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Healthcare Speaker Programs: New OIG Alert

In a rare Special Fraud Alert issued on November 16, 2020 (the “Alert”), the Office of Inspector General (“OIG”) urged companies who host speaker programs to reassess their programs in light of the “inherent risks” associated with these activities. The Alert reports that, in the last three years, drug and device companies have reported paying nearly $2 billion to health care professionals for speaker-related services.

For the purpose of the Alert, speaker programs are defined as “company-sponsored events at which a physician or other health care professional (collectively, “HCP”) makes a speech or presentation to other HCPs about a drug or device product or a disease state on behalf of the company.” The company will typically pay the speaker an honorarium, and often provides some sort of incentive (for example, free meals) to encourage attendance. While honorariums are not illegal per se, because much of the information presented in these programs is available elsewhere, the OIG warns that often, “at least one purpose of remuneration associated with speaker programs is often to induce or reward referrals,” which is in violation of the federal Anti-Kickback Statute (“AKS”).

The AKS is an intent-based statute, so an analysis of a speaker program will depend on the facts and circumstances surrounding the program. The Alert provides a helpful list of suspect characteristics that, if present in a speaker program arrangement, could indicate that the speaker program violates the AKS. These characteristics include:

  • No Substantive Content. Programs where there is little or no substantive information actually presented at the program.
  • Expensive Food, Alcohol Available. Programs that offer alcohol (risk heightened if alcohol is free) or a meal exceeding “modest value” to program attendees.
  • Venue. Programs held in locations that are not conducive to the exchange of educational information (e.g. restaurants, entertainment, and sports venues).
  • Number of Programs. A company sponsors a large number of programs on the same or similar topic or product, especially if there have been no recent substantive changes in relevant information.
  • Program Does Not Follow New Product or Indication. Programs conducted where there has been a “significant period of time” with no new medical or scientific information published about the product nor new-FDA approval of the product to discuss.
  • Repeat Attendance. Programs where the attendees have attended other programs on the same or substantially the same topics more than once (as a repeat attendee or as an attendee after serving as a speaker for the same topic).
  • Attendance by Friends, Family, and Staff. Program attendees or invitees include individuals who do not have a legitimate business reason to attend the program. For example: friends, significant others, and family members of the speaker or HCP attendees; HCP practice employees and other staff; and “other individuals with no use for the information.”
  • Sales Involvement. Programs in which sales representatives or marketing personnel are involved in the selection of speakers, or the company selects HCP speakers or attendees based on past or potential revenue generated by orders of the company’s products (e.g., a return on investment analysis).
  • Payment Exceeds FMV. Payment to HCP speakers exceeds fair market value for the speaking service, or compensation considers the volume or value of business generated by the HCPs for the company.

Speaking programs with one or more of the above characteristics will be considered suspicious by the OIG and subject to further scrutiny. As a result of an investigation into a speaking program, if the OIG finds that requisite intent is present, both the company and the HCPs may be subject to criminal, civil, and administrative enforcement actions.

This Alert was published now to encourage drug and device companies and HCPs to reassess their speaker programs as in-person speaking programs start to resume. The OIG advises companies to scrutinize 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. HCPs should also evaluate 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.

Please contact BMD Healthcare and Hospital Law Member Jeana Singleton at jmsingleton@bmdllc.com or Attorney Ashley Watson at abwatson@bmdllc.com if you have any questions regarding health care fraud and abuse guidelines and how to ensure your practice can remain compliant.

Changes to Physician Assistant Statutes in Florida

In the last year, there have been many changes to the scope of practice and collaboration/supervision requirements for advanced practice providers such as APRNs and physician assistants in the state of Florida. In a previous Client Alert we discussed House Bill 607, which expanded the autonomous practice of APRNs providing primary care services in Florida.

Ohio Senate Bill 49 – Ohio Expands Lien Rights for Design Professionals

Effective September 30, 2021, Ohio granted limited lien rights to design professionals, including architects, landscape architects, engineers, and surveyors. Ohio Governor Mike DeWine signed Senate Bill 49 into law on July 1, 2021. This new law established a statutory right to lien commercial real estate by Ohio design professionals who, until now, could not file a lien for non-payment of professional services. Senator Vernon Sykes, a primary sponsor of Senate Bill 49, stated that the “legislation ensures that architects, engineers and other designers will get paid for their work, regardless of the outcome of their projects . . . It will support hardworking Ohioans by protecting the value of their labor . . ..”

Primary Care Practice Officially Defined in Florida for APRNs Practicing Autonomously

As many providers in Florida are aware, House Bill 607 (the “Bill”), which was passed in February of last year, gives certain APRNs in Florida the ability to practice autonomously. The only catch is that they must work in primary practice. When the Bill was initially passed, there was question as to what was exactly considered primary care, absent a definition from the Florida Board of Nursing. However, as of February 25, 2021, “primary care practice” has officially been defined.

Part II of the No Surprises Act

The Department of Health and Human Services (“HHS”) published Part II of the No Surprises Act on September 30, 2021, which will take effect on January 1, 2022. The new guidance, in large part, focuses on the independent dispute resolution process that was briefly mentioned in Part I of the Act. In addition, there is now guidance on good faith estimate requirements, the patient-provider dispute resolution processes, and added external review provisions.

Safer Federal Workforce Task Force - Guidance for Federal Contractors and Subcontractors

The Safer Federal Workforce Task Force has issued its Guidance for Federal Contractors and Subcontractors (Guidance). Note that the Guidance applies only to “covered contracts,” which are contracts that include the clause (Clause) set forth in Sec. 2(a) of Executive Order 14042 (Ensuring Adequate COVID Safety Protocols for Federal Contractors). The Federal Acquisition Regulatory Council (FARC) is to conduct rulemaking and take related action to ensure that the Clause is incorporated into federal contracts. Until that happens, federal contractors likely will not see the Clause in its contracts. Following is a broad summary of the Guidance.