340B Contract Pharmacy Arrangements: Structuring Arrangements, Meeting Legal and Regulatory Requirements
Recording of a 90-minute CLE video webinar with Q&A
This CLE course will provide guidance to healthcare counsel on contract pharmacy arrangements and the key legal and regulatory considerations for structuring and documenting the arrangements in an uncertain regulatory environment.
Outline
- Recent 340B developments: What is the going forward impact on 340B contract pharmacy arrangements?
- Structuring and implementing contract pharmacy arrangements
- HRSA essential compliance elements
- Fee structures
- Discounts for uninsured patients
- Reconciliation (including DIR Fees)
- 340B entity compliance issues
- Prohibition against diversion
- Prohibition against duplicate discounts
- Inventory management issues
- HRSA audit enforcement, and litigation
Benefits
The panel will review these and other key issues:
- What compliance challenges must be overcome when structuring a contract pharmacy arrangement?
- What does the future compliance landscape for contract pharmacy arrangements look like?
- What operational and contractual considerations should counsel keep in mind when structuring and implementing these 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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Jesse C. Dresser
Partner
Frier Levitt
Mr. Dresser heads the firm’s Pharmacy Practice Group. In this role, his practice is dedicated to representing a... | Read More
Mr. Dresser heads the firm’s Pharmacy Practice Group. In this role, 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, digital pharmacies, and dispensing physician practices. Mr. Dresser represents pharmacy providers nationally regarding issues with payors and Pharmacy Benefit Managers (PBMs), including PBM audit appeals, network terminations, network access and credentialing applications, and reimbursement issues.
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