Healthcare Speaker Programs and AKS Compliance: Regulatory Update, Lessons Learned From Recent Settlements
A live 90-minute CLE video webinar with interactive Q&A
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.
Outline
- Introduction
- Purpose of healthcare speaker programs
- Increased government scrutiny
- Overview of speaker program regulation
- AKS requirements
- HHS-OIG guidance
- PhRMA code update
- Lessons learned from recent settlements
- Pfizer/Biohaven
- Biogen
- Gilead
- Others
- Best practices for speaker program compliance
- 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?
Faculty
Katy Herman
Attorney
Gardner Law
Ms. Herman is a highly skilled legal professional, providing counsel on a wide range of healthcare compliance matters... | Read More
Ms. Herman is a highly skilled legal professional, providing counsel on a wide range of healthcare compliance matters for drug and device manufacturers. Her primary expertise lies in supporting companies with Medicare and Medicaid billing compliance, where she works closely with clients to ensure adherence to the stringent regulations governing reimbursement processes. In addition to billing compliance, Ms. Herman is well-versed in Medicare and Medicaid accreditation requirements. She assists clients in meeting the rigorous standards necessary for accreditation, ensuring that healthcare organizations maintain the highest level of quality and adherence to regulatory guidelines. Ms. Herman extends her expertise to cover Durable Medical Equipment, Prosthetics, Orthotics and Supplies (DMEPOS) Supplier and Quality Standards. She advises clients on the standards and regulations governing the supply of DME, ensuring they meet the necessary quality benchmarks to provide exceptional patient care. Moreover, Ms. Herman is well-versed in healthcare fraud and abuse laws, providing critical guidance to clients navigating these complex regulations. Her expertise helps healthcare organizations establish robust compliance programs and safeguards to prevent fraudulent activities and ensure adherence to the law. Prior to joining the firm Ms. Herman was in-house counsel with a DME maker for seven years.
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Rachel E. Yount
Of Counsel
Mintz Levin Cohn Ferris Glovsky and Popeo
Ms. Yount’s practice involves a variety of regulatory, compliance, and transactional matters for a broad range... | Read More
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.
CloseEarly Discount (through 07/11/25)