Rule2021-19382
Medicare and Medicaid Programs; Adjustment of Civil Monetary Penalties for Inflation; Continuation of Effectiveness and Extension of Timeline for Publication of the Final Rule
Primary source
Metadata and text below are from the Federal Register, a public-domain U.S. government work. Always verify the official published version before relying on it for any legal matter.
Published
September 8, 2021
Effective
September 3, 2021
Issuing agencies
Health and Human Services DepartmentCenters for Medicare & Medicaid Services
Abstract
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.
Full Text
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<title>Federal Register, Volume 86 Issue 171 (Wednesday, September 8, 2021)</title>
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[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 [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[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\ <a href="https://www.phe.gov/emergency/news/healthactions/section1135/Pages/covid19-13March20.aspx">https://www.phe.gov/emergency/news/healthactions/section1135/Pages/covid19-13March20.aspx</a>.
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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
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</html>Indexed from Federal Register on September 8, 2021.
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