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

Navigating Corporate Practice of Medicine/Pharmacy, Anti-Kickback and Stark Laws, and State Regulation

Recording of a 90-minute CLE webinar with Q&A


Conducted on Wednesday, May 3, 2017
Recorded event now available


This CLE webinar will prepare counsel to institutional providers, physicians and pharmacies to anticipate and minimize risks arising under the Stark Law, Anti-Kickback statute, and other federal and state laws when establishing physician-pharmacy and institution-physician ventures. The panel will examine implications for reimbursement and offer best practices for structuring these arrangements.

Description

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.

Outline

  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

Benefits

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?

Faculty

Reesa N. Handelsman, Partner
Wachler & Associates, Royal Oak, Mich.

Ms. Handelsman practices in all areas of health care law and devotes a substantial portion of her practice to transactional and regulatory matters. She counsels and represents various health providers nationwide on a variety of health care-related issues, including physician in-office ancillary arrangements; physician employment relationships; hospital and physician transactions and contracting; Fraud and Abuse, Anti-Kickback Statute, and Stark Law compliance; physician transactions with management companies; regulatory compliance; business and real estate transactions; and general health care matters.

Rick L. Hindmand, Member
McDonald Hopkins, Chicago

Mr. Hindman focuses his practice on healthcare regulatory, data privacy, cybersecurity, corporate, and transactional matters. He represents physicians and other healthcare providers and organizations in structuring group practices, joint ventures, medical device companies, as well as physician/hospital alignment strategies and involvement in accountable care organizations (ACOs). He also assits healthcare providers and businesses with potential compliance challenges, including compliance with the Stark physician self-referral law, federal and state anti-kickback laws, and corporate practice and fee-splitting restrictions.

Todd A. Nova, Shareholder
Hall Render Killian Heath & Lyman, Milwaukee

Mr. Nova focuses on health law issues for health care providers across the country including health care systems, hospitals, pharmacies, post-acute providers and physician organizations. He advises providers regarding corporate structure and reorganizations, health care licensing and certifications, regulatory compliance, government reimbursement and third party payor issues.


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Aron P. Goldfeld

TeamHealth

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Crystal Run Healthcare

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Health Law Advisory Board

Lowell C. Brown

Partner

Arent Fox

Jennifer L. Evans

Shareholder

Polsinelli

Ryan S. Johnson

Shareholder

Fredrikson & Byron

Gina M. Kastel

Partner

Faegre Baker Daniels

Karen S. Lovitch

Member

Mintz, Levin, Cohn, Ferris, Glovsky and Popeo

David A. Manko

Partner

Rivkin Radler

John J. Miles

Principal

Ober Kaler

C. Elizabeth O'Keeffe

Counsel

Wyatt, Tarrant & Combs

J. Peter Rich

Partner

McDermott Will & Emery

Donald H. Romano

Of Counsel

Foley & Lardner

Judith A. Waltz

Partner

Foley & Lardner

John R. Washlick

Shareholder

Buchanan Ingersoll & Rooney

Jesse A. Witten

Partner

Drinker Biddle & Reath

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