Proposed Rule2022-00932
Clinical Laboratory Improvement Amendments of 1988 (CLIA) Proficiency Testing Regulations Related to Analytes and Acceptable Performance; Extension of Timeline for Publication of 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
January 19, 2022
Issuing agencies
Health and Human Services DepartmentCenters for Medicare & Medicaid Services
Abstract
The Social Security Act (the Act) specifies that a Medicare final rule must be published no later than 3 years after the publication date of the proposed rule or interim final rule, as applicable, except under exceptional circumstances. In accordance with the Act, this document announces an extension of the timeline for publication of the final rule and includes a brief explanation of the justification for the variation.
Full Text
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<title>Federal Register, Volume 87 Issue 12 (Wednesday, January 19, 2022)</title>
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[Federal Register Volume 87, Number 12 (Wednesday, January 19, 2022)]
[Proposed Rules]
[Page 2736]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2022-00932]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Centers for Medicare & Medicaid Services
42 CFR Part 493
[CMS-3355-RCN]
RIN 0938-AT55
Clinical Laboratory Improvement Amendments of 1988 (CLIA)
Proficiency Testing Regulations Related to Analytes and Acceptable
Performance; Extension of Timeline for Publication of Final Rule
AGENCY: Centers for Medicare & Medicaid Services (CMS), Department of
Health and Human Services (HHS); Centers for Disease Control and
Prevention (CDC), HHS.
ACTION: Extension of timeline for publication of final rule.
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SUMMARY: The Social Security Act (the Act) specifies that a Medicare
final rule must be published no later than 3 years after the
publication date of the proposed rule or interim final rule, as
applicable, except under exceptional circumstances. In accordance with
the Act, this document announces an extension of the timeline for
publication of the final rule and includes a brief explanation of the
justification for the variation.
DATES: As of January 18, 2022, the timeline for publication of the
final rule to finalize the provisions of the proposed rule published on
February 4, 2019 (84 FR 1536), is extended until February 4, 2023.
FOR FURTHER INFORMATION CONTACT: Sarah Bennett, CMS, (410) 786-3531 or
Nancy Anderson, CDC, (404) 498-2741.
SUPPLEMENTARY INFORMATION: In the February 4, 2019, Federal Register
(84 FR 1536), we published a proposed rule entitled ``Clinical
Laboratory Improvement Amendments of 1988 (CLIA) Proficiency Testing
Regulations Related to Analytes and Acceptable Performance'', which
would update proficiency testing (PT) regulations under the CLIA to
address current analytes (that is, substances or constituents for which
the laboratory conducts testing) and newer technologies. This proposed
rule would also make additional technical changes to PT referral
regulations to more closely align with the CLIA statute.
Section 1871(a)(3)(B) of the Social Security Act (the Act) requires
the Secretary to publish a Medicare final rule no later than 3 years
after the publication date of the proposed rule or interim final rule,
as applicable, except under exceptional circumstances. In such
circumstances, the Secretary may vary the final rule publication
timeline if the Secretary publishes a Federal Register notice of the
different timeline, including a brief explanation of the justification
for the variation, by no later than the previously established
timeline. To meet the 3-year timeline, the final rule would have to be
published by February 4, 2022. For the reasons discussed below, we are
unable to publish the final rule by February 4, 2022. In accordance
with section 1871(a)(3)(B) of the Act, this document announces an
extension of the timeline for publication of the final rule by 1 year
until February 4, 2023.
Since the COVID-19 public health emergency was effective January
27, 2020, we prioritized our efforts to issue appropriate regulatory
flexibility provisions to increase access to reliable and accurate
testing relevant to COVID-19, while minimizing unnecessary regulatory
burdens. This redirection continues to require considerable focus and
resources, especially to prioritize the publication of notices relevant
to COVID-19 and to provide guidance to laboratories involved in COVID-
19 testing. Therefore, we cannot meet the February 4, 2022 deadline.
However, we intend to publish the final rule by February 4, 2023.
Extension of the timeline to allow for issuing the final rule is
critical as the release of the final rule is anticipated, and we expect
stakeholders, including the laboratory community and others, will react
positively to the changes to the CLIA regulations. The practice of
laboratory medicine has changed significantly since the PT regulations
were published in 1992. There are several clinically important analytes
in common use today for which PT was not required in the 1992 rule. The
laboratory community is aware of this and other gaps that will be
addressed by this final rule. Stakeholders are actively requesting
updates to the PT analytes, acceptance limits, and microbiology model
and have frequently inquired about the status of the final rule since
2019. For these reasons and based on comments we received in response
to the proposed rule, it is important to extend the timeline to issue
this final rule to revise and update the CLIA PT regulations.
Karuna Seshasai,
Executive Secretary to the Department, Department of Health and Human
Services.
[FR Doc. 2022-00932 Filed 1-18-22; 8:45 am]
BILLING CODE 4120-01-P
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</html>Indexed from Federal Register on January 19, 2022.
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