On November 16, 2020, the Office of Inspector General (OIG) issued a Special Fraud Alert (the Alert) regarding speaker programs hosted by pharmaceutical and medical device companies. Speaker programs are company-sponsored events where a healthcare professional or physician (collectively, HCP) presents to other HCPs regarding a drug or device product or a disease state on behalf of the company. The Alert can be found here.

Speaker programs between manufacturers of medical products and HCPs have long been the subject of government scrutiny. OIG's Alert is intended to emphasize the inherent risks under the federal Anti-Kickback Statute (AKS) related to live speaker programs and to guide companies and HCPs in assessing the risks such programs for potential speakers, attendees, and sponsors. We set out below the suspect characteristics of problematic speaker programs that are spotlighted in the Alert. The list is illustrative only and should not be considered exhaustive. The presence or absence of any one of these "red flags" is not determinative of whether the OIG would consider a particular arrangement to be suspect under the AKS.

• 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 U.S. Food and Drug Administration (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.

Importantly, the Alert is not meant to prohibit or discourage legitimate and meaningful HCP training and education. The Alert notes the "many other ways" for HCPs to access information about drug and device products that do not offer risky remuneration to HCPs. Online resources, the product's package insert, third-party educational conferences, and medical journals are among the alternative avenues for HCPs to obtain the same information that would otherwise be presented at a speaker program. OIG tacitly endorses low risk methods for educating and informing HCPs and urges that manufacturers give them renewed consideration. Presumably, there remains room for suitably planned and managed manufacturer-sponsored speaker programs as well.

The Alert warns, however, that where a manufacturer specifically offers recreation, travel, entertainment, meals, or other valuable benefits in association with information or marketing presentations, such arrangements potentially implicate the anti-kickback statute. Physicians are further advised to consider the propriety of any proposed relationship with a company and confirm that their compensation is not related to their ability to prescribe a drug or device or refer patients for services or supplies as those types of arrangements are most likely to implicate healthcare fraud and abuse laws.

Over some 30 years, OIG has only published approximately a dozen Special Fraud Alerts. It is particularly striking that OIG should publish an alert on this particular topic during a surging pandemic when presumably few HCPs are likely traveling for recreation or entertainment, let alone live speaker events. More than anything else, publishing a Special Fraud Alert requires the focused attention and concerted activity of officials at OIG and the Department of Justice. When OIG states that the Alert responds jointly with the Department of Justice that remuneration tied to various speaker programs violated the AKS, we should therefore take it at its word. We should also therefore take OIG seriously when it suggests that participants in (at least some) speaker programs, including both companies and HCPs, will be subject to "increased scrutiny" in the future.

The AKS was enacted by Congress, in part, to protect patients from HCPs who may be providing referrals influenced by inappropriate financial incentives. The AKS makes it a criminal offense to offer any reward for referrals, items, or services reimbursable by a federal healthcare program. Violation of the statute is a felony punishable by a maximum fine of $100,000, imprisonment up to 10 years, or both. Criminal conviction may also lead to mandatory exclusion from federal healthcare programs such as Medicare and Medicaid.