The U.S. Health Resources and Services Administration, for now at least, is setting aside a proposed change to 340B program forms that a provider group warned might lead to covered entities losing access to 340B pricing under some drug manufacturers’ contract pharmacy restrictions.
HRSA announced its decision in an Oct. 28 Federal Register notice. It was a follow-up to a notice that HRSA published on June 14.
A 1980 federal law requires agencies to get White House Office of Management and Budget approval for the forms they use to collect information from the public. Existing forms have to be re-approved about every three years whether they are revised or not. Many 340B program forms will expire Nov. 30 unless OMB gives its approval.
HRSA began the process of getting its 340B program forms reapproved when it published the June 14 Federal Register notice. Comments were due by Aug. 15. “HRSA is requesting approval for existing information collections,” the notice said. “HRSA notes that the previously approved collections are mostly unchanged, except some of the forms have been revised to increase program efficiency and integrity.”
HRSA said in the notice that it wanted to change its 340B registration, recertification, and change request forms to “provid[e] additional clarification for covered entities to complete the [pharmacy] shipping address section in 340B OPAIS [the 340B program database] to assist in determining the exact shipping address location and relationship to the covered entity. This clarification will not change burden on entities.”
The notice did not link to draft versions of HRSA’s proposed new forms. It did, however, include an email address and telephone number to request copies.
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Ryan While Clinics for 340B Access submitted comments to HRSA on Aug. 15. It said it “is particularly concerned that HRSA failed to provide proper notice of its new policy for listing pharmacies as shipping addresses.”
RWC-340B said “the ‘additional clarification’ that HRSA proposes to add to the registration, recertification and change request process for listing pharmacies as shipping addresses, however, is not simply a clarification. Rather, the proposal makes substantive changes to current HRSA policy.”
RWC-340B said its review of HRSA’s draft documents “shows that HRSA proposes to require covered entities to provide documentation to demonstrate that the covered entity owns a retail pharmacy in order to register the pharmacy as a shipping address at the time that the covered entity registers, adds the shipping address through a change request, and at recertification. The draft documents also state that, if the pharmacy is not directly owned by the covered entity, ‘The pharmacy must be registered as a contract pharmacy.’”
RWC-340B said, “Requiring covered entities to register pharmacies that are within their health care system but not directly owned by the covered entity as contract pharmacies is particularly problematic given the restrictions that manufacturers are currently placing on obtaining 340B pricing at contract pharmacies. Implementation of the proposed change by HRSA will mean that covered entities that have previously listed system-owned pharmacies as shipping addresses will have to enter into contract pharmacy agreements with those pharmacies. Consequently, under the policies of some drug manufacturers, those covered entities will lose access to 340B pricing at those pharmacies.”
It asked HRSA to “continue its current policy of allowing covered entities the flexibility to list a pharmacy that is owned within a covered entity’s health system as either a shipping address or to register the pharmacy as a contract pharmacy.”
HRSA said in its Oct. 28 Federal Register notice that it is removing the language that RWC-340B complained about from the forms. HRSA said it “will plan to release guidance on shipping address locations in the future.”
HRSA said it received five comments total on its June 14 notice. It did not identify the commenters. Nor are the comments available on the HHS, OMB, or Regulations.gov websites.
Comments on HRSA’s Oct. 28 notice are due by Nov. 28.
