HHS OIG Issues Special Fraud Alert on Speaker Programs
The HHS Office of Inspector General issued a special fraud alert on Nov. 16 on speaker programs saying the office “is skeptical about the educational value of such programs” and that “parties involved in speaker programs may be subject to increased scrutiny.”
The OIG noted that in the past three years, medical product companies have reported paying nearly $2 billion to health care professionals (HCPs) for speaker-related services and that the OIG and Department of Justice “have investigated and resolved numerous fraud cases involving allegations that remuneration offered and paid in connection with speaker programs violated the anti-kickback statute.”
“Our investigations have revealed that, often, HCPs 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,” OIG said.
The alert contended “there are many other ways for HCPs to obtain information about drug and device products and disease states that do not involve remuneration to HCPs. 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 to HCPs further suggests that at least one purpose of remuneration associated with speaker programs is often to induce or reward referrals.”
The alert added the agency “has long expressed concerns over the practice of drug and device companies providing anything of value to HCPs in a position to make or influence referrals to such companies’ products” and that “when a drug or device company engages in ‘entertainment, recreation, travel, meals or other benefits in association with information or marketing presentations,’ such arrangements may potentially implicate the anti-kickback statute.”
The alert also noted that the OIG has warned physicians that “a consultant or speaking arrangement with a drug or device company could be an improper inducement ‘to prescribe or use [company] products on the basis of . . . loyalty to the company or to get more money from the company, rather than because it is the best treatment for the patient.’”
The OIG has recommended that physicians consider the propriety of any proposed relationship with a company and advised that if the basis for a physician’s compensation “is your ability to prescribe a drug or use a medical device or refer your patients for particular services or supplies, the proposed consulting arrangement likely is one you should avoid as it could violate fraud and abuse laws.”
The alert warned that “HCPs could face liability under the anti-kickback statute for knowingly and willfully soliciting or receiving remuneration in connection with speaker programs in return for prescribing or ordering products reimbursable by a federal health care program.”
The OIG recognized that “the lawfulness of any remunerative arrangement, including speaker program arrangements, under the anti-kickback statute depends on the facts and circumstances and intent of the parties.”
The alert provided a list of program characteristics, which separately or together, “potentially indicate a speaker program arrangement that could violate the anti-kickback statute. … This list of suspect characteristics is illustrative, not exhaustive, and the presence or absence of any one of these factors is not determinative of whether a particular arrangement would be suspect under the anti-kickback statute.”
- The company sponsors speaker programs where little or no substantive information is actually presented;
- 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);
- The program is held at a location that is not conducive to the exchange of educational information (e.g., restaurants or entertainment or sports venues);
- The company sponsors a large number of programs on the same or substantially the same topic or product, especially in situations involving no recent substantive change in relevant information;
- There has been a significant period of time with no new medical or scientific information nor a new FDA-approved or cleared indication for the product;
- 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);
- Attendees include individuals who don’t have a legitimate business reason to attend the program, including, for example, 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;
- 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);
- The company pays HCP speakers more than fair market value for the speaking service or pays compensation that takes into account the volume or value of past business generated or potential future business generated by the HCPs.
The OIG added the alert “is not intended to discourage meaningful HCP training and education. Rather, the purpose of this Special Fraud Alert is to highlight certain inherent risks of remuneration related to speaker programs.” The OIG added that medical product companies and HCPs “should consider the risks when assessing whether to offer, pay, solicit, or receive remuneration related to speaker programs.”
The alert noted many companies have decreased in-person speaker program-related remuneration to HCPs during the COVID-19 pandemic; however, “the risks associated with speaker programs will become more pronounced if companies resume in-person speaker programs or increase speaker program-related remuneration to HCPs.”
The OIG advised that “companies should assess the need for in-person programs given the risks associated with offering or paying related remuneration and consider alternative less-risky means for conveying information to HCPs. HCPs should likewise consider the risks of soliciting or receiving remuneration related to speaker programs given other available means to gather information relevant to providing appropriate treatment for patients.”
The alert noted that if a company or HCP has questions about a specific speaker program arrangement involving remuneration to referral sources, the OIG Advisory Opinion process is available.