Last week, the White House Office of Management and Budget (OMB) received the Health Resources and Service Administration’s (HRSA’s) 340B Program Omnibus Guidelines (RIN 0906-AB08) for review. The OMB review process is expected to last approximately 90 days from May 6, the date the RegInfo.gov website notes that the OMB received the proposed guidelines.
The guidelines submitted to the OMB are expected to address key policy issues, including the definition of an eligible patient, compliance requirements for contract pharmacy arrangements, hospital eligibility criteria, and eligibility of off-site facilities – many of the same issues that were expected to be covered in last year’s proposed “mega reg” from HRSA. In addition, at the 340B Coalition winter meeting in San Francisco in February of this year, Cmdr. Krista Pedley, director of HRSA’s Office of Pharmacy Affairs (OPA), indicated that the guidance may also cover annual recertification, audits, Medicaid fee-for-service and managed care duplicate discounts, manufacturer limited distribution plans, manufacturers refunds and credits to covered entities, and more.
The mega reg was abandoned late last year after a federal judge ruled that HRSA lacked the legislative authority to create and enforce final legislative rulings related to many of these issues, and clarified that the agency has regulatory authority over only three areas of the 340B Program: imposing manufacturer monetary penalties, calculating 340B ceiling prices and implementing a dispute resolution process. Since the ruling, HRSA has issued guidance outside of its regulatory scope in the form of “interpretive rules,” rather than legislative ones.
After the OMB completes its review, HRSA will publish the new guidelines in the Federal Register and begin a 60-day public comment period where stakeholders are encouraged to provide feedback before the guidance is finalized. Allowing for the OMB’s average 90-day review period, and assuming the OMB approves the guidance, the public comment period would begin in August 2015. However, because the content in the Omnibus Guidelines is likely very similar to the previously-submitted mega reg from last year, the OMB may not require the full 90-day review period, and the public comment period could begin sooner than expected.