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.
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.
For More Information
For more information please contact James Ravitz, David Hoffmeister, Georgia Ravitz, Melissa Hudzik, Jeff Weinstein, or any other member of Wilson Sonsini's FDA Regulatory, Healthcare, and Consumer Products practice.