we estimate that this rule generates $60 million in annualized cost savings, or $46 million per year on an ongoing basis discounted at 7 percent relative to year 2016, over a perpetual time horizon beginning in CY 2020. Finally, the estimated cost impact to each potential home infusion therapy AO is $35,711. The cost of $12,453 would be incurred by the home infusion AO for the preparation and submission of their initial application to CMS seeking CMS approval of the AO's home infusion therapy accreditation program. The AO will incur this $12,453 cost with the submission of their initial application and then every 6 years thereafter, with the submission of their renewal application. The remaining costs of $23,258, which represents the costs associated with the home infusion therapy AO`s participation in ongoing CMS AO overview, monitoring and program review activities will be incurred on a bi-yearly basis.
We estimate that this rulemaking is “economically significant” as measured by the $100 million threshold, and hence also 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 rulemaking.
The RFA requires agencies to analyze options for regulatory relief of small entities, if a rule has a significant impact on a substantial number of small entities. For purposes of the RFA, small entities include small businesses, nonprofit organizations, and small governmental jurisdictions. Most hospitals and most other providers and suppliers are small entities, either by nonprofit status or by having revenues of less than $7.5 million to $38.5 million in any one year. For the purposes of the RFA, we estimate that almost all HHAs are small entities as that term is used in the RFA. Individuals and states are not included in the definition of a small entity. The economic impact assessment is based on estimated Medicare payments (revenues) and HHS's practice in interpreting the RFA is to consider effects economically “significant” only if greater than 5 percent of providers
In addition, section 1102(b) of the Act requires us to prepare a RIA if a rule may 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 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. This rule is not applicable to hospitals. Therefore, the Secretary has determined this final rule with comment period would not have a significant economic impact on the operations of small rural hospitals.
Section 202 of the Unfunded Mandates Reform Act of 1995 (UMRA) also requires that agencies assess anticipated costs and benefits before issuing any rule whose mandates require spending in any 1 year of $100 million in 1995 dollars, updated annually for inflation. In 2018, that threshold is approximately $150 million. This rule is not anticipated to have an effect on State, local, or tribal governments, in the aggregate, or on the private sector of $150 million or more.
Executive Order 13132 establishes certain requirements that an agency must meet when it promulgates a final rule (and subsequent final rule) that imposes substantial direct requirement costs on state and local governments, preempts State law, or otherwise has Federalism implications. We have reviewed this final rule with comment period under these criteria of Executive Order 13132, and have determined that it will not impose substantial direct costs on state or local governments. If regulations impose administrative costs on private entities, such as the time needed to read and interpret this final rule with comment period, we must estimate the cost associated with regulatory review. Due to the uncertainty involved with accurately quantifying the number of entities that would review the rule, we assume that the total number of unique commenters on this year's final rule would be the similar to the number of reviewers of last year's final rule. We acknowledge that this assumption may understate or overstate the costs of reviewing this rule. It is possible that not all commenters reviewed this year's rule in detail, and it is also possible that some reviewers chose not to comment on the proposed rule. For these reasons we believe that the number of past commenters would be a fair estimate of the number of reviewers of this rule. We welcome any comments on the approach in estimating the number of entities which would review this final rule with comment period. We also recognize that different types of entities are in many cases affected by mutually exclusive sections of this final rule with comment period, and therefore for the purposes of our estimate we assume that each reviewer reads approximately 50 percent of the rule. Using the wage information from the BLS for medical and health service managers (Code 11-9111), we estimate that the cost of reviewing this rule is $107.38 per hour, including overhead and fringe benefits (
The update set forth in this rule applies to Medicare payments under HH PPS in CY 2019. Accordingly, the following analysis describes the impact in CY 2019 only. We estimate that the net impact of the policies in this rule is approximately $420 million in increased payments to HHAs in CY 2019. We applied a wage index budget neutrality factor and a case-mix weight budget neutrality factor to the rates as discussed in section III.C.3 of this final rule with comment period. Therefore, the estimated impact of the 2019 wage index and the recalibration of the case-mix weights for CY 2019 is $0 million. The $420 million increase reflects the distributional effects of the CY 2019 home health payment update of 2.2 percent ($420 million increase), a 0.1 percent increase in payments due to the new lower FDL ratio, which will increase outlier payments in order to target to pay no more than 2.5 percent of total payments as outlier payments ($20 million increase) and a 0.1 percent decrease in payments due to the new rural add-on policy mandated by the BBA of 2018 for CY 2019 ($20 million decrease). The $420 million in increased payments is reflected in the last column of the first row in Table 44 as a 2.2 percent increase in expenditures when comparing CY 2018 payments to estimated CY 2019 payments.
With regard to options for regulatory relief, the rural add-on policy for CYs 2019 through 2022 is statutory and we do not have the authority to alter the methodology used to categorize rural counties or to revise the rural add-on percentages.
We estimate no net impact of the policies related to the implementation of the PDGM for the CY 2020 HH PPS, as the transition to the 30-day unit of payment is required to be budget neutral. However, since the PDGM eliminates the use of therapy thresholds as a factor in determining payment, HHAs that provide more nursing visits, and thus experience lower margins under the current payment system which may incentivize overutilization of therapy, may experience higher payments. Conversely, HHAs that provide more therapy visits compared to nursing visits, and thus may profit more from the current payment system, may experience lower payments.
Sections 1814(a)(2)(C) and 1835(a)(2)(A) of the Act require, as a condition of payment, that a physician must certify (and recertify, when home health services are furnished over a period of time) that the individual is eligible for home health services. The regulations at § 424.22(b)(2) set forth the content and basis for recertification requirements and states that the recertification statement must indicate the continuing need for services and estimate how much longer the services will be required. This requirement has been longstanding policy that predates the Paperwork Reduction Act of 1995 requirements. Therefore, there is no corresponding Collection of Information that was submitted to the Office of Management and Budget (OMB) for review and approval for the burden estimate for the recertification requirement that the certifying physician must estimate how much longer home health services will be required.
In section III.G. of this final rule with comment period, we eliminate the regulatory requirement as set forth at 42 CFR 424.22(b)(1), that the certifying physician, as part of the recertification process, include an estimate of how much longer home health services will be required at each home health recertification. While all other recertification content requirements under § 424.22 will remain unchanged, the certifying physician would not be required to provide his/her estimation as to how much longer the patient will require home health services on recertifications on and after January 1, 2019. Therefore, we believe this would result in a reduction of burden for certifying physicians by reducing the amount of time physicians spend on the recertification process and we are providing an estimate on the reduction in burden in this final rule with comment period. All salary information is based on the May 2017 wage data for physicians and surgeons from the Bureau of Labor Statistics (BLS) website at (
Using CY 2017 claims, we estimate that of the total number of Medicare home health claims (5.8 million), 37 percent were recertifications (2.1 million) completed by 284,615 certifying physicians.
Under the HHVBP Model, the first payment adjustment applies in CY 2018 based on PY1 (2016) data and the final payment adjustment will apply in CY 2022 based on PY5 (2020) data. In the CY 2016 HH PPS final rule, we estimated that the overall impact of the HHVBP Model from CY 2018 through CY 2022 was a reduction of approximately $380 million (80 FR 68716). In the CY 2017 HH PPS final rule, we estimated that the overall impact of the HHVBP Model from CY 2018 through CY 2022 was a reduction of approximately $378 million (81 FR 76795). We do not believe the changes finalized in this rule would affect the prior estimates.
Section 5012 of the Cures Act (Pub. L. 114-255), which amended section 1861(s)(2) of the Social Security Act (the Act), established a new Medicare home infusion therapy benefit. Section 1861(iii) of the Act, as added by section 5012 of the Cures Act defines, the Medicare home infusion therapy benefit and covers professional services including nursing services, training and education, and remote monitoring and monitoring services associated with administering certain infusion drugs in a patient's home. This benefit would ensure consistency in coverage for home infusion benefits for all Medicare beneficiaries. Section 1861(iii) of the Act, as added by the Cures Act, sets forth elements for home infusion therapy suppliers in three areas: (1) Ensuring that all patients have a plan of care established and updated by a physician that sets out the care and prescribed infusion therapy necessary to meet the patient-specific needs; (2) having procedures to ensure that remote monitoring services associated with administering infusion drugs in a patient's home are provided; and (3) having procedures to ensure that patients receive education and training on the effective use of medications and equipment in the home.
We implement the following requirements for home infusion therapy suppliers—
• Ensure that all patients must have a plan of care established by a physician that prescribes the type, amount and duration of infusion therapy services that are furnished. The plan of care would specify the care and services necessary to meet the patient specific needs.
• Ensure that the plan of care for each patient is periodically reviewed by the physician.
• Ensure that patients have infusion therapy support services at all times through the provision of professional services, including nursing services, furnished in accordance with the plan of care on a 7-day-a-week, 24-hour-a-day schedule.
• Provide patient training and education.
• Provide remote monitoring and monitoring services for the provision of home infusion therapy and home infusion drugs.
• All home infusion therapy suppliers must provide home infusion therapy services in accordance with nationally recognized standards of practice, and in accordance with all applicable state and federal laws and regulations (including the applicable provisions in the Federal Food, Drug, and Cosmetic Act).
All current standards established by AOs already address the requirements set forth in this rule. Furthermore, all existing home infusion therapy suppliers are already accredited by an existing AO for home infusion therapy to meet requirements established by private insurers and Medicare Advantage plans. Therefore, we assume that there would be no new burden imposed on home infusion therapy suppliers in order to meet the health and safety standards. Additionally, we assume that these health and safety provisions would not impose a new burden on home infusion therapy AOs that are likely to apply to be Medicare approved AOs for home infusion therapy because their existing standards would already meet or exceed those that would be established in this rule.
We estimate that the net impact of the policies in this rule is approximately $48 million (not including $12 million in beneficiary cost-sharing) in increased Medicare payments to home infusion suppliers in CY 2019. This increase reflects the cost of providing infusion therapy services to existing Medicare beneficiaries who are receiving DME home infusion therapy (at a 4-hour rate), as the temporary transitional payment applies only to existing Medicare eligible home infusion suppliers (that is, DME suppliers that are enrolled as pharmacies that provide external infusion pumps and supplies are considered eligible home infusion suppliers). Prior to the implementation of the temporary transitional payment, home infusion suppliers have not been separately paid for providing these services under the DME benefit. For the temporary transitional payment we do not anticipate an increase in beneficiaries receiving home infusion therapy services as referral patterns are not likely to change significantly due to the inability for other provider types (for example, physicians, HHAs) to become home infusion therapy suppliers prior to CY 2021 and given that existing DME suppliers already provide home infusion therapy services without separate reimbursement.
The requirement for accreditation of home infusion therapy suppliers will
Section 1834(u)(5)(B) of the Act requires the Secretary to designate AOs to accredit suppliers furnishing home infusion therapy not later than January 1, 2021. To date, we have not solicited nor approved any AOs to accredit home infusion therapy suppliers as required by section 1834(u)(5)(B) of the Act.
The AOs that respond to the solicitation notice would be required to submit an application to CMS requesting CMS-approval of a home infusion therapy accreditation program for Medicare. If CMS approves the AOs application, the home infusion therapy AO would also be required to meet, on an ongoing basis, the requirements set forth i§§ 488.1010 through 488.1050. The following is a discussion of the burden associated with specific sections of the home infusion therapy AO approval and oversight regulations at §§ 488.1010 through 488.1050.
The AOs that accredit home infusion therapy suppliers would incur time and costs burdens associated with the preparation of the application they submit to CMS requesting approval of their home infusion therapy accreditation program. This would include the preparation, gathering or obtaining of all the documentation required in § 488.1010(a)(1) through (24).
If the AO has never submitted an application to CMS, we estimate that it would take approximately 70 hours of time to gather, obtain or prepare all documentation required by § 488.1010(a)(1) through (23). However, for an existing AO that has previously submitted an application to CMS for any type of accreditation program, we estimate that it would take approximately 45 hours to gather, obtain or prepare all required documentation. We believe that it would take less time for an AO that has previously submitted an application to CMS to prepare an application requesting approval of a home infusion therapy accreditation program because this AO would already be familiar with the application process and requirements. The application requirements for home infusion therapy AOs, set forth at § 488.1010(a)(1) through (23), are consistent with those for Medicare-certified providers and suppliers which are set forth at § 488.5.
The home infusion therapy AO would incur costs associated with the preparation and submission of the home infusion therapy accreditation program application. The home infusion therapy AO would incur costs for the wages of all AO staff that work on the preparation of the application. We estimate that the AO would have 2 staff work on the preparation of the application. We believe that the AO staff that works on the AOs application would be clinicians such as registered nurses or medical or health services manager. According to the U.S. Bureau of Labor Statistics, the mean hourly wage for a registered nurse is $35.36 (
As stated previously, we estimate that it would take approximately 70 hours for an AO that has never submitted an application before to prepare and submit their home infusion therapy accreditation program application to CMS. We estimate that the home infusion therapy AO would incur wages for 70 hours of time by a registered nurse and 70 hours of time by a medical or health services manager in the amount of $12,453 (70 hours × $35.36 per hour = $2,475.20) + (70 hours × $53.59 = $3,751.30) + ($6,226,50 for fringe benefits and overhead).
In addition, AOs are required to submit 2 hard copies of their application to CMS in notebooks with dividers and an electronic copy of their application on a thumb drive. Because of this requirement, the home infusion therapy AO would incur costs for the notebooks, dividers, thumb drive, photocopying, paper and ink, and postage costs for mailing the notebooks with the hard copies of the application to the CMS Central Office. We estimate that these costs would be no more than $250.
At this time, there are five HHA AOs that accredit home infusion therapy suppliers as part of the deeming accreditation of a home health accreditation program (that is, The Joint Commission (TJC), Accreditation Commission for Health Care (ACHC), The Compliance Team (TCT), Community Health Accreditation Partner (CHAP), Healthcare Quality Association on Accreditation (HQAA)). The other three home infusion therapy AOs are pharmacy associations that provide non-Medicare approved accreditation to home infusion therapy suppliers. (That is, the National Association of Boards of Pharmacy, the Center for Pharmacy Practice Accreditation (CPPA) and URAC). The home infusion therapy accreditation programs offers by these 8 AO have not been approved under the requirements of section 1834(u)(5)(A) of the Act. Therefore, in order for the home infusion therapy suppliers accredited by these AOs to continue to receive payment for the home infusion therapy services furnished to Medicare beneficiaries, these AOs must obtain Medicare approval for a home infusion therapy accreditation program. If all of these eight AOs were to submit applications to CMS for approval of a home infusion therapy accreditation program, the cost incurred across all of these potential home infusion therapy AOs for the preparation and submission of their applications would be $64,116 ($4,007.25 × 8 AOs = $32,058) + ($32,058 for fringe benefits and overhead).
To obtain this CMS approval, these AOs would be required to submit an application to CMS seeking approval of a home infusion therapy accreditation program that meets the requirements set forth in the new home infusion therapy AO approval and oversight regulations set forth at § 488.1010(a)(1) through (a)(24) and the new home infusion therapy health and safety regulations at 42 CFR part 466, subpart I. We have further that the home infusion therapy accreditation programs submitted to CMS for approval by the existing home infusion therapy AOs be consistent with the requirements of section 5102 of the 21st Century CURES Act and section 1861(iii) of the Act. We would also require that the home infusion therapy
The AOs that currently provide home infusion therapy accreditation would incur the time and costs associated with the preparation of the CMS application and required supporting documentation. We estimate that it would take these AOs approximately 45 hours to prepare their applications and supporting documentation because they have previously submitted applications for approval of their home health accreditation programs. The existing AOs that accredit home infusion therapy suppliers would also incur costs for the wages for all AO staff involved with the preparation and submission of the application. The AO would also incur costs for printing the hard copies of the application, ink and paper, notebooks and dividers, and postage.
In accordance with § 488.1030(b) CMS would perform a comparability review if CMS makes changes to the home infusion therapy AO approval and oversight regulations or home infusion therapy health and safety regulation. The purpose of the comparability review is to allow CMS to assess the equivalency of a home infusion therapy AO's accreditation standards with the comparable Medicare home infusion therapy accreditation requirements after CMS imposes new or revised Medicare home infusion therapy accreditation requirements.
Section 488.1030(b)(1) would provide that if CMS were to make changes to the home infusion therapy AO approval and oversight accreditation regulations or the home infusion therapy health and safety regulations, CMS would send a written notice of the changes to the home infusion therapy AOs. Section 488.1030(b)(2) would provide that CMS would provide a deadline of not less than 30 day by which the AO must submit its revised home infusion therapy accreditation program standards to CMS.
Section 488.1030(b)(2) would require the home infusion therapy AOs to revise their home infusion therapy accreditation standards so as to incorporate the changes made by CMS. The AO must submit their revised home infusion therapy accreditation program standards to CMS by the deadline specified in CMS' written notice. The AO may submit a request for an extension of the submission deadline, so long as the request is submitted prior to the original submission deadline.
The home infusion therapy AOs would incur a time burden associated with the time required for the AO staff to review CMS' notice of the revisions to the home infusion therapy AO approval and oversight accreditation standards or home infusion therapy health and safety standards. We estimate that it would take no more than 1 hour for the AO to review the notice from CMS notifying the AO of the changes to the AO approval and oversight regulations or health and safety regulation.
The home infusion therapy AOs would incur a cost burden for the wages of the AO staff that are involved with reviewing the CMS notice and the preparation of the home infusion therapy AO's revised accreditation program standards. We believe that the AO staff that would review the notice from CMS regarding changes to the CMS home infusion therapy regulations would be clinicians such as registered nurses. According to the U.S. Bureau of Labor Statistics, the mean hourly wage for a non-industry specific registered nurse is $35.36 (
The home infusion therapy would also incur a cost burden for the wages of the AO staff for the time spent preparing the AOs revised home infusion therapy accreditation standards. There is uncertainty around our estimate of this cost because the amount of wages incurred would be dependent on the amount of time spent by the AO staff preparing the AOs revised accreditation standards.
We believe that the AO staff that would prepare the home infusion therapy AOs revised home infusion therapy accreditation standards would be a clinician such as registered nurses. According to the U.S. Bureau of Labor Statistics, the mean hourly wage for a non-industry specific registered nurse is $35.36 (
At this time, there are five HHA AOs that accredit home infusion therapy suppliers as part of the deeming accreditation of a home health accreditation program (that is, The Joint Commission (TJC), Accreditation Commission for Health Care (ACHC), The Compliance Team (TCT), Community Health Accreditation Partner (CHAP), Healthcare Quality Association on Accreditation (HQAA)). The other three home infusion therapy AOs are pharmacy associations that provide non-Medicare approved accreditation to home infusion therapy suppliers (that is, the National Association of Boards of Pharmacy, the Center for Pharmacy Practice Accreditation (CPPA) and URAC). The home infusion therapy accreditation programs offers by these 8 AO have not been approved under the requirements of section 1834(u)(5)(A) of the Act. If all of these eight AOs were to submit applications to CMS for approval of a home infusion therapy accreditation program, the cost incurred across all of these AOs for the preparation of revised accreditation standards would be $2,828.80 ($176.80 × 8 AOs = $1,414.40) + ($1,414.40 for fringe benefits and overhead). As provided by § 488.1030(b)(4), a home infusion therapy AO may request an extension of the deadline by which they must submit their revised accreditation home infusion therapy standards, so long as the extension request is submitted prior to the submission deadline. If the home infusion therapy AO requested an extension of the submission deadline, the AO would incur burden for the time required to prepare and submit the deadline extension request, however, we believe this burden would be minimal. We believe that the extension request could be sent in the form of an email to CMS, would consist of no more than a few paragraphs and would take no more than 15 minutes to prepare and send.
The AO would incur a cost burden for the wages for the AO staff who prepares the extension request. We believe that this email would be sent by an administrative assistant. According to the U.S. Bureau of Labor Statistics, the mean hourly wage for an executive administrative assistant is $28.56 (
At this time, there are eight AOs that accredit home infusion therapy suppliers (that is—The Joint Commission (TJC), Accreditation Commission for Health Care (ACHC), The Compliance Team (TCT),
Section § 488.1030(b)(7) would provide that if CMS were to make significant substantial changes to the home infusion therapy AO approval and oversight accreditation standards or the home infusion therapy health and safety standards, we may require the home infusion therapy AOs to submit a new application for approval of their revised home infusion therapy accreditation programs. If this were to occur, the home infusion therapy AOs would incur a time burden for the time associated the preparation of the AOs new application.
We estimate that it would take the home infusion therapy AO approximately 45 hours to prepare and submit their new application to CMS. This would include the time and costs required to gather and prepare the required supporting documentation to go with the application. We believe that the home infusion therapy AOs would already be familiar with the CMS application process and would be able to use their previous application and supporting documentation with updates, therefore, the reapplication process would be less burdensome.
The home infusion therapy AO would also incur costs associated with the preparation and submission of a new application. The home infusion therapy AO would incur costs for the wages of all AO staff that work on the preparation of the application. We estimate that the AO would have 2 staff persons work on the preparation of the application. Furthermore, we believe that the AO staff that works on the AOs application would be clinicians such as a registered nurse and a medical or health services manager. According to the U.S. Bureau of Labor Statistics, the mean hourly wage for a non-industry specific registered nurse is $35.36 (
In addition, AOs are required to submit 2 hard copies of their application to CMS in notebooks with dividers and an electronic copy of their application on a thumb drive. Because of this requirement, the home infusion therapy AO would incur costs for the notebooks, dividers, thumb drive, photocopying, paper and ink, and postage costs for mailing the notebooks with the hard copies of the application to the CMS Central Office. We estimate that these costs would be no more than $250.
In accordance with § 488.1030(c), CMS will perform a standards review when the home infusion therapy AO makes updates to its accreditation standards and surveys processes. Section 488.1030(c)(1) would require that when a home infusion therapy AO proposed to adopt new or revised accreditation standards, requirements or changes in its survey process, the home infusion therapy AO must submit its revised accreditation standards and survey processes to CMS for review, at least 60 days prior to the implementation date of the revised standards. Section 488.1030(c)(3) would require that the home infusion therapy AO provide CMS with a detailed description of the changes that are to be made to the AO's home infusion therapy accreditation standards, requirements and survey processes and a detailed crosswalk (in table format) that states the exact language of the organization's revised accreditation requirements and the applicable Medicare requirements for each. Section 488.1030(c)(4) would provide that CMS must provide a written notice to the home infusion therapy accrediting organization which states whether the home infusion therapy accreditation program, including the revisions, continues or does not continue to meet or exceed all applicable Medicare home infusion therapy requirements within 60 days of receipt of the home infusion therapy accrediting organization's changes. Section 488.1030(c)(5) would provide that if a home infusion therapy AO implements changes that have neither been determined nor deemed by CMS to be comparable to the applicable Medicare home infusion therapy requirements, CMS may open a home infusion therapy accreditation program review in accordance with § 488.1030(c) or (d).
The burden to the home infusion therapy AO associated with the standards review includes the time required for the home infusion therapy AO to prepare its revised accreditation standards and detailed crosswalk for submission to CMS and submit them to CMS for review. This burden would also include the time required for the AO staff to read and respond to CMS' written response. It is important to note that we do not include in our burden estimate the time that would be spent by the home infusion therapy AO in making voluntary revisions to their accreditation standards that are not required by CMS nor prompted by a regulatory change.
The home infusion therapy AO would also incur costs for the wages of the AO staff involved with the preparation of the AO's revised home infusion therapy accreditation standards and the detailed crosswalk for submission to CMS. The AO would also incur costs for wages for the time the AO staff spent reviewing CMS' response. However, the AO could send their revised accreditation standards to CMS via email, therefore the AO would not incur costs for postage.
We are not able to accurately estimate the total time and cost burden associated with the standards review because the time required for the home infusion therapy AO to prepare its revised home infusion therapy accreditation standards and detailed crosswalk would depend on the extent of the revision the AO has made to its home infusion therapy accreditation standards or survey processes. The burden would also depend of the content and length of CMS' response letter. However, we do estimate that the preparation of the home infusion therapy AOs revised accreditation standard and detailed crosswalk for submission to CMS would take no less than 5 hours.
We believe that the AO staff that would prepare the home infusion therapy AOs revised home infusion therapy accreditation standards and detailed crosswalk for submission to CMS would be clinicians such as registered nurses. According to the U.S.
We further estimate that it would take the home infusion therapy AO approximately 30 minutes for the home infusion therapy AO to review the CMS response to their submission of the revised home infusion therapy accreditation standards and detailed crosswalk. We believe that a clinician such as a registered nurse would review the CMS response letter. Therefore, the cost burden to the home infusion therapy AO associated with this task would be $53.04 (45 minutes × $35.36 per hour = $26.52) + ($26.52 for fringe benefits and overhead).
It is important to note that we have not calculated this burden across all of the potential home infusion therapy AOs. We have not done so because the submission of revised home infusion therapy accreditation standards by a home infusion therapy AO would only occur on an occasional basis and would never be done by all 6 potential AOs at the same time.
In accordance with § 488.1030(d), CMS may perform a home infusion therapy accreditation program review if a comparability, performance, or standards review reveals evidence of substantial non-compliance of a home infusion therapy AO's CMS-approved home infusion therapy accreditation program with the requirements of the home infusion therapy AO approval and oversight regulation at 42 CFR part 488, subpart L. If a home infusion therapy accreditation program review is initiated, CMS will provide written notice to the home infusion therapy AO indicating that its CMS-approved accreditation program approval may be in jeopardy and that a home infusion therapy accreditation program review is being initiated. The notice would provide all of the following information:
• A statement of the instances, rates or patterns of non-compliance identified, as well as other related information, if applicable.
• A description of the process to be followed during the review, including a description of the opportunities for the home infusion therapy accrediting organization to offer factual information related to CMS' findings.
• A description of the possible actions that may be imposed by CMS based on the findings of the home infusion therapy accreditation program review.
• The actions the home infusion therapy accrediting organization must take to address the identified deficiencies.
• A timeline for implementation of the home infusion therapy accrediting organization's corrective action plan, not to exceed 180 calendar days after receipt of the notice that CMS is initiating a home infusion therapy accreditation program review.
Section 488.1030(d)(3) would provide that CMS will monitor the performance of the AO's home infusion therapy and the implementation of the corrective action plan during a probation period of up to 180 days. Section 488.1030(d)(4) would provide that if CMS determines, as a result of the home infusion therapy accreditation program review or a review of an application for renewal of the accrediting organizations existing CMS-approved home infusion therapy accreditation program, that the home infusion therapy accrediting organization has failed to meet any of the requirements of the regulations at §§ 488.1010 through 488.1050, CMS may place the home infusion therapy AO's CMS-approved home infusion therapy accreditation program on an additional probation period of up to 180 calendar days subsequent to the period described in § 488.1030(d)(1)(iv).
The time burden associated with the home infusion therapy accreditation program review includes the time burden associated with the AO's review of CMS' written notice which indicates that the home infusion therapy AO's CMS-approved accreditation program approval may be in jeopardy and that a home infusion therapy accreditation program review is being initiated. The time required for the review of the CMS letter will depend on the length of CMS' finding. However, we estimate it would take no more than 60 minutes to review this letter.
The AO would incur costs for the wages of the AO staff who performs the review of the CMS letter. We believe that an AO staff person with a clinical background such as a registered nurse would review the CMS letter. According to the U.S. Bureau of Labor Statistics, the mean hourly wage for a registered nurse is $35.36 (
There is further burden associated with the requirement that the AO prepare and submit a written response to the CMS letter and a corrective action plan. However, we are unable to accurately estimate the time burden associated with this task because the amount of time required for the home infusion therapy AO to prepare the response letter and corrective plan would be dependent on the number and type of findings identified in CMS' letter.
However, we believe that an AO staff person with a clinical background such as a registered nurse would prepare the home infusion therapy AO's written response to the CMS letter and a corrective action plan. According to the U.S. Bureau of Labor Statistics, the mean hourly wage for a registered nurse is $35.36 (
The home infusion therapy AO would incur a time burden for the time spent by the AO staff making corrections to the AOs corrective action plan. We are unable to accurately estimate how long it would take for the AO to revise its corrective action plan because the revision to be made to the corrective action plan would be dependent on the extent of the correction requested by CMS.
However, we believe that an AO staff person with a clinical background such as a registered nurse would make the corrections to the AOs corrective action plan. According to the U.S. Bureau of Labor Statistics, the mean hourly wage for a registered nurse is $35.36 (
The home infusion therapy AO would also incur burden associated with the time required to participate in the periodic phone calls with CMS. We are not able to accurately estimate the amount of time that would be required for these periodic phone calls because we do not know how often the AO would be required to participate in phone calls with CMS or how long these phone calls would last. However, we do not believe that these phone calls would be held more often that monthly or last more than one hour. The AO would incur costs for the wages of all AO staff that participate in the periodic telephone calls. We are not able to accurately estimate the total cost burden for wages that would be incurred by the home infusion therapy AO at this time, because we do not know who from the AO would be attending these meetings.
If we were to estimate that these phone calls were to be held on a monthly basis during the 180 day probation period for a period of one hour period per call, the home infusion therapy AO would incur a time burden in the amount of 6 hours per each staff member that participates in these phone calls. We believe that the AO would have a minimum of 3 staff that are clinicians, such as registered nurses, participate on the call. According to the U.S. Bureau of Labor Statistics, the mean hourly wage for a registered nurse is $35.36 (
At or near the end of the first 180 day probationary period, CMS will make a decision as to whether the home infusion therapy AO has successfully come into compliance with the home infusion therapy regulations, or whether the AO has failed to do so. Section 488.1030(d)(4) would provide that if CMS finds that the home infusion therapy AO has failed to properly implement the plan of correction and come into compliance with the requirements of the home infusion therapy AO approval and oversight regulation or the home infusion therapy health and safety regulations, CMS may place the home infusion therapy AO's on an additional probation period of up to 180 calendar days. If this were to occur, the AO would incur the same or similar time and cost burdens as in the initial 180 day probationary period. (See previous estimates for the estimated time and cost burden associated with the 180-day probationary period).
It is important to note that we have not calculated the burden associated with the tasks required of the home infusion therapy AO under § 488.1030(d) across all of the potential home infusion therapy AOs. We have not done so because the act of CMS placing a home infusion therapy AO on an accreditation program review would only occur on a sporadic and as needed basis. There is unlikely to ever be a situation in which all 8 potential AOs would be under an accreditation program review at the same time.
Section 488.1035 titled “Ongoing responsibilities of a CMS-approved home infusion therapy accrediting organization” would require that the home infusion therapy AO carry out certain activities and submit certain documents to CMS on an ongoing basis. Section 488.1035(a) would require the home infusion therapy AO to submit the following documents to CMS: (1) Copies of all home infusion therapy accreditation surveys, together with any survey-related information that CMS may require (including corrective action plans and summaries of findings with respect to unmet CMS requirements); (2) notice of all accreditation decisions; (3) notice of all complaints related to providers or suppliers; (4) information about all home infusion therapy accredited suppliers against which the home infusion therapy accreditation organization has taken remedial or adverse action, including revocation, withdrawal, or revision of the providers or suppliers accreditation; (5) the home infusion therapy accrediting organization must provide, on an annual basis, summary data specified by CMS that relate to the past year's accreditation activities and trends; (6) notice of any changes in the home infusion therapy accrediting organization's accreditation standards or requirements or survey process.
We believe that there would be little burden associated with this requirements for several reasons. First, while the home infusion therapy AOs would be required to provide copies of all survey reports and any survey-related information that CMS may require, the AOs would only be required to provide this information upon request. CMS may not request the home infusion therapy AO to submit this information if there are no compliance concerns. Second, we believe the home infusion therapy AO would keep these records in the normal course of their business as a home infusion therapy AO and would store the survey records in electronic format. As the AO already has this information prepared and stored in an electronic format, it would place little if any burden on the home infusion therapy AO to provide this information to CMS. We believe that the AO could send this information to CMS
We estimate that it would take approximately 30 minutes to locate the required survey information files and approximately 15 minutes for the AO staff to prepare an email to CMS and attach the electronic files to the email. We believe that the person at the AO that would prepare the email sending the survey information to CMS would most likely be a clinician such as a registered nurse. According to the U.S. Bureau of Labor Statistics, the mean hourly wage for a registered nurse is $35.36 (
Section 488.1035(a)(2) would require the home infusion therapy AO to provide CMS with notice of all accreditation decisions made for each home infusion therapy supplier that files an application for accreditation. This would consist of a list of each home infusion therapy supplier that had filed an application with the home infusion therapy AO for accreditation and the accreditation decision made by the AO.
We believe that these accreditation decisions would be made by the AO in the normal course of the AOs business of performing accreditation of home infusion therapy suppliers. We further believe that there would be little burden associated with the requirement that the AO provide CMS with a list of the accreditation decisions made by the AO as this is information that would be readily available to the AO and that could quickly and easily be provided to CMS via email. We estimate that it would take approximately 15 minutes for the home infusion AO to gather the required accreditation decision information in preparation for sending it to CMS.
We believe that this information can be sent to CMS via email and estimate that it would take an additional 15 minutes for the AO staff to prepare an email to CMS and attach the electronic files containing the accreditation decision information to the email. We believe that the person at the AO who would prepare the accreditation decision information and prepare the email to CMS would most likely be a clinician such as a registered nurse. According to the U.S. Bureau of Labor Statistics, the mean hourly wage for a registered nurse is $35.36 (
Section 488.1035(a)(3) would require the AO to report complaint information to CMS. Complaint information is typically reported to CMS by other AOs by email on a monthly basis for the previous month. The contents of the complaint information reported to CMS would depend on whether the AO had received any complaints during the previous month. For example, if the AO received no complaint during the previous month, this email could consist of a sentence stating that the AO had received no complaints If the AO had received one or more complaints during the previous month, the AO would be required to provide information about the nature of each complaint, a description of the investigation performed, a description of how the complaint was resolved and the date resolved.
We believe that there would be little burden associated with the reporting of complaint information by the home infusion therapy AO to CMS for several reasons. First, we estimate that the home infusion therapy AOs will rarely receive complaints about their accredited home infusion therapy suppliers. Second, we believe that the home infusion therapy AO will store information about any complaints received in an electronic format. Therefore, complaint information can be reported by the home infusion therapy AO to CMS via email. We estimate that the preparation of the complaint information email would take only no more than 15 minutes to prepare and send.
We believe that the person at the AO who would prepare the complaint information email and sent it to CMS would most likely be a clinician such as a registered nurse. According to the U.S. Bureau of Labor Statistics, the mean hourly wage for a registered nurse is $35.36 (
The estimated monthly cost across the potential 8 home infusion therapy AOs for these tasks would be $141.44 ($17.68 × 8 home infusion therapy AOs = $141.44). The estimated yearly cost across the 6 potential home infusion therapy AOs would be $1,697.28 ($17.68 × 8 AOs = $141.44 per all AOs per month and $141.44 per year × 12 months per year = $1,697.28). Section 488.1035(a)(4) would require the AO to provide CMS with information about all home infusion therapy accredited suppliers against which the home infusion therapy AO has taken remedial or adverse action, including revocation, withdrawal, or revision of the providers or suppliers accreditation. The information to be sent to CMS would simply consist of a list of the home infusion therapy suppliers and the type of remedial or adverse action taken.
We expect that when a home infusion therapy AO takes remedial or adverse action against its accredited supplier, the AO would prepare documentation which states the action taken and the reason this action was taken. We further believe that the AO would store this information electronically. This would enable the AO to send the required information to CMS via email. Therefore, we believe that there would be little burden associated with this requirement.
We believe that the home infusion therapy AOs could send information about adverse or remedial actions they have taken against their accredited suppliers via email. We estimate that it would take approximately 30 minutes for a home infusion therapy AO to prepare a report about the adverse or remedial actions taken against its accredited suppliers and approximately 15 minutes to prepare an email to CMS, attach the electronic file with the required information and send it to CMS. The home infusion therapy AOs would be required to report this information to CMS on a monthly basis.
The AO would incur a cost burden for the wages of the AO staff for the time spent preparing the report of the adverse or remedial action taken against the AO's accredited home infusion therapy suppliers and the time spent preparing
The estimated monthly cost across the potential 8 home infusion therapy AOs for these tasks would be $424.32 ($53.04 × 8 home infusion therapy AOs = $424.32). The estimated yearly cost across the 8 potential home infusion therapy AOs would be $5,091.84 ($53.04 × 8 AOs = $424.32 per all AOs per month and $424.32 per year × 12 months per year = $5,091.84).
Section 488.1035(a)(5) would require the home infusion therapy accrediting organization to provide, on an annual basis, summary data specified by CMS that relates to the past year's accreditation activities and trends. This summary data might include information such as the total number of complaints received during the year, the total number of immediate jeopardy situations found during the year, and the total number of deficiencies cited. We believe this is information that the AO would collect and document throughout the year in the normal course of business. We further believe that the home infusion therapy AO would prepare this year end summary data for their own informational, quality improvement, and research purposes.
We believe that there would be little, if any time burden associated with the submission of the documents and information required by § 488.1035(a)(5) by the home infusion therapy AOs to CMS, because these are documents which the AO would keep in the normal course of business, therefore these documents would be easily accessible to the home infusion therapy AO. Title 5 CFR 1320.3(b)(2) states that the time, effort, and financial resources necessary to comply with a collection of information that would be incurred in the normal course of their activities (for example in compiling and maintaining business records) will be excluded from the burden if the agency demonstrates that the reporting, recordkeeping, or disclosure activities needed to comply are usual and customary. Further, we believe that most, if not all of the home infusion therapy AOs would store these documents electronically and would be able to send them electronically to CMS via email.
The home infusion therapy AO would incur a time burden for the preparation and submission of the annual summary data to CMS. We estimate that it would take approximately 60 minutes for the home infusion therapy AO to locate the required annual summary data information and prepare it for submission to CMS. We further estimate that it would take an additional 15 minutes to prepare an email to CMS and attach the electronic files containing the summary data.
The home infusion therapy AO would incur a cost burden for the wages of the AO staff who prepares that summary data for submission to CMS and prepares the email to in which the annual summary data are submitted to CMS. We believe that the person at the AO who would prepare the summary data for submission to CMS and also prepare the email to CMS would most likely be a clinician such as a registered nurse. According to the U.S. Bureau of Labor Statistics, the mean hourly wage for a registered nurse is $35.36 (
Section 488.1035(b) would require that within 30 calendar days after a change in CMS requirements, the home infusion therapy accrediting organization must submit an acknowledgment of receipt of CMS' notification to CMS. The time burden associated with this requirement would be the time required for an AO staff person to review the notification from CMS about the change in home infusion therapy accreditation program requirements and the time required for the AO staff person to compose and send an acknowledgement email to CMS.
We estimate the time required for the AO staff to review the notice of a change in CMS requirements would be 1 hour. We further estimate that the time that would be required to prepare and submit the acknowledgement of receipt of the CMS notice would be approximately 15 minutes because this notice could be sent to CMS via email and would only consist of 1-2 paragraphs.
The home infusion therapy AO would incur a cost burden for the wages of the staff for the time required to review the notice from CMS of the change in CMS requirements. The home infusion therapy AO would incur a cost burden for the wages of the staff for the time required to prepare the acknowledgement and submits it to CMS. We believe that the person at the AO who would prepare the email to CMS acknowledging receipt of the CMS notice would most likely be a clinician such as a registered nurse. According to the U.S. Bureau of Labor Statistics, the mean hourly wage for a registered nurse is $35.36 (
The estimated cost burden to the home infusion therapy AO associated with the review of the notice from CMS of changes to the CMS requirements would be $70.72 (1 hour × $35.36 per hour) + ($35.36 for fringe benefits and overhead). The estimated cost burden associated with the preparation and submission of the acknowledgement by the home infusion therapy AO would be $17.68 (15 minutes × $35.36 per hour = $8.84) + ($8.84 for fringe benefits and overhead). The estimates cost across the 8 potential home infusion therapy AOs would be $707.20 ($70.72 × 8 = $565.76) + ($17.68 × 8 = $141.44).
It is important to note that the home infusion therapy AOs would only have to perform these tasks if CMS were to make a change to the home infusion therapy standards. We believe that this would occur on an infrequent basis, therefore, the home infusion therapy AOs would incur these time and cost burdens on an infrequent basis.
Section 488.1035(c) would require that the home infusion therapy AO permit its surveyors to serve as witnesses if CMS takes an adverse action based on accreditation findings. An example in which a surveyor would be needed to testify as a witness would be if there was litigation about CMS' termination of a home infusion therapy supplier's participation in the Medicare program and the surveyor that had performed a survey of that home infusion therapy supplier was needed to
The home infusion therapy AO would incur a time burden for the time required for the AO's surveyor to serve as a witness. This would include travel time to and from the location where the hearing is being held. The AO would also incur cost burdens for the wages paid to the surveyor during the time they are serving as a witness and also for any travel expenses the AO may be required to pay, that are not reimbursed.
It is important to note that the home infusion therapy AO surveyors would rarely, if ever, be required to act as a witness. Therefore, this is a burden that the home infusion therapy AOs would not be likely to incur.
Section 488.1035(d) would require that, within 2 business days of identifying a deficiency of an accredited home infusion therapy supplier that poses immediate jeopardy to a beneficiary or to the general public, the home infusion therapy AO must provide CMS with written notice of the deficiency and any adverse action implemented by the AO. The burden associated with this requirement is the time required to provide notice to CMS of the immediate jeopardy situation and the wages for the AO staff person for the time spent preparing and submitting this notice.
We believe that the AO would keep this information in the normal course of their business of providing home infusion therapy accreditation. Therefore, the AO should have these readily available. We further believe that the home infusion therapy AOs would keep records related to immediate jeopardy findings in an electronic format.
The AO would incur a time burden for the time required to report the immediate jeopardy information to CMS. We estimate that it would take the AO no more than 20 minutes to prepare an email to CMS in which they provide the required information about the immediate jeopardy situation that has been discovered. The AO can attach electronic files to the email that contain the required information. It is important to note that we do not count, as a burden, the time spent by the home infusion therapy AO in finding the immediate jeopardy situation or resolving it, because it is the duty of any CMS-approved AO to monitor it's accredited providers or supplier to ensure they are providing care that meets the accreditation standards and that they do not have any situation that put the patients or general public in imminent danger of harm. The home infusion therapy AO would incur a cost burden for the wages of the AO staff that prepares the email to CMS which notified CMS of the immediate jeopardy situation. We believe that the person at the AO who would prepare the immediate jeopardy notification email to CMS would most likely be a clinician such as a registered nurse. According to the U.S. Bureau of Labor Statistics, the mean hourly wage for a registered nurse is $35.36 (
The home infusion therapy AOs would have to perform these tasks and incur these time and costs burdens only if they discover an immediate jeopardy situation with an accredited home infusion therapy supplier. We would like to point out that this would not be a regular time and cost burden that would be incurred by the home infusion therapy AOs, as the discovery of immediate jeopardy situations by AOs do not occur frequently.
It is important to note that we have not calculated the burden associated with the tasks required of the home infusion therapy AO under § 488.1035(d) across all of the potential home infusion therapy AOs. We have not done so because the need for a home infusion therapy AO to report an immediate jeopardy situation to CMS would only occur on a sporadic basis. Section 488.1035(e) would require that within 10 calendar days after CMS' notice to a CMS-approved home infusion therapy AO that CMS intends to withdraw approval of the AO's home infusion therapy accreditation program, the home infusion therapy AO must provide written notice of the withdrawal to all of the home infusion therapy AO's accredited suppliers. The time burden associated with this requirement would be the time spent by the AO staff to prepare the required notice that must be sent to all of the AOs accredited home infusion therapy suppliers and the time required for the AO to send this notice out to all of its accredited suppliers.
We estimate that it would take that home infusion therapy AO approximately 45 minutes to prepare the notice that they must send out to their accredited suppliers. We believe it would take an additional 2 minutes per letter to be sent by the home infusion therapy AO to its accredited suppliers to prepare these letters for mailing (that is—fold letter, place in envelope, affix correct amount of postage and place the letter into the outgoing mail). We are not able to accurately estimate the amount of time it would take for the AO to send this notice out to all of its accredited suppliers because this would be dependent on the number of accredited suppliers the AO has at the time. However, if were to assume that a home infusion therapy AO had 50 accredited home infusion therapy suppliers, this task would take the AO staff 1.7 hours to complete (2 minutes × 50 letters = 100 minutes) and (100 minutes divided by 60 minutes per hour = 1.7 hours).
The home infusion therapy AO would incur a cost burden for the wages of the AO staff person that prepares the required notification. We believe that the person at the AO who would prepare the required notification would most likely be a clinician such as a registered nurse. According to the U.S. Bureau of Labor Statistics, the mean hourly wage for a registered nurse is $35.36 (
The home infusion therapy would also incur a cost burden for the wages of the staff person for the time spent preparing the required notices for mailing and mailing them. We are unable to accurately estimate this cost burden because the time required to perform this task would be dependent on the number of accredited home infusion therapy supplier the AO has at the time. However, if were to assume that a home infusion therapy AO had 50 accredited home infusion therapy suppliers, this task would take the AO staff 1.7 hours to complete (2 minutes × 50 letters = 100 minutes/100 minutes divided by 60 minutes per hour = 1.7 hours). We believe that the person that would perform this task would be an Administrative Assistant. According to the U.S. Bureau of Labor Statistics, the mean hourly wage for an executive administrative Assistant is $28.56 (
It is important to note that the home infusion therapy AO surveyors would rarely, if ever, be required to perform the tasks required by § 488.1035(e) because we would rarely withdraw the CMS approval of a home infusion therapy AO. We would do so if there were serious, unresolved compliance concerns that the AO was unable or unwilling to rectify, even after being placed on an accreditation program probationary period.
Section 488.1040 would require that as part of the application review process, the ongoing review process, or the continuing oversight of an home infusion therapy AO's performance, CMS may conduct onsite inspections of the home infusion therapy AO's operations and offices at any time to verify the home infusion therapy AO's representations and to assess the home infusion therapy AO's compliance with its own policies and procedures. Section 488.1040(b) provides that the activities to be performed by CMS staff during the onsite inspections may include, but are not limited to the following: (1) Interviews with various AO staff; (2) review of documents, survey files, audit tools, and related records; (3) observation of meetings concerning the home infusion therapy accreditation process; (4) auditing meetings concerning the accreditation process; (5) observation of in-progress surveys and audits; and (6) evaluation of the AO's survey results and accreditation decision-making process.
We believe that there would be little burden associated with the onsite visits made by CMS to the home infusion therapy AO's operations and offices because most of the activities related to the onsite visit involve work performed by the CMS staff, which would not impose burden on the AO staff (such as review of records or observation of meeting held at the AOs offices). We estimate that the time burden to the home infusion therapy AO associated with these onsite visits would include the time required for the AO staff to greet the CMS team upon arrival and show them to the conference room, the time required to locate the records the CMS team requests for review, and the time required for CMS to conduct interviews of AO staff members. If the home infusion therapy AOs records are electronic, an AO staff member may need to remain with the CMS team during their record review to assist them with access to the AO's records.
We are not able to accurately estimate the total time that would be required for these activities because we have not yet accredited any home infusion therapy AOs, nor have we had an opportunity to perform an onsite visit to a home infusion therapy AO. We do not yet know what type of accreditation standards and surveys processes the home infusion therapy AOs would use. Also, we do not know the amount and type of records we would seek to review during an onsite visit to a home infusion therapy AO or approximately how much time we would need to review these records. Likewise, we do not yet know how much interaction we would need to have with the home infusion therapy AO staff or which AO staff members we would choose to interview. The onsite AO visits we have performed for other types of AOs have lasted 1 to 2 days depending on the type of AO.
However, if we estimate that it would take 1 hour for the CMS team entrance conference, 8 hours for the CMS team to perform their records review and 1 hour for the CMS team conduct the exit conference, the home infusion therapy AO would incur a time burden in the amount of 1 hour for each AO staff person that attends the entrance conference, 8 hours for any staff that remains with the CMS team to assist them with the record review and 1 hour of time for each AO staff person that attends the exit conference. We believe that the AO staff that would be attending the entrance and exit conferences and assisting the CMS staff with their records review would most likely be clinicians such as registered nurses. According to the U.S. Bureau of Labor Statistics, the mean hourly wage for a non-industry specific registered nurse is $35.36 (
Based on the a previously stated time estimate, we estimate that the home infusion therapy AO would incur a cost burden in the amount of $282.88 for wages for four AO staff for attendance at the entrance conference. ($35.36 per hour per each AO staff × 1 hour = $35.36/$35.36 per hour × 4 AO staff = $141.44) + ($141.44 for fringe benefits and overhead).
We further estimate that the AO would incur a cost burden in the amount of $282.88 for the wages of the four AO staff for attendance at the exit conference. ($35.36 per hour per each AO staff × 1 hour = $35.36/$35.36 per hour × 4 AO staff = $141.44) + ($141.44 for fringe benefits and overhead).
We also estimate that the AO would incur a cost burden in the amount of $565.76 for the wages of the AO staff person that would remain with the CMS team to assist them with their record review. (8 hours × $35.36 = $282.88) + ($282.88 for fringe benefits and overhead).
The total estimated cost burden to the home infusion therapy AO associated with the CMS onsite visit is $1,131.52 ($282.88 for entrance conference + $282.88 for exit conference + $565.76 for assisting CMS staff with record review = $1,131.52). The estimated cost burden across all of the potential eight home infusion therapy AOs would be $9,052.16 ($1,131.52 × 8 potential AOs = $9,052.16).
In this final rule with comment period, we have the eight AOs that currently provide accreditation to home infusion therapy suppliers must submit an application to CMS for approval of a separate and distinct home infusion therapy accreditation program. A corporate onsite visit to the home infusion therapy AOs office is a part of the application review and approval process. Therefore, each of the AOs that submit an application to CMS for approval of a home infusion therapy program would incur the previously stated estimated burden related to the corporate onsite visit. However, after the initial application process has been completed, CMS would only make additional corporate onsite visits every 6 years when the home infusion therapy AOs submit their renewal application. Therefore, this would not be is a frequent or ongoing burden incurred by the home infusion therapy AOs.
Section § 488.1045 contains regulations related to the voluntary and involuntary termination of the CMS
The requirement that the home infusion therapy AO provide notice of its decision to voluntarily terminate its CMS approved home infusion therapy accreditation program to CMS and all of its accredited home infusion therapy suppliers would cause the AO to incur the following time burdens: (1) The time required to prepare and send the required notice to CMS; and (2) the time required to prepare and send the required notice to all of the AOs accredited home infusion therapy suppliers. We would require that the AO send the required notice of their decision to voluntarily terminate its CMS-approved accreditation program to CMS by U.S. mail. We would also require the AO to send the required notice to all of its accredited home infusion therapy suppliers by U.S. mail. We estimate that it would take approximately 60 minutes for the AO staff person to prepare the letter to CMS in which the AO notified CMS that the AO wishes to voluntarily terminate its CMS-approved home infusion therapy accreditation program, print the letter and mail it.
We further estimate that it would take the AO staff person another 4 hours to perform the following tasks: (1) Draft a letter its accredited home infusion therapy suppliers, giving notice that the AO is voluntarily terminating its CMS approved home infusion therapy accreditation program; (2) perform a mail merge to prepare a copy of the letter addressed to each accredited home infusion therapy supplier; (3) print out a letter to each accredited supplier and envelope; put the letters into the envelopes; (4) affix the correct amount of postage; and (5) put the envelopes in the outgoing mail. We believe that the person at the AO who would perform these tasks would most likely be a clinician such as a registered nurse. According to the U.S. Bureau of Labor Statistics, the mean hourly wage for a registered nurse is $35.36 (
The home infusion therapy AO would also incur a cost burden for the wages of the staff person for the time spent preparing and mailing the required notices to be sent to the AO's accredited home infusion therapy suppliers. As stated previously, we estimate that it would take approximately 4 hours of time for an AO staff person to prepare the required notification letter to the AOs accredited providers, print out a copy of the letter for each accredited home infusion therapy supplier and put these letters into the mail. We believe that the person at the AO who would perform these tasks would most likely be a clinician such as a registered nurse. According to the U.S. Bureau of Labor Statistics, the mean hourly wage for a registered nurse is $35.36 (
The home infusion therapy AO would incur an additional burden for miscellaneous costs associated with the preparation of the required notices to be sent to CMS and the AOs accredited home infusion therapy suppliers, including the cost of the paper on which the notices are printed, the printer ink used, the cost of the envelopes used, and the postage required to mail all of the notices. We are unable to accurately estimate these costs as they are dependent on the number of notices that would need to be sent. However we believe these costs would not exceed $200. We seek comment on how to estimate this burden.
It is important to note that we have not calculated the burden associated with the tasks required of the home infusion therapy AO under § 488.1045 across all of the potential home infusion therapy AOs. We have not done so because the need for a home infusion therapy AO to perform these tasks only arise if a home infusion therapy AO voluntarily decides to terminate its CMS approved home infusion therapy accreditation program. This would occur rarely, if ever.
Section 488.1045(b) states that once CMS publishes a notice in the
The time burden associated with § 488.1045(b) would be the time it takes for the home infusion therapy AO to prepare and send the required written notification to all accredited home infusion therapy suppliers which states that CMS is withdrawing the AOs approval of the home infusion therapy accreditation program and which also states the implications for the home infusion therapy suppliers payment status. We estimate that it would take no more than 4 hours for an AO staff person to perform the following tasks: (1) Draft the required notification letter; (2) perform a mail merge to prepare a copy of the letter that is addressed to each home infusion therapy supplier accredited by the AO; (3) print copies of the notification letters for each of the AOs accredited home infusion therapy suppliers; (4) put each notifications letter into an envelope; (5) affix the correct amount of postage to the envelope and (6) put the envelopes into the outgoing mail.
The home infusion therapy AO would incur a cost burden for the wages for the AO staff who performs the previously stated tasks. We believe that the person at the AO who would perform these tasks would most likely be a clinician such as a registered nurse. According to the U.S. Bureau of Labor Statistics, the mean hourly wage for a registered nurse is $35.36 (
The home infusion therapy AO would incur an additional burden for miscellaneous costs associated with the preparation of the required notices to be sent to the AOs accredited home infusion therapy suppliers, including the cost of the paper on which the notices are printed, the printer ink used, the cost of the envelopes used, and the postage required to mail all of the notices. We believe that these costs would not exceed $200.
It is important to note that we have not calculated the burden associated with the tasks required of the home infusion therapy AO under § 488.1045 across all of the potential home infusion therapy AOs. We have not done so because the need for a home infusion therapy AO to perform these tasks required by § 488.1045(b) would only arise if CMS decides to involuntarily terminate the CMS approval of the AO's home infusion therapy accreditation program. This would occur rarely, if ever.
Section 488.1045(c)(3) would require that for both voluntary and involuntary terminations of a home infusion therapy AOs CMS approved home infusion therapy accreditation program, the home infusion therapy AO must provide a second written notification to all of its accredited home infusion therapy suppliers ten calendar days prior to the AO's accreditation program termination effective date. We estimate that the time and cost burdens associated with this requirement would be the same as our estimated burden for proposed § 488.1045(b) set forth previously.
Section 488.1045(d) sets forth the required steps that a home infusion therapy AO must take when one of its accredited home infusion therapy suppliers has requested a voluntary withdrawal from accreditation. The withdrawal from accreditation by the home infusion therapy supplier may not become effective until the AO completes all of the following 3 steps: (1) The home infusion therapy AO must contact the home infusion therapy supplier to seek written confirmation that the home infusion therapy supplier intends to voluntarily withdraw from the home infusion therapy accreditation program; (2) the home infusion therapy AO must advise the home infusion therapy supplier, in writing, of the statutory requirement for accreditation for all home infusion therapy suppliers and the possible payment consequences for a lapse in accreditation status; (3) the home infusion therapy AO must submit their final notice of the voluntary withdrawal of accreditation by the home infusion therapy supplier to CMS by no later than 5 business days after the request for voluntary withdrawal is ultimately processed and effective.
The burden associated with the requirement that the home infusion therapy AO contact the home infusion therapy supplier to seek written confirmation that the home infusion therapy supplier intends to voluntarily withdraw from the home infusion therapy accreditation program would include the time required for the AO to contact the home infusion therapy supplier to request written confirmation that the home infusion therapy supplier does indeed want to terminate their home infusion therapy accreditation. We estimate that the AO would most likely contact the home infusion therapy supplier to make this request by telephone or email. We estimate this would take no more than 15 minutes.
The AO would incur a cost burden for the wages of the AO staff person for the time spent contacting the home infusion therapy supplier to confirm they intend to voluntarily withdraw from the home infusion therapy accreditation program. We believe that the person at the AO who would perform this task would most likely be a clinician such as a registered nurse. According to the U.S. Bureau of Labor Statistics, the mean hourly wage for a registered nurse is $35.36 (
The home infusion therapy AO would also incur a time burden associated with the requirement that they send a written notice to the home infusion therapy supplier that is voluntarily terminating their home infusion therapy accreditation, which provides notice of the statutory requirement for accreditation for all home infusion therapy suppliers and the possible payment consequences for a lapse in accreditation status. We estimate that it would take the home infusion therapy no more than 60 minutes to prepare the written notification.
We believe that the person at the AO who would prepare the required written notice to be sent to the home infusion therapy supplier that is voluntarily terminating its home infusion therapy accreditation would most likely be a clinician such as a registered nurse. According to the U.S. Bureau of Labor Statistics, the mean hourly wage for a registered nurse is $35.36 (
Finally, we estimate the burden associated with § 488.1045(d)(3) would include the time required for the home infusion therapy AO staff to prepare a final notice of voluntary withdrawal of accreditation by the home infusion therapy supplier and the time required to send this notice to CMS. We estimate that it would only take the AO staff 15 minutes or less to prepare the required notice for CMS, because this notice could be sent to CMS by email. We estimate it would take an additional 10 minutes of time for the AO staff to prepare the email and attach the written notice to the email.
The AO would incur a cost burden for the wages of the AO staff for the time spent preparing the notice and sending it to CMS. We believe that the person at the AO who would prepare the required written notice to be sent to CMS would most likely be a clinician such as a registered nurse. According to the U.S. Bureau of Labor Statistics, the mean hourly wage for a registered nurse is $35.36 (
It is important to note that we have not calculated the burden associated with the tasks required of the home infusion therapy AO under § 488.1045(d) across all of the potential home infusion therapy AOs. We have not done so because the need for a home infusion therapy AO to perform these tasks would only arise if a home infusion therapy supplier would decide to voluntarily terminate its accreditation with the home infusion therapy AO. This would occur on an infrequent basis. We do not believe that there would ever be a situation in which all 6 of the potential home infusion therapy AOs would have a home infusion therapy supplier decide to voluntarily terminate the accreditation with their home infusion therapy AOs simultaneously.
Section 488.1050(a) would provide that a home infusion therapy AO that is dissatisfied with a determination, made by CMS, that its home infusion therapy accreditation requirements do not provide or do not continue to provide reasonable assurance that the suppliers accredited by the home infusion therapy AO meet the applicable quality standards is entitled to reconsideration.
Section 488.1050(b)(1) would require that a written request for reconsideration be filed within 30 calendar days of the receipt of CMS' notice of an adverse determination or non-renewal. Section 488.1050(b)(2) would provide that the written request for reconsideration must specify the findings or issues with which the home infusion therapy AO disagrees and the reasons for the disagreement. Section 488.1050(c)(1) provides the opportunity for a hearing to be conducted by a hearing officer appointed by the Administrator of CMS and § 488.1050(c)(2) provides that written notice of the time and place of the hearing will be provided at least 10 business days before the scheduled date.
We estimate that it would take approximately 2 hours for a home infusion therapy AO to prepare its request for reconsideration. We believe that the person at the AO who would prepare the request for reconsideration would most likely be a clinician such as a registered nurse. According to the U.S. Bureau of Labor Statistics, the mean hourly wage for a registered nurse is $35.36 (
The remaining information that would be submitted in connection with a request for reconsideration or a reconsideration hearing, including any evidence or testimony provided is not considered “information” in accordance with 5 CFR 1320.3(h)(8), which excludes as “information” any “facts or opinions obtained or solicited at or in connection with public hearings.”
It is important to note that we have not calculated the burden associated with the tasks required of the home infusion therapy AO under § 488.1050 across all of the potential home infusion therapy AOs. We have not done so because we believe that the filing of a request for reconsideration by a home infusion therapy AO would occur rarely, if ever. Further, we do not believe that there would ever be a situation in which all 6 of the potential home infusion therapy AOs would decide to file a request for reconsideration at the same time. Therefore, there would never be an occurrence where all the home infusion therapy AOs would incur the previously stated burden simultaneously.
The home infusion therapy AO would incur time and cost associated the accreditation of home infusion therapy suppliers. These would include the time and costs required to perform an onsite survey, offsite survey or other type of survey activity for each home infusion therapy supplier that has hired that AO to provide accreditation. However, as we have not approved any home infusion therapy AOs, we do not yet know what type of home infusion therapy accreditation standards they will use, or what the home infusion therapy accreditation survey process will consist of. Therefore, we are unable to accurately estimate the time and cost burden associated with the survey of home infusion therapy suppliers.
However, we can state that if the home infusion therapy AO were to perform an onsite survey, it would incur wages for each of the surveyors that are sent to perform the survey for the amount of time spent performing the survey. The AO would also incur wages for the time spent by the surveyors or other home infusion therapy AO staff in reviewing the survey documents, making a decision about whether to grant accreditation to the home infusion therapy supplier that was surveyed and preparing the decision letter to the home infusion therapy supplier. The AO would also incur travel costs for the AO staff to travel to the home infusion therapy supplier's location to perform the survey.
If the home infusion therapy AO were to do an offsite records audit survey, the AO would request that the home infusion therapy supply the AO with specific records. The AO would incur costs for the wages of the AO staff that performed the audit of the documents provided by the home infusion therapy supplier. The AO would also incur wages for the time spent by the surveyors or other home infusion therapy AO staff in making a decision about whether to grant accreditation to the home infusion therapy supplier that was audited and preparing the decision letter to the home infusion therapy supplier.
We solicited comment on how to estimate this burden and receive none.
All existing home infusion therapy suppliers are already accredited by existing home infusion therapy AOs to meet requirements established by private insurers and Medicare Advantage plans. We that, in order for the existing home infusion therapy suppliers accredited by these AOs to continue to receive payment for the home infusion therapy services provided, these AOs must obtain Medicare approval for a home infusion therapy accreditation program. To obtain this CMS approval, we that these AOs would be required to submit an application to CMS seeking approval of a home infusion therapy accreditation program that meets the requirements set forth in the new home infusion therapy AO approval and oversight regulations and new home infusion therapy health and safety regulations. We would also require that the home infusion therapy program submitted by these AOs be separate and distinct from the AOs home health deeming accreditation program.
It is likely that the home infusion therapy suppliers would need to be resurveyed after their home infusion therapy AO obtains CMS approval of a home infusion therapy accreditation program, under section 1861(iii)(3)(D)(i)(III) of the Act. We believe this resurvey would be necessary because the AOs would have to determine if the home infusion therapy suppliers they accredit meet their new Medicare-approved home infusion therapy accreditation program accreditation standards. However, if a current home infusion therapy AOs current home infusion therapy standards already meet or exceed the home infusion therapy health and safety standards, so that a revision of that AOs home infusion therapy accreditation standards is not required, then a resurvey of that AO's accredited home infusion therapy suppliers may not be necessary.
The home infusion therapy supplier would incur some time burden in order to come into compliance with the home infusion therapy AOs new home infusion therapy accreditation program requirements initially and thus prepare for the accreditation survey. However, all existing home infusion therapy suppliers are already accredited by existing home infusion therapy AOs to meet requirements established by private insurers and Medicare Advantage plans. Therefore, we assume that there would be little, is any new burden imposed on home infusion therapy suppliers in order to implement the new health and safety standards.
The home infusion therapy supplier would be charged a fee by the AO for providing accreditation services. Fees for the home infusion therapy
We recognize that cost and time burdens associated with becoming accredited may be a barrier for small suppliers such as home infusion therapy suppliers. We are implementing the following to minimize the burden of accreditation on suppliers, including small businesses:
• Multiple accreditation organizations—We expect that more than one AO would submit an application to become a designated Home Infusion Therapy AO. We believe that selection of more than one home infusion therapy AO would introduce competition resulting in reductions in accreditation costs.
• Required plan for small businesses—During the application process we would require prospective home infusion therapy AOs to include a plan that details their methodology to reduce accreditation fees and burden for small or specialty suppliers. This would need to include that the AO's fees are based on the size of the organization.
• Reasonable quality standards—The quality standards that would be used to evaluate the services rendered by each home infusion therapy supplier are being in this rule. Many home infusion therapy suppliers already comply with the standards and have incorporated these practices into their daily operations. It is our belief that compliance with the quality standards would result in more efficient and effective business practices and would assist suppliers in reducing overall costs.
There are at least two important sources of uncertainty in estimating the impact of accreditation on home infusion therapy suppliers. First, our estimates assume that all home infusion therapy suppliers with positive Medicare payments would seek accreditation. We assume that home infusion therapy suppliers who currently receive no Medicare allowed charges would choose not to seek accreditation. It is also possible that many of the home infusion therapy suppliers with allowed charges between $1 and $1,000 may decide not to incur the costs of accreditation.
Second, it is difficult to predict what accreditation fees would be in the future. Our experience with other accreditation programs has lead us to believe that the accreditation rates would go up, due to factors such as wage increases, and increased travel costs. To monitor accreditation fees, we proposed to require the AOs for home infusion therapy suppliers to submit their fees to CMS for review for reasonableness. We would require home infusion therapy AOs to notify CMS anytime there is an increase in accreditation fees.
We proposed to modify the AO approval and oversight regulations for Medicare-certified providers and suppliers by adding two new requirements. The first new requirement would have been to add to 42 CFR 488.5(a)(7) a requirement that in their application for CMS approval, the AOs that accredited Medicare-certified providers and suppliers include a statement acknowledging that all accrediting organization surveyors have completed or will complete the relevant program-specific CMS online trainings established for state surveyors, initially, and thereafter. As stated previously, after consideration of the numerous comments we received in response to this proposal, we decided not to finalize this proposal. Therefore the burden estimates provided in the proposed rule regarding the proposed time and cost burden related to the requirement that AO surveyors take the CMS online surveyor training are no longer relevant.
The second requirement was to add § 488.5(a)(18)(iii) to would require that the AOs for Medicare-certified providers and suppliers include a written statement in their application for CMS approval agreeing that if a fully accredited and deemed facility in good standing provides written notification that they wish to voluntarily withdraw from the accrediting organization's CMS-approved accreditation program, the accrediting organization must continue the facility's current accreditation in full force and effect until the effective date of withdrawal identified by the facility or the expiration date of the term of accreditation, whichever comes first. As stated previously, we have made a decision to finalize this proposal without change or modifications.
A number of commenters expressed concern that the requirement that AO surveyors take the CMS online training would impose significant burden on the surveyors. Other commenters stated the belief that the AO training was adequate and that it was similar to the CMS online training, therefore the training requirement would be duplicative. Therefore, after consideration of the comments received, we have decided not to finalize the proposal to require AO surveyors to take the CMS online surveyor training.
We finalized that AOs approved in accordance with section 1865 of the Act, and regulated under part 488 subpart A, provide a written statement in their application in which they agree to continue a provider's or supplier's current accreditation in full force and effect until the effective date of withdrawal identified by the facility or the expiration date of the term of accreditation, whichever comes first.
Section 488.5(a)(18)(iii) would require the AOs for Medicare-certified providers and suppliers to include a written statement in their application for CMS approval of their accreditation program, agreeing that if a fully accredited and deemed facility in good standing provides written notification that they wish to voluntarily withdraw from the accrediting organization's CMS-approved accreditation program, the accrediting organization must continue the facility's current accreditation in full force and effect until the effective date of withdrawal identified by the facility or the expiration date of the term of accreditation, whichever comes first.
We believe that the AOs that accredit Medicare-certified providers and suppliers would incur limited burden associated with this requirement, because this regulation simply requires that the AOs to include a statement in their application stating that they agree to continue the facility's current accreditation in full force and effect until the effective date of withdrawal identified by the facility or the expiration date of the term of accreditation, whichever comes first, if a provider of supplier provides written notification that they wish to voluntarily withdraw from the accrediting organization's CMS-approved accreditation program. We believe that this written statement to be provided by the AO would consist of
We believe that a clinicians such as registered nurses would prepare the required statement to be included in the AOs application. According to the U.S. Bureau of Labor Statistics, the mean hourly wage for a registered nurse is $35.36 (
There are nine AOs that accredit Medicare-certified providers and suppliers. The cost across all AOs for the completion of this task would be $158.12 (($8.84 × 9 AOs = $79.56) + ($79.56 for fringe benefits and overhead)). However, AOs for Medicare-certified providers and suppliers are required to submit a renewal application only every 6 years. Therefore, the existing AOs would be required to submit the statement stating that they agree to continue the facility's current accreditation in full force and effect until the effective date of withdrawal identified by the facility or the expiration date of the term of accreditation, whichever comes first, if a provider of supplier provides written notification that they wish to voluntarily withdraw from the accrediting organization's CMS-approved accreditation program with their next renewal application which is submitted after the publication of the final rule. While we have calculated the cost for the performance of this task across all AOs that accredit Medicare-certified providers and suppliers, it is important to note that the existing AOs are scheduled to submit their renewal applications at varying dates and times over a period of several years. Therefore there will be no time period in which all of these AOs will incur these expenses simultaneously.
This rule finalizes updates for the CY 2019 HH PPS rates contained in the CY 2018 HH PPS final rule (82 FR 51676 through 51752). The impact analysis of this final rule with comment period presents the estimated expenditure effects of policy changes in this final rule with comment period. We use the latest data and best analysis available, but we do not make adjustments for future changes in such variables as number of visits or case-mix.
This analysis incorporates the latest estimates of growth in service use and payments under the Medicare HH benefit, based primarily on Medicare claims data from 2017. We note that certain events may combine to limit the scope or accuracy of our impact analysis, because such an analysis is future-oriented and, thus, susceptible to errors resulting from other changes in the impact time period assessed. Some examples of such possible events are newly-legislated general Medicare program funding changes made by the Congress, or changes specifically related to HHAs. In addition, changes to the Medicare program may continue to be made as a result of the Affordable Care Act, or new statutory provisions. Although these changes may not be specific to the HH PPS, the nature of the Medicare program is such that the changes may interact, and the complexity of the interaction of these changes could make it difficult to predict accurately the full scope of the impact upon HHAs.
Table 44 represents how HHA revenues are likely to be affected by the policy changes in this rule for CY 2019. For this analysis, we used an analytic file with linked CY 2017 OASIS assessments and HH claims data for dates of service that ended on or before December 31, 2017. The first column of Table 44 classifies HHAs according to a number of characteristics including provider type, geographic region, and urban and rural locations. The second column shows the number of facilities in the impact analysis. The third column shows the payment effects of the CY 2019 wage index and revised labor share. The fourth column shows the payment effects of the CY 2019 case-mix weights. The fifth column shows the effects of the new rural add-on payment provision in statute. The sixth column shows the effects of the revised FDL ratio used to calculate outlier payments, and the seventh column shows the effects of the CY 2019 home health payment update percentage.
The last column shows the combined effects of all the policies in this rule. Overall, it is projected that aggregate payments in CY 2019 would increase by 2.2 percent. As illustrated in Table 44, the combined effects of all of the changes vary by specific types of providers and by location. We note that some individual HHAs within the same group may experience different impacts on payments than others due to the distributional impact of the CY 2019 wage index, the extent to which HHAs had episodes in case-mix groups where the case-mix weight decreased for CY 2019 relative to CY 2018, the percentage of total HH PPS payments that were subject to the low-utilization payment adjustment (LUPA) or paid as outlier payments, and the degree of Medicare utilization.
Table 45 represents how HHA revenues are likely to be affected by the policy changes in this rule for CY 2020. For this analysis, we used an analytic file with linked CY 2017 OASIS assessments and CY 2017 HH claims data (as of March 2, 2018) for dates of service that ended on or before December 31, 2017. The first column of Table 45 classifies HHAs according to a number of characteristics including provider type, geographic region, and urban and rural locations. The second column shows the number of HHAs in the impact analysis. The PDGM, as required by Section 51001(a)(2)(A) of the BBA of 2018, will be implemented in a budget neutral manner and the third column shows the total impact of the PDGM as outlined in section III.F of this final rule with comment period. As illustrated in Table 45, the effect of the PDGM varies by specific types of providers and location. We note that some individual HHAs within the same group may experience different impacts on payments than others. This is due to distributional differences among HHAs with regards to the percentage of total HH PPS payments that were subject to the low-utilization payment adjustment (LUPA) or paid as outlier payments, the degree of Medicare utilization, and the ratio of overall visits that were provided as therapy versus skilled nursing.
As outlined in section III.F of this final rule with comment period, several OASIS items would no longer be needed to case-mix adjust the 30-day payment under the PDGM; therefore, we would make 19 current OASIS items (48 data elements) optional at the follow-up (FU) time point starting January 1, 2020. As also discussed in section III.F. of this final rule with comment period, in order to calculate the case-mix adjusted payment amount for the PDGM, we would add the collection of two current OASIS items (10 data elements) at the FU time point starting January 1, 2020. Section X. of this final rule with comment period provides a detailed description of the net decrease in burden associated with these changes in conjunction with the changes in burden that result from OASIS item collection changes due to the removal of certain measures required under HH QRP, also effective for January 1, 2020 as outlined in section V.E. of this final rule with comment period. Due to the modifications to OASIS item collection as a result of the changes to the HH QRP and the changes to the HH PPS (PDGM), both effective on and after January 1, 2020, we estimate that this rule generates $60 million in annualized cost savings, or $46 million per year on an ongoing basis discounted at 7 percent relative to year 2016, over a perpetual time horizon beginning in CY 2020.
In response to the CY 2019 case-mix adjustment methodology refinements proposed in the CY 2018 HH PPS proposed rule (82 FR 35270), a few commenters requested that CMS include more information in the impact table for the PDGM, specifically how payments are impacted for patients with selected clinical conditions as was included in the Technical Report which is available at:
Table 47 displays our analysis of the distribution for possible payment adjustments at the maximum 7-percent and 8-percent rates that will be used in Years 4 and 5 of the Model. These analyses use performance year data from 2016, the first year of HHVBP, the most recent year for which complete performance year data are available. The estimated impacts are for the following finalized changes, each of which will take effect beginning with PY4 (2019):
• Remove two OASIS-based measures (Influenza Immunization Received for Current Flu Season and Pneumococcal Polysaccharide Vaccine Ever Received);
• Replace three OASIS-based measures (Improvement in Bathing, Improvement in Bed Transferring, and Improvement in Ambulation-Locomotion) with two composite measures (Total Change in Self Care, Total Change in Mobility);
• Reduce the maximum possible improvement points from 10 to 9 (13.5 for the two composite measures); and,
• Change the weights given to the performance measures used in the Model so that the OASIS and claims-based measures each count for 35 percent and the HHCAHPS measures count for 30 percent of the 90 percent of the Total Performance Score (TPS) that is based on performance on the Clinical Quality of Care, Care Coordination and Efficiency, and Person and Caregiver-Centered Experience measures. Data reporting for each New Measure will continue to have equal weight and account for the 10 percent of the TPS that is based on the New Measures collected as part of the Model. The weight of the unplanned hospitalization measure will also be increased so that it has three times the weight of the ED use without hospitalization measure.
We analyzed the payment adjustment percentage and the number of eligible HHAs under current policy to determine the impacts of the changes finalized in this rule. We used PY1 (CY2016) data to measure the impacts. The data sources for these analyses are data from the QIES system for the existing OASIS and claims-based measures, OASIS assessments for the two composite measures, HHCAHPS data received from the HHCAHPS contractor, and New Measure data submitted by Model participants. HHAs are classified as being in the smaller or larger volume cohort using the 2016 Quality Episode File, which is created using OASIS assessments. We note that this impact analysis is based on the aggregate value across all nine Model states.
Table 48 displays our analysis of the estimated impact of the policies finalized in this rule on the number of eligible HHAs and the distribution of percentage change in payment adjustment percentage based on the same PY1 (CY2016) data used to calculate Table 47. We note that this impact analysis is based on the aggregate value across all nine Model
This analysis reflects only HHAs that would have data for at least five measures that meet the requirements of § 484.305 and would be included in the Linear Exchange Function and would have a payment adjustment calculated. Value-based incentive payment adjustments for the estimated eligible 1,579 HHAs in the selected states that would compete in the HHVBP Model are stratified by size as described in section IV.B. of the CY 2017 HH PPS final rule. As finalized in section IV.B. of the CY 2017 final rule, there must be a minimum of eight HHAs in any cohort.
Those HHAs that are in states that do not have at least eight smaller-volume HHAs will not have a separate smaller-volume cohort and thus there will only be one cohort that will include all the HHAs in that state. As indicated in Table 48, Maryland, North Carolina, Tennessee, Washington, and Arizona would have only one cohort while Florida, Iowa, Massachusetts, and Nebraska would have both a smaller-volume cohort and a larger-volume cohort. For example, Iowa would have 17 HHAs eligible to be exempt from being required to have their beneficiaries' complete HHCAHPS surveys because they provide HHA services to less than 60 beneficiaries. Therefore, those 17 HHAs would be competing in Iowa's smaller-volume cohort for CY 2019 (PY4) under the Model.
Table 48 shows the distribution of percentage change in payment adjustment percentage resulting from the policies finalized in this rule. Using 2016 data and the maximum payment adjustment for performance year 4 of 7 percent (as applied in CY 2021), based on the six finalized OASIS quality measures and two claims-based measures in QIES, the five HHCAHPS measures, and the three New Measures, we see that, across all nine states, 31 HHAs would no longer be eligible for a payment adjustment for PY4 because they would not have data on at least five measures that meet the requirements of § 484.305. The distribution of scores by percentile shows the distribution of the change in percent payment adjustment. For example, the distribution for HHAs in Florida in the smaller-volume cohort ranges from −2.5 percent at the 10th percentile to +2.9 percent at the 90th percentile. This means that, for 7 of the 77 HHAs in the smaller-volume cohort in Florida, the changes would decrease their payment adjustment percentage by −2.5 percent or more while, for another 7 HHAs these changes would increase their payment adjustment percentage by 2.9 percent or more. For half of the HHAs in Florida's smaller volume cohort, the impact of these changes on their payment adjustment percentage would be between −1.1 percent and +1.3 percent. These impact analyses suggest that, for most participating HHAs, the impacts of the changes would be modest.
Table 49 provides the payment adjustment distribution based on agency size, proportion of dually-eligible beneficiaries, average case mix (using the average case-mix for non-LUPA episodes), the proportion of the HHA's beneficiaries that reside in rural areas and HHA organizational status. HHAs with a higher proportion of dually-eligible beneficiaries and HHAs whose beneficiaries have higher acuity tend to have a more negative impact associated with the policies finalized in this rule based on the 50th percentile of the impact of the changes on payment adjustment percentage.
Table 50 shows the current and revised weights, as finalized in this rule, for individual performance measures by measure category and possible applicable measure category scenarios to demonstrate the weight of the individual measures when an HHA has scores on All Measures or if an HHA is missing all measures in a measure category. For example, for an HHA that has quality measure scores on All Measures in all the measure categories (OASIS-based, claims-based and HHCAHPS) under the current weighting method, the individual measures are weighted equally. The Finalized Weights columns show the revised weights for the individual performance measures based on the changes to the weighting methodology finalized in this final rule with comment period; specifically, to weight the measure categories so that the OASIS-based measure category and the claims-based measure category will each count for 35 percent and the HHCAHPS measure category will count for 30 percent of the 90 percent of the TPS that is based on performance of the Clinical Quality of Care, Care Coordination and Efficiency, and Person and Caregiver-Centered Experience measures. For example, for HHAs with scores on All Measures, the OASIS-based measures account for 35 percent, with equal weighting given to the Improvement in Oral Medications, Improvement in Dyspnea, Improvement in Pain, and Discharge to Community measures. The Composite Self-Care and Composite Mobility measures will be weighted 1.5 times more than the other OASIS-based measures so that the maximum score for the two composite measures is the same as for the three functional OASIS-based measures that they are replacing (Improvement in Ambulation, Bathing and Bed Transferring). Under the revised weights, the two claims-based measures, which will collectively account for 35 percent, will not be weighted equally. We are finalizing that the weight of the acute care hospitalization measure will be three times higher than that of the ED Use measure. Thus, its weight will be 26.25 percent while the weight of the ED Use measure will be 8.75 percent for an HHA that reported on all measures. The HHCAHPS measures will account for 30 percent and each measure will be weighted equally.
Table 50 also shows the number of HHAs that would have enough measures to receive a payment adjustment under each possible scoring scenario under both the current and revised weighting methodologies. Most of the HHAs that would no longer receive a payment adjustment with the changes finalized in this rule are those with no claims or HHCAHPS measures. With only OASIS measures, these HHAs are more impacted by the finalized policy to remove the two immunization measures and the finalized policy to replace three OASIS functional measures with the two composite measures. The number of HHAs without claims or HHCAHPS measures that would have enough OASIS-based measures to receive a payment adjustment would drop from 99 to 73 (a decrease of 26 HHAs), and the majority of these HHAs would be smaller HHAs (16 of the 26 HHAs).
Failure to submit data required under section 1895(b)(3)(B)(v) of the Act with respect to a calendar year will result in the reduction of the annual home health market basket percentage increase otherwise applicable to a HHA for that calendar year by 2 percentage points. In section V.G. of this final rule with comment period, we revised our regulations at § 484.250(a) to clarify that not all OASIS data described in § 484.55(b) and (d) are needed for purposes of complying with the requirements of the HH QRP. There are no changes in this final rule with comment period in our method for applying the 2 percentage point reduction to HHAs that fail to meet the HH QRP requirements. For the CY 2018 annual payment update determination, 1,311 of the 11,776 active Medicare-certified HHAs, or approximately 11.1 percent, did not receive the full annual percentage increase. Information is not available to determine the precise number of HHAs that would not meet the requirements to receive the full annual percentage increase for the CY 2019 payment determination.
In section V.E. of this final rule with comment period, we are removing seven measures from the HH QRP: Depression Assessment Conducted, Diabetic Foot Care and Patient/Caregiver Education Implemented during All Episodes of Care, Multifactor Fall Risk Assessment Conducted For All Patients Who Can Ambulate (NQF #0537), Pneumococcal Polysaccharide Vaccine Ever Received, Improvement in the Status of Surgical Wounds, Emergency Department Use without Hospital Readmission during the First 30 Days of HH (NQF #2505), and Rehospitalization during the First 30 Days of HH (NQF #2380). Their associated burden decreases are for CY 2020 because HHAs will no longer be required to submit data on these measures beginning CY 2020. As noted previously, section X. of this final rule with comment period provides a detailed description of the net decrease in burden associated with these changes in conjunction with the changes in burden that result from the implementation of the PDGM for CY 2020. Due to the modifications to OASIS item collection as a result of the changes to the HH QRP and the changes to the HH PPS (PDGM), both effective on and after January 1, 2020; we estimate that this rule generates $60 million in annualized cost savings, or $46 million per year on an ongoing basis discounted at 7 percent relative to year 2016, over a perpetual time horizon beginning in CY 2020.
The following analysis applies to the Temporary Transitional Payment for Home Infusion Therapy as set forth in section 1834(u)(7) of the Act, as added by section 50401 of the BBA of 2018 (Pub. L. 115-123), and accordingly, describes the impact for CY 2019 only. Table 51 represents the estimated increased Medicare costs of existing beneficiaries who are furnished DME and are currently using home infusion therapy services. We used CY 2017 data to identify beneficiaries with DME claims containing 1 of the 37 HCPCS codes identified in section 1834(u)(7)(C) of the Act, which are shown in column 2. In column 3, 2017 claims were again used to determine the total weeks of care, which is the sum of weeks of care across all beneficiaries found in each category. Weeks of care for payment categories 1 and 3 are defined as the week of the last infusion drug or pump claim minus the week of the first infusion drug or pump claim plus one. For Category 2, we used the median number of weeks of care, 47, as many patients use immune globulin for the whole year. Column four assumes the initial week of care requires two nurse visits, and all subsequent weeks only require one visit, in order to estimate the total visits of care per category. In general, nursing visits for payment category 2, subcutaneous immune globulin (SCIG) administration, occur once per month; therefore, we assume the estimated number of visits for these patients is 12. The fifth column multiplies the volume of nurse visits across beneficiaries by the payment rate (using the 2018 Physician Fee Schedule amounts) in order to estimate the increased cost per each of the three infusion drug categories.
Table 52 displays the estimated regional impacts using the beneficiary enrollment address reported in the Medicare Master Beneficiary Summary File. Table 53 displays impacts based on rural or urban designations. All beneficiaries identified had at least one applicable home infusion claim (claims with 1 of the 37 drug codes listed in section 1834(u)(7)(C) of the Act) in CY 2017. Unknown beneficiaries were those without valid state and county
Section 1895(b)(3)(B) of the Act requires that the standard prospective payment amounts for CY 2019 be increased by a factor equal to the applicable HH market basket update for those HHAs that submit quality data as required by the Secretary. For CY 2019, Section 1895(b)(3)(B)(vi) of the Act requires that the market basket update under the HHA prospective payment system be adjusted by changes in economy-wide productivity. The 0.8 percentage point multifactor productivity adjustment to the CY 2019 home health market basket update of 3.0 percent, is discussed in the preamble of this final rule with comment period and is not discretionary as it is a requirement in section 1895(b)(3)(B)(vi)(I) of the Act.
We considered not rebasing the home health market basket. However, we believe that it is desirable to rebase the home health market basket periodically so that the cost category weights reflect changes in the mix of goods and services that HHAs purchase in furnishing home health care. In addition, we considered not implementing the revision to the labor-related share of 76.1 percent in a budget neutral manner. However, we believe it is more prudent to implement the revision to the labor-related share in a manner that does not increase or decrease budgetary expenditures.
With regards to payments made under the HH PPS for high-cost outlier episodes of care (that is, episodes of care with unusual variations in the type or amount of medically necessary care), we did not consider maintaining the current FDL ratio of 0.55. As discussed in section III.E.3. of this final rule with comment period, we revise the FDL ratio to 0.51. Simulations using CY 2017 claims data and the CY 2019 HH PPS payment rates resulted in an estimated 2.32 percent of total HH PPS payments being paid as outlier payments using the existing methodology for calculating the cost of an episode of care. The FDL ratio and the loss-sharing ratio must be selected so that the estimated outlier payments do not exceed the 2.5 percent of total HH PPS payments (as required by section 1895(b)(5)(A) of the Act). Therefore, lowering the FDL ratio results in 2.32% in outlier payments that rises closer to but does not exceed the 2.5% in total outlier payments. We did not consider proposing a change to the loss sharing ratio (0.80) in order for the HH PPS to remain consistent with payment for high-cost outliers in other Medicare payment systems (for example, IRF PPS, IPPS, etc.)
For CY 2020, we did not consider alternatives to changing the unit of payment from 60 days to 30 days, eliminating the use of therapy thresholds for the case-mix adjustment, and requiring the revised payments to be budget neutral. Section 51001 of the BBA of 2018 requires the change in the unit of payment from 60 days to 30 days to be made in a budget neutral manner and mandates the elimination of the use of therapy thresholds for case-mix adjustment purposes. The BBA of 2018 also requires these measures to be implemented on January 1, 2020 and that we make assumptions about behavior changes that could occur as a result of the implementation of the 30-day unit of payment and as a result of the case-mix adjustment factors that are implemented in CY 2020 in calculating a 30-day payment amount for CY 2020 in a budget neutral manner.
Alternatives to making 19 current OASIS items (48 data elements) optional at the FU time point as outlined in section X. of this final rule with comment period, would be to either not implement the case-mix adjustment methodology changes under the PDGM or to continue collecting the 19 current OASIS items at the FU time point, even though they would not be used to case-mix adjust payments under the PDGM. Similarly, an alternative to adding collection of two current OASIS items (10 data elements) at the FU time point as discussed in section X. of this final rule with comment period would be to either not adopt the PDGM or not to include the two current OASIS items (M1800 and M1033) as part of the case-mix adjustment methodology under the PDGM. As noted previously, we did not consider not implementing the case-mix methodology changes under the PDGM as a new case-mix adjustment methodology is required to be implemented in accordance with section 51001 of the BBA of 2018, which mandates the elimination of the use of therapy thresholds for case-mix adjustment purposes by January 1, 2020. We believe that continuing to require HHAs to report responses for the 19 current OASIS items at the FU time point that are no longer needed for case-mix adjustment purposes under the PDGM results in unnecessary burden for HHAs. While requiring HHAs to report responses for two current OASIS items at the FU time point results in a small increase in burden if CMS were to not make 19 current OASIS items optional at the FU time point, those two OASIS items (M1800 and M1033) are correlated with increases in resource use and are used to determine the patient's functional impairment level under the HHGM, thus they are important for case-mix adjustment purposes in order to ensure accurate payments to HHAs under the PDGM.
We considered whether to continue using the wage-weighted minutes of care (WWMC) approach to estimate resource use under the PDGM, as described in section III.F.2. of this final rule with comment period. Although the relationship in relative costs between the WWMC approach and the cost-per-minute plus non-routine supplies (CPM+NRS) approach is very similar (correlation coefficient equal to 0.8512), the WWMC approach does not as evenly weight skilled nursing costs relative to therapy costs as evidenced in the cost report data and would require us to maintain a separate case-mix adjustment mechanism for NRS. If we were to maintain the current WWMC approach, skilled nursing and therapy costs would not be as evenly weighted and a certain level of complexity in calculating payments under the HH PPS would persist as we would need to continue with the current method of case-mix adjusting NRS payments separate from service costs (that is, skilled nursing, physical therapy, occupational therapy, speech-language pathology, home health aide, and medical social services) under the HH PPS.
In this final rule with comment period and to begin in CY 2020, we considered proposing a phase-out of the split percentage payment approach by reducing the percentage of the upfront payment over a period of time and requiring a notice of admission (NOA) to be submitted upon full elimination of the split-percentage payment. However, we wanted to take the opportunity in this year's rule to more clearly signal our intent to potentially eliminate the split percentage payment approach over time as a reduced timeframe for the unit of payment (30 days rather than 60 days) is now required in statute. Given that existing HHAs (certified with effective dates prior to January 1, 2019) would need to adapt to changes in cash flow with the elimination of the split percentage payment approach, we hope to receive additional feedback on the timeframes for a phase-out of the split percentage payment approach and whether there is a need for an NOA upon completion of a phase-out of the split percentage payment approach that we can take into consideration for potential future rulemaking.
We considered various alternatives to our proposals for the HHVBP Model. For the vaccination measures, we considered continuing to include them in the applicable measure set instead of removing them. However, for the reasons discussed in section IV of this final rule with comment period, we are finalizing our proposal to remove the two vaccination measures beginning with PY4.
With regard to our proposal to replace three OASIS-based measures with two composite measures, we also considered making no changes to the OASIS-based measures category.
Another alternative to this proposal would be to finalize one but not both composite measures. We discussed in the proposed rule the proposed scoring that would apply if we adopted this alternative. However, for the reasons discussed in section IV.B of this final rule with comment period, we are finalizing the replacement of the three OASIS-based measures with the two new composite measures.
An alternative to rescoring the maximum improvement points from 10 points to 9 points would be to keep the current scoring methodology. However, for the reasons discussed in section IV.B in this final rule with comment period, we are finalizing our proposal to rescore the maximum improvement points from 10 points to 9 points (or 13.5 points for the composite measures).
An alternative to reweighting the OASIS-based, claims-based and HHCAHPS measure categories would be to keep the current equally weighted methodology. For the reasons discussed in section IV.B of this final rule with comment period, we are finalizing reweighting of the OASIS-based measure category to 35 percent, the claims-based measure category to 35 percent and the HHCAHPS measure category to 30 percent in order to encourage increased focus on the claims-based measures.
An alternative to removing seven measures from the HH QRP (Depression Assessment Conducted, Diabetic Foot Care and Patient/Caregiver Education Implemented during All Episodes of Care, Multifactor Fall Risk Assessment Conducted For All Patients Who Can Ambulate (NQF #0537), Pneumococcal Polysaccharide Vaccine Ever Received, Improvement in the Status of Surgical Wounds, Emergency Department Use without Hospital Readmission during the First 30 Days of HH (NQF #2505), Rehospitalization during the First 30 Days of HH (NQF #2380)), as discussed in section V.E. of this final rule with comment period, would have been to retain these measures in the HH QRP.
We considered establishing additional health and safety requirements related to patient assessment, infection control and quality improvement. However, according to the home infusion therapy supplier industry, and our research, we believe there are already some AOs that include requirements related to patient assessment, quality improvement, and infection control. To the extent that we subsequently determine that federal standards are necessary, we will propose them in subsequent notice and comment rulemaking.
We did not consider alternatives to implementing the home infusion therapy benefit for CY 2019 and 2020 because section 1834(u)(7) of the Act requires the Secretary to provide a temporary transitional payment to eligible home infusion therapy suppliers for items and services associated with the furnishing of transitional home infusion drugs.
AOs that accredit home infusion therapy suppliers must become accredited by an AO designated by the Secretary. In these options, we have attempted to minimize the burden of accreditation on home infusion therapy suppliers, which include approving home infusion therapy AOs that consider the unique needs of small home infusion therapy suppliers. Also, it is likely that the surveys of home infusion therapy suppliers would be performed as a desk review instead of an onsite survey. Doing a desk audit survey would prevent the travel time and cost that is required when the AO has to send a survey team to the home infusion therapy supplier's location to perform an onsite survey.
As required by OMB Circular A-4 (available at
Executive Order 13771, entitled “Reducing Regulation and Controlling Regulatory Costs,” was issued on January 30, 2017 and requires that the costs associated with significant new regulations “shall, to the extent permitted by law, be offset by the elimination of existing costs associated with at least two prior regulations.” Details on the estimated costs of this final rule with comment period, including limitations on the ability thus far to quantify some categories of impacts, can be found in the rule's economic analysis. This final rule with comment period is considered an E.O. 13771 deregulatory action. Details on the estimated cost savings of this final rule with comment period can be found in the rule's PRA and economic analysis. Due to the modifications to OASIS item collection as a result of the changes to the HH QRP and the changes to the HH PPS (PDGM), both effective on and after January 1, 2020, we estimate that this rule generates $60 million in annualized cost savings, or $46 million per year on an ongoing basis discounted at 7 percent relative to year 2016, over a perpetual time horizon beginning in CY 2020.
In conclusion, we estimate that the net impact of the HH PPS policies in this rule is an increase of 2.2 percent, or $420 million, in Medicare payments to HHAs for CY 2019. The $420 million increase reflects the effects of the CY 2019 home health payment update of 2.2 percent ($420 million increase), a 0.1 percent increase in payments due to decreasing the FDL ratio in order to target to pay no more than 2.5 percent of total payments as outlier payments ($20 million increase), and a −0.1 percent decrease in CY 2019 payments due to the new rural add-on policy mandated by the BBA of 2018 ($20 million decrease).
In conclusion, we estimate that Medicare payments to HHAs for CY 2020 will remain the same compared to CY 2019 as a result of the implementation of the PDGM. Section 51001(a) of the BBA of 2018 requires the Secretary to implement the 30-day unit of payment in a budget-neutral manner.
In conclusion, we estimate that the changes to OASIS item collection as a result of the changes to the HH QRP and the changes to the HH PPS (PDGM), both effective on and after January 1, 2020, would result in a net $60 million in annualized cost savings, discounted at 7 percent relative to year 2016, over
In conclusion, due to the modifications to OASIS item collection as a result of the changes to the HH QRP and the changes to the HH PPS (PDGM), both effective on and after January 1, 2020, we estimate that this rule generates $60 million in annualized cost savings, or $46 million per year on an ongoing basis discounted at 7 percent relative to year 2016, over a perpetual time horizon beginning in CY 2020.
In summary, the health and safety standards would not have any economic impact on home infusion therapy suppliers or accreditation organizations.
In conclusion, we estimate that the net impact of the temporary transitional payment to eligible home infusion suppliers for items and services associated with the furnishing of transitional home infusion drugs would result in approximately $48 million in additional Medicare payments to home infusion suppliers in CY 2019.
In summary, AOs that accredit HIT suppliers must become accredited by an AO designated by the Secretary. In these options, we have attempted to minimize the burden of accreditation on HIT suppliers, which include approving AOs that consider the unique needs of small HIT suppliers. Also, it is likely that the surveys of HIT suppliers will be performed as a desk review instead of an onsite survey. Doing a desk audit survey would prevent the travel time and cost that is required when the AO has to send a survey team to the HIT supplier's location to perform an onsite survey.
This analysis, together with the remainder of this preamble, provides an initial Regulatory Flexibility Analysis.
In accordance with the provisions of Executive Order 12866, this finalized rule was reviewed by the Office of Management and Budget.
Health facilities, Medicare.
Emergency medical services, Health facilities, Health professions, Medicare, Reporting and recordkeeping requirements.
Health facilities, Health professions, Medicare, Reporting and recordkeeping requirements.
Grant programs-health, Health facilities, Medicare, Reporting and recordkeeping requirements, X-rays.
Administrative practice and procedure, Health facilities, Medicare, Reporting and recordkeeping requirements.
For the reasons set forth in the preamble, the Centers for Medicare & Medicaid Services amends 42 CFR chapter IV as set forth below:
42 U.S.C. 1302 and 1395hh.
(e)
42 U.S.C. 1302 and 1395hh.
(b) * * *
(2)
(i) Need for occupational therapy may be the basis for continuing services that were initiated because the individual needed skilled nursing care or physical therapy or speech therapy.
(ii) If a patient's underlying condition or complication requires a registered nurse to ensure that essential non-skilled care is achieving its purpose, and necessitates a registered nurse be involved in the development, management, and evaluation of a patient's care plan, the physician must include a brief narrative describing the clinical justification of this need. If the narrative—
(A) Is part of the recertification form, then the narrative must be located immediately prior to the physician's signature.
(B) Exists as an addendum to the recertification form, in addition to the physician's signature on the recertification form, the physician must sign immediately following the narrative in the addendum.
(c)
(i) The documentation from the HHA can be corroborated by other medical record entries in the certifying physician's medical record for the patient or the acute/post-acute care facility's medical record for the patient or both, thereby creating a clinically consistent picture that the patient is eligible for Medicare home health services.
(ii)(A) The certifying physician signs and dates the HHA documentation demonstrating that the documentation from the HHA was considered when certifying patient eligibility for Medicare home health services.
(B) HHA documentation can include, but is not limited to, the patient's plan of care required under § 409.43 of this chapter, or the initial or comprehensive assessment of the patient required under § 484.55 of this chapter.
(2) The documentation must be provided upon request to review entities or CMS or both. If the documentation used as the basis for the certification of eligibility is not sufficient to demonstrate that the patient is or was eligible to receive services under the Medicare home health benefit, payment is not rendered for home health services provided.
42 U.S.C. 1302 and 1395hh unless otherwise indicated.
(a)
(b)
(2)
(c)
(d)
(1) A low-utilization payment adjustment (LUPA) of a predetermined per-visit rate as specified in § 484.230.
(2) A partial payment adjustment as specified in § 484.235.
(3) An outlier payment as specified in § 484.240.
(e)
(1) Beneficiary eligibility.
(2) Medical necessity determinations.
(3) Case-mix group assignment.
(f)
(g)
(1)
(B) The residual final payment for initial episodes is paid at 40 percent of the case-mix and wage-adjusted 60-day episode rate.
(ii)
(B) The residual final payment for subsequent episodes is paid at 50 percent of the case-mix and wage-adjusted 60-day episode rate.
(2)
(B) The residual final payment for initial 30-day periods is paid at 40 percent of the case-mix and wage-adjusted 30-day payment rate.
(ii)
(B) The residual final payment for subsequent 30-day periods is paid at 50 percent of the case-mix and wage-adjusted 30-day payment rate.
(iii)
(h)
(i) After the OASIS assessment required at § 484.55(b)(1) and (d) is complete, locked or export ready, or there is an agency-wide internal policy establishing the OASIS data is finalized for transmission to the national assessment system.
(ii) Once a physician's verbal orders for home care have been received and documented as required at §§ 484.60(b) and 409.43(d) of this chapter.
(iii) A plan of care has been established and sent to the physician as required at § 409.43(c) of this chapter.
(iv) The first service visit under that plan has been delivered.
(2) A RAP is based on the physician signature requirements in § 409.43(c) of this chapter and is not a Medicare claim for purposes of the Act (although it is a “claim” for purposes of Federal, civil, criminal, and administrative law enforcement authorities, including but not limited to the following:
(i) Civil Monetary Penalties Law (as defined in 42 U.S.C. 1320a-7a(i)(2)).
(ii) The Civil False Claims Act (as defined in 31 U.S.C. 3729(c)).
(iii) The Criminal False Claims Act (18 U.S.C. 287)).
(iv) The RAP is canceled and recovered unless the claim is submitted within the greater of 60 days from the end date of the appropriate unit of payment, as defined in paragraph (b) of this section, or 60 days from the issuance of the RAP.
(3) CMS has the authority to reduce, disprove, or cancel a RAP in situations when protecting Medicare program integrity warrants this action.
The revision and addition reads as follows:
(f) For periods beginning on or after January 1, 2020, a national, standardized prospective 30-day payment rate applies. The national, standardized prospective 30-day payment rate is an amount determined by the Secretary, as subsequently adjusted in accordance with § 484.225.
The revisions read as follows:
CMS adjusts the national, standardized prospective payment rates as referenced in § 484.215 to account for the following:
The revision and addition reads as follows:
(a) CMS annually updates the unadjusted national, standardized prospective payment rate on a calendar year basis (in accordance with section 1895(b)(1)(B) of the Act).
(d) For CY 2020, the national, standardized prospective 30-day payment amount is an amount determined by the Secretary. CMS annually updates this amount on a calendar year basis in accordance with paragraphs (a) through (c) of this section.
(a) For episodes beginning on or before December 31, 2019, an episode with four or fewer visits is paid the national per-visit amount by discipline determined in accordance with § 484.215(a) and updated annually by the applicable market basket for each visit type, in accordance with § 484.225.
(1) The national per-visit amount is adjusted by the appropriate wage index based on the site of service of the beneficiary.
(2) An amount is added to the low-utilization payment adjustments for low-utilization episodes that occur as the beneficiary's only episode or initial episode in a sequence of adjacent episodes.
(3) For purposes of the home health PPS, a sequence of adjacent episodes for a beneficiary is a series of claims with no more than 60 days without home care between the end of one episode, which is the 60th day (except for episodes that have been PEP-adjusted), and the beginning of the next episode.
(b) For periods beginning on or after January 1, 2020, an HHA receives a national 30-day payment of a predetermined rate for home health services, unless CMS determines at the end of the 30-day period that the HHA furnished minimal services to a patient during the 30-day period.
(1) For each payment group used to case-mix adjust the 30-day payment rate, the 10th percentile value of total visits during a 30-day period of care is used to create payment group specific thresholds with a minimum threshold of at least 2 visits for each case-mix group.
(2) A 30-day period with a total number of visits less than the threshold is paid the national per-visit amount by discipline determined in accordance with § 484.215(a) and updated annually by the applicable market basket for each visit type, in accordance with § 484.225.
(3) The national per-visit amount is adjusted by the appropriate wage index based on the site of service for the beneficiary.
(c) An amount is added to low-utilization payment adjustments for low-utilization periods that occur as the beneficiary's only 30-day period or initial 30-day period in a sequence of adjacent periods of care. For purposes of the home health PPS, a sequence of adjacent periods of care for a beneficiary is a series of claims with no more than 60 days without home care between the end of one period, which is the 30th day (except for episodes that have been partial payment adjusted), and the beginning of the next episode.
(a)
(2) The PEP adjustment does not apply in situations of transfers among HHAs of common ownership.
(i) Those situations are considered services provided under arrangement on behalf of the originating HHA by the receiving HHA with the common
(ii) The common ownership exception to the transfer PEP adjustment does not apply if the beneficiary moves to a different MSA or Non-MSA during the 60-day episode before the transfer to the receiving HHA.
(iii) The transferring HHA in situations of common ownership not only serves as a billing agent, but must also exercise professional responsibility over the arranged-for services in order for services provided under arrangements to be paid.
(3) If the intervening event warrants a new 60-day payment and a new physician certification and a new plan of care, the initial HHA receives a partial episode payment adjustment reflecting the length of time the patient remained under its care based on the first billable visit date through and including the last billable visit date. The PEP is calculated by determining the actual days served as a proportion of 60 multiplied by the initial 60-day payment amount.
(b)
(2) The partial payment adjustment does not apply in situations of transfers among HHAs of common ownership.
(i) Those situations are considered services provided under arrangement on behalf of the originating HHA by the receiving HHA with the common ownership interest for the balance of the 30-day period.
(ii) The common ownership exception to the transfer partial payment adjustment does not apply if the beneficiary moves to a different MSA or Non-MSA during the 30-day period before the transfer to the receiving HHA.
(iii) The transferring HHA in situations of common ownership not only serves as a billing agent, but must also exercise professional responsibility over the arranged-for services in order for services provided under arrangements to be paid.
(3) If the intervening event warrants a new 30-day payment and a new physician certification and a new plan of care, the initial HHA receives a partial payment adjustment reflecting the length of time the patient remained under its care based on the first billable visit date through and including the last billable visit date. The partial payment is calculated by determining the actual days served as a proportion of 30 multiplied by the initial 30-day payment amount.
(a) For episodes beginning on or before December 31, 2019, an HHA receives an outlier payment for an episode whose estimated costs exceeds a threshold amount for each case-mix group. The outlier threshold for each case-mix group is the episode payment amount for that group, or the PEP adjustment amount for the episode, plus a fixed dollar loss amount that is the same for all case-mix groups.
(b) For periods beginning on or after January 1, 2020, an HHA receives an outlier payment for a 30-day period whose estimated cost exceeds a threshold amount for each case-mix group. The outlier threshold for each case-mix group is the 30-day payment amount for that group, or the partial payment adjustment amount for the 30-day period, plus a fixed dollar loss amount that is the same for all case-mix groups.
(c) The outlier payment is a proportion of the amount of imputed cost beyond the threshold.
(d) CMS imputes the cost for each claim by multiplying the national per-15 minute unit amount of each discipline by the number of 15 minute units in the discipline and computing the total imputed cost for all disciplines.
(a) * * *
(1) Such OASIS data described at § 484.55(b) and (d) as is necessary for CMS to administer the payment rate methodologies described in §§ 484.215, 484.220, 484.230, 484.235, and 484.240; and such OASIS data described at § 484.55(b) and (d) as is necessary to meet the quality reporting requirements of section 1895(b)(3)(B)(v) of the Act.
(c)(1) For performance years 1 through 3, CMS will sum all points awarded for each applicable measure excluding the New Measures, weighted equally at the individual measure level to calculate a value worth 90 percent of the Total Performance Score.
(2) For performance years 4 and 5, CMS will sum all points awarded for each applicable measure within each category of measures (OASIS-based, claims-based and HHCAHPS) excluding the New Measures, weighted at 35 percent for the OASIS-based measure category, 35 percent for the claims-based measure category, and 30 percent for the HHCAHPS measure category when all three measure categories are reported, to calculate a value worth 90 percent of the Total Performance Score.
42 U.S.C. 1302 and 1395hh.
Section 1861(s)(2)(iii) of the Act requires the Secretary to establish the conditions that home infusion therapy suppliers must meet in order to participate in the Medicare program and which are considered necessary to ensure the health and safety of patients.
As used in §§ 486.520 and 486.525:
(1) Furnishes infusion therapy to individuals with acute or chronic conditions requiring administration of home infusion drugs.
(2) Ensures the safe and effective provision and administration of home infusion therapy on a 7-day-a-week, 24-hour-a-day basis.
(3) Is accredited by an organization designated by the Secretary in accordance with section 1834(u)(5) of the Act.
(4) Meets such other requirements as the Secretary determines appropriate.
The qualified home infusion therapy supplier ensures the following:
(a) All patients must be under the care of an applicable provider.
(b) All patients must have a plan of care established by a physician that prescribes the type, amount, and duration of the home infusion therapy services that are to be furnished.
(c) The plan of care for each patient must be periodically reviewed by the physician.
(a) The qualified home infusion therapy supplier must provide the following services on a 7-day-a-week, 24-hour-a-day basis in accordance with the plan of care:
(1) Professional services, including nursing services.
(2) Patient training and education not otherwise paid for as durable medical equipment as described in § 424.57(c)(12) of this chapter.
(3) Remote monitoring and monitoring services for the provision of home infusion therapy services and home infusion drugs.
(b) All home infusion therapy suppliers must provide home infusion therapy services in accordance with nationally recognized standards of practice, and in accordance with all applicable state and federal laws and regulations.
42 U.S.C 1302 and 1395hh.
The additions read as follows:
(a) * * *
(17) * * *
(iii) Include a written statement that if a fully accredited and deemed facility in good standing provides written notification that they wish to voluntarily withdraw from the accrediting organization's CMS-approved accreditation program, the accrediting organization must continue the facility's current accreditation in full force and effect until the effective date of withdrawal identified by the facility or the expiration date of the term of accreditation, whichever comes first.
(a)
(b)
(2) Section 1834(u)(5) of the Act require the Secretary to designate and approve independent organizations for the purposes of accrediting qualified home infusion therapy suppliers.
(c)
(1) Application and reapplication procedures for national accrediting organizations seeking approval or re-approval of authority to accredit qualified home infusion therapy suppliers.
(2) Ongoing CMS oversight processes for approved accrediting organizations that accredit qualified home infusion therapy suppliers.
(3) Appeal procedures for accrediting organizations that accredit qualified home infusion therapy suppliers.
As used in this subpart—
(1) Furnishes infusion therapy to individuals with acute or chronic conditions requiring administration of home infusion drugs.
(2) Ensures the safe and effective provision and administration of home infusion therapy on a 7-day-a-week, 24-hour-a-day basis.
(3) Is accredited by an organization designated by the Secretary in accordance with section 1834(u)(5) of the Act.
(4) Meets such other requirements as the Secretary determines appropriate.
(a)
(1) Documentation that demonstrates the organization meets the definition of a national accrediting organization under § 488.1005 as it relates to the accreditation program.
(2) The Medicare provider or supplier type for which the organization is requesting approval or reapproval.
(3) Documentation that demonstrates the home infusion therapy accrediting organization's ability to take into account the capacities of rural home infusion therapy suppliers (as required by section 1834(u)(5)(A)(ii) of the Act).
(4) Information that demonstrates the home infusion therapy accrediting organization's knowledge, expertise, and experience in home infusion therapy.
(5) A detailed crosswalk (in table format) that identifies, for each of the applicable Medicare requirements, the exact language of the organization's comparable accreditation requirements and standards.
(6) A detailed description of the home infusion therapy accrediting organization's survey processes to confirm that a home infusion therapy supplier's processes are comparable to those of Medicare. This description must include all of the following:
(i) The types and frequency of surveys performed, and a rationale for which accreditation requirements will be evaluated via onsite surveys and which will be evaluated via offsite audits, or other strategies for ensuring accredited home infusion therapy suppliers maintain adherence to the home infusion therapy accreditation program requirements, including an explanation of how the accrediting organization will maintain the schedule it proposes.
(ii) Copies of the home infusion therapy accrediting organizations survey and audit forms, guidelines, and instructions to surveyors.
(iii) Documentation demonstrating that the home infusion therapy accrediting organization's onsite survey or offsite audit reports identify, for each finding of non-compliance with accreditation standards, the comparable Medicare home infusion therapy accreditation requirements, as applicable.
(iv) A description of the home infusion therapy accrediting organization's accreditation survey review process.
(v) A description of the home infusion therapy accrediting organization's procedures and timelines for notifying a surveyed or audited home infusion therapy supplier of non-compliance with the home infusion therapy accreditation program's standards.
(vi) A description of the home infusion therapy accrediting organization's procedures and timelines for monitoring the home infusion therapy supplier's correction of identified non-compliance with the accreditation program's standards.
(vii) The ability of the home infusion therapy accrediting organization to conduct timely reviews of accreditation applications.
(viii) A statement acknowledging that, as a condition for CMS approval of a national accrediting organization's accreditation program, the home infusion therapy accrediting organization agrees to provide CMS with information extracted from each home infusion therapy accreditation onsite survey, offsite audit or other evaluation strategies as part of its data submissions required under paragraph (a)(19) of this section, and, upon request from CMS, a copy of the most recent accreditation onsite survey, offsite audit, or other evaluation strategy together with any other information related to the survey as CMS may require (including corrective action plans).
(ix) A statement acknowledging that the home infusion therapy accrediting organization will provide timely notification to CMS when an accreditation survey or complaint investigation identifies an immediate jeopardy as that term is defined at § 488.1005. Using the format specified by CMS, the home infusion therapy accrediting organization must notify CMS within 2 business days from the date the accrediting organization identifies the immediate jeopardy.
(7) Procedures to ensure that—
(i) Unannounced onsite surveys, as appropriate, will be conducted periodically, including procedures that protect against unannounced surveys becoming known to the provider or supplier in advance of the visit; or
(ii) Offsite survey audits are performed to evaluate the quality of services provided which may be followed up with periodic onsite visits.
(8) The criteria for determining the size and composition of the home infusion therapy accrediting organization's survey, audit and other evaluation strategy teams for individual supplier onsite surveys. The home infusion therapy accrediting organization's criteria should include, but not be limited to the following information:
(i) The expected number of individual home infusion therapy supplier locations to be surveyed using an onsite survey.
(ii) The number of home infusion therapy suppliers to be surveyed using off-site audits.
(iii) A description of other types of home infusion therapy accreditation review activities to be used.
(iv) The reasons for each type of survey (that is, initial accreditation survey, reaccreditation survey, and complaint survey).
(9) The overall adequacy of the number of the home infusion therapy accrediting organization's surveyors, auditors, and other staff available to perform survey related activities, including how the organization will increase the size of the survey, audit, and other evaluation staff to match growth in the number of accredited facilities or programs while maintaining re-accreditation intervals for existing accredited facilities or programs.
(10) Detailed information about the individuals who perform onsite surveys, offsite audits or other strategies for ensuring accredited home infusion therapy suppliers maintain adherence to the home infusion therapy accreditation program requirements, including all of the following information:
(i) The number and types of professional and technical staff available for conducting onsite surveys, offsite audits, or other strategies for ensuring accredited home infusion therapy suppliers maintain adherence to the home infusion therapy accreditation program requirements.
(ii) The education, employment, and experience requirements surveyors and auditors must meet.
(iii) The content and length of the orientation program.
(11) The content, frequency and types of in-service training provided to survey and audit personnel.
(12) The evaluation systems used to monitor the performance of individual surveyors, auditors and survey teams.
(13) The home infusion therapy accrediting organization's policies and procedures to avoid conflicts of interest, including the appearance of conflicts of interest, involving individuals who conduct surveys, audits or participate in accreditation decisions.
(14) The policies and procedures used when a home infusion therapy supplier has a dispute regarding survey or audit findings, or an adverse decision.
(15) Procedures for the home infusion therapy supplier to use to notify the home infusion therapy accrediting organization when the accredited home infusion therapy supplier does the either of the following:
(i) Removes or ceases furnishing services for which they are accredited.
(ii) Adds services for which they are not accredited.
(16) The home infusion therapy accrediting organization's procedures for responding to, and investigating complaints against accredited facilities, including policies and procedures regarding referrals, when applicable, to appropriate licensing bodies, ombudsmen offices, and CMS.
(17) A description of the home infusion therapy accrediting organization's accreditation status decision-making process. The home infusion therapy accrediting organization must furnish the following:
(i) Its process for addressing deficiencies identified with accreditation program requirements, and the procedures used to monitor the correction of deficiencies identified during an accreditation survey and audit process.
(ii) A description of all types and categories of accreditation decisions associated with the program, including the duration of each of the organization's accreditation decisions.
(iii) Its policies and procedures for the granting, withholding or removal of accreditation status for facilities that fail to meet the accrediting organization's standards or requirements, assignment of less than full accreditation status or other actions taken by the organization in response to non-compliance with its standards and requirements.
(iv) A statement acknowledging that the home infusion therapy accrediting organization agrees to notify CMS (in a manner CMS specifies) of any decision to revoke, terminate, or revise the accreditation status of a home infusion therapy supplier, within 3 business days from the date the organization takes an action.
(18) A list of all currently accredited home infusion therapy suppliers, the type and category of accreditation, currently held by each, and the expiration date for each home infusion therapy supplier's current accreditation.
(19) A schedule of all survey activity (such as onsite surveys, offsite audits and other types if survey strategies) expected to be conducted by the organization during the 6-month period following submission of an initial or renewal application.
(20) A written presentation that demonstrates the organization's ability to furnish CMS with electronic data.
(21) A description of the home infusion therapy accrediting organization's data management and analysis system with respect to its surveys and accreditation decisions, including all of the following:
(i) A detailed description of how the home infusion therapy accrediting organization uses its data to assure the compliance of its home infusion therapy accreditation program with the Medicare home infusion therapy accreditation program requirements.
(ii) A written statement acknowledging that the home infusion therapy accrediting organization agrees to submit timely, accurate, and complete data that CMS has determined is both necessary to evaluate the accrediting organization's performance and is not unduly burdensome for the accrediting organization to submit.
(A) The organization must submit necessary data according to the instructions and timeframes CMS specifies.
(B) Data to be submitted includes the following:
(
(
(
(
(22) The three most recent annual audited financial statements of the home infusion therapy accrediting organization that demonstrate that the organization's staffing, funding, and other resources are adequate to perform the required surveys, audits, and related activities to maintain the accreditation program.
(23) A written statement acknowledging that, as a condition for approval, the home infusion therapy accrediting organization agrees to the following:
(i)
(ii)
(A) For both voluntary and involuntary terminations, provide a second written notification to all
(B) Notify CMS, in writing (electronically or hard copy), within 2 business days of a deficiency identified in any accredited home infusion therapy supplier from any source where the deficiency poses an immediate jeopardy to the home infusion therapy supplier's beneficiaries or a hazard to the general public.
(iii)
(A) Deficiencies.
(B) Complaints.
(C) Terminations.
(D) Withdrawals.
(E) Denials.
(F) Accreditation decisions.
(G) Other survey-related activities as specified by CMS.
(iv)
(v)
(vi)
(A) The proposed changes must be submitted within 30 calendar days of the date of the written CMS notice to the home infusion therapy accrediting organization or by a date specified in the notice, whichever is later. CMS gives due consideration to a home infusion therapy accrediting organization's request for an extension of the deadline as long as it is submitted prior to the due date.
(B) The proposed changes are not to be implemented without prior written notice of continued program approval from CMS, except as provided for at § 488.1040(b)(2)(ii).
(24) The organization's proposed fees for accreditation, including any plans for reducing the burden and cost of accreditation to small and rural suppliers.
(b)
(c)
(d)
(1) The basis for the decision.
(2) The effective date.
(3) The term of the approval (not exceed 6 years).
(a) Except as provided in paragraph (b) of this section, a home infusion therapy accrediting organization whose request for CMS's approval or re-approval of an accreditation program has been denied, or a home infusion therapy accrediting organization that has voluntarily withdrawn an initial application, may resubmit its application if the home infusion therapy accrediting organization satisfies all of the following requirements:
(1) Revises its home infusion therapy accreditation program to address the issues related to the denial of its previous request or its voluntary withdrawal.
(2) Resubmits the application in its entirety.
(b) If a home infusion therapy accrediting organization has requested, in accordance with § 488.1050, a reconsideration of CMS's disapproval, it may not submit a new application for approval of a home infusion therapy accreditation program until such reconsideration is administratively final.
CMS publishes a notice in the
(a)
(b)
(1)
(i) A description of how the home infusion therapy accreditation program meets or exceeds Medicare home infusion therapy accreditation program requirements.
(ii) The effective date of approval (no later than the publication date of the notice).
(iii) The term of the approval (6 years or less).
(2)
(i) How the home infusion therapy accrediting organization fails to meet
(ii) The effective date of the decision.
The home infusion therapy accrediting organization must include, in its accreditation agreement with each supplier, an acknowledgement that the supplier agrees to release to CMS a copy of its most current accreditation survey and any information related to the survey that CMS may require, corrective action plans.
(a) CMS may determine that a home infusion therapy supplier does not meet the applicable Medicare conditions or requirements on the basis of its own investigation of the accreditation survey or any other information related to the survey.
(b) With the exception of home health agency surveys, general disclosure of an accrediting organization's survey information is prohibited under section 1865(b) of the Act. CMS may publically disclose an accreditation survey and information related to the survey, upon written request, to the extent that the accreditation survey and survey information are related to an enforcement action taken by CMS.
(a)
(1) The home infusion therapy accrediting organization's survey activity.
(2) The home infusion therapy accrediting organization's continued fulfillment of the requirements at §§ 488.1010 and 488.1035.
(b)
(1) CMS provides the home infusion therapy accrediting organizations with written notice of the changes to the to the Medicare home infusion therapy accreditation requirements.
(2) The home infusion therapy accrediting organization must make revisions to its home infusion therapy accreditation standards or survey processes which incorporate the new or revised Medicare accreditation requirements.
(3) In the written notice, CMS specifies the deadline (no less than 30 calendar days) by which the home infusion therapy accrediting organization must submit its proposed revised home infusion therapy accreditation standard or survey process revisions, and the timeframe(s) for implementation of these revised home infusion therapy accreditation standards.
(4) CMS may extend the submission deadline by which the accrediting organization must submit its proposed revised home infusion therapy accreditation standards and survey processes, if both of the following occur:
(i) The accrediting organization submits a written request for an extension of the submission deadline.
(ii) The request for extension is submitted prior to the original submission deadline.
(5) After completing the comparability review of the home infusion therapy accrediting organizations revised home infusion therapy accreditation standards and survey processes, CMS shall provide written notification to the home infusion therapy accrediting organization regarding whether or not its home infusion therapy accreditation program, including the proposed revised home infusion therapy accreditation standards and implementation timeframe(s), continues to meet or exceed all applicable Medicare requirements.
(6) If, no later than 60 calendar days after receipt of the home infusion therapy accrediting organization's proposed changes, CMS does not provide the written notice to the home infusion therapy accrediting organization required, then the revised home infusion therapy accreditation standards and program is deemed to meet or exceed all applicable Medicare requirements and to have continued CMS-approval.
(7) If a home infusion therapy accrediting organization is required to submit a new application because CMS imposes new home infusion therapy regulations or makes significant substantive revisions to the existing home infusion therapy regulations, CMS provides notice of the decision to approve or disapprove the new application submitted by the home infusion therapy accrediting organization within the time period specified in § 488.1010(d).
(8) If a home infusion therapy accrediting organization fails to submit its proposed changes to its home infusion therapy accreditation standards and survey processes within the required timeframe, or fails to implement the proposed changes that have been determined or deemed by CMS to be comparable, CMS may open an accreditation program review in accordance with paragraph (d) of this section.
(c)
(1) Provide CMS with written notice of any proposed changes in home infusion therapy accreditation standards, requirements or survey process at least 60 days prior to the proposed implementation date of the proposed changes.
(2) Not implement any of the proposed changes before receiving CMS's approval, except as provided in paragraph (c)(4) of this section.
(3) Provide written notice to CMS that includes all of the following:
(i) A detailed description of the changes that are to be made to the organization's home infusion therapy accreditation standards, requirements and survey processes.
(ii) A detailed crosswalk (in table format) that states the exact language of the organization's revised accreditation requirements and the applicable Medicare requirements for each.
(4) CMS must provide a written notice to the home infusion therapy accrediting organization which states whether the home infusion therapy accreditation program, including the proposed revisions, continues or does not continue to meet or exceed all applicable Medicare home infusion therapy requirements within 60 days of receipt of the home infusion therapy accrediting organization's proposed changes. If CMS has made a finding that the home infusion therapy accrediting organization's home infusion therapy accreditation program, accreditation requirements and survey processes, including the proposed revisions does not continue to meet or exceed all applicable Medicare home infusion therapy requirements. CMS must state the reasons for these findings.
(5) If, no later than 60 calendar days after receipt of the home infusion therapy accrediting organization's proposed changes, CMS does not provide written notice to the home infusion therapy accrediting organization that the home infusion
(6) If a home infusion therapy accrediting organization implements changes that have neither been determined nor deemed by CMS to be comparable to the applicable Medicare home infusion therapy requirements, CMS may open a home infusion therapy accreditation program review in accordance with paragraph (d) of this section.
(d)
(1) If a home infusion therapy accreditation program review is initiated, CMS will provide written notice to the home infusion therapy accrediting organization indicating that its CMS-approved accreditation program approval may be in jeopardy and that a home infusion therapy accreditation program review is being initiated. The notice will provide all of the following information:
(i) A statement of the instances, rates or patterns of non-compliance identified, as well as other related information, if applicable.
(ii) A description of the process to be followed during the review, including a description of the opportunities for the home infusion therapy accrediting organization to offer factual information related to CMS' findings.
(iii) A description of the possible actions that may be imposed by CMS based on the findings of the home infusion therapy accreditation program review.
(iv) The actions the home infusion therapy accrediting organization must take to address the identified deficiencies
(v) The length of the accreditation program review probation period, which will include monitoring of the home infusion therapy accrediting organization's performance and implementation of the corrective action plan. The probation period is not to exceed 180 calendar days from the date that CMS approves the AOs corrective action plan.
(2) CMS will review and approve the home infusion therapy accrediting organization's plan of correction for acceptability within 30 days after receipt.
(3) CMS will monitor the AO's performance and implementation of the plan of correction during the probation period which is not to exceed 180 days from the date of approval of the plan of correction.
(4) If CMS determines, as a result of the home infusion therapy accreditation program review or a review of an application for renewal of the accrediting organizations existing CMS-approved home infusion therapy accreditation program, that the home infusion therapy accrediting organization has failed to meet any of the requirements of this subpart, CMS may place the home infusion therapy accrediting organization's CMS-approved home infusion therapy accreditation program on an additional probation period of up to 180 calendar days subsequent to the 180-day probation period described in paragraph (d)(1)(v) of this section to implement additional corrective actions or demonstrate sustained compliance, not to exceed the home infusion therapy accrediting organization's current term of approval. In the case of a renewal application where CMS has already placed the home infusion therapy accreditation program on probation, CMS indicates that any approval of the application is conditional while the program is placed on probation.
(i) Within 60 calendar days after the end of any probationary period, CMS issues a written determination to the home infusion therapy accrediting organization as to whether or not its CMS-approved home infusion therapy accreditation program continues to meet the requirements of this subpart, including the reasons for the determination.
(ii) If CMS determines that the home infusion therapy accrediting organization does not meet the requirements, CMS may withdraw approval of the CMS-approved home infusion therapy accreditation program. The notice of determination provided to the home infusion therapy accrediting organization includes notice of the removal of approval, reason for the removal, including the effective date determined in accordance with paragraph (d)(4)(iii) of this section.
(iii) CMS publishes in the
(e)
(f)
A home infusion therapy accreditation organization approved by CMS must carry out the following activities on an ongoing basis:
(a) Provide CMS with all of the following in written format (either electronic or hard copy):
(1) Copies of all home infusion therapy accreditation surveys, together with any survey-related information that CMS may require (including corrective action plans and summaries of findings with respect to unmet CMS requirements).
(2) Notice of all accreditation decisions.
(3) Notice of all complaints related to providers or suppliers.
(4) Information about all home infusion therapy accredited suppliers against which the home infusion therapy accreditation organization has taken remedial or adverse action, including revocation, withdrawal, or revision of the providers or suppliers accreditation.
(5) The home infusion therapy accrediting organization must provide, on an annual basis, summary data specified by CMS that relate to the past year's accreditation activities and trends.
(6) Notice of any proposed changes in the home infusion therapy accrediting organization's accreditation standards or requirements or survey process. If the home infusion therapy accrediting organization implements the changes before or without CMS' approval, CMS may withdraw its approval of the accrediting organization.
(b) Within 30 calendar days after a change in CMS requirements, the home infusion therapy accrediting organization must submit an acknowledgment of receipt of CMS' notification to CMS.
(c) The home infusion therapy accrediting organization must permit its surveyors to serve as witnesses if CMS takes an adverse action based on accreditation findings.
(d) Within 2 business days of identifying a deficiency of an accredited home infusion therapy supplier that poses immediate jeopardy to a beneficiary or to the general public, the home infusion therapy accrediting organization must provide CMS with written notice of the deficiency and any adverse action implemented by the accrediting organization.
(e) Within 10 calendar days after CMS' notice to a CMS-approved home infusion therapy accrediting organization that CMS intends to withdraw approval of the home infusion therapy accrediting organization, the home infusion therapy accrediting organization must provide written notice of the withdrawal to all of the home infusion therapy accrediting organization's accredited suppliers.
(a) As part of the application review process, the ongoing review process, or the continuing oversight of a home infusion therapy accrediting organization's performance, CMS may conduct onsite inspections of the home infusion therapy accrediting organization's operations and offices at any time to verify the home infusion therapy accrediting organization's representations and to assess the home infusion therapy accrediting organization's compliance with its own policies and procedures.
(b) Activities to be performed by CMS staff during the onsite inspections may include, but are not limited to the following:
(1) Interviews with various accrediting organization staff.
(2) Review of documents, survey files, audit tools, and related records.
(3) Observation of meetings concerning the home infusion therapy accreditation process.
(4) Auditing meetings concerning the accreditation process.
(5) Observation of in-progress surveys and audits.
(6) Evaluation of the accrediting organization's survey results and accreditation decision-making process.
(a)
(b)
(c)
(1) The accreditation status of affected home infusion therapy suppliers is considered to remain in effect until their current term of accreditation expires;
(2) If the home infusion therapy supplier wishes to avoid a suspension of payment, it must provide written notice to CMS at least 60-calendar days prior to its accreditation expiration date that it has submitted an application for home infusion therapy accreditation under another CMS-approved home infusion therapy accreditation program. Failure to comply with this 60-calendar day requirement prior to expiration of their current home infusion therapy accreditation stations within could result in a suspension of payment; and
(3) The home infusion therapy accrediting organization provides a second written notification to all accredited home infusion therapy suppliers ten calendar days prior to the organization's accreditation program effective date of termination.
(d)
(1) The accrediting organization must contact the home infusion therapy supplier to seek written confirmation that the home infusion therapy supplier intends to voluntarily withdraw from the home infusion therapy accreditation program.
(2) The home infusion therapy accrediting organization must advise the home infusion therapy supplier, in writing, of the statutory requirement for accreditation for all home infusion therapy suppliers and the possible payment consequences for a lapse in accreditation status.
(3) The home infusion therapy accrediting organization must submit their final notice of the voluntary withdrawal of accreditation by the home infusion therapy supplier to CMS by 5 business days after the request for voluntary withdrawal is ultimately processed and effective.
(a)
(b)
(2) The written request for reconsideration must specify the findings or issues with which the home infusion therapy accrediting organization disagrees and the reasons for the disagreement.
(3) A requestor may withdraw its written request for reconsideration at
(c)
(1) The opportunity for a hearing to be conducted by a hearing officer appointed by the Administrator of CMS and provide the accrediting organization the opportunity to present, in writing and in person, evidence or documentation to refute the determination to deny approval, or to withdraw or not renew designation; and
(2) Written notice of the time and place of the hearing at least 10 business days before the scheduled date.
(d)
(i) Authorized representatives and staff from CMS, including, but not limited to, the following:
(A) Technical advisors (individuals with knowledge of the facts of the case or presenting interpretation of the facts).
(B) Legal counsel.
(C) Non-technical witnesses with personal knowledge of the facts of the case.
(ii) Representatives from the accrediting organization requesting the reconsideration including, but not limited to, the following:
(A) Authorized representatives and staff from the accrediting organization.
(B) Technical advisors (individuals with knowledge of the facts of the case or presenting interpretation of the facts).
(C) Legal counsel.
(D) Non-technical witnesses, such as patients and family members that have personal knowledge of the facts of the case.
(2) The hearing is conducted by the hearing officer who receives testimony and documents related to the proposed action.
(3) Testimony and other evidence may be accepted by the hearing officer even though such evidence may be inadmissible under the Federal Rules of Civil Procedure.
(4) The hearing officer does not have the authority to compel by subpoena the production of witnesses, papers, or other evidence.
(5) Within 45 calendar days after the close of the hearing, the hearing officer will present the findings and recommendations to the accrediting organization that requested the reconsideration.
(6) The written report of the hearing officer will include separate numbered findings of fact and the legal conclusions of the hearing officer.
(7) The hearing officer's decision is final.
National Credit Union Administration (NCUA).
Proposed rule.
The NCUA Board (Board) is proposing to update, clarify, and simplify the federal credit union bylaws (FCU Bylaws). The Board also is proposing changes that will update and conform the FCU Bylaws to legal opinions issued by the NCUA's Office of General Counsel and/or provide greater flexibility to FCUs. Finally, the Board is proposing other changes that are designed to remove outdated or obsolete provisions.
Comments must be received by January 14, 2019.
You may submit comments by any of the following methods (Please send comments by one method only):
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•
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Benjamin M. Litchfield, Staff Attorney, Office of General Counsel, 1775 Duke Street, Alexandria, Virginia 22314, or by telephone at (703) 518-6540.
Section 108 of the Federal Credit Union Act (FCU Act) requires the Board to periodically prepare a form of bylaws to be used by FCU incorporators and to provide that form to FCU incorporators upon request.
The FCU Bylaws are set out in Appendix A to part 701 of the NCUA's regulations.
FCUs often express concerns that the FCU Bylaws do not provide sufficient operational flexibility to allow an FCU to respond to changing market practices or to address basic corporate governance matters in a prompt and efficient manner. These arguments are well taken. Accordingly, the NCUA has engaged in an ongoing review of the FCU Bylaws to determine what, if any, changes may be necessary to provide additional flexibility to FCUs.
In 2013, the NCUA's Office of General Counsel consulted with representatives from the credit union industry regarding the FCU Bylaws. The NCUA received many comments during the 2013 consultation, many of which focused on relatively narrow aspects of the FCU Bylaws. For example, FCUs recommended that the NCUA provide more staff commentary on the meaning and interpretation of specific bylaw provisions. They also encouraged the NCUA to make a concerted effort to modernize the FCU Bylaws by using consistent terms throughout and deleting inapplicable language that is no longer useful. Commenters specifically recommended that the NCUA update the preamble to the FCU Bylaws and ensure that the instructions are current.
On March 15, 2018, the Board issued an advance notice of proposed rulemaking (ANPR) soliciting comments on how to update, clarify, and simplify the FCU Bylaws.
The Board received a wide variety of comments to the ANPR from FCUs, federally insured, state-chartered credit unions, national credit union trade associations, state credit union trade associations, and law firms. Commenters generally appreciated the Board's efforts to provide an enhanced opportunity to participate in the rulemaking process. Nearly all of the commenters raised issues with specific aspects of the FCU Bylaws and requested that the Board provide the greatest amount of regulatory relief permissible under the FCU Act.
Based on the comments the Board has received in response to the ANPR and throughout its ongoing review of the FCU Bylaws, the Board is proposing to make significant revisions to modernize the FCU Bylaws.
The Board is issuing this proposed rule pursuant to its specific authority in the FCU Act to adopt a form of bylaws to be used by FCU incorporators when chartering an FCU,
The proposed rule incorporates many of the suggestions the Board received in response to the ANPR and throughout the NCUA's ongoing review of the FCU Bylaws. In addition, the proposed rule clarifies provisions that have created confusion in the past, as reflected by the numerous inquiries the NCUA has received from FCUs and members. In some instances, a proposed change offers more detail or further elaboration to help FCU officials, employees, and members better understand a provision.
The proposed rule also makes stylistic and grammatical changes throughout the FCU Bylaws, which provide for a much clearer and more readable document. For example, the proposed rule moves the entire body of staff commentary to the end of the FCU Bylaws, with corresponding references to the articles and section numbers that are the subject of the commentary.
However, the proposed rule does not permit an FCU to draft its own bylaws. The FCU Act requires the Board to develop a form of bylaws that “shall be used” by FCU incorporators and mandates that FCUs operate according to their NCUA-approved bylaws.
This proposed rule modernizes the introductory language to the FCU Bylaws. It changes the instructions for bylaw amendments to reflect that the NCUA's Office of Credit Union Resources and Expansion (CURE) now is the primary office handling bylaw amendments, and consults with the NCUA's Office of General Counsel as necessary. The proposed rule also establishes an explicit 90 calendar day deadline for CURE to reach a decision on a bylaw amendment.
In the ANPR, the Board specifically requested comments on improving the bylaw amendment process. Commenters requested that the Board adopt a deadline for CURE to process bylaw amendments, with a majority favoring 30 calendar days. While the Board agrees that the NCUA should process bylaw amendments as expeditiously as possible to allow the FCU to address any pressing operational concerns, the Board remains concerned that 30 calendar days may be an insufficient amount of time. Accordingly, the proposed rule adopts a 90-calendar day deadline. The Board believes that this time period will provide CURE with sufficient time to consider the bylaw amendment without imposing an undue operational burden on the FCU. The Board requests specific comments on this aspect of the proposed rule including whether another time period, such as 60 calendar days, would be more appropriate to ensure that CURE processes proposed bylaw amendments in a timely manner.
Commenters to the ANPR also requested that the Board automatically approve any bylaw amendment that CURE does not approve within this deadline. The Board does not believe that it is appropriate to automatically approve proposed bylaw amendments, as this could result in adoption of a bylaw that has a material adverse effect on fundamental member rights, poses a safety and soundness risk to the FCU, or is otherwise contrary to law. Instead, the Board believes it is appropriate to treat the failure to approve a bylaw amendment within the prescribed deadline as a denial, which the FCU may then appeal to the Board pursuant to the appeals procedures set out in subpart B to part 746 of the NCUA's regulations.
Article I states the FCU's name and mission. The proposed rule amends section 2, which outlines the FCU's purposes, by changing the reference in the second sentence from “consumers” to “members.” The Board is proposing to change this term because FCUs are not limited in their mission to serving consumers. There may be small businesses and other organizations within the field of membership that can benefit from the FCU's services, and this change is designed to reflect this benefit.
Article II outlines the requirements for obtaining and continuing FCU membership. The proposed rule includes an expanded discussion in the staff commentary of measures that an FCU may take to address abusive and disruptive members. In addition, to facilitate an FCU's implementation of any limitation of services policy, the proposed rule adds a new section 5, describing the concept of a “member in good standing.” As long as a member remains in good standing, that member retains all of the rights and privileges associated with FCU membership. A member not in good standing, however, may be subject to an FCU's limitation of services policy.
In the ANPR, the Board specifically requested suggestions on ways to clarify an FCU's right to limit services or restrict access to credit union facilities to disruptive or abusive members. Some commenters recommended that the Board incorporate into the FCU Bylaws prior legal opinions by the NCUA's Office of General Counsel addressing this matter. Those legal opinions state than an FCU may limit services or access to credit union facilities to violent, belligerent, disruptive, or abusive members provided that there is a logical relationship between the objectionable conduct and the services to be suspended. The member must also receive adequate notice of the FCU's limitation of services policy.
The Board agrees that incorporating these legal opinions into the FCU Bylaws is appropriate to provide additional clarity on an FCU's right to limit services or access to credit union facilities. Accordingly, the proposed rule includes staff commentary to Article II, based on these prior legal opinions, that details how an FCU may
The staff commentary also notes that the policy need not be identical or applied uniformly in all cases, provided that the FCU has a legitimate purpose for any disparate treatment of members. For additional clarity, the staff commentary contains cross references to procedures that FCUs must use to expel a member, and it refers to Article XVI, § 1 of the FCU Bylaws, which contains language reiterating that no member may access or utilize an FCU's services in furtherance of an illegal objective.
To facilitate an FCU's implementation of its limitation of services policy, the proposed rule amends Article II to distinguish between a member that retains all of the rights and privileges associated with FCU membership and a member that is subject to a limitation on services or a restriction on access to credit union facilities. As noted, the proposed rule adds a new section 5, describing the concept of a “member in good standing.” A member in good standing retains all the rights of FCU membership. To remain in good standing, a member must be current on credit union loans, avoid engaging in any violent, belligerent, disruptive, or abusive behavior towards credit union staff or other credit union members in the FCU or its surrounding property, and not cause a financial loss to the credit union. A member that fails to observe any of these basic requirements may be subject to reasonable limitations of service or access to credit union facilities pursuant to the FCU's limitation of services policy.
The Board recognizes that terms such as “violent,” “belligerent,” “disruptive,” and “abusive” are subjective and, therefore, may not provide FCUs with absolute clarity regarding the circumstances under which a limitation of services or access to credit union facilities may be appropriate. The Board believes that, without question, certain actions warrant immediate limitations of service or access to credit union facilities, such as violence against other credit union members or credit union staff in the credit union facility or the surrounding property. In fact, the Board believes that an FCU has an obligation to take immediate action against such individuals. Other actions, such as rude behavior or potential threats of violence, may warrant limitations of service or restrictions of access to credit union facilities based on the specific facts and circumstances of that case. Accordingly, the Board requests comments on ways to clarify these terms, including specific examples of conduct that FCUs believe to be “disruptive,” “abusive,” and “belligerent.” Based on the persuasiveness of the comments, the Board may incorporate examples of “violent,” “belligerent,” “disruptive,” and “abusive” conduct into staff commentary to provide additional clarity for FCUs.
The Board notes that, in addition to the rights granted under Article II, an FCU may immediately take actions such as contacting local law enforcement, seeking a restraining order, or pursuing other lawful means, to protect the credit union, credit union members, and staff. Nothing in the FCU Act or the FCU Bylaws prevents an FCU from using whatever lawful means it deems necessary to address circumstances where a member poses a risk of harm to the FCU, its members, or its staff.
Article III provides basic information about issues related to members' share accounts, including the par value of the membership share, trust accounts, and membership status of joint account holders. The proposed rule adds new language under Section 1 providing representative examples for FCUs to choose in establishing varying par values for different classes of membership (such as students, minors, or non-natural persons), provided that such differences conform to applicable legal requirements established by federal, state, or municipal anti-discrimination laws. The new language also clarifies that FCUs have options regarding whether to require all members to maintain a regular share account, or whether to permit members to base their qualification for membership on some other type of account. Additional staff commentary elaborates more fully on this option. The proposed rule revises the text of Article III to incorporate plain English writing principles and delete unnecessary provisions.
Commenters to the ANPR requested that the Board provide additional guidance on trust accounts. New staff commentary addresses some of the considerations that apply in the context of trust accounts, including a discussion of the pertinent differences between revocable and irrevocable trusts. It also clarifies that, in the case of a revocable trust, the individual who establishes the trust (also known as the settlor) maintains ownership and control of the funds during that person's lifetime. Thus, the NCUA requires the settlor to join the FCU in order to establish a revocable trust account for that individual, thus requiring the settlor to be within the FCU's field of membership. The staff commentary notes that there is no requirement that the settlor first establish a regular share account to become a member. Rather, the settlor may satisfy the membership through the opening of the revocable trust account itself.
In contrast, the staff commentary clarifies that membership requirements for an irrevocable trust account may be met through the settlor, who is the original owner of the funds,
The staff commentary also notes that a trust itself, whether revocable or irrevocable, may be a member of an FCU in its own right if all parties to the trust, including the settlors, beneficiaries and trustees, are within the field of membership and actually join the FCU.
Article IV addresses procedures related to annual and special meetings of an FCU's membership. In the ANPR, the Board specifically requested comments on methods to encourage member attendance at annual and special meetings. The proposed rule makes several changes to Article IV to encourage greater member participation, including enhanced notice requirements and adjustments to quorum requirements.
To ensure that members receive adequate notice of an annual or special meeting, the proposed rule requires that the notice for the annual meeting be posted in a conspicuous place in the FCU's physical office of the FCU, such as at the teller windows or on the front door of the FCU's office, at least 30 calendar days before the meeting. The notice must also be prominently displayed on the FCU's website if the credit union then maintains a website. An FCU is not required to establish and maintain a website solely for this purpose, however. The proposed rule also deletes the option to waive prior notice if all members entitled to vote waived the notice requirement. The Board believes that these changes are appropriate because members are more likely to participate in annual and special meetings if the notice is widely announced.
In the staff commentary, the proposed rule encourages FCUs to provide a live webcast of annual and special meetings for interested members, as well as post a video of the annual meeting on the FCU's website. The NCUA encourages this policy only for FCUs with a website at the time of any such meeting; nothing requires FCUs to establish or maintain a website solely for this purpose. This policy encourages members to participate in the annual meeting, while also providing access to members who cannot attend meetings in person.
The proposed rule also adjusts the quorum requirement for meetings. It requires 12 members, excluding the board, credit union staff, and officials, for a quorum. The Board is proposing this adjustment to encourage FCUs to have wider participation from members, rather than allowing credit union staff and board members to control all corporate decision making within the credit union.
The proposed rule, however, does not change the total number of member signatures required to call a special meeting. During the 2013 consultation process with members of the credit union industry, commenters favored increasing the total number of member signatures required to call a special meeting. They posited that special meetings are expensive and time-consuming to conduct and, thus, should be reserved only for matters of interest to a broad group of members. These comments are well taken. The Board does not believe that adopting a blanket increase is appropriate, however, given its potential to disenfranchise members of smaller FCUs. Accordingly, the Board is not proposing to make any changes to the provisions in Article IV that impose a limit on the total number of member signatures required to call a special meeting. Instead, the Board believes that a preferable approach is to continue the NCUA's current practice of considering requests from individual FCUs to increase this signature requirement on a case-by-case basis.
Furthermore, the proposed rule does not generally allow an FCU to conduct a virtual or hybrid (combined virtual and in-person) annual or special meeting. Commenters to the ANPR noted that at least 22 states currently permit corporations to host virtual or hybrid meetings, with several of those states extending the same flexibility to state-chartered financial institutions. The commenters argued that FCUs with the appropriate size, complexity, and sophistication should be allowed to take advantage of these solutions to provide greater flexibility for their members to attend annual or special meetings. The Board is sympathetic to the commenters' arguments. Due to its concerns about member disenfranchisement, however, the Board does not currently support adopting this position in a rulemaking that affects all FCUs. The Board is particularly concerned with the rights of members that do not have access to electronic devices or that may live in areas without access to broadband internet.
The NCUA will, however, consider bylaw amendment requests allowing for hybrid meetings on a case-by-case basis depending on, among other things, the FCU's size, nature, and field of membership. For example, the NCUA may grant such a bylaw amendment for an FCU that offers a majority of its financial services online or an FCU with a geographically dispersed field of membership. To avoid the possibility of member disenfranchisement, however, the Board does not believe it is appropriate to allow a virtual meeting to completely supplant a member meeting. Therefore, FCUs holding hybrid meetings must always offer an option for in-person attendance as well as online.
The FCU Bylaws already grant an FCU considerable discretion to hold meetings in a location that is convenient for most of its members. Article IV allows an FCU to hold an annual or special meeting in the county in which any office of the FCU is located or within a radius of 100 miles of such an office, provided that the FCU does not pick a location designed to limit member participation or that has such an effect. Accordingly, the Board believes that an FCU has sufficient flexibility to ensure broad participation from members without the need for entirely virtual meetings and would be reluctant to approve any bylaw amendment allowing for entirely electronic voting. The Board encourages FCUs to be mindful when selecting a location for a member meeting to choose a location that maximizes member participation.
Article V addresses procedures for electing FCU Board members, and allows FCUs to select one of four options for conducting nominations and elections. During the 2013 consultation process with members of the credit union industry, the NCUA received comments that focused on several discrete aspects of this Article. Commenters suggested that, in regulating the voting process, the NCUA should take modern technology into consideration, including an option for electronic-only voting. Some commenters requested clarification on the appropriate procedures in cases of uncontested elections. Other commenters asked about the procedures for, and permissibility of, imposing additional director qualifications, and how to permit board-established qualifications.
The proposed rule provides staff commentary clarifying electronic voting. The staff commentary states that an FCU may use as many forms of electronic voting (
The proposed rule also provides staff commentary clarifying procedures for
Lastly, the proposed rule amends the staff commentary to encourage FCUs to take steps to increase the number of members who vote in FCU elections by increasing the range of voting options. The NCUA recently has approved several bylaw amendments that essentially combine the election options, for example, by adding a provision for mail or electronic ballots to one of the in-person voting options. The Board believes that, where possible, FCUs using one of the in-person voting options should consider offering mail or electronic ballots in addition to in-person voting. Similarly, FCUs conducting elections by mail and electronic means should consider also offering in-person voting. These changes currently require interested FCUs to pursue bylaw amendments individually. Accordingly, the Board seeks comment on whether the FCU Bylaws should include an additional option for conducting elections that would allow FCUs to use a combination of voting methods without needing to make individual requests to do so.
The Board seeks specific comments on whether the FCU Bylaws should require that the nominating committee widely publicize to all FCU members the call for nominations by any medium the FCU determines and interview every member who volunteers to serve. In addition, the Board asks whether the secretary should post the nominations by petition along with those of the nominating committee on the credit union's website (if the credit union maintains a website). The Board believes that widely publicizing the nomination process and posting the nominations by petition on the credit union's website will provide more opportunities for member participation and is considering adopting such requirements in the final rule.
This Article provides the requirements related to the board of directors, such as the number of members, the composition of the board, the terms of office, and the responsibilities of the board. It also describes the regular and special meetings of the board. In addition, this Article provides the requirements for quorums, attendance and removal of board or credit committee members, and the suspension of supervisory committee members.
As part of the 2013 consultation process with members of the credit union industry, the NCUA received comments suggesting that the FCU Bylaws be revised to provide specific guidance to FCUs interested in establishing director emeritus and associate director positions. Commenters suggested that greater flexibility in regard to these types of arrangements will enable an FCU to better plan for vacancies in board positions and retirements among current directors. They also recommended enhanced flexibility regarding the composition of the board and reorganization of board duties. Moreover, commenters requested greater flexibility with regard to options concerning attendance by directors at meetings, and criteria and procedures by which incumbent directors may be removed. Commenters to the ANPR reiterated the need for additional guidance on associate director positions.
The Board agrees that an FCU should have the ability to establish, as a matter of FCU board policy, the position of director emeritus for former directors who faithfully fulfilled their responsibilities as members of the board for at least a specified minimum number of years. Accordingly, the proposed rule includes a new section 10 that an FCU may adopt to create such positions. It also includes specific staff commentary to this section that states that the decision to establish a director emeritus position, as well as any selection of individuals to become directors emeriti, is solely within the discretion of the FCU's board. The staff commentary clarifies that a director emeritus may attend and participate in board meetings, but may not vote on any matter before the board or exercise any official duties of a director.
To provide additional guidance to FCUs on associate director positions, the proposed rule clarifies, through staff commentary, that an FCU may establish associate director positions through board policy. The staff commentary notes that the purpose of these positions is to provide qualified individuals with an opportunity to gain exposure to board meetings and discussions, but without formal director responsibility or the right to vote. As with the director emeritus position, the decision to establish an associate director position, as well as the selection of the individual(s) to become associate directors, is solely within the discretion of the FCU's board.
To provide FCUs with greater flexibility to address concerns regarding director and credit committee member attendance at monthly meetings, the proposed rule amends the option for FCUs to remove a director or a credit committee member for failure to attend regular meetings. The current bylaw language allows FCUs to remove a director or credit committee member that has missed 3 consecutive months, or 4 meetings in a calendar year. Under the proposed rule, an FCU may remove a director or credit committee member for missing 3 consecutive months or for missing 4 meetings within any 12 consecutive months. The Board believes this change provides FCUs with greater flexibility to address situations where a director or credit committee member misses a substantial number of consecutive meetings but would otherwise not qualify for removal because the missed meetings do not all occur within the same calendar year. In addition, the proposed rule adds language to allow FCUs to choose whether directors or credit committee members may be paid employees after such positions end.
The proposed rule also adds language that clarifies the existing restriction on the number of employees and family members of employees who may simultaneously serve on the board. The NCUA has received numerous questions regarding this issue since the FCU Bylaws were first incorporated into the NCUA's regulations in 2007. The current bylaw language prohibits FCU employees, their family members, or a combination of FCU employees and their family members from constituting a majority of the board. The purpose of this restriction is to prevent conflicts of interest that may arise when a majority of the board has a personal or pecuniary interest in a matter currently being reviewed by the board.
The Board has historically interpreted this provision of the FCU Bylaws to prohibit any combination of FCU employees, their family members, or FCU employees and their family members from constituting a majority of the board. To provide FCUs with
For FCUs that elect not to have a specifically appointed credit committee, the proposed rule adds two new options to provide additional flexibility in addressing an applicant's request for review of a denied loan application. The FCU Act requires a board, at the request of the applicant, to review any application that has been denied by a loan officer.
Under the first new option, the board may elect to establish a subcommittee of three members and two alternates. The term of office of the subcommittee members may be for up to 3 years. Any number of lending professionals within the credit union may serve on the subcommittee, provided that no loan officer reviews any loan that the loan officer denied. At least 3 members of the subcommittee must review loan denials, none of whom have been a party to denying the loan. Under the second new option, the board may, by resolution, change the number of committee members to an odd number no less than 3 and no more than 7. The board has the discretion to set the length of each subcommittee member's term upon appointment and stagger terms to prevent a complete turnover of subcommittee members. This option requires the board to file a copy of the resolution covering any increase or decrease in the number of subcommittee members with the official copy of the FCU's bylaws.
The proposed rule also adds staff commentary that encourages FCUs to form a board of directors that reflects the FCU's field of membership. This policy encourages FCUs to consider all members in its leadership. While the Board does not have specific concerns regarding board diversity or representativeness at this time, it believes in the importance of including such statements in the FCU Bylaws to remind stakeholders that credit unions are fundamentally different than many other depository financial institutions. Accordingly, the Board believes that credit unions should strive to have a board that reflects their membership to the greatest extent possible.
Finally, the proposed rule adds staff commentary that encourages FCUs to notify members, through a website posting (if the credit union then maintains a website), whenever the FCU's board adopts a resolution that changes the size of the FCU's board of directors. An FCU that does not then maintain a website can post such a notice in a conspicuous place in the FCU's offices, such as at the teller windows or on the FCU's front doors.
Article VII provides the requirements related to board officers, such as their election and their terms of office. It lists the duties of the chair, vice chair, financial officer, management officials, and secretary of the board. Article VII also explains the board powers regarding employees and the provisions for an executive committee and an investment committee.
The proposed rule makes certain clarifications and improvements to the readability of the language in this Article. For example, this Article utilizes the term “financial officer,” and the NCUA has received comments that this term is confusing. The proposed rule, therefore, modifies the definition of “financial officer” in Article XVIII to mean “treasurer.” The proposed rule also updates the language in section 8 to allow different options for addressing when directors or committee members may serve as paid employees of the credit union after their terms as directors and/or committee members have ended.
The proposed rule adds more staff commentary under this Article, addressing procedural questions that arise in connection with specified board officer positions that may be held by directors, such as the president, vice president, and secretary of the board. The staff commentary clarifies that officers hold their respective board officer positions for a term of one year, until the first board meeting following the next annual meeting of the members. At that board meeting, board officer positions are again filled. Each board officer holds his or her position until the election and qualification of his or her successors. Thus, a board officer who is re-elected to the position the officer is currently holding serves for another year. Where another director is chosen to fill the position, the director takes office effective as of the date of the election, assuming the director is qualified.
The proposed rule adds additional staff commentary to address questions relating to temporary appointments of board officers, succession, replacement of director positions that may have become vacant between election cycles, and notifying members about membership on FCU committees. The staff commentary notes that, in the absence of both the chair and vice chair, those directors who are present at a meeting may select from among themselves an individual director to act as temporary chair for that particular meeting. Actions taken by the board under the direction of the temporary chair have the same validity and effect as if taken under the direction of the chair or the vice chair, provided a quorum of the board, including the temporary chair, is present. There is no requirement for the board to ratify actions taken under the temporary chair at a subsequent meeting of the board where either the chair or vice chair are present.
This Article provides the requirements for the credit committee, if an FCU elects to have one. This Article also lists the requirements for loan officers if an FCU does not have a credit committee. The proposed rule modernizes the language of this Article and incorporates plain English writing principles. In addition, the proposed rule incorporates into the FCU Bylaws several NCUA Office of General Counsel opinion letters permitting FCUs to use automated systems to process,
Article IX provides the requirements for the supervisory committee, such as the appointment and membership of the committee, its duties, and the required officers. This Article also lists the powers of the supervisory committee. The FCU Act requires each FCU to have a supervisory committee. The supervisory committee must conduct or arrange for annual audits and verify members' deposits at least once every two years.
The proposed rule modernizes the language of this Article. In addition, the proposed rule deletes paragraph (c) of section 3, as it is duplicative of paragraph (b). During the 2013 consultation process, commenters requested a number of changes to this Article to allow for greater flexibility. For example, one commenter requested that the Board amend section 3 to allow an FCU to call a special meeting 30 calendar days after all director positions become vacant, rather than the 7-14 calendar days currently set out in the FCU Bylaws. Another commenter requested that the Board amend section 6 to limit the actions members could take at a special meeting called to consider allegations of unsafe or illegal activity by a credit union director or credit committee member. These requested changes require statutory amendments to the FCU Act, so the proposed rule does not include any other substantive changes to this Article.
Some commenters have noted that the provisions in Article X, which govern the initial organizational meeting by which the FCU is established, effectively become obsolete and irrelevant after that initial organizational meeting. Although the Board acknowledges that this Article serves a limited purpose, it does not agree that the Article is necessarily irrelevant after the FCU has been established. Nevertheless, the proposed rule includes an option whereby FCUs may eliminate the Article after five years of operation. For FCUs electing this option, Article X will become “reserved” and its language inoperative.
Article XI lists loan purposes for members and addresses member delinquencies on loans. The proposed rule slightly edits the language of this Article for readability, but there are no other substantive changes.
Article XII establishes the power of the board to declare dividends. The proposed rule slightly edits the language of this Article for readability. There are no other substantive changes.
The proposed rule makes no changes to this Article.
Article XIV addresses the expulsion and withdrawal procedures for members. The Board notes that expulsion from membership is a very serious remedy that may only be accomplished in accordance with the procedures set forth in the FCU Act. An FCU may only expel a member upon a two-thirds majority vote of the membership at a special meeting called for that purpose or by operation of a board-approved nonparticipation policy.
New staff commentary to this Article reiterates that the FCU Act provides only two methods for an FCU to expel a member and clarifies that only in-person voting is permitted in conjunction with a special meeting held for that purpose. This gives the affected member an opportunity to present his or her case against expulsion and an opportunity to respond to the FCU's concerns. The staff commentary clarifies that, short of expulsion, an FCU has a wide range of measures available to address abusive or disruptive members, and it specifically references Article XVI, Section 1 of the FCU Bylaws, which addresses situations when members use their accounts for unlawful purposes.
During the 2013 consultation process with representatives of the credit union industry, commenters pressed for ways to make the expulsion of a disruptive member easier to accomplish. Commenters to the ANPR reiterated many of the same concerns. Many commenters requested that the Board either amend the FCU Bylaws or include staff commentary interpreting the FCU Act to allow an FCU to expel a member for actions such as filing for bankruptcy, habitual default, or misconduct under the FCU's board-approved nonparticipation policy. The FCU Act does not permit such an interpretation. A word used in a statute is given its ordinary or plain meaning unless context indicates otherwise.
As the Board notes in the discussion of changes to Article II above, FCUs have the option to address violent, belligerent, disruptive, and abusive members by limiting their access to products and services provided that there is a logical relationship between the objectionable conduct and the services to be suspended and the member has received adequate notice of the FCU's limitation of services policy.
Furthermore, as noted in the discussion of changes to Article II above, neither the FCU Act nor the NCUA's regulations prohibit an FCU from using lawful means to immediately protect the credit union, credit union members, and staff such as contacting local law enforcement, seeking a restraining order, or pursuing other forms of legal redress. The Board fully expects that an FCU would use these lawful means in addition to its limitation of services policy to proactively limit security threats or financial harm caused by violent, belligerent, disruptive, or abusive credit union members.
This Article provides that minors are permitted to own shares and that the rights of minors to transact business with the FCU are governed by state law. The proposed rule slightly edits the language of this Article for readability, but there are no other substantive changes.
Article XVI addresses other general requirements, such as complying with other laws and regulations, confidentiality, and conflicts of interest. It also provides requirements related to records, indemnification, and the removal of directors and committee members.
During the 2013 consultation process with representatives of the credit union industry, the NCUA received comments regarding section 3, requesting a simplified procedure for confirmation by the membership of the suspension of a director or committee member by the supervisory committee. Commenters suggested that the confirmation of suspension be accomplished through balloting rather than a special meeting at which members must vote in person to accomplish the removal. The Board notes, in this respect, that these procedures are mandated by statute. The FCU Act requires that membership confirmation of supervisory committee suspension be accomplished only by majority vote of the members at a special meeting called for that purpose.
The staff commentary also adds new language regarding section 1 of this Article, which specifies that the credit union, its powers and duties, as well as the functions of its members, officers, and directors, are all strictly circumscribed by law and regulation. It notes that, insofar as section 1 is included in the FCU Bylaws, an FCU need not adopt a specific policy or requirement that members use credit union products or services for lawful purposes. Furthermore, it confirms that this bylaw provision supports an FCU's decision to impose limits on products and services available to any individual who is found to be using the FCU in furtherance of unlawful purposes.
The proposed rule also amends section 6 to require FCUs with websites to post their bylaws on the website. The Board believes that adding this new requirement will ensure that members without access to an FCU's physical location where they can request a copy of the bylaws, can still have access to the FCU's corporate governance documents. Some FCUs operate over a wide geographic area, employing shared branch networks and/or online banking as a way to provide fast and reliable services to their members. It may be difficult for members of these FCUs, particularly in rural areas, to travel to the nearest branch office to request a copy of the FCU's bylaws. Accordingly, the Board believes that, to the extent an FCU maintains a website, an FCU should post its current bylaws on that website to provide these members with immediate access.
Finally, the proposed rule adds a new section 9 which clarifies the use of singular and plural terms as well as pronouns in the bylaws. The NCUA has received questions in the past in this regard. New section 9 clarifies that, unless the context requires otherwise, words denoting the singular may be construed as denoting the plural, words of the plural may be construed as denoting the singular, and words of one gender may be construed as denoting another gender as appropriate.
Article XVII provides the requirements for amending an FCU's bylaws or charter. The proposed rule modernizes the language of this Article and incorporates plain English writing principles. In addition, in conjunction with the proposed rule's requirement for an FCU to post its current bylaws on its website (if the FCU maintains a website), the proposed rule requires an FCU to update the posting if it amends its bylaws.
Article XVIII lists the definitions applicable to all of the FCU Bylaws. The proposed rule makes a few technical changes to this Article and adds several new definitions, which the Board believes are useful for purposes of clarification. These include new definitions for “Agency,” “Charter,” “Field of Membership,” “Loans,” and “Membership Officer.” In addition, the definitions include a listing of approved board officers. This article also includes the term “Member,” the definition of which identifies the characteristics and actions an individual must take to become a qualified member. Finally, the definitions include the term “Management,” which is defined to include the Board, Financial Officer, and Management Official.
The Regulatory Flexibility Act (RFA)
The Paperwork Reduction Act of 1995 (PRA) applies to rulemaking in which an agency by rule creates a new paperwork burden on regulated entities or modifies an existing burden.
The current proposal clarifies many bylaws provisions and adds a few substantive changes.
The amendments under this proposal would affect newly chartered FCUs or FCUs that choose to adopt these provisions. These provisions are:
• Article IV, § 2—The proposed rule would require FCUs to post annual meeting notices in a conspicuous place in the office of the credit union at least 30 days before the annual meeting, and to post the notice on the credit union's website, if the FCU has a website.
• Article V—The nominating committee must widely publicize the call for nominations to all members by any medium and interview each member who volunteers. The secretary must post the nominations by petition along with those of the nominating committee on the credit union's website, if the FCU has a website.
• Article XVI, § 6—If an FCU has a website, the FCU must post the bylaws on the website.
• Article XVII—After adopting amendments, a FCU must update the bylaws posted on its website, if the FCU has a website.
The information collection requirements under OMB control number 3133-0052 will be revised as follows due to the following program changes:
The current information collection requirements under Article IV is related to notices related to member meetings. The NCUA estimated the current burden hours at 3,721. NCUA has determined that the new changes from the proposed rule would only increase the burden for each FCU by 15 minutes.
Each FCU is estimated to spend 10 minutes posting notices for an increase of 620 hours, and each FCU with a website is estimated to spend 5 minutes posting notices to their website for an increase of 301 hours. NCUA estimates that 3,617 of the total number of FCUs have websites. This new disclosure requirement will increase the burden hours associated with the information collection under Article IV by 921 hours; for a total of 4,642 hours.
The current information collection requirements under Article V covers the burden associated with the recordkeeping requirements for FCU elections. NCUA estimated the current burden hours to be 29,768. The NCUA has determined that the new changes from the proposed rule would increase the burden for each FCU by 40 minutes. Each FCU is estimated to spend 30 minutes publicizing the call for nominations for an increase of 1,851 burden hours; and each FCU with a website is estimated to spend 10 minutes posting nominations to their website for an increase of 603 hours. The NCUA estimates that 3,617 of the total number of FCUs have websites. This new disclosure requirement will increase the burden hours associated with the information collection under Article V by 2,464 hours; for a total of 32,232 hours.
The information collection requirement associated with section 6 of Article V, Report of Officials, is cleared under OMB control number 3133-0004.
The current information collection requirements under Article XVI is FCU recordkeeping requirements specified in sections 5 and 6. The proposed rule does not affect the current recordkeeping requirements; however, under section 6 of Article XVI, a one-time burden of 1 hour will be reported for FCU's with a website to post their bylaws. This new disclosure requirements will increase the burden associated with Article XVI by 3,617 hours; for a total of 92,921 hours.
A new information collection requirement proposed under Article XVII is that FCU, who maintains a website, would be required to update its bylaws on its website after adopting any amendments. The NCUA estimates that it would take an FCU 30 minutes to update its bylaws on its website annually; for a total of 1,809 burden hours.
The total increase in burden hours due to these proposed program changes is 8,810 and action will be taken to amend OMB control number 3133-0052 to reflect this increase.
The Board invites comment on (a) whether the collections of information are necessary for the proper performance of the agency's function, including whether the information has practical utility; (b) the accuracy of estimates of the burden of the information collections, including the validity of the methodology and assumptions used; (c) ways to enhance the quality, utility, and clarity of the information being collected; (d) ways to minimize the burden of the information collection on respondents, including through the use of automated collection techniques or other forms of information technology; and (e) estimates of capital or start-up costs and costs of operation, maintenance, and purchase of services to provide information.
All comments are a matter of public record. Comments regarding the information collection requirements of this rule should be sent to (1) Dawn Wolfgang, NCUA PRA Clearance Officer, National Credit Union Administration, 1775 Duke Street, Suite 5080, Alexandria, Virginia 22314, or Fax No. 703-519-8572, or Email at
Executive Order 13132 encourages independent regulatory agencies to consider the impact of their actions on state and local interests. The NCUA, an independent regulatory agency as defined in 44 U.S.C. 3502(5), voluntarily complies with the executive order to adhere to fundamental federalism principles. This rule will not have a 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. This proposed rule will only apply to FCUs. Accordingly, the NCUA has determined this proposed rule does not constitute a policy that has federalism implications for purposes of the executive order.
The NCUA has determined that this proposed rule will not affect family well-being within the meaning of Section 654 of the Treasury and General Government Appropriations Act, 1999, Public Law 105-277, 112 Stat. 2681 (1998).
Credit, Credit unions, Federal credit union bylaws.
For the reasons stated above, NCUA proposes to amend 12 CFR part 701, Appendix A as follows:
12 U.S.C. 1752(5), 1755, 1756, 1757, 1758, 1759, 1761a, 1761b, 1766, 1767, 1782, 1784, 1785, 1786, 1787, 1788, 1789. Section 701.6 is also authorized by 15 U.S.C. 3717. Section 701.31 is also authorized by 15 U.S.C. 1601
1.
2.
3.
b. FCUs continue to have the flexibility to request bylaw amendments. The NCUA must approve all bylaw amendments except for the provisions noted above. In the past, the NCUA has published a “Standard Bylaw Amendments” booklet containing a list of “standard” preapproved and optional amendments not included in the FCU Bylaws. That document remains on the NCUA's website for historical purposes. However, FCUs may not adopt amendments from the “Standard Bylaw Amendments” booklet, as the FCU Bylaws include sufficient flexibility to make a separate list of standard bylaw amendments unnecessary. Thus, the NCUA no longer makes a distinction between “standard” and “nonstandard” bylaw amendments. Consequently, the NCUA considers any change to the FCU Bylaws that is not a “fill-in-the-blank” provision or part of a range of options to be a bylaw amendment that requires the NCUA approval.
c. The procedure for approval of a bylaw amendment is as follows:
i. The FCU must submit its request to the Office of Credit Union Resources and Expansion (CURE).
ii. The request must include:
1. The section of the FCU Bylaws to be amended;
2. The reason for, or purpose of, the amendment;
3. An explanation of why the amendment is desirable and what it will accomplish for the federal credit union; and
4. The specific wording of the proposed amendment.
iii. CURE will advise the credit union within 90 days if it approved the proposed amendment after its review and, if necessary, consultation with the NCUA's Office of General Counsel. If CURE denies a proposed amendment, the credit union may appeal that decision to the NCUA Board in accordance with the procedures set out in subpart B to part 746 of this chapter. For purposes of this provision, if CURE does not reach a decision within 90 days, the proposed amendment is considered to be denied.
d. Federal credit unions considering an amendment may find it useful to review the bylaws section of the agency website, which includes the NCUA's Office of General Counsel opinions on proposed bylaw amendments.
e. Because each decision by CURE is made on a case-by-case basis that depends on the unique facts and circumstances applicable to each FCU, the credit union must submit a proposed amendment to the NCUA for review under the procedure listed above, even if the NCUA previously approved an identical or similar amendment for another credit union.
4.
b. The FCU Bylaws supplement the broad provisions of:
• A federal credit union's charter, which establishes the existence of a federal credit union;
• The Federal Credit Union Act, which establishes the powers of federal credit unions; and
• The NCUA's regulations, which implement the Federal Credit Union Act.
As a legal matter, a federal credit union's bylaws must conform to, and cannot be inconsistent with, any provision of its charter, the Federal Credit Union Act, the NCUA's regulations, or other laws or regulations applicable to the credit union's operations.
c. The NCUA expects federal credit unions and their members will make every effort to resolve bylaw disputes using the credit union's internal member complaint resolution process. If a bylaw dispute cannot be resolved internally, credit union officials or members should contact the regional office with oversight over the credit union for assistance in resolving the dispute.
d. The NCUA has discretion to take administrative actions when a credit union is not in compliance with its bylaws. If a potential violation is identified, the NCUA will carefully consider all of the facts and circumstances in deciding whether to take enforcement action. The NCUA will not generally take action against minor or technical violations, but emphasizes that it retains discretion to enforce the FCU Bylaws in appropriate cases, such as safety and soundness concerns or threats to fundamental, material credit union member rights.
Section 1.
Section 2.
Section 1.
Section 2.
Section 3.
Section 4.
Section 5.
Section 1.
Section 2.
Section 3.
Section 4.
• Fails to complete payment of one share within ____ of admission to membership, or
• Fails to complete payment of one share within ____ from the increase in the par value of shares, or
• Reduces the share balance below the par value of one share and does not increase the balance to at least the par value of one share within ____ of the reduction.
Section 5.
Section 6.
(a) The board has the right, at any time, to require members, or a subset of members, to give up to 60 days written notice of intention to withdraw all or part of the amounts they paid in.
(b) Reserved.
(c) A member delinquent on any loan or obligation to the credit union may not withdraw their shares below the delinquent amount without the written approval of the credit committee or loan officer. This withdrawal restriction also applies if the member is a comaker, endorser, or guarantor of a delinquent loan. Coverage of overdrafts under an overdraft protection policy does not constitute delinquency for purposes of this paragraph. Shares issued in an irrevocable trust as provided in Section 6 of this article are not subject to withdrawal restrictions except as stated in the trust agreement.
(d) The share account of a deceased member (other than one held in joint tenancy with another member) may be continued until the close of the dividend period in which the administration of the deceased's estate is completed.
(e) The board can impose a fee for excessive share withdrawals from
Section 7.
(a) Shares issued in a revocable trust—the settlor must be a member of this credit union in his or her own right.
(b) Shares issued in an irrevocable trust—either the settlor or the beneficiary must be a member of this credit union.
(c) Both a revocable and irrevocable trust must state the name of the beneficiary.
A trust may be a member of the credit union as an entity if all parties to the trust, including all settlors, beneficiaries and trustees, are within the credit union's field of membership.
(d) Shares issued through a pension plan authorized by the rules and regulations will be treated as an irrevocable trust unless otherwise indicated in the rules and regulations.
Section 8.
Owners of a joint account may both be members of the credit union without opening separate accounts. For joint membership, both owners are required to fulfill all of the membership requirements including each member purchasing and maintaining at least one share in the account and filling out the membership card.
Each member must purchase and maintain at least one share in a share account that names the member as the sole or primary owner. Being named as a joint owner of a joint account is not sufficient to establish membership.
Section 1.
Section 2.
b. All special meeting notices must state the purpose of the meeting. The officials and members may only transact business related to the stated purpose at the meeting.
Section 3.
b. The credit union may hold a special meeting at any location permitted for the annual meeting.
Section 4.
(a) Ascertain that a quorum is present.
(b) Reading and approval or correction of the minutes of the last meeting.
(c) Report of directors, if there is one. For credit unions participating in the Community Development Revolving Loan Program, the directors must report on the credit union's progress on providing needed community services, if required by NCUA Regulations.
(d) Report of the financial officer or the chief management official.
(e) Report of the credit committee, if there is one.
(f) Report of the supervisory committee, as required by Section 115 of the Act.
(g) Unfinished business.
(h) New business other than elections.
(i) Elections, as required by Section 111 of the Act.
(j) Adjournment.
(k) To the extent consistent with these bylaws, the board will conduct all meetings of the members according to____. The order of business for the annual meeting may vary from the suggested order, provided it includes all required items and complies with the rules of procedure adopted by the credit union.
Section 5.
Section 1.
Section 2.
Section 1.
b. At least 90 days before the annual meeting, the nominating committee files its nominations with the secretary of the credit union. At least 75 days before the annual meeting, the secretary notifies, in writing, all members eligible to vote that they may make nominations for vacancies by petition signed by 1% of the members with a minimum of 20 and a maximum of 500. The secretary may use electronic mail to notify members who have opted to receive notices or statements electronically.
c. The written notice must specify that the credit union will not conduct the election by ballot and there will be no nominations from the floor when the number of nominees equals the number of open positions.
d. The notice will include, in a form approved by the board of directors, a brief statement of qualifications and biographical data for each nominee submitted by the nominating committee. Each nominee by petition must submit a similar statement of qualifications and biographical data with the petition.
e. The written notice must state the closing date for receiving nominations by petition. At least 40 days before the annual meeting, nominee(s) must file the nomination petition with the secretary of the credit union. To be effective, nominee(s) must include a signed certificate with the nomination petition stating that they are agreeable to nomination and will serve if elected to office.
f. At least 35 days before the annual meeting, the secretary will post the nominations by petition along with those of the nominating committee in a conspicuous place in each credit union office and on the credit union's website.
Section 2.
b. There are no nominations from the floor if there are sufficient nominations by the nominating committee or by petition to provide at least one nominee for each open position. If there are nominations from the floor and they result in more nominees than open positions, the chair will close nominations, and appoint election tellers. The election tellers distribute the ballots, collect the ballots and tally the votes, and the chair announces the results. If there is only one nominee for each open office, the chair may take a voice vote or declare the election of each nominee by general consent or acclamation.
Section 1.
b. At least 90 days before the annual meeting, the nominating committee files its nominations with the secretary of the credit union. At least 75 days before the annual meeting, the secretary notifies, in writing, all members eligible to vote that they may make nominations for vacancies by petition signed by 1% of the members with a minimum of 20 and a maximum of 500. The secretary may use electronic mail to notify members who have opted to receive notices or statements electronically.
c. The written notice must specify that the credit union will not conduct the election by ballot and there will be no nominations from the floor when the number of nominees equals the number of open positions.
d. The notice will include, in a form approved by the board of directors, a brief statement of qualifications and biographical data for each nominee submitted by the nominating committee. Each nominee by petition must submit a similar statement of qualifications and biographical data with the petition.
e. The written notice must state the closing date for receiving nominations by petition. At least 40 days before the annual meeting, nominee(s) must file the nomination petition with the secretary of the credit union. To be effective, nominee(s) must include a signed certificate with the nomination petition stating that they are agreeable to nomination and will serve if elected to office.
f. At least 35 days before the annual meeting, the secretary will post the nominations by petition along with those of the nominating committee in a conspicuous place in each credit union office and on the credit union's website.
Section 2.
(a) The board of directors will appoint the election tellers;
(b) At least 10 days before the annual meeting, the secretary will direct the preparation and placement of ballot boxes, printed ballots, or voting machines if there are sufficient nominations made by the nominating committee or by petition to provide more nominees than open positions. The secretary will place the boxes or voting machines in conspicuous locations as determined by the board of directors. The secretary will post the names of the candidates near the boxes or voting machines. The posting will include a brief statement of the candidates' qualifications and biographical data in a form approved by the board of directors;
(c) The members have 24 hours to vote at conspicuous locations as the board determines. After 24 hours, election tellers will open the ballot boxes or voting machines, tally the vote, place the tally in the ballot boxes, and reseal the ballot boxes. The election tellers are responsible at all times for the ballot boxes or voting machines and the integrity of the vote. The election tellers will keep a record of all persons voting
(d) The election tellers will take the ballot boxes to the annual meeting and place them in conspicuous locations with the names of the candidates posted near them. At the annual meeting, the election tellers will distribute printed ballots to those in attendance who have not voted. Members will deposit their votes in the ballot boxes placed by the election tellers. After giving the members an opportunity to vote at the annual meeting, the chair will close balloting. The election tellers will open the ballot boxes, tally the vote, and add the vote to the previous count. The chair will then announce the result of the vote.
Section 1.
b. At least 90 days before the annual meeting, the nominating committee files its nominations with the secretary of the credit union. At least 75 days before the annual meeting, the secretary notifies, in writing, all members eligible to vote that they may make nominations for vacancies by petition signed by 1% of the members with a minimum of 20 and a maximum of 500. The secretary may use electronic mail to notify members who have opted to receive notices or statements electronically.
c. The written notice must specify that the credit union will not conduct the election by ballot and there will be no nominations from the floor when the number of nominees equals the number of open positions.
d. The notice will include, in a form approved by the board of directors, a brief statement of qualifications and biographical data for each nominee submitted by the nominating committee. Each nominee by petition must submit a similar statement of qualifications and biographical data with the petition.
e. The written notice must state the closing date for receiving nominations by petition. At least 40 days before the annual meeting, nominee(s) must file the nomination petition with the secretary of the credit union. To be effective, nominee(s) must include a signed certificate with the nomination petition stating that they are agreeable to nomination and will serve if elected to office.
f. At least 35 days before the annual meeting, the secretary will post the nominations by petition along with those of the nominating committee in a conspicuous place in each credit union office and on the credit union's website (if the credit union maintains a website).
Section 2.
(a) The board of directors will appoint the election tellers;
(b) At least 30 days before the annual meeting, the secretary will ensure either a printed ballot or notice of ballot is mailed to all members eligible to vote if there are sufficient nominations made by the nominating committee or by petition to provide more nominees than open positions. The secretary may use electronic mail to provide the notice of ballot to members who have opted to receive notices or statements electronically;
(c) If the credit union conducts its elections electronically, the secretary will ensure the transmission of the following materials to each eligible voter using the following procedures:
(1) One notice of balloting stating the names of the candidates for the board of directors and the candidates for other separately identified offices or committees. The notice must include a brief statement of qualifications and biographical data for each candidate in a form approved by the board of directors. The secretary may use electronic mail to provide the notice of ballot to members who have opted to receive notices or statements electronically.
(2) One mail ballot that conforms to Section 2(d) of this article, as well as instructions for the electronic election procedure, including how to access and use the system and the timeframe for voting. The instructions will state that members without the requisite electronic device necessary to vote on the system may vote by submitting the enclosed mail ballot and specify the date the mail ballot must be received by the credit union. For members who have opted to receive notices or statements electronically, the mail ballot is not required and the secretary may use electronic mail to provide the instructions for the electronic election procedure.
(3) The election tellers verify, or cause to be verified, the name of the voter and their credit union account number as registered in the electronic balloting system. The election tellers will test the integrity of the balloting system at regular intervals during the election period.
(4) Election tellers must receive ballots no later than midnight, 5 calendar days before the annual meeting.
(5) Election tellers will tally the vote and the chair will make the result of the vote public at the annual meeting.
(6) If the electronic balloting system malfunctions, the board of directors may, in its discretion, hold the election by mail ballot only. The mail ballots must conform to Section 2(d) of this article and the secretary must mail them once more to all eligible members 30 days before the annual meeting. The board may make reasonable adjustments to the voting time frames above, or postpone the annual meeting when necessary, to complete the elections before the annual meeting.
(d) If the credit union conducts its election by mail ballot, the secretary will ensure the mailing of the following materials to each member using the following procedures:
(1) One ballot, clearly identified as the ballot, with the names of the candidates for the board of directors and the candidates for other separately identified offices or committees printed in random order. A brief statement of qualifications and biographical data for each candidate, in a form approved by the board of directors, will accompany the ballot;
(2) One ballot envelope, with instructions to place the completed ballot placed in the envelope and seal the envelope;
(3) One identification form the member completes that includes their name, address, signature and credit union account number;
(4) One mailing envelope that instructs the member to insert the sealed ballot envelope and the identification form. The mailing envelope must have prepaid postage and be preaddressed for return to the election tellers;
(5) When properly designed with features that preserve the secrecy of the ballot, the ballot, identification form, and prepaid postage and preaddressed return envelope may be combined;
(6) The election tellers will verify, or cause to be verified, the name and credit union account number of the voter as
(7) Election tellers must receive ballots mailed to them no later than midnight 5 days before the date of the annual meeting;
(8) The election tellers will tally the vote. They will verify the result at the annual meeting and the chair will make the result of the vote public at the annual meeting.
Section 3.
(a) Nominations for directors.
(b) Nominations for credit committee members, if applicable. Elections may be by separate ballots following the same order as the above nominations or, if preferred, may be by one ballot for all offices.
Section 4.
Section 5.
Section 6.
Section 7.
The credit union may select the following option:
Section 7. Members must be at least ____ years of age by the date of the meeting in order to vote at meetings of the members, sign nominating petitions, or sign petitions requesting special meetings. Members must be at least ____ years of age to hold elective or appointive office.
(a) The board of directors will appoint the election tellers;
(b) If there are sufficient nominations made by the nominating committee or by petition to provide more than one nominee for each open position, at least 30 days before the annual meeting, the secretary will ensure a printed ballot is mailed to all members of the credit union who are eligible to vote and who have submitted a written or electronic request for an absentee ballot;
(c) The secretary will ensure the following materials are mailed to each eligible voter who submitted a written or electronic request for an absentee ballot:
(1) One ballot, clearly identified as the ballot, with the names of the candidates for the board of directors and the candidates for other separately identified offices or committees printed in random order. A brief statement of qualifications and biographical data for each candidate, in a form approved by the board of directors, will accompany the ballot;
(2) One ballot envelope clearly marked with instructions to place the completed ballot placed in the envelope and seal the envelope;
(3) One identification form the member completes that includes their name, address, signature and credit union account number;
(4) One mailing envelope that instructs the member to insert the sealed ballot envelope and the identification form. The mailing envelope must have prepaid postage and be preaddressed for return to the election tellers;
(5) When properly designed with features that preserve the secrecy of the ballot, the ballot, identification form, and prepaid postage and preaddressed return envelope may be combined;
(d) The election tellers will verify, or cause to be verified, the name and credit union account number of the voter as appearing on the identification form. The tellers will retain the verified identification and the sealed ballot envelope until the vote count is completed. In the event of a questionable or challenged identification form, the tellers must retain the identification form and the sealed ballot envelope together until the verification or challenge is resolved. If more than one voting procedure is used, the tellers must verify that no eligible voter voted more than one time;
(e) Election tellers must receive ballots mailed to them no later than midnight 5 days before the date of the annual meeting;
(f) Members or authorized personnel will deposit absentee ballots in the ballot boxes taken to the annual meeting or included in a precount in accordance with procedures specified in Article V, Section 2; and
(g) If a member has chosen to receive statements and notices electronically, the credit union may provide notices required in this section by email and provide instructions for voting via electronic means instead of mail ballots.
Section 1.
Section 2.
b. __ (Fill in the number, which may be zero) immediate family members, or those persons living in the same household, of a director may be a paid employee of the credit union.
c. The total number of directors serving who fall into each of the
• Management official plus assistant management official(s) plus other employees;
• Immediate family members or persons in the same household as the management official, assistant management official(s), and other employees; or
• Management official plus assistant management official(s) plus other employees, plus immediate family members or persons in the same household as management officials, assistant management officials and other employees.
d. __ (Fill in the number, which may be zero) committee member(s) may be a paid employee of the credit union. __ (Fill in the number, which may be zero) immediate family members, or those persons living in the same household, of a committee member(s) may be a paid employee of the credit union.
Section 3.
Section 4.
Section 5.
Section 6.
(a) Directing the affairs of the credit union in accordance with the Act, these bylaws, the rules and regulations and sound business practices.
(b) Establishing programs to achieve the purposes of this credit union as stated in Article I, Section 2, of these bylaws.
(c) Establishing lending policies, a loan collection program, and authorizing the charge-off of uncollectible loans.
(d) Establishing policies to address training for directors and volunteer officials in areas such as ethics and fiduciary responsibility, regulatory compliance, and accounting.
(e) Ensuring that staff and volunteers who handle the receipt, payment or custody of money or other property of this credit union; or property in its custody as collateral or otherwise, are properly bonded in accordance with the Act and regulations.
(f) Performing additional acts and exercising additional powers as required or authorized by applicable law and regulation.
(g) Reviewing denied loan applications of members who file written requests for review.
(h) Appointing one or more loan officers and delegating to those officers the power to approve or disapprove loans, lines of credit or advances from lines of credit.
(i) In its discretion, appointing a loan review (the credit union may fill in another name if desired) committee to review loan denials and delegating to the committee the power to overturn denials of loan applications. The committee will function as a mid-level appeal committee for the board. The board must review all loans denied by the committee upon written request of the member.
(g) Appointing an odd number of credit committee members as provided in Article VIII of these bylaws.
Section 7.
Section 8.
b. The board may remove any board officer from office for failure to perform any significant duties as an officer. Prior to removal, the board must give the officer reasonable notice and an opportunity to respond to the issues.
c. When any board officer, membership officer, executive committee member or investment committee member is absent, disqualified, or otherwise unable to perform the duties of the office, the board may by resolution designate another member of this credit union to fill the position temporarily. The board may also, by resolution, designate another member or members of this credit union to act on the credit committee when necessary in order to obtain a quorum.
Section 9.
Section 10.
Section 1.
Section 2.
Section 3.
Section 4.
Section 5.
Section 6.
(a) Have charge over all funds, securities, valuable papers and other assets of this credit union.
(b) Provide and maintain full and complete records of all the assets and liabilities of this credit union in accordance with prescribed law, regulation, and Administration guidance.
(c) Within 20 days after the close of each month, prepare and submit to the board a financial statement showing the condition of this credit union as of the end of the month, including a summary of delinquent loans; and post a copy of the statement in a conspicuous place in the office of the credit union where it will remain until replaced by the next month's financial statement.
(d) Ensure that financial and other reports the Administration may require are prepared and sent.
(e) Within standards and limitations set by the board, employ sufficient staff to run the credit union, and have the power to remove these employees.
(f) Perform other duties customarily assigned to the office of the financial officer or duties assigned by board resolution that are not inconsistent with the Act, regulations, and these bylaws.
ii. The board may employ one or more assistant financial officers, none of whom may also hold office as chair or vice chair. The board may authorize them, under the direction of the financial officer, to perform any of the duties falling to the financial officer, including the signing of checks. When
Section 7.
Section 8.
Section 9.
Section 10.
Section 11.
Section 1.
Section 2.
Section 3.
Section 4.
Section 5.
Section 6.
Section 7.
Section 8.
Section 1.
Section 2.
Section 3.
Section 4.
Section 1.
Section 2.
Section 3.
a. The supervisory committee makes, or arranges for, the audits, and prepares and submits the written reports required by the Act and regulations. The committee may employ and use the clerical and auditing assistance required to carry out its responsibilities. The committee may request the board to provide compensation for this assistance. It will prepare and forward to the Administration required reports.
b. If all director positions become vacant at once, the supervisory committee immediately assumes the role of the board of directors. The supervisory committee acting as the board must generally call and hold a special meeting to elect a board. That board will serve until the next annual meeting. They must hold the special meeting at least 7 but no more than 14 days after all director positions became vacant. Nominations for the board at the special meeting are by petition or from the floor. However, the supervisory committee may forego the special meeting if the next annual meeting will occur within 45 days after all the director positions become vacant.
c. The supervisory committee acting as the board may not act on policy matters. However, directors elected at a special meeting have the same powers as directors elected at the annual meeting.
Section 4.
Section 5.
Section 6.
Section 1.
Section 2.
Section 3.
Article X of the bylaws shall be amended to read as follows:
Section 1.
Section 2.
Section 1.
Section 1.
• Call a special meeting of the members;
• Provide the member the opportunity to be heard; and
• Obtain a two-thirds vote of the members present at the special meeting.
The credit union may also expel a member under a nonparticipation policy given to each member that follows the requirements found in the Act. Expulsion or withdrawal does not relieve a member of any liability to this credit union. The credit union will pay all of their shares upon their expulsion or withdrawal less any amounts due to this credit union.
Section 1.
Section 1.
Section 2.
Section 3.
Section 4.
b. If the board receives a matter affecting any director's interest, the director must withdraw from the consideration or determination of that matter. If the remaining qualified directors present at the meeting plus the disqualified director or directors constitute a quorum, the remaining qualified directors, by majority vote, may exercise with respect to this matter all the powers of the board. In the event of the disqualification of any member of the credit committee, if applicable, or the supervisory committee, that committee member must withdraw from the deliberation or determination.
Section 5.
Section 6.
Section 7.
Section 8.
[ ] Law of the State of __:
[ ] Model Business Corporation Act:
The following individuals from any liability asserted against them and expenses reasonably incurred by them in connection with judicial or administrative proceedings to which they are or may become parties by reason of the performance of their official duties (check as appropriate).
[ ] Current officials.
[ ] Former officials.
[ ] Current employees.
[ ] Former employees.
(b) The credit union may purchase and maintain insurance on behalf of the individuals indicated in (a) above against any liability asserted against them and expenses reasonably incurred by them in their official capacities and arising out of the performance of their official duties to the extent such insurance is permitted by the applicable State law or the Model Business Corporation Act.
(c) The term “official” in this bylaw means a person who is a member of the board of directors, credit committee, supervisory committee, other volunteer committee (including elected or appointed loan officers or membership officers), established by the board of directors.
Section 9.
Section 1.
Section 1.
“Act” means the Federal Credit Union Act, as amended.
“Administration” means the National Credit Union Administration.
“Agency” means the Regional Director, the Director of the Office of National Examinations and Supervision, or the Director of the Office of Credit Union Resources and Expansion.
“Applicable law and regulations” means the Federal Credit Union Act and rules and regulations issued thereunder or other applicable federal and state statutes and rules and regulations issued thereunder as the context indicates.
“Board” means board of directors of the federal credit union.
“Board officers” means:
1. “Chair” means Presiding Board officer, President of the Board, Presiding Board Officer, or Chairperson.
2. “Vice Chair” means Vice President.
3. “Financial Officer” means Treasurer.
4. “Secretary” means Recording Officer.
5. “Management Official” means General Manager, Manager, President, or Chief Executive Officer.
“Charter” means the approved organization certificate and field of membership issued by the National Credit Union Administration or one of its predecessors. It is the document that authorizes a group to operate as a credit union, defines the fundamental limits of its operating authority, and includes the persons the credit union is permitted to accept for membership.
“Field of membership” means the persons (including organizations and other legal entities) a credit union is permitted to accept for membership.
“Immediate family member” means spouse, child, sibling, parent, grandparent, grandchild, stepparents, stepchildren, stepsiblings, and adoptive relationships.
“Loans” means any type of loan product the credit union offers. This includes, but is not limited to, consumer loans, lines of credit, credit cards, member business loans, commercial loans, and real estate loans.
“Management” means the Board, Financial Officer, and Management Official.
“Member” means a person must:
1. Be eligible for membership under Section 5 of the charter;
2. Sign membership forms as approved by the credit union board;
3. Subscribe to at least one share (par value) of stock;
4. Pay the initial installment;
5. Pay an entrance fee, if required; and
6. Be eligible to vote upon reaching the minimum age the credit union establishes for voting and participation in the affairs of the credit union.
“Membership Officer” means a majority of the board of directors, a majority of the members of a duly authorized executive committee, or an individual(s) appointed by the board of directors to serve as such.
“NCUA Board” means the Board of the National Credit Union Administration.
“Person in the same household” means an individual living in the same residence maintaining a single economic unit.
“Regulation” or “regulations” means rules and regulations issued by the NCUA Board.
“Share” or “shares” means all classes of shares and share certificates that may be held in accordance with applicable law and regulations.
b. FCUs should also make specific note of Article XIV, § 1 of the bylaws, which spells out in detail the procedure required to expel an individual from membership. This procedure is mandated by the Act.
b. There is no requirement that the beneficiaries be members, since they may never actually come to own the funds or have a right to them. Furthermore, in the case of a revocable trust, since it is essentially indistinguishable from the member, there is no need for the trust to have a separate account number assigned or for it to be viewed as a legal entity separate from the member who set it up.
c. In the case of an irrevocable trust, the requirements are somewhat different. Membership requirements here may be met though either the settlor, who is the original owner of the funds, or the beneficiary, who obtains an equitable, beneficial interest in the funds once the trust is established. So long as one or the other is eligible for membership, the credit union may accept the account. Furthermore, as with revocable trusts, the membership obligation can be met through the opening of the trust account itself; it is not required that the beneficiary or the settlor have previously established a separate, regular share account. Most irrevocable trusts have a trustee who has administrative responsibility for the account, and so the credit union will typically deal with the trustee for purposes such as sending monthly statements and year-end tax reporting. However, the trustee need not actually be a member of the credit union, and the credit union need not necessarily view the trust account as a separate legal entity, with its own separate tax ID number. Instead, it need only verify and confirm the eligibility of either the settlor or the beneficiary (or all of the settlors or all of the beneficiaries in the case of multiple settlors or beneficiaries) to join the credit union.
d. A trust itself, either revocable or irrevocable, may be a member of the credit union in its own right if all parties to the trust, including all settlors, beneficiaries and trustees, are within the field of membership.
(a) The individual must be a member of the FCU before distribution of ballots;
(b) The individual cannot have been convicted of a crime involving dishonesty or breach of trust unless the NCUA Board has waived the prohibition for the conviction; and
(c) The individual meets the minimum age requirement established under Article V, § 7 of the FCU Bylaws.
Anyone meeting the three eligibility requirements may run for a seat on the board of directors if properly nominated. It is the nominating committee's duty to ascertain that all nominated candidates, including those nominated by petition, meet the eligibility requirements.
The contents of the notice to members required in section (1)(c) does not alter the basic election procedures the credit union has selected. Should the number of the nominating committee nominees fall below the number of positions to be filled after the member notice is sent, this section does not permit nominations from the floor. Only option A1 permits nominations from the floor.
To assist them in providing advice, Directors emeriti have access to confidential information, including but not limited to the credit union's examination reports and CAMEL ratings, to the same extent as members of the board. Directors emeriti are also subject to the same confidentiality and conflict of interest standards applicable to directors.
b. To assist their learning process, the board may determine to permit associate directors to have access to confidential information, including but not limited to the credit union's examination reports and CAMEL ratings, to the same extent as members of the board. Associate directors are also subject to the same confidentiality and conflict of interest standards applicable to directors.
b. Members of the board must hold the vote for the specified officer positions at the first board meeting following the annual meeting of the members. This board meeting should be held not later than seven days after the annual meeting. The Act requires the credit union to file a record of the names and addresses of the executive offices, members of the supervisory committee, credit committee, and loan officers be filed with the Administration within ten days after election or appointment.
c. Officers hold their respective officer positions for a term of one year, until the first board meeting that follows the next annual meeting of the members. At that board meeting, officer positions are again filled. Each board officer holds his or her position until the election and qualification of his or her successor. Thus, a board officer who is re-elected to the position he or she is currently holding serves for another year. Where another director is chosen to fill the position, he or she takes office effective as of the date of the election, assuming he or she is qualified—meaning simply that he or she was properly elected by the membership to the board in the first place and is in good standing as a director.
d. As specified in this bylaw, the board chair presides at all board meetings. In the absence of the chair or his or her inability to act, the vice chair presides at the meeting. In the absence or inability to act of both the chair and the vice chair, those directors who are present may select from among their number an individual director to act as temporary chair for that particular meeting. Actions taken by the board under the direction of the temporary chair have the same validity and effect as if taken under the direction of the chair or the vice chair, provided a quorum of the board, including the temporary chair, is present. If the board secretary is absent for any reason from a meeting, the chair (or acting chair) must select another director to fulfill the secretary's function at the meeting.
• The bylaws govern the conduct of special meetings;
• Members must have the opportunity to vote, at a meeting, on the Supervisory Committee's suspension of a director;
• FCU members may be expelled by vote of members present at a meeting called for that purpose.
Commodity Futures Trading Commission.
Final rule.
The Commodity Futures Trading Commission (“Commission” or “CFTC”) is amending the de minimis exception within the “swap dealer” definition in the Commission's regulations by setting the aggregate gross notional amount threshold for the de minimis exception at $8 billion in swap dealing activity entered into by a person over the preceding 12 months.
This rule is effective November 13, 2018.
Matthew Kulkin, Director, 202-418-5213,
Title VII of the Dodd-Frank Wall Street Reform and Consumer Protection Act (“Dodd-Frank Act”)
CEA section 1a(49) defines the term “swap dealer” to include any person who: (1) Holds itself out as a dealer in swaps; (2) makes a market in swaps; (3) regularly enters into swaps with counterparties as an ordinary course of business for its own account; or (4) engages in any activity causing the person to be commonly known in the trade as a dealer or market maker in swaps (collectively referred to as “swap dealing,” “swap dealing activity,” or “dealing activity”).
Pursuant to the statutory requirements, in December 2010, the Commissions issued a proposing release (“SD Definition Proposing Release”)
When the $3 billion AGNA threshold was established, the Commissions explained that the information then available regarding certain portions of the swap market was limited, and that they expected more information to be available in the future (following the implementation of swap data reporting), which would enable the Commissions to make a more informed assessment of the De Minimis Exception and to revise it as appropriate.
In November 2015, staff issued a preliminary report concerning the De Minimis Exception (“Preliminary Staff Report”).
To provide additional time for more information to become available to study the De Minimis Exception, in October 2016 the Commission issued an order, pursuant to paragraph (4)(ii)(C)(
The policy goals underlying SD registration and regulation generally include reducing systemic risk, increasing counterparty protections, and increasing market efficiency, orderliness, and transparency.
Consistent with Congressional intent, “an appropriately calibrated de minimis exception has the potential to advance other interests.”
As noted in the SD Definition Adopting Release, “implementing the de minimis exception requires a careful balancing that considers the regulatory interests that could be undermined by an unduly broad exception as well as those regulatory interests that may be promoted by an appropriately limited exception.”
Generally, a person must count towards its AGNA threshold all swaps it enters into for dealing purposes over the preceding 12-month period. In addition, each person whose own swaps do not exceed the AGNA threshold must also include in its de minimis calculation the AGNA of swaps of any other unregistered affiliate controlling, controlled by, or under common control with that person (referred to as “aggregation”).
Pursuant to various CFTC regulations, certain swaps, subject to specific conditions, need not be considered in determining whether a person is an SD, including: (1) Swaps entered into by an IDI with a customer in connection with originating a loan to that customer;
On June 12, 2018, the Commission published for public comment a Notice of Proposed Rulemaking (“NPRM”) to amend the De Minimis Exception by: (1) Setting the AGNA threshold for the De Minimis Exception at $8 billion in swap dealing activity entered into by a person over the preceding 12 months; (2) adding new factors to the De Minimis Exception that would lead to excepting from the AGNA calculation: (a) Certain swaps entered into with a customer by an IDI in connection with originating a loan to that customer, (b) certain swaps entered into to hedge financial or physical positions, and (c) certain swaps resulting from multilateral portfolio compression exercises; and (3) providing that the Commission may determine the methodology to be used to calculate the notional amount for any group, category, type, or class of swaps, and delegating to the Director of the Division of Swap Dealer and Intermediary Oversight (“DSIO”) the authority to make such determinations (collectively, the “Proposal”).
In addition, the Commission sought comment on the following additional potential changes to the De Minimis Exception: (1) Adding as a factor a minimum dealing counterparty count threshold and/or a minimum dealing transaction count threshold; (2) adding as a factor whether a swap is exchange-traded and/or cleared; and (3) adding as a factor whether a swap is categorized as a non-deliverable forward transaction.
The various aspects of the NPRM are discussed in further detail below. The Commission received 43 letters and Commission staff participated in four ex parte meetings
Given the more complete information now available regarding certain portions of the swap market, the data analytical capabilities developed since the SD regulations were adopted, five years of implementation experience, and comments received in response to the NPRM, in this adopting release the Commission is amending the De Minimis Exception by setting the AGNA threshold at $8 billion in swap dealing activity. The CFTC may in the future separately propose or adopt rules addressing any aspect of the NPRM that is not finalized in this release.
This change to the De Minimis Exception is being adopted pursuant to the Commission's authority under CEA section 1a(49)(D), which requires the Commission to exempt from designation as an SD an entity that engages in a de minimis quantity of swap dealing in connection with transactions with or on behalf of its customers, and to promulgate regulations to establish factors with respect to the making of this determination to exempt.
The Commission proposed to amend paragraph (4)(i)(A) of the De Minimis Exception by setting the AGNA threshold at $8 billion. For added clarity, the Commission also proposed
The Commission proposed to maintain the AGNA threshold at $8 billion, and also solicited comment on whether to reduce the threshold to $3 billion, or increase the threshold. The Commission cited as relevant an analysis of SDR data from January 1, 2017, through December 31, 2017 (the “review period”).
Generally employing methodologies similar to those used for purposes of the Staff Reports, staff attempted to calculate persons' swaps activity in terms of AGNA to assess how the swap market might be impacted by potential changes to the current De Minimis Exception. The reason an entity enters into a swap (
With the benefits of improved data quality and analytical tools, staff conducted a more granular analysis (as compared to the Staff Reports) to more accurately identify those entities that, based on their observable business activities, were potentially engaging in swap dealing activity (“In-Scope Entities”)
With respect to NFC swaps, Commission staff encountered a number of challenges in calculating notional amounts, including: (1) The vast array of underlying commodities with differing characteristics; (2) the multiple types of swaps (
The analysis conducted for the Proposal largely confirmed the analysis conducted for the Staff Reports;
To assess the relative impact on the swap market of potential changes to the De Minimis Exception, CFTC staff analyzed the extent to which the swap market was subject to SD regulation during the review period because at least one counterparty to a swap was a registered SD (“2017 Regulatory Coverage”). Specifically, with regard to 2017 Regulatory Coverage, staff identified the extent to which: (1) Swaps activity, measured in terms of AGNA or transaction count, was subject to SD regulation during the review period because at least one counterparty to a swap was a registered SD (“2017 AGNA Coverage” or “2017 Transaction Coverage,” as applicable); and (2) counterparties in the swap market transacted with at least one registered SD during the review period (“2017 Counterparty Coverage”).
Additionally, staff estimated regulatory coverage by assessing the extent to which the swap market would have been subject to SD regulation at different AGNA thresholds because at least one counterparty to a swap was identified as a “Likely SD” (“Estimated Regulatory Coverage”). For purposes of this analysis, the term “Likely SD”
Most commenters that addressed this aspect of the Proposal stated that the AGNA threshold should not decrease to $3 billion, and/or supported setting the threshold at $8 billion.
Specifically, commenters stated that a reduced AGNA threshold could lead to some entities reducing or ceasing swaps activity to avoid registration and its related costs, which could lead to negative impacts for swap market participants. For example, fewer de minimis dealers could mean that small and mid-sized end-users and commercial entities who utilize swaps for hedging purposes, as well as NFC swap market participants, would have fewer dealers available to them.
Several commenters also noted that the current $8 billion threshold already subjects the vast majority of transactions to SD regulation, or that a reduced threshold would not capture significant additional dealing activity.
Some commenters stated that the nature of the swaps activity entered into by certain entities poses less systemic risk—
Several commenters stated that maintaining the $8 billion threshold provides regulatory stability or alleviates the uncertainty currently experienced by market participants with an AGNA of swap dealing activity between $3 billion and $8 billion.
Some commenters suggested that maintaining the $8 billion threshold would enable the Commission to focus its limited resources on entities whose swap dealing is sufficient in size and scope to warrant oversight.
With respect to NFC swaps, EEI/EPSA and NGSA expressed concern that a lower AGNA threshold would provide less accommodation for increasing NFC prices, which could lead to market participants reducing their swap dealing activity to remain below the threshold.
A few commenters addressed the compliance costs associated with SD registration,
BDA stated that the CFTC should clarify whether changes to the De Minimis Exception would be applicable to activity that occurred in the preceding 12 months.
Some commenters stated that the Commission should also consider a higher AGNA threshold, maintaining generally that the policy goals for SD registration and a de minimis exception would be better advanced if the threshold was higher than $8 billion.
Specifically, several commenters stated that an increased threshold would not lead to a significant decrease in regulatory coverage of swap dealing activity.
Further, a few commenters stated that given the costs of SD registration, a higher threshold would encourage new participants to engage in swap dealing activity, which SVB noted as important given the highly concentrated nature of the SD market, where the nation's largest banks control the vast majority of swap market share.
Additionally, ABA indicated that an increased threshold would result in aggregate compliance cost savings for market participants. For example, AGNA thresholds of $15 billion and $50 billion would result in potential aggregate savings of $81 million and $170 million, respectively, on a net present value basis, as compared to an $8 billion threshold.
Better Markets and the Senators stated that the Commission should permit the AGNA threshold to decrease to $3 billion, contending generally that the data insufficiently or misleadingly justifies maintaining the threshold at $8 billion,
The Senators stated that though notional amount data for NFC swaps was not used in considering the Proposal, the data that was available for NFC swaps shows significantly less regulatory coverage under an $8 billion threshold than in other asset classes. The Senators commented that though the Proposal notes the “unique characteristics” of NFC swaps, the analysis provided to justify the $8 billion threshold indicates a series of assumptions and possibilities rather than concrete data. The Senators also questioned why, given the lack of relevant notional amount data for NFC swaps, it is necessary to maintain the $8 billion threshold for SDs involved with energy-related swaps.
Better Markets claimed that the regulatory coverage statistics are incomplete, misleading, and irrelevant to the Dodd-Frank Act's activities-based standard for SD registration, stating that the high AGNA and transaction coverage percentages are not indicative of the absolute level of swap dealing activities relevant to SD registration under CEA section 1a(49)(A). Further, in connection with the 680 additional counterparties that would potentially benefit from SD regulations under a lower $3 billion threshold, Better Markets asserted that expanding counterparty protections to hundreds of market participants would have more than a “limited” effect on counterparty protection once relative statistics are abandoned.
Better Markets also asserted that the data filtering methodology was flawed and inadequately explained. Better Markets explained that, with respect to the 10 counterparty count filter, if a commodities affiliate of a large firm held itself out as an SD or stood ready to accommodate the demand of nine counterparties, that affiliate should have been treated, for purposes of the analysis, as an SD on account of its swap dealing activities, unless those activities did not exceed the AGNA threshold or otherwise were excluded from the SD registration analysis. Further, Better Markets argued that: (1) The CFTC should have provided an opportunity for public comment on the assumptions that were made in the CFTC's analysis; (2) there was some ambiguity in the terms used in the CFTC's analysis; (3) the CFTC's reliance upon a 10 unique counterparty filter was based on fatally flawed logic; (4) the data limitations demonstrate the benefits of better field-level and affiliate reporting of swaps, which would give the CFTC an informed basis to consider changes to the $3 billion threshold; and (5) the CFTC must first amend its swap data and chief compliance officer reporting regulations to ensure it has sufficient data to provide an informed basis for administrative action.
Further, Better Markets commented that the de minimis threshold framework should be revised to focus on strict, observable measures like total notional amount or transactional activities, rather than a subset of such activities that potential registrants are able to interpret for themselves, and are not presently required by regulation to monitor, report, or internally track across the firm.
Better Markets also asserted that the statutory provision regarding the de minimis exception authorizes the CFTC to issue exemptive orders for individual or similarly-situated legal entities based upon generally applicable factors for determining whether such entities may be involved in a de minimis amount of swap dealing activities. Better Markets noted that it is unreasonable to conclude that Congress intended a wholesale exemption from registration that is divorced from the particular circumstances of any one petitioner. Further, Better Markets argued that the language in the exemptive mandate must be construed in a manner that is faithful to Congress' intent that the quantity of exempted swap dealing activities be minimal, a concept that has boundaries that can be drawn far short of billions of dollars and thousands of transactions by unregulated entities.
AFR stated that, though the improved data adds weight to the claim that an $8 billion threshold is appropriate for some financial swaps, arguments against the $8 billion threshold are particularly strong in the case of NFC markets. Specifically, AFR asserted that the Commission should be willing to vary the de minimis threshold based on market characteristics, and in particular should reduce the $8 billion threshold in NFC markets where $8 billion in notional amount represents a different level of economic significance than in some other markets. AFR elaborated that the Commission continues to lack data on the notional amount for NFC swaps, making it difficult to draw definitive conclusions on the economic significance of the activity that is not subject to SD regulation, and stated that significant dealing activity in the NFC market is not subject to SD regulation since roughly half of all the entities with 10 or more NFC swap counterparties are not registered as SDs.
AFR also stated that the AGNA threshold analysis does not account for the numerous other exceptions proposed, which could exclude very large amounts of swaps activity from being considered in the de minimis calculation.
IATP stated that the data analysis does not support the idea that more ancillary dealing would promote greater competition, and thus more efficient and transparent price discovery. IATP asserted that the Commission's true motivation for maintaining an $8 billion threshold is the regulatory compliance cost and burden reduction objective of Project KISS, rather than promoting improved price discovery. Further, IATP claimed that the AGNA of activity in the swap market has shrunk due to the clearing of swaps on centralized platforms and the migration of swaps to the futures markets, not because of constraints of the de minimis threshold or because of the lack of exemptions to the calculation of that threshold. IATP also stated that though it did not have a data-based argument for changing the $8 billion threshold, it believed that maintaining the $8 billion threshold because of potential administrative burdens involved in lowering the threshold is a poor, Project KISS-based, rationale that does not consider the benefits of SD registration for the financial integrity and price discovery of the swap market.
Some commenters addressed the testing frequency for the threshold. Commenters stated that the AGNA threshold calculation should continue to be based primarily on a rolling 12-month test of the AGNA of swap dealing activity.
A number of commenters addressed whether the Commission should consider an alternative to a threshold based on the AGNA of swap dealing activity.
AFR and IECA noted that using AGNA as the relevant criterion for SD registration, as compared to other options, is beneficial because: (1) Resources have been expended to comply with the current approach, and changing that approach would add costs for no perceived benefit;
AFR stated that controlling operational risk, not simply market risk, is a major reason for SD designation, and AGNA remains a good measure of the total operational risks incurred by an entity,
However, IECA indicated that although using an alternative netting option (
Commenters also stated that a tiered SD registration structure should not be considered, noting that a tiered structure could: (1) Create more uncertainty for situations where legal and regulatory certainty is important;
Several commenters also addressed whether the Commission should consider counterparty count and transaction count as additional metrics to be included in the de minimis threshold, as discussed in section IV.A below.
Commenters addressed other calculation changes the Commission should consider for the de minimis threshold.
Virtu stated that the CFTC should exempt swap transactions where one party is a registered SD or one party holds their account with a registered SD since these transactions are already subject to the existing reporting
JBA stated that the CFTC should specify that the termination and modification of terms and conditions of existing transactions do not count towards the threshold, noting that termination of transactions mitigates counterparty credit risk and reduces the outstanding AGNA of swaps.
BDA argued that the CFTC should consider increasing the “special entity” threshold to $100 million in order to provide special entities with more access to the marketplace. BDA maintained that the $25 million threshold results in many mid-sized firms deciding not to enter into swaps with special entities, while an increase in that threshold could provide better market access for special entities while having no material impact on the overall regulation of SDs.
Virtu asserted that transactions by market makers maintaining net open positions not exceeding $1 billion (over a 12-month period) should be exempted from the de minimis threshold calculation.
IIB stated that entities that have discontinued new swap dealing activity should not have to count towards their AGNA threshold certain transactions that modify legacy swaps entered into by those entities, including: (1) Partial or full terminations; (2) modifications that shorten the duration of an outstanding swap; (3) partial or full novations of legacy swap transactions; or (4) swaps submitted for clearing.
With respect to cross-border issues, JBA stated that the market has been divided into two groups because non-SD entities outside of the U.S. avoid transactions with U.S. persons, thereby undermining the diversity of U.S. markets.
Upon consideration of the comments,
As discussed in the Proposal,
During the review period, almost all swap transactions involved at least one registered SD as a counterparty—greater than 99 percent for IRS, CDS, FX swaps, and equity swaps. For NFC swaps, approximately 86 percent of transactions involved at least one registered SD as a counterparty. Overall, approximately 98 percent of transactions involved at least one registered SD. Further, almost all AGNA of swaps activity included at least one registered SD—greater than 99 percent for IRS, CDS, FX swaps, and equity swaps. The Commission notes that the 2017 Counterparty Coverage was approximately 83.5 percent—
Given the high percentage of swaps that were subject to SD regulation at the existing $8 billion threshold during the review period, a lower threshold of $3 billion would result in only a small amount of additional activity being directly subjected to SD regulation. Specifically, the Estimated AGNA Coverage would have increased from approximately $221,020 billion (99.95 percent) to $221,039 billion (99.96 percent)—an increase of $19 billion (a 0.01 percentage point increase). The Estimated Transaction Coverage would have increased from 3,795,330 trades (99.77 percent) to 3,797,734 trades (99.83 percent)—an increase of 2,404 trades (a 0.06 percentage point increase). The Estimated Counterparty Coverage would have increased from 30,879 counterparties (88.80 percent) to 31,559 counterparties (90.75 percent)—an increase of 680 counterparties (a 1.96 percentage point increase). These small increases in Estimated Regulatory Coverage indicate that the systemic risk mitigation, counterparty protection, and market efficiency benefits of SD regulation would be enhanced in only a very limited manner if the threshold decreased from $8 billion to $3 billion. Additionally, the limited regulatory and market benefits of a $3 billion threshold should be considered in conjunction with the costs associated with a lower threshold (
Additionally, as discussed by the Commission and most commenters, a $3 billion AGNA threshold could lead certain entities to reduce or cease swap dealing activity to avoid registration and its related costs.
Further, although approximately 86 percent of NFC swaps involved at least one registered SD compared to approximately 99 percent for other asset classes, as discussed in the Proposal, the Commission is of the view that lower SD regulatory coverage is acceptable given the special characteristics of the NFC swap market. A reduced threshold likely would have negative impacts on NFC swap liquidity as some entities (
The Commission disagrees with the few commenters that stated that the AGNA threshold should decrease to $3 billion.
Better Markets stated that the high regulatory coverage ratios are not indicative of the absolute level of swap dealing activities relevant to SD registration, and asserted that maintaining an $8 billion threshold would have more than a limited detrimental effect on counterparty protections.
Additionally, as stated in the SD Definition Proposing Release and the SD Definition Adopting Release, the de minimis exception “should be interpreted to address amounts of dealing activity that are sufficiently small that they do not warrant registration to address concerns implicated by the regulations governing swap dealers and security-based swap dealers. In other words, the exception should apply only when an entity's dealing activity is so minimal that applying dealer regulations to the entity would not be warranted.”
As noted above in section II.B.3, Better Markets also asserted that the statutory provision regarding the de minimis exception authorizes the CFTC to issue exemptive orders for individual or similarly-situated legal entities based upon generally applicable factors for determining whether such entities may be involved in de minimis swap dealing activities. Better Markets contends that it is unreasonable to conclude that Congress intended a wholesale exemption from registration that is divorced from the particular circumstances of any one petitioner.
Also as noted above, with respect to the data analysis methodology, Better Markets and the Senators stated that the data insufficiently or misleadingly justifies maintaining the threshold at $8 billion.
First, with respect to Better Markets' comment that the Commission should have provided an opportunity for public comment on alternative assumptions for the data analysis, the Commission notes that the methodology used by Commission staff to analyze data in relation to the de minimis threshold was first laid out in the Preliminary Staff Report, on which the public had the opportunity to comment. The Final Staff Report updated that analysis, and then the Proposal explained how the data related specifically to the proposal to maintain the $8 billion threshold. As discussed in the Proposal, the updated analysis largely confirmed the analysis conducted for the Staff Reports. However, there is greater confidence in the results given the improved data and refined methodology. The Commission believes that the public has had an appropriate opportunity to comment on the data, the methodology, the assumptions about the data, and how the data relates to the maintenance of the $8 billion threshold.
Second, the Commission cannot assess Better Markets' comment that the analysis discussed in the Proposal contained ambiguous terms because Better Markets does not state which terms were ambiguous.
Third, the Commission disagrees with Better Markets' comment that “the fact that CFTC-registered swap dealers, including every major Wall Street bank, tend to have more than 10 counterparties is irrelevant.”
The Commission also believes that the 10 counterparty filter is appropriate for purposes of this analysis based on its observations of registered SDs and unregistered entities active in the swap market. As noted in the Proposal, data analysis showed that 83 percent of registered SDs had 10 or more counterparties, without weighting the results.
Fourth, the Commission does not believe that the data limitations warrant a delay in setting the threshold at $8 billion. As discussed, the data has improved since the analysis in the Staff Reports. Further, the Commission believes its analysis was appropriately conservative, particularly given that the volume of activity it analyzed was over-inclusive (since hedging and other non-dealing activity could not be excluded), and given that its entity-level exclusions were based on an informed assessment of the likely activity of swap market participants.
In the SD Definition Adopting Release, the Commission noted that “comprehensive information regarding the total size of the domestic swap market is incomplete, with more information available with respect to certain asset classes than others.”
Fifth, for similar reasons, the Commission does not believe it should wait to amend its swap data and chief compliance officer reporting regulations before setting the threshold at $8 billion. As noted above, the Commission believes that it does have sufficient data to support this action, so it is not necessary to wait for future changes to the data reporting regime.
As noted above, Better Markets also commented that the de minimis threshold framework should be revised to focus on strict, observable measures like total notional amount or transactional activities, rather than a subset of such activities that potential registrants are able to interpret for themselves, and are not presently required by regulation to monitor, report, or internally track across the firm.
As noted, the Senators stated that the data that was available for NFC swaps shows significantly less coverage for that asset class under an $8 billion threshold compared to other asset classes.
Further, AFR stated that, though the improved data adds weight to the claim that an $8 billion threshold is appropriate for some financial swaps, arguments against the $8 billion threshold are particularly strong in the case of NFC swaps.
Lastly, the Commission disagrees with IATP's assertion that promoting improved price discovery is not the true rationale for maintaining an $8 billion threshold, and that rather, the motivation is the regulatory compliance cost and burden reduction objective of Project KISS.
Although several commenters suggested a higher threshold, the Commission is declining to increase the AGNA threshold from the current $8 billion level. As discussed in the Proposal,
As the Commission and commenters have stated, the small decrease in Estimated AGNA Coverage and Estimated Transaction Coverage at higher thresholds potentially indicates that increasing the threshold to up to $100 billion may have a limited adverse effect on the systemic risk and market efficiency policy considerations of SD regulation.
Further, maintaining the status quo signals long-term stability of the de minimis threshold, and should provide for the efficient application of the SD Definition, as it allows for long-term planning based on the current AGNA threshold.
With respect to BDA's comment regarding permitting month-end only testing for the de minimis threshold, the Commission notes that several commenters indicated that the market has adapted to the current requirements and that changes would not be beneficial.
Similarly, in response to the commenters that recommended alternatives to the single AGNA threshold or other calculation changes,
Additionally, any modification to the special entity threshold is outside of the scope of the Proposal,
The Commission proposed adding an IDI loan-related factor in the De Minimis Exception (the “IDI De Minimis Provision”) to address concerns that there are circumstances where swaps not covered by the IDI loan-related swap exclusion in paragraph (5) of the SD Definition (the “IDI Swap Dealing Exclusion”) should be excluded from the de minimis calculation. Specifically, the Commission proposed to add specific characteristics that an IDI can consider when assessing whether swaps entered into with customers in connection with loans to those customers must be counted towards the IDI's de minimis calculation. The proposed IDI De Minimis Provision would have encompassed a broader scope of loan-related swaps than the IDI Swap Dealing Exclusion. The proposed IDI De Minimis Provision included: (1) A lengthier timing requirement for when the swap must be entered into; (2) an expansion of the types of swaps that are eligible; (3) a reduced syndication percentage requirement; and (4) an elimination of the notional amount cap. The IDI could exclude qualifying swaps from the de minimis calculation pursuant to the IDI De Minimis Provision regardless of whether the swaps would qualify for the IDI Swap Dealing Exclusion.
Almost all commenters that addressed the IDI De Minimis Provision expressed general support for the proposed amendment.
Commenters generally supported proposed new paragraph (4)(i)(C)(
Proposed new paragraph (4)(i)(C)(
Proposed new paragraph (4)(i)(C)(
Proposed new paragraph (4)(i)(C)(
The proposed IDI De Minimis Provision did not include the requirement in the IDI Swap Dealing Exclusion that the AGNA of swaps entered into in connection with the loan not exceed the principal amount outstanding,
In response to a question in the Proposal, three commenters stated that the CFTC should not impose any prior notice requirement or other conditions on the ability of IDIs to rely on the proposed IDI De Minimis Provision.
Two commenters discussed whether the IDI De Minimis Provision could be promulgated without a joint rulemaking.
The Commission has determined not to adopt the IDI De Minimis Provision at this time. The Commission continues to consider the issues raised by commenters. For example, the various contexts in which IDIs enter into swaps with their loan customers, and the relation between those swaps and the larger swap market, may merit further consideration.
The Commission proposed adding a provision in new paragraph (4)(i)(D) of the De Minimis Exception, to include as a factor whether a swap was entered into primarily for the purpose of hedging and met certain related conditions (the “Hedging De Minimis Provision”).
Most commenters supported including an express hedging exception that would clarify which physical and financial hedging swaps do not need to be included in the AGNA threshold calculation.
Generally, commenters supported adding the Hedging De Minimis Provision to the De Minimis Exception to provide more certainty and/or clarity regarding the treatment of hedging activity.
Several commenters noted that the price maker condition included in the proposed Hedging De Minimis Provision could be viewed as more
ISDA/SIFMA was of the view that the requirement that the primary purpose for entering into the swap must be to reduce or otherwise mitigate one or more “specific” risks is unreasonably restrictive.
AFR and Better Markets objected to the Hedging De Minimis Provision, stating that it could allow even large dealers to escape registration, and that the exclusion of anticipatory hedges allows too much discretion to institutional judgment.
Better Markets expressed concern that the Hedging De Minimis Provision promotes unregulated swap dealing and is therefore “not a valid statutory objective.” Furthermore, Better Markets stated that the Commission does not need to provide clarity for the existing hedging exemption because the existing standard of using facts and circumstances to distinguish dealing swaps is a “well-settled framework.”
AFR and Better Markets also asserted that the Hedging De Minimis Provision should not be included in the De Minimis Exception because enforcement of the conditions would be impractical.
The comments generally confirmed that nuanced facts and circumstances may be relevant to determining whether a swap that hedges financial risk, but also has dealing characteristics or is connected to dealing activities, should be counted toward the AGNA threshold. However, the comments also raised specific implementation and compliance issues. For these reasons, the Commission has determined not to adopt the Hedging De Minimis Provision at this time.
The Commission confirms that the “relevant facts and circumstances” test established in the SD Definition Adopting Release and further discussed in the DSIO FAQ Guidance
The Commission proposed new paragraph (4)(i)(E) of the De Minimis Exception, which would add as a factor in the de minimis calculation whether a swap results from multilateral portfolio compression exercises (“MPCE De Minimis Provision”). Specifically, the Proposal stated that for purposes of determining whether a person has exceeded the AGNA threshold set forth in paragraph (4)(i)(A), the person may exclude swaps that result from multilateral portfolio compression exercises, as defined in § 23.500 of Commission regulations, to the extent the person does not enter into the multilateral portfolio compression exercise in connection with activity structured to evade designation as an SD. The Proposal was consistent with DSIO no-action relief issued on December 21, 2012 (“Staff Letter 12-62”).
Most commenters addressing this aspect of the Proposal supported excepting from the de minimis threshold swaps that result from multilateral portfolio compression exercises,
Several commenters also stated that, given the policy-related similarities between bilateral and multilateral portfolio compression, the Commission should also exclude from counting towards the De Minimis Exception swaps that result from bilateral portfolio compression exercises.
On the other hand, AFR and IATP expressed concerns with the MPCE De Minimis Provision.
The Commission has determined not to adopt the MPCE De Minimis Provision at this time. The Commission believes that further action on this provision may require additional consideration of the various relevant issues.
Given the variety of potential methods that could be used to calculate the notional amount for certain swaps, particularly for swaps where notional amount is not a contractual term of the transaction (
Several commenters generally supported Commission efforts to provide certainty and clarity regarding calculation of notional amounts.
NRECA/APPA suggested that the Commission should not determine the methodology for calculating notional amounts, stating that the word “determine” in proposed new paragraph (4)(vii) of the De Minimis Exception should be changed to “provide guidance with respect to.”
Several commenters did not support the proposal to delegate to the Director of DSIO the authority to make notional calculation determinations.
On the other hand, several commenters supported the proposal to delegate to the Director of DSIO the authority to make notional calculation determinations.
Several commenters stated that notional calculation methodologies should be subject to a formal public notice and comment process.
Commenters also provided feedback regarding specific notional amount calculation methodologies.
The comments raised a number of issues with the proposed authority and delegation regarding the methodology for calculating notional amounts. Given the nature and significance of these issues, the Commission has determined to not adopt this provision at this time.
In the NPRM, the Commission did not propose, but sought comment on the following additional potential changes to the De Minimis Exception: (1) Adding a minimum dealing counterparty count threshold and/or a minimum dealing transaction count threshold; (2) establishing as a factor in the de minimis determination whether a given swap was exchange-traded and/or cleared; and (3) establishing as a factor in the de minimis determination whether a given swap is a non-deliverable forward transaction. The Commission did not propose rule text for any of these topics.
At this time, the Commission is not adopting final rules regarding any of these three potential changes. The Commission may take subsequent action
The Commission sought comment on whether an entity should be able to qualify for the de minimis exception if its level of swap dealing activity is below
The Commission sought comment on whether an exception from the de minimis calculation for swaps that are executed on an exchange (
The Commission sought comment on whether an exception from the de minimis calculation for non-deliverable forwards is appropriate. Most commenters generally supported including an exception for NDFs,
The Regulatory Flexibility Act (“RFA”) requires that agencies consider whether the regulations they propose will have a significant economic impact on a substantial number of small entities.
Accordingly, the Chairman, on behalf of the Commission, hereby certifies pursuant to 5 U.S.C. 605(b) that these regulations will not have a significant economic impact on a substantial number of small entities.
The Paperwork Reduction Act of 1955 (“PRA”)
The Commission notes that all reporting and recordkeeping requirements applicable to SDs result from other rulemakings, for which the CFTC has sought OMB approval, and are outside the scope of rulemakings related to the De Minimis Exception.
Section 15(a) of the CEA requires the Commission to consider the costs and benefits of its actions before promulgating a regulation under the CEA or issuing certain orders.
In this adopting release, the Commission is amending the De Minimis Exception by setting the AGNA threshold at $8 billion in swap dealing activity. The Proposal requested public comment on the costs and benefits of the proposed regulations, and specifically invited comments on: (1) The costs and benefits to market participants associated with each change; (2) the direct costs associated with SD registration and compliance; (3) the indirect benefits to registering as an SD; (4) the indirect costs to becoming a registered SD; (5) whether entities with dealing activity between $3 billion and $8 billion incur similar registration and compliance costs as compared to entities with dealing activity above $8 billion; (6) the costs and benefits to the public associated with each proposed change; (7) how each proposed change affects each of the Section 15(a) factors; (8) whether the Commission identified all of the relevant categories of costs and benefits in its preliminary consideration of the costs and benefits; and (9) whether the costs and benefits of the proposed changes, as applied in cross-border contexts, differ from those costs and benefits resulting from their domestic application, and, if so, in what ways and to what extent.
As part of this cost-benefit consideration, the Commission will discuss the costs and benefits of the adopted change and analyze the amendment as it relates to each of the
As discussed above, the De Minimis Exception provides an exception from the SD Definition for persons who engage in a de minimis amount of swap dealing activity. Currently, a person shall not be deemed to be an SD unless swaps entered into in connection with swap dealing activity exceed an AGNA threshold of $3 billion (measured over the prior 12-month period), subject to a phase-in period that is currently in effect, during which the AGNA threshold is set at $8 billion. The Commission is amending the De Minimis Exception to set the AGNA threshold at the current $8 billion phase-in level.
There are market-wide costs and benefits associated with setting the AGNA threshold at $8 billion. In addition, setting the threshold at $8 billion would have specific monetary costs and benefits as compared to a lower or higher threshold. The current $8 billion phase-in level threshold, along with the prospect that the threshold would decrease to $3 billion after December 31, 2019, in the absence of further Commission action, sets the baseline for the Commission's consideration of the costs and benefits of the proposed alternatives. Accordingly, the Commission considers the costs and benefits that would result from maintaining the current $8 billion phase-in level threshold, or alternatively, a threshold level below or above the current $8 billion threshold. The status quo baseline also includes other aspects of existing rules related to the De Minimis Exception. The analysis also takes into account any relevant no-action relief, to the extent such relief is being relied upon. As the Commission is of the belief that existing no-action relief related to the De Minimis Exception is being fully relied upon by market participants, the cost-benefit discussion that follows also considers the effects of that relief.
There are several policy objectives underlying SD regulation and the de minimis exception to SD registration, which have associated with them general costs and benefits depending on the level of the AGNA threshold. As discussed above in section I.A.3, costs and benefits may be associated with the primary policy objectives of SD regulation, which include reducing systemic risk, increasing counterparty protections, and increasing market efficiency, orderliness, and transparency.
As noted by the Commission and a few commenters, generally, the lower the threshold, the greater the number of entities that are subject to the SD-related regulatory requirements, which could decrease systemic risk, increase counterparty protections, and promote swap market efficiency, orderliness, and transparency.
On the other hand, and as discussed further below, the higher the threshold, the greater the number of entities that are able to engage in dealing activity without being required to register, which could increase competition and liquidity in the swap market. However, a higher AGNA threshold could potentially decrease the number of registered SDs, which could have a negative impact on achieving the general benefits associated with the policy objectives of SD regulation. This might adversely affect the swap market to some extent.
The comments received for this proposed amendment were generally supportive.
The Commission believes that this limited activity indicates that to the extent these entities are engaging in swap dealing activities, such activity is likely ancillary and in connection with other client services, potentially indicating that the benefits associated with the policy objectives of SD registration and the de minimis
Commenters generally agreed with the Commission's position. For example, many commenters noted that the current $8 billion threshold already subjects the vast majority of transactions to SD regulation, or that a reduced threshold would not capture significant additional dealing activity.
However, as discussed above, Better Markets stated that the high regulatory coverage ratios are not indicative of the absolute level of swap dealing activities relevant to SD registration, and noted that maintaining an $8 billion threshold would have more than a limited effect on counterparty protections.
Additionally, the Senators stated that though notional amount data for NFC swaps was not used in considering the Proposal, the data that was available for NFC swaps shows significantly less coverage for NFC swaps under an $8 billion threshold than in other asset classes.
The Commission is of the view that the systemic risk mitigation, counterparty protection, and market efficiency benefits of SD regulation would be enhanced in only a very limited manner if the AGNA threshold decreased from $8 billion to $3 billion, as would be the case if the current regulation and the existing Commission order establishing an end to the phase-in period on December 31, 2019 were left unchanged. As discussed, Estimated AGNA Coverage would increase from approximately $221,020 billion (99.95 percent) to $221,039 billion (99.96 percent), an increase of $19 billion (a 0.01 percentage point increase); Estimated Transaction Coverage would increase from 3,795,330 trades (99.77 percent) to 3,797,734 trades (99.83 percent), an increase of 2,404 trades (a 0.06 percentage point increase); and Estimated Counterparty Coverage would increase from 30,879 counterparties (88.80 percent) to 31,559 counterparties (90.75 percent), an increase of 680 counterparties (a 1.96 percentage point increase).
As discussed, a lower AGNA threshold could lead to certain entities reducing or ceasing swaps activity to avoid registration and its related costs.
Most commenters generally agreed with the Commission's position. For example, commenters indicated that there would be a market-wide costs associated with a lower threshold given that if entities reduced or ceased swaps activity to avoid registration and its related costs, the small and mid-sized end-users and commercial entities who utilize swaps for hedging purposes and NFC swap market participants would have fewer dealers available to them.
IATP suggested that contrary to the assumption that small banks may avoid the swap market due to the costs of SD registration at a $3 billion threshold, the costs and obligations of SD registration would not discourage swap dealing
However, the Senators questioned why, given the lack of relevant data for NFC swaps, it is necessary to remove the phase-in reduction of the AGNA threshold for energy-related SDs.
The Commission notes that although AGNA data was not available for NFC swaps, the OCC publishes the Quarterly Report on Bank Derivatives Activities, including end-of-quarter gross notional amount position data from call reports filed by insured U.S. commercial banks and savings associations. Although point-in-time position data is not directly comparable to the transaction volume calculations that are required for evaluating AGNA threshold calculations, the report does provide outstanding commodity notional amount position totals in comparison with IRS, CDS, FX swaps, and equity swaps. According to the OCC, as of the end of 2017, NFC swaps represented $1,373 billion out of the $171,964 billion total notional amount reported outstanding, or approximately 0.8 percent of the total.
Conversely, a higher AGNA threshold would potentially decrease the number of registered SDs, which could have a negative impact on achieving the general benefits associated with the policy objectives of SD regulation. For example, a higher threshold would allow a greater amount of swap dealing to be undertaken without certain counterparty protections.
Some commenters agreed that the small decrease in Estimated AGNA Coverage and Estimated Transaction Coverage at higher thresholds potentially indicates that increasing the threshold to up to $100 billion may have a limited effect on the systemic risk and market efficiency-related benefits of SD regulation.
Additionally, though it did not conduct an analysis of AGNA activity for NFC swaps, the Commission is of the view that increasing the AGNA threshold could potentially lead to fewer registered SDs participating in in the NFC swap market, similar to its observations with respect to IRS, CDS, FX swaps, and equity swaps discussed above in section II.C.2. This could reduce the number of entities transacting with registered SDs.
The cost of reduced protections for counterparties would be realized to the extent that a higher threshold would result in fewer swaps involving at least one registered SD. Additionally, depending on how the swap market adapts to a higher threshold, it is also possible that the reduction in Estimated Regulatory Coverage would be greater than the data indicates to the extent that a higher threshold leads to an increased amount of swap dealing activity between entities that are not registered SDs. In such a scenario, Estimated Regulatory Coverage could potentially decrease more than the data indicates, increasing the general costs associated with the De Minimis Exception.
As discussed in the Proposal, for any AGNA threshold, some firms will have AGNA of swap dealing activity sufficiently close to the threshold so as to require analysis to determine whether their activity qualifies as de minimis. Hence, (1) with a $3 billion threshold,
Based on the available data, the Commission estimates that if the AGNA threshold were set at $3 billion, approximately 22 currently unregistered entities would need to conduct an initial analysis of whether they would be above the threshold.
The estimates of the hourly costs for these personnel are from SIFMA's Management & Professional Earnings in the Securities Industry 2013 survey, modified to account for an 1800-hour work-year and multiplied by 5.35 to account for firm size, employee benefits, and overhead, which is the same multiplier that was used when the SD Definition was adopted.
The Commission recognizes that particular entities may, based on their circumstances, incur costs substantially greater or less than the estimated averages.
Certain of those entities with ongoing swap dealing activity that is near a $3 billion threshold may also need to conduct periodic de minimis calculation analyses to assess whether they qualify for the exception. The Commission estimates that approximately 11 entities may need to conduct such analyses.
Conversely, the Commission assumes that a higher threshold would permit certain entities to no longer incur ongoing costs of assessing whether they are above the threshold. The Commission estimates the savings that would result from a higher AGNA threshold of $20 billion. Based on the available data, the Commission estimates that if the threshold were set at $20 billion, approximately 29 entities would no longer need to conduct an ongoing analysis of whether they would be above the new threshold, while 4 entities may begin conducting such an analysis.
The Commission notes that ABA submitted a study that evaluated the costs and benefits of SD registration for member banks at various AGNA thresholds, prepared by NERA Economic Consulting (“NERA”).
First, to estimate initial and ongoing SD registration determination costs, NERA sent a survey to 22 bank holding companies that participate in the swap market and received eight responses.
NERA's survey of banking entities indicates significantly higher initial and ongoing SD determination monitoring costs than the Commission's cost estimates on a per entity annualized basis. NERA's per entity cost estimates were based on the eight responses to their survey, while the Commission's estimates were based on: (1) Estimates
Second, to estimate the number of entities that would be required to register at different AGNA thresholds, NERA evaluated four different scenarios, including various combinations of an AGNA threshold, a risk-based threshold, and amendments to date restrictions related to the IDI Swap Dealing Exclusion. At various AGNA thresholds—including $3 billion, $8 billion, and $15 billion—NERA estimated the number of bank holding companies expected to register as SDs for each scenario it evaluated. To allow for a more direct comparison with the Commission's estimates, the Commission made an assumption that the difference in the number of entities required to register at $3 billion and $15 billion thresholds, as compared to an $8 billion threshold, would also be the number of entities that would incur ongoing costs or cost savings related to assessing whether they would be required to register as SDs. Depending on the scenario evaluated, the Commission believes that NERA estimated that 13 to 17 additional bank holding companies would conduct ongoing SD registration-related analyses at the $3 billion threshold as compared to the $8 billion threshold.
In general, the Commission believes that its per entity estimated costs reflect the broader nature of the types of entities that would need to conduct such an analysis. For example, NERA's analysis focused on survey responses from consolidated bank holding companies, whereas the Commission's estimates also account for smaller financial institutions and non-financial entities that may have less operational complexity and therefore may incur lower costs in making determinations. Additionally, the Commission's estimates of the number of entities that would incur costs related to SD registration analyses are based on non-public SDR data on AGNA activity, while NERA's implied estimates are based on publicly available swap position data from the Federal Reserve Bank of Chicago's “Holding Company Data” for bank holding companies with greater than $10 billion in assets on a consolidated basis.
However, given the different methods and sources of information utilized, the Commission is providing a range of estimated costs or cost savings that combine the per entity costs and the counts of the number of entities required to conduct SD registration analyses, as estimated by the Commission and NERA. The tables below summarize the estimates for initial and ongoing SD determination costs. Since NERA conducted estimates using four different scenarios, the tables below include information based on the highest and lowest number
Based on its analysis, and incorporating information provided by NERA, the Commission estimates that for the 13 to 22 entities at a $3 billion AGNA threshold that may need to conduct an initial SD registration analyses, at per entity average costs of $79,000 to $657,696, the estimated aggregate initial determination cost ranges from $1,027,000 to $14,469,312, as indicated in Table 1.
Additionally, for the 11 to 17 entities at a $3 billion AGNA threshold that may need to conduct ongoing SD registration analyses, at per entity average costs of $40,000 to $89,209, the estimated aggregate annual ongoing monitoring cost ranges from $440,000 to $1,516,553, as indicated in Table 2.
Lastly, for the 7 to 25 entities at a $15 billion or $20 billion AGNA threshold that would no longer need to conduct ongoing SD registration analyses, at per entity average cost savings of $40,000 to $89,209, the estimated aggregate annual ongoing monitoring cost savings ranges from $280,000 to $2,230,225, as indicated in Table 3.
The Commission notes that the aggregate estimates of initial and ongoing SD determination and monitoring costs, based on either the Commission or NERA's per entity cost estimates or marginal entity count estimates, buttress the Commission's decision to adopt an $8 billion threshold and not let it decrease to $3 billion. Additionally, the Commission is of the view that the cost savings at $15 billion or $20 billion thresholds would not sway its decision to maintain the threshold at $8 billion given the general costs and benefits discussed above. Lastly, in light of all the considerations, the Commission would come to the same conclusion, regardless of where the most accurate cost falls in the range of potential initial and ongoing costs.
Section 15(a) of the CEA requires the Commission to consider the effects of its actions in light of the following five factors:
Providing regulatory protections for swap counterparties who may be less experienced or knowledgeable about the swap products offered by SDs (particularly end-users who use swaps for hedging or investment purposes) is a fundamental benefit advanced by registration of SDs. For example, registered SDs are required to provide mid-mark quotes and perform scenario analyses. However, these requirements are not in standard ISDA agreements and are not required of entities that deal a de minimis amount of swaps.
The Commission is maintaining the current de minimis phase-in threshold of $8 billion in AGNA of swap dealing activity. As discussed above, the Commission recognizes that a $3 billion threshold may result in more entities being required to register as SDs compared to the proposed (and currently in-effect) $8 billion threshold, thereby extending counterparty protections to a greater number of market participants. However, this benefit is relatively small because, at the current $8 billion phase-in threshold, the substantial majority of transactions are already covered by SD regulation—and related counterparty protection requirements—since they include at least one registered SD as a counterparty.
On the other hand, as noted above, a threshold above $8 billion may result in fewer entities being required to register as SDs, thus extending counterparty protections to a fewer number of market participants. Although the Estimated Transaction Coverage and Estimated AGNA Coverage would not decrease much at higher thresholds of up to $100 billion, the decrease in Estimated Counterparty Coverage is more pronounced at higher AGNA thresholds, potentially indicating that the benefit of SD counterparty protections requirements could be reduced at higher thresholds.
SD registration is also intended to reduce systemic risk in the swap market. Pursuant to the Dodd-Frank Act, the Commission has proposed or adopted regulations for SDs, including margin and risk management requirements, designed to mitigate the potential systemic risk inherent in the swap market. Therefore, the Commission recognizes that a lower threshold may result in more entities being required to register as SDs, thereby potentially further reducing systemic risk. Conversely, a higher threshold may result in fewer entities being required to register an SD and, thus, possibly increase systemic risk.
However, the data appears to indicate that the additional entities that would need to register at the $3 billion threshold are engaged in a comparatively smaller amount of swap dealing activity. Many of these entities might be expected to have fewer counterparties and smaller overall risk exposures as compared to the SDs that engage in swap dealing in excess of the $8 billion level. Accordingly, the Commission believes that that the incremental reduction in systemic risk that may be achieved by registering dealers that engage in dealing between the $3 billion and $8 billion thresholds is limited.
The data also indicates that at higher thresholds of $20 billion, $50 billion, or $100 billion, fewer entities would be required to register as SDs, though the change in regulatory coverage as measured by Estimated AGNA Coverage and Estimated Transaction Coverage would be small. Thus, the Commission believes that the increase in systemic risk that may occur due to a higher threshold would not be significant. However, depending on how the market adapts to a higher threshold, the level of regulatory coverage could potentially decrease more than the data indicates.
The Commission believes that setting the AGNA threshold at $8 billion will not substantially diminish the protection of market participants and the public as compared to a $3 billion threshold. Further, as discussed, the Commission does not expect that an increase in the threshold would
Another goal of SD registration is swap market efficiency, orderliness, and transparency. These market benefits are achieved through regulations regarding, for example, recordkeeping, reporting, disclosure, and risk management.
As compared to a $3 billion threshold, an $8 billion threshold may have a negative effect on the efficiency and integrity of the markets as fewer entities are required to register as SDs and fewer transactions become subject to SD-related regulations. However, the Commission also recognizes that the efficiency and competitiveness of the swap market may be negatively impacted if the AGNA threshold is set too low, by potentially increasing barriers to entry that may stifle competition and reduce swap market efficiency. For example, if entities choose to reduce or cease their swap dealing activities in response to the $3 billion threshold, the number or availability of market makers for swaps may be reduced, which could lead to increased costs for potential counterparties and end-users. Conversely, a higher threshold may increase market liquidity, efficiency, and competition as more entities engage in swap dealing without SD registration as a barrier to entry. However, a higher threshold may also result in fewer swaps being subject to SD-related regulations, potentially reducing the financial integrity of markets.
Considering these countervailing factors, the Commission believes that setting the AGNA threshold at $8 billion will not significantly diminish the efficiency, competitiveness, and financial integrity of markets as compared to a $3 billion threshold. Further, as discussed, an increase in the threshold would potentially have both positive and negative effects to the efficiency, competitiveness, and financial integrity of the markets.
All else being equal, the Commission believes that price discovery will not be harmed and might be improved if there are more entities engaging in ancillary dealing due to increased competitiveness among swap counterparties. The Commission is of the view that, as compared to a $3 billion threshold, an $8 billion threshold would encourage participation of new swap dealing businesses and promote ancillary dealing because those entities engaged in swap dealing activities below the threshold would not need to incur the direct costs of registration until they exceeded a higher threshold.
Similarly, raising the threshold above $8 billion could lead to even more entities engaging in ancillary dealing.
The Commission notes that some counterparties might be more likely to transact at off-market prices if they trade with an entity that does not provide mid-market quotes or scenario analyses, as would be required if the entity were a registered SD. If so, such transactions might harm post-trade price discovery since these transactions would occur at off-market prices.
The Commission notes that a higher AGNA threshold could lead to impaired risk management practices because a lower number of entities would be required by regulation to: (1) Develop and implement detailed risk management programs; (2) adhere to business conduct standards that reduce operational and other risks; and (3) satisfy margin requirements for uncleared swaps. For the same reason, a lower threshold could positively impact risk management since more entities would be required to comply with the above mentioned risk-related SD regulations. The Commission also notes that to the extent an entity that is not required to register as an SD at a higher threshold is a prudentially regulated bank, that entity would be subject to the risk management requirements of its prudential regulator.
The Commission has not identified any other public interest considerations with respect to setting the AGNA threshold at $8 billion in swap dealing activity.
Section 15(b) of the CEA requires the Commission to take into consideration the public interest to be protected by the antitrust laws and endeavor to take the least anticompetitive means of achieving the purposes of the CEA, in issuing any order or adopting any Commission rule or regulation (including any exemption under section 4(c) or 4c(b)), or in requiring or approving any bylaw, rule, or regulation of a contract market or registered futures association established pursuant to section 17 of the CEA.
The Commission has considered this final rule to determine whether it is anti-competitive and has identified no anti-competitive effects. Because the Commission has determined that the final rulemaking is not anti-competitive and has no anti-competitive effects, the Commission has not identified any less anti-competitive means of achieving the purposes of the CEA.
Commodity futures, Definitions, De minimis exception, Insured depository institutions, Swaps, Swap dealers.
For the reasons stated in the preamble, the Commodity Futures Trading Commission amends 17 CFR part 1 as follows:
7 U.S.C. 1a, 2, 5, 6, 6a, 6b, 6c, 6d, 6e, 6f, 6g, 6h, 6i, 6k, 6
The revision reads as follows:
(4)
The following appendicies will not appear in the Code of Federal Regulations.
On this matter, Chairman Giancarlo, and Commissioners Quintenz, Behnam, Stump, and Berkovitz voted in the affirmative. No Commissioner voted in the negative.
Today's final rule on the numeric threshold for swap dealer
The action before us is without prejudice to all other items in the Commission's June 2018 NPRM. That includes various proposed rule amendments and other topics for consideration. Those proposals and considerations are clearly of wide ranging interest as evidenced by the public comments received. They remain under staff consideration pending further Commission action.
Indeed, I will direct CFTC staff to continue their analysis of the range of matters raised in the June 2018 NPRM and comments submitted by the public.
I will specifically ask staff to conduct a study on possible alternative metrics for the calculation of the swap dealer de minimis threshold drawing upon proposals in the June 2018 NPRM, including the feasibility of: (i) Removing cleared swaps from the current
I deliberately decline at this time to express any view on the appropriateness of whether any of the proposals in the June 2018 NPRM not before us today should be addressed by CFTC unilateral rulemaking or joint consideration with the U.S. Securities and Exchange Commission (SEC).
Be assured that SEC Chairman Clayton and I—and our fellow CFTC and SEC Commissioners—are committed to working together on robust harmonization where appropriate and working jointly where necessary on these and other matters.
With respect to IDIs, staff has informed me that they would consider no-action relief for IDIs pending formal Commission action should they receive a meritorious request.
In sum, I am hopeful that we will today provide market certainty that the
Surely, it has taken a while to reach this point. Yet, I am hopeful that we may achieve it with a good degree of consensus across the full Commission. Assuming so, then we have increased market certainty—a very good thing in trading markets.
Sometimes it's worth the wait.
I support today's final rule to rescind the
However, this is just the first of many necessary steps toward correcting what I believe is a flawed swap dealer registration policy. Therefore, it is my hope that today's final rule should be viewed with finality only in this one regard.
The Dodd-Frank Act advanced three main and substantial policy objectives for swap dealer registration: Systemic risk reduction, counterparty protection, and enhanced swap market transparency and efficiency. As I have emphasized on many prior occasions, given the significant costs of swap dealer regulation, it is critical that the
As I have also said repeatedly in the past, notional value is a poor measure of activity, and it is a meaningless measure of risk. Therefore, by itself, notional value is an incredibly deficient metric by which to impose large costs and achieve substantial policy objectives. A one-size-fits-all notional value test for swap dealer registration captures entities that engage in low volume, low risk activity with high notional amounts, and places those firms under the same regulatory regime as the world's largest, most complex financial institutions that deal in
I have heard anecdotally from certain small to mid-sized players in the swap markets that the breakeven point of the costs of swap dealer registration as measured by a level of notional swap dealing activity is much higher than the $8 billion level in this rule. If that is the case, the current $8 billion notional threshold effectively forces these smaller players to curtail their swap dealing business, thereby limiting competition and further concentrating swaps activity with their larger competitors.
In my view, an appropriately calibrated
I am pleased the Chairman continues to recognize this and has directed staff to study many of the alternative risk-based registration metrics that were suggested in the proposed rule. The staff report will provide the Commission with additional data and insights into the impact that alternative approaches may have on swap dealer registration. For example, staff's analysis should show how removing or haircutting cleared swaps from the
In addition, many of the policy recommendations discussed in the proposed rule, such as better allowing insured depository institutions to assist their customers in hedging loan-related risks and excluding non-deliverable forwards from an entity's
Any
The Commission's regulatory framework for the swap market has greatly evolved from its state six years ago; it is only common sense that the swap dealer registration threshold should evolve as well. It will be a great day when financial regulators, including the CFTC, finally move away from gross notional value as any sort of metric or test of derivatives exposure, activity, or risk. I look forward to that day, and I am committed to working with the Chairman, my fellow Commissioners, and our staff to make sure we get the swap dealer
Today, the Commission acts decisively to set the aggregate gross notional amount (“AGNA”) threshold for the
Today's decision to maintain the AGNA threshold at $8 billion follows a period of prolonged uncertainty during which Commission staff conducted more complete data analysis regarding the
It is my hope that Commission staff will continue to examine and monitor data and activities in the NFC swap market to ensure that concentrated activity by unregistered NFC counterparties in segments of that swap market, such as in energy-related swaps, do not present outsized risk or harm to end-users, and most importantly, the general public.
I support amending the swap dealer de minimis exception to set the threshold at $8 billion. This limited amendment relies on extensive data analysis to achieve a balance between the policy objectives of the de minimis exception and the registration of swap dealers.
At the outset, I would like to acknowledge the leadership of Chairman Giancarlo and the efforts of my fellow Commissioners to achieve consensus on this rulemaking. I look forward to working together to continue to find areas of agreement where it makes sense for our markets and the American people.
Title VII of the Dodd-Frank Act directed the Commodity Futures Trading Commission (“Commission”) and the U.S. Securities and Exchange Commission (“SEC”) to jointly further define, among other things, the term “swap dealer.”
In 2012, the Commission—jointly with the SEC—adopted the further definition of the term swap dealer. In this rulemaking, the de minimis swap dealing threshold was set at $3 billion. However, recognizing that a lack of swap trading data made it difficult to set an appropriate threshold, the Commission implemented a long phase-in period during which the threshold was set at $8 billion.
To this end, the staff built a comprehensive database to aggregate data from all four SDRs. Over several years, the staff developed and refined new techniques to sort and evaluate the data, published two reports on the de minimis exception, and continued to revise its analysis in response to public comments. This process was not without considerable challenges, but the staff worked diligently to produce meaningful, data-driven information to guide the Commission's decision-making regarding the appropriate de minimis threshold.
This effort provided a highly significant data point: Approximately 98 percent of all swap transactions involved at least one registered swap dealer. We now know that at the $8 billion threshold, nearly all swap transactions benefit from swap dealer regulation.
The staff's analysis also showed that reducing the threshold to $3 billion would have a minimal impact on the amount of swaps activity that would be subject to swap dealer regulation. Indeed, based on the analysis, reducing the threshold to $3 billion would only add swap dealer coverage to less than one-tenth of one percent of reported swaps. By the same token, the analysis demonstrated that increasing the threshold quantity above $8 billion would have almost no impact on the amount of swaps subject to dealer regulation until that threshold reaches a significantly higher level. At those levels, the effect on specific categories of swaps—notably non-financial commodity swaps (“NFC”)—becomes much more significant.
When considering amending a rule, the Commission should consider both the
On the other hand, decreasing the threshold from its current level would impose tangible costs on market participants. If the threshold were lowered to $3 billion, unregistered dealers that are currently under the $8 billion level, but that could exceed the $3 billion threshold, would have to re-evaluate whether swap dealing in excess of $3 billion would continue to make business sense. The de minimis rulemaking proposal
The Commission should seek to preserve and foster competition for swap dealer services. One of the fundamental purposes of the CEA is to “promote . . . fair competition among boards of trade, other markets and market participants.”
It is important to note that this rulemaking represents one of the first times in which the Commission has relied on SDR data to set policy, and the staff that undertook this principled and thorough analysis should be commended for their efforts. Given the technological advancements in data collection and analysis, effective use of data to inform policy making is critical for the Commission to meet its policy objectives of fostering open, transparent, competitive, and financially sound markets.
In sum, the data demonstrates that the current de minimis threshold level is largely accomplishing its intended purposes. Where the current regulations are working, regulatory stability also is an important objective. Accordingly, after considering the results of the swap data analysis, relevant policy implications, and limited benefits and potential costs of altering the de minimis threshold quantity, I believe that maintaining the threshold at $8 billion is appropriate and sound public policy.
The proposal noted that Commission staff encountered challenges in measuring the aggregate gross notional amount of NFC swaps. Instead, the staff used counterparty and transaction counts to approximate swap dealing activity for NFC swaps. The staff's analysis indicated that fewer NFC swap transactions—86 percent—involved at least one registered swap dealer, as opposed to 99 percent for other swap categories.
The market participants who use physical commodity swaps to hedge their risks typically include farmers, ranchers, farm product processors, energy producers and consumers, manufacturers, and other end users. These consumer-facing businesses need a properly functioning physical commodity derivatives marketplace to maintain consistent prices for their customers. Ultimately, the American people benefit from stable prices on the products that these businesses produce and distribute.
I am therefore calling on the Commission to continue to focus on improving our data collection and analysis for NFC swaps. More robust data collection will help us improve regulation in this space, including considering ways to balance the benefits of de minimis swap dealing in physical commodities with the need for customer protections and the other benefits of swap dealer registration.
I am voting today solely in favor of setting the de minimis exception threshold quantity at $8 billion because it is within the Commission's authority to do so. Looking forward, however, I will not support other amendments to the swap dealer definition without a joint rulemaking with the SEC, as required by the Dodd-Frank Act.
In addition to setting the threshold level, the proposal sought to alter the swap dealer definition by excluding from counting toward that de minimis threshold: (1) Swaps entered into by an insured depository institution (“IDI”) in connection with originating loans; (2) swaps hedging financial or physical positions; and (3) swaps resulting from multilateral portfolio compression exercises. The proposal also asked questions about excluding from the threshold calculation swaps that are cleared and/or exchange traded and non-deliverable forwards.
Although the Commission is not adopting these provisions today, my view is that any such changes would effectively amount to an amendment of the swap dealer definition, not the de minimis exception. Doing so unilaterally and not as a joint rulemaking with the SEC would be contrary to the statutory language and inconsistent with Congressional intent.
When Congress enacted Title VII of the Dodd-Frank Act, its intent was clear: “[T]he [Commission] and the [SEC], in consultation with the Board of Governors, shall further define the term[] . . . `swap dealer,' ” among other terms.
Congress created one exception to the joint rulemaking requirement. CEA subsection 1a(49)(D) authorizes “the Commission” to exempt from designation as a swap dealer “an entity that engages in a de minimis
By its terms, the de minimis exception relates solely to exempting a numerical
The proposal framed these additional proposed changes to the swap dealer definition as “factors” in the de minimis threshold determination. In doing so, the proposal sought to use the Commission's unilateral authority to “establish factors” as provided in the second sentence in CEA subsection 1a(49)(D). However, that interpretation is a misreading of the statutory provision. The second sentence in CEA subsection 1a(49)(D) authorizes the Commission to promulgate regulations to “establish factors with respect to the making of this determination to exempt.”
This point is clear when we examine what would happen if each of the five categories of swap dealing activity identified in the proposal as “factors” (
For these reasons, while I am amenable to considering further refinements to the swap dealer definition and what gets counted as dealing, I am of the view that this cannot be accomplished without joint rulemaking with the SEC.
| 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 |