May 12, 2015

Long-awaited 340B guidance under review by OMB

From: Sentry Data Systems

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 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.

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