The problem: Created in 1992, the 340B Drug Pricing Program functionally requires drug manufacturers to sell outpatient drugs at steep discounts to certain hospitals and clinics, with the stated purpose of allowing those entities to “stretch scarce federal resources” in serving needy patients. The discounts typically range from 22.5 to 50 percent off a drug’s average sales price (ASP). However, nothing in the statute requires covered entities to pass those discounts on to patients or payers. Hospitals purchase drugs at the discounted price, bill patients, government programs, and insurers at customary or higher rates, and retain the difference.
Medicare Part B illustrates this issue: Part B ordinarily reimburses providers at ASP plus 6 percent, a formula intended to approximate acquisition cost plus the overhead for administering the drug. For a 340B hospital acquiring drugs well below ASP, Medicare’s payment substantially exceeds acquisition cost. As Paragon has documented, this government-driven arbitrage opportunity has contributed to rapid program growth—from 39 participating hospitals in 1992 to nearly 3,000 today, with discounted purchases rising from $5 billion in 2010 to more than $81 billion in 2024. It has also encouraged hospitals to acquire physician practices and open satellite sites in higher-income communities, and it rewards the use of more expensive drugs, since the margin grows with a drug’s price.
CMS previously attempted to address this. From 2018 through 2022, the agency paid for 340B drugs at ASP minus 22.5 percent, but the Supreme Court invalidated the policy in American Hospital Association v. Becerra (2022) on the grounds that CMS had not first conducted the acquisition cost survey the statute requires before varying payment rates for 340B hospitals as compared to other hospitals. The payment change was budget neutral and increased payment for non-340B drug items and services due to statutory requirements that were not disputed as part of the lawsuit. Paragon subsequently recommended that CMS conduct the survey and reinstate an acquisition-based payment rate.
What the rule does: CMS surveyed the drug acquisition costs of all OPPS hospitals between January and early April of 2026. The survey found substantial differences between 340B and non-340B acquisition costs; in some instances, an enrollee’s 20 percent coinsurance under current policy exceeds the hospital’s full acquisition cost for the drug. Based on the survey results, CMS proposes to pay for 340B-acquired drugs at ASP minus 33.4 percent beginning in 2027.
The rule additionally revisits the remedy CMS adopted after the Becerra decision. In 2023, CMS issued lump-sum payments to hospitals affected by the invalidated policy and planned to recoup the corresponding $7.8 billion in inflated non-drug payments through a 0.5 percent annual reduction over roughly 16 years. In a comment letter at the time, Paragon argued that a 16-year recoupment period was too long for a variety of reasons. The proposed rule would raise the annual offset from 0.5 percent to 3 percent beginning in 2027, completing the recoupment by 2029.
Expected effects: CMS estimates first-year savings of $4.55 billion for the Medicare program and $1.15 billion in reduced enrollee out-of-pocket costs. Because the OPPS operates under a budget neutrality requirement, these savings would again be redistributed as higher payments for non-drug services across all OPPS hospitals.
More important than the immediate fiscal savings, the proposal improves the government incentives that have fueled hospital consolidation and higher health care costs. Paying near acquisition cost removes the Medicare portion of the 340B margin through which government policy has encouraged hospitals to acquire physician practices and expand their outpatient footprint. Reduced government-driven consolidation pressure should help preserve competition and moderate some of the cost growth affecting premiums in employer-sponsored insurance and other private coverage, where 340B-related costs have been significant. The change should also weaken the distorted financial incentive to select higher-priced drugs when clinically comparable, lower-cost alternatives are available. However, the larger 340B commercial spread still exists and will continue to fuel higher costs and consolidation until the subsidy provided through the program is divorced from drug arbitrage.
With regard to the accelerated lump-sum payment recoupment, the proposal is consistent with Paragon’s recommendation and would improve both the accuracy and fiscal value of the remedy.