340B “Mega-Reg” Under Review by OMB – 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.
Physician Payment Data Posted by CMS – In keeping with its earlier announcement that it would provide “unprecedented access” to information on services delivered by individual physicians and certain other health care professionals in 2012, CMS has posted on its website the Medicare Provider Utilization and Payment Data: Physician and Other Supplier Public Use File. The published data provides the public with insight on how much physicians were paid by the Medicare program in 2012 for services provided to Medicare beneficiaries. Since its publication, the data release has been criticized by many physicians as a raw data release with little context for the public to interpret the data.
Ninth Circuit Upholds Penalty for Late Data Submissions – In an April 7, 2014 decision, the United States Court of Appeals for the Ninth Circuit upheld CMS’s decision to penalize a hospital more than $500,000 for the late submission of quality data. The hospital had a contract with a third-party vendor to submit data on the hospital’s behalf for the Reporting Hospital Quality Data for Annual Payment Update (RHQDAPU) Program. The vendor did not submit the data to CMS until 12 hours after the established deadline. The hospital argued that the late submission was inconsequential to the RHQDAPU Program’s objectives, but the court held that CMS’s strict adherence to the deadline – and the agency’s decision to hold hospitals responsible for the actions of third-party vendors – was not arbitrary and capricious. The opinion is available here.