Pharma’s expanding field roles challenge traditional boundaries

Pharmaceutical field-facing interacting roles have evolved far beyond the traditional sales representative roles.

According to panelists at the Pharmaceutical Compliance Congress, companies now deploy an array of specialized field professionals including field reimbursement managers (FRMs) and thought leader liaisons (TLLs).

Speaker Sarah Whipple, vice president, global chief compliance officer, at Apellis Pharmaceuticals, began the session, titled, “New Wave of Field Facing Interactions and Challenges,” by highlighting the complexity many compliance professionals face when managing these distinct roles.

She acknowledged to the attendees her occasional difficulty in maintaining clear distinctions between these various positions.

With these evolving positions, Jamie Darch, partner at Ropes & Gray, pointed out the web of laws that impact these field interactions.

Those laws include:

• Anti-Kickback Statute: Prohibits offering anything of value to generate business for

• False Claims Act: Prevents providing false claims to the government

• Civil Monetary Penalties Law: Focuses on preventing inducement of beneficiaries

• HIPAA and state privacy laws: Protect patient information

The government has shown particular concern about practices like “pre-populating clinical information on claims forms, coaching HCPs on diagnoses, filling out prior authorization forms on behalf of HCPs, and contacting payers and not disclosing that you’re on behalf of a pharmaceutical company,” Darch explained.

Field reimbursement managers

FRMs typically serve as a liaison between healthcare providers, payers, and patients. According to the panel discussion, these roles will continue to evolve as products grow more complex and reimbursement pathways change.

There’s also a shift toward patient centricity in the role, according to Karen Lowney, head of the office of ethics and compliance at Sun Pharmaceutical Industries. She shared how her company is reconsidering rebranding the role.

“We were talking with the team, and they said we want to change the name again from FRM because they felt that just saying reimbursement was very narrow and limited ... they felt that it was risky to say that they’re there to help reimbursement of a buy and bill product with a physician,” she said.

“I think they want to call them access right, a field access manager ... because they really want that focus to be more around the patient, making sure your patient gets access to the right medications that the payer is covering it,” Lowney further added.

Meanwhile, panelists Darch and Whipple highlighted the compliance challenges that FRMs face, particularly regarding patient information. Darch explained that “under HIPAA, treatment is pretty broadly defined, and care coordination could encompass a lot of things,” but pharmaceutical reimbursement support was not necessarily what regulators had in mind when creating these exceptions.

Access to patient information through HIPAA authorizations is “probably one of the biggest reasons that sales reps and FRMs don’t do joint interactions or joint calls.” This creates a clear separation between them and sales representatives, she noted.

Another significant compliance concern arises when field roles engage in discussions about financial aspects of pharmaceutical products. Whipple highlighted the “concern around marketing on the spread, which transcends all, the FRM, the corporate accounts, the strategic accounts, all those type of people who are talking about money."

The panelists emphasized that these financial discussions should be kept separate from product promotion conversations to maintain compliance boundaries.

Thought leader liaisons

TLLs are “gaining a lot of traction lately,” according to Lowney, who admitted to “struggling with these roles on what they actually do because some people think they just go out and wine and dine doctors.”

Whipple noted that at Apellis, TLLs primarily manage speaker programs and work as relationship builders.

“If we have a speaker who needs retraining, they’ll do that. They also identify speakers ... help with issues with the contract and the speaker ... they’re like the person that sort of blocks and tackles all that stuff,” she said.

However, the role requires strict boundaries to maintain compliance. “You can’t detail. You cannot be a sales rep. The minute you turn into a sales rep, you can no longer take these guys out to dinner,” Lowney said. Additionally, she noted despite sometimes sitting in medical affairs, TLLs are “very, very much commercial” and should avoid “deep dive clinical discussions.”

“That’s not what this role is supposed to be having. It’s supposed to be very strategic about the company and relationships,” she continued.

Compensation structures also reflect the role’s commercial description, with some companies tying compensation “to the overall performance of the business” rather than solely MBOs (management by objectives), ensuring TLLs have “something in the game,” according to Whipple.

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