[author: Ashley Kenny]
Takeaways:
- Individuals should be wary of the Speaker Programs they choose to attend. Simply attending a Speaker Program where alcohol or an expensive meal is served can be viewed as remuneration in violation of the AKS.
- HCPs should be extremely selective of the Speaker Programs they choose to participate in. The receipt of compensation through an honorarium has been proven by studies to have an effect on the HCP’s drug prescribing and medical device ordering habits.
- Companies should evaluate the educational value of in-person Speaker Programs. COVID-19 has proven that in-person events are not a necessity – the same programs can be offered virtually through electronic videoconferencing platforms. Virtual programs eliminate much of the risks associated with being an attendee or speaker and are a way to ensure that HCPs are participating in the program solely for educational purposes.
On November 16, 2020, the Department of Health and Human Services, Office of the Inspector General issued another Special Fraud Alert. This Special Fraud Alert deals with Speaker Programs. Speaker Programs are defined as “company-sponsored events at which a physician or other health care professional (collectively, ‘HCP’) makes a speech or presentation to other HCPs about a drug or device product or a disease state on behalf of the company.”[1] Over the years, the Office of Inspector General (OIG) and Department of Justice (DOJ) have investigated numerous cases regarding illegal remuneration that is offered and paid by companies to speakers and attendees for their participation in Speaker Programs. Based on their findings, the OIG has come to the conclusion that many Speaker Programs violate the Anti-Kickback Statute (“AKS”).
Under the AKS, it is a criminal offense to solicit, receive, offer, or pay any remuneration to induce or reward, referrals for, or orders of, items or services reimbursable by a Federal health care program.[2] Remuneration includes anything of value such as monetary payments, entertainment, travel, or meals and alcohol. Violation of the AKS is a felony that is punishable by imprisonment of up to 10 years, a maximum fine of $100,000, or both.
The OIG declared that Speaker Programs, while intended to educate and inform HCPs on the benefits, risks, and uses of a company’s product, often offer little educational value. Speaker Programs are often held at restaurants or larger venues where food and alcohol are served, and attendees often have the option of bringing along family members. The information presented at Speaker Programs could be absorbed by HCPs much more efficiently and thoroughly by reading the drug or product brochures, packing inserts, and online articles. This creates the inference that Speaker Programs are intended to induce the HCPs in attendance or speaking at the event to prescribe or order the companies’ product which is in violation of the AKS.
The OIG has concluded, and studies have confirmed, that HCPs who receive remuneration from a company are more likely to prescribe or order that company’s products. HCPs become more concerned with the financial benefits they can receive than the wellbeing of their patients. This is a direct interference with the HCP’s independent medical judgment and is exactly what the AKS seeks to prevent.
[1] HHS OIG, “Special Fraud Alert: Speaker Programs,” November 16, 2020, https://oig.hhs.gov/fraud/docs/alertsandbulletins/2020/SpecialFraudAlertSpeakerPrograms.pdf
[2] 42 U.S.C. § 1320a-7b(b)(1)–(2).
