BioCentury
ARTICLE | Politics & Policy

HHS considering appeal of 340B district court decision

June 14, 2014 12:40 AM UTC

HHS is considering appealing a May ruling that vacated its July 2013 final rule that discounted Orphan drugs when used in non-Orphan indications under Medicare's 340B program. In last month's decision, the U.S. District Court for the District of Columbia said HHS lacked authority to make the rule, but declined to rule on whether HHS's final rule could be upheld as an "interpretative rule." In its notice to the court on Thursday, HHS said it is also considering issuing guidance that would "set forth [its] interpretation" of 340B (see BioCentury Extra, May 27).

The 340B program requires manufacturers to deeply discount outpatient drugs to hospitals and clinics bearing the brunt of healthcare for low income and other special populations. In 2010, Congress amended 340B to exclude Orphan drugs from discounting, but the law was unclear on whether the exclusion applied when the drugs were used for non-Orphan indications. In 2013, HHS issued the final rule saying the drugs were to be discounted when used in non-Orphan indications, and the Pharmaceutical Research and Manufacturers of America subsequently sued to challenge it. ...