January 2023 - After Medicare Setback, Ketamine Taskforce Pivots to Pursue FDA Approval

Medicare has declined to pass a national coverage determination for the use of ketamine in the treatment of major depressive disorder.

In response, the Ketamine Taskforce has made the decision to press forward and seek full FDA approval for racemic ketamine as a treatment for major depressive disorder. We are partnering with a large university on a longitudinal research study designed to prove ketamine's effectiveness for this condition. Once FDA approval is secured, insurance companies will no longer be able to classify this treatment as experimental — removing one of the primary barriers patients currently face in accessing care.

Alongside this effort, the Taskforce will also be pursuing FDA approval of racemic ketamine for the treatment of Complex Regional Pain Syndrome (CRPS) and chronic pain.

While Medicare's decision is a setback, it has not changed our direction. If anything, it has clarified the most direct path forward: full FDA approval, backed by rigorous research, that leaves insurers no room to deny coverage on the grounds of experimental use.

We'll share updates as the research study and FDA approval process move forward.