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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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Rocky Rollout Spells Trouble for Medicare Prescription Payment Plan

 
• By Lauren Flynn Kelly

Enrollment in the new Medicare Prescription Payment Plan was lower than expected in the first year and well below CMS expectations, and invoicing data indicates members are slow to pay.

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Industry Leaders Grapple With Trump’s Most Favored Nation Pricing Plan

 
• By Jessica Merrill

At the Bank of America health care conference, pharma leaders speculated on the impact of Trump’s most favored nation pricing executive order on US and European markets.

New Guidance Suggests SubQ Keytruda, Opdivo Formulations May Not Avoid Medicare Negotiations

 
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New draft guidance on the third cycle of Medicare drug price negotiations goes against Merck and BMS expectations for their cancer drugs. The guidance also tackles Part B and renegotiated prices for the first time.

More from Government Payers

Will International Prices Influence Medicare Price Negotiation?

 
• By Cathy Kelly

A former CMS official suggested the most likely way it could happen is through a Center for Medicare and Medicaid Innovation demonstration.

Industry Leaders Grapple With Trump’s Most Favored Nation Pricing Plan

 
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At the Bank of America health care conference, pharma leaders speculated on the impact of Trump’s most favored nation pricing executive order on US and European markets.

Most Favored Nation Policy ‘Lazy, Misguided,’ But US Price Reforms Politically ‘Inevitable’

 
• By Cathy Kelly

Policy experts and pharma executives react to President Trump’s executive order on “equalizing” drug prices between the US and comparable nations at the ISPOR 2025 conference.