CMS is considering adding new medical device cybersecurity requirements for hospitals participating in Medicare after receiving recommendations from the HHS Office of Inspector General, according to a ...

The U.S. Food and Drug Administration (FDA) and the Centers for Medicare & Medicaid Services (CMS) have launched two coordinated initiatives: the ...

The Transitional Coverage for Emerging Technologies Pathway will expedite the coverage of certain FDA-designated breakthrough devices, according to an Aug. 8 news release from the agency. Each year, ...

On August 7, 2024, the Centers for Medicare & Medicaid Services (CMS) released a Final Notice for Transitional Coverage for Emerging Technologies (TCET) (Final Notice). The long-anticipated Final ...

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The Food and Drug Administration's headquarters is in Silver Spring, Maryland. This story was originally published on MedTech Dive. To receive daily news and insights, subscribe to our free daily ...

The CMS could use its competitive bidding program to address price concerns, after payments for the devices swelled over five years, the government watchdog said. Medicare first started covering CGMs ...

Medicare will speed nationwide payment decisions for as many as five promising new medical devices a year, a move that could get some products to patients earlier and spare companies from a ...

Twelve Members of the Independence Through Enhancement of Medicare and Medicaid (ITEM) Coalition Sign Letter to CMS Seeking Clarification of Prior Decision Making and Action to Bring Novel Hearing ...

The Centers for Medicare and Medicaid Services shared a final notice on Wednesday for a new pathway to cover breakthrough medical devices. The pathway, called Transitional Coverage for Emerging ...