HHS is moving forward with its plan to allow certain hospitals to receive discounts on orphan drugs when they are used for non-orphan conditions despite a court ruling that said the agency did not have the authority to do so.
The government this week updated a Web page with information about the orphan-drug exclusion rule, asserting that the U.S. District Court for the District of Columbia's ruling in May did not in fact invalidate HHS' interpretation. The rule applies to four types of hospitals that participate in the 340B federal drug discount program, which gives discounts on covered outpatient drugs to healthcare providers that serve large numbers of low-income and indigent patients.
The Health Resources and Services Administration, the HHS agency that administers the 340B program, said participating providers and manufacturers “should attempt to work out any issues in good faith” prior to the start of the new quarter July 1. Manufacturers that do not comply may be required to refund covered hospitals entities or have agreements terminated, an HRSA spokesman said in a statement.