[Federal Register Volume 85, Number 174 (Tuesday, September 8, 2020)]
[Rules and Regulations]
[Pages 55385-55386]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2020-19657]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Centers for Medicare & Medicaid Services

42 CFR Parts 402, 403, 411, 412, 422, 423, 460, 483, 488, and 493

[CMS-6076-RCN2]
RIN 0991-AC07


Medicare and Medicaid Programs; Adjustment of Civil Monetary 
Penalties for Inflation; Continuation of Effectiveness and Extension of 
Timeline for Publication of the Final Rule

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

ACTION: Continuation of effectiveness and extension of timeline for 
publication of the final rule.

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SUMMARY: This document announces the continuation of, effectiveness of, 
and the extension of the timeline for publication of a final rule. We 
are issuing this document in accordance with section 1871(a)(3)(C) of 
the Social Security Act (the Act), which allows an interim final rule 
to remain in effect after the expiration of the timeline specified in 
section 1871(a)(3)(B) of the Act if the Secretary publishes a notice of 
continuation explaining why we did not comply with the regular 
publication timeline.

DATES: Effective September 4, 2020, the Medicare provisions adopted in 
the interim final rule published on September 6, 2016 (81 FR 61538), 
continue in effect and the regular timeline for publication of the 
final rule is extended for an additional year, until September 6, 2021.

FOR FURTHER INFORMATION CONTACT: Steve Forry (410) 786-1564 or 
Jaqueline Cipa (410) 786-3259.

SUPPLEMENTARY INFORMATION: Section 1871(a) of the Social Security Act 
(the Act) sets forth certain procedures for promulgating regulations 
necessary to carry out the administration of the insurance programs 
under Title XVIII of the Act. Section 1871(a)(3)(A) of the Act requires 
the Secretary, in consultation with the Director of the Office of 
Management and Budget (OMB), to establish a regular timeline for the 
publication of final regulations based on the previous publication of a 
proposed rule or an interim final rule. In accordance with section 
1871(a)(3)(B) of the Act, such timeline may vary among different rules, 
based on the complexity of the rule, the number and scope of the 
comments received, and other relevant factors. However, the timeline 
for publishing the final rule, cannot exceed 3 years from the date of 
publication of the proposed or interim final rule, unless there are 
exceptional circumstances. After consultation with the Director of OMB, 
the Secretary published a document, which appeared in the December 30, 
2004 Federal Register on (69 FR 78442), establishing a general 3-year 
timeline for publishing Medicare final rules after the publication of a 
proposed or interim final rule.
    Section 1871(a)(3)(C) of the Act states that upon expiration of the 
regular timeline for the publication of a final regulation after 
opportunity for public comment, a Medicare interim final rule shall not 
continue in effect unless the Secretary publishes a notice of 
continuation of the regulation that includes an explanation of why the 
regular timeline was not met. Upon publication of such notice, the 
regular timeline for publication of the final regulation is treated as 
having been extended for 1 additional year.
    On September 6, 2016 Federal Register (81 FR 61538), the Department 
of Health and Human Services (HHS) issued a department-wide interim 
final rule titled ``Adjustment of Civil Monetary Penalties for 
Inflation'' that established new regulations at 45 CFR part 102 to 
adjust for inflation the maximum civil monetary penalty amounts for the 
various civil monetary penalty authorities for all agencies within the 
Department. HHS took this action to comply with the Federal Civil 
Penalties Inflation Adjustment Act of 1990 (the Inflation Adjustment 
Act) (28 U.S.C. 2461 note 2(a)), as amended by the Federal Civil 
Penalties Inflation Adjustment Act Improvements Act of 2015 (section 
701 of the Bipartisan Budget Act of 2015, (Pub. L. 114-74), enacted on 
November 2, 2015). In addition, this September 2016 interim final rule 
included updates to certain agency-specific regulations to reflect the 
new provisions governing the adjustment of civil monetary penalties for 
inflation in 45 CFR part 102.
    One of the purposes of the Inflation Adjustment Act was to create a 
mechanism to allow for regular inflationary adjustments to federal 
civil monetary penalties. Section 2(b)(1) of the Inflation Adjustment 
Act. The 2015 amendments removed an inflation update exclusion that 
previously

[[Page 55386]]

applied to the Social Security Act as well as to the Occupational 
Safety and Health Act. The 2015 amendments also ``reset'' the inflation 
calculations by excluding prior inflationary adjustments under the 
Inflation Adjustment Act and requiring agencies to identify, for each 
penalty, the year and corresponding amount(s) for which the maximum 
penalty level or range of minimum and maximum penalties was established 
(that is, originally enacted by Congress) or last adjusted other than 
pursuant to the Inflation Adjustment Act. In accordance with section 4 
of the Inflation Adjustment Act, agencies were required to: (1) Adjust 
the level of civil monetary penalties with an initial ``catch-up'' 
adjustment through an interim final rulemaking (IFR) to take effect by 
August 1, 2016; and (2) make subsequent annual adjustments for 
inflation.
    In the September 2016 interim final rule, HHS adopted new 
regulations at 45 CFR part 102 to govern adjustment of civil monetary 
penalties for inflation. The regulation at 45 CFR 102.1 provides that 
part 102 applies to each statutory provision under the laws 
administered by the Department of Health and Human Services concerning 
civil monetary penalties, and that the regulations in part 102 
supersede existing HHS regulations setting forth civil monetary penalty 
amounts. The civil money penalties and the adjusted penalty amounts 
administered by all HHS agencies are listed in tabular form in 45 CFR 
102.3. In addition to codifying the adjusted penalty amounts identified 
in Sec.  102.3, the HHS-wide interim final rule included several 
technical conforming updates to certain agency-specific regulations, 
including various CMS regulations, to identify their updated 
information, and incorporate a cross-reference to the location of HHS-
wide regulations.
    Because the conforming changes to the Medicare provisions were part 
of a larger, omnibus departmental interim final rule, we inadvertently 
missed setting a target date for the final rule to make permanent the 
changes to the Medicare regulations in accordance with section 
1871(a)(3)(A) of the Act and the procedures outlined in the December 
2004 document. Therefore, in the January 2, 2020 Federal Register (85 
FR 7), we published a document continuing the effectiveness of effect 
and the regular timeline for publication of the final rule for an 
additional year, until September 6, 2020.
    Consistent with section 1871(a)(3)(C) of the Act, we are publishing 
this second notice of continuation extending the effectiveness of the 
technical conforming changes to the Medicare regulations that were 
implemented through interim final rule and to allow time to publish a 
final rule.
    On January 31, 2020, pursuant to section 319 of the Public Health 
Service Act (PHSA), the Secretary determined that a Public Health 
Emergency (PHE) exists for the United States to aid the nation's 
healthcare community in responding to COVID-19. On March 11, 2020, the 
World Health Organization (WHO) publicly declared COVID-19 a pandemic. 
On March 13, 2020, the President declared the COVID-19 pandemic a 
national emergency. This declaration, along with the Secretary's 
January 31, 2020 declaration of a PHE, conferred on the Secretary 
certain waiver authorities under section 1135 of the Act. On March 13, 
2020, the Secretary authorized waivers under section 1135 of the Act, 
effective March 1, 2020.\1\ Effective July 25, 2020, the Secretary 
renewed the January 31, 2020 determination that was previously renewed 
on April 21, 2020, that a PHE exists and has existed since January 27, 
2020. The unprecedented nature of this national emergency has placed 
enormous responsibilities upon CMS to respond appropriately, and 
resources have had to be re-allocated throughout the agency in order to 
be responsive. Therefore, the Medicare provisions adopted in interim 
final regulation continue in effect and the regular timeline for 
publication of the final rule is extended for an additional year, until 
September 6, 2021.
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    \1\ https://www.phe.gov/emergency/news/healthactions/section1135/Pages/covid19-13March20.aspx.

Wilma M. Robinson,
Deputy Executive Secretary to the Department, Department of Health and 
Human Services.
[FR Doc. 2020-19657 Filed 9-4-20; 8:45 am]
BILLING CODE 4120-01-P