A federal district court in South Carolina ordered 340B Report late yesterday to destroy and not release information from more than 9,000 pages of documents that the federal government filed in a public database Thursday in a community health center’s lawsuit over the legality of the 340B program’s patient definition.
U.S. Chief Judge R. Bryan Harwell signed the order Jan. 9 and the deputy clerk of the court emailed it to 340B Report last night.
Harwell’s order said the federal defendants in the case “inadvertently filed” the documents in the federal judiciary’s online court records repository.
The documents are the certified administrative record in South Carolina community health center Genesis Health Care’s lawsuit against the U.S. Health Resources and Services (HRSA) over Genesis’ brief expulsion from the 340B program after auditors concluded that Genesis failed to maintain auditable records and dispensed 340B drugs to ineligible patients.
HRSA removed Genesis, its grantee sites, and contract pharmacies from 340B on June 26, 2018. It reinstated them on July 5, 2018, the day before a scheduled court hearing on Genesis’ emergency motion for a stay. The government voided the audit on June 6, 2019, after concluding it lacked the power to enforce its 1996 340B patient definition.
Despite its reinstatement to the 340B program, Genesis continues to challenge the 340B patient definition’s legality. A federal appeals court ruled last year that Genesis’ case was not moot because HRSA’s patient definition remains in place and Genesis potentially could be expelled from 340B again.
HRSA’s patient definition is at 340B’s core. A court ruling invalidating it could change 340B profoundly.
The records that HRSA filed in the case late Thursday were available in the lawsuit’s publicly accessible online case docket until mid-morning Friday, when the court withdrew them. 340B Report accessed the documents early Friday, when they could have been read and saved by anyone with a Public Access to Court Electronic Records (PACER) account.
During a telephone call yesterday afternoon, the deputy court clerk said “a small number” of non-parties to the lawsuit accessed the documents while they were available to the public.
The documents included some patient protected health information. They also included correspondence between HRSA and its audit contractor Bizzell, between HRSA and Genesis, and between HRSA and the 340B prime vendor Apexus that does not contain confidential patient or commercial information. 340B Report was not going to publish patient protected health information.
340B Report has written extensively about the Genesis case including a two-part series in April 2022.
