[Federal Register Volume 87, Number 12 (Wednesday, January 19, 2022)]
[Proposed Rules]
[Page 2736]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[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]
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