Exploring trends in Medicare utilization and reimbursement of germline genetic testing for cancer from 2017-2022.

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5 Background: Germline genetic testing is recommended in NCCN and ASCO guidelines to enable personalized treatment and assess hereditary cancer risk. Studies have found a significant prevalence of actionable germline mutations in the elderly population. Germline testing in the elderly is underutilized due lack of insurance coverage, lack of knowledge and confounding test results. In 2020, national coverage of Next Generation Sequencing for germline testing was approved allowing its greater utilization. Methods: CPT codes for germline genetic tests were identified and classified into single-gene and multi-gene panels. The publicly available national summary file for Medicare Part B from 2017-2022 were searched to assess the utilization and reimbursement of germline genetic testing based on the CPT codes collected. The total cumulative cost of germline genetic testing, cost per beneficiary and the total number of utilizations were calculated and compared across 2017-2022. All costs were adjusted for inflation (using Inflation Calculator based on the average Consumer Price Index data). The proportion of single and multi-gene panel were also calculated to assess trends and the impact of policy changes. Results: A total of 55 CPT codes were identified pertaining to germline genetic testing in cancer. The total reimbursement for germline testing genes increased steadily from $32.7 million to $343.6 million before decreasing and plateauing around $110.5 million in 2022. The total number of beneficiaries was maximum in 2019 when 485313 availed of germline genetic testing, following which it dropped in the following years to 107306 in 2022. The cost per beneficiary displayed an increasing trend from $375.6 in 2017 to $1371.2 in 2021 before declining to $1030.1 in 2022. The proportion of multi-gene testing was lower than 50% from 2017-19 and 2022(2017-41.0%, 2018-25.3%, 2019-21.9%, 2022-45.1%) and greater than 50% in 2020-21(2020-62.1%, 2021-74.5%). Conclusions: Trends in Medicare indicate a decreased utilization of germline genetic testing post-2019, increasing cost per beneficiary, and a greater proportion of multi-gene panel testing in recent years. These trends may be explained by National Coverage of Next-Generation Sequencing policy changes between 2018-2020. Another reason for the trends may be implementation of rigorous approval practices after $2.1 billion Medicare genetic testing fraud in 2019. Trends in germline genetic testing. 2022 2021 2020 2019 2018 2017 Total reimbursement (in millions) unadjusted 110.5 112.0 129.7 343.6 195.3 32.7 Inflation factor 1 1.075 1.09 1.12 1.13 1.13 Total reimbursement (in millions)adjusted for inflation 110.5 120.4 141.3 384.8 220.7 37.9 Total number of beneficiaries 107306 87805 139617 485313 268290 100994 Cost per unit beneficiary 1030.1 1371.2 1012.2 793 822.5 375.6 Percentage of multi-gene panel testing 45.2 74.5 62.1 22 25.3 41

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