Structuring a Compensation Framework for Clinical Research

Mitigating Fraud and Abuse Risks for Healthcare Providers, Navigating FMV in Clinical Research Budgeting, Lessons From Recent Enforcement

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


Conducted on Wednesday, May 24, 2017
Recorded event now available


This CLE webinar will review the status of, and recent developments in, the laws implicated by clinical research relationships, and provide guidance to healthcare counsel to create a framework for smart research funding and compensation planning.

Description

Funding and budgeting for clinical research may implicate a number of state and Federal laws. Given recent changes to the enforcement environment, counsel involved with clinical research operations should have an understanding of and framework for evaluating the implications of financing and compensation decisions for research. Various providers and research sponsors, including hospitals, academic medical centers, physicians and pharmaceutical and medical device companies, have had to pay a steep price to resolve issues and allegations related to improper payments in the context of clinical research.

Listen as our authoritative panel of healthcare attorneys examines the healthcare providers’ role in clinical research and recent trends in compensation and enforcement. The panel will discuss what puts providers at risk and will offer guidance on creating a framework for compensation that complies with federal laws.

Outline

  1. Physicians and clinical research activity
  2. Areas of risk
    1. Stark Law
    2. AKS
    3. Inducements
  3. Best practices for creating a framework for compensation
    1. Factors to consider
      1. Sponsor needs and goals
      2. Investigator needs and goals
      3. Regulatory enforcement environment
    2. Role of fair market value in clinical research budgeting

Benefits

Discussion topics will include specific legal risks and strategies for mitigating those risks, including:

  • How the flow of clinical research dollars from sponsors to providers may or may not implicate Federal and state laws, such as anti-kickback laws, self-referral laws, tax exemption requirements for not-for-profit entities, and the Foreign Corrupt Practices Act for parties engaged in international research activities.
  • Lessons learned from recent enforcement actions, including the importance of (and factors that determine) reasonable, fair market value research compensation.
  • Real world examples, tips and strategies for creating a long term and sustainable regulatory compliance and risk mitigation framework for clients involved in clinical research.

Faculty

Leanne Binkley, Associate General Counsel
LifePoint Health, Brentwood, Tenn.

Ms. Binkley is operations counsel for LifePoint Health affiliated hospitals, providing support for 15 hospital campuses in 8 states. She has worked as ops counsel for multiple systems with varying levels of clinical research programs. She has served in both the operations capacity as a hospital COO as well as in the legal capacity as counsel to various types of clients in the healthcare industry, including non-urban and urban for-profit hospitals as well as clinical research centers and physician groups affiliated with those systems.

KT Farley, JD, MS, Counsel
Sutter Health, Emeryville, Calif.

Ms. Farley advises on clinical research matters, including the development of research budgets, negotiation of clinical trial agreements, protection of human subjects, and compliance with the regulatory framework governing the intricacies of such work. Prior to joining Sutter Health, KT worked for an academic medical center, where she managed agreements for research and innovation initiatives and oversaw the contracting, compliance and regulatory functions of a centralized clinical trials office with a large, diverse research portfolio. KT has also advised healthcare groups across the country on information security and privacy matters.

Andrea M. Ferrari, JD, MPH, Director
HealthCare Appraisers, Delray Beach, Fla.

Ms. Ferrari focuses on physician payments related to hospital physician alignment and efficiency improvement strategies, valuation of services provided by physician hospital organizations, payments for services provided in connection with clinical research/clinical trial agreements, payments for physician supervision of midlevel practitioners, and health practitioner recruitment and support arrangements. She has provided counsel and representation to various types of clients in the healthcare industry, including hospitals, physicians and physician groups, and pharmaceutical and medical device vendors, distributors and manufacturers.

Paula Ramer, Counsel
Arnold & Porter Kaye Scholer, New York

Ms. Ramer represents major pharmaceutical and medical device companies in criminal and civil government investigations involving allegations of healthcare fraud, including off-label promotion, anti-kickback statute violations, False Claims Act violations and other issues related to sales, marketing and pricing practices. She also conducts internal investigations and litigates cases brought under the federal False Claims Act and state laws, including state false claims acts and deceptive trade practices statutes. In addition, Ms. Ramer has developed fraud and abuse training for clients and advises companies on their compliance programs.


Recordings

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CLE On-Demand Video $297.00

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Program Materials

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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

Proskauer Rose

John J. Miles

Senior Counsel

Baker Donelson

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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