MEDICARE COST OF MINIMALLY INVASIVE BIOMARKER TESTS TO DETECT DONOR-DERIVED CELL-FREE DNA (DD-CFDNA)
Author(s)
Nabin Poudel, PhD1, Roberto S. Kalil, MD2, Nikhil Reddy, PharmD candidate1, Julia F. Slejko, PhD1;
1University of Maryland Baltimore, Baltimore, MD, USA, 2University of Maryland School of Medicine, Baltimore, MD, USA
1University of Maryland Baltimore, Baltimore, MD, USA, 2University of Maryland School of Medicine, Baltimore, MD, USA
OBJECTIVES: To estimate Medicare costs for minimally invasive donor-derived cell-free DNA (dd-cfDNA) biomarker tests. A secondary objective was to estimate such costs among beneficiaries with a history of kidney transplantation.
METHODS: We conducted a retrospective analysis using a random 20% sample of the 2021 Medicare Chronic Conditions Data Warehouse. We identified dd-cfDNA tests across fee-for-service outpatient and carrier claims processed within 2021 using Current Procedural Terminology and Healthcare Common Procedure Coding System codes, including 81479 (unlisted molecular pathology procedure), 0540U (AlloSure® [CareDx]), 0493U (Prospera™ [Natera™]), 0118U (Viracor TRAC™ [Eurofins]), and 0508U/0509U/0544U (VitaGraft/AlloMap Kidney [Oncocyte]). Medicare costs were derived from paid amounts on claims, using revenue center payments for outpatient services and line-item payments for carrier claims. Kidney transplant beneficiaries were identified using any inpatient, outpatient, and carrier claims using ICD-10-CM diagnosis codes (Z94.0, Z48.22) and ICD-10-PCS procedure codes (0TY00Z0, 0TY00Z1, 0TY00Z2, 0TY10Z0, 0TY10Z1, 0TY10Z2). We summarized Medicare costs as total costs and mean costs per beneficiary.
RESULTS: In our 2021 sample of 13.4 million Medicare beneficiaries, 38,961 received dd-cfDNA testing, resulting in a total Medicare cost of $85.4 million. The mean annual cost was $2,193 per beneficiary (SD = $3,780). Among kidney transplant recipients (n = 4,613), total Medicare cost for dd-cfDNA testing was $34.5 million, with a substantially higher mean annual cost of $7,468 per beneficiary (SD = $7,778). Within this subgroup, mean costs were higher for tests billed as unlisted molecular pathology procedures ($7,403; SD = $7,757) compared with Viracor TRAC™ testing ($2,379; SD = $1,387).
CONCLUSIONS: Medicare spending on dd-cfDNA testing was substantial in 2021, with higher per beneficiary costs among kidney transplant recipients and notable variation by billing pathway. These findings highlight the need for future cost-benefit evaluations of biomarker use. Evidence-based coverage policies can support appropriate use and fiscal sustainability of dd-cfDNA testing within Medicare.
METHODS: We conducted a retrospective analysis using a random 20% sample of the 2021 Medicare Chronic Conditions Data Warehouse. We identified dd-cfDNA tests across fee-for-service outpatient and carrier claims processed within 2021 using Current Procedural Terminology and Healthcare Common Procedure Coding System codes, including 81479 (unlisted molecular pathology procedure), 0540U (AlloSure® [CareDx]), 0493U (Prospera™ [Natera™]), 0118U (Viracor TRAC™ [Eurofins]), and 0508U/0509U/0544U (VitaGraft/AlloMap Kidney [Oncocyte]). Medicare costs were derived from paid amounts on claims, using revenue center payments for outpatient services and line-item payments for carrier claims. Kidney transplant beneficiaries were identified using any inpatient, outpatient, and carrier claims using ICD-10-CM diagnosis codes (Z94.0, Z48.22) and ICD-10-PCS procedure codes (0TY00Z0, 0TY00Z1, 0TY00Z2, 0TY10Z0, 0TY10Z1, 0TY10Z2). We summarized Medicare costs as total costs and mean costs per beneficiary.
RESULTS: In our 2021 sample of 13.4 million Medicare beneficiaries, 38,961 received dd-cfDNA testing, resulting in a total Medicare cost of $85.4 million. The mean annual cost was $2,193 per beneficiary (SD = $3,780). Among kidney transplant recipients (n = 4,613), total Medicare cost for dd-cfDNA testing was $34.5 million, with a substantially higher mean annual cost of $7,468 per beneficiary (SD = $7,778). Within this subgroup, mean costs were higher for tests billed as unlisted molecular pathology procedures ($7,403; SD = $7,757) compared with Viracor TRAC™ testing ($2,379; SD = $1,387).
CONCLUSIONS: Medicare spending on dd-cfDNA testing was substantial in 2021, with higher per beneficiary costs among kidney transplant recipients and notable variation by billing pathway. These findings highlight the need for future cost-benefit evaluations of biomarker use. Evidence-based coverage policies can support appropriate use and fiscal sustainability of dd-cfDNA testing within Medicare.
Conference/Value in Health Info
2026-05, ISPOR 2026, Philadelphia, PA, USA
Value in Health, Volume 29, Issue S6
Code
EE311
Topic
Economic Evaluation
Disease
No Additional Disease & Conditions/Specialized Treatment Areas