[Federal Register Volume 86, Number 171 (Wednesday, September 8, 2021)]
[Rules and Regulations]
[Pages 50263-50264]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2021-19382]


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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-RCN3]
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 the Social Security Act 
(the Act), which allows an interim final rule to remain in effect after 
the expiration of the timeline specified in the Act if the Secretary 
publishes a notice of continuation explaining why we did not comply 
with the regular publication timeline.

DATES: Effective September 3, 2021, 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, 2022.

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 notice, 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 (see section 
2(b)(1)) was to create a mechanism to allow for regular inflationary 
adjustments to federal civil monetary penalties. The 2015 amendments 
removed an inflation update exclusion that previously 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 HHS 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 publication of the final rule to make 
permanent the conforming changes to the Medicare regulations in 
accordance with section 1871(a)(3)(A) of the Act and the procedures 
outlined in the December 2004 notice. Therefore, in the January 2, 2020 
Federal Register (85 FR 7), we published a document continuing the 
effectiveness of the interim final rule for an additional year, until 
September 6, 2020.
    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

[[Page 50264]]

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 20, 2021, the 
Secretary renewed the January 31, 2020 determination that was 
previously renewed on April 21, 2020, July 23, 2020, October 2, 2020, 
January 7, 2021, April 15, 2021, and July 19, 2021, 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.
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    \1\ https://www.phe.gov/emergency/news/healthactions/section1135/Pages/covid19-13March20.aspx.
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    Due to the PHE and in accordance with section 1871(a)(3)(C) of the 
Act, on September 8, 2020 (85 FR 55385), we published a second document 
continuing the effectiveness of effect and the regular timeline for 
publication of the final rule for an additional year, until September 
6, 2021.
    Because of CMS's continued efforts to address resource challenges 
resulting from the PHE and consistent with section 1871(a)(3)(C) of the 
Act, we are publishing a third 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. 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, 2022.

Karuna Seshasai,
Executive Secretary to the Department, Department of Health and Human 
Services.
[FR Doc. 2021-19382 Filed 9-3-21; 11:15 am]
BILLING CODE 4120-01-P