Drug prices & Part D
Comment Period Closes September 18 on How Drug Companies Must Apply Medicare-Negotiated Prices at Clinics and Doctor's Offices Starting in 2028
A CMS draft guidance describes the step-by-step process manufacturers must follow to make sure negotiated Medicare prices actually reach patients receiving infused or injected medicines at a doctor's office or outpatient clinic. Public comments are due September 18, 2026.
By the Goodsurance editorial teamSeptember 3, 2026
The Centers for Medicare and Medicaid Services issued draft guidance on July 16, 2026 describing how drug manufacturers must implement the Maximum Fair Price for medications covered under Medicare Part B, beginning January 1, 2028. The public comment period closes September 18, 2026 at 11:59 p.m. Pacific Time.
Medicare Part B covers drugs that are typically administered in a physician's office, hospital outpatient clinic, or dialysis center rather than dispensed at a retail pharmacy. Examples include infused cancer therapies, rheumatology biologics, and certain injectables. Unlike Part D, where negotiated prices flow through plan formularies, Part B drug payments pass directly from Medicare to the provider administering the drug.
Comments close September 18 on a CMS plan describing how drug companies must pass Medicare-negotiated prices to clinic patients starting in 2028.
The guidance addresses "effectuation," the operational process by which manufacturers credit or reimburse providers so that the lower negotiated price is applied at the point of care rather than the standard list price. This framework is particularly relevant for the third cycle of Medicare drug price negotiation, announced January 27, 2026, which selected 15 drugs covered under Part B or Part D for prices effective January 1, 2028.
CMS invited comments from pharmaceutical manufacturers, pharmacy benefit managers, provider organizations, and patient advocacy groups. The agency said it will issue final guidance in the fall of 2026 after reviewing submitted comments.
For patients who receive Part B drugs under that third negotiation cycle, the effectuation rules determine whether the lower negotiated price shows up in their cost-sharing at the time of the appointment.
In plain words
When Medicare agrees on a lower price for a drug, that lower price has to actually reach the patient. For drugs you pick up at a pharmacy, the drug plan handles this. But some medicines are given as a shot or infusion at a doctor's office or clinic, and those work differently. CMS wrote a plan explaining how drug companies must make sure the lower negotiated price is the one used when you get your medicine at the clinic. This applies to drugs with new lower prices starting in 2028. Anyone can send in comments on this plan before September 18, 2026.
Understand the basics first
Source: CMS
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