AAT Augmentation denied as not medically necessary by Blue Cross Blue Shield?

Blue Cross Blue Shield's specific coverage criteria for aat augmentation 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 Denies AAT Augmentation on Medical-Necessity Grounds

Alpha-1 antitrypsin (AAT) augmentation therapy is an IV infusion treatment for individuals with diagnosed AAT deficiency — a hereditary condition that can lead to progressive lung disease. Blue Cross Blue Shield plans typically apply a medical-necessity standard that requires documented AAT deficiency confirmed by laboratory testing, evidence of lung function impairment, and an active smoking-cessation effort. When clinical records do not clearly establish each of these elements, a medical-necessity denial follows.

This denial is appealable. BCBS plans are required under ACA §2719 to offer internal appeal and, for non-grandfathered plans, external review by an independent organization. ERISA §503 entitles members of employer-sponsored plans to a full-and-fair review of any adverse benefit determination. You generally have up to 180 days from receipt of a denial to file an internal appeal, and if you remain covered during a course of treatment, you may qualify for an expedited review (decision within 72 hours). Once internal appeals are exhausted, external review must be requested within four months of the final internal denial.

## What to Gather

• Confirmed diagnosis: Laboratory documentation of AAT deficiency (phenotype/genotype testing) from a qualified laboratory, accompanied by your treating physician's diagnosis letter.
• Lung function evidence: Pulmonary function test (PFT) results with your pulmonologist's interpretation showing the degree of obstructive impairment and its trajectory over time.
• Smoking-cessation documentation: Records confirming non-smoking status or active participation in a cessation program if required by the plan.
• Treatment history: Prior medications tried for lung disease management, with start/stop dates and clinical outcomes, to show augmentation is not the first-line step.
• Medical-necessity letter: A detailed letter from your treating physician explaining why augmentation therapy is medically necessary for you specifically, referencing your chart data.

## Criteria-Mapping Structure

Obtain the exact eligibility criteria from two sources: (1) the FDA-approved prescribing information for the specific AAT product prescribed, and (2) BCBS's published medical policy for AAT augmentation therapy. Create a two-column document that lists each criterion from those sources in the left column and the specific chart fact, test result, or clinical note that satisfies it in the right column. Attach the underlying records as exhibits. This structure forces the reviewer to engage with each criterion individually rather than issue a blanket denial.

The applicable guideline organizations — including the American Thoracic Society and the Alpha-1 Foundation — have published clinical guidance on patient selection for augmentation therapy. Your physician's letter should reference the relevant guideline (by organization name) and confirm that your case meets its criteria, without requiring the reviewer to independently look up the standard.

## Timeline

1. File internal appeal within 180 days of denial (sooner is better). 2. BCBS must decide within 30 days for pre-service appeals, 60 days for post-service. 3. If denied internally, request external review within 4 months. 4. For urgent ongoing treatment, request expedited review simultaneously.