Digital Health Stakeholders: Weigh In on CMS 2026 Chronic Disease and Virtual Care RFIs

The 2026 Medicare Physician Fee Schedule (MPFS) Proposed Rule includes several important Requests for Information (RFIs) that could significantly shape the future of digital health, chronic disease prevention, and virtual care. These RFIs offer digital health companies, providers, and other stakeholders a critical opportunity to weigh in on CMS’s thinking around new payment pathways, services, and innovations. We strongly encourage stakeholders to submit comments. CMS is required to review every comment received, and we have seen comments that we helped our clients submit directly referenced in final rules. Your voice can truly make a difference in shaping Medicare policy.

The sections below summarize key RFIs and comment solicitations in the proposed rule that are most relevant for digital health and virtual care stakeholders, including opportunities to influence future payment policy for Software as a Service (SaaS), virtual care visits in FQHCs and RHCs, digital therapeutics for autism and ADHD, chronic disease management interventions, and more.

RFI: Prevention and Management of Chronic Disease

CMS is exploring new ways to support chronic disease prevention and management, with a focus on addressing upstream health behaviors and social determinants. CMS is seeking input on the following specific questions:

  • How could CMS better support prevention and self-management of chronic disease?

  • Are there services—such as those addressing root causes, physical activity, or social isolation—that aren’t adequately captured by current MPFS codes?

  • Should CMS create new codes for:

    • Intensive lifestyle interventions?

    • Medically tailored meals?

    • FDA-cleared digital therapeutics to manage chronic conditions?

  • How can CMS improve uptake and usefulness of the Annual Wellness Visit (AWV)?

  • How could CMS support greater collaboration with community-based organizations like Area Agencies on Aging?

Why it matters:

These questions present major opportunities for companies offering tech-enabled solutions in nutrition, exercise, behavioral support, and chronic care engagement. CMS’s interest in digital therapeutics and remote delivery models signals the potential for new reimbursement pathways. Stakeholders should advocate for coding and reimbursement that aligns with modern care delivery models—including digital platforms and AI-driven interventions.

Motivational Interviewing and Health Coaching

CMS is considering new coding and payment mechanisms for motivational interviewing (MI) and services furnished by health coaches, potentially under general supervision. They are soliciting feedback on:

  • Whether separate codes should be developed

  • Who is qualified to deliver MI and health coaching

  • Typical session length and training requirements

  • Whether these services can be delivered via telehealth

  • How such coding could support programs funded by the Administration for Community Living (ACL)

Why it matters:

Digital health companies using behavior change frameworks or deploying health coaches through virtual platforms may see future changes from CMS that support these interventions. It is important to note, however, that health coaches are not currently recognized as “clinical staff” for purposes of CMS reimbursement in any US state.

Digital Mental Health Treatment (DMHT): Use Cases and Expansion

Building on its 2025 recognition of FDA-cleared digital mental health treatments, CMS is now requesting comments on:

  • Whether coverage should be extended to digital therapeutics (DTx) targeting autism spectrum disorder

  • How to refine payment models for DMHTs in clinical practice

  • What future use cases CMS should consider for DTx

Why it matters:

This is a pivotal opportunity for digital health stakeholders to shape the future of Medicare coverage for software-based clinical treatments. CMS has already established a precedent by recognizing and reimbursing FDA-cleared Digital Mental Health Treatment (DMHT) tools — a milestone that validated digital therapeutics (DTx) as legitimate modalities of care. Now, by explicitly soliciting feedback on what additional use cases should follow, CMS is opening the door to a broader category of digital therapeutics that target chronic conditions, substance use disorders, neurological disorders, cardiometabolic diseases, and more.

Software-as-a-Service (SaaS) Payment Policy

In this proposed Rule, CMS acknowledges that its current practice expense (PE) methodology for computing RVUs — and therefore determining reimbursement for healthcare services, does not adequately account for the widespread use of “Innovative Technologies” such as software algorithms, AI, and SaaS by healthcare providers and practices. CMS traditionally considers most computer software, along with related analysis and licensing fees, as "indirect costs” tied to costs for associated hardware considered to be medical equipment. CMS is seeking public comment on how the use of SaaS and AI technologies affects care delivery and how to incorporate SaaS costs into evolving payment frameworks, including risk-based arrangements.

Specifically, CMS is asking:

  • What factors should be considered when paying for SaaS?

  • How have participants in risk-based payment models incorporated SaaS into their arrangements?

  • Do current risk-based models reflect the value of SaaS to clinical practice?

  • What alternative pricing strategies should CMS consider, given the limitations of the current Practice Expense (PE) methodology?

  • How should CMS value the physician work involved in using and interpreting outputs from SaaS and AI tools?

  • What alternative data sources could help CMS better understand the true costs of SaaS and AI technologies?

  • How are these technologies being used to treat chronic disease?

  • How can CMS best evaluate the quality and efficacy of SaaS and AI tools?

Why it matters

Traditional Medicare payment methodologies were not designed for subscription-based platforms or AI-powered clinical tools. This RFI signals CMS’s recognition that value in digital health often lies in ongoing software-driven services rather than discrete encounters. Digital health companies leveraging SaaS or AI should provide comments aimed at helping define new pathways for reimbursement that better reflect their cost structures, workflows, and clinical value.

Future of Virtual Care in RHCs and FQHCs

CMS is soliciting comments on whether and how telehealth (and potentially other forms of virtual care) should be integrated into the All-Inclusive Rate (AIR) for Rural Health Clinics (RHCs) and the Prospective Payment System (PPS) for Federally Qualified Health Centers (FQHCs).

Why it matters

Virtual care platforms serving safety net providers need clarity on how remote visits and asynchronous care might be reimbursed long-term. Stakeholders should weigh in to ensure that telehealth and hybrid models remain financially sustainable within these essential care delivery systems.

Call to Action for all Digital Health Stakeholders

CMS has opened the door for innovators to help reimagine how Medicare supports prevention, behavioral health, chronic condition management, and virtual care. Digital health companies are uniquely positioned to inform this evolution—if they engage.

CMS is accepting public comments through midnight (ET) on September 12, 2025. If you’re a stakeholder in digital health, DTx, or healthcare innovation more generally, now is the time to make your voice heard. Every comment counts. Let yours be one of them.

Need help drafting and submitting comments? Nixon Law Group is here for you. Contact us to learn more.