“These additions are critical, as they reflect the growing clinical evidence supporting the effectiveness of DTx across a broader range of chronic and comorbid conditions. ATA Action strongly supports these proposed expansions and urges CMS to continue broadening the list of eligible conditions to reflect both clinical need and innovation in the digital health space.”

“Due to the variability between devices, many of our members would prefer to see codes specific to each device rather than by device classification. We understand such an approach may not be viable at this point, ATA Action recommends CMS consider multiple pathways to improve DMHT code valuation.”

“In the near term, we strongly urge CMS to create new supply codes for the four additional FDA device classifications discussed above and that the Agency consider modifiers for such codes if necessary to distinguish between mental health conditions treated by the same device class to allow for more specific analyses of treatments and pricing.”

“In the longer term, ATA Action urges CMS to pursue a structure of differential pricing primarily by therapeutic indication, consistent with regulatory and clinical practice frameworks. While recognizing that variation in complexity and return on investment can exist within indications, indication-based categorization provides a transparent and practical foundation. Within each indication, CMS may incorporate secondary adjustments to reflect substantial differences in development complexity, evidence base, or treatment models, thus balancing clarity and flexibility while avoiding overly burdensome complexity metrics.”

“Unfortunately, the MAC pricing process has been slow, and the MACs are questioning DMHT coverage. Furthermore, there are concerns about fair and accurate pricing for DMHT devices which seem to be driven by a continued lack of understanding between various types of technologies (e.g. unregulated wellness apps, remote monitoring devices, and DTx) and when DMHT use is clinically indicated. The MACs do not seem to appreciate that DMHTs deliver clinically validated cognitive behavioral therapy (CBT), and thus treatment using a DMHT device would be clinically indicated in the same circumstances as other forms of CBT.”

• “Explain to the MACs the rationale for coverage of specific FDA classifications of devices (e.g. what is required to meet special control requirements) and what level of clinical evidence review is appropriate in light of the specific controls required by FDA and the relatively low level of risk posed by DMHTs as Class II devices;
• Instruct the MACs to use DMHT device invoices reflecting the cost to physician practices for purposes of establishing fair and accurate DMHT device pricing;
• Direct the MACs to communicate the documentation required for G0552 device coverage; and
• Instruct the MACs to develop a timely and transparent process for G0552 device claims review.”

“CMS should ensure that the MDPP payment model for online delivery accurately reflects the real costs of providing the program. Although virtual care has the potential to improve outcomes at lower overall cost, online providers still face significant upfront expenses, such as technology platform costs and supplying each participant with a medical-grade, cellular-enabled weight scale so that beneficiaries can track their weight reliably at home. We strongly encourage CMS to further evaluate the costs to MDPP providers and establish fair and accurate payment for MDPP services.”

“RTM and RPM treatment management codes remain significantly undervalued compared to similar services like Chronic Care Management (CCM), which have received appropriate upward adjustments. To ensure continued access to high-quality care and support the long-term viability of remote monitoring, we urge CMS to update these code valuations accordingly and ideally align RTM and RPM reimbursement rates with those of CCM, given the comparable time, complexity, and value involved in delivering these services.”

“As a board-certified gastroenterology provider, I urge CMS to expand Medicare’s Digital Mental Health Treatment (DMHT) payment policy to include FDA-cleared devices classified under 21 CFR 876.5960: Computerized behavioral therapy device for treating symptoms of gastrointestinal conditions. IBS affects 4 to 5 percent of the US population, and guidelines currently recommend GI behavioral therapy to improve IBS patient symptoms and quality of life. However, Medicare beneficiaries cannot access these therapies due to severe workforce shortages — only a few hundred providers nationwide are trained to deliver these treatments. FDA-cleared digital therapeutics under §876.5960 deliver the same evidence-based interventions in a scalable, accessible format.”

“Health coaching, which includes but is not limited to motivational interviewing, has strong evidence of improving both medical and behavioral outcomes and therefore we recommend that CMS should:

• Move health coaching T-codes (0591T–0593T) to permanent G-codes
• Allow incident-to billing for health coaches under general supervision
• Ensure codes explicitly capture prevention, caregiver support, social isolation, and physical activity interventions
• Permit delivery via telehealth to increase accessibility and equity”

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