White House urges Congress to adopt 'Great Healthcare Plan' to cut drug costs and increase price transparency

“Most-Favored-Nation” (MFN) drug-pricing deals are agreements where a drug company commits that the price it charges in the U.S. will be no higher than (or tied to) the lowest price it charges in comparable developed countries. Under President Trump’s 2025 MFN initiative, manufacturers agreed to sell certain drugs to Medicaid and directly to patients at these MFN prices and to apply MFN pricing to future drugs.

Codifying these deals in the Great Healthcare Plan would write this MFN approach into federal law instead of relying only on executive orders and voluntary contracts. For the affected drugs, that would generally push U.S. prices down toward European-level prices, since U.S. prices are typically 2–3 times higher than abroad, though the exact impact would depend on which drugs are covered and how broadly Congress applies the MFN rules.

HHS (the U.S. Department of Health and Human Services) is the cabinet-level department responsible for federal health programs. CMS (the Centers for Medicare & Medicaid Services) is an operating division within HHS that runs Medicare, Medicaid, and the Affordable Care Act marketplaces and already negotiates or sets many payment rates.

Under the MFN policy and the Great Healthcare Plan:

• HHS sets overall policy, issues executive orders or regulations, and directs negotiations with drug companies.
• CMS, acting for HHS, would be the main operational negotiator and enforcer: it communicates MFN price targets to manufacturers, negotiates agreement terms, and then ensures that Medicare, Medicaid, and possibly marketplace plans actually pay no more than the agreed MFN prices. CMS already plays a similar role under the Inflation Reduction Act’s Medicare Drug Price Negotiation Program, where it develops initial offers, holds negotiation meetings, and then enforces the resulting “maximum fair prices.”

Pharmacy benefit managers (PBMs) are intermediaries hired by health insurers, employers, Medicare drug plans, and Medicaid programs to manage prescription benefits. They design drug formularies, negotiate rebates and discounts with drug manufacturers, set rules like prior authorization, and reimburse pharmacies.

“Kickbacks” in this context are the manufacturer rebates and other payments that PBMs (and related middlemen) receive in exchange for putting a drug on a preferred formulary tier. These can affect premiums in two opposing ways:

• Rebates often lower the plan’s net drug spending, which can help hold down average premiums.
• But because PBMs may favor high‑priced drugs with big rebates over lower‑priced alternatives, manufacturers have an incentive to keep list prices high. Patients whose cost‑sharing is based on the list price (deductibles or coinsurance) and people without insurance can pay more at the pharmacy counter, and overall system costs and thus premiums can be higher than if lower‑priced drugs were favored.

Critics therefore argue that rebate‑based PBM “kickbacks” contribute to higher list prices and can ultimately raise insurance costs, especially for people who use expensive drugs.

Saying that voluntarily negotiated deals with HHS/CMS will be “grandfathered in” means that existing MFN contracts the administration has already signed with drug manufacturers would be allowed to continue under their current terms after Congress passes the Great Healthcare Plan.

In practice, those manufacturers would keep honoring the specific discounts and MFN pricing formulas they already agreed to, even if the new law later tweaks how future MFN prices are calculated or applied. The law would not force those earlier agreements to be renegotiated or voided.

Under the Affordable Care Act (ACA), cost‑sharing reductions (CSRs) lower deductibles, copays, and other out‑of‑pocket costs for marketplace enrollees with incomes up to 250% of the federal poverty level. Insurers must provide these richer benefits; before 2017 the federal government reimbursed them directly for the added cost.

When the Trump administration stopped paying CSR reimbursements in 2017, insurers responded by “silver loading” – building the unfunded CSR cost into premiums for silver‑tier plans. Because ACA premium tax credits are tied to silver premiums, this drove federal subsidy spending up even though low‑income enrollees’ cost‑sharing protections remained.

The Great Healthcare Plan proposes to explicitly fund CSR reimbursements again. In practice that would mean:

• The federal government resumes direct payments to insurers for CSR costs.
• Insurers are expected (or required) to reverse silver loading and reduce silver plan premiums.

The fact sheet’s claim of at least $36 billion in taxpayer savings comes from Congressional Budget Office (CBO) analyses showing that appropriating CSR funds reduces federal deficits: by lowering silver premiums, it shrinks premium tax credit outlays even after the government resumes CSR payments. CBO and later analyses of the Lower Health Care Premiums for All Americans Act projected deficit reductions on the order of $32–$37 billion over a decade, along with roughly 10% or more reductions in average silver premiums, which is the estimate the fact sheet cites.

For a drug to be sold over the counter (OTC) without a prescription, the FDA must determine that it is safe and effective for self‑use under labeled conditions. There are two main pathways:

1. OTC monograph pathway

• FDA issues an OTC drug monograph for a therapeutic category (for example, antacids or sunscreen).
• The monograph is essentially a “rule book” specifying which active ingredients, doses, indications, warnings, labeling, and testing are “generally recognized as safe and effective” (GRASE).
• Any product that strictly follows an applicable OTC monograph can be marketed without an individual FDA approval.

2. New Drug Application (NDA) pathway

• A company submits safety and effectiveness data for a specific OTC product.
• FDA reviews the data and, if adequate, approves that product for OTC sale at specified doses and labeling.

In both pathways, the verification that a drug is “safe” for OTC use is performed by the FDA’s Center for Drug Evaluation and Research (CDER), applying the GRASE standard set out in federal law (21 U.S.C. 355g) and regulations (21 CFR Part 330).

The Great Healthcare Plan fact sheet describes the “Plain English” insurance standard as a requirement for insurers to publish clear, jargon‑free rate and coverage comparisons and key metrics (such as the share of premiums spent on claims and claim denial rates), but it does not specify how this would be enforced or what penalties would apply.

Because no bill text or implementing regulations have been released, the enforcement mechanisms and sanctions for noncompliance are not currently known.

Public information on the administration’s MFN deals covers many, but not all, of the drugs involved.

What drugs are covered (based on released examples)

• A December 19, 2025 White House fact sheet on nine new MFN agreements lists specific products whose U.S. direct‑to‑patient prices will fall sharply when bought through the TrumpRx platform, including:
  • Repatha (Amgen) – cholesterol‑lowering biologic.
  • Reyataz (Bristol Myers Squibb) – HIV medication.
  • Jentadueto (Boehringer Ingelheim) – type 2 diabetes drug.
  • Xofluza (Genentech) – influenza treatment.
  • Epclusa (Gilead Sciences) – hepatitis C treatment.
  • Advair Diskus and other inhalers (GSK) – asthma/COPD.
  • Januvia (Merck) – type 2 diabetes.
  • Mayzent (Novartis) – multiple sclerosis.
  • Plavix and various insulins (Sanofi) – blood thinner and insulin products.
• The same fact sheet says these agreements also apply MFN prices to “all new innovative medicines” these nine firms bring to market and to a broad set of Medicaid drugs for conditions including diabetes, rheumatoid arthritis, MS, asthma/COPD, hepatitis B and C, HIV, and some cancers.
• News reports on the December announcement note that earlier MFN agreements had been reached with AstraZeneca, EMD Serono, Eli Lilly, Novo Nordisk, and Pfizer, bringing the total to 14 of the 17 largest global manufacturers before the Great Healthcare Plan fact sheet updated that count to 16 deals.

How savings were measured

• The December 2025 White House MFN fact sheet states that giving state Medicaid programs access to MFN prices on these manufacturers’ products will produce “billions of dollars in savings” and provides examples of old list prices versus new TrumpRx prices, but it does not disclose the detailed methodology or volume assumptions behind those savings claims.
• Independent analysts (for example, KFF) have noted that while these MFN agreements are intended to lower prices, the overall impact and savings from these efforts are not yet known because comprehensive data on which specific drugs, volumes, and net price changes are covered have not been made public.

So far, only illustrative drug‑by‑drug price cuts and broad program descriptions have been released; a complete list of all covered products and a transparent savings calculation have not.