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CMS Delays Clinical Laboratory Proficiency Testing Rulemaking by a Year

The Centers for Medicare & Medicaid Services (CMS or the Agency) announced on January 19, 2022 that it was delaying the publication of a Clinical Laboratory Improvement Amendments of 1988 (CLIA) final rulemaking by one year.  The goal of this rulemaking is to update clinical laboratory proficiency testing (PT) regulations.  PT is the testing of unknown samples sent to a clinical laboratory by a CMS-approved program.  Such testing is used by CMS, accreditation organizations, and clinical laboratories to verify the accuracy and reliability of a laboratory’s testing activities.

CMS published the PT proposed rulemaking in February 2019.  Under the Social Security Act, a Medicare final rule must be published within three years of the proposed rule (absent exceptional circumstances).  CMS originally slated the PT final rulemaking for publication in February of this year.  Now, the Agency is expecting finalization of the rule by February 2023.

The PT rulemaking is intended to address current analytes and newer technologies by updating CLIA regulations (42 CFR Part 493).  In the February 2019 proposed rule, CMS proposed, among other items:

  • Requiring PT for an additional 29 analytes;

  • Mandating a minimum of 10 laboratory participants before a PT program offers an analyte;

  • Increasing the number of challenges per PT event for certain types of testing (e.g., susceptibility or resistance testing for each microbiology subspecialty would increase from one to two challenges); and

  • Requiring that PT programs limit participants’ online submission of PT data to one submission or that a method be provided to track changes made to electronically-reported results.

CMS received over 100 comments concerning the proposed rulemaking.  In delaying the publication of the final rulemaking by a year, CMS cited the COVID-19 public health emergency.  The Agency is currently prioritizing the “publication of notices relevant to COVID-19 and to provide guidance to laboratories involved in COVID-19 testing.”  Because of these ongoing public health demands, CMS explained that it cannot meet the original February 2022 deadline.

According to the Fall 2021 Unified Agenda, CMS is scheduled to publish another clinical laboratory-focused proposed rulemaking in March of this year.  That rulemaking will focus on updates to the clinical laboratory personnel, histocompatibility, and alternative sanctions regulations as well as CLIA-related program fees.  Because of the COVID-19 public health emergency, it is unclear if the Agency will postpone publication of this proposed rulemaking as well.

Copyright ©2022 Nelson Mullins Riley & Scarborough LLPNational Law Review, Volume XII, Number 21
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About this Author

Christopher Hanson Medical Regulation Attorney Nelson Mullins
Partner

Christopher assists clients in tackling their most sophisticated and high-stakes regulatory issues involving medical devices, in vitro diagnostics (IVDs), clinical laboratories, human and animal drugs, cosmetics, and radiation-emitting electronic products. He has aided clients in interactions with federal, state, and foreign regulatory agencies, including the U.S. Food and Drug Administration (FDA), the Centers for Medicare & Medicaid Services (CMS), and the Federal Trade Commission (FTC).

Christopher crafts creative and practical solutions for clients. His work includes...

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