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CMS Drug Coverage Could Be Driven By Commercial Plan Decisions Under Proposal

 
• By Brenda Sandburg

Proposed rule would also clarify standard for determining whether coverage of a drug, device, or biologic is ‘reasonable and necessary.’

Text sign showing Medicare. Conceptual photo the federal government plan in US for paying certain hospital.
CMS proposed rule would speed coverage of breakthrough medical devices • Source: Shutterstock

The US Centers for Medicare & Medicaid Services is seeking public comment on whether a proposed rule to establish a Medicare coverage pathway to enable Medicare beneficiaries to get access to breakthrough devices at the time of US Food and Drug Administration approval should also apply to drugs and biologics, which traditionally have not experienced the same coverage delays.

The proposed rule follows an Executive Order on Protecting and Improving Medicare for Our Nation’s Seniors, which President Trump issued in October. CMS said it is limiting the Medicare...

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