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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.

New York, Kansas, Massachusetts, and Delaware Become the latest States to Adopt Full Practice Authority for Nurse Practitioners

While the COVID-19 pandemic certainly created many obstacles and hardships, it also created many opportunities to try doing things differently. This can be seen in the instant rise of remote work opportunities, telehealth visits, and virtual meetings. Many States took the challenges of the pandemic and turned them into an opportunity to adjust the regulations governing licensed professionals, including for advanced practice registered nurses (APRNs).

Explosive Growth in Pot of Gold Opportunity for Bank (and Other) Cannabis Lenders Driving Erosion of the Barriers

Our original article on bank lending to the cannabis industry anticipated that the convergence of interest between banks and the cannabis industry would draw more and larger banks to the industry. Banks were awash in liquidity with limited deployment options, while bankable cannabis businesses had rapidly growing needs for more and lower cost credit. Since then, the pot of gold opportunity for banks to lend into the cannabis industry has grown exponentially due to a combination of market constraints on equity causing a dramatic shift to debt and the ever-increasing capital needs of one of the country’s fastest growing industries. At the same time, hurdles to entry of new banks are being systematically cleared as the yellow brick road to the cannabis industry’s access to the financial markets is being paved, brick by brick, by the progressively increasing number and size of banks that are now entering the market.

2021 EEOC Charge Statistics: Retaliation & Impact of Remote Work

The U.S. Equal Employment Opportunity Commission (EEOC) released its detailed information on workplace discrimination charges it received in 2021. Unsurprisingly, for the second year in a row, the total number of charges decreased as COVID-19 either shut down workplaces or disconnected employees from each other. In 2021, the agency received a total of approximately 61,000 workplace discrimination charges - the fewest in 25 years by a wide margin. For reference, the agency received over 67,000 charges in 2020, and averaged almost 90,000 charges per year over the previous 10 years.

Ohio’s Managed Care Overhaul Delayed – New Implementation Timeline

At the direction of Governor Mike DeWine, the Ohio Department of Medicaid (ODM) launched the Medicaid Managed Care Procurement process in 2019. ODM’s stated vision for the procurement was to focus on people and not just the business of managed care. This is the first structural change to Ohio’s managed care system since the Centers for Medicare & Medicaid Services' (CMS) approval of Ohio’s Medicaid program in 2005. Initially, all of the new managed care programs were supposed to be implemented starting on July 1, 2022. However, ODM Director Maureen Corcoran recently confirmed that this date will be pushed back for several managed care-related programs.

Laboratory Specimen Collection Arrangements with Contract Hospitals - OIG Advisory Opinion 22-09

On April 28, 2022, the Department of Health and Human Services, Office of Inspector General (“OIG”) published an Advisory Opinion[1] in which it evaluated a proposed arrangement where a network of clinical laboratories (the “Requestor”) would compensate hospitals (each a “Contract Hospital”) for specimen collection, processing, and handling services (“Collection Services”) for laboratory tests furnished by the Requestor (the “Proposed Arrangement”). The OIG concluded that the Proposed Arrangement would generate prohibited remuneration under the federal Anti-Kickback Statute (“AKS”) if the requisite intent were present. This is due to both the possibility that the proposed per-patient-encounter fee would be used to induce or reward referrals to Requestor and the associated risk of improperly steering patients to Requestor.