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CMS Announces Regulatory Flexibility for CLIA Laboratories

The Centers for Medicare and Medicaid Services has temporarily modified certain operational and regulatory requirements that may help Clinical Laboratory Improvement Amendments (CLIA) certified laboratories adapt their operations in response to the Coronavirus (COVID-19) pandemic. These modifications are only in effect for the duration of the public health emergency, and all other CLIA requirements continue to apply.

IN DEPTH


On March 26, 2020, the Centers for Medicare and Medicaid Services (CMS) issued a memorandum (CLIA Laboratory Guidance During COVID-19 Public Health Emergency (QSO-20-21-CLIA)) outlining certain modifications to its implementation and enforcement of Clinical Laboratory Improvement Amendments (CLIA) requirements for clinical laboratories during the Coronavirus (COVID-19) public health emergency.

In the memorandum, CMS confirms that it does not have the authority to waive CLIA regulatory requirements, which apply to most facilities performing clinical laboratory testing for patients in the United States. As a result, the memorandum does not create a pathway for facilities to offer diagnostic testing without first receiving a CLIA certificate (and/or any clinical laboratory license that may be required under applicable state law) and complying with CLIA requirements. Nor does it modify the CLIA requirement that a facility be certified to perform high-complexity testing before performing a laboratory-developed test. However, the memorandum does temporarily modify certain operational and/or regulatory requirements that may help CLIA-certified laboratories adapt their operations in response to the pandemic.

Key takeaways from the memorandum include the following:

  • Expediting Review of CLIA Applications. While a CLIA certificate continues to be required to perform diagnostic testing (including COVID-19 testing) for patients, CMS will review applications for a CLIA certificate on an expedited basis. Specifically, once a laboratory has identified a qualified laboratory director and submitted a complete CMS-116 application, CMS will issue a CLIA number. Although laboratories typically must wait to start testing until a physical copy of the CLIA certificate arrives in the mail, CMS will temporarily allow testing to begin as soon as a CLIA number is assigned to the laboratory, provided that applicable CLIA requirements have been met (i.e., performance specifications for all tests offered to patients have been established or verified, as applicable).
  • Allowing Remote Review of Cytology Slides. In general, CLIA requires a separate certificate for each location where cytology slides are reviewed. To facilitate remote review of slides during the pandemic, CMS will temporarily allow pathologists to review cytology slides from a location without its own CLIA certification (e.g., a pathologist’s home), provided that the laboratory’s primary site or home base has an appropriate CLIA certification, and the work performed at the temporary location falls within the primary site’s certificate (among other requirements).
  • Modifying Proficiency Testing Requirements. While laboratories must continue to comply with proficiency testing (PT) requirements, they will not be penalized for lack of PT results if a laboratory suspends performing a specific test because of a shortage of supplies, reagents or personnel, provided the laboratory documents the timeframe during which the test was not performed, and notifies the inspecting agency and the PT program of the reason for the suspension. If a PT provider postpones, cancels or suspends a PT event during the public health emergency, the laboratory will not be penalized provided the cancelation is documented (e.g., the laboratory retains the notification letter from the PT program) and PT is conducted in a timely manner once the emergency ends. Notwithstanding the above, CMS encourages laboratories to perform their own self-assessments until PT resumes as usual.
  • Modifying Inspection Priorities (to Focus Primarily on “Immediate Jeopardy” Situations). CMS will generally exercise enforcement discretion for technical violations that do not put patients, laboratory professionals or the general public in “immediate jeopardy.” Under CLIA, “immediate jeopardy” means a situation where immediate corrective action is necessary because the laboratory’s noncompliance with one or more requirements has already caused, is causing or is likely to cause, at any time, serious injury or harm, or death, to individuals served by the laboratory, or to the health or safety of the general public.

CMS emphasizes that these changes to CLIA regulations are only applicable during the public health emergency. Otherwise, all CLIA regulations, except as described herein, remain in effect.

© 2020 McDermott Will & Emery

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Michael Ryan Attorney specializing in Pharma law McDermott Law Firm
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Michael W. Ryan is a partner in the law firm of McDermott Will & Emery LLP and is based in the Firm’s Washington, D.C. office.

Michael focuses his practice on the legal, regulatory and reimbursement issues that manufacturers and investors encounter in the development and commercialization of pharmaceuticals, medical devices, biotechnology products and laboratory services.  Michael counsels entities as they seek to obtain authorization to market their products from the U.S. Food and Drug Administration, maintain compliance with applicable laws and regulations (including the...

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Gregory E. Fosheim advises healthcare and life sciences clients across a variety of corporate, transactional and regulatory compliance matters. Working with hospitals, physician practice groups, clinical research programs, pharmaceutical companies, device manufacturers and others, Greg provides counsel on healthcare fraud and abuse risks, Medicare, Medicaid, and private payor billing, and clinical research and laboratory compliance in connection with federal grants, among other issues. Greg also provides regulatory due diligence support on healthcare transactions and collaborations, helping his clients drive innovation and expand their businesses.

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Caroline Reigart counsels healthcare clients, including for-profit and nonprofit hospitals, health systems, physician groups and others, in planning healthcare transactions and other business arrangements, with a focus on conducting regulatory due diligence and bond financing diligence review.

Caroline also assists clients with internal and government investigations related to the False Claims Act, Stark Law and Anti-Kickback Statue. Her experience navigating civil and criminal investigations within the healthcare space allows her to take a strategic approach to risk management in...

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