HHS still plans to enforce 340B Orphan rule

HHS's Health Resources and Services Administration (HRSA) said it will continue to enforce a July 2013 final rule that discounts Orphan drugs when used in non-Orphan indications under Medicare's 340B program, despite a court ruling last month that vacated the final rule. 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. HHS issued a final rule saying drugs were to be discounted when used in non-Orphan indications. The Pharmaceutical Research and Manufacturers of America subsequently challenged the final rule, and last month the U.S. District Court for the District of Columbia vacated the final rule. ...