The Health Resources and Service Administration (HRSA), Office of Pharmacy Affairs sent the long-awaited 340B Proposed Rule to the Office of Budget and Management Affairs (OMB) last week for the proposed rule’s next level of review before publication in the Federal Register, which is anticipated to be in June.  The OMB’s website reflects that the proposed rule was received on April 9.  Often referred to as the “mega-reg,” the proposed rule is expected to cover, among other issues, the definition of an eligible patient, compliance requirements for contract pharmacies, hospital eligibility criteria, and eligibility of off-site facilities.  Additionally, HRSA has posted on its website updated hospital registration instructions for the 340B program, now requiring certain worksheets from the hospital’s most recently filed cost report, as well as a detailed outline covering HRSA’s  review process for determining eligibility in the 340B program.