340B Discount Drug Program: Inflation Reduction Act, Reimbursement Challenges, Contract Pharmacy Restrictions, and More
Recording of a 90-minute CLE video webinar with Q&A
This CLE webinar will guide healthcare counsel on the impact of recent activity related to the 340B program. The panel will discuss the implications of the Inflation Reduction Act's drug pricing provisions on the 340B program. The panel will also address manufacturer restrictions on access to 340B pricing for drugs dispensed through contract pharmacies, changes to Medicare reimbursement for 340B drugs in light of a recent Supreme Court decision, and state legislation addressing reimbursement challenges. The panel will offer best practices for navigating the current 340B environment.
Outline
- Inflation Reduction Act and its impact on 340B program
- Manufacturer restrictions on contract pharmacies
- Reimbursement challenges and state action
- Supreme Court ruling
- Best practices for navigating 340B in light of recent activity
Benefits
The panel will review these and other key issues:
- How does the Inflation Reduction Act impact the 340B drug program?
- What impact will the recent state legislative activity have on the 340B drug program?
- What do the recent developments mean for future contract pharmacy arrangements?
Faculty
Jeffrey I. Davis
Member
Bass Berry & Sims
Mr. Davis advises healthcare organizations on Medicare and Medicaid billing and reimbursement issues, with a special... | Read More
Mr. Davis advises healthcare organizations on Medicare and Medicaid billing and reimbursement issues, with a special focus on the federal 340B drug pricing program. He also counsels clients on emerging healthcare regulatory issues, including COVID-19 relief funding, surprise medical billing, and hospital price transparency, and provides strategic insights to clients on public policy matters under consideration by the U.S. Congress and federal agencies, such as drug pricing policy and nonprofit hospital issues. Mr. Davis forged his deep knowledge of the 340B program and other Medicare and Medicaid reimbursement issues while working in the federal public policy arena. He spent more than seven years working as vice president and legislative and policy counsel for 340B Health, an association of more than 1,400 hospitals and health systems participating in the 340B program. In this role, he provided technical assistance to member hospitals, directed research and policy efforts, and helped lead government relations efforts to educate federal policymakers on 340B issues. Mr. Davis draws on this experience to advise hospitals, pharmacies, other provider organizations and vendors on 340B issues including enrollment, contracting, audits, compliance and self-disclosures.
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Samantha D. Marshall
Attorney
Hogan Lovells
Ms. Marshall helps healthcare industry clients navigate complex federal healthcare program requirements, including... | Read More
Ms. Marshall helps healthcare industry clients navigate complex federal healthcare program requirements, including coverage and reimbursement issues for drugs and devices and drug price reporting obligations under Medicare, Medicaid, and the 340B Drug Pricing program. She helps pharmaceutical manufacturers comply with federal drug price reporting requirements as applied in the context of each manufacturer's specific business model. Across all of these programs, Ms. Marshall assists clients with responding to and growing with the changing regulatory environment through help with drafting comments on new U.S. Department of Health & Human Services regulations as well as implementing final regulations and guidance as part of company policies and programs.
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Joseph W. Metro
Partner
Reed Smith
Mr. Metro is a member of the firm’s Life Sciences Health Industry Group, practicing in the area of healthcare... | Read More
Mr. Metro is a member of the firm’s Life Sciences Health Industry Group, practicing in the area of healthcare regulatory law. His practice focuses on counseling healthcare manufacturers, distributors and providers on reimbursement, regulatory, and fraud and abuse issues. For more than 20 years, Mr. Metro has provided analysis and counseling on behalf of manufacturers with respect to government pricing matters including: the Medicaid drug rebate statute, the Veterans Health Care Act’s drug pricing standards, the federal anti-kickback statute, and other state and federal laws relating to the promotion of prescription drugs and medical devices. In this area, he has assisted with day-to-day methodological counseling, contract pricing strategies, recalculation matters, government pricing investigations, and due diligence on government pricing matters. Mr. Metro has been listed in the LMG Life Sciences Guide since its inception as a life science “star” in the pricing and reimbursement area. In addition, he regularly works with manufacturers on healthcare fraud and abuse compliance, including regulatory, transactional and litigation matters.
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