Alan J. Arville and Kala K. Shankle, attorneys in the Health Care & Life Sciences practice, in the firm’s Washington, DC, office, co-authored an article in Kitcheck, titled “Congressional Legislation Seeks to Ensure ‘Equitable Treatment’ in the 340B Program.”

Following is an excerpt:

In 2021, Congressman David McKinley (R-WV) and Abigail Spanberger (D-VA) introduced H.R. 4390, the “Preserving Rules Ordered for The Entities Covered Through 340B Act of 2021” or the “PROTECT 340B Act of 2021,” which seeks “to ensure the equitable treatment of covered entities and pharmacies participating in the 340B drug discount program.” The proposed legislation follows significant industry activity in the 340B program over the past two years, including actions by certain pharmaceutical manufacturers to limit the availability of 340B drug discounted drugs at contract pharmacies of covered entities. Such actions set off a whirlwind of federal agency action, litigation, and state legislation. In addition, several states have passed legislation intended to protect covered entities and their contract pharmacies in at least some manner from disparate treatment from third-party payors and pharmacy benefit managers (PBMs) as it specifically relates to the 340B program.

H.R. 4390 was developed in an effort to create a national standard (rather than a patchwork of individual state laws) to prohibit third-party payors and pharmacy benefit managers (PBMs) from imposing certain requirements on covered entities or their contract pharmacies that are specific to their participation in the 340B program. For now, political realities may put the legislation on the backburner because it is unlikely that the legislation will move in the upcoming election season and subsequent lame duck session. The bill’s co-sponsor, Congressman McKinley, also lost his primary on May 10, 2022, meaning he will leave office on January 3, 2023. Nonetheless, Congresswoman Spanberger could reintroduce the legislation next Congress and find a co-sponsor across the aisle from the bill’s current list of 110 co-sponsors.

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