Brainsway Dtms denied as non-formulary by Humana?

Humana's specific coverage criteria for brainsway dtms 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 Humana May Deny BrainsWay Deep TMS as Non-Formulary

BrainsWay Deep TMS is a medical device procedure rather than a pharmaceutical, so a "non-formulary" framing from Humana typically means the procedure is not listed as a covered benefit under the plan's coverage schedule, or that it falls under a benefits category—such as outpatient mental health or durable medical equipment—that requires specific authorization or is explicitly excluded. The pathway to appeal depends on which of these applies to your plan.

This denial is worth appealing because coverage policies for neuromodulation treatments continue to evolve, and plan documents sometimes exclude treatments that are nonetheless covered under the plan's mental health parity obligations.

## Federal Appeal Framework

• Mental Health Parity and Addiction Equity Act (MHPAEA): Plans that cover mental health conditions must apply the same benefit limitations to mental health treatments as to analogous medical/surgical benefits. If Humana covers comparable neuromodulation or procedural treatments for medical conditions, parity may require similar coverage for psychiatric indications.
• ACA §2719 / External Review: Available for most non-grandfathered plans within approximately 4 months (180 days) of denial. Expedited review is available for urgent situations.
• ERISA §503: Guarantees access to the plan document, the specific exclusion language cited, and a full-and-fair internal review.

## Appeal Process and Timeline

1. Review your Summary Plan Description (SPD) or Evidence of Coverage (EOC) — identify the specific exclusion or non-coverage language Humana is applying. 2. Internal appeal — contest the exclusion on medical-necessity and, where applicable, mental health parity grounds. Standard decision timeline is 30 days; urgent is 72 hours. 3. External review — if the internal appeal fails, request independent review, particularly if a parity argument applies.

## Documentation to Gather

• Plan document language: The exact exclusion or benefit limitation language from your EOC or SPD.
• Diagnosis and medical-necessity documentation: Chart notes, validated assessments, and a prescriber letter establishing clinical need.
• Prior treatment history with dates and outcomes: Evidence of prior treatments tried, supporting that this is not a first-line request.
• FDA clearance confirmation: Documentation that BrainsWay Deep TMS is FDA-cleared for the diagnosed condition.
• Parity comparator (if applicable): Examples of analogous medical/surgical procedures covered by the plan, to support a MHPAEA argument.

## Criteria-Mapping Structure

Work through the denial by addressing each layer:

| Issue | Evidence to Submit | |---|---| | Specific exclusion cited by Humana | [Quote from denial letter + plan document] | | Medical necessity for this treatment | [Prescriber letter + chart documentation] | | FDA clearance for this indication | [510(k) clearance reference] | | Mental health parity argument (if applicable) | [Comparable covered medical procedures] |

Obtain both your plan's current benefit document and Humana's published Deep TMS medical policy before filing. These may differ, and both are relevant.