ED Implant denied as not FDA-approved for this use by Blue Cross Blue Shield?

Blue Cross Blue Shield's specific coverage criteria for ed implant 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 BCBS Denied Your Penile Implant as Not FDA-Approved — and How to Appeal

A "not FDA-approved" denial from Blue Cross Blue Shield asserts that the specific penile prosthesis device lacks FDA marketing authorization for the indicated use. This denial is uncommon for established penile implant devices — most have FDA 510(k) clearance — but can occur when a claim is coded in a way that suggests an off-label use, when a newer device iteration is involved, or when administrative coding errors lead BCBS to apply the wrong policy.

### Why This Denial Is Appealable

FDA 510(k) clearance and FDA premarket approval (PMA) are both valid forms of FDA marketing authorization. Most penile prosthesis devices on the U.S. market have received one of these authorizations. If the device has FDA clearance or approval, this denial rests on a factual error and can be overturned by supplying the correct FDA documentation. If the denial actually reflects a coding issue, correcting the CPT or HCPCS code with a corrected claim may resolve the matter before a formal appeal is needed. Confirm with your urologist's billing office which pathway applies.

### Federal Appeal Framework

• Corrected claim (first step): If the denial results from a coding error, submit a corrected claim with the proper device code and FDA clearance documentation before filing a formal appeal.
• Internal appeal: If the denial persists, file a written internal appeal within the deadline on the Explanation of Benefits. Request the specific BCBS policy basis for the not-FDA-approved determination.
• External review (ACA §2719): After internal exhaustion, request independent external review. The window is approximately four months from the denial date for most plans; confirm your exact deadline.
• Expedited review: If delay would seriously jeopardize health, request expedited review. Decisions are typically required within 72 hours.

### What to Gather

1. FDA clearance or approval documentation — the 510(k) clearance letter or PMA approval for the specific device, available from the FDA's publicly searchable device database (search by device name or manufacturer at fda.gov/medical-devices). 2. Device identification information — manufacturer name, device trade name, model number, and the FDA product code or K-number from the clearance letter. 3. Surgeon's operative or pre-authorization records — confirming which specific device was or will be implanted. 4. Coding review — ask the billing office to confirm the CPT, HCPCS, and ICD-10 codes submitted and whether they accurately represent the device and the clinical indication. 5. Prescriber medical-necessity letter — noting that the device is FDA-cleared for the intended use and is the standard of care per AUA guidelines.

### Criteria-Mapping Structure

For this denial type, the appeal is primarily factual rather than clinical. Present the FDA clearance documentation first and most prominently. Then address each specific claim BCBS made to support the not-FDA-approved finding, with the corresponding document that refutes it. If the denial is based on a coding mismatch, include the corrected codes and an explanation of the correction.