Reimbursement Assessment for New Diagnostic

Reimbursement Case Brief

An independent clinical laboratory has been developing two commercially promising diagnostics. Both are designed to help demonstrate increased cancer risk:

A Clinical Laboratory Improvement Amendment (CLIA) waived Point-of-Care (POC) test,
A more complex lab test.

Initially, our client believed coding would be the most viable path to reimbursement. However, they wanted a clear understanding of the factors and implications associated with a coding strategy. They also sought guidance in prioritizing the development and launch of both tests.

Our Role
JR Associates consultants conducted a comprehensive coding, payment and coverage analysis – identifying reimbursement barriers and opportunities, and evaluating the tradeoffs of a coding strategy for each test.

Our assessment illuminated details of today’s challenging coverage environment for pre-diagnostic tests, and the clinical evidence required to establish these tests in healthcare settings. Based on the findings, we recommended repositioning the tests and the clinical trial focus to target a patient segment with likely coverage barriers.

In addition, this analysis revealed several other key considerations:

CPT coding is the lesser challenge,
Patients may be willing to pay for testing out-of-pocket, and
In some cases, payers may allow the POC test with fewer barriers.

Our consultants provided a rationale that led the company to prioritize the POC test, with an initial focus on clinical evidence and the self-pay market. Our client is realigning its strategy, accordingly.

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