The Office of Inspector General (OIG) recently announced a special fraud alert focusing on Speaker Programs. In this strongly worded communication, OIG highlighted the inherent risks associated with speaker programs conducted by pharmaceutical and medical device companies, identified specific characteristics of speaker programs that contribute to these risks, and cautioned companies and health care providers (HCPs) to consider these risks when assessing whether to offer, pay, solicit or receive remuneration related to speaker programs.
OIG further indicated that parties involved in speaker programs may be subject to increased scrutiny, because these arrangements potentially implicate the federal Anti-Kickback Statute (AKS), especially when they involve entertainment, recreation, travel, meals or other benefits offered in conjunction with the programs.
OIG also warned HCPs to evaluate any proposed relationship with a company, cautioning that they may be liable under the AKS if the basis for a proposed relationship is the HCPs ability to prescribe or use a product or refer patients for particular services or supplies.
OIG acknowledged that it issued this alert during the pandemic, while companies have curtailed in-person activities and before they resume in-person speaker programs or increase speaker program-related remuneration to HCPs. OIG cautioned companies, prior to resuming speaker programs, to assess the need for in-person programs in light of enumerated risks and to consider alternative, less-risky ways for conveying information to HCPs. Likewise, HCPs should evaluate the risks of soliciting or receiving remuneration related to speaker programs given other available means to gather information relevant to providing appropriate medical treatment for patients.
In the fraud alert, OIG questions the educational value of speaker programs, which it defines as “company-sponsored events at which a physician or other HCP makes a speech or presentation to other HCPs about a drug or device product or a disease state on behalf of the company, for which the company pays the HCP for the services and may also provide free meals to the attendees.” Referring to the results of recent enforcement activities and settlements focused on speaker programs, OIG confirmed that HCPs receive generous compensation: (i) to speak at programs offered under circumstances that are not conducive to learning, or (ii) to speak to audience members who have no legitimate reason to attend. It is the belief of OIG that these settlements strongly suggest that one purpose of the remuneration to the HCP speaker and attendees is to induce or reward referrals.
OIG further notes that, in many instances, speaker programs may be redundant, because there are other ways for HCPs to obtain information about medical products that obviate the need to pay HCPs to act as speakers. These options include various online resources, the product’s package insert, third-party educational conferences, and medical journals. OIG specifically states that the availability of public information further supports the OIG’s belief that at least one purpose of remuneration associated with speaker programs is to induce or reward referrals.
OIG described some conditions that, taken separately or together, potentially indicate a speaker program arrangement that could violate the AKS, including:
- Venue is not conducive to exchange of educational information (e.g., restaurants or entertainment or sports venues).
- Little or no substantive educational information is presented.
- Alcohol is available or a meal exceeding modest value is provided.
- Company sponsors a large number of programs on the same or substantially the same topic or product (i) where there has been no recent substantive change in relevant information or (ii) where a significant period of time has passed with no new medical or scientific information.
- HCPs attend multiple programs on the same or substantially the same topics (as either a repeat attendee or as an attendee after being a speaker on the same or substantially the same topic).
- Attendees include individuals with no legitimate business reason to attend the program (e.g., 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 generated 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.