Medicare Program; Modernizing and Clarifying the Physician Self-Referral Regulations Extension of Timeline for Publication of Final Rule, 52940-52941 [2020-18867]

Download as PDF 52940 Federal Register / Vol. 85, No. 167 / Thursday, August 27, 2020 / Proposed Rules currently 20 unique registrations authorized to handle N-ethylpentylone specifically, as well as a number of registered analytical labs that are authorized to handle schedule I controlled substances generally. From review of entity names, DEA estimates these 20 registrations represent 16 entities. Some of these entities are likely to be small entities. However, since DEA does not have information of registrant size and the majority of DEA registrants are small entities or are employed by small entities, DEA estimates a maximum of 16 entities are small entities. Therefore, DEA conservatively estimates as many as 16 small entities are affected by this proposed rule. A review of the 20 registrations indicates that all entities that currently handle N-ethylpentylone also handle other schedule I controlled substances, and thus they have established and implemented (or maintain) the systems and processes required to handle Nethylpentylone as a schedule I substance. Therefore, DEA anticipates that this proposed rule will impose minimal or no economic impact on any affected entities, and, thus, will not have a significant economic impact on any of the 16 affected small entities. Therefore, DEA has concluded that this proposed rule will not have a significant effect on a substantial number of small entities. Unfunded Mandates Reform Act of 1995 In accordance with the Unfunded Mandates Reform Act (UMRA) of 1995, 2 U.S.C. 1501 et seq., DEA has determined and certifies that this action would not result in any Federal mandate that may result ‘‘in the expenditure by State, local, and tribal governments, in the aggregate, or by the private sector, of $100,000,000 or more (adjusted annually for inflation) in any 1 year * * *.’’ Therefore, neither a Small Government Agency Plan nor any other action is required under UMRA of 1995. khammond on DSKJM1Z7X2PROD with PROPOSALS Paperwork Reduction Act of 1995 This action does not impose a new collection of information under the Paperwork Reduction Act of 1995. 44 U.S.C. 3501–3521. This action would not impose recordkeeping or reporting requirements on State or local governments, individuals, businesses, or organizations. An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB control number. VerDate Sep<11>2014 16:33 Aug 26, 2020 Jkt 250001 List of Subjects in 21 CFR Part 1308 Administrative practice and procedure, Drug traffic control, Reporting and recordkeeping requirements. For the reasons set out above, DEA proposes to amend 21 CFR part 1308 as follows: FOR FURTHER INFORMATION CONTACT: Lisa O. Wilson, (410) 786–8852. In the October 17, 2019 Federal Register (84 FR 55766), we published a proposed rule that addressed undue regulatory impact and burden of the physician selfreferral law. The proposed rule was issued in conjunction with the Centers for Medicare & Medicaid Services’ PART 1308—SCHEDULES OF (CMS) Patients over Paperwork CONTROLLED SUBSTANCES initiative and the Department of Health ■ 1. The authority citation for part 1308 and Human Services’ (the Department continues to read as follows: or HHS) Regulatory Sprint to Coordinated Care. In the proposed rule, Authority: 21 U.S.C. 811, 812, 871(b), 956(b), unless otherwise noted. we proposed exceptions to the physician self-referral law for certain ■ 2. In § 1308.11, add paragraph (d)(86) value-based compensation arrangements and remove and reserve paragraph between or among physicians, (h)(36). providers, and suppliers; a new The addition reads as follows: exception for certain arrangements § 1308.11 Schedule I. under which a physician receives limited remuneration for items or * * * * * services actually provided by the (d) * * * physician; a new exception for (86) N-Ethylpentylone (Other donations of cybersecurity technology names: ephylone, 1-(1,3benzodioxol-5-yl)-2and related services; and amendments (ethylamino)pentan-1-one) ...... 7543 to the existing exception for electronic health records (EHR) items and services. * * * * * The proposed rule also provides Dated: August 24, 2020. critically necessary guidance for Timothy J. Shea, physicians and health care providers Acting Administrator. and suppliers whose financial [FR Doc. 2020–19007 Filed 8–26–20; 8:45 am] relationships are governed by the BILLING CODE 4410–09–P physician self-referral statute and regulations. This notice announces an extension of the timeline for publication of the final rule and the continuation of DEPARTMENT OF HEALTH AND effectiveness of the proposed rule. HUMAN SERVICES Section 1871(a)(3)(A) of the Social Centers for Medicare & Medicaid Security Act (the Act) requires us to Services establish and publish a regular timeline for the publication of final regulations 42 CFR Part 411 based on the previous publication of a proposed regulation. In accordance with [CMS–1720–RCN] section 1871(a)(3)(B) of the Act, the RIN 0938–AT64 timeline may vary among different regulations based on differences in the Medicare Program; Modernizing and complexity of the regulation, the Clarifying the Physician Self-Referral number and scope of comments Regulations Extension of Timeline for received, and other relevant factors, but Publication of Final Rule may not be longer than 3 years except under exceptional circumstances. In AGENCY: Centers for Medicare & addition, in accordance with section Medicaid Services (CMS), HHS. 1871(a)(3)(B) of the Act, the Secretary ACTION: Extension of timeline for may extend the initial targeted publication of final rule. publication date of the final regulation SUMMARY: This notice announces an if the Secretary, no later than the extension of the timeline for publication regulation’s previously established of a Medicare final rule in accordance proposed publication date, publishes a with the Social Security Act, which notice with the new target date, and allows us to extend the timeline for such notice includes a brief explanation publication of the final rule. of the justification for the variation. We announced in the Spring 2020 DATES: As of August 26, 2020, the timeline for publication of the final rule Unified Agenda (June 30, 2020, to finalize the provisions of the October www.reginfo.gov) that we would issue 17, 2019 proposed rule (84 FR 55766) is the final rule in August 2020. However, we are still working through the extended until August 31, 2021. PO 00000 Frm 00011 Fmt 4702 Sfmt 4702 SUPPLEMENTARY INFORMATION: E:\FR\FM\27AUP1.SGM 27AUP1 Federal Register / Vol. 85, No. 167 / Thursday, August 27, 2020 / Proposed Rules complexity of the issues raised by comments received on the proposed rule and therefore we are not able to meet the announced publication target date. This notice extends the timeline for publication of the final rule until August 31, 2021. 52941 Dated: August 24, 2020. Wilma M. Robinson, Deputy Executive Secretary to the Department, Department of Health and Human Services. [FR Doc. 2020–18867 Filed 8–26–20; 8:45 am] khammond on DSKJM1Z7X2PROD with PROPOSALS BILLING CODE 4120–01–P VerDate Sep<11>2014 16:33 Aug 26, 2020 Jkt 250001 PO 00000 Frm 00012 Fmt 4702 Sfmt 9990 E:\FR\FM\27AUP1.SGM 27AUP1

Agencies

[Federal Register Volume 85, Number 167 (Thursday, August 27, 2020)]
[Proposed Rules]
[Pages 52940-52941]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2020-18867]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Centers for Medicare & Medicaid Services

42 CFR Part 411

[CMS-1720-RCN]
RIN 0938-AT64


Medicare Program; Modernizing and Clarifying the Physician Self-
Referral Regulations Extension of Timeline for Publication of Final 
Rule

AGENCY: Centers for Medicare & Medicaid Services (CMS), HHS.

ACTION: Extension of timeline for publication of final rule.

-----------------------------------------------------------------------

SUMMARY: This notice announces an extension of the timeline for 
publication of a Medicare final rule in accordance with the Social 
Security Act, which allows us to extend the timeline for publication of 
the final rule.

DATES: As of August 26, 2020, the timeline for publication of the final 
rule to finalize the provisions of the October 17, 2019 proposed rule 
(84 FR 55766) is extended until August 31, 2021.

FOR FURTHER INFORMATION CONTACT: Lisa O. Wilson, (410) 786-8852.

SUPPLEMENTARY INFORMATION: In the October 17, 2019 Federal Register (84 
FR 55766), we published a proposed rule that addressed undue regulatory 
impact and burden of the physician self-referral law. The proposed rule 
was issued in conjunction with the Centers for Medicare & Medicaid 
Services' (CMS) Patients over Paperwork initiative and the Department 
of Health and Human Services' (the Department or HHS) Regulatory Sprint 
to Coordinated Care. In the proposed rule, we proposed exceptions to 
the physician self-referral law for certain value-based compensation 
arrangements between or among physicians, providers, and suppliers; a 
new exception for certain arrangements under which a physician receives 
limited remuneration for items or services actually provided by the 
physician; a new exception for donations of cybersecurity technology 
and related services; and amendments to the existing exception for 
electronic health records (EHR) items and services. The proposed rule 
also provides critically necessary guidance for physicians and health 
care providers and suppliers whose financial relationships are governed 
by the physician self-referral statute and regulations. This notice 
announces an extension of the timeline for publication of the final 
rule and the continuation of effectiveness of the proposed rule.
    Section 1871(a)(3)(A) of the Social Security Act (the Act) requires 
us to establish and publish a regular timeline for the publication of 
final regulations based on the previous publication of a proposed 
regulation. In accordance with section 1871(a)(3)(B) of the Act, the 
timeline may vary among different regulations based on differences in 
the complexity of the regulation, the number and scope of comments 
received, and other relevant factors, but may not be longer than 3 
years except under exceptional circumstances. In addition, in 
accordance with section 1871(a)(3)(B) of the Act, the Secretary may 
extend the initial targeted publication date of the final regulation if 
the Secretary, no later than the regulation's previously established 
proposed publication date, publishes a notice with the new target date, 
and such notice includes a brief explanation of the justification for 
the variation.
    We announced in the Spring 2020 Unified Agenda (June 30, 2020, 
www.reginfo.gov) that we would issue the final rule in August 2020. 
However, we are still working through the

[[Page 52941]]

complexity of the issues raised by comments received on the proposed 
rule and therefore we are not able to meet the announced publication 
target date. This notice extends the timeline for publication of the 
final rule until August 31, 2021.

    Dated: August 24, 2020.
Wilma M. Robinson,
Deputy Executive Secretary to the Department, Department of Health and 
Human Services.
[FR Doc. 2020-18867 Filed 8-26-20; 8:45 am]
BILLING CODE 4120-01-P
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