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

or call 1-800-926-7926
Program Materials

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.

READ MORE

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
Leanne Binkley
Associate General Counsel
LifePoint Health

Ms. Binkley is operations counsel for LifePoint Health affiliated hospitals, providing support for 15 hospital campuses...  |  Read More

KT Farley, JD, MS
KT Farley, JD, MS
Counsel
Sutter Health

Ms. Farley advises on clinical research matters, including the development of research budgets, negotiation of clinical...  |  Read More

Andrea M. Ferrari, JD, MPH
Andrea M. Ferrari, JD, MPH

Director
HealthCare Appraisers

Ms. Ferrari focuses on physician payments related to hospital physician alignment and efficiency improvement...  |  Read More

Paula Ramer
Paula Ramer

Counsel
Arnold & Porter Kaye Scholer

Ms. Ramer represents major pharmaceutical and medical device companies in criminal and civil government investigations...  |  Read More

Other Formats
— Anytime, Anywhere

Strafford will process CLE credit for one person on each recording. All formats include program handouts. To find out which recorded format will provide the best CLE option, select your state:

CLE On-Demand Video

$297

Download

$297