81 FR 80003 - Medicaid Program; Covered Outpatient Drug; Delay in Change in Definitions of States and United States
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Centers for Medicare & Medicaid Services Federal Register Volume 81, Issue 220 (November 15, 2016)
Centers for Medicare & Medicaid Services
Federal Register Volume 81, Issue 220 (November 15, 2016)
| Page Range | 80003-80005 | |
| FR Document | 2016-27423 |
[Federal Register Volume 81, Number 220 (Tuesday, November 15, 2016)] [Rules and Regulations] [Pages 80003-80005] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2016-27423] ======================================================================= ----------------------------------------------------------------------- DEPARTMENT OF HEALTH AND HUMAN SERVICES Centers for Medicare & Medicaid Services 42 CFR Part 447 [CMS-2345-IFC] RIN 0938-AT09 Medicaid Program; Covered Outpatient Drug; Delay in Change in Definitions of States and United States AGENCY: Centers for Medicare & Medicaid Services (CMS), HHS. ACTION: Interim final rule with comment period. ----------------------------------------------------------------------- SUMMARY: The Covered Outpatient Drug final rule with comment period was published in the February 1, 2016 Federal Register. As part of that final rule with comment, we amended the regulatory definitions of ``States'' and ``United States'' to include the U.S. territories (American Samoa, the Northern Mariana Islands, Guam, the Commonwealth of Puerto Rico, and the Virgin Islands) beginning April 1, 2017. This interim final rule with comment period delays the inclusion of the territories in the definition of ``States'' and ``United States'' until April 1, 2020. DATES: Effective date: These regulations are effective on November 15, 2016. Comment date: To be assured consideration, comments must be received at one of the addresses provided below, no later than 5 p.m. on January 17, 2017. ADDRESSES: In commenting, please refer to file code CMS-2345-IFC. Because of staff and resource limitations, we cannot accept comments by facsimile (FAX) transmission. You may submit comments in one of four ways (please choose only one of the ways listed) 1. Electronically. You may submit electronic comments on this regulation to http://www.regulations.gov. Follow the ``Submit a comment'' instructions. 2. By regular mail. You may mail written comments to the following address ONLY: Centers for Medicare & Medicaid Services, Department of Health and Human Services, Attention: CMS-2345-IFC, P.O. Box 8016, Baltimore, MD 21244-8016. Please allow sufficient time for mailed comments to be received before the close of the comment period. 3. By express or overnight mail. You may send written comments to the following address ONLY: Centers for Medicare & Medicaid Services, Department of Health and Human Services, Attention: CMS-2345-IFC, Mail Stop C4-26-05, 7500 Security Boulevard, Baltimore, MD 21244-1850. 4. By hand or courier. Alternatively, you may deliver (by hand or courier) your written comments ONLY to the following addresses prior to the close of the comment period: a. For delivery in Washington, DC--Centers for Medicare & Medicaid Services, Department of Health and Human Services, Room 445-G, Hubert H. Humphrey Building, 200 Independence Avenue SW., Washington, DC 20201. (Because access to the interior of the Hubert H. Humphrey Building is not readily available to persons without Federal government identification, commenters are encouraged to leave their comments in the CMS drop slots located in the main lobby of the building. A stamp- in clock is available for persons wishing to retain a proof of filing by stamping in and retaining an extra copy of the comments being filed.) b. For delivery in Baltimore, MD--Centers for Medicare & Medicaid Services, Department of Health and Human Services, 7500 Security Boulevard, Baltimore, MD 21244-1850. If you intend to deliver your comments to the Baltimore address, call telephone number (410) 786-7195 in advance to schedule your arrival with one of our staff members. Comments erroneously mailed to the addresses indicated as appropriate for hand or courier delivery may be delayed and received after the comment period. For information on viewing public comments, see the beginning of the SUPPLEMENTARY INFORMATION section. FOR FURTHER INFORMATION CONTACT: Wendy Tuttle, (410) 786-8690. SUPPLEMENTARY INFORMATION: Inspection of Public Comments: All comments received before the close of the comment period are available for viewing by the public, including any personally identifiable or confidential business information that is included in a comment. We post all comments received before the close of the comment period on the following Web site as soon as possible after they have been received: http://regulations.gov. Follow the search instructions on that Web site to view public comments. Comments received timely will be also available for public inspection as they are received, generally beginning approximately 3 weeks after publication of a document, at the headquarters of the Centers for Medicare & Medicaid Services, 7500 Security Boulevard, Baltimore, Maryland 21244, Monday through Friday of each week from 8:30 a.m. to 4 p.m. To schedule an appointment to view public comments, phone 1-800-743-3951. I. Background A. Introduction The Covered Outpatient Drug final rule with comment period was published in the February 1, 2016 Federal Register (81 FR 5170). That final rule with comment period implemented provisions of section 1927 of the Social Security Act (the Act) that were added by the Patient Protection and Affordable Care Act of 2010, as amended by the Health Care and [[Page 80004]] Education Reconciliation Act of 2010 (collectively referred to as the Affordable Care Act) pertaining to Medicaid reimbursement for covered outpatient drugs (CODs). That final rule with comment period also revised other requirements related to CODs, including key aspects of Medicaid coverage and payment and the Medicaid Drug Rebate (MDR) program under section 1927 of the Act. The rule became effective on April 1, 2016. However, the regulatory definitions of ``States'' and ``United States'' under Sec. 447.502, included the U.S. territories (American Samoa, Northern Mariana Islands, Guam, Puerto Rico, and the Virgin Islands) beginning April 1, 2017. We stated in the preamble to the final rule with comment period that U.S. territories may use existing waiver authority to elect not to participate in the MDR program consistent with the statutory waiver standards. The Northern Mariana Islands and American Samoa may seek to opt out of participation under the broad waiver that has been granted to them in accordance with section 1902(j) of the Act. Puerto Rico, the Virgin Islands, and Guam may use waiver authority under section 1115(a)(1) of the Act to waive section 1902(a)(54) of the Act, which requires state compliance with the applicable requirements of section 1927 of the Act (81 FR 5203 through 5204). We also stated in the final rule with comment period that, effective with the change in the definition of ``United States,'' drug manufacturers would be required to include prices paid by entities located in one of the U.S. territories in the same manner in which they include prices paid by entities located in one of the 50 states and District of Columbia (81 FR 5224) in their calculations of average manufacturer price (AMP) and best price. This change requires manufacturers to include eligible sales and associated discounts, rebates, and other financial transactions that take place in the U.S. territories in their calculations of AMP and best price once the revised definitions of States and United States become effective, regardless of whether the U.S. territories seek to waive participation in the MDR program. B. Impracticability of Implementation by April 1, 2017 Based on discussions with the U.S. territories, it has become evident that interested U.S. territories could not be ready to implement the program by April 1, 2017, although a few territories have expressed interest in participating once they have made the necessary systems changes. Specifically, the territories need time to develop and change electronic claims processing systems to identify and report utilization (taking into account all of the complexities in tracking utilization by National drug code numbers) and to match utilization with the unit rebate amounts to generate rebate invoices. Further, these systems must be capable of collecting, reporting, validating and tracking drug utilization on an ongoing basis. In addition, they require extensive advance planning and budgeting. We received comments during the comment period of the proposed rule which requested that CMS delay the inclusion of the territories in the MDR program because the manufacturers and territories would need this additional time to implement provisions necessary to include territories in all aspects of the MDR program. We took these comments into consideration and in the final rule delayed the inclusion of the territories into the definitions of States and United States until 1 year after the effective date of the final rule (81 FR 5203, 5204). Despite this 1 year delay, it has since become evident that we underestimated the timeline required, particularly in light of other demands on territorial systems development and the fact that the territories are at various stages of planning and development with respect to these systems. While the U.S. territories have the ability to seek a waiver from the requirements that they would have to meet when classified as ``states,'' doing so would impose some burdens on a territory, particularly for those territories that are not included in the broad waiver authority under section 1902(j) of the Act. Moreover, waivers under section 1115 of the Act are limited to requirements applicable to states or territories under section 1902(a) of the Act, and would not apply to the requirements placed on drug manufacturers that sell in the territories. These manufacturers cannot be waived from the section 1927 of the Act requirements under which manufacturers must include sales that take place in the U.S. territories when determining AMP and best price. We have heard from various stakeholders who have reiterated many of the concerns that were summarized in the final rule with comment (81 FR 5224) that drug manufacturers will likely be prompted to increase drug prices, including prices paid by U.S. territory Medicaid programs. This would result in the U.S. territories that receive a waiver realizing an increase in their Medicaid drug costs without the offsetting benefit of receiving Medicaid rebates. Furthermore, the increase in Medicaid costs could adversely impact territories because of their Medicaid funding cap. II. Provisions of the Interim Final Rule For the reasons discussed in the Background section, this interim final rule with comment period amends the regulatory definitions of ``States'' and ``United States'' under Sec. 447.502 to include the U.S. territories (American Samoa, Northern Mariana Islands, Guam, Puerto Rico, and the Virgin Islands) beginning April 1, 2020 rather than April 1, 2017. III. Waiver of Proposed Rulemaking We ordinarily publish a notice of proposed rulemaking in the Federal Register and invite public comment on the proposed rule. The notice of proposed rulemaking includes a reference to the legal authority under which the rule is proposed, and the terms and substances of the proposed rule or a description of the subjects and issues involved. This procedure can be waived, however, if an agency finds good cause that a notice-and-comment procedure is impracticable, unnecessary, or contrary to the public interest and incorporates a statement of the finding and its reasons in the rule issued. As discussed in section I.B. of this interim final rule with comment period, in light of the longer time frames needed by territories for planning, budgeting and developing systems necessary to implement the Medicaid drug rebate program, the competing demand on system development resources, and the long time frames for manufacturer pricing determinations, we believe it is necessary to provide territories and manufacturers with advance notice of any change in the timing for the inclusion of territories in the Medicaid drug rebate program. Issuance of a proposed rule would be impracticable because it would result in a notice of the final rule without sufficient time for territories or manufacturers to adjust their actions to take into account the revised timing. Thus, we find good cause to waive the requirement for proposed rulemaking because the short time frame before the inclusion of territories would otherwise take effect does not permit sufficient time to both undertake proposed rulemaking and provide the necessary advance notice for territories and manufacturers to meaningfully adjust planning and systems development to accommodate the revised timing. Furthermore, we find good cause to waive the requirement for proposed rulemaking [[Page 80005]] because it would be contrary to public interest to delay notifying manufacturers of the change in the timing of the territorial inclusion in light of the potential that, absent sufficient advance notice, drug manufacturers may raise prices on drugs sold in the territories and thereby increase drug costs for both Medicaid and non-Medicaid consumers in the territories. Therefore, we find good cause to waive the notice of proposed rulemaking and to issue this final rule on an interim basis. We are providing a 60-day public comment period. IV. Collection of Information Requirements This rule's delay in including the territories in the definitions of ``States'' and ``United States'' until April 1, 2020, does not impose any new or revised information collection, reporting, recordkeeping or third-party disclosure requirements or burden. Consequently, there is no need for review by the Office of Management and Budget under the authority of the Paperwork Reduction Act of 1995 (44 U.S.C. 3501 et seq.). V. Response to Comments Because of the large number of public comments we normally receive on Federal Register documents, we are not able to acknowledge or respond to them individually. We will consider all comments we receive by the date and time specified in the DATES section of this preamble, and, when we proceed with a subsequent document, we will respond to the comments in the preamble to that document. VI. Regulatory Impact Statement We have examined the impact 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) and the Congressional Review Act (5 U.S.C. 804(2)). Executive Orders 12866 and 13563 direct agencies to assess all costs and benefits of available regulatory alternatives and, if regulation is necessary, to select regulatory approaches that maximize net benefits (including potential economic, environmental, public health and safety effects, distributive impacts, and equity). A regulatory impact analysis (RIA) must be prepared for major rules with economically significant effects ($100 million or more in any 1 year). This rule does not reach the economic threshold and thus is not considered a major rule. The RFA requires agencies to analyze options for regulatory relief 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 1 year. Individuals and states are not included in the definition of a small entity. We are not preparing an analysis for the RFA because we have determined, and the Secretary certifies, that this interim final rule with comment period will not have a significant economic impact on a substantial number of small entities. In addition, section 1102(b) of the Act requires us to prepare a regulatory impact analysis 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 the RFA. For purposes of section 1102(b) of the Act, we define a small rural hospital as a hospital that is located outside of a Metropolitan Statistical Area for Medicare payment regulations and has fewer than 100 beds. We are not preparing an analysis for section 1102(b) of the Act because we have determined, and the Secretary certifies, that this interim final rule with comment period will not have a significant impact on the operations of a substantial number of small rural hospitals. Section 202 of the Unfunded Mandates Reform Act of 1995 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 2016, that threshold is approximately $146 million. This rule will have no consequential effect on state, local, or tribal governments or on the private sector. Executive Order 13132 establishes certain requirements that an agency must meet when it promulgates a proposed rule (and subsequent final rule) that imposes substantial direct requirement costs on State and local governments, preempts state law, or otherwise has federalism implications. Since this regulation does not impose any costs on state or local governments, the requirements of Executive Order 13132 are not applicable. In accordance with the provisions of Executive Order 12866, this regulation was reviewed by the Office of Management and Budget. List of Subjects in 42 CFR Part 447 Accounting, Administrative practice and procedure, Drugs, Grant programs--health, Health facilities, Health professions, Medicaid, Reporting and recordkeeping requirements, Rural areas. For the reasons set forth in the preamble, the Centers for Medicare & Medicaid Services amends 42 CFR chapter IV as set forth below: PART 447--PAYMENTS FOR SERVICES 0 1. The authority citation for part 447 continues to read as follows: Authority: Sec. 1102 of the Social Security Act (42 U.S.C. 1302). 0 2. Section 447.502 is amended by revising the definitions of ``States'' and ``United States'' to read as follows: Sec. 447.502 Definitions. * * * * * States means the 50 States and the District of Columbia and, beginning April 1, 2020, also includes the Commonwealth of Puerto Rico, the Virgin Islands, Guam, the Northern Mariana Islands and American Samoa. United States means the 50 States and the District of Columbia and, beginning April 1, 2020, also includes the Commonwealth of Puerto Rico, the Virgin Islands, Guam, the Northern Mariana Islands and American Samoa. * * * * * Dated: October 5, 2016. Andrew M. Slavitt, Acting Administrator, Centers for Medicare & Medicaid Services. Dated: November 8, 2016. Sylvia M. Burwell, Secretary, Department of Health and Human Services. [FR Doc. 2016-27423 Filed 11-14-16; 8:45 am] BILLING CODE 4120-01-P
![Federal Register / Vol. 81, No. 220 / Tuesday, November 15, 2016 / Rules and Regulations 80003
■ 3. In appendix C to part 4022, Rate Set Appendix C to Part 4022—Lump Sum
278, as set forth below, is added to the Interest Rates For Private-Sector
table. Payments
* * * * *
For plans with a Deferred annuities
valuation date Immediate (percent)
Rate set annuity rate
On or (percent)
Before i1 i2 i3 n1 n2
after
* * * * * * *
278 12–1–16 1–1–17 0.75 4.00 4.00 4.00 7 8
Judith Starr, You may submit comments in one of If you intend to deliver your
General Counsel, Pension Benefit Guaranty four ways (please choose only one of the comments to the Baltimore address, call
Corporation. ways listed) telephone number (410) 786–7195 in
[FR Doc. 2016–27384 Filed 11–14–16; 8:45 am] 1. Electronically. You may submit advance to schedule your arrival with
BILLING CODE 7709–02–P electronic comments on this regulation one of our staff members.
to http://www.regulations.gov. Follow Comments erroneously mailed to the
the ‘‘Submit a comment’’ instructions. addresses indicated as appropriate for
DEPARTMENT OF HEALTH AND 2. By regular mail. You may mail hand or courier delivery may be delayed
HUMAN SERVICES written comments to the following and received after the comment period.
address ONLY: Centers for Medicare & For information on viewing public
Centers for Medicare & Medicaid Medicaid Services, Department of comments, see the beginning of the
Services Health and Human Services, Attention: SUPPLEMENTARY INFORMATION section.
CMS–2345–IFC, P.O. Box 8016, FOR FURTHER INFORMATION CONTACT:
42 CFR Part 447 Baltimore, MD 21244–8016. Wendy Tuttle, (410) 786–8690.
[CMS–2345–IFC] Please allow sufficient time for mailed SUPPLEMENTARY INFORMATION:
comments to be received before the Inspection of Public Comments: All
RIN 0938–AT09 close of the comment period. comments received before the close of
3. By express or overnight mail. You the comment period are available for
Medicaid Program; Covered Outpatient may send written comments to the viewing by the public, including any
Drug; Delay in Change in Definitions of following address ONLY: Centers for personally identifiable or confidential
States and United States Medicare & Medicaid Services, business information that is included in
AGENCY: Centers for Medicare & Department of Health and Human a comment. We post all comments
Medicaid Services (CMS), HHS. Services, Attention: CMS–2345–IFC, received before the close of the
ACTION: Interim final rule with comment Mail Stop C4–26–05, 7500 Security comment period on the following Web
period. Boulevard, Baltimore, MD 21244–1850. site as soon as possible after they have
4. By hand or courier. Alternatively, been received: http://regulations.gov.
SUMMARY: The Covered Outpatient Drug you may deliver (by hand or courier) Follow the search instructions on that
final rule with comment period was your written comments ONLY to the Web site to view public comments.
published in the February 1, 2016 following addresses prior to the close of Comments received timely will be
Federal Register. As part of that final the comment period: also available for public inspection as
rule with comment, we amended the a. For delivery in Washington, DC— they are received, generally beginning
regulatory definitions of ‘‘States’’ and Centers for Medicare & Medicaid approximately 3 weeks after publication
‘‘United States’’ to include the U.S. Services, Department of Health and of a document, at the headquarters of
territories (American Samoa, the Human Services, Room 445–G, Hubert the Centers for Medicare & Medicaid
Northern Mariana Islands, Guam, the H. Humphrey Building, 200 Services, 7500 Security Boulevard,
Commonwealth of Puerto Rico, and the Independence Avenue SW., Baltimore, Maryland 21244, Monday
Virgin Islands) beginning April 1, 2017. Washington, DC 20201. through Friday of each week from 8:30
This interim final rule with comment (Because access to the interior of the a.m. to 4 p.m. To schedule an
period delays the inclusion of the Hubert H. Humphrey Building is not appointment to view public comments,
territories in the definition of ‘‘States’’ readily available to persons without phone 1–800–743–3951.
and ‘‘United States’’ until April 1, 2020. Federal government identification, I. Background
DATES: Effective date: These regulations commenters are encouraged to leave
are effective on November 15, 2016. their comments in the CMS drop slots A. Introduction
Comment date: To be assured located in the main lobby of the The Covered Outpatient Drug final
consideration, comments must be building. A stamp-in clock is available rule with comment period was
received at one of the addresses for persons wishing to retain a proof of published in the February 1, 2016
mstockstill on DSK3G9T082PROD with RULES
provided below, no later than 5 p.m. on filing by stamping in and retaining an Federal Register (81 FR 5170). That
January 17, 2017. extra copy of the comments being filed.) final rule with comment period
ADDRESSES: In commenting, please refer b. For delivery in Baltimore, MD— implemented provisions of section 1927
to file code CMS–2345–IFC. Because of Centers for Medicare & Medicaid of the Social Security Act (the Act) that
staff and resource limitations, we cannot Services, Department of Health and were added by the Patient Protection
accept comments by facsimile (FAX) Human Services, 7500 Security and Affordable Care Act of 2010, as
transmission. Boulevard, Baltimore, MD 21244–1850. amended by the Health Care and
VerDate Sep<11>2014 16:28 Nov 11, 2016 Jkt 241001 PO 00000 Frm 00013 Fmt 4700 Sfmt 4700 E:\FR\FM\15NOR1.SGM 15NOR1](https://thefederalregister.org/doc/81_FR_80223/page/1.svg)
![Federal Register / Vol. 81, No. 220 / Tuesday, November 15, 2016 / Rules and Regulations 80005
because it would be contrary to public equity). A regulatory impact analysis the requirements of Executive Order
interest to delay notifying (RIA) must be prepared for major rules 13132 are not applicable.
manufacturers of the change in the with economically significant effects In accordance with the provisions of
timing of the territorial inclusion in ($100 million or more in any 1 year). Executive Order 12866, this regulation
light of the potential that, absent This rule does not reach the economic was reviewed by the Office of
sufficient advance notice, drug threshold and thus is not considered a
Management and Budget.
manufacturers may raise prices on drugs major rule.
sold in the territories and thereby The RFA requires agencies to analyze List of Subjects in 42 CFR Part 447
increase drug costs for both Medicaid options for regulatory relief of small
and non-Medicaid consumers in the entities. For purposes of the RFA, small Accounting, Administrative practice
territories. entities include small businesses, and procedure, Drugs, Grant programs—
Therefore, we find good cause to nonprofit organizations, and small health, Health facilities, Health
waive the notice of proposed governmental jurisdictions. Most professions, Medicaid, Reporting and
rulemaking and to issue this final rule hospitals and most other providers and recordkeeping requirements, Rural
on an interim basis. We are providing a suppliers are small entities, either by areas.
60-day public comment period. nonprofit status or by having revenues For the reasons set forth in the
IV. Collection of Information of less than $7.5 million to $38.5 preamble, the Centers for Medicare &
Requirements million in any 1 year. Individuals and Medicaid Services amends 42 CFR
states are not included in the definition chapter IV as set forth below:
This rule’s delay in including the of a small entity. We are not preparing
territories in the definitions of ‘‘States’’ an analysis for the RFA because we have
and ‘‘United States’’ until April 1, 2020, PART 447—PAYMENTS FOR
determined, and the Secretary certifies, SERVICES
does not impose any new or revised that this interim final rule with
information collection, reporting, comment period will not have a
recordkeeping or third-party disclosure ■ 1. The authority citation for part 447
significant economic impact on a
requirements or burden. Consequently, continues to read as follows:
substantial number of small entities.
there is no need for review by the Office In addition, section 1102(b) of the Act Authority: Sec. 1102 of the Social Security
of Management and Budget under the requires us to prepare a regulatory Act (42 U.S.C. 1302).
authority of the Paperwork Reduction impact analysis if a rule may have a
Act of 1995 (44 U.S.C. 3501 et seq.). ■ 2. Section 447.502 is amended by
significant impact on the operations of
revising the definitions of ‘‘States’’ and
V. Response to Comments a substantial number of small rural
hospitals. This analysis must conform to ‘‘United States’’ to read as follows:
Because of the large number of public
comments we normally receive on the provisions of section 604 of the § 447.502 Definitions.
Federal Register documents, we are not RFA. For purposes of section 1102(b) of
* * * * *
able to acknowledge or respond to them the Act, we define a small rural hospital
as a hospital that is located outside of States means the 50 States and the
individually. We will consider all
a Metropolitan Statistical Area for District of Columbia and, beginning
comments we receive by the date and
Medicare payment regulations and has April 1, 2020, also includes the
time specified in the DATES section of
this preamble, and, when we proceed fewer than 100 beds. We are not Commonwealth of Puerto Rico, the
with a subsequent document, we will preparing an analysis for section 1102(b) Virgin Islands, Guam, the Northern
respond to the comments in the of the Act because we have determined, Mariana Islands and American Samoa.
preamble to that document. and the Secretary certifies, that this United States means the 50 States and
interim final rule with comment period the District of Columbia and, beginning
VI. Regulatory Impact Statement will not have a significant impact on the
April 1, 2020, also includes the
We have examined the impact of this operations of a substantial number of
Commonwealth of Puerto Rico, the
rule as required by Executive Order small rural hospitals.
Virgin Islands, Guam, the Northern
12866 on Regulatory Planning and Section 202 of the Unfunded
Mariana Islands and American Samoa.
Review (September 30, 1993), Executive Mandates Reform Act of 1995 also
Order 13563 on Improving Regulation requires that agencies assess anticipated * * * * *
and Regulatory Review (January 18, costs and benefits before issuing any Dated: October 5, 2016.
2011), the Regulatory Flexibility Act rule whose mandates require spending Andrew M. Slavitt,
(RFA) (September 19, 1980, Pub. L. 96– in any 1 year of $100 million in 1995
Acting Administrator, Centers for Medicare
354), section 1102(b) of the Social dollars, updated annually for inflation.
& Medicaid Services.
Security Act, section 202 of the In 2016, that threshold is approximately
$146 million. This rule will have no Dated: November 8, 2016.
Unfunded Mandates Reform Act of 1995
(March 22, 1995; Pub. L. 104–4), consequential effect on state, local, or Sylvia M. Burwell,
Executive Order 13132 on Federalism tribal governments or on the private Secretary, Department of Health and Human
(August 4, 1999) and the Congressional sector. Services.
Review Act (5 U.S.C. 804(2)). Executive Order 13132 establishes [FR Doc. 2016–27423 Filed 11–14–16; 8:45 am]
Executive Orders 12866 and 13563 certain requirements that an agency BILLING CODE 4120–01–P
direct agencies to assess all costs and must meet when it promulgates a
mstockstill on DSK3G9T082PROD with RULES
benefits of available regulatory proposed rule (and subsequent final
alternatives and, if regulation is rule) that imposes substantial direct
necessary, to select regulatory requirement costs on State and local
approaches that maximize net benefits governments, preempts state law, or
(including potential economic, otherwise has federalism implications.
environmental, public health and safety Since this regulation does not impose
effects, distributive impacts, and any costs on state or local governments,
VerDate Sep<11>2014 16:28 Nov 11, 2016 Jkt 241001 PO 00000 Frm 00015 Fmt 4700 Sfmt 9990 E:\FR\FM\15NOR1.SGM 15NOR1](https://thefederalregister.org/doc/81_FR_80223/page/3.svg)
Document Created: 2016-11-15 00:48:22
Document Modified: 2016-11-15 00:48:22
| 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 | |
| Section | Rules and Regulations | |
| Action | Interim final rule with comment period. | |
| Contact | Wendy Tuttle, (410) 786-8690. | |
| FR Citation | 81 FR 80003 | |
| RIN Number | 0938-AT09 | |
| CFR Associated | Accounting; Administrative Practice and Procedure; Drugs; Grant Programs-Health; Health Facilities; Health Professions; Medicaid; Reporting and Recordkeeping Requirements and Rural Areas |
2025 Federal Register | Disclaimer | Privacy Policy
USC | CFR | eCFR