The new administration has had an immediate impact on the federal 340B Drug Discount Program.
There have been two significant developments in the first days since President Trump took office: (1) the withdrawal of the final 340B Program Omnibus Guidance, which was pending before the White House Office of Management and Budget (“OMB”); and (2) an expected delay in the effective date of the final rule issued by the Health Resources and Services Administration (“HRSA”) on 340B drug pricing and civil monetary penalties (“CMPs”) for drug manufacturers.
Ryan J. Severson
K&L Gates LLP
Ryan J. Severson is an associate at K&L Gates. Mr. Severson focuses his practice on health care regulatory matters. He regularly advises clients on a wide variety of issues, including federal and state fraud and abuse compliance, the federal 340B Drug Pricing Program, Medicare and Medicaid enrollment and reimbursement, and others. His practice covers complex transactions between health care providers, as well, including legal compliance reviews and change of ownership filings.
Richard P. Church
- Health care partner at K&L Gates, whose health care practice is ranked in the Top 20 nationally by Modern Healthcare
- Listed in Band 1 in Chambers USA 2014 and 2015 for health care, North Carolina
- Recent articles include: “340B Program Omnibus Guidance: Mega-Changes on the Horizon?”, American Health Lawyers Association Rap Sheet Article, November 2015; “340B Orphan Drug Interpretive Rule Struck Down by D.C. District Court: HHS and HRSA Lose In Second Round of Litigation Over 340B Orphan Drug Rules”, October 2015; “HRSA Issues 340B Program Omnibus Guidance”, September 2015; “Preparing for Successful Medicare Shared Savings Program Enrollment”, AHLA Connections Magazine, July 2015, and “340B Update: HRSA Proposes Penalties for Drug Manufacturers that Overcharge Covered Entities”, June 2015
- Recent presentations include: “340B Program Omnibus Guidance”, webinar presented to the North Carolina Society for Health Care Attorneys, October 2015; “340B Compliance in a Fast-Changing and Heightened Regulatory Environment”, webinar presented to Healthcare Financial Management Association, May 2015
- Recent representative work include representation of hospitals and health systems with respect to OPA audits and manufacturer enquiries; development of comments on HRSA’s 340B Program Omnibus Guidance for a leading academic medical center, contract pharmacy provider, and other safety net providers; execution of a complete review and overhaul of academic medical center’s 340B Program operations and policies; facilitation of the transfer of a 340B covered entity’s Ryan White grant to ensure a seamless transition in care for the entity’s patients and enrollment in the 340B Program; representation of a mail order contract pharmacy in operational and compliance matters, assisting on issues ranging from day-to-day compliance to strategic discussions on 340B policies and procedures
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