What is Going on in Billing Compliance for Clinical Trials?

Kelly Willenberg, DBA, RN, CCRP, CHC, CHRC, Manager of Kelly Willenberg & Associates

Clinical trial billing compliance—ensuring that charges for therapies and other study-related elements are sent to the appropriate party—is a key concern for academic medical centers and other research organizations. Incorrect billing can result in federal and state violations as well as financial penalties.

“To ensure billing compliance, research professionals should inspect their program, measure risks, and assemble the team members who can make billing compliance better,” said Kelly Willenberg, DBA, RN, CHRC, CHC, CCRP, Manager of Kelly Willenberg & Associates.

Speaking at ACRP 2023 in Dallas, Texas, earlier this year, Willenberg explained that inspecting the research program should include a thorough examination of workflow issues. “Important elements include ensuring that the billing process is integrated with the electronic health record and clinical trial management system, and making sure that issues do not arise due to siloed departments and remote workers,” she advised. “The ‘great resignation’ may also pose risks due to workforce shortages.”

Payer issues should also be addressed, Willenberg noted. “These include pre-authorization and benefit verification, complying with Medicaid requirements and the Appropriations Act, and accounting for payer differences in coding,” she said.

When measuring the risks related to clinical trial billing compliance, Willenberg proposed answering four questions: Are you billing payers appropriately? Do you lose revenue in research? Are you calculating fair market value correctly? Do you ensure subjects are fully informed?

“Some research institutions’ processes may lack good business practice and good clinical practice,” stated Willenberg. “Good business practice requires full oversight of billing compliance, properly identified roles, and adequate policies and procedures, while good clinical practice demands appropriate principal investigator oversight, clearly defined responsibilities, and thorough training.”

Willenberg advised research professionals to develop a compliant billing process. “This should include coverage analysis; budget, contract, and consent review; participant registration and tracking; medical documentation for medical necessity; charge capture, segregation, and research pricing; Medicare Advantage commercial payers; and audit and review,” she said.

Proposals for ACRP 2024 educational sessions—held May 3-6, 2024, in Anaheim, CA—are being accepted through July 24. ACRP seeks submissions that enhance the competencies, skills, professional advancement, and knowledge of mid- to advanced-level clinical research professionals. Submit your proposal online > 

Seven steps can help mitigate clinical trial billing risks, according to Willenberg:

  1. Collect key documents and perform a coverage analysis
  2. Carry out a “document concordance” review
  3. Identify every subject on every study for every visit
  4. Perform a full bill hold on all patients
  5. “Work the queue” by monitoring orders, claims, and invoices through the institution’s systems and review for correct billing, payer, coding, etc.
  6. Ensure coding is applied properly and the correct payer is billed
  7. Review denials

Examples of potential clinical trial billing errors highlighted by Willenberg include billing for services that are paid for by the sponsor or are invoiceable; promised for free or at no cost in the informed consent process; for research purposes only; or are part of a non-qualifying clinical trial without a policy.

Finally, Willenberg cautioned research professionals not to “roll the dice,” noting that it is a crime to knowingly make a false record or file a false claim, with violations risking significant fines and penalties. She concluded that “a proactive approach to clinical trial billing compliance can help mitigate these risks.”

Editor: Jill Dawson