In April 2022, the Center for Medicare and Medicaid Services (CMS) implemented a new HCPCS code A9291: Prescription digital behavioral therapy, FDA cleared, per course of treatment. As we discussed previously, payers have been reluctant to cover digital therapeutics, often citing insufficient clinical evidence as a reason. This is in spite of manufacturers of the technology providing adequate evidence to be granted FDA 510K, DeNovo and/ or Breakthrough designation for digital therapeutics.