Clinical research- Five essential elements for RCM

Billing and capturing payments for patients in clinical trials has often been overlooked, or actually misunderstood, by healthcare finance.

In some cases, finance professionals have the misconception that a clinical trial sponsor (pharmaceutical device and biotech companies) pays for all medical care and interventions for patients enrolled in the trial, leading them to believe that standard accounting practices do not apply. In reality, the trial sponsor only pays for activities specifically prescribed by the protocol that are not standard of care. 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. Simply put, RCM also applies to patients on clinical trials, though with some additional caveats. Clinical Research Revenue Cycle Management (CR-RCM) is absolutely necessary for an organization conducting clinical trials, as 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

But CR-RCM requires additional attention. The top five functions that are the essential elements of a successful CR-RCM program:
• 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. Understanding the risks and charging the right departments with the success of the research billing compliance program to follow comprehensive, well-documented and trained workflows is the only path to appropriate research finance management. The same groups responsible for RCM should be same groups responsible for CR-RCM, but with the addition of the research department and personnel.

Employing experienced clinical research billing personnel or outsourcing this activity to an expert vendor, deploying technology solutions such as a clinical trials management system (CTMS) with a robust CR-RCM module, and implementing clear and logical workflows and standard operating procedures (SOPs) is essential. And just as important is communicating, training and engaging the key departments involved such as research, finance, accounting, coding, medical records and IT. Development of solid processes will result in a highly successful and compliant Clinical Research Revenue Cycle Management Program.

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