Hereditary Cancer Panel denied as not FDA-approved for this use by Blue Cross Blue Shield?

Blue Cross Blue Shield's specific coverage criteria for hereditary cancer panel are defined in its own published medical/coverage policy and the FDA-approved prescribing label. A successful appeal documents that your medical records satisfy each criterion those sources list — confirmed diagnosis, any required prior treatments (with dates and outcomes), and clinical severity. If the exact criteria weren't included with your denial, request them in writing; your appeal then maps each requirement to the matching fact in your chart.

## Why This Denial Happens

Hereditary cancer panel tests are laboratory-developed tests (LDTs) regulated under the CLIA framework rather than through the FDA's premarket approval pathway used for drugs and some medical devices. BCBS may issue a "not FDA-approved" denial when its claims or utilization management system flags the test using criteria designed for drugs or devices, or when the plan's coverage policy requires FDA clearance for genetic tests without distinguishing LDTs from device-regulated tests. This is often a coding or policy-classification error rather than a substantive clinical finding, and it is one of the most technically correctable denials.

## Why This Is Appealable

The correct regulatory framework for most hereditary cancer panels is CLIA certification and, where applicable, New York State Clinical Laboratory Evaluation Program (CLEP) approval — not FDA premarket approval. Your appeal should clarify the applicable regulatory pathway and demonstrate that the performing laboratory holds the required CLIA certification. An ordering clinician letter and a one-page explanation of the LDT regulatory framework typically resolves this class of denial at the internal level. If not, an external reviewer applying objective clinical and regulatory standards will have the same analysis available.

## Federal Appeal Framework

• Internal appeal: File within the deadline on the denial notice. This type of denial is often resolved quickly at the internal level when the correct regulatory information is supplied.
• External review (ACA §2719): After final internal denial, external review is available — generally within four months. The independent reviewer will apply current regulatory standards.
• Expedited review: Available when the patient's condition is urgent.
• ERISA §503: Applies to self-funded plans; full-and-fair review and federal court access after exhaustion.
• State insurance department: For fully-insured plans, a parallel complaint is appropriate if BCBS maintains a facially incorrect regulatory basis for denial.

## Documentation to Gather

1. CLIA certificate for the performing laboratory — downloadable from the CMS CLIA database — confirming the lab is certified for high-complexity testing. 2. New York CLEP approval if applicable (required for samples from NY patients at many labs). 3. Ordering clinician's letter explaining that hereditary cancer panel tests are laboratory-developed tests regulated under CLIA, not subject to FDA premarket approval, and that the performing lab holds all required certifications. 4. Lab's test information sheet or technical summary confirming regulatory status and certifications. 5. BCBS medical policy — obtain to identify whether the "not FDA-approved" language in the denial reflects the policy's actual text or a claims-processing error.

## Criteria-Mapping Structure

If BCBS's coverage policy genuinely requires FDA approval for this service, the appeal should include a two-column table addressing each coverage criterion. For the regulatory criterion specifically, place the policy language on the left and on the right provide the CLIA framework explanation plus the lab's CLIA certificate. If the denial appears to be a claims-processing error rather than a policy-driven denial, note that explicitly in the appeal letter and request that the claim be reprocessed under the correct criteria.