Overview
DreamBig Health (DBH) collaborated with DiaCarta, a diagnostics company specializing in oncology testing, to secure an appropriate crosswalk candidate during the Centers for Medicare and Medicaid Services (CMS) 2025 Clinical Lab Fee Schedule Annual Payment Determination Process for its Prostate Test (CPT 0497U). Despite overwhelming support from the Clinical Diagnostic Laboratory Test (CDLT) Advisory Panel for a crosswalk to CPT 0047U, CMS initially proposed a less favorable crosswalk to CPT 0005U, which would have resulted in a payment reduction. DBH was engaged to develop a strategic approach to secure the appropriate crosswalk and reimbursement.

Challenges Faced
CMS Disagreement with Advisory Panel. Despite near-unanimous support from the CDLT Advisory Panel for CPT 0047U, CMS preliminarily recommended a crosswalk to CPT 0005U, citing methodological similarities.

Complex Methodological Comparisons

CMS’s rationale was based on perceived similarities between CPT 0497U and CPT 0005U, requiring a detailed evidentiary response to counter this assertion and align with the more appropriate CPT 0047U.

Navigating Regulatory Frameworks 

DiaCarta needed to ensure its argument was compliant with statutory and regulatory requirements, particularly Section 1834A of the Social Security Act and 42 CFR § 414.508, to refute CMS’s approach and secure the desired crosswalk.

DreamBig Health's Solution
DBH leveraged its expertise in market access, health economics, coding, coverage, and reimbursement strategy to develop a comprehensive and compelling case for DiaCarta. The team provided strategic guidance based on their extensive experience in securing CMS National Coverage Determinations and navigating CPT coding and payment processes for innovative diagnostics.

DBH developed a detailed analysis demonstrating the similarities between CPT 0497U and CPT 0047U in terms of sample processing, RNA extraction, and analysis workflows, reinforcing the validity of DiaCarta’s original crosswalk proposal. To maintain flexibility in negotiations, DBH proposed CPT 81541 as a secondary crosswalk, offering CMS an additional viable option. The submission was carefully structured to align with Section 1834A of the Social Security Act, emphasizing that a gapfill process was not permissible due to existing comparable tests. Additionally, DBH actively engaged with CMS, facilitating discussions to clarify technical points, address concerns, and reinforce the rationale for the appropriate crosswalk decision.

Impact to Client
As a result of DBH’s strategic advocacy, CMS ultimately adopted the crosswalk initially proposed by DiaCarta and supported by the CDLT Advisory Panel. This outcome demonstrated the critical role of expert-led market access strategies in influencing reimbursement decisions and ensuring appropriate payment levels. Engaging experienced market access professionals with deep industry knowledge can significantly impact reimbursement success, particularly when leveraging well-supported evidentiary submissions to build a compelling case. Early and consistent communication with regulatory bodies is essential to effectively navigate challenges, and having backup strategies ensures flexibility in negotiations, increasing the likelihood of a favorable outcome.

If you need expert assistance in developing a market access strategy that aligns with your goals, reach out! Successfully navigating the reimbursement landscape requires specialized expertise and strategic foresight. DreamBig Health’s team is equipped to help companies optimize their market entry, reimbursement, and commercialization strategies for long-term success.