Key Challenges Still Loom for Covered Entities
On Monday, May 12, the White House issued an Executive Order (EO) aimed at addressing prescription drug prices. The EO opens with a remarkable claim: that disproportionately high U.S. drug prices are the result of "a purposeful scheme in which drug manufacturers deeply discount their products to access foreign markets, and subsidize that decrease through enormously high prices in the United States." The EO promises that the Administration will act to end this "global freeloading," and warns that if manufacturers fail to offer Americans the lowest, "most-favored-nation price", it will take "additional aggressive action."
However, aside from directing the Secretary of Health and Human Services to "propose a rulemaking plan" if manufacturers don't voluntarily comply, the EO is light on the details about how the Administration intends to secure better pricing for American consumers absent new Congressional authority.
The lack of specifics in the latest EO stands in contrast to last month's Executive Order directing the U.S. Department of Health and Human Services (HHS) to implement a controversial and highly localized directive from the first Trump Administration requiring community health centers to provide insulin and epinephrine to a broad array of patients at cost, regardless of their ability to pay. That directive appears to conflict with the statutory requirements on federally qualified health centers (FQHCs) to implement a strict sliding fee scale. Notably, the earlier EO did not require manufacturers to address their pricing, nor did it affect the price for those drugs paid by most American consumers who are neither FQHC patients generally nor fall within the EO's specific categories within FQHC patients.
While Executive Orders like these tend to generate headlines, more consequential developments are unfolding elsewhere. For example, the emerging budget bill in Congress that could remove millions of qualifying Americans from Medicaid or the Administration's not-yet-revealed plan to restructure HHS to place responsibility for the 340B drug discount statute under CMS rather than HRSA, are likely to have far more significant impact on 340B covered entities and the vulnerable population they serve.
For safety-net providers, the key is to remain focused on what the Administration and Congress actually do—not just what they say—to safeguard the continuity of care and public health
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