Structuring Physician-Pharmacy Ventures: Minimizing Regulatory Risks, Ensuring Reimbursement

Healthcare providers, including physicians and pharmacies, are tasked with navigating the complexities associated with increased incentives for traditionally independent healthcare providers to coordinate care, including the pharmacy component of care. This care coordination must appropriately recognize the unique challenges associated with a continued shift from the office-based and hospital-based infusions to orally administered drugs.

Physician-owned pharmacies, hospital-owned pharmacies, joint venture pharmacies and other collaborative pharmacy structures, as distinct from traditional independent retail pharmacy models, offer an opportunity to better achieve these care coordination goals.

Physicians, pharmacies, institutional providers and their counsel must weigh several considerations when determining whether to enter into and then structuring such an arrangement. They must consider compliance challenges, including the Anti-Kickback statute, Stark law and similar state laws. Further, they should consider the reimbursement implications in light of increasing bundled payment initiatives.

Counsel for hospitals and physicians must understand the legal and regulatory hurdles involved when establishing physician-pharmacy ventures and carefully structure such arrangements to overcome those hurdles and avoid risks under both federal and state laws.

Listen as our panel prepares counsel to physicians, pharmacies and institutional providers to anticipate and minimize risks arising under the Stark Law, Anti-Kickback statute, and other federal and state laws when establishing physician-pharmacy collaborative arrangements. The panel will examine implications for reimbursement and offer best practices for structuring these arrangements.

1. Risks and challenges in physician-pharmacy ventures
2. Reimbursement implications
3. Compliance issues
   1. Corporate practice of medicine
   2. Corporate practice of pharmacy
   3. Anti-Kickback statute
   4. Stark law
   5. Investment interests safe harbor
   6. State regulations
4. Best practices for structuring physician-pharmacy ventures

The panel will review these and other key issues:

• What are the Stark Law and Anti-Kickback risks for physician-pharmacy ventures?
• What are the Medicare and Medicaid reimbursement implications?
• What strategies have proven effective for physician and pharmacy counsel during the creation of joint ventures?