A preliminary review of adoption of new HCPCS codes for NGS in CMS claims

ABSTRACT

Background: Adequate reimbursement is considered a prerequisite for adoption of new diagnostic technologies that facilitate patient access to better treatments. Detailed longitudinal investigation of the adoption of new HCPCS codes and the factors influencing it are scarce, although the availability of large-scale claims databases should facilitate such studies. We examined claims for three CPT codes used for next generation sequencing (NGS) 81445, 81450 and 81455 in a large database of claims data from CMS and attempted to correlate presumptive drivers of test adoption such as coverage decisions and payments with test volume. Methods: CMS claims data were accessed using CMS' Virtual Research Data Center (VRDC) under data use agreement 50486. Any claim with a CPT code of 81445, 81450 or 81455 was extracted from the data and analysed using SAS Enterprise Guide with results summarised in Microsoft Excel. Data relating to national/local coverage determinations were located by internet searches. Results: Test volumes for all 3 codes showed significant variability, including a large decrease around Q1-2 of 2020, likely due to the COVID-19 pandemic. Utilization of the 3 CPT codes varied by patient diagnosis. Details of the top 5 diagnoses for each CPT are given in the Table. The top 30 diagnoses for each CPT code accounted for 80.33%-88.45% of patients. Conclusions: Utilisation of NGS testing from 2016-2021 was highly variable, confounding attempts to match potential drivers to changes in monthly test volumes. A relatively small number of conditions accounted for >80% test use. Increased use of 81445 and 81450 from 2019 onwards may be related to CMS LCD issued in March 2018, suggesting that it can take 8-9 months or more for a LCD to filter through to testing practice. Decreases in test volume around March 2020 coincide with decreased patient presentation and testing for cancer because of the COVID-19 pandemic indicating that factors beyond reimbursement can significantly affect test use. Changes in reimbursement or adoption of proprietary lab analysis (PLA) codes covering specific NGS tests may have caused the drop in test volumes in the latter half of 2021. This study demonstrates that determination of factors affecting adoption of a test technology can be problematic due to wide variation in claims over a relatively short space of time. However, determination of these factors is important as they ultimately affect patient access to testing and potentially to therapy. (Table Presented).