OIG issued a Special Fraud Alert that applies to pharmaceutical and medical technology company-sponsored speaker programs
The Office of Inspector General, U.S. Department of Health & Human Services (“OIG”) issued the Special Fraud Alert manufacturer-sponsored speaker programs on Monday, November 16, 2020. The OIG wrote, “This Special Fraud 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.” Virtual programs have been a success during the pandemic. Gregory E. Demske, the OIG’s chief counsel, was quoted in a Law360 article stating that manufacturers “should think very carefully about the risks of speaker programs, and in particular in-person speaker programs”.
The OIG noted in the Alert that the pandemic is “[c]urtailing many in-person activities.” That companies have “[d]ecreased in-person speaker program-related remuneration to HCPs”. And that, “[r]isks associated with speaker programs will become more pronounced if companies resume in-person speaker programs or increase speaker program-related remuneration to HCPs.”
The government also noted that in the last three years (’17-’19), drug and device companies have reported paying nearly $2 billion to HCPs for speaker-related services. The “OIG is skeptical about the educational value of such [speaker] programs.” That is, despite support for such programs from both PhRMA and AdvaMed, as outlined in their respective codes. The OIG stated that, “[S]uch [recent] cases strongly suggest that one purpose of the remuneration to the HCP speaker and attendees is to induce or reward referrals.” Nevertheless, the government stated that the “OIG recognizes that the lawfulness of any remunerative arrangement, including speaker program arrangements, under the anti-kickback statute depends on the facts and circumstances and intent of the parties.”
OIG highlights speaker program “suspect characteristics” test in its Special Fraud Alert
OIG Suspect Characteristics Test:
- 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 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); and
- 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.
Does this mean that the OIG is banning speaker programs? No.
But the government appears less tolerant of in-person 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.” In other words, the government is advocating that industry not hold in-person programs.
Have you audited your speaker program for compliance?
Here are some tips on how to meet OIG expectations.
- Design, deploy, and train to a policy and standard operating procedure that governs speaker programs—assuming your organization is going to continue to hold them.
- Consider incorporating the OIG “suspect characteristics” test into your policy and procedure.
- Set guidance on when to use a paid HCP presenter/trainer, versus a company staff member—e.g., someone from Medical- or Clinical- Affairs.
- Do you have to have in-person meetings or will virtual do the job?
- Set parameters. Virtual training can be challenging, for example.
- Should virtual meal limits be lower than in-person?
- Are you going to stop serving alcohol regardless of medium?
- Are you going to limit attendance? No frequent flyers?
- Who selects speakers? What’s the process?
- Are your biggest customers all on your speaker bureau? What percentage?
- Are you listening to compliance concerns and following up on them?
- Are you monitoring and auditing your speaker program regularly?
- Recall that nearly everything you do is subject to discovery unless its (successfully) protected by privilege.
Want to watch a recording of our webinar on the Special Fraud Alert and other topics?
- OIG Speaker Program Special Fraud Alert;
- Virtual detailing;
- Recent fraud & abuse case review;
- 2021 Sunshine Act updates; and
- EU manufacturer healthcare compliance.