Medicare now pays for some digital therapies and remote monitoring, within limits
A 2025 rule created billing codes for FDA-cleared mental-health software. The 2026 rule adds short-episode remote-monitoring codes but declines to widen the digital-therapy benefit.
Medicare began paying clinicians for certain FDA-cleared digital mental-health treatment software on 1 January 2025, and for 2026 it has added new billing codes for shorter episodes of remote patient monitoring [s1]. But in the same 2026 rule the programme declined to extend the digital-therapy benefit beyond mental-health software, leaving coverage real but deliberately narrow [s1].
This matters because the commercial case for digital therapeutics and remote monitoring rests heavily on whether a payer will reimburse them. A tool that a clinician cannot bill for is a tool most practices will not deploy at scale. The detail of what Medicare will and will not pay for therefore shapes which of these products reach patients — separately from whether the underlying evidence for digital therapy is strong, which it often is not.
The digital mental-health benefit, and its edges
In its physician fee schedule rule for 2025, the Centers for Medicare & Medicaid Services (CMS) established Medicare payment for "digital mental health treatment" (DMHT) devices — software cleared, approved or granted De Novo authorisation by the FDA that delivers a mental-health treatment intervention, used alongside ongoing behavioural health care [s1]. Effective 1 January 2025, CMS finalised three billing codes: G0552 for supplying the device plus initial education and onboarding, G0553 for the first 20 minutes of monthly treatment-management services, and G0554 for each additional 20 minutes [s1].
The conditions attached are strict. To be payable, the device must have been cleared under section 510(k) of the Federal Food, Drug, and Cosmetic Act or granted De Novo authorisation by the FDA and classified under a specific regulation for computerised behavioural therapy devices [s1]. The billing practitioner must incur the cost of the device, must diagnose the patient with a mental-health condition, and must prescribe or order the device, which has to be furnished incident to the practitioner's services under a behavioural-health plan of care [s1].
In the 2026 rule, CMS was asked to broaden this — to pay for FDA-cleared digital treatments aimed at conditions other than mental illness, and for a wider set of digital tools used in care. It declined. "At this time, we are not further expanding payment under our DMHT payment policy," the agency wrote, adding that it might consider expansion in future rulemaking [s1]. Commenters had also pushed CMS to pay for digital tools not cleared by the FDA as devices; many others argued no payment should be made for anything without FDA clearance, and CMS did not finalise any new payment for uncleared tools [s1]. The boundary of the benefit, for now, is an FDA clearance for a mental-health indication.
New remote-monitoring codes for shorter episodes
The 2026 rule also reworks remote monitoring. Remote physiologic monitoring (RPM) covers tracking of parameters such as weight, blood pressure and pulse oximetry; remote therapeutic monitoring (RTM) covers adherence to at-home therapeutic interventions for respiratory, musculoskeletal and cognitive-behavioural-therapy uses [s1]. Until now the main RPM device code, CPT 99454, effectively required at least 16 days of data transmission in a 30-day period — a threshold that excluded shorter courses of monitoring [s1].
For 2026 the CPT Editorial Panel created two new RPM codes, 99445 and 99470, describing fewer than 16 days of data transmission and fewer than 20 minutes of interactive communication per month, and four new RTM codes including 98984, 98985 and 98979 for the same short-duration use [s1]. CMS adopted them. The agency said the shorter-episode codes "could be valuable for beneficiaries with acute conditions or [who] are more stable in their treatment," while noting some commenters' worry that fewer monitoring days deliver less clinical value and raise the potential for inappropriate billing [s1]. CMS stressed that, like any service, the new codes must be "reasonable and necessary for the diagnosis and treatment of illness or injury" to be paid [s1].
Two further points set the monitoring rules in context. First, CMS clarified that DMHT, RPM and RTM are not Medicare telehealth services: because they are inherently non-face-to-face, they fall outside the statutory definition of telehealth and are not bound by its place-of-service restrictions [s1]. That is an advantage — it frees them from the geographic limits that constrain video visits. Second, the valuations are unsettled: CMS said several RPM codes did not meet the survey requirements for pricing and will be resurveyed, and the new RTM codes are treated as new technology to be reviewed after three years of data, in 2030 [s1].
What to watch
The direction of travel is incremental. CMS has built a coverage pathway that is explicit about FDA clearance and tightly scoped to mental-health software, while steadily adding monitoring codes for shorter and more varied episodes of care. The proposed physician fee schedule for 2027, published in July 2026, continues the annual reworking of Part B payment policy and is the document in which any expansion of the digital-therapy benefit would first appear [s2].
For companies selling digital therapeutics, the lesson of the 2026 rule is that an FDA clearance is the entry ticket to Medicare payment but not a guarantee of it, and that the categories CMS will pay for expand slowly and on its own schedule. For the wider shift toward care delivered at home, the monitoring codes are the plumbing that decides whether it can be billed.
Sources
- Medicare and Medicaid Programs; CY 2026 Payment Policies Under the Physician Fee Schedule (final rule, 90 FR 49266) — US Centers for Medicare & Medicaid Services , November 5, 2025
- Medicare and Medicaid Programs; CY 2027 Payment Policies Under the Physician Fee Schedule (proposed rule, 91 FR 43842) — US Centers for Medicare & Medicaid Services , July 16, 2026
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