In November of 2020, the Office of Inspector General (OIG) released a Special Fraud Alert related to the misconduct of pharmaceutical and medical device speaker programs. The alert “highlights the fraud and abuse risks associated with the offer, payment, solicitation, or receipt of remuneration relating to speaker programs by pharmaceutical and medical device companies.” Below we identify some of the areas highlighted in the alert and our suggestions on how you can remain compliant.

Suspect Characteristic #1:  The company sponsors speaker programs where little or no substantive information is actually presented. 

How to Remain Compliant: Continually capture feedback from attendees to ensure the program material is delivering the information they need to provide better care for their patients. Additionally, you can measure attendees’ knowledge on a topic before and after the program to show the Return on Education the program provides.

Suspect Characteristic #2:  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).

How to Remain Compliant: Create strict company protocols for alcohol consumption and what is considered a “modest value” for a meal. Monitor programs to guarantee protocols are being followed.

Suspect Characteristic #3:  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).

How to Remain Compliant: Be vigilant on your company’s restaurant and venue selection to ensure the locations are appropriate for educational exchange. Construct clear rules as to which venues are or are not approved and continually observe that the rules are being followed.

Suspect Characteristic #4:  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.

How to Remain Compliant: Obtain audience feedback to determine if the material your company is presenting is new and is something attendees can use in their practice moving forward. Set guidelines for how often program material should be updated and when a program should be terminated.

Suspect Characteristic #5:  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.

How to Remain Compliant: Talk to your attendees to see if they are saying the information is new to them. If the program material is no longer new, it is time to retire the program or offer it as an on-demand “refresher program” that provides no incentive to attendees other than educational value.

Suspect Characteristic #6:  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).

How to Remain Compliant: Keep track of who is attending your programs and the time between attending the same program.  Establish clear limits on how many times an attendee can attend the same meeting. If an attendee wants to attend a program more than once, encourage them to view the on-demand “refresher programs”.

Suspect Characteristic #7:  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.

How to Remain Compliant:  Consider creating a “who should attend” list when developing your program and monitor your attendees to ensure the appropriate personnel are attending. Be clear with attendees that all “non-legitimate” personnel will be turned away from attending the program.

Suspect Characteristic #8: 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).

How to Remain Compliant: Keep a detailed file of criteria used for speaker selection and renewal of contracts. Ensure that you are remaining unbiased in your selection process. One option is to blind the names of the candidates when selecting and choose candidates solely based on their credentials for the job.

Suspect Characteristic #9: 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.

How to Remain Compliant: It is important to stay abreast of industry norms to ensure your company is operating within those guidelines.  Consider using an independent third party to keep track of industry standards.

Speaker programs provide an invaluable service to healthcare providers, which in turn leads to better patient outcomes. They are a crucial component in the exchange of educational information between pharmaceutical companies and healthcare providers. However, the OIG raises legitimate concerns, and we want to ensure that these programs are serving the purpose they were intended to do: educate.

At TL Health, we offer solutions that make sure you are remaining compliant by talking to your customers and helping you stay in-line with industry standards. Our post program evaluations allow you to capture feedback from attendees to confirm your program’s material is meeting their educational needs and help you identify when program material needs to be updated or retired. In addition, our benchmark research identifies if you are staying within industry standards across several different metrics. To see our full list of Speaker Program 360 offerings, please click here.