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340B Drug Pricing Program Omnibus Guidance Withdrawn

Last week, on Jan. 30, 2017, the Office of Management and Budget (OMB) withdrew the U.S. Department of Health and Human Services (HHS) Health Resources and Services Administration’s (HRSA) 340B Drug Pricing Program Omnibus Guidance (Omnibus Guidance). The Omnibus Guidance was originally published on Aug. 28, 2015. The intent of the Omnibus Guidance was to clarify and further define many aspects of the 340B Program, including, most significantly, the definition of a 340B eligible patient. Other proposed changes and clarifications were around Child Site eligibility and registration requirements, Disproportionate Share Hospital eligibility, outpatient status, manufacturer requirements, contract pharmacy requirements and record retention requirements, among others. However, this is not the first time HRSA’s proposed guidance regarding the 340B Drug Pricing Program has been quashed. In 2014, HRSA both published and withdrew its “mega rule” after it was questioned as to its rulemaking authority. Therefore, in 2015, HRSA chose to issue guidance regarding the 340B Drug Pricing Program rather than a rule. As we previously mentioned, on Jan. 20, 2017, the Trump administration suspended all new and pending federal regulations. We suspect HRSA’s recently finalized rule on 340B Drug Pricing Program calculations and Civil Monetary Penalties for drug manufacturers will also be delayed or otherwise affected by the Trump administration’s regulatory freeze.

Copyright © 2020 Godfrey & Kahn S.C.National Law Review, Volume VII, Number 41


About this Author

Wend Arends Government Attorney
Special Counsel

Wendy Arends is special counsel in the firm’s Madison office where she advises businesses, organizations and trade associations regarding their interactions with local, state and federal government. Her practice focuses on matters involving antitrust and consumer protection, health care, and international trade compliance. Prior to joining Godfrey & Kahn, Wendy practiced for more than four years at a large national law firm in Washington, D.C. where she worked on a variety of complex commercial litigation and regulatory matters.

As a member...

Sean Bosak Litigation Attorney

Sean Bosack is a shareholder in the Litigation Practice Group in the Milwaukee office and a member of the Government Investigations, White Collar & Compliance Practice Group. Since joining the firm in 1997, Sean has focused his practice on complex business and corporate civil and criminal litigation. Sean devotes a substantial portion of his practice representing corporations conducting internal investigations involving various forms of fraud and corporate governance issues, and representing corporate and individual clients in white collar criminal matters in industries including...

Thomas Shorter Healthcare Attorney Godfrey Kahn Law Firm

Thomas N. Shorter is a shareholder in the firm's Madison office and Chair of the Health Care Team. Tom represents hospitals, physicians' groups, research institutions and health care related organizations, as well as other businesses, providing counsel on health care, corporate, labor and employment and regulatory matters. For clients in the health care industry, Tom handles matters regarding Medicare compliance, Health Insurance Portability and Accountability Act (HIPAA), Emergency Medical Treatment and Labor Act (EMTALA), Physician Self-Referral (Stark), and Anti-Kickback. Additionally,...