HRSA Expects to Issue 340B Omnibus Guidelines in June


Commander Krista Pedley, the director of the Health Resources and Services Administration's (HRSA) Office of Pharmacy Affairs, discussed the agency's regulatory plans in a speech at the 340B Coalition Winter Meeting two weeks ago in the wake of rescinding the so-called proposed "Mega Reg" last fall. The video has also been posted in the "News" section of HRSA's 340B webpage.

She stated that HRSA is working to draft regulations where they have explicit authority, and guidelines subject to notice and comment where they do not.

The agency does have explicit authority for civil monetary penalties (CMPs) for manufacturers and administrative dispute resolution (ADR). She expects the CMPs' notice of proposed regulation (NPRM) to publish in Spring 2015, and it will include calculation of the 340B ceiling price. The ADR NPRM is expected to publish in Fall 2015.

Pedley also indicated additional policies will be addressed in the 340B "omnibus guidelines," expected to be published in June 2015. They will include topics where HRSA does not have regulatory authority, such as:

  • Patient definition
  • Hospital eligibility
  • Contract pharmacies
  • Recertification
  • Audits
  • Duplicate discounts including Medicaid managed care
  • Manufacturer limited distribution plans

Per Pedley, the guidance will be proposed and have a public comment period.

The above excerpt was featured in the 2/20/2015 issue of Health Policy WeeklyHealth Policy Weekly, a weekly e-newsletter delivered every Friday, recaps legislative and regulatory developments and healthcare reform news that impacts the healthcare industry. Health Policy Weekly is developed by Xcenda as a complimentary service for clients of AmerisourceBergen Corporation as well as industry decision makers within the manufacturer, managed care, healthcare provider and pharmacy community. Click here for more information or to subscribe to Health Policy Weekly



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