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Diagnostic Tests Regulatory Requirements Centers for Medicare & Medicaid Services (CMS)

Venable LLP

Summary of LDT Rule: An In-depth Look at the Final Rule Regarding Laboratory-Developed Tests

Venable LLP on

The U.S. Food and Drug Administration (FDA or the Agency) issued a Final Rule on May 6, 2024 (89 FR 37286), that will, over the next four years, radically alter the landscape for laboratory-developed tests (LDTs) and "correct...more

Stotler Hayes Group, LLC

Provider Requirement to post Cash Price of COVID-19 Diagnostic Testing pursuant to CARES Act & Potential to Incur Civil Monetary...

Stotler Hayes Group, LLC on

All providers should take note of an under the radar provision of the CARES Act, 3202(a) & 3202(b), that requires all providers of diagnostic testing for COVID-19 to publicly post the cash price for such a test on the...more

Mintz - Health Care Viewpoints

CMS Allows Pharmacies and Other Suppliers to Bill Medicare for COVID-19 Testing

In an effort to address the need to increase the availability of COVID-19 testing, the Centers for Medicare & Medicaid Services (CMS) has issued guidance notifying pharmacies and other Medicare-enrolled suppliers that they...more

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