September 4, 2013—The Health Resources and Services Administration (HRSA) Office of Pharmacy Affairs (OPA) has published its first quarterly list of orphan drugs subject to exclusion from 340B pricing in certain circumstances.[ms-protect-content id=”2799″]
OPA said on its website that the list, which it complied yesterday, will govern all sales subject to the 340B orphan drug exclusion from Oct. 1 through Dec. 31.
The 2010 health care reform law contained language excluding hospitals registered in 340B as free-standing cancer hospitals, critical access hospitals, rural referral centers, and sole community hospitals from access to 340B drug pricing for orphan drugs. HRSA published a regulation implementing the exclusion on July 22 that allows affected hospitals to purchase orphan drugs through 340B as long as they are not used to treat orphan indications. The rule formally takes effect on Oct. 1. However, as part of the recertification of all hospitals’ 340B eligibility now underway, rural and cancer hospitals are in the process of putting on record:
- Whether they will buy their orphan drugs through 340B and keep auditable records to demonstrate their compliance with the orphan drug exclusion; or
- If they cannot or do not wish to keep such records, whether they will buy their orphan drugs outside of 340B regardless of the indication for which the drug is used (and, for cancer hospitals, they will not use a group purchasing organization to buy those drugs).
Some affected hospitals reportedly have been waiting to see and evaluate OPA’s orphan drug list before making that declaration. Hospitals have until Sept. 13 to complete the recertification process.
HRSA said it developed its list “based upon specific fields captured from the list of orphan drug designations” kept by the U.S. Food and Drug Administration (FDA) Office of Orphan Products Development (OOPD).
“The list posted should be the source used by 340B stakeholders to ensure compliance with the orphan drug exclusion,” HRSA said. “Covered entities may need to conduct additional analyses of the drugs provided on this list to determine the appropriate orphan drugs to exclude from the 340B program.”
HRSA said it recognizes “that orphan drug designation sponsors listed on the FDA orphan drug list may not be the current manufacturer for an orphan drug. The sponsor listed reflects the latest information reported by the sponsor” to the FDA.
“HRSA encourages 340B stakeholders to work, in good faith, to resolve any potential disputes that may result from the use of this list,” the agency said. “HRSA will continue to improve the list that is posted on a quarterly basis to ensure covered entities have the information they need to comply with the orphan drug exclusion.”
Drug manufacturers will be allowed to audit affected 340B hospitals for compliance with the orphan drug exclusion.[/ms-protect-content]