Why Clinical Research Revenue Cycle Management is Vital to Business

Shirley Trainor-Thomas, MHSA, Chief Strategy Officer, eNRE

Shirley Trainor-Thomas, MHSA, Chief Strategy Officer, eNRE

The unique complexities of billing and capturing payments for patients in clinical trials have often been overlooked, or actually misunderstood, in the context of healthcare organizations’ finances, according to experts from the GuideStar clinical trials support service.

“In some cases, finance professionals have the misconception that a clinical trial sponsor pays for all medical care and interventions for patients enrolled in the trial, leading them to believe that standard accounting practices do not apply,” says Rhonda Paz, PhD, chief operating officer for GuideStar in New Orleans, La.

In reality, the trial sponsor only pays for activities specifically prescribed by the protocol that are not standard of care. Paz says that it is up to the healthcare provider to bill the third-party payor for non-protocol activity, or standard of care. The lack of understanding exposes the provider to a great deal of risk.

“As belts are tightening and healthcare organizations are searching for ways to improve accounts receivables, it is becoming evident that they must do a better job managing the billing and collections for clinical trial patients,” adds Shirley Trainor-Thomas, MHSA, chief strategy officer for GuideStar and a member of ACRP’s Editorial Advisory Board. “Simply put, revenue cycle management also applies to patients on clinical trials, though with some additional caveats.”

Paz and Trainor-Thomas explain that clinical research revenue cycle management (CR-RCM) is absolutely necessary for an organization conducting clinical trials. Otherwise, there is a significant financial loss as a result of not tracking and collecting applicable payments, and the organization is exposed to major billing compliance risks.

The goals for CR-RCM are the same as traditional RCM:

  • Optimizing financial performance
  • Reducing operational costs
  • Avoiding billing compliance risk

However, CR-RCM requires additional attention. The functions that are the essential elements of a successful CR-RCM program include:

  • Cost and coverage analysis
  • Budget development
  • Contract language and payment term negotiation
  • Sponsor invoicing and collections for research-related interventions
  • Proper trial coding, billing, and collections for insurance reimbursement of standard of care

“Overlooking CR-RCM in the overall RCM practice places an organization conducting research at risk for losing a substantial amount of money, as well as exposure to a significant deal of billing compliance risk,” Paz says. “Understanding the risks, communicating with the key departments involved, documenting the strategies, and training and engaging with those you’ve entrusted with the success of the research billing compliance program are key steps on the path to appropriate research finance management.”

The groups responsible for RCM should be same groups responsible for CR-RCM, but with the addition of representatives of the research department and specialized personnel, Trainor-Thomas adds. “Employing experienced clinical research billing personnel or outsourcing this activity to an expert vendor, deploying technology solutions such as a clinical trials management system with a robust CR-RCM module, and implementing clear and logical workflows and standard operating procedures are essential considerations,” she says.

Author: Gary Cramer