Some genetic testing services may be contractually excluded for self-funded groups that have opted out of expanded biomarker testing under the state mandate (R.I.G.L. §27-19-81). Coverage for those groups is governed by the groupspecific Benefit Booklet or Subscriber Agreement; a list of which genetic testing services are covered with prior authorization, considered not medically necessary, or excluded by contract can be found in the Coding section of the Genetic Testing Services or Proprietary Laboratory Analyses policies. Providers should verify the member's benefit booklet to determine whether the member's plan includes expanded biomarker coverage.

ctDNA-based MRD assays are designed to detect residual disease specific to the tumor(s) targeted by the assay and therefore cannot be used to detect a separate second primary tumor, even if located in the same organ. Additionally, the assay requires a sufficient quantity of circulating tumor DNA in the tested compartment (typically plasma); insufficient ctDNA limits test applicability and may produce false-negative or indeterminate results. Interpretation is further complicated by tumor heterogeneity, clonal evolution, and potential confounding from CHIP (clonal hematopoiesis), which can produce somatic variants in cfDNA that mimic tumor-derived mutations.

This policy is provided for informational purposes only and does not guarantee payment. Coverage and payment decisions are determined by the member's subscriber agreement, member certificate, and/or employer agreement, which take precedence over this policy. Providers should not treat this document as authorization or assurance of coverage without verifying the member's specific benefits and any required preauthorization.

Benefits and covered services may vary by group and contract. Determinations of whether a service is covered or considered not medically necessary are made based on the member's Benefit Booklet, Evidence of Coverage, or Subscriber Agreement. Providers must verify member-specific benefits and consult applicable participation or employer agreements when planning testing or billing.

ctDNA MRD assays that do not use paired controls (for example, a matched whole-blood sample) or that do not account for CHIP-related variants may misclassify somatic changes detected in cfDNA as tumor-derived. Such misclassification can lead to incorrect clinical decisions (for example, inappropriate eligibility determination for targeted therapies) and misleading MRD interpretations. Where available, paired blood or tissue controls or analytic approaches that filter CHIP-associated variants are recommended to reduce this risk.

Services determined to be not medically necessary or non-covered benefits may not be paid. Providers may not bill or collect payment from a member for services that are denied as not medically necessary unless the member has been informed in advance and has provided written agreement to accept financial responsibility. For member-specific coverage or billing questions, contact the provider call center and review the member's subscriber documentation.

Measurable residual disease (MRD) testing employs highly sensitive genomic technologies such as targeted PCR assays or next-generation sequencing (NGS) to detect tumor-derived genetic material at very low levels in blood or other minimally invasive specimens. Liquid-based MRD approaches commonly analyze circulating tumor DNA (ctDNA or cell-free DNA) and often require establishing a tumor baseline from diagnostic tissue or prior plasma samples, with subsequent serial testing to monitor for molecular recurrence, progression, or therapeutic response. Established single-gene PCR MRD tests (for example, BCR-ABL1 in CML) follow disease-specific guideline testing schedules and can guide treatment decisions when performed with appropriate sensitivity and clinical context.