In a new special fraud alert, the Department of Health and Human Services highlighted the risk of fraud and abuse associated with paid speaking programs offered by pharmaceutical and medical device companies. “OIG has significant concerns about companies offering or paying remuneration (and HCPs soliciting or receiving remuneration) in connection with speaker programs,” the alert states. “Based on our investigations and enforcement actions, this remuneration is often offered or paid to induce (or solicited or received in return for) ordering or prescribing items paid for by federal health care programs. If the requisite intent is present, both the company and the HCPs may be subject to criminal, civil, and administrative enforcement actions.”
HHS defines such programs as company-sponsored events at which a physician or other health care professional makes a speech or presentation to other HCPs about a drug, device, or disease, on behalf of the company, in exchange for a fee. In the last three years, drug and device companies have reported paying nearly $2 billion to HCPs for speaker-related services, OIG noted.
OIG and the Department of Justice have investigated numerous allegations that these arrangements have violated the Anti-Kickback Statute. These cases have alleged that drug and device manufacturers have improperly rewarded healthcare professionals who frequently prescribe their products; conditioned participation in the programs on the number of prescriptions written; held events that provided little value; and invited participants, such as family members, who had no legitimate reason to attend. Many of these investigations resulted in civil or criminal cases against the entities involved.
The alert highlights some of the inherent fraud and abuse risks associated with the offer, payment, solicitation, or receipt of remuneration related to company-sponsored speaker programs, including potential violations of the Anti-Kickback Statute, and other fraud and abuse, such as the risk of unnecessary or improper prescriptions, and the risk that physicians would make medical decisions based on their financial interests rather than patient need.
OIG notes that parties involved in speaker programs may be subject to increased scrutiny, including the drug or device company, as well as any speakers and attendees. OIG also acknowledged that the lawfulness of these programs depends on the individual circumstances, and suggested some characteristics and conduct that would suggest an improper relationship. Examples of improper conduct include programs where: little or no substantive value is presented; alcohol is available and costly meals are served; the location is questionable; the sponsor presents multiple programs on the same topic, even though the information has not substantially changed; the company’s sales or marketing teams influence the selection of speakers or speakers are selected based on prescribing habits; or speakers are paid more than fair market value for their time.
OIG did not discourage meaningful training and education events, but reiterated its caution about the inherent risks. While companies have reduced the number of in-person events due to the COVID-19 pandemic, there are risks whenever payment is offered to healthcare professionals who generate business with federal healthcare programs. “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,” OIG wrote. “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.”
