CMS 2025 Proposed Physician Fee Schedule Released, Adds Codes for Digital Therapeutic Products

This sets a precedent for Medicare coding, coverage, and reimbursement that can be applied to additional therapeutic categories.

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The CMS 2025 Proposed Physician Fee Schedule (PFS) was released yesterday and, for the first time, includes codes specifically for digital therapeutic products. The three proposed new codes were created to cover the supply and management of FDA cleared “digital mental health treatment (DMHT) devices” as a physician service. The three new codes are listed below with detail.

Years of hard work from DTA, its members, and partners have gotten us to this point. This sets a precedent for the future of the industry. We have a lot of work to do, but let’s take a moment to celebrate this monumental milestone.

Last year at this time, DTA worked with its members in responding to the request for information on digital therapies from CMS in the proposed PFS last year. DTA strongly encouraged CMS to leverage their authority to classify these products under the durable medical equipment (DME) and incident-to physician services benefit categories.

While we asked for coverage of all federally regulated DTx under multiple benefit categories, and did not get everything we requested, it is clear that CMS has responded favorably by introducing incremental updates.

Read DTA’s full 2023 Comment Letter here.

What is the PFS? 

The PFS is the primary method of payment for enrolled health care providers. Medicare uses the PFS when paying:

• Professional services of physicians and other health care providers in private practice.
• Services covered incident to physicians’ services (other than certain drugs covered as incident to services)

The PFS is updated annually with the proposal for the following year released mid-year and the final rule released at the end of the year.

What does the proposed rule state that applies to me?

Coding, coverage, and reimbursement are critical to national access in the US. CMS is a coverage trend setter and has historically not covered digital therapeutic products in any streamlined capacity. This is the first time CMS has provided Medicare reimbursable codes for digital therapeutic products. These codes are furnished through physician services, which may apply to your products already.

If you haven’t looked at your product as a physician service, consider if this applies to you. To understand if your product is a physician service, DTA Members can join the upcoming webinar, 2025 Proposed Medicare PFS: DTA Member Update.

Is this good news?

Yes! This is the first acknowledgement of a pathway for reimbursement for a certain sector of digital therapeutic interventions. This sets a precedent for Medicare coding, coverage, and reimbursement that can be applied to additional therapeutic categories. This allows for fewer payment workarounds to gain traction for your product.

Additionally, this signals to the investment community that there is truly a viable reimbursement pathway for DTx.

If you are not FDA cleared, then this does not directly apply to you. However, you must look at this and keep working with DTA to ensure that your business model is up to date with the evolving landscape.

What will happen next?

DTA will submit a response within 60 days. To prepare, we are seeking Member volunteers to work as a temporary sub-committee to develop an initial draft that we will share with the US Policy Task Group in mid-August for their feedback.

If you have interest and time to commit to the Sub-Committee, please reach out to Molly (molly@dtxalliance.org).

We will not lose sight of the additional reimbursement pathways necessary to complete the picture. There is much work to be done for all of the therapeutic categories and business models.

Three Proposed Codes

GMBT1 (Supply of digital mental health treatment device and initial education and onboarding, per course of treatment that augments a behavioral therapy plan)

Valuation of GMBT1: CMS is proposing contractor pricing for GMBT1 and seeking comments on which national pricing methodologies may be considered, including crosswalks.  Other Considerations for GMBT1:

• GMBT1 requires billing practitioner who diagnosed patient and prescribed / ordered DMHT device or billing practitioner’s clinical staff monitor patient’s therapeutic response to the DMHT device and adjust the behavioral health therapy plan as needed
• Payable only if device has been FDA cleared and billing practitioner is incurring the cost of furnishing the DMHT device to the beneficiary
• Furnishing device must be incident to practitioner’s professional services in association with ongoing treatment under a plan of care
• Practitioner must diagnose the patient and prescribe or order the DMHT device
• Patient could use DMHT device at home or perhaps in an office or other outpatient setting, if that is how the device has been cleared by FDA
• Device must have demonstrated reasonable assurance of safety and effectiveness
• GMBT1 would not be payable in cases where the billing practitioner incurs no cost

GMBT2 (First 20 minutes of monthly treatment management services directly related to the patient’s therapeutic use of the digital mental health treatment (DMHT)

Valuation of GMBT2:  CMS proposes a direct crosswalk to CPT code 98980 (RTM first 20 minutes), that is assigned a work RVU of .62 and has a 2024 National Payment Amount of $50.60 (non-facility) and $30.29 (facility).  Other Considerations for GMBT2:

• The device augments a behavioral therapy plan, physician/other qualified health care professional time reviewing data generated from the DMHT device from patient observations and patient specific inputs in a calendar month
• Requires at least one interactive communication with the patient/caregiver during the calendar month)
• Should only be billed when there is “ongoing use of the DMHT device” and should “not be billed in cases where the patient discontinues use of the DMHT device”
• CMS believes work and PE described by these crosswalk codes are analogous to the services described in GMBT2 and GMBT3, because they include similar physician/other qualified health care professional time in a calendar month requiring at least one interactive communication with the patient/caregiver during the calendar month
• CMS welcome comments on the proposed RVU’s

GMBT3 (Each additional 20 minutes of monthly treatment management services directly related to the patient’s therapeutic use of the digital mental health treatment (DMHT)

Valuation of GMBT3: CMS proposes a crosswalk to CPT code 98981 (RTM each additional 20 minutes), that is assigned a work RVU of .61 and has a 2024 National Payment Amount of $39.95 (non-facility) and $29.96 (facility).  Other Considerations for GMBT3:

• Device augments a behavioral therapy plan, physician/other qualified health care professional time reviewing data generated from the DMHT device from patient observations and patient specific inputs in a calendar month
• Requires at least one interactive communication with the patient/caregiver during the calendar month
• Should only be billed when there is “ongoing use of the DMHT device” and should “not be billed in cases where the patient discontinues use of the DMHT device”
• CMS believes work and PE described by these crosswalk codes are analogous to the services described in GMBT2 and GMBT3, because they include similar physician/other qualified health care professional time in a calendar month requiring at least one interactive communication with the patient/caregiver during the calendar month
• CMS welcome comments on the proposed RVU’s