On October 26, the Health Resources and Services Administration (HRSA) published a Federal Register notice addressing the use of 340B drugs at off-campus hospital outpatient locations that have not yet appeared on a filed Medicare cost report. These locations are known as “unregistered child sites.”

In the notice, HRSA maintains that its prior policy allowing the use of 340B drugs at unregistered child sites was intended only to be a waiver during the COVID-19 public health emergency (PHE) and that the waiver is no longer needed. HRSA further explains that the waiver created challenges in its ability to oversee the integrity of the 340B program.

HRSA states in the notice that some covered entities believed that the use of 340B drugs at unregistered child sites was a permanent policy change. HRSA is providing two compliance options for covered entities that used 340B drugs at unregistered child sites after the end of the PHE:

1. For off-site outpatient locations that have appeared on a filed Medicare cost report with associated outpatient costs and charges, but have not yet registered in the Office of Pharmacy Affairs Information System (OPAIS), HRSA will allow registration in January 2024.
2. For off-site outpatient locations that began using 340B drugs prior to the publication of the notice, but have not yet appeared on a filed Medicare cost report with associated outpatient costs and charges, HRSA will allow their continued use of 340B drugs if the covered entities provide the following information to HRSA within [...]
   
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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: 340B Covered Entity

• In a case involving a 340B covered entity’s termination from the 340B program, the court granted the covered entity’s temporary restraining order.
• In a case involving the definition of “patient,” HHS filed its reply brief in support of its cross-motion for summary judgment, and an amicus curiae brief was filed.

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

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: 340B Covered Entity

• The Ninth Circuit granted the prime vendor program appellee’s request for an extension to file its appellee brief.
• A 340B Covered Entity filed suit against HHS, alleging it was improperly removed from the 340B Program.
• Defendants in a qui tam action filed a Motion to Dismiss, which will be heard by the District Court for the Central District of California in December 2023.
• The plaintiff in a case aiming to invalidate a state law governing contract pharmacy arrangements filed a First Amended Complaint.

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

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: 340B Covered Entity

• A medical group filed an antitrust case in Pennsylvania federal court against a 340B covered entity.
• In a case involving the definition of “patient”, the covered entity filed a reply brief.
• The covered entity appellant in a Ninth Circuit case filed its opening brief against the prime vendor program appellee.

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

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: 340B Covered Entity

• The appeal court mediator released the parties from the mediation program in a case involving a covered entity appellant and a prime vendor program appellee.
• The appeal court set the date for oral argument in a state law case involving a trade association appellant and a government appellee.
• In a case involving the definition of “patient”, the covered entity filed a response in opposition to the recent motions for leave to file amici curiae briefs in support of HHS.

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