340B Discount Drug Program: Inflation Reduction Act, Reimbursement Challenges, Contract Pharmacy Restrictions, and 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.

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.