On June 4, 2025, the Policy Center for Maternal Mental Health submitted written comments in response to a Request for Information (RFI) from the Centers for Medicare & Medicaid Services (CMS) and the Office of the National Coordinator for Health Information Technology (ONC) on Strengthening the Health Technology Ecosystem.
Our comments focus on the unique needs and opportunities in maternal mental health particularly the importance of evidence-based digital health tools, including digital therapeutics, to expand access and improve outcomes. We also address the critical role of electronic medical records (EMRs), reimbursement policies, and digital literacy in advancing equitable maternal mental health care.
The full text of our response is shared below.
June 4, 2025
Centers for Medicare & Medicaid Services,
Department of Health and Human Services
Attention: CMS-0042-NC
P.O. Box 8013
Baltimore, MD 21244-8013
Re: CMS & Office of the National Coordinator (ONC) Request for Information (RFI) on Strengthening the Health Technology Ecosystem
To Whom it May Concern,
The Policy Center for Maternal Mental Health is a non-profit, non-partisan policy and research think tank. We appreciate the opportunity to comment on this important RFI regarding digital health solutions.
As you are likely aware, mental health resources are often accessed by the public through smartphone/device applications, and child bearing aged women are also very likely to access healthcare resources via their devices. Further there are significant mental health provider shortages as well as obstetric provider shortages which support your inquiry into use of these technologies to augment these shortages.
In the field of maternal mental health, there is a growing interest in determining which of these digital resources are evidence-based and therefore could be recommended by treating providers or others such as community-based organizations.
With that in mind, we have been exploring digital therapeutics (DTx). These digital first interventions are developed and validated through rigorous clinical trials and research to ensure their safety and efficacy. For maternal mental health (MMH), DTx represents a vital, adjunct care solution that can be seamlessly integrated into the continuum of maternal health services. These tools provide targeted, timely interventions, such as cognitive behavioral therapy and condition-specific support, that complement in-person care and help close gaps in access, especially for underserved populations. By embedding MMH DTx into electronic medical records and care coordination systems, they become part of an integrated care approach that supports early identification, personalized treatment, and ongoing monitoring. Expanding access to these solutions will require federal investment in digital literacy, clear billing and reimbursement pathways, and support for implementation in diverse care settings.
We also encourage CMS to consider its role in standardizing and requiring specific content in Electronic Medical Record (EMR) platforms. Specifically, we believe all primary care and Obstetric Care EMRs should include prompts for care that is recommended in applicable clinical practice guidelines/recommendations. In the case of maternal mental health, a prompt and/or embedded screener for maternal depression and anxiety would assist in the implementation of such guidelines.
Following are our answers to your specific and relevant questions relative to the Patient and Caregiver questions in the RFI:
B. Patients and Caregivers
1. Patient Needs
PC-3. Are you aware of health management, care navigation, or personal health record apps that would be useful to Medicare beneficiaries and their caregivers?
Response:
As mentioned above, we believe that digital therapeutics are important digital tools for both patients and providers to prescribe, given they are rigorously tested.
In April of 2024, the first DTx for maternal mental health, MamaLift Plus™, was approved by the FDA. The treatment, developed by Curio, was studied by randomized control trial.
As per the American College of Obstetricians and Gynecologist (ACOG) guidelines, providers are encouraged to screen during and after pregnancy. This is enabled by the MamaLift Plus app. Screeners are presented to patients in a gamified fashion, encouraging patients to respond openly and honestly without the stigma and pressure of sitting in front of a clinician.
The prescribed app leverages proprietary algorithms and personalized digital behavioral interventions to facilitate the timely identification of which patients need intervention support and treatment.
The FDA found MamaLift Plus effectively connects patients to appropriate intervention, diverting approximately 2 out of 3 cases that would have developed into severe depression.
In addition, MamaLift Plus integrates with provider EMRs, allowing clinicians to monitor screening scores, engagement metrics, and treatment progress. In urgent cases, patient coaches coordinate with prescribing providers to ensure timely follow-up. This integration facilitates a continuous care model and reduces the risk of patients falling through the cracks. Its EMR integration not only enhances clinical oversight and documentation but also supports real-time decision-making, ensuring that interventions are both timely and tailored to patient needs. This closed-loop system of communication between patient, provider, and care coach improves continuity of care, promotes accountability, and helps reduce the burden on overwhelmed healthcare systems.
PC-5a. What technology solutions, policy changes, or program design changes can increase patient and caregiver adoption of digital health products (for example, enhancements to data access, reimbursement adjustments, or new beneficiary communications)?
Response:
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.
While the 2025 Physician Fee Schedule final rule, effective January 1, 2025, takes a positive step toward expanding access to behavioral health services by establishing coding and separate payment for select digital mental health therapeutic (DMHT) devices, CMS has yet to provide a national billing framework for mental health-focused digital therapeutics. In the absence of such guidance, CMS is expected to defer to the seven regional Medicare Administrative Contractors (MACs), each of which may set its own reimbursement rates. This fragmented approach could lead to significant variability across regions and create uncertainty for providers and developers, ultimately deterring broader adoption of these innovative tools.
PC-6. What features are most important to make digital health products accessible and easy to use for Medicare beneficiaries and caregivers, particularly those with limited prior experience using digital tools and services?
Response:
Effective policies to increase accessibility and feasibility of digital health products include the expansion of broadband.
In addition, the federal government can establish block grants so that states can create localized training to improve digital literacy. Improving tech literacy is necessary as the digital divide grows and is critical in addressing maternal mental health disparities and stark differences in access to treatment and care based on geography and transportation access.
2. Data Access and Integration
PC-8c. What specific opportunities and challenges exist to improve accessibility, interoperability and integration of clinical data from different sources to enable more meaningful clinical research and generation of actionable evidence?
Response:
A key opportunity to improve accessibility, interoperability, and integration of clinical data lies in the standardization of EMRR platforms. CMS can play a leadership role by requiring that EMRs, particularly in primary care and obstetric settings, include standardized prompts and clinical decision support tools aligned with evidence-based guidelines. For example, embedding validated screeners for maternal depression and anxiety directly into obstetric EMRs would help ensure consistent data collection and adherence to clinical recommendations.
Such standardization would not only support improved patient care but also generate structured, comparable clinical data across systems and populations. This, in turn, would enhance the quality and utility of real-world data for research and evidence generation.
However, current challenges include variability in EMR functionality across vendors, lack of alignment in data fields and coding systems, and limited interoperability between health systems. These issues make it difficult to aggregate and analyze data meaningfully across settings. Addressing these challenges will require CMS to coordinate with vendors, providers, and standards bodies to define core data elements and workflows that support both care delivery and clinical research.
C. Providers
1. Digital Health Apps
PR-1. What can CMS and its partners do to encourage providers, including those in rural areas, to leverage approved (see description in PC-5) digital health products for their patients? What are the current obstacles?
Response:
To encourage the use of approved digital health products, including digital therapeutics (DTx), CMS and its partners should prioritize provider education and engagement. This includes developing targeted outreach to clarify what DTx are, how they differ from general wellness apps, and how they can be safely and effectively prescribed to improve patient outcomes. Providing clinical use cases, reimbursement guidance, and integration strategies within existing care models, especially for underserved populations, would further accelerate adoption.
Current obstacles to utilization, particularly in rural areas, include persistent underinvestment in broadband infrastructure, which limits access to internet-based health interventions such as DTx. Inadequate digital literacy among both patients and some providers, limited awareness of FDA-approved digital products, and a lack of reimbursement clarity also pose significant barriers. Addressing these systemic issues through coordinated investment, training, and policy support is essential to ensure equitable access to digital health innovations across all communities.
a. What information should providers share with patients when using digital products in the provision of their care?
Response:
Providers should underscore how scientifically rigorous assessments of DTx have been, namely that they are subject to rigorous clinical trial requirements and regulatory oversight, similar to medication or medical devices.
In addition to their proven clinical value, DTx platforms are also held to strict standards for data privacy and security. Patient health information shared through these tools is protected under HIPAA and other relevant federal and state regulations. Platforms like MamaLift Plus use encrypted data transmission, secure storage, and controlled access protocols to ensure that sensitive health information remains confidential and is only shared with authorized care team members. This commitment to privacy, paired with clinical transparency and oversight, strengthens patient trust and enables providers to confidently integrate digital therapeutics into care plans.
b. What responsibilities do providers have when recommending use of a digital product by a patient?
Response:
Providers should ensure that patients are still connected to clinical care as this app and other DTx are to be used as an adjunct to clinician‐managed outpatient care.
Thank you for the opportunity to offer public comments on this important issue.
Sincerely,
Kathryn Santoro
Principal
Policy Center for Maternal Mental Health
Regan Moss
Policy & Programs AnalystPolicy Center for Maternal Mental Health
