Medicare now pays clinicians for some FDA-authorized therapy apps, substance use included, under narrow rules

The short version

Since January 1, 2025, Medicare has paid clinicians who supply certain FDA-authorized therapy software to patients as part of ongoing mental health treatment. CMS, the agency that runs Medicare, says this covers substance use disorders.

The rules are narrow. The software must fall under a specific FDA classification, a clinician must prescribe or order it, and the clinician must pay for it and then bill Medicare. In its 2026 rule, CMS wrote that claims under the new codes had remained low in volume.

What the rule does

CMS created three billing codes for what it calls digital mental health treatment devices:

• G0552 pays for supplying the device, plus initial education and onboarding, once per course of treatment.
• G0553 pays for the first 20 minutes in a month that a clinician spends managing the patient's use of the device. It requires at least one interactive contact with the patient or caregiver that month.
• G0554 pays for each additional 20 minutes.

The software must be cleared or authorized by the FDA and classified under 21 CFR 882.5801, the FDA category for computerized behavioral therapy devices for psychiatric disorders. reSET, the first app the FDA authorized to help treat substance use disorder, was classified there in 2017 (see our entry on reSET and Pear Therapeutics). CMS wrote that devices for insomnia, substance use disorder, depression, and anxiety have been classified under it.

The clinician has to incur the cost of the device, and its use has to be part of the clinician's own services, within ongoing behavioral health treatment under a plan of care. The patient must have a mental health diagnosis, and the device must be prescribed or ordered. Medicare pays only for the use the FDA authorized, not off-label use.

CMS explained why it drew the line at this FDA category. Devices in it must provide clinical data validating the therapy as the software delivers it, and CMS said it lacks the capacity to evaluate each product itself. Wellness apps without FDA authorization are not covered. CMS wrote that, apart from some digital therapeutics, few such apps show evidence of improving behavioral health outcomes.

What changed for 2026

The 2026 rule added devices classified under 21 CFR 882.5803, the FDA category for digital therapy for ADHD. It declined, for now, to add categories for gastrointestinal conditions, fibromyalgia, and sleep disturbance. It also clarified that the patient needs a mental health diagnosis, but the billing clinician does not have to be the one who made it.

What it does not show

The rule sets billing terms. It says nothing about whether any particular app works.

It sets no national price for the device code. G0552 is priced by each regional Medicare contractor, so payment can differ by region. In the 2026 rule, CMS summarized comments reporting inconsistent contractor pricing and said it would work with the contractors on the billing rules. The two management codes were valued by comparison with existing remote monitoring codes.

It does not guarantee access. The device code can be billed only when the clinician buys the device and supplies it. If a company gives the app to the clinician at no cost, or the patient gets it on their own, that code cannot be billed. In the 2026 rule, CMS said there may be several reasons claims have stayed low, and noted that this buy-and-supply requirement may not fit the direct-to-consumer models some of these products used before the rule. Commenters also told CMS that uneven contractor pricing had discouraged clinicians. CMS did not give a claims count.

It covers Medicare only. Medicaid programs and private insurers set their own rules.

It does not tell you which substance use apps are available now. Our sources do not list products currently marketed under the FDA category, and the company behind the first one, Pear Therapeutics, went bankrupt in 2023.

Why it matters

Before 2025, Medicare had no billing codes built for these devices, and interested parties had asked CMS to create them. Now there is a way to pay, inside a clinician's care and with strings attached.

If you are on Medicare and a clinician offers a therapy app, it is fair to ask whether it is FDA-authorized for your condition, whether it is being billed to Medicare, and what your share of the cost will be. An app outside this FDA category may still be offered to you. This payment policy just does not cover it.

For clinicians and programs, the practical questions are cost and paperwork. The practice buys the device, pricing depends on the regional contractor, and the monthly management codes require documented time and at least one interactive contact a month. CMS has called this an early stage and said the policy will keep evolving.