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What Awaits in the First Year of Medicare Drug Price Negotiations? CMS Issues Guidance and Solicits Comment on the 2026 Inflation Reduction Act Part D Negotiation Process

On March 15, 2023, the Centers for Medicare & Medicaid Services (“CMS”) issued an initial guidance memorandum (“Memorandum”) describing how it proposes to implement the Inflation Reduction Act Medicare Drug Price Negotiation Program (“Negotiation Program”) for the Initial Price Applicability Year of 2026 (the “Initial Year”). In the Memorandum, CMS provides further guidance regarding (i) how it intends to select the Medicare Part D drugs and biologics for which it will negotiate a maximum fair price (“MFP”) for the Initial Year (the “Selected Drugs”), (ii) the data and evidence that manufacturers will be required to submit that will inform CMS’s initial price proposals, (iii) the structure of the negotiation process, and (iv) implementation and enforcement of the MFP.

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New CMS Guidance Clarifies Medicare Coverage for Clinical Trial Services


Time to Read: 1 minutes Practices: Health Care

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The Centers for Medicare & Medicaid Services (CMS) issued guidance earlier this week, clarifying Medicare coverage for services provided in clinical trials. Specifically, CMS is applying to clinical trials the general Medicare principle that Medicare will not pay for services for which neither the beneficiary nor any other party has any legal obligation to pay. The application of this principle calls into question Medicare coverage for clinical trial services when a sponsor has agreed to pay for the services to the extent the services are not covered by insurance (which language has previously raised concerns under Medicare secondary payer rules in the research injury context). CMS does, however, affirm Medicare coverage for clinical trial services when a provider waives charges or the collection of beneficiary cost-sharing amounts (such as co-pays) for such services for patients who are indigent. Finally, CMS reminds providers that payment by a research sponsor for beneficiary cost-sharing amounts in a clinical trial raises fraud and abuse concerns.

Providers involved in clinical trials and research sponsors should consider their clinical trial funding, budgeting and/or billing practices in light of the new CMS guidance.

If you have any questions about this guidance, please contact Eve Brunts, Terry Coleman or your usual Ropes & Gray attorney. 

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