CMS Finalizes Drug Price Negotiation Rule: Permanent Framework for Prices Effective in 2029
The Centers for Medicare & Medicaid Services (CMS) on November 5 issued a final rule establishing a permanent framework for negotiating prices of high-cost drugs. The rule sets policies for the Medicare Drug Price Negotiation Program beginning with prices effective in 2029, providing greater predictability for participating manufacturers and supporting continued innovation.
"President Trump directed us to lower drug costs for Americans using every tool at our disposal," said CMS Administrator Dr. Mehmet Oz. "This rule provides additional tools to help CMS negotiate better deals, achieve greater savings for taxpayers and beneficiaries, and improve health outcomes for seniors who rely on the Medicare Prescription Drug Program." By February 1, 2027, CMS will select up to 20 additional negotiation-eligible drugs covered under Part D and/or payable under Part B, as well as select drugs for renegotiation, as appropriate, for the fourth cycle of negotiations.
The rule finalizes a policy on specific fixed combination drugs that CMS determines are new formulations of existing drugs, so that a manufacturer cannot shift patients to a new formulation to circumvent the maximum fair price (MFP). It also implements the Temporary Floor for Small Biotech Drugs required by law for initial price applicability years 2029 and 2030, and codifies two Part D policies: Part D plans must include selected drugs with an MFP in effect on their formularies, and the negotiated prices plans pay dispensing entities are limited to the MFP plus any dispensing fees.
(Source: Centers for Medicare & Medicaid Services)
Source: Centers for Medicare & Medicaid Services
Published by GSM · USA (original Chinese edition)
Photo: 图：美国联邦医疗保险卡样本（2018年版式）。美国联邦医疗保险与医疗补助服务中心发布，公共领域，经 Wikimedia Commons。 / Photo: Sample U.S. Medicare card (2018 design), issued by the Centers for Medicare & Medicaid Services, public domain, via Wikimedia Commons.
