“Expand remote monitoring codes to cover:

• Asynchronous Communication, which minimizes hassle for patients and providers and allow for between-encounter check-ins and updates;
• Digital Navigation Tools, which help patients find experienced providers who match their needs for access;
• Caregiver Portals, to incentivize provider use of advanced tooling for tracking patient progress, visualizing change over time and across patients, identifying potential flags for interventions, providing comparative information to other providers; and
• PRO and Passive Monitoring Tools, which help patients track their progress, and specifically which take advantage of AI tools that can provide insights and support patients and their care teams in shared decision-making;

Allow reimbursement for services delivered by a wider array of licensed behavioral health professionals, including coaches, social workers, and out-of-state providers under interstate licensure compacts; and Pilot a digital-first Alternative Payment Model (“APM”) comparing AI-enabled and traditional models, using [an outcomes framework Spring outlined in a different part of its letter], with a goal of establishing the value proposition for both the provider and the patient in using AI tools and illustrating how these tools can be used successfully in routine care settings.”

Create new reimbursement codes specific to digital care so that real world data and digital health-driven outcomes could be better studied

“Omada believes the best way [for CMS] to collect [real world] data would be to enable healthcare providers who use digital health tools and digital health products to submit claims for that care. If this were to occur, digital care, like traditional care today, would produce substantive clinical data that can be used to further study digital care and its efficacy, safety, and economics (both immediate cost and long-term ROI), just as we study the claims data of traditional care today. Unfortunately, there are current impediments to this analysis. For example:

• A significant majority of CPT codes require synchronous care or are not otherwise amenable to use by providers of asynchronous care. In addition, there are even more Category 1 E&M codes that describe care that can safely and effectively be supplied asynchronously with the support of digital health tools and products but cannot be billed for using existing CPT codes. Some research has been conducted on the quantity of Category 1 E&M CPT codes for services that could be supplied asynchronously as well as synchronously.
• Not all digital health tools and digital health products (and perhaps even very few) are FDA-regulated devices, and many, if not most, should not be treated as devices under the provisions of the 21st Century Cures Act. This means, however, that category 2 CPT codes (for devices) are not usable for many health care services . Using device codes would muddy the analytic data about what care services actually occurred and could undermine the integrity of results on outcomes or costs.”

“Expanding Medicare coverage of digital care navigation services beyond breast and cervical cancer is essential to ensure equitable access to timely, coordinated care across a broader range of conditions. While recent policy changes rightly acknowledge the value of navigation in cancer screening and follow-up, beneficiaries facing other complex or chronic health conditions including diabetes, cardiovascular disease, musculoskeletal disorders, and mental health challenges, stand to benefit equally from personalized, technology-enabled support.”

“Remove the regulatory cap on ‘non-standard’ plan design to encourage innovation and the expansion of virtual-first plan offerings on Federally-facilitated Exchanges (FFEs) and State-based Exchanges on the Federal platform (SBE-FPs).”

“CMS should lower the barrier to access for proven digital health tools, including evidence-based wearable devices, through the following mechanisms: a. Medicare Coverage Expansion: cover wearable devices and apps under Medicare as durable medical equipment or remote monitoring tools. b. Medicaid Waivers and State Innovation: allow states to cover wearable devices via Medicaid 1115 waivers or incentives. The federal government could create a streamlined template for states to use. c. Medicare Advantage and Private Plan Benefits: encourage/require MA and private plans to offer evidence-based wearable devices as wellness or chronic care benefits.”

“CMS could create a registry of health applications and request submissions of outcomes data tied to these apps. This could be as simple as a link to PubMed or other journal articles. AI could be used to summarize key points in a user-friendly way, or app owners could submit their own summaries.”

“To accelerate the adoption and effective use of digital health tools in accountable care organizations (ACOs), we recommend a multi-faceted approach. This includes offering higher shared savings percentages for ACOs demonstrating effective digital tool implementation, providing grants or subsidies to offset initial investment costs, and introducing bonus payments tied to patient engagement metrics via digital platforms. Additionally, allowing digital health investments to count towards risk-bearing requirements can reward further adoption. These measures should support the implementation of crucial technologies, such as real-time patient event notifications, automated quality reporting, predictive analytics, telehealth services, and integration of diverse data sources including EHRs, claims, and patient-reported outcomes.”

“The RFI notes the fractured, labor-intensive nature of managing multiple provider portals. A modern Personal Health Record (PHR) can solve this, but it must be more than a simple data repository; it must be a dynamic, patient-controlled hub for engagement that fosters a competitive marketplace of innovation… One option is for CMS to foster an ecosystem built on a multi-cloud platform where third-party applications, including PHRs, can securely access a beneficiary’s data from multiple sources with their express consent.”

“Recommendation: CMS can provide the key infrastructure components for this ecosystem. Drawing on our experience with Public Sector cloud projects and the Medical Records Android API, this would involve:

• A Secure Identity Layer: Fostering an ecosystem of compatible and trusted digital identity providers. This allows beneficiaries to use a compliant identity of their choice (NIST 800-63-3 IAL2/AAL2) to eliminate the need for multiple portal logins and passwords.
• An API Gateway: Building on the success of Blue Button 2.0, create a robust API gateway that allows authenticated and authorized third-party apps to access data from participating payers and providers, enforcing security and consent protocols.”

“In summary, FDA should consider a commensurate risk-based framework for postmarketing surveillance of safety and effectiveness for deployed AI-enabled medical products, and CMS could leverage shared insights from surveillance activities to inform and predictably implement coverage determinations or novel payment structures for AI-enabled medical products perhaps with support and input from diverse stakeholder discussions.”

“It is strongly recommended that CMS offer programs and incentives that can act as examples to encourage favorable coverage from payers for FDA-authorized [Software-Enhanced] Medicines. This guidance should recognize the unique value proposition of SE Medicines as integrated therapeutic solutions and acknowledge their FDA authorization status, including of any added clinical benefit claims (e.g., favorable pricing or formulary positioning for added clinical benefits, and better reimbursement rates to plans/payers achieving superior SE Medicine utilization).”

“CMS should actively encourage and support the development and implementation of innovative payment models for SE Medicines, including value-based contracts. Given that SE Medicines can generate rich datasets on usage and outcomes, they are particularly well-suited for arrangements where reimbursement is tied to achieving pre-defined clinical or economic endpoints.”

“Payer reluctance often stems from uncertainty about the cost-effectiveness of new technologies and the absence of established billing and reimbursement mechanisms. As a major payer, CMS’s actions have a profound influence on the broader payer landscape. If CMS establishes incentive programs for SE Medicines within Medicare and Medicaid and spearheads the development of specific HCPCS codes for the software components and associated services, it would send a powerful signal to private payers regarding the legitimacy, value, and expectation of coverage for these therapies. This can create a positive cascade, encouraging wider payer adoption and thereby facilitating improved patient access to SE Medicines.”

“CMS should also consider forming strategic partnerships with major consumer health platforms (e.g., Samsung Health) to enable real-time insurance eligibility verification, benefit coverage checks, and prior authorization workflows direction with digital health applications as well as data-sharing integrations with Medicare. A significant barrier to patient engagement and adoption of digital health interventions is uncertainty about insurance coverage. By partnering with platforms like Samsung Health, CMS can integrate seamless payer eligibility and prior authorization processes, empowering Medicare beneficiaries with immediate clarity on covered services. This integration would significantly accelerate the implementation of frictionless digital enrollment pathways, encouraging patients to engage proactively with personalized health recommendations that are verified as reimbursable by insurance, thereby reducing uncertainty and promoting widespread adoption of beneficial digital health interventions.”

“[Open] pathways for remote therapeutic monitoring (RTM) and remote physiological monitoring (RPM) reimbursement for non-traditional platforms… much of the value lies in passive monitoring, digital coaching, asynchronous alerts, and non-billable coordination activities that contribute significantly to clinical outcomes, especially for high-risk patients.” “Samsung urges CMS to explore reimbursement for digital health tools for prevention and rehabilitation.”

“Today, patients and caregivers often navigate a disjointed digital experience – using separate applications for continuous glucose monitoring, insulin management tools, medication adherence, and coaching – each with its own login, data silos, and learning curve. This fragmentation creates cognitive and operational burdens, especially for patients managing chronic conditions. Tools like Samsung Health can serve as orchestration platforms that unify these services into one interface, streamline the experience, and enable seamless data sharing with caregivers and providers. Providing development incentives and introducing ‘orchestration reimbursement codes’ would stimulate the creation of more scalable, integrated solutions while addressing the current inefficiencies and complexity in managing multiple apps and device.”

“CMS should support devices and technologies that deliver predictive analytics, personalized alerts, and care plan integration. Additionally, CMS could allow wearable engagement to count toward quality measures and offer bonus payments tied to usage thresholds. This bonus payment mechanism could live within Medicare Advantage or value-based care arrangements with incentives tied to defined wearable usage thresholds. For example, CMS might establish a tiered incentive structure in which providers receive performance-based bonuses if a certain percentage of attributed beneficiaries meet sustained engagement criteria with approved wearable devices.”

“Based on our experience, savings from outcome‑based contracts can fund $0 cost‑sharing and targeted roll‑outs for example in rural or dually‑eligible populations, where the benefits of digital health products might be most beneficial. CMS can modernize digital health reimbursement by moving from ‘minutes monitored’ to ‘outcomes delivered.’ An outcomes‑based episode, grounded in the real‑world data infrastructure outlined above, will (a) protect beneficiaries from ineffective products, (b) unleash innovation among high‑performing vendors, and (c) curb the unchecked spending growth from the past few years.”