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policypros.bsky.social
@policypros.bsky.social
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Over 30 years of experience is Medicare policy. Consulting with pharma, diagnostic and med techs to help navigate through Medicare coverage, coding and reimbursement issues.
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alexander-a-tin.bsky.social
From FDA and CMS on phasing out enforcement discretion for laboratory development tests

"patients and their doctors need to know that LDTs are valid"

"CMS does not have the expertise to assure that tests work; the FDA does"

www.fda.gov/medical-devi...
A screenshot of text that reads in part: "Both CMS and the FDA believe that patients and their doctors need to know that LDTs are valid. The FDA and CMS both provide oversight to help assure the accuracy of test results, however, they have different roles. CMS regulates laboratories that perform testing on individuals in the U.S. through the Clinical Laboratory Improvement Amendments of 1988 (CLIA) by establishing quality standards for all laboratory testing to help ensure the accuracy, reliability and timeliness of patient test results. In 2013, CMS published a fact sheet on LDTs, outlining each agency’s authority and the complementary roles of the two regulatory schemes. That said, a decade later, in connection with the FDA’s notice of proposed rulemaking, we are – together – reiterating that CMS’s CLIA program is separate in scope and purpose from FDA oversight. Some have suggested that concerns with LDTs should be addressed through expansion of CLIA. This is not the answer. As was
January 18, 2024 at 8:17 PM