A fine balance with health systems’ HCP interactions

Compliance in health systems requires a comprehensive approach for provider-rep relations at multiple facilities.

Yale New Haven Health System, which operates five hospitals and nearly 250 sites in four states, featured its experts on a panel at the Pharmaceutical Compliance Congress. Here, the primarily pharmaceutical legal attendee heard from the other side how reps can operate more effectively with HCPs in their system.

“We’re not trying to say no to everything,” explained Beth Valentino, senior compliance and conflict of interest specialist at Yale New Haven Health. “We try to say yes when we can. It’s not that every one of these situations or scenarios is bad, but again, it’s the perception, and our policies speak pretty clearly.”

Tanya White, systems compliance operations officer at Yale New Haven Health, who was a pharmaceutical representative early on in her career, noted that one of the most significant shifts are around meals and educational sessions. The once-common practice of providing food during meetings has become increasingly restricted. As she noted, “We had an office tell us the rep called and said he wanted to talk to the doctor over Teams, and it was a requirement that he send food. We have to explain to them that this isn’t acceptable; you can have the conversation, but there can be absolutely no food.”Panelists at HCP Perspective on Transparency Reporting on stage.

A single meal may seem extreme, but the financial implications of questionable provider-rep or company behavior are easily supported by past and expensive cases regarding the False Claims Act, including qui tam or whistleblower events. Early this year, the DOJ released its 2024 figures—$2.9 billion, with qui tam a party to 979 lawsuits, the highest number ever. The larger healthcare category, which includes pharma, represented $1.67 billion of the total. The panel noted that healthcare fraud investigations have proven highly effective, with government efforts yielding nearly $9 for every dollar invested.

Valentino and White’s efforts to reimagine the traditional pharma rep and provider relationship was an exercise in change management that began in earnest in 2019. That is when the health system, along with Yale University, prohibited its workforce from speaking on a speakers bureau. White explained: “We worked closely with our medical leadership to say there are other opportunities that we want our workforce to engage in when it comes to pharma or medical devices. It’s really consulting, it’s speaking, but maybe it’s at a conference where they have full control over the slides.”

There was still some confusion on the provider side and much more communication happened across the system. However, when the OIG’s Special Fraud Alert on Speaker Programs was released at the height of COVID, it became very clear that White and Valentino were reading the tea leaves correctly.

Communicating compliance

Outside of guidances the DOJ issues, White and Valentino described other strategies they use to ensure compliance and communication with its providers and vendors.

Using CMS Open Payments, where pharma and medical devices report their payments to providers and teaching hospitals annually, the team reviews to ensure compliance, as well as dispute any claims. White and Valentino also use the database to bolster teaching moments for staff. For example, taking prescribing data of what and when HCPs were prescribing and seeing if it aligned with speaking engagements. If there is direct correlation, which could also be verified by research articles authored in JAMA, which would also be discoverable by a government entity, then the conversation would look like, “What is the physician really getting out of it?”

The compliance team has been known to frequent the open areas at lunchtime to see what reps are bringing in food and where they are going. “That allows us to have a conversation with the rep, as well as the doctor,” White said.

However, this strict environment doesn’t mean that all interaction between healthcare providers and pharmaceutical representatives must cease. Instead, it calls for a reimagining of these relationships with a focus on educational value and professional development. She said to the pharma audience, “Use your money on different types of opportunities. We want to advance medicine with you.” They just want this to happen in appropriate ways.

The panel noted that more and more pharmaceutical representatives and companies are engaging in dialogue to find that middle ground of education and meaningful scientific communication.

Yale New Haven Health System is finding success by establishing clear guidelines that allow for meaningful interaction while maintaining ethical boundaries.

These include:

• No Gifts Policy: Providers may not accept any gifts, regardless of value
• Meal Restrictions: On-site meals are prohibited
• Educational Events: Providers must pay for their own meals at industry-sponsored talks
• Holiday Guidelines: Only shared, perishable items are permitted during holiday seasons

Learn more about this topic at our upcoming conference.

Image header: Depositphotos@@ alphaspirit

Panel image includes John Kelly, Chair of Barnes & Thornburg’s Healthcare Department and Industry Practice who moderated the panel.