Physician Services Arrangements with Pharmaceutical and Medical Device Companies

Evaluating Scope of Services, Establishing Defensible FMV, and Complying with Anti-Kickback and Other Regulations

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


Conducted on Monday, July 29, 2013

Recorded event now available

or call 1-800-926-7926
Program Materials

This CLE webinar will provide guidance to counsel for overcoming the regulatory challenges and establishing defensible fair market value (FMV) when forming physician services arrangements.

Description

Pharmaceutical and medical device companies regularly contract with physicians to provide consulting and research services relating to companies’ products and services. Federal regulations require that such arrangements between these companies and physicians be consistent with FMV and commercially reasonable.

These companies face increased scrutiny by federal regulatory enforcement agencies. Beginning in 2013, they must report all payments or other transfer of value they provide to physicians and teaching hospitals to the U.S. Dep't of Health and Human Services under the Physician Payments Sunshine Act.

To establish a defensible FMV compensation rate for physician consulting services, counsel must understand the valuation issues, including the scope of services and the required qualifications of the individual providing services.

Listen as our authoritative panel of attorneys examines the regulatory challenges involved in physician services arrangements and addresses the valuations issues. The panel will offer best practices for overcoming the regulatory hurdles and establishing defensible FMV.

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Outline

  1. Overcoming regulatory challenges in physician service arrangements
    1. Anti-kickback Statute
    2. Stark law
    3. False Claims Act
    4. Sunshine Act
  2. Valuation issues
    1. Scope of services
    2. Analysis and categorization of qualifications
    3. Interdependencies between duties/responsibilities and qualifications requirements
  3. Best practices

Benefits

The panel will review these and other key questions:

  • How will the transparency requirements of the Physician Payment Sunshine Act impact life sciences companies' interaction with physicians?
  • What factors must be considered when establishing a defensible FMV?
  • What are the considerations in determining the FMV for non-U.S.-based healthcare providers?
  • What steps can counsel take to ensure life sciences companies and physicians meet the regulatory requirements when forming physician services arrangements?

Following the speaker presentations, you'll have an opportunity to get answers to your specific questions during the interactive Q&A.

Faculty

Ann S. Brandt, Ph.D.
Ann S. Brandt, Ph.D.

Partner
HealthCare Appraisers

She specializes in valuing compensation arrangements which may have Stark and/or Anti-Kickback implications. Working...  |  Read More

Danielle Drissel
Danielle Drissel

Atty
Hogan Lovells US

She assists health care providers, pharmaceutical and device manufacturers, and health care technology companies on...  |  Read More

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