On January 31, 2017, the Health Resources and Services Administration (“HRSA”) withdrew the 340B Program Omnibus Guidance (often referred to as the Mega Guidance). The guidance addressed a number of significant issues under the 340B Program, including the definition of eligible patient and contract pharmacy arrangements. The Mega Guidance was issued by HRSA in August 2015 after a HRSA “Mega Rule” was withdrawn in response to concerns that the issuance of the issuance of the “Mega Rule” exceeded HRSA’s regulatory authority.
On November 10, 2016, the Office of Inspector General (“the OIG”) of the U.S. Department of Health and Human Services (“DHHS”) released its 2017 Work Plan. Published annually and updated throughout the year, the Work Plan identifies the OIG’s key areas of focus as it carries out its mission of protecting the integrity of programs within DHHS. The OIG is charged with ensuring the integrity of more than 100 programs administered by DHHS, including those within the Centers for Medicare and Medicaid Services, Center for Disease Control and Prevention, the Food and Drug Administration, and the National Institute of Health. The OIG Work Plan summarizes the OIG’s current activities – comprised of both new and revised activities — along with information regarding previously identified activities that have been completed, postponed, or cancelled.
The Work Plan highlights new and continuing priorities applicable to various provider types, including hospitals, nursing homes, hospices, home health, clinical laboratories, physicians and other health professionals, medical equipment suppliers and manufacturers, pharmaceutical manufacturers and other providers and suppliers.
The 2017 Work Plan is available here.
The following is a sampling of some of the new and ongoing efforts highlighted in the Work Plan:
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).