Are Your Providers’ Speaker Engagements Legal?
OIG issues Special Fraud Alert on speaker programs organized by pharmaceutical and medical device companies.
The Office of Inspector General (OIG) issued a rare warning on Nov. 16, 2020, in the form of a Special Fraud Alert (Alert), highlighting the fraud and abuse risks posed by physicians or other healthcare professionals (HCPs) receiving remuneration for participating in speaker programs sponsored by device and drug companies. The OIG does not frequently issue Special Fraud Alerts — the last one, regarding laboratories making payments to referring physicians, was issued back in 2004. This Alert came just days before the OIG announced it was alleviating certain liabilities associated with value-based programs.
Examine the Legality of Speaker Programs
Speaker programs are a very common industry practice, particularly with device and drug companies. They are typically company-sponsored events where an HCP makes a speech or presentation to other HCPs about a company drug or device on behalf of the company. The device or drug company will pay the HCP an honorarium and often also pays other types of remuneration to the speaker (and attendees) such as free meals and alcohol.
The OIG notes that numerous enforcement actions have been brought by the Department of Justice against device and drug companies under the federal anti-kickback statute related to remuneration offered and paid in connection with speaker programs. Relying on Open Payments data reflecting payments for such programs in recent years, the OIG concluded that drug and device companies paid HCPs nearly $2 billion under the category of “compensation for services other than consulting, including serving as faculty or as a speaker at a venue other than a continuing education program” for years 2017, 2018, and 2019 combined.
Telltale Signs That Your Speaker
Engagement Violates the Anti-kickback Statute
In the alert, the OIG sets forth a list of “suspect characteristics” of speaker programs that, taken separately or together, could violate the anti-kickback statute if the requisite intent to violate the statute was present:
- No substantive content. The company sponsors speaker programs where little to no substantive information is presented.
- Alcohol is served. Alcohol is available or a meal exceeding modest value is provided to the attendees of the program (the concern is heightened when the alcohol is free).
- Upscale venues. The program is held at a location that is not conducive to the exchange of educational information (e.g., restaurants or entertainment/sports venues).
- Too many programs. The company sponsors a lot of programs on the same, or substantially the same, topic or product, especially in situations involving no recent substantive change in relevant information.
- Nothing new to say. There has been a significant period of time with no new medical or scientific information nor a newly approved or cleared indication for the product.
- Repeat attendees. HCPs attend programs on the same, or substantially the same, topics more than once (as either a repeat attendee or as an attendee after being a speaker on the same or substantially the same topic).
- Friends and family. Attendees include individuals who don’t have a legitimate business reason to attend the program such as friends, significant others, or family members of the speaker or HCP attendee; employees or medical professionals who are members of the speaker’s own medical practice; staff of facilities for which the speaker is a medical director; and other individuals with no use for the information being presented by the speaker.
- The sales pitch. The company’s sales or marketing business units influence the selection of speakers or the company selects HCP speakers or attendees based on past or expected revenue that the speakers or attendees have or will generate by prescribing or ordering the company’s product(s) (e.g., a return-on-investment analysis is considered in identifying participants).
- Payment beyond fair market value. The company pays HCP speakers more than fair market value for the speaking service or pays compensation that accounts for the volume or value of past business generated or potential future business generated by the HCPs.
Think Before You Speak
In the Alert, the OIG specifically states that it is “skeptical about the educational value of such programs” and that HCPs “can access the same or similar information provided in a speaker program using various online resources, the product’s package insert, third-party educational conferences, medical journals, and more. The availability of this information through means that do not involve remuneration … further suggests that at least one purpose of remuneration associated with speaker programs is often to induce or reward referrals.”
OIG investigations have revealed that HCPs often “receive generous compensation to speak at programs offered under circumstances that are not conducive to learning or to speak to audience members who have no legitimate reason to attend.” Such cases “strongly suggest that one purpose of the remuneration to the HCP speaker and attendees is to induce or reward referrals.” The OIG alarmingly concludes the Alert by stating how “remuneration to HCPs may skew their clinical decision making in favor of their own and the company’s financial interests, rather than the patient’s best interests.”
It is easy to understand why HCPs may be sought after as speakers to present information relevant to device and drug company products at speaker programs. Oftentimes, such speaking opportunities may serve to provide necessary scientific and educational information to the medical community. However, before agreeing to participate in a speaker program activity, HCPs would be wise to ensure that they retain full control of the educational content and the scientific integrity of the information they present.
Payments to the HCP must be commensurate with fair market value for the tasks performed considering the HCP’s specialty, expertise, experience, and reputation. The venue where the information is presented must be primarily dedicated to informing HCPs about a product or treatment, providing scientific information, and promoting educational discourse on the topic presented. The venue must also be conducive to informational communication, and any meals should be provided in a manner conducive to informational communication. In addition, inclusion of spouses or other guests in a meal accompanying an informational presentation made by or on behalf of a device or drug company is not appropriate.
Expect Increased Scrutiny
The Alert signals the OIG’s clear and unambiguous warning that device and drug companies and HCPs should anticipate increased scrutiny of promotional speaker programs in the future. HCPs participating in such activity should re-examine the structure of the speaker program and ensure that the program contains the safeguards outlined above to protect against the “suspect characteristics” identified in the Alert. Of course, the least risky option would be to “just say no” and avoid promotional speaking programs altogether.
The OIG recognizes that this most recent Alert is being issued in the middle of a pandemic, a time when device and drug companies have likely curtailed most speaker program-related remuneration. Device and drug companies are strongly encouraged to evaluate the need for restarting in-person speaker programs that have been curtailed during the COVID-19 pandemic.