When Billable Doesn’t Mean Paid: Rethinking Clinical Trial Economics

When Billable Doesn’t Mean Paid: Rethinking Clinical Trial Economics

Hospitals today are operating on razor-thin margins, often around 1% or less.¹ At the same time, they continue to support clinical research, absorbing the operational and financial complexity that comes with it. Yet in the clinical trial space, we tend to focus on a single question: What can be billed?

The more important question may be: What are hospitals getting reimbursed for?

Having worked in coverage analysis for more than 15 years, I’ve spent countless hours evaluating protocol requirements and determining what qualifies as billable to Medicare. Like many in this field, my lens has largely been defined by compliance, ensuring alignment with NCD 310.1 and other regulatory requirements.

That perspective shifted recently after reading Meade and Conway’s Clinical Research & Health Insurance. While the book is an excellent technical resource on billing compliance and coverage analysis, it also prompted a more fundamental question: Are we overlooking the broader financial reality behind what we bill?

The Difference Between Billing Compliance and Financial Reimbursement

Broader industry data reinforces the urgency of that question. Hospital margins remain under sustained pressure, driven by rising labor costs and chronic underpayment from Medicare and Medicaid. In fact, Medicare reimbursed hospitals only about 83 cents for every dollar spent on patient care in 2023.² Against that backdrop, even small gaps between what is billed and what is reimbursed can have meaningful financial consequences.

Coverage Analysis has long been the foundation of clinical trial billing compliance, but it has limitations.

Why Coverage Analysis Doesn’t Tell the Full Financial Story

When we stop at coverage analysis, we confirm what is permissible to bill. But we don’t fully understand what is actually reimbursed, and more importantly, what costs hospitals may ultimately absorb.

This is where a Prospective Reimbursement Analysis becomes essential.

Under the Ambulatory Payment Classification (APC) system, many services are bundled in ways that obscure true reimbursement. Ancillary services, such as laboratory testing and lower-cost drugs, are often packaged with a primary CPT code, effectively eliminating incremental reimbursement for those services. Similarly, when multiple imaging procedures are performed on the same day, only the highest-cost study may be reimbursed.

The result is a structural gap between cost and payment.

How Prospective Reimbursement Analysis Identifies Hidden Trial Costs

In a healthcare environment where margins are already measured in single digits, that gap matters. Even a few thousand dollars in unreimbursed costs per patient can quickly add up across a clinical trial, turning into hundreds of thousands or even millions in absorbed expenses for a health system.

And the financial impact doesn’t stop with the hospital; patients are feeling the pain, too.

Patients are increasingly enrolled in high-deductible health plans, and clinical trial participation can carry unexpected out-of-pocket costs. Protocol-required services, even when categorized as “routine,” may still be subject to deductibles and coinsurance. For patients, this creates a form of financial exposure that is often underappreciated in trial design and execution.

In that sense, the question of reimbursement is not just an operational or financial issue; it is also a patient access and equity issue.

For years, clinical trial evaluation has been anchored in the framework of NCD 310.1 and the determination of billable routine costs. That framework remains essential. But in today’s financial environment, it is no longer sufficient on its own.

If we continue to focus only on what can be billed, we risk overlooking what hospitals and patients are truly paying.

In addition to our traditional Coverage Analysis and budget services, Attain Partners offers a model for conducting Prospective Reimbursement Analysis. I would love to talk to you about how we could incorporate Prospective Reimbursement Analysis into your clinical research billing and compliance program.

About the Author

Shanna Ford, MHA, is a Senior Consultant with more than 15 years of experience in clinical trial billing compliance and financial management. She supports Academic Medical Centers, Site Networks, and hospitals with clinical trial office support, including budget negotiations, Coverage Analysis, Post Award, CTMS implementation, and process improvement.