Recently, I hosted a webinar titled, “Special Fraud Alerts: What You Need to Know.” During this hour-long session I discussed the recent fraud alert that the OIG issued in November, which highlighted the fraud and abuse associated with speaker programs. These speaker programs, which are defined as events where a physician publicly speaks about a drug or device, on behalf of a sponsoring company. Why are they a big deal, and why have they caught the attention of the OIG? Well, in the last three years, drug and device companies have reported paying nearly $2 billion for speaker-related services.
During the Q&A, I was able to answer a ton of the audiences’ questions before time ran out. But as I mentioned at the conclusion of the webinar, I would spend some time answering those questions we didn’t have time for. So, true to my word, the following are my collected answers.
If you have any additional questions, be sure to leave them in the Comments section below.
1. What do you recommend a compliance officer do, if after a physician has been told of the regulations and/or enforcement actions, but they state that they (or our organization) “is too small to be investigated?”
If the physician is violating an organizational policy, I would raise the issue with a higher authority within the organization that can discipline appropriately. I would also remind the physician that no one is too small to be investigated. Consider sharing some of the enforcement examples from the webinar. In many cases, the enforcement was against a single physician or small group practices. Lastly, there might be a bigger issue within the corporate culture if the main incentive for compliance is to ‘avoid being investigated.’ An organization’s Code of Conduct should spell out the organization’s commitment to appropriate behavior and ethical conduct.
2. Would lunches provided by pharmaceutical companies be dangerous to have in our office?
When it comes to lunches in the office, I would suggest reviewing the office lunch activity against the red flags outlined in the slide from the webinar. For example, if the lunch is a legitimate training session on a new drug, or a drug with a newly approved indication, then it might make sense to train physicians over a lunch break. But if non-prescribing office staff are included in the lunch, there is not a legitimate educational session occurring. Or, if the lunches are frequent and no new information is being shared, one might need to review the legitimacy of the company representative spending money on lunch for everyone. These scenarios are typically fact specific, and a thorough compliance review might help answer these questions. If that is something of interest, reach out to Healthicity for a discussion on our consulting services.
3. Does this Fraud Alert also apply to community liaison programs, such as those commonly hosted by HIV drug manufacturers that are geared to case management staff?
Potentially, yes, the Fraud Alert could apply in those scenarios. The red flags discussed in the webinar would be good to review for this specific program and similar to the answer to question #2, if a more thorough compliance review is desired, please reach out to discuss Healthicity’s consulting services.
4. How do you handle speaker events for cosmetics, when your organization has a facial plastics service line, but also sees patients for medical issues?
Handling that situation is probably going to depend on the organization’s own comfort level. The OIG Fraud Alert is focused on speaker programs for items that are reimbursed by federal healthcare programs. Since it is unlikely an organization will be submitting claims to a government payor for cosmetics, the risk is probably considerably lower, if there are any anti-kickback risk exists at all.
5. Does OIG have a subscription where I can sign up to get the alerts real-time?
Yes, you can sign up for email notifications on the OIG’s website at https://cloud.connect.hhs.gov/OIG. On the same site provided, you can also connect with the OIG on Twitter, Facebook, YouTube and LinkedIn.
6. Are Open Payments available to search on the web?
Yes, Open Payments is available for public search on the internet. That is actually the intent behind posting the information, so the public can see for themselves the transfers of value made to healthcare providers. You can access Open Payments here: https://www.cms.gov/OpenPayments
7. Could we incorporate Speaking Engagements into our Conflict of Interest (COI) documentation?
Yes, absolutely. Many organizations already do this. They have specific questions about speaking engagements in their annual conflict of interest disclosure requests.
8. To your point of conflict with pharma companies, according to the OIG, what are legitimate reasons for a for-profit pharma company to have speaker programs not directly, or indirectly, linked to revenue increase? Can those programs exist without creating risk?
Your question really gets at the heart of the matter which - is the legitimacy of these programs at all. I believe that is why the OIG stated in their Fraud Alert that they were skeptical of such programs. However, I can think of scenarios where speaking programs could have some legitimacy. A program that is designed to avoid all the red flags discussed in the webinar might be a good start. On the other hand, I also mentioned in the webinar the tension that exists for the for-profit companies sponsoring these programs. If the programs are truly not designed to influence sales, then the company’s fiduciary board and stockholders should be asking, “Why are you spending so much money on these programs, if they don’t have a direct or even indirect impact on sales?” A company can’t have it both ways.
9. Was the Novartis settlement that was discussed in the webinar, a whistleblower case?
The information was initially brought to the government’s attention from a whistleblower under the False Claims Act. You may be interested in reading the press release here: https://www.justice.gov/usao-sdny/pr/acting-manhattan-us-attorney-announces-678-million-settlement-fraud-lawsuit-against as well as the settlement and stipulation document here: https://www.justice.gov/usao-sdny/press-release/file/1291316/download