Industry-Sponsored Speaker Programs—End of the Line?

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Industry-Sponsored Speaker
Programs—End of the Line?
Eli Y. Adashi, MD, MS1; I. Glenn Cohen, JD2

On November 16, 2020, the Office of Inspector General (OIG) for the US Department of Health and Human Services (HHS) issued a rare Special Fraud Alert intent on highlighting the fraud and abuse risks associated with the offer, payment, solicitation, or receipt of remuneration relating to industry-sponsored speaker programs.1 Only 6 such alerts have been issued by the OIG over the last 20 years. The Special Fraud Alert was released in the wake of newly completed enforcement actions against pharmaceutical and medical device companies and reinforces the major ethical concerns that have been discussed about industry-sponsored speaker programs.1

On July 1, 2020, Novartis agreed to a $678 million settlement to resolve civil fraud charges including the payment of more than $100 million to physicians in the course of nearly 80,000 speaker programs.2 As noted by the US attorney for the Southern District of New York, Novartis violated the federal False Claims Act and Anti-Kickback Statute by providing doctors with cash payments, recreational outings, lavish meals, and expensive alcohol to induce them to prescribe Novartis cardiovascular and diabetes drugs reimbursed by federal healthcare programs. In this Viewpoint we examine the Special Fraud Alert, review its recommendations, and discuss its implications to industry-sponsored speaker programs.

Industry-sponsored speaker programs constitute company-driven events in which a physician or other health care professional makes a presentation to other clinicians about a drug or device product or a disease state on behalf of the company.1 The speaker in question, who is not an employee of the company, may nevertheless make use of a presentation developed and approved by the sponsoring company.1 As is customary in this context, the company pays the speaker an honorarium. The company may also remunerate program attendees in kind (eg, free meals).1 From 2017 to 2019, drug and device companies reported paying health care professionals nearly $2 billion in compensation for services other than consulting, including serving as faculty or as a speaker at a venue other than a continuing education program.1

The institution of industry-sponsored speaker programs dates back to the 1950s. Concerns over informational bias have plagued these commercially sponsored constructs ever since. Alleged violations rooted in inescapable conflicts of interest have been the subject of frequent civil and criminal litigation. Examples of legal actions include cases wherein drug and device companies were alleged to have selected high-prescribing clinicians as speakers, linked speaker remuneration to sales targets, or held speaker programs at entertainment venues in a manner that is not conducive to an educational presentation.1 For example, a 2004 case involving Warner-Lambert alleged the payment of kickbacks to physicians in the form of lavish trips to attend presentations about the unapproved off-label use of Neurontin (gabapentin).3 In 2004, Warner-Lambert settled the attendant criminal charges and civil liabilities for $430 million.3 Repeated calls for the discontinuation of industry-sponsored speaker programs went unheeded.4
The Anti-Kickback Statute, a criminal health care fraud and abuse statute, was enacted, in part,to protect patients from referrals or recommendations by health care practitioners who may be influenced by inappropriate financial incentives.1 The statute is violated if and when remuneration is paid purposefully to induce or reward referrals of items or services payable by a Federal health care program.1 Conviction frequently triggers mandatory exclusion from Federal health care programs, including Medicare and Medicaid as well as all other federal plans and programs that provide health benefits. Criminal conviction may also be punishable by a fine, imprisonment, or both.1 Whereas drug and device companies may well constitute the most frequent targets of scrutiny, consideration by the OIG of HHS and by US district attorneys is also being given to durable medical equipment suppliers, health care group purchasing organizations, clinical chemistry laboratories, and home health care companies to name a few commercial health care enterprises.

In pointing out the fraud and abuse risks of industry-sponsored speaker programs, the Special Fraud Alert singles out their educational value given that they are offered under circumstances that are not conducive to learning.1 The alert further suggested that one purpose of the remuneration to the HCP [health care professional] speaker and attendees is to induce or reward referrals.1 In support of this contention, the Special Fraud Alert cited several peer-reviewed studies according to which HCPs who receive remuneration from a company are more likely to prescribe or order that company’s products.1,5,6
To facilitate the identification of industry-sponsored speaker programs that could violate the Anti-Kickback Statute, a number of suspect characteristics are being offered as guidance by the Special Fraud Alert.1 Leading this listing are the absence of substantive information…presented at a location that is not conducive to the exchange of educational information.1 Additional concerns entail the involvement of sales or marketing business units in the selection of speakers who are being paid more than fair market value for the speaking service.1

Continuing medical education (CME) remains an important tool in helping ensure that physicians are kept apprised of the latest developments in both medicine and science. CME credits are invariably required by state medical boards as a prerequisite for medical license renewal. In recognition of this reality, a variety of organizations have taken on the task of ensuring the ongoing delivery of CME. In-house efforts intent on the provision of CME have taken the form of grand rounds, case discussions, and journal clubs. Yet other CME opportunities are afforded by professional associations, institutions of higher learning, and peer-reviewed professional journals. Regulatory oversight of these activities is the domain of the Accreditation Council for Continuing Medical Education. Yet, commercial sponsorship of CME remains an ongoing reality. According to a 2009 report from the Institute of Medicine (IOM), CME has become far too reliant on industry funding and that such funding tends to promote a narrow focus on products and to neglect the provision of a broader education on alternative strategies for managing health conditions and other important issues, such as communication and prevention.7

The Special Fraud Alert was not intended to discourage meaningful conflict-free industry-sponsored CME, but rather called for a reevaluation of current practices. In particular, consideration is to be given to the elimination of the highly conflicted self-serving in-person CME programs wherein the risks associated with offering or paying related remuneration remain prohibitive. Risk reduction could be enhanced by a shift to online CME offerings, especially considering that the technology for these programs has been substantially improved in the course of the COVID-19 pandemic. In so doing, industry would be taking a small step toward fulfilling the IOM vision of a new system of funding accredited continuing medical education…that enhances public trust in the integrity of the system and provides high-quality education.7 To help achieve this vision, industry-sponsored speaker programs should become a thing of the past.

Ref: JAMA. Published online April 12, 2021. doi:10.1001/jama.2020.26580