Drug prices & Part D
CMS Issues First Draft Rules on How Drugmakers Must Honor 2028 Negotiated Prices for Infused and Injected Drugs
New draft guidance addresses for the first time how manufacturers must deliver negotiated Maximum Fair Prices to the clinics and provider offices that administer drugs, not just pharmacies that dispense them.
By the Goodsurance editorial teamJuly 12, 2026
The Centers for Medicare and Medicaid Services released draft guidance on July 16, 2026, explaining how manufacturers of certain Medicare drugs must deliver negotiated prices to health care providers for medications patients receive in clinical settings rather than picking up at a pharmacy.
The guidance covers the initial price applicability year 2028 and focuses on drugs under Medicare Part B, which pays for medications administered in doctors' offices, hospital outpatient departments, dialysis centers, and similar settings. Earlier guidance addressed how negotiated prices flow through pharmacies under Part D. This document tackles the more operationally complex provider channel.
CMS is spelling out for the first time how drugmakers must pass 2028 negotiated prices to infusion clinics and provider offices, not just pharmacies.
Under the Inflation Reduction Act of 2022, CMS can negotiate prices on high-cost drugs with no generic or biosimilar competition. Manufacturers of selected drugs must make the Maximum Fair Price available to those who purchase and administer them. For Part B drugs, CMS plans to route transactions through a government-created intermediary called the Medicare Transaction Facilitator.
The draft guidance is open for public comment through September 18, 2026. CMS said it builds on final guidance for Part D drugs published in September 2025.
For beneficiaries, Part B drugs carry a standard 20 percent cost-sharing requirement under original Medicare, though supplemental coverage and Medicare Advantage plans alter what enrollees actually pay.
In plain words
Some medicines are not picked up at a pharmacy. They are given as shots or drips at a doctor's office or clinic. Medicare pays for these under Part B. New draft rules from CMS explain how drug companies must charge Medicare the lower, agreed-upon price when a provider gives patients one of these medicines. A government helper called the Medicare Transaction Facilitator will process the payments. This applies starting in 2028. The public can send comments until September 18, 2026.
Understand the basics first
Source: CMS
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