Stark Law and Anti-Kickback Statute Compliance in Hospital-Physician Transactions
Recording of a 90-minute CLE video webinar with Q&A
This CLE course will guide healthcare counsel on ensuring compliance with the Stark Law and Anti-Kickback Statute (AKS) in transactions between hospitals and physician groups. The panel will also provide best practices for counsel on structuring arrangements to fit within the AKS safe harbors and Stark exceptions.
Outline
- Stark Law
- Financial arrangements: ownership vs. compensation
- Key considerations
- Fair market value
- Commercial reasonableness
- Prohibition against taking referrals or other business generated into account
- Exceptions
- Isolated transactions
- Bona fide employment relationships
- Exceptions for fair market value exchanges (e.g., space and leases, services, etc.)
- Indirect compensation arrangements
- AKS
- Implications
- Scienter (state of mind)
- Inducement: one-purpose test
- The role of “hope” and “expectation” versus inducement
- Exceptions and safe harbors
- Bona fide employment
- Personal services and management contracts
- Space and equipment leases
- Others
- Transactions not covered by an exception/safe harbor
- Implications
- Stark and AKS
- Overlap and distinction
- Predicates for federal False Claims action
Benefits
The panel will review these and other key issues:
- What is the scope of the Stark Law exceptions?
- What guidance has the OIG provided regarding the application of AKS safe harbors?
- What steps should counsel take when deal planning to ensure compliance with Stark Law and AKS?
Faculty
Donald H. Romano
Special Counsel
Foley & Lardner
Mr. Romano has extensive experience counseling hospitals, skilled nursing facilities and academic medical centers and... | Read More
Mr. Romano has extensive experience counseling hospitals, skilled nursing facilities and academic medical centers and health systems on compliance, reimbursement and litigation issues involving the complex array of federal regulations governing relationships with physicians. He counsels clients on payment issues relating to the Medicare and Medicaid programs, and regulatory compliance matters, particularly those pertaining to the Anti-Kickback Statute, the physician self-referral statute (Stark Law), HIPAA, and the Medicare enrollment regulations. He previously was a partner in another D.C. based law firm, and prior to that he had over 25 years of experience in the Department of Health and Services, including as a senior attorney in the Office of General Counsel.
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Gadi Weinreich
Partner
Dentons
Mr. Weinreich is one of the nation’s more experienced and sought-after healthcare fraud and abuse and regulatory... | Read More
Mr. Weinreich is one of the nation’s more experienced and sought-after healthcare fraud and abuse and regulatory compliance lawyers. He has 30-plus years’ experience representing hospitals, health systems and academic medical centers; pharmaceutical (including vaccine) developers and manufacturers, medical device and durable medical equipment manufacturers and suppliers, faculty practice plans and medical practices, group purchasing organizations, accountable care organizations, managed care organizations, and information technology companies in a wide variety of matters. Mr. Weinreich is widely recognized as a senior thought leader in the areas of healthcare fraud and abuse and regulatory compliance, and frequently writes and speaks on these topics for national audiences. He co-authored one of the leading treatises on the Stark Law and its implementing regulations, The Stark Law: A User's Guide to Achieving Compliance, Second Edition, HCPro, September 2009.
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