340B After Genesis and Other Recent Developments: Definition of Patient, Registration of Child Sites, 340B Repayment

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.

In addition to Ms. Cook’s role as a national authority on the 340B drug pricing program, she helps clients navigate the full suite of federal and state regulations that are essential to healthcare operations. Ms. Cook partners with a wide range of organizations, including non-traditional service providers and new market entrants to identify, protect and expand revenue opportunities, including via private-equity-backed ventures. Her comprehensive counsel encompasses evolving issues such as No Surprises Act implementation, development of new provider types, Medicare provider-based and co-location rules, and trends in qui tam litigation and government investigations. Ms. Cook’s deep insights into U.S. healthcare regulation stem from her previous tenure at the HHS Health Resources and Services Administration.