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Proposed Mega Rule Abandoned Under the 340B program

    Client Alerts
  • November 18, 2014

In very broad terms, the 340B program allows some safety-net health care providers to provide qualifying patients with affordable prescription drugs. In January, the Office of Pharmacy Affairs (OPA) of the Health Resources and Services Administration (HRSA) announced its intent to issue a proposed regulation for notice and comment by June. OPA stated that the proposed regulation would cover (i) the definition of an eligible patient under the 340B program, (ii) hospital and off-site facilities eligibility criteria, and (iii) compliance requirements for contract pharmacy arrangements.   Because of the proposed breathe of the rule, it was nicknamed the “Mega Rule”.

2014 has already been a big year for the 340B program. Developments this year have included ongoing developments in a lawsuit brought by members of the drug industry regarding 340B pricing on orphan drugs, ongoing audits of 340B covered entities and an Office of Inspector General report/OPA letter placing 340B providers on notice to monitor closely for potential diversion and duplicate discounts of drugs purchased under the program.  The 340B program has also been the target for criticism by the drug industry and lawmakers.

Last week, HRSA announced that the proposed Mega Rule has been abandoned. Instead, HRSA will be publishing interpretive guidance next year (2015).