{"id":10558,"date":"2026-02-02T11:09:38","date_gmt":"2026-02-02T16:09:38","guid":{"rendered":"https:\/\/www.appliedpolicy.com\/staging\/7403\/?p=10558"},"modified":"2026-02-05T10:15:32","modified_gmt":"2026-02-05T15:15:32","slug":"winter-drug-pricing-recap-where-we-are-and-whats-next","status":"publish","type":"post","link":"https:\/\/www.appliedpolicy.com\/staging\/7403\/winter-drug-pricing-recap-where-we-are-and-whats-next\/","title":{"rendered":"Winter Drug Pricing Recap: Where We are and What\u2019s Next"},"content":{"rendered":"

Although we are less than halfway through winter, we have already seen significant activity in drug pricing. In this article, we explore what has happened in recent months and consider the areas in which we anticipate continuing activity in 2026.<\/p>\n

Most Favored Nation (MFN) Deals and TrumpRx<\/h3>\n

Where We Are:<\/em><\/strong> Since last summer, President Trump has announced deals with 16 out of the 17 manufacturers to whom he sent letters<\/a>, directing them to voluntarily align their U.S. prices with those paid in other countries. AbbVie<\/a> and Johnson & Johnson<\/a> were the most recent companies to announce agreements. These announcements followed a series of individual agreements made throughout the fall, as well as the White House\u2019s December 19 announcement<\/a> of agreements with nine manufacturers. AbbVie and Johnson & Johnson will participate in selling drugs on TrumpRx<\/a>, offer drugs to Medicaid at prices comparable to those paid in other countries, and invest in U.S. manufacturing. Although specific details have not been made public, the companies\u2019 press releases suggest that the agreements include exemptions from U.S. tariffs. Across the board, the agreements between the White House and drug manufacturers are generally confidential.<\/p>\n

President Trump has also called on Congress to codify these agreements in his \u201cGreat Healthcare Plan<\/a>\u201d outline, but similarly, details are limited, and, if enacted by Congress, the provisions would likely require further implementation via regulation. Tariff exemptions would also require coordination with the Department of Commerce.<\/p>\n

What\u2019s Next<\/strong>: Regeneron remains the only one of the 17 manufacturers that received letters<\/a> from President Trump directing them to implement most-favored-nation pricing that has not announced an agreement. Even so, a deal may be forthcoming. In a recent interview<\/a>, Regeneron\u2019s chief scientist said, \u201cI don\u2019t think there\u2019s any pressing need, but we assume it\u2019s going to happen,\u201d referring to the possibility of a Regeneron MFN agreement.<\/p>\n

We are also watching for the launch of TrumpRx, which will connect \u201cpatients directly with the best prices,\u201d rather than selling medications directly. While the launch was originally planned for January 2026, Politico<\/a> recently reported that it has been delayed, with HHS Secretary Robert F. Kennedy Jr., saying the launch will \u201cprobably [happen] in the next 10 days.\u201d\u00a0 Anti-kickback statute concerns are likely contributing to the delay.<\/p>\n

On Tuesday, January 27, HHS Office of Inspector General (OIG) released a Medicare and State Health Care Programs: Fraud and Abuse; Request for Information Regarding the Federal Anti-Kickback Statute and Beneficiary Inducements CMP<\/a>, seeking input on additions or modifications needed to the safe harbor regulations under the federal anti-kickback statute (AKS) or the exceptions to the civil monetary provisions that prohibit inducements to beneficiaries (Beneficiary Inducements CMP) to effectuate direct-to-consumer (DTC) sales programs from pharmaceutical manufacturers, including those that will be made available through TrumpRx. Comments are due March 30, 2026.<\/p>\n

On the same day, HHS OIG released a Special Advisory Bulletin: Application of the Federal Anti-Kickback Statute to Direct-to-Consumer Prescription Drug Sales by Manufacturers to Patients With Federal Health Care Program Coverage<\/a>, addressing the application of the AKS to DTC programs and when they are low risk. Alongside potential anti-kickback concerns, questions remain about how TrumpRx and potentially increasing DTC sales will impact patients, plans, and manufacturers.<\/p>\n

GUARD, GLOBE, and GENEROUS Models<\/strong><\/h3>\n

Where We Are:<\/strong> On December 19, the Centers for Medicare & Medicaid Services (CMS) released the Global Benchmark for Efficient Drug Pricing (GLOBE) Model (CMS-5545-P)<\/a> and Guarding U.S. Medicare Against Rising Drug Costs (GUARD) Model (CMS-5546-P)<\/a> Proposed Rules, alongside the GLOBE Model<\/a> webpage and GUARD Model<\/a> webpage. Both proposed models would operate similarly to the current Medicare inflation rebates program, where manufacturers of eligible drugs pay rebates directly to CMS when they raise their prices above a benchmark. For these models, the benchmark would be based on international pricing information, rather than domestic pricing information. Both models look to expand MFN pricing across drugs in Medicare, though each model is limited to a subset of Medicare beneficiaries in certain geographic areas.<\/p>\n

As Applied Policy has previously reported<\/a>, CMS also announced an MFN model for Medicaid, called the GENErating cost Reductions fOr U.S. Medicaid (GENEROUS<\/a>) Model, in November. In contrast to GLOBE and GUARD Models, this model is voluntary and incorporates standardized coverage terms for participating manufacturers.<\/p>\n

What\u2019s Next:<\/strong> Comments on the proposed rules for the GUARD and GLOBE Models are due February 23, 2026. While CMS has not provided a timeline for when final rules will be released, we expect that these models are high priority for the agency, particularly with the proposed performance periods beginning on October 1, 2026, and January 1, 2027, for the GLOBE Model and GUARD Model, respectively. The final rules may be released at the same time, or separately. The final rules will likely include operational changes to how CMS implements the model, and many will be watching to see whether the agency makes changes to how it determines whether drugs are included in the model.<\/p>\n

Drugs Selected for Negotiation for 2028<\/h3>\n

Where We Are:<\/strong> To meet the February 1 announcement deadline, as required by statute, the Trump Administration announced the next round of drugs selected for negotiation<\/a> on January 27. The list includes 15 newly selected drugs, and one previously selected drug. The drugs selected for negotiation and renegotiation treat a range of conditions, including Type 2 diabetes, cancer, asthma, mental health, HIV, and autoimmune diseases. For the first time, Medicare Part B drugs are eligible for negotiation \u2013 only Part D drugs were eligible in the first two rounds.<\/p>\n

What\u2019s Next:<\/strong> CMS will begin the negotiation process<\/a>, which includes the submission of manufacturer data, public engagement opportunities, and meetings between the agency and manufacturers of selected drugs. CMS is required to announce the maximum fair prices for drugs selected for negotiation for 2028 by November 30, 2026.<\/p>\n

The inclusion of Part B drugs in the negotiation process has raised numerous questions for health policy stakeholders across the supply chain. While CMS addressed some aspects of negotiation for Part B drugs, the agency intends to provide detailed Part B MFP effectuation policy in the future. With the release of this new set of drugs, we may see this guidance sooner rather than later.<\/p>\n

We further explore the negotiation process and remaining questions here<\/a>.<\/p>\n

Looking ahead<\/h3>\n

Applied Policy will continue to monitor developments across federal drug pricing policy and assess their implications for stakeholders navigating these changes.<\/p>\n","protected":false},"excerpt":{"rendered":"

Although we are less than halfway through winter, we have already seen significant activity in drug pricing. In this article, we explore what has happened in recent months and consider the areas in which we anticipate continuing activity in 2026. Most Favored Nation (MFN) Deals and TrumpRx Where We Are: Since last summer, President Trump […]<\/p>\n","protected":false},"author":24,"featured_media":10559,"comment_status":"closed","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"nf_dc_page":"","ap4_related_services":"","footnotes":""},"categories":[503,428,629,431],"tags":[],"class_list":["post-10558","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-health-care-spending","category-life-sciences-companies","category-medicaid","category-medicare-reimbursement"],"yoast_head":"\nWinter Drug Pricing Recap: Where We are and What\u2019s Next - Applied Policy<\/title>\n<meta name=\"description\" content=\"Applied Policy reviews recent federal drug pricing developments and highlights areas of expected policy activity in 2026.\" \/>\n<meta name=\"robots\" content=\"index, follow, max-snippet:-1, max-image-preview:large, max-video-preview:-1\" \/>\n<link rel=\"canonical\" href=\"https:\/\/www.appliedpolicy.com\/winter-drug-pricing-recap-where-we-are-and-whats-next\/\" \/>\n<meta property=\"og:locale\" content=\"en_US\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"Winter Drug Pricing Recap: Where We are and What\u2019s Next - 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