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Course Details

Course Information
  • smart_display Format

    On-Demand

  • signal_cellular_alt Difficulty Level

  • work Practice Area

    Health

Date & Time
  • event Date

    Wednesday, November 16, 2022

  • schedule Time

    1:00 p.m. ET./10:00 a.m. PT

  • timer Program Length

    90 minutes

Credit Information

  • This 90-minute webinar is eligible in most states for 1.5 CLE credits.

$297.00
CLE
ALL

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.

Faculty

Gadi Weinreich
Partner
Dentons Law Firm

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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Donald H. Romano
Miscellaneous

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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Description

When structuring a transaction involving healthcare providers, counsel must beware of, and carefully navigate, the myriad of (often non-intuitive) federal and state statutes that apply to the healthcare industry. Violations may result in significant civil and criminal penalties. To that end, this CLE course will address principal compliance considerations under the federal physician-self referral statute and its implementing regulations (Stark Law) and the federal healthcare program anti-kickback statute (AKS) in transactions and contractual arrangements between hospitals and physicians and their medical practices, including, broadly, joint ventures, services and lease arrangements, and employment agreements. The panel will also provide insights on how counsel may contend with the obstacles and pitfalls presented by these transactions and arrangements, including a discussion of potential exceptions and safe harbors.

Listen as our authoritative panel examines the tension and overlap of the Stark Law and AKS analyses in a hospital-physician transaction. The panel will discuss recurring issues emerging from recent case law and settlements of False Claims Act cases challenging hospital-physician arrangements.

Outline

  1. Stark Law
    1. Financial arrangements: ownership vs. compensation
    2. Key considerations
      1. Fair market value
      2. Commercial reasonableness
      3. Prohibition against taking referrals or other business generated into account
    3. Exceptions
      1. Isolated transactions
      2. Bona fide employment relationships
      3. Exceptions for fair market value exchanges (e.g., space and leases, services, etc.)
      4. Indirect compensation arrangements
  2. AKS
    1. Implications
      1. Scienter (state of mind)
      2. Inducement: one-purpose test
        1. The role of “hope” and “expectation” versus inducement
    2. Exceptions and safe harbors
      1. Bona fide employment
      2. Personal services and management contracts
      3. Space and equipment leases
      4. Others
    3. Transactions not covered by an exception/safe harbor
  3. Stark and AKS
    1. Overlap and distinction
  4. 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?