(386) Do claims data support use of CPT category II codes for real-world evidence clinical outcomes?

Background: : Medical claims data include details on enrollment, procedures performed, diagnoses, and pharmacy dispenses; however, they typically lack detailed outcome measurements found in laboratory results.
CPT Category II codes (Cat II) are a supplemental extension of the AMA’s Current Procedural Terminology (CPT) that were intended to facilitate quality of care documentation without labor-intensive manual review of the medical record. Cat II topics range from patient management and history to documenting laboratory result values.
The suitability of Cat II for real-world evidence (RWE) research has been raised, but use of the optional coding was initially very low. However, in the past 5 years payors have implemented Cat II incentives while provider thought leaders (such as the AAP and AMA) recommend adopting Cat II codes for quality improvement purposes.

Objective: : The goal of this study is to quantify the concordance between laboratory results and claims-reported Cat II codes for two commonly performed laboratory tests: HbA1c and LDL cholesterol.

Methods: : This analysis examined closed claims and corresponding laboratory results representing 1.2 million insured members with available labs between January 2021 through December 2024. Concordance was defined as the occurrence of a corresponding Cat II code in claims within a 12-month window following laboratory test results.

Results: : In the diabetes cohort, 997,459 members had 1,950,297 HbA1c tests during the study period. In the cholesterol cohort, 1,048,005 members had 2,249,844 LDL tests during the study period. On average, 8.0% of the HbA1C tests and 1.5% of the LDL tests ha d corresponding Cat II codes. CPT II codes were reported more frequently in Medicare Advantage compared to Commercial Insurance (HbA1c: 85.9 v 55.8, LDL: 16.1 v 12.8 per 1000).

Conclusions: : The U.S. FDA issued guidance for industry on the use of RWE to support regulatory decision-making for drug and biologic therapies, including underscoring the importance of assessing data reliably in RWE[5]. Specifically, whether CPT II codes are valid proxy for lab values and if claims data without lab integration is suitable for quality reporting or research. The average annual LDL Cat II code for the reporting period examined appears to have increased since last reported by Russo and Williams (15.6 per 1000 v 11.1 per 1000).
Given the growing emphasis on clinical quality and the role they play in value-based-contracting, Cat II codes are likely to remain high in relevance. The potential value using of Cat II codes for RWE clinical outcomes remains worth continued examination.

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