Multicancer Early Detection Testing
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Defines coverage stance for multicancer early detection blood-based screening tests (eg, Galleri) for Medicare Advantage and commercial members of Blue Cross Blue Shield - Rhode Island.
No material clinical or coverage changes in this revision.
Coverage Determinations
Coverage determinations
Coverage determinations by product:
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Some genetic testing services may not be covered for members of self-funded groups that have excluded expanded biomarker testing coverage under the state mandate (R.I.G.L. §27-19-81). For these groups, coverage status—whether a service requires prior authorization, is considered not medically necessary, or is a contract exclusion—is determined by the member’s specific plan provisions and is listed in the Coding section of the Genetic Testing Services or Proprietary Laboratory Analyses policies. Refer to the member’s Benefit Booklet or Evidence of Coverage to confirm whether the plan has customized benefit coverage.
For Commercial products, the use of multicancer early detection (MCED) tests (for example, Galleri) for cancer screening is considered not medically necessary because the evidence is insufficient to demonstrate an improvement in net health outcome. Claims should be adjudicated according to this medical necessity determination and the member’s specific plan benefits.
Coding Guidance
| Unlisted | CPT codes have not been assigned to the test(s) addressed in this policy; use an unlisted code. |
Provider Actions & Billing
Prior authorization and coding
No prior authorization is applicable for multicancer early detection (MCED) testing per this policy. CPT codes have not been assigned to the test(s) addressed in this policy; use an unlisted code when submitting claims.
- Prior authorization: No applicable (per policy).
- Coding: CPT codes have not been assigned; use an unlisted code.
Step therapy
Not applicable.
Benefit verification
Verify member-specific benefits and eligibility by referring to the member's benefit booklet, Evidence of Coverage/Subscriber Agreement, or by contacting the provider call center before ordering MCED testing.
- Benefits and eligibility are determined by the member's subscriber agreement or member certificate and/or the employer agreement.
- For member-specific benefits, call the provider call center or refer to the Benefit Booklet.
Coverage denial triggers
Claims for MCED tests used for cancer screening may be denied: MCED testing is not covered for Medicare Advantage members and is considered not medically necessary for commercial products.
- Medicare Advantage: Use of MCED tests for cancer screening is not covered.
- Commercial products: Use of MCED tests is considered not medically necessary.
Background
Multicancer early detection (MCED) tests are minimally invasive, blood-based “liquid biopsy” assays intended to screen asymptomatic individuals for multiple cancer types by detecting biological signals such as circulating cell-free DNA alterations (methylation patterns, mutations), fragmentation profiles, protein biomarkers, and immune markers. These tests predict the possible presence of cancer rather than provide a definitive diagnosis. Current evidence includes systematic reviews and prospective studies but lacks randomized clinical trials demonstrating improved mortality or other clinical outcomes; additionally, no MCED test has received FDA approval to date.
Key Definitions
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