Genesis Health Care building and signage
Genesis Health Care's proposed 340B patient definition would remove all limits on dispensing 340B drugs, HHS and HRSA told a federal district judge.

Feds and S.C. Health Center Spar Over Center’s Access to Government Info in its 340B Patient Definition Case

A South Carolina health center and the federal government are sparring over whether the center should have access to more information from the government than it already possesses in its fight to clarify the 340B patient definition.

Oct. 26 court filings in Genesis Health Care’s lawsuit against the Health Resources and Services Administration show the two sides are at loggerheads over the nature of Genesis’ suit and whether it should be allowed to obtain evidence such as documents and depositions from the government in preparation for trial.

Lawyers for Genesis said in their report to U.S. Chief District Judge R. Bryan Harwell that the center’s request for a declaration that HRSA’s 1996 340B patient definition guidelines are inconsistent with the 340B statute presents a live controversy. As such, Genesis is entitled to conduct discovery, they said.

Lawyers for HRSA and the Department of Health and Human Services countered that Genesis’s case is an ordinary Administrative Procedure Act lawsuit. “As this court likely knows, challenges to agency action under the APA do not proceed like other civil litigation. Typically, the agency produces an administrative record; the parties file cross- motions for summary judgment based on that record; and the reviewing court issues dispositive judgment without the need for a trial. Extra-record discovery is rare.”

“Plaintiff has made no effort to meet its heavy burden to show that the administrative record is somehow inadequate,” the government said.

Bryan gave Genesis until tomorrow, Nov. 2, to reply to the government’s latest filing.

Genesis wants the court to declare that:

  • the only statutory requirement for 340B eligibility of a person is that the person be a patient of a covered entity
  • the plain meaning of the wording of the 340B statute requires that any prescription from any source is available to a patient of a covered entity
  • HRSA interpretations of or guidance on the 340B statute’s prohibition on resale of drugs to a person who is not a patient of the entity are unlawful and unenforceable.

A federal court decision invalidating the 340B patient definition would likely increase calls for Congress to intervene to help determine what patients are eligible for 340B discounts.  

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