EO 14273 directs Medicare drug-pricing programme changes

On 15 April 2025 President Donald J. Trump signed Executive Order 14273, “Lowering Drug Prices by Once Again Putting Americans First,” echoing the title of Executive Order 13948 of 24 September 2020.¹² Section 3 directs the Secretary of Health and Human Services to “propose guidance, including for plan year 2026, to improve the Medicare Drug Price Negotiation Program” within 60 days, with the stated policy goals of improving “the transparency of the Medicare Drug Price Negotiation Program,” prioritising “the selection of prescription drugs with high costs to the Medicare program” and minimising “any negative impacts of the maximum fair price on pharmaceutical innovation”; § 3(b) directs the Secretary within 180 days to “work with the Congress to modify the Negotiation Program to align with the principles” the order states.¹ Section 4 directs the selection within one year of a Center for Medicare and Medicaid Innovation payment model for “high-cost drugs covered by Medicare”; § 10 directs streamlining of the § 804 drug importation programme within 90 days; § 11 directs site-neutral payment proposals for Medicare Part B; and § 12 directs ERISA and pharmacy-benefit- manager transparency measures.¹ The Pharmaceutical Research and Manufacturers of America (PhRMA) issued a same-day statement opposing the order.³

1. The Inflation Reduction Act of 2022, Pub. L. 117-169 §§ 11001–11002, established the Medicare Drug Price Negotiation Program at Part E of Title XI of the Social Security Act, codified at 42 U.S.C. §§ 1320f-1320f-7, and the operative guidance under EO 14273 § 3 modifies CMS’s implementation of that statutory framework without changing the statute itself.⁴

2. Drug importation from foreign markets requires a finding by the Secretary of HHS under § 804(l) of the Federal Food, Drug, and Cosmetic Act, 21 U.S.C. § 384(l), that the imported drugs pose no additional risk to public health and “result in a significant reduction in the cost” of covered products to the American consumer.⁵ State personal-importation programmes continue to require federal authorisation.

3. Section 7 directs that grant conditions favour federally qualified health centres that “make insulin and injectable epinephrine available to their patients at or below the discounted price paid by” the centre under the 340B Drug Pricing Program, 42 U.S.C. § 256b; § 13 directs a review of anti-competitive conduct in the pharmaceutical sector.¹⁶