Webinar: Reimbursement for Liquid Biopsy Testing in the United States

Webinar summary

In this webinar, Charles Mathews, Partner at ClearView HealthCare Partners, presents an overview of the evolving reimbursement landscape for liquid biopsy technologies in the United States. The discussion focuses on reimbursement considerations for circulating tumor DNA (ctDNA)-based assays, including payer coverage, CPT coding, payment pathways, and emerging applications such as minimal residual disease (MRD) and early cancer detection.

Study overview

The presentation examines reimbursement as a multidimensional framework consisting of three interdependent components:

• Coverage policies
• Coding structures
• Payment methodologies

The webinar focuses primarily on ctDNA technologies used for comprehensive genomic profiling in treatment selection settings, while also discussing evolving reimbursement considerations for MRD monitoring and early cancer detection applications.

The discussion includes analysis of:

• Medicare national and local coverage pathways
• Commercial payer reimbursement trends
• CPT coding evolution for liquid biopsy assays
• Gap-fill and crosswalk payment methodologies
• Emerging policy and evidence requirements shaping the field

Key findings

Liquid biopsy functions as an enabling technology across multiple applications

• ctDNA technologies support a range of molecular applications, including treatment selection, MRD monitoring, and early cancer detection
• Comprehensive genomic profiling was identified as the most established reimbursement use case to date

Reimbursement requires alignment across coverage, coding, and payment

• Successful reimbursement depends on coordinated interaction between payer coverage decisions, procedural coding, and payment assignment
• Coverage determines medical necessity, coding defines assay methodology, and payment establishes reimbursement value

Medicare coverage includes both national and local pathways

• National coverage determinations (NCDs) support FDA-approved or FDA-cleared next-generation sequencing technologies used in recurrent, relapsed, or refractory cancers
• Local coverage determinations (LCDs), particularly through the MolDX program, provide additional pathways for laboratory-developed liquid biopsy assays

MolDX policies have expanded liquid biopsy coverage

• MolDX policies support plasma genomic profiling when tissue biopsy is infeasible or insufficient
• Certain policies also support specific liquid biopsy technologies in lung cancer workflows following initial tissue-based biomarker testing

Commercial payer coverage is expanding

• Commercial payer policies increasingly recognize the clinical role of liquid biopsy technologies
• Earlier policies frequently restricted coverage to cases where tissue biopsy was not feasible
• More recent policy updates support broader use of multi-gene profiling independent of tissue feasibility requirements

CPT coding for liquid biopsy has evolved

• Liquid biopsy assays initially relied heavily on proprietary laboratory analysis (PLA) codes
• New genomic sequencing procedure (GSP) codes specific to cell-free nucleic acid analysis have now been established
• Coding structures distinguish between base assays and assays incorporating microsatellite instability (MSI) or tumor mutational burden (TMB)

Gap-fill methodology established new payment rates

• CMS ultimately applied gap-fill methodologies rather than crosswalk methodologies for several liquid biopsy GSP codes
• Finalized payment values reflected pooled input from Medicare administrative contractors

MRD represents an emerging reimbursement category

• Hematologic MRD applications currently have broader reimbursement support relative to solid tumor MRD applications
• Emerging solid tumor MRD technologies are beginning to secure selective commercial and Medicare coverage

Early cancer detection faces significant reimbursement challenges

• Multi-cancer early detection applications require substantial evidence generation, including demonstration of clinical utility and health economic value
• Preventive screening reimbursement pathways remain complex and highly evidence dependent

Regulatory and policy evolution continues to shape the market

• Ongoing discussions regarding laboratory-developed test regulation, payment reform, and evolving evidence standards are expected to influence future reimbursement dynamics
• Continued innovation in liquid biopsy technologies will likely require ongoing adaptation of reimbursement frameworks 

This webinar highlights the rapidly evolving reimbursement environment for liquid biopsy technologies in the United States. While comprehensive genomic profiling applications have achieved increasing payer acceptance, reimbursement remains highly dependent on alignment between coverage policies, coding structures, and payment methodologies.

Emerging applications such as MRD monitoring and early cancer detection continue to advance, although broader adoption will require additional evidence generation, regulatory clarity, and payer engagement. Collectively, these developments underscore the importance of evolving reimbursement frameworks in supporting continued innovation in liquid biopsy technologies.

Thermo Fisher Scientific makes no express or implied statement, promise or guarantee related to: (1) The propriety of seeking reimbursement for any item or utilizing a particular code or service; (2) A payer organization's decision whether to reimburse; (3) Any level of reimbursement, payment or charge; or (4) The accuracy of the information included herein. The resource is not intended to increase or maximize reimbursement by any payer. It is the responsibility of the recipient to (a) Obtain current, accurate information from government payers and commercial payers; and (b) Identify and learn more about local and/or payer-specific reimbursement policies and practices. Any reimbursement, payment, or economic information is provided for informational purposes only.

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