OIG Advisory Opinion On Continuing Education Provides Insight On Risk Areas

• Published date: 22 July 2022
• Subject Matter: Consumer Protection, Food, Drugs, Healthcare, Life Sciences, Criminal Law, Compliance, Education, Food and Drugs Law, Biotechnology & Nanotechnology, White Collar Crime, Anti-Corruption & Fraud
• Law Firm: Arnold & Porter
• Author: Mr Mahnu Davar, Jeffrey Handwerker and Abraham Gitterman

In June 2022, the Office of the Inspector General (OIG) for the US Department of Health and Human Services (HHS) issued Advisory Opinion 22-14¹ regarding an ophthalmology practice's (Requestor) proposal to offer two annual continuing education (CE) programs to local optometrists in Requestor's service area. As outlined below, the Requestor proposed four ways to offer these CE programs to optometrists, including two proposals that would involve a grant from pharmaceutical and medical device manufacturers (Manufacturers). OIG found that all four proposals implicated the Anti-Kickback Statute (AKS) because the subsidized or free CE programs could induce CE program attendees to refer patients to the ophthalmology practice or to Manufacturer products. OIG found that the two proposals that would have included grants from Manufacturers raised more than minimal risks of fraud and abuse because the grants would be given to an entity directly involved in the provision of patient care, which OIG reasoned posed more than a minimal risk under the AKS that healthcare professionals (HCPs) serving as faculty or attending the CE programs would be induced to prescribe a Manufacturer's product.

Overall, Advisory Opinion 22-14 does not change OIG's historic position² that grants by Manufacturers to independent, accredited education providers (e.g., accredited by the Accreditation Council for Continuing Medical Education (ACCME), professional medical societies or organizations, or accredited education departments of hospitals or healthcare institutions) "raise little risk of fraud and abuse"³ when such arrangements are structured to comply with the 2003 OIG Compliance Program Guidance for Pharmaceutical Manufacturers and the US Food and Drug Administration (FDA),⁴ as well as the ACCME Standards for Independence and Integrity (SII" (f/k/a Standards for Commercial Support).

Brief Overview of the AKS and OIG Guidance on Manufacturer's and Educational Grants

The OIG starts with its position that the AKS prohibits any person from knowingly and willfully paying remuneration (e.g., a thing of value) to any person with the intent to induce that person to purchase, prescribe, recommend, or refer a person for the furnishing of items or services payable under a federal health care program (FHCP).⁵ According to OIG, the AKS and the conspiracy statute can reach the payment maker, the payment recipient, and parties involved in furthering the payment, and as a result, financial arrangements among Manufacturers of government reimbursed products, educational providers, and healthcare providers (as learners, attendees, or facilitators) must be reviewed carefully under the law. ⁶

In 2003, OIG's Compliance Program Guidance for Pharmaceutical Manufacturers (CPG) recognized that "grants or support for educational activities sponsored and organized by medical professional organizations raise little risk of fraud or abuse, provided that": (1) "the grant or support is not restricted or conditioned with respect to content or faculty"; and (2) grant funding is not being used...