Evaluating when to say yes to sponsored educational programs

Although it is clear that the OIG views paid speaker programs with a healthy dose of skepticism, legitimate education and training opportunities will likely continue to be offered to HCPs. Bona fide sponsored educational opportunities do play an important role in professional development for many HCPs, and as such, organizations are unlikely to entirely prohibit participation. This is especially the case in times when resources for training and education are limited. Well-designed and credible sponsored training and education programs often make possible learning opportunities to which some HCPs may not otherwise have meaningful access. Organizations must balance the potential benefits to their HCPs against any potential downside risk associated with participation.

There are several steps organizations can take to mitigate the risk of their HCPs attending or speaking at sham sponsored programs. The organization’s compliance officer should communicate to its HCPs and other stakeholders in the organization the risks that may be associated with sponsored educational opportunities and explain the heightened scrutiny around paid speaker programs in particular. Compliance officers should point out that the OIG and Department of Justice (DOJ) have investigated and resolved numerous fraud cases against both companies and individual HCPs that involved paid speaker program arrangements. Nefarious speaker programs have often been cited as running afoul of the Anti-Kickback Statute, a federal criminal statute that prohibits anyone from offering or paying remunerations to induce referrals of items or services covered by Medicare, Medicaid, and other federally funded programs. The DOJ’s recent settlement with Novartis Pharmaceuticals Corporation demonstrates that paid speaker programs continue to be an enforcement area of interest for the government.^[2] In July 2020, the DOJ settled with Novartis, which, allegedly, among other things, instructed their managers to select “high-volume prescribers to serve as…paid ‘speakers’…to induce them to write more…Novartis prescriptions.”

Despite recent investigations and enforcement activities, some HCPs are still unaware that their industry interactions carry risk. Although government oversight of industry interactions is not a new phenomenon, some HCPs have failed to keep pace with changes in both the public and government expectations for industry interactions that may have emerged over the course of their career. Compliance officers should not take for granted that HCPs or their leaders know what is appropriate to receive in exchange for presenting or attending an educational event, as expectations have changed significantly over the years.

Compliance officers should educate HCPs, leaders, and stakeholders so that they can make informed decisions about educational opportunities that may be presented to them. Organizations should consider instituting centralized approval channels for sponsored educational events that include review and oversight by the compliance department. Because many sponsored training events are designed to be enticing based on the entertainment rather than educational value, organizations may find it beneficial to have the compliance officer or some other impartial third party assist in evaluating the merits of sponsored education opportunities. Compliance officers can proactively offer to assist in analyzing the opportunities or provide the decision-makers an evaluation tool based on the OIG’s guidance. This will help decision makers arrive at a more informed decision on which opportunities to pursue or reject.

What the alert means for annual conflict of interest disclosures

It is also important that organizations reevaluate the controls that are in place to prevent and detect potential high-risk industry interactions. One such control has traditionally been the organization’s annual disclosure program. While most organizations today have instituted a process for at least annually collecting and analyzing the disclosures of potential conflicts of interest and industry relationships for key employees and physicians, it may be time to cast a wider net to include other HCPs within the organization’s annual disclosure process. Expanding the scope of the annual disclosure will become even more critical in 2021 in light of the expansion of the Centers for Medicare & Medicaid Services (CMS) Open Payments Program website.^[3] The CMS Open Payments Program is a national disclosure program that collects and publishes payment data, including speaker honoraria, royalties, and entertainment and travel expenses paid by entities to certain HCPs. It is clear that the OIG is taking note of the CMS Open Payments website and even references the data in its alert, stating that “[i]n the last three years, drug and device companies have reported paying nearly $2 billion to HCPs for speaker-related services.”^[4] Beginning in 2021, CMS will begin collecting payment data on five new provider types, including:^[5]

• “Physician assistants

• “Nurse practitioners

• “Clinical nurse specialists

• “Certified registered nurse anesthetists & Anesthesiologist assistants

• “Certified nurse-midwives”

Data on these newly covered provider types are expected to be published by CMS in 2022 and will be viewable by both the government and the public. Now that new HCPs are being added to the CMS Open Payments Program, organizations should consider adding these roles to their annual disclosure process and monitor disclosures from these HCPs for inappropriate educational activities or other risky industry interactions.

Conclusion

The November 2020 OIG special fraud alert on speaker programs is an unequivocal signal to the provider, pharmaceutical, and medical device industries that paid speaker programs can no longer operate as thinly veiled shells for entertainment or other improper activities that are of little or no educational value. The alert, coupled with the expansion of the CMS Open Payments website, will likely result in more government scrutiny to the industry interactions of HCPs beyond physicians. Despite the heightened government scrutiny, HCPs will likely continue to participate in sponsored educational activities and accept paid speaker opportunities. Organizations should enhance controls to reduce the risk of HCPs participating in questionable sponsored education activities. Compliance officers should clearly communicate to HCPs and stakeholders these recent changes and the risks associated with participation, especially as a paid speaker. HCPs that were traditionally unmonitored or excluded from the annual conflict of interest disclosure processes should be considered for inclusion in the future. Serious consideration should be given to requiring centralized approval channels for paid speaker programs that include review by the compliance department, which can serve as an unbiased evaluator of the educational opportunity.

Takeaways

• The Office of Inspector General is skeptical about the educational value of sponsored speaker programs and as a result will be viewing these activities with heighten scrutiny.

• Beginning in 2021, the reach of the Centers for Medicare & Medicaid Services Open Payments Program will be expanding to include five new provider roles.

• Compliance officers should not assume that healthcare professionals are aware of the risks associated with sponsored speaker programs and communicate to them the recent changes.

• Compliance officers should seek to be proactively included in the evaluation and approval of paid speaker program opportunities.

• Organizations should update their annual disclosure process to include new roles that will now be in scope of the Centers for Medicare & Medicaid Services Open Payments Program website.