> ## Content Index > Fetch the complete content index at: https://www.theamericanquorum.com/llms.txt > Use this file to discover other available public pages before exploring further. # CMS Finalizes First Medicare Drug-Negotiation Framework After More Than 7,500 Comments, With 10 Part D Drugs Due by September - URL: https://www.theamericanquorum.com/taq-historical-2023-07-01-healthcare/ - Published: 2023-07-02T03:59:00.000Z - Updated: 2023-07-02T03:59:00.000Z - Description: CMS issued revised rules for Medicare’s first prescription-drug negotiations after thousands of comments, setting the path to select 10 Part D drugs by September 1. - Author: Kenneth R. Deans Jr. - Tags: Healthcare, #Import 2026-09-01 03:02 The Centers for Medicare & Medicaid Services on Friday released revised guidance for the first round of Medicare prescription-drug price negotiations, moving a new authority created by the Inflation Reduction Act from statute toward operation after receiving **more than 7,500 public comments**. CMS is scheduled to identify the first 10 high-expenditure Medicare Part D drugs for negotiation by September 1, with negotiated prices taking effect in 2026. The June 30 [announcement](https://www.cms.gov/newsroom/press-releases/cms-releases-revised-guidance-historic-medicare-drug-price-negotiation-program?ref=theamericanquorum.com) lays out how the agency will select eligible drugs, gather information from manufacturers and the public, develop initial offers, conduct negotiation meetings and implement what the law calls a “maximum fair price.” The process is unprecedented for Medicare, which historically has relied on private Part D plans and other mechanisms rather than direct federal negotiation of selected drug prices. ## Ten Part D drugs will start the program The first cycle applies to 10 drugs covered under Medicare Part D. Under the statutory timetable, CMS must publish the selected-drug list by September 1, 2023, complete negotiations during 2023 and 2024, publish agreed maximum fair prices by September 1, 2024, and make those prices effective January 1, 2026\. CMS’s [revised guidance](https://www.cms.gov/files/document/revised-medicare-drug-price-negotiation-program-guidance-june-2023.pdf?ref=theamericanquorum.com) describes the mechanics in detail. Selection is not based simply on list price. The Inflation Reduction Act directs CMS toward high-spending, single-source drugs without qualifying generic or biosimilar competition, subject to statutory exclusions and timing rules. The first round is confined to Part D, while later years expand both the number of selected drugs and, beginning in 2028, eligibility to certain Part B physician-administered products. CMS’s June [fact sheet](https://www.cms.gov/files/document/fact-sheetrevised-drug-price-negotiation-program-guidance-june-2023.pdf?ref=theamericanquorum.com) summarizes the first-year structure and the information the agency expects to consider. The revised framework reflects feedback from patients, manufacturers, clinicians, plans, pharmacies and other stakeholders after CMS published its initial proposal in March. ## Negotiation will include evidence beyond current prices Once a drug is selected, the manufacturer and CMS enter a structured exchange rather than a single take-it-or-leave-it calculation. The agency will consider factors specified by Congress, including research and development costs, production and distribution expenses, federal financial support, market data, patents and exclusivities. It will also examine evidence about therapeutic alternatives, comparative effectiveness and unmet medical need. CMS is inviting patients, clinicians and other members of the public to submit information on therapeutic alternatives and impacts on specific populations. The agency plans listening sessions for selected drugs, giving people with relevant clinical or lived experience a route to inform the record. That creates a negotiation process that is partly economic and partly evidence-based, rather than relying only on a formula tied to existing market prices. The March 15 [initial guidance](https://www.cms.gov/newsroom/press-releases/hhs-releases-initial-guidance-historic-medicare-drug-price-negotiation-program-price-applicability?ref=theamericanquorum.com) opened many of these questions for comment. CMS asked about manufacturer submissions, confidentiality, evidence, the negotiation process and implementation. The revised version responds to that feedback while retaining the broad statutory timetable. ## The law creates both leverage and limits The negotiation program gives the federal government direct leverage over selected drugs, but it is not unlimited. The Inflation Reduction Act defines the categories of drugs eligible for selection, establishes ceilings and factors for the maximum fair price, and creates a phased schedule. Manufacturers of selected drugs face choices and obligations established in the law, including agreements needed for their products to remain available under Medicare and Medicaid on statutory terms. CMS began preparing the market for that schedule months ago. A January 11 [timeline](https://www.cms.gov/newsroom/press-releases/hhs-announces-key-dates-first-year-inflation-reduction-acts-medicare-drug-price-negotiation-program?ref=theamericanquorum.com) identified the September 2023 selection date and the September 2024 price-publication deadline, giving drug companies and other stakeholders advance notice of the first milestones. The first 10 selections will also reveal how the statutory criteria interact with real-world spending. A drug can be expensive for an individual patient without ranking among Medicare’s highest aggregate expenditures, and a high-spending product may be excluded if a qualifying generic or biosimilar is marketed. Selection therefore depends on program spending, market exclusivity and statutory eligibility at a specific point in time. ## Negotiation is one part of a broader drug-cost law The Inflation Reduction Act changes Medicare drug policy through several mechanisms. In addition to negotiation, it establishes inflation rebates when certain drug prices rise faster than inflation, restructures Part D beneficiary costs, caps monthly insulin cost-sharing for covered products and creates other affordability provisions. CMS has been implementing those programs on separate but overlapping tracks. For example, the agency’s February [inflation-rebate guidance](https://www.cms.gov/newsroom/press-releases/hhs-releases-initial-guidance-medicare-prescription-drug-inflation-rebate-program?ref=theamericanquorum.com) addressed a different provision requiring manufacturers to pay rebates to Medicare when price growth for certain Part B and Part D drugs exceeds inflation. The two policies work differently: one directly negotiates selected prices, while the other imposes a financial consequence tied to price increases. CMS has also published a broader [implementation overview](https://www.cms.gov/newsroom/fact-sheets/inflation-reduction-act-lowers-health-care-costs-millions-americans?ref=theamericanquorum.com) explaining how the drug provisions are intended to reduce out-of-pocket costs and federal program spending. For beneficiaries, however, the timing varies. Some protections are already taking effect, while negotiated prices from the new program will not appear until 2026. ## Industry objections will test the new framework Drug manufacturers and industry groups have raised concerns that the negotiation system could reduce incentives for investment in new medicines and that some statutory provisions give the government disproportionate bargaining power. Supporters of the law argue that Medicare’s purchasing scale should provide leverage against high prices and that the program incorporates safeguards for innovation, including periods of exclusivity before many products become eligible. Those disagreements are moving beyond policy debate. Manufacturers and industry organizations are beginning legal challenges to elements of the negotiation program, creating a parallel track of litigation as CMS proceeds with implementation. The agency’s position is that it is carrying out a law enacted by Congress and that the revised guidance provides a transparent structure for the first cycle. The practical effects cannot yet be measured because no drug has been selected and no price has been negotiated. That makes the next two months especially important. By September 1, the abstract framework becomes a list of real products and manufacturers, each with large Medicare spending and a direct stake in the new process. Friday’s guidance therefore marks the last major procedural step before selection. CMS has moved from statutory authority to an initial proposal, public comment and now a revised operating framework. The next milestone will identify the first 10 Part D drugs, beginning a negotiation process that will determine whether Medicare’s new authority can materially change prices when the first agreements take effect in 2026.