May 2, 2013—The Health Resources and Services Administration (HRSA) “is continuing to work” with the White House Office of Management and Budget (OMB) on a final regulation to implement the Affordable Care Act’s (ACA) restriction on 340B discounts for orphan drugs purchased by hospitals that became eligible for 340B under health care reform, a HRSA spokesperson said this morning.[ms-protect-content id=”2799″]
HRSA sent its draft final rule to OMB’s Office of Information and Regulatory Affairs (OIRA), which reviews all federal agencies’ draft rules at both the proposed and final stages of rulemaking, on Jan. 31. Under a 1993 executive order, OIRA is generally required to complete its review of final rules within 90 calendar days. Yesterday, May 1, was the 90th day of the orphan drug rule’s review.
The Affordable Care Act added free-standing cancer hospitals, critical access hospitals, sole community hospitals, and rural referral centers to the list of health care providers eligible for 340B drug discounts. A related budget reconciliation bill passed a few days after ACA became law excluded orphan drugs “for a rare disease of condition” from the definition of 340B covered outpatient drug for the newly-eligible hospitals as well as for children’s hospitals, which gained eligibility for 340B discounts under a 2005 law. Congress lifted the restriction for children’s hospitals in December 2010.
HRSA issued a notice of proposed rulemaking on May 20, 2011 stating that rural and freestanding cancer hospitals should be allowed to buy orphan drugs at 340B-discounted prices when they use the medicines to treat non-orphan diseases or conditions.[/ms-protect-content]