qordata hosted a webinar with Seth Lundy and Brian Bohnenkamp from King & Spalding to keep the compliance community updated with recent changes in PhRMA Code and the implications on life sciences compliance after those revisions. A number of questions were raised in our webinar that Seth and Brian tried to answer. Here’s a summary of those questions and the responses by our esteemed panel.
Please note this blog, the webinar or any material shared on our platforms does not constitute as legal advice. This content is shared solely for the purpose of knowledge sharing and should not be perceived as legal advice given by qordata and/or King & Spalding.
What the community asked: Should senior sales leaders be involved in nominating a speaker for the Speaker Programs?
Our expert panel’s response: As you get closer to the field sales team, the risks will shoot up. When we talk about remuneration or payments that can come through speaker programs, are meals and the payments to the HCPs. The latter can implicate both companies and HCPs in the Anti-Kickback Statute. That’s why OIG suggests that wherever sales and marketing may be involved, it creates a perception that the selection of the speakers could factor in how many prescriptions they would write in the future.
What the community asked: Is AdvaMed is going to follow the PhRMA guidance?
Our expert panel’s response: AdvaMed seems to be working on an update to the AdvaMed Code that would address the OIG Special Fraud Alert; however, it is not certain that AdvaMed will take all of the same positions as PhRMA. The compliance community will need to wait until AdvaMed is ready to publicly announce any updates.
What the community asked: Would the new PhRMA Code allow for non-HCPs with direct responsibility for patient care to attend these Speaker Programs?
Our expert panel’s response: The revised PhRMA Code requires that Speaker Program attendees be limited to those with a bona fide educational need. Accordingly, a manufacturer conducting a Speaker Program would need to assess in each case whether the combination of the content being presented and the specific responsibilities of the non-HCP would make for a true educational need that will benefit the non-HCP attendee and patients. The answer may differ from situation to situation. Note that, while the PhRMA Code arguably only applies to “interactions with HCPs”, the inclusion of non-HCPs could still affect Code compliance (e.g., by undermining a manufacturer’s basis for justifying a bona fide educational need).
What the community asked: Would a company with only nutrition products that are not covered by federal or state programs have risk with respect to the PhRMA Code’s updates?
Our expert panel’s response: While a company that does not manufacture, market or sell any products or services that are reimbursed by federal or state health care programs would arguably not be at risk under the federal Anti-Kickback Statute if the company nonetheless publicly states that it adheres to the PhRMA code there could be potential ramifications for non-compliance. For example, investors or shareholders might take issue with a company’s misstatements about compliance or, if the company is required to comply with a state law that mandates PhRMA or AdvaMed Code compliance, the company could be in violation of state law.
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