Future prospects: Pharmaceutical and medical device manufacturers should evaluate their speaker programs to ensure offers comply with the latest OIG guidelines. All parties participating in speaker programs, including health professionals, can expect increased government oversight and a more skeptical attitude towards these joint activities. A recent special fraud alert from the OIG highlighted the importance of managing the risks of fraud and abuse associated with speaker programs. Our powerful data collection and storage tools enable your compliance team to quickly identify and mitigate potential risks based on OIG policies, including reviewing participant credentials, monitoring venue and program costs, and event request processes in the approval workflow. Their insightful dashboard gives you all the data analytics and reporting tools you need to ensure regulatory compliance. Result: Although the OIG has warned against abusing speaker programs in the past, this new special scam warning goes much further than previous guidelines to actually discourage speaker programs. The Office of the Inspector General recognizes that it is issuing the COVID-19 pandemic warning when the number of speaker programs has decreased significantly. However, the OIG notes in the warning that the availability of information about products and diseases during the pandemic through other means (e.g. B the product leaflet or medical journals) “further suggests that at least one compensation objective related to speaker programs is often to induce or reward referrals.” The OIG`s legal director, Gregory Demske, reportedly expressed similar concerns in an interview with Law360.
Pointing to the recent trend towards virtual communication, Demske expressed skepticism that technical information can only be effectively conveyed in person and not virtually. As a result, the OIG urges companies to consider “other, less risky ways to convey information to health professionals” instead of speaker programs, even after the pandemic is over. With our robust speaker desk and KOL monitoring tools, you can securely capture, store, and organize sensitive data about product profiles and usage. Presenters and KOLs can create their own presentations by giving them access to pre-approved slide sets, on-demand training materials, and other resources. Stay compliant with the Sunshine Act by tracking and reporting fee payments, expenses, and cap management data more accurately. Healthcare professionals can also conduct their own research, create accurate compliance reports, or register for upcoming events. In the warning, the OIG characterizes both the payments and the free meal as potentially illegal compensation within the meaning of the Anti-Bribery Act (“AKS”) if the purpose of such compensation is to “induce” or “reward” drug prescriptions or device orders. The OIG notes that its fraud warning follows a number of enforcement actions regarding speaker programs that allegedly violated the AKS. See e.B. Corporate Integrity Agreement between OIG and Novartis Corporation (June 30, 2020).
According to the OIG, his law enforcement experience — along with data provided to the Centers for Medicare and Medicaid Services under the Physician Payments Sunshine Act — suggests that companies provide significant compensation to healthcare professionals through speaker programs, and that these programs present “inherent risks of fraud and abuse.” While the special fraud warning is not binding, it does provide important information about the current view of the Office of the Inspector General and possibly federal law enforcement agencies on the risks associated with manufacturer-sponsored speaker programs. To mitigate their risks, companies offering these programs would be well advised to carefully reassess their compliance safeguards to ensure that speaker programs and related agreements with health professionals are offered, designed and documented in a manner that takes into account the guidance contained in the warning and recent enforcement actions regarding speaker programs. From a single dashboard, you can coordinate key event planning and tracking tasks with sales team members, speakers, and venue contacts. Our single, fully automated hub feature allows you to stay in touch with attendees, track finances, and securely transfer sensitive data to third-party providers. Use our event management tools to improve your team`s productivity and ensure that the success of events doesn`t have to blow up your advertising budget. Our Speaker Program module is included at no additional cost when you invest in our all-inclusive HCP compliance software package. The situation: The Ministry of Health and Human Services, Office of the Inspector General (“Big Big”), issued a special fraud alert in which it identified the “inherent risks of fraud and abuse” associated with speaker programs – educational presentations conducted by health care providers (“HCPs”) and compensated by the manufacturer – that pharmaceutical and medical device manufacturers have long used as a way to educate health professionals about their products. In the first special fraud alert it issued in more than six years, the Office of the Inspector General – the federal agency responsible for combating fraud and abuse in the Medicare and Medicaid programs – informed pharmaceutical and medical device companies of the fraud and abuse risks associated with the company`s sponsored speaker programs with medical professionals. These speaker programs, which are common in the industry, typically include a health care professional who makes a presentation to other health professionals on behalf of the sponsoring manufacturer about a drug or medical device or disease. The presenting SP is usually paid for the presentation (the content of which is often developed by the company) and sometimes for the time spent in preparation.
Use the attendee tracking feature to send invitations, surveys, and post-event ratings, or to digitally capture attendees` signatures. Manage participant relationships remotely, communicate with sales team members, or access valuable expense data without using confusing spreadsheets! Our training event module is specifically designed to integrate seamlessly with all other HCP compliance tools on our platform. Our software also integrates well with most centralized healthcare provider databases to ensure more accurate data collection, data transfer, and compliance reporting. Your fully customized MedCompli dashboard includes all the tools you need. MedCompli`s cloud-hosted event management platform is specifically designed to prioritize the user experience. Your feedback will also help shape our services in the future. Managing the workflow of your educational event has never been easier when you use your fully customized and easy-to-navigate personal dashboard. The OIG states that the warning is not intended to discourage “meaningful training and education of health professionals” and acknowledges that the legality of an agreement under the AKS depends on the facts, circumstances and intent of the parties. Notably, however, the fraud warning calls into question part of the PhRMA Code of Conduct for Interactions with Healthcare Professionals (the “PhRMA Code”), an industry publication that manufacturers often rely on to develop policies and procedures related to healthcare professionals. .
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