340B Contract Pharmacy Arrangements: Structuring Arrangements, Meeting Legal and Regulatory Requirements

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. Dresser, Esq. is a Partner in Frier Levitt’s Life Sciences Department and heads the firm’s Pharmacy Practice Group. His practice is dedicated to representing a broad cross-section of pharmacies and pharmacy providers, including community retail pharmacies, chain pharmacies, compounding pharmacies, specialty pharmacies, mail order pharmacies, home infusion providers, and dispensing physician practices. Jesse represents pharmacy providers nationally on issues with payors and Pharmacy Benefit Managers (PBMs), including PBM audit appeals, network terminations, network access and credentialing applications, and reimbursement issues. In addition to his work with pharmacy clients, Mr. Dresser also represents a variety of other entities across the healthcare and life sciences spectrum, including other healthcare providers, pharmaceutical and biotech manufacturers, pharmaceutical wholesalers and distributors, and healthcare technology companies. Through this work, he has focused on the intersection between the law and economic considerations, including drug pricing, marketing techniques, and benefits management. Mr. Dresser frequently lectures across the country at national and regional pharmacy and healthcare conferences and organizations, including the International Academy of Compounding Pharmacists (IACP), the American College of Apothecaries (ACA), the American College of Veterinary Pharmacists (ACVP), the National Association of Specialty Pharmacy (NASP), the Community Oncology Alliance (COA) the Community Oncology Pharmacy Association (COPA), the National Home Infusion Association (NHIA), and the Immunoglobulin National Society (IgNS). He also regularly hosts pharmacy industry webinars for a variety of industry organizations and affiliated companies.