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Course Details

Course Information
  • smart_display Format

    Live Online with Live Q&A

  • signal_cellular_alt Difficulty Level

    Intermediate

  • work Practice Area

    Health

Date & Time
  • event Date

    Wednesday, August 6, 2025

  • schedule Time

    1:00 p.m. ET./10:00 a.m. PT

  • timer Program Length

    90 minutes

Credit Information

  • This 90-minute webinar is eligible in most states for 1.5 CLE credits.

$297.00
CLE
ALL

This CLE webinar will examine the use of speaker programs for promotional purposes in the healthcare industry and the inherent risks of violating the Anti-Kickback Statute (AKS). The panel will look at recent costly settlements and discuss lessons learned. The panel will also offer best practices for utilizing speaker programs while minimizing the risk of enforcement action.

Faculty

Rachel E. Yount
Of Counsel
Mintz Levin Cohn Ferris Glovsky & Popeo PC

Ms. Yount’s practice involves a variety of regulatory, compliance, and transactional matters for a broad range clients across the healthcare industry, including healthcare systems, managed care organizations, pharmacies, device and pharmaceutical manufacturers, long-term and post-acute care providers, and private equity firms investing in the health care industry. She is particularly well versed in the federal anti-kickback statute, the Stark Law, state fraud and abuse laws, beneficiary inducement prohibitions, provider-based rules, Medicare and Medicaid program requirements, and the federal Physician Payments Sunshine Act. Ms. Yount regularly advises clients on the regulatory framework for value-based healthcare, including new and evolving CMS-sponsored payment models (e.g., ACO REACH, Medicare Shared Savings Program, Kidney Care Choices). She is particularly adept at assisting healthcare companies in navigating the anti-kickback statute safe harbors and Stark Law exceptions for value-based care. Ms. Yount is frequently invited to speak on healthcare fraud and abuse, compliance, and other health law matters.

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Description

The pharmaceutical and medical device industries have long used speaker programs to educate healthcare professionals on the uses of company products and emerging developments. However, the government continues to increase scrutiny of these programs, looking for potential AKS noncompliance and imposing severe penalties for violations.

The AKS prohibits offering or paying anything of value to induce the referral of items or services covered by Medicare, Medicaid, and other federal programs so that medical providers' judgments are not compromised by improper financial incentives. HHS-OIG issued a special fraud alert related to these programs and the inherent abuse risks where the agency found that participating healthcare providers often receive generous compensation to speak at programs that "are not conducive to learning or to speak to audience members who have no legitimate reason to attend" thereby suggesting that the purpose of the remuneration to the speakers and attendees is to induce or reward referrals in violation of the AKS.

Subsequent to HHS-OIG's fraud alert, the Pharmaceutical Research and Manufacturers of America (PhRMA), updated its Code on Interactions with Health Care Professionals with guidance on speaker program conduct that is less likely to violate the AKS.

However, despite this guidance, companies continue to offer speaker programs that violate the AKS and have been subject to severe penalties as demonstrated by recent settlements such as the $202 million Gilead Sciences Inc. settlement to resolve claims that it used speaker programs to induce physicians to prescribe its HIV drugs. Or the $3.6 million Assertio Therapeutics Inc. settlement to resolve similar allegations related to its fentanyl product.

Listen as our expert panel takes a closer look at the use of speaker programs in the healthcare industry and the history of government scrutiny and guidance. The panel will examine notable recent settlements related to speaker programs and discuss lessons learned. The panel will also offer best practices for developing compliant speaker programs and minimizing the risk of enforcement action.

Outline

I. Introduction

A. Purpose of healthcare speaker programs

B. Increased government scrutiny

II. Overview of speaker program regulation

A. AKS requirements

B. HHS-OIG guidance

C. PhRMA code update

III. Lessons learned from recent settlements

A. Pfizer/Biohaven

B. Biogen

C. Gilead

D. Others

IV. Best practices for speaker program compliance

V. Practitioner takeaways

Benefits

The panel will review these and other key issues:

  • How do speaker programs risk AKS violations?
  • What federal guidance is available to counsel and clients when developing or reviewing current speaker programs?
  • What lessons may be learned from recent settlements?
  • What points should counsel and their clients consider when developing or reviewing current speaker programs to minimize the risk of AKS violations?