SECURING PAYMENT AND U.S. MARKET ACCESS
Situation
A life sciences innovator that specializes in clinical laboratory diagnostics was developing a novel test for a disease measure that medical practitioners increasingly use to inform treatment. This diagnostic is performed with a straightforward methodology currently used by most hospitals and reference laboratories. Alternative test methodologies to measure the same protein involve complex, costly equipment that few labs have or regularly use.
Company leaders wanted to expand access to this diagnostic internationally, including the U.S. market. The goal was to seek FDA clearance and apply for a new CPT code while the diagnostic was under development. But because the company is based outside the U.S., its leaders were unfamiliar with the criteria and process for securing a CPT code and appropriate payment.
Our Role
We knew that although the measure was gaining recognition among clinical experts, coverage for alternative test methods was inconsistent. We also understood that FDA clearance would be a critical factor in expanding coverage and securing a CPT code.
Our consultants positioned the test for Category I CPT code eligibility with an associated payment. Alternatively, we could have pursued a Category III CPT code denoting an emerging technology. However, that wouldn’t include an associated payment, so it could have put the diagnostic at risk for non-coverage by payers.
We developed and implemented a cohesive, 5-pronged strategy:
• Evaluate peer-reviewed clinical evidence and treatment guidelines associated with measuring the target protein.
• Enlist key opinion leaders in laboratory methodology and clinical use of the test to inform patient treatment.
• Develop the application to define the clinical value of the test and the most effective methodology to position it for a Category I CPT code.
• Investigate the timing and process for collaborating with the Clinical Laboratory Coding Caucus and medical specialty societies to meet their timelines for pre-review prior to AMA Editorial Panel submission.
• Work with the Coding Caucus to refine the application and clarify requested points prior to final review and submission to the AMA CPT Editorial Panel.
Outcome
We submitted the CPT code application and followed-up with CPT staff to verify that the application was accepted. Our pre-planning with relevant medical societies and the AMA ensured that the application was accepted and presented at the desired CPT Editorial Panel meeting.
Our consultants also briefed the clinical experts on AMA CPT panel presentation criteria and rules, so they could address panel questions effectively. As a result, the presentation proceeded smoothly. Soon afterward, the panel agreed to create a Category I CPT code describing the test procedure.
Subsequently, our consultants worked with the same clinical laboratory and medical specialty societies, as well as the Centers for Medicare and Medicaid Services (CMS), to ensure that the test method and procedure were clearly understood, so payment would be aligned.
Impact
As a result of our efforts, payment for this diagnostic was appropriately determined (or “crosswalked”), with support from clinical laboratory societies whose members perform the test. Ultimately, this paved the way for a successful U.S. market entry.
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