340B Orphan Drug Exclusion Upheld

October 152015340B Orphan Drug Exclusion Upheld

This ruling means that rural referral centers, sole community hospitals, critical access hospitals and cancer hospitals will no longer be able to purchase orphan drugs at 340B pricing for any condition. The ruling does not affect disproportionate share hospitals or pediatric hospitals.

Orphan drugs are associated with highest price tags, this ruling is expected to greatly affect small community hospitals providing significant amounts of uncompensated care and already running on tight margins may be unable to absorb the higher drug costs of these pricey medications.

Hospitals affected by this ruling need to ensure that a measured approach to exclude specific orphan drugs is engaged. However, it is important to also ensure that applied filters do not exclude specific drugs that are not designated as orphan drugs such as generic equivalents and manufacturer specific NDC’s.

Denying defendants’motion for summary judgment and granting plaintiff’s motion for summary judgment

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