Anti-Kickback Safe Harbor Provisions: HHS and OIG Changes to Regulate and Restrict Remuneration
New Safe Harbor for POS Price Reductions on Prescription Drugs and PBM Service Fees, Loss of Safe Harbor for Drug Rebates
Recording of a 90-minute CLE webinar with Q&A
This CLE course will guide healthcare counsel on the changes to Anti-Kickback Statute (AKS) safe harbors. The panel will examine the removal of protection for rebates to pharmacy benefit managers (PBMs) and the new safe harbors for point-of-sale discounts and service fees. The panel will discuss how stakeholders in the healthcare industry can take advantage of the changes and ensure compliance.
Outline
- Overview and background of proposed rulemaking
- Removal of safe harbor protections for PBM and health plan rebates
- New safe harbors
- Point-of-sale discounts
- PBM service fees
- Impact of the changes
- What stakeholders in the healthcare industry and counsel need to do
Benefits
The panel will review these and other key issues:
- What is the impact of the changes on drug distribution and reimbursement?
- What is the scope of application of the proposed changes?
- What must stakeholders in the healthcare industry do to ensure compliance with the safe harbor changes?
Faculty
Clinton Mikel
Partner
The Health Law Partners
Mr. Mikel has practiced in almost all areas of healthcare law but has focused his practice on compliance with federal... | Read More
Mr. Mikel has practiced in almost all areas of healthcare law but has focused his practice on compliance with federal and state health care regulations and transactional matters. He specializes in HIPAA and state privacy laws, federal and state information breaches (strategic investigations and disclosures), state and federal telehealth/telemedicine issues, federal and state self-referral laws, including Stark, federal and state anti-kickback laws, and information technology issues. He represents a variety of health care providers, including telemedicine providers, physician groups, hospitals, large health systems, critical access hospitals, rural health centers, and sleep laboratories.
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Charles B. Oppenheim
Partner
Hooper Lundy & Bookman
Mr. Oppenheim’s practice includes all aspects of transactional, operational and regulatory healthcare law,... | Read More
Mr. Oppenheim’s practice includes all aspects of transactional, operational and regulatory healthcare law, including mergers & acquisitions, affiliations, joint ventures and the formation of integrated delivery systems. Among his clients are many of the largest healthcare companies and hospital systems in the U.S. A nationally-recognized expert on anti-kickback and Stark Law issues, Mr. Oppenheim wrote the 2014 American Health Lawyers Association Monograph on Stark. He has served as an expert on anti-kickback and Stark Law issues in arbitration and litigation, in both civil and criminal proceedings. In addition, he creates and implements compliance programs, investigates compliance issues, responds to government enforcement actions, and negotiates settlements for many types of healthcare providers.
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Jill S. Wright
Special Counsel
Foley & Lardner
Ms. Wright’s practice focuses on healthcare fraud and abuse and compliance issues, including the federal... | Read More
Ms. Wright’s practice focuses on healthcare fraud and abuse and compliance issues, including the federal Anti-Kickback and Physician Self-Referral/Stark laws, civil monetary penalties law, false claims and overpayments, government investigations, and exclusions from federal healthcare programs. She was formerly a senior counsel for the U.S. Department of Health and Human Services Office of the Inspector General, where she represented the OIG in cases involving civil monetary penalties and the False Claims Act, including matters premised on allegations involving the Anti-Kickback and Stark laws, and quality of care issues. Ms. Wright also has experience conducting investigations and negotiating settlements and corporate integrity agreements.
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