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HHS Issues Guidance Requiring Manufacturers to Provide 340B Discount at Contract Pharmacies

For CFOs, finance & reimbursement staff, government relations staff, pharmacy managers

This post has been archived and contains information that may be out of date.

On Dec. 30,  the U.S. Department of Health and Human Services general counsel issued an advisory opinion requiring pharmaceutical manufacturers to sell covered entities 340B drugs at or below the ceiling price when those drugs are distributed through a contract pharmacy.  

The analysis concludes that when contract pharmacies are acting as agents of a covered entity, a drug manufacturer in the 340B program is obligated to deliver its covered outpatient drugs to those contract pharmacies and to charge the covered entity no more than the 340B ceiling price for those drugs.  

The opinion recognizes that many covered entities are, due to their safety net nature, constrained to use contract pharmacies to access the 340B program. Shutting off this means of access would greatly diminish the 340B program’s effectiveness and is inconsistent with Congress’ intent when it established the program.