Overview
Digital therapeutics (DTX) provide evidence-based treatments via smartphone or tablet to prevent, manage, or treat various physical and behavioral health conditions. DTX are subject to a higher level of scrutiny and regulation than other digital health solutions because the app itself is the mechanism of care rather than a mechanism to enable provider-delivered care.
To date, U.S. adoption of DTX has been slow due to limited insurance reimbursement structures, lack of integration into healthcare systems, and low patient awareness. That’s a challenge because DTX could significantly impact healthcare by offering patients non-pharmaceutical alternative treatment options that can be more efficiently monitored and providing economic benefits for providers by introducing new and more frequent billing opportunities.
Why Haven’t DTX Been Widely Adopted?
On November 1, 2024, the Centers for Medicare and Medicaid Services (CMS) published the Proposed 2025 Medicare Physician Fee Schedule, introducing three new Healthcare Common Procedure Coding System (HCPCS) billing codes solely applicable to FDA-cleared DTXs that treat mental health conditions. This class of DTX, known as Digital Mental Health Treatment Devices (DMHTs), must be delivered in conjunction with ongoing behavioral healthcare treatment.
The three new codes include:
- GMBT1: Supply of DMHT devices and initial education and onboarding per course of treatment that augments a behavioral therapy plan.
- GMBT2: First 20 minutes of monthly treatment management services directly related to the patient’s therapeutic use of the DMHT device, requiring at least one interactive communication with the patient/caregiver during the calendar month.
- GMBT3: Each additional 20 minutes of monthly treatment management services directly related to the patient’s therapeutic use of the DMHT device, requiring at least one interactive communication with the patient/caregiver during the calendar month.
CMS is also finalizing six G codes to be billed by practitioners in specialties whose covered services are limited by statute to those related to the diagnosis and treatment of mental illness. These HCPCS and G codes mirror current interprofessional consultation CPT codes used by practitioners who are eligible to bill for evaluation and management (E/M) visits.
If finalized, the new codes will become effective January 1, 2025, and will be monitored by CMS under the behavioral health umbrella. The finalized 2025 Medicare Physician Fee Schedule is expected to closely follow the proposed one but is subject to change based on public comment. While these codes focus solely on DTX that treat mental health conditions, the consensus belief is that by keeping the new codes focused solely on DMHT, CMS can use it as a trial to evaluate a broader DTX reimbursement rollout.
Maternal Mental Health and DTX
DTX company, Curio’s, Mama Lift Plus™ became the first FDA-cleared DTX for mild to moderate postpartum depression (PPD) in April 2024. Critically, PPD affects as many as one in seven women (~500,000 annually) in the perinatal period in the U.S. alone. Mama Lift Plus™ offers a non-pharmaceutical alternative to those struggling with PPD and is approved for patients over age 22 as an adjunct to outpatient therapy. It offers eight weeks of daily digital interventions like Cognitive Behavioral Therapy (CBT), Behavioral Activation Therapy (BAT), Interpersonal Therapy (IPT), and Dialectical Behaviour Therapy (DBT). Mama Lift Plus™ demonstrated meaningful symptom improvement of at least four points on the Edinburgh Postnatal Depression Scale (EPDS) for 86.3% of patients in its national Supporting Maternal Mental Health and Emotional Regulation sham-controlled randomized controlled trial (n=141).
Challenges to Accessibility
This is not the first time CMS has attempted to provide billing mechanisms for mental health-focused DTX. In March 2023 CMS attempted to do so but fatally didn’t develop the framework for a national reimbursement rate and potential commercial insurance adoption. It is unlikely that CMS will set a national price for approved DTXs this time around. Instead, CMS will likely rely on the seven regional Medicare Administrative Contractors (MACs) who will set their own reimbursement rates, which may differ wildly from each other. The lack of a clear, national reimbursement rate might deter stakeholders from its adoption.
The timeline for finalizing reimbursement rates is unclear and will likely not be available by the January 2025 ready-for-use date. Even once the rates from each of the seven MAC regions are released and the Fee Schedule is finalized, commercial insurance uptake is not guaranteed. That means hospitals and providers who want to start billing for the DMHT apps must do so before they know the reimbursement rates or timeline for reimbursement. Similarly, patient financial responsibility (in the form of co-pays, deductibles, and/or co-insurance) remains a black box.
Next Steps
CMS’s proposed HCPCS and G codes mark a milestone for DTX recognition and integration as legitimate medical interventions. For the first time, FDA-cleared DTXs like Mama Lift Plus™ will have a clear pathway for Medicare billing and reimbursement. Stakeholders will be watching closely as final rules and reimbursement rates are established and commercial insurers consider their position.
The Policy Center will continue to track these developments and report them to the field.
Join us at the 2025 Maternal Mental Health FORUM to discuss DTX.
