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Centers for Medicare and Medicaid Services

FDA Will Have No Authority Over Laboratory-Developed Tests, HHS Says

This is an excerpt of a 2,029-word article in the August 24, 2020 issue of THE DARK REPORT (TDR). The full article is available to members of The Dark Intelligence Group. CEO SUMMARY: A directive from the federal Department of Health and Human Services (HHS) may have long-lasting implic…

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HHS ‘Stands Down’ FDA on Its Oversight of LDTs

CEO SUMMARY: A directive from the federal Department of Health and Human Services (HHS) may have long-lasting implications for the federal Food and Drug Administration’s efforts to assert regulatory oversight of laboratory-developed tests (LDTs). In a statement last week, HHS said t…

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Proposed Medicare 2021 PFS Cuts Pathology Fees by 9%

IF THE PROPOSED MEDICARE 2012 PHYSICIAN FEE SCHEDULE (PFS) RULE—published by the Centers for Medicare and Medicaid Services (CMS) on Aug. 4—takes effect as currently written, pathology professional fees will be cut by 9%, effective Jan. 1, 2021. This was not…

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Lab, Path Finances Crash; Next Test Wave: Serology

CEO SUMMARY: For clinical laboratories and anatomic pathology groups, the day-by-day impact of the COVID-19 pandemic is unfolding much like Hurricane Katrina hitting New Orleans in 2005. Every 24 hours, labs get unwelcome news, along with uncertainty about whether it will …

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