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
This CLE course will provide guidance to counsel for overcoming the regulatory challenges and establishing defensible fair market value (FMV) when forming physician services arrangements.
Outline
-
Overcoming regulatory challenges in physician service arrangements
- Anti-kickback Statute
- Stark law
- False Claims Act
- Sunshine Act
-
Valuation issues
- Scope of services
- Analysis and categorization of qualifications
- Interdependencies between duties/responsibilities and qualifications requirements
- 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.
Partner
HealthCare Appraisers
She specializes in valuing compensation arrangements which may have Stark and/or Anti-Kickback implications. Working... | Read More
She specializes in valuing compensation arrangements which may have Stark and/or Anti-Kickback implications. Working primarily with hospitals, pharmaceutical companies and medical device companies, she has specific expertise in valuing thought leader compensation and data acquisition arrangements as well as clinical trials and principal investigator compensation. In addition, she has extensive experience in providing valuation and consulting services related to co-management and physician management arrangements.
CloseDanielle Drissel
Atty
Hogan Lovells US
She assists health care providers, pharmaceutical and device manufacturers, and health care technology companies on... | Read More
She assists health care providers, pharmaceutical and device manufacturers, and health care technology companies on potential fraud and abuse or other regulatory concerns, including anti-kickback, false claims, physician self-referral issues and compliance with marketing and price disclosure requirements. She frequently assists with the implementation and review of corporate compliance programs
Close