Speaker programs undeniably represent the highest risk marketing practice in the industry, with a focus on paying HCPs who often prescribe a product to promote products to other clinicians. The US OIG (Office of Inspector General) has increased scrutiny of speaker programs in the recent few years, culminating in an SFA (Special Fraud Alert) released in November 2021, as well as prompting PhRMA (Pharmaceutical Research and Manufacturers of America) to update the PhRMA Code in August 2021 with an effective date of Jan 1, 2022. As we consider the impact of changes to speaker programs in the US, it’s useful to consider the OIG’s role which is their responsibility to ensure the fiscal integrity of federal healthcare programs such as Medicare and Medicaid. The OIG has the authority to exclude entities and people from participation in federal healthcare programs. Their exclusion authority serves as powerful leverage to impose significant compliance program requirements through CIAs (corporate integrity agreements).
In understanding the recent OIG sanctions, the SFA represents a means of notifying the industry that they are aware of certain abusive practices that they plan to pursue and prosecute and/or to bring civil and administrative actions, as appropriate. The OIG SFA focused on speaker programs identified a series of concerns from cases that the US DOJ (Department of Justice) has already prosecuted. The OIG views speaker programs that drug and device companies organize and pay for as having the intent to induce HCPs to prescribe or order products and is thereby highly critical of such programs. Their legal concerns stem from breaching the AKS (Anti-Kickback Statute) and at some times, the potential for violating the FCA (False Claims Act) based on past cases.
Speaker programs involve an HCP presentation to clinician attendees about a drug, device or product, or disease state on behalf of a company; HCP speakers receive compensation from the company, and HCP attendees often receive remuneration in the form of free meals, beverages, and other perks. OIG has made it clear that this type of arrangement, if not executed compliantly, implicates the AKS. The AKS defines remuneration broadly and can include anything of value where the offer, payment of receipt of items can be direct or indirect, overt or covert, and in cash or in kind. Information published by OIG notes that they do not seek to discourage meaningful HCP training and education. It appears their focus is on reining in speaker programs that are lavish or go beyond compliance boundaries. All parties involved in speaker programs including companies, speakers, and attendees will likely be subject to increased scrutiny going forward.
The updated PhRMA Code has taken effect on Jan 1, 2022, inspired by recent government enforcement activity and guidance on industry speaker programs. The PhRMA Code recognizes that company-sponsored speaker programs provide important substantive educational information about the benefits, risks, and appropriate uses of company medicines and diseases. They pivot from a position where speaker programs should present substantive education designed to address a bona fide educational need among attendees, considering recent updates for relevant scientific and medical information. Attendees of these programs must have a real need for the educational content provided at speaker programs.
Meals at speaker programs must be incidental to the educational information provided; this is to say that the education is center stage and the meal should not overtake the attendees’ attention or focus. Incidental meals are provided at speaker programs as a business courtesy and must be modest in venue and food/beverage provided as judged by local standards. The venue or meal cannot be extravagant, the main attraction, or be perceived as such.
The updated PhRMA Code clarifies attendance at speaker programs, stating that repeat attendance at a speaker program on the same or substantially the same topic where a meal is provided to the attendee is generally not appropriate unless the attendee can be shown to have a bona fide need for the education presented. This is a tough hurdle to overcome if one would concede that the attendee had been educated in the initial speaker program of the same or substantially the same content. Companies will need to institute a system when HCPs register for a speaker program to avoid repeat attendees. The Code also notes that attendance at programs by a speaker as an attendee is not appropriate. Not surprising is the finding that spouses, family, friends, and other guests of a clinician attending a program are not appropriate unless they are HCPs for whom the educational information is appropriate.
Items that violate the AKS include:
- Little or no substantive information actually presented
- Alcohol is available (not viewed as allowing for an educational interaction; may be viewed as entertainment)
- Attendee meal exceeds modest value (concern is heightened by free alcohol)
- Program venue is not conducive to exchange of educational information (noise levels, entertainment, distractions, et al)
- Company sponsors a large number of programs on the same or substantially same topic, especially when there has been no recent change in relevant information
- Company commercial team influence speaker selection with a focus on past or anticipated revenue from prescriptions; use of a ROI analysis to identify participants
- Paying speakers above FMV (fair market value) or payment to speakers based on past or potential business they generate
- No new medical or scientific information; repeat HCP attendees to same or substantially same program or as a speaker attendee
- Attendees with no legitimate business reason to attend a speaker program; includes attendees who are medical professionals at speaker’s own practice, staff of facilities where speaker is the medical director and individuals with no use for the educational information
The OIG has put companies and HCPs on notice regarding their concerns about speaker programs and they also lay out a framework for compliance for these types of programs. It is vital to assure compliance when planning programs in order to execute them properly and mitigate risks.
MSLs perform an essential role at speaker programs to assure speakers are trained and fully prepared to present on a company’s product and disease state education. MSL activities at speaker programs, if permitted to attend per the company policies, must be independent of substantive commercial influence. The MSL role is focused on educating speakers and is not promotional in nature. MSLs may attend occasional speaker programs if company supports this; MSL attendance may attract off label requests and MSLs must exercise caution in this situation and follow their policy and procedures. There are times when MSLs may be allowed to present at a promotional speaker program in lieu of an HCP speaker. In these instances, with company leadership and legal approval and processes in place, MSLs would have to adhere to promotional standards at the event with no off label information and staying within the bounds of approved content in the presentation.
Some recommendations for MSL role in speaker training based on the OIG concerns about speaker programs:
- Define and establish clear guidelines as to how the MSL should provide speaker training support
- Document MSL speaker training and questions addressed with HCP
- Document off label requests and how the request was delivered
- Define and establish how MSLs should address off label questions
- Define and establish how MSL speaker training role is communicated to speakers
Some potential shifts may be on the horizon! Perhaps we will see fewer speaker programs, less speakers, less speaker training needs for MSLs. We may also see fewer HCPs agreeing to attend speaker programs, particularly live programs with a meal involved. Will alcohol be taken off the table for medical meetings or other HCP engagement beyond speaker programs if it is deemed not appropriate to facilitate HCP education? HCP consulting arrangements will undoubtedly be impacted as companies revisit FMV rates. Review of speakers who happen to be high prescribers may also identify risk. Perhaps there will be more demand for MSL or medical programs in light of the scrutiny on commercial speaker programs. There seems to be an emphasis on leading more virtual programs where no meal is involved to avoid this perception of remuneration. Commercial speaker programs may fade away as enforcement cases are elevated.
Company speaker programs provide important substantive educational information about the benefits, risks and appropriate uses of new medicines and updated information about disease states. PhRMA and FDA both support this effort and the need for HCP education. PhRMA also made updates to other sections of the Code pertaining to meals offered by company personnel during informational presentations, HCP consulting arrangements and company support for third party educational or professional meetings. OIG encourages companies to assess the need for speaker programs and consider the risks associated with paying remuneration, particularly since there are alternative means for conveying the information. HCPs and speakers are similarly encouraged to consider the risks of receiving remuneration for speaking and attending such events.
Stay tuned for more compliance updates!
Cherie Hyder, PharmD, MSL-BC
Cherie Hyder is Syndicated National MSL Director at Syneos Health. In her previous job at Biohaven Pharmaceuticals she supported a virtual launch of Nurtec ODT for acute migraine. She has been involved in drug development for more than 30 years, working at FDA in CDER and pharmaceutical companies including Pfizer, Lilly, Novartis, Solvay, and Avanir, among others. At University of Missouri, she received a Doctor of Pharmacy degree with the intention to devote her career to pharmaceutical research. She has multiple adjunct faculty appointments and enjoys teaching opportunities.