CMS Drug Price Negotiation

The passage of the Inflation Reduction Act in 2022 was the first instance of the federal government allowing Medicare to negotiate drug prices, leading to lower costs for patients who may be prescribed selected high-cost medications. These negotiations with the Department of Health and Human Services involve working directly with pharmaceutical companies and manufacturers to negotiate the maximum fair price, or the highest price that a Medicare Part D plan sponsor can pay for a selected drug.1

There are rules for the number of drugs allowed to be negotiated each year, the type or class of drug, and strict timelines for negotiations. The drugs selected are those that account for the largest portion of Medicare’s spend and have no generic or biosimilar competitors; often, these drugs are prescribed for chronic diseases such as diabetes or heart failure.2 Revised prices for these Medicare Part D drugs typically go into effect 2 years after negotiations, so those drugs finalized in 2024 will be available at the negotiated price beginning in January 2026.

Earlier this year, it was announced that as part of the third cycle of negotiations, the Centers for Medicare & Medicaid Services (CMS) will include select Medicare Part B drugs—injectables or infused drugs, such as chemotherapy—administered in hospitals or outpatient settings. These negotiated drug prices will go into effect beginning in January of 2028.

CMS issued its annual draft guidance for the Medicare Drug Price Negotiation Program on May 12, 2025, which gives the granular details of identified drugs, drug pricing that may be renegotiated, classes of drugs, requirements for manufacturers, and payment stipulations, among other topics.3 When such directives are issued, CMS seeks public comments from patient organizations, professional medical societies, and pharmacy organizations to understand where changes may need to be made or where other issues may arise that may be unaccounted for.

Like many others, the Association of Cancer Care Centers (ACCC) responded to the request for comments and urged CMS to take 2 actions in a public letter sent on June 26, 2025:

1 Protect access, health, and well-being for patients with cancer by ensuring that US cancer centers and cancer care profession­als can continue to provide selected drugs and the full array of support services those patients need.
2 Develop detailed implementation policies for Part B drugs selected for the Medicare Drug Price Negotiation Program and expeditiously issue such policies for public notice and comment.

Drug price negotiations could lead to significantly lower reimbursements, meaning payments for oncology-specific drugs could be drastically reduced. These reductions, in turn, have downstream impacts on health care systems, especially smaller programs or those in rural or underserved areas that are more reliant on Medicare reimbursements. Reimbursement reductions on this scale could force physicians to choose alternative therapies or sacrifice support services, such as patient navigation services, which reimbursements help to cover and are critical when caring for patients with cancer.

The complex nature of cancer care makes adequate reimbursement essential for maintaining high-quality services and coordinated care. Already strained by increasing patient volumes, a workforce shortage, and complex treatments, cancer centers rely on reimbursement to maintain specialized facilities, highly trained staff, and comprehensive support services so their patients can receive safe, effective cancer care.

Additionally, ACCC believes that while acting in good faith to seek comments related to the implementation of drug price negotiations for Part B drugs, CMS must swiftly develop detailed implementation policies related to these drugs. Doing so would give broader protections and guidance for all stakeholders involved in the conversa­tion, including patients and providers, the latter of whom need sufficient time to assess the financial impact of negotiated prices on their unique patient populations.

Now that the public comment period is closed, CMS will spend the next few months analyzing the responses and, in some cases, making changes to the drafted guidance. In the fall of 2025, 2 additional sets of revised guidance will be released, each followed by an open comment period. By February 2026, a list of up to 15 drugs eligible for price negotiations and applicability will be published. ACCC will continue to monitor—and, when appropriate, comment on—the drugs selected for negotiation, as well as initial price applicability as it impacts patients’ health outcomes and providers’ ability to treat.

Emily Hope Carroll, MHA, is a manager of association services for the Association of Cancer Care Centers (ACCC) in Rockville, Maryland.

References
1. Cubanski J, Neuman T, Freed M. Explaining the prescription drug provisions in the Inflation Reduction Act. KFF. January 24, 2023. Accessed June 29, 2025. https://www.kff.org/medicare/issue-brief/ explaining-the-prescription-drug-provisions-in-the­
inflation-reduction-act/

2. Martin K. Medicare drug price negotiations: all you need to know. The Commonwealth Fund. May 15, 2025. Accessed June 29, 2025. https://www.common wealthfund.org/publications/explainer/2025/may/ medicare-drug-price-negotiations-all-you-need-know

3.Centers for Medicare & Medicaid Services. Medicare Drug Price Negotiation Program: Draft Guidance, Implementation of Sections 1191 – 1198 of the Social Security Act for Initial Price Applicability Year 2028 and Manufacturer Effectuation of the Maximum Fair Price in 2026, 2027, and 2028. May 12, 2025. Accessed June 30, 2025. https://www.cms.gov/files/document/ ipay-2028-draft-guidance.pdf