HHS to Enforce Orphan Exclusion Rule for 340B Drug Discounts
- By BSTQ Staff
The Department of Health and Human Services (HHS) will allow certain hospitals to receive discounts on orphan drugs when they are used for non-orphan conditions, despite a ruling by the U.S. District Court for the District of Columbia that HHS did not have the authority to do so. In June, HHS said in a court filing that it planned to either appeal the federal ruling or issue guidance that would replace the rule and continue to require drugmakers to provide the discounts.
The rule applies to four types of hospitals that participate in the 340B drug program, which gives discounts on covered outpatient drugs to healthcare providers that serve large numbers of low-income or indigent patients. The Health Resources and Services Administration, the HHS agency that administers the 340B program, urged providers and manufacturers to “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 or have agreements terminated.
Providers in the 340B program do not have access to discounts on orphan drugs when used to treat designated orphan diseases or conditions — those that affect fewer than 200,000 people in the U.S. Orphan drugs are some of the costliest drugs on the market, and many have multiple indications, including some for orphan diseases or conditions and others for common issues that affect a broader number of patients.
