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.
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.
We’re ready to help your organization drive medical innovation forward
To discuss how you can achieve better reimbursement results…