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Get to Know 340B: Update on HHS ADR Panel

 
The Health Resources and Services Administration (HRSA) will be issuing a new rule regarding a process to allow 340B-covered entities to bring claims against drug manufacturers. Read on to more about how this decision affects community health centers.
 
The Health Resources and Services Administration (HRSA) announced that it will issue a new “Notice of Proposed Rulemaking” regarding the Administrative Dispute Resolution (ADR) process. The U.S. Department of Health and Human Services (HHS) initially instituted the ADR process in January of 2021 to allow 340B-covered entities, including community health centers, to bring petitions before a panel in response to actions by drug manufacturers to restrict the use of contract pharmacies.  
 
What is the status of the ADR process?  
Once the ADR process was instituted in January of 2021, the National Association of Community Health Centers (NACHC) filed a petition against several drug manufacturers for restricting the shipment of 340B-priced medications to contract pharmacies or making shipments contingent upon receiving certain data from health centers. In October 2021, HRSA assigned members to the Administrative Dispute Resolution (ADR) panel to review NACHC's petition but no decision has been issued regarding the petition.  
 
How did drug manufacturers respond to the ADR process? 
During the past year, several drug manufacturers have sued HHS over the ADR rule. Soon after implementation, a court allowed a preliminary injunction against the ADR process for Eli Lilly, preventing HRSA from enforcing the rule for that manufacturer.1 However, in November, the District Court that heard the Sanofi case upheld the Administrative Dispute Resolution rule.2
 
What does the ‘Notice of Proposed Rulemaking' mean for health centers? 
HRSA will be publishing a new rule regarding the ADR process that will include a public comment period. Given the court challenges to the current rule, HRSA may hope to improve the process for future petitions, although the fate of those currently under consideration is uncertain.  
 
 
 
[1]  340B Administrative Dispute Resolution (ADR). (2021). Retrieved from https://www.hrsa.gov/opa/340b-administrative-dispute-resolution
[2]  District Courts Issue Key Decisions in 340B Contract Pharmacy Cases | JD Supra. (2021). Retrieved from https://www.jdsupra.com/legalnews/district-courts-issue-key-decisions-in-4236170/
 

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