All PlansCoverageHigh impact
Investigational Gene Expression, Biomarker, and Multianalyte Testing
Regence BlueShield·Oncology, Neurology, Gastroenterology +7 more·Coding
Effective date
Jul 1, 2026
We identified it
Jul 7, 2026
Summary
Effective July 1, 2026, this new policy establishes that investigational gene expression, biomarker, and multianalyte tests are NOT covered by insurance. The policy lists 80+ specific tests (including MindX™, aiSLE™ DX, DecisionDx®-SCC, and others) as investigational due to insufficient evidence of clinical utility. Providers may bill patients directly for these tests, but must inform patients in advance that they will be financially responsible.
Action Required
By June 30, 2026: Billing team must update billing system and encounter forms to flag all 80+ investigational tests listed in Policy LAB77 as non-covered. Create a denial protocol for claims using CPT codes 0006M, 0007M, 0019M, 0063U, 0108U, 0170U, 0258U, 0263U, 0288U, and others per the policy list. Providers must obtain written acknowledgment from patients BEFORE ordering any of these tests, confirming patient understands the tests are investigational and patient assumes full financial responsibility. Implement a pre-visit notification process to inform patients of this policy. Billing staff should deny all claims for these tests with explanation: 'Test is investigational and not covered per Policy LAB77.' Train all clinical staff on the complete list of investigational tests to avoid ordering non-covered services. Failure to obtain patient authorization will result in payment disputes and potential patient complaints.