Exploring Critical Business and Legal Issues across the Healthcare and Life Sciences Industries
Exploring Critical Business and Legal Issues across the Healthcare and Life Sciences Industries

This Week in 340B: October 31 – November 5, 2023

By and on November 9, 2023
Posted In 340B

This weekly series provides brief summaries to help you stay in the know on how 340B cases are developing across the country. Each week we comb through the dockets of more than 50 340B cases to provide you with a quick summary of relevant updates from the prior week in this industry-shaping body of litigation.

Issues at Stake: Contract Pharmacy, 340B Covered Entity

  • A number of 340B covered entities filed suit against HRSA, seeking relief from its requirement that child sites appear on a covered entity’s Medicare cost report and be registered as a child site in OPAIS before the locations can be considered part of the covered entity under the 340B Program.
  • In a case involving the definition of “patient,” the court issued an order ruling on the parties’ respective motions for summary judgment.
  • In two separate cases aiming to invalidate the same state law governing contract pharmacy arrangements, each plaintiff filed a motion for summary judgment and the parties in each case filed a joint motion to set the briefing schedule.
  • A state government agency filed a motion to dismiss a case attempting to invalidate a state law governing contract pharmacy arrangements.
  • A case alleging that a covered entity was improperly removed from the 340B Program was dismissed with prejudice following confirmation of the covered entity’s continued participation in the program.

Get more details on these 340B cases with the 340B Litigation Tracker, a subscription product from McDermott+Consulting.

Emily Jane Cook
Emily Cook is a practice area leader for McDermott's Healthcare Regulatory & Compliance practice. She is a national authority on the 340B drug pricing program, and also helps clients navigate the full suite of federal and state regulations that are essential to healthcare operations. Learn more about Emily's practice here.

Kelsey Reinhardt
Kelsey R. Reinhardt focuses her practice on regulatory and transactional matters affecting a wide range of clients across the healthcare industry. Learn more about Kelsey's practice here.




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