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CMS Encourages Faster COVID-19 Diagnostic Testing

CMS is changing its payment methodology to encourage higher throughput of COVID-19 diagnostic testing. Previously, CMS would reimburse $100 per test Starting January 1, 2021, Medicare will pay lower the base rate to $75. However, if the laboratory can complete the test within two (2) calendar days from the date the specimens is collected, CMS […]

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CMS Issues Cease and Desist Orders to Uncertified Labs Performing COVID-19 Testing

Since August 12, 2020, CMS issued 171 cease and desist letters to entities across the U.S. that were testing for COVID-19 without the appropriate certifications under the Clinical Laboratory Improvement Amendments of 1988 (CLIA). Every facility that conducts COVID-19 testing is considered a “laboratory” and must be certified under CLIA, which verifies that labs meet […]

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HHS Renews Public Health Emergency Declaration through January 20, 2021

On Friday, October 2, the U.S. Department of Health & Human Services (HHS) announced that the Public Health Emergency (PHE) declaration for COVID‑19 will be renewed for another 90 days, beginning on October 23 (the date the PHE was previously scheduled to expire) and extending through January 20, 2021. Source: Renewal of Determination That A […]

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FDA Will No Longer Review EUA Requests for COVID-19 Laboratory Developed Tests

The Food and Drug Administration (FDA) will no longer require premarket review of laboratory developed tests (LDTs), including COVID-19 tests, decline to review emergency use authorization (EUA) request for LDTs. Instead, the FDA will prioritize review of EUAs for point-of-care tests, home collection tests, at-home tests, tests that reduce reliance on test supplies, and high-throughput, […]

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Unapproved and Misbranded COVID Treatments Get FDA Attention

There is no FDA-approved treatment for COVID-19, but that hasn’t stopped one compounding pharmacy from making bold claims. Marketing products as “COVID PACK” and “COVID ‘POSITIVE’ PACK” for the “treatment and recovery from the Covid-19 virus” apparently crossed the line. These products appear to be nothing more than vitamins. It wasn’t the products that got […]