You’ve seen this story before. Maybe it’s your story.
A company builds a tech-enabled service for a high-need population—say, dual-eligible patients or those with multiple chronic conditions.
- They develop a centralized platform that connects patients, primary care, specialists, and community supports.
- They streamline communication and workflows across fragmented providers.
- They reduce ER visits and hospital admissions with proactive, data-driven coordination.
It works. It saves money. Patients love it.
But then comes the legal reality check: unless you’re part of large provider or payor model with CMS’ blessing, you likely can’t qualify for the fraud and abuse waivers that would make this care model fully compliant. And, maybe there aren’t any reimbursement mechanisms in place that would adequately align incentives among the participating parties.
Here's the real problem:
- The existing exceptions to the Stark Law and Anti-Kickback Statute are narrow, technical, often expensive, and incredibly difficult to navigate.
- The existing reimbursement models don’t align with the needs of separate entities who wish to work together, using their own unique skills and resources, to deliver coordinated care
In short: If you're an innovative digital health company, the system isn’t just hard to navigate—it was never built for you in the first place.
Now, for the first time, CMS is openly asking the digital health industry:
- “How have our policies stood in your way?”
- “What would it take to support safe, innovative care models?”
- “How can we modernize compliance frameworks to reflect how care is actually delivered in 2025?”
This is your chance to help CMS see what they’ve been missing.
The May 2025 RFI from CMS Is a Rare—and Powerful—Invitation
On May 16, CMS dropped a Request for Information (RFI) that every digital health founder should be paying attention to. It’s not just a policy brainstorm. It’s a public request for advice on how CMS should evolve to support modern care models—the kind your company is likely already building. (And it's due before the 2026 Medicare Physician Fee Schedule (MPFS) drops this summer, so comments could inform policy as early as next year!)
The agency wants feedback on how to:
- Support tech-enabled care coordination across providers
- Remove regulatory barriers to innovation (yes, including fraud and abuse laws)
- Design payment systems that reflect how people actually deliver care today
This is a once-in-a-decade opportunity to help rewrite the playbook—and make it easier for your business model to thrive. If you’ve ever said, “We know this works—why won’t CMS let us do it?” this is the moment to explain.
What CMS Wants to Know
This RFI covers a wide range of digital health issues, but here’s what’s especially relevant for startup innovators:
- What use cases should CMS prioritize in future payment models?
- How can CMS modernize fraud and abuse policies to allow legitimate, coordinated care models?
- What tech infrastructure (APIs, FHIR access, TEFCA participation) do you need to deliver high-quality services?
- How can CMS make data more accessible to you and your providers?
- What barriers—policy, legal, or technical—are killing innovation before it starts?
They want specific examples. Screenshots. Workflow videos. You don’t need to write a white paper—you just need to show them what you want to do and explain what’s stopping you from doing more of it.
The RFI digs into the real barriers you face - patient needs, data access, integration, information blocking, and reimbursement. CMS published the RFI with the following explicitly stated purposes in mind:
(1) to "continue to build on the existing policy framework to drive large-scale adoption of health management and care navigation applications, reduce barriers to data access and exchange, realize the potential of recent innovations in healthcare that promote better health outcomes, and accelerate progress towards a patient-centric learning health system."
(2) to "achieve the potential of digital health technology."
(3) to identify "which elements of today's digital health ecosystem are working, which are working inconsistently and need improvement, and which are impeding rapid progress."
(4) to identify "policies to ease health data exchange and promote innovation in consumer digital health products."
(5) to "encourage patient, caregiver, and provider engagement with digital health products.
The RFI presents more than 100 questions pertaining to each of five major stakeholder groups: Patients and Caregivers, Providers, Payers, "Technology vendors, data providers, and networks", and Value-base care organizations. They encourage comment from industry on any or all of these questions (so don't just scroll to the "tech" section if you're a digital health company. They want to know about impact (or barrier to impact) on your customers as well!
Here's what CMS is asking, and where your voice can shape the future:
Patients and Caregivers
"What health management or care navigation apps would help you understand and manage your (or your loved ones) health needs, as well as the actions you should take?"
"What are the obstacles to accessing your own or your loved ones’ complete health information electronically and using it for managing health conditions or finding the best care."
"What role, if any, should CMS have in reviewing or approving digital health products on the basis of their efficacy, quality or impact or both on health outcomes (not approving in the sense of a coverage determination)? What criteria should be used if there is a review process? 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)?"
"What are the most valuable operational health data use cases for patients and caregivers that, if addressed, would create more efficient care navigation or eliminate barriers to competition among providers or both?"
Providers
"What are obstacles that prevent development, deployment, or effective utilization of the most useful and innovative applications for physician workflows, such as quality measurement reporting, clinical documentation, and billing tasks? How could these obstacles be mitigated?"
"What strategies can CMS implement to support providers in making high-quality, timely, and comprehensive healthcare data available for interoperability in the digital product ecosystem?"
"Should ASTP/ONC consider removing or revising any of the information blocking exceptions or conditions within the exceptions (45 CFR part 171, subparts B through D) to further the access, exchange, and use of electronic health information (EHI) and to promote market competition?"
Payers
"How can CMS encourage payers to accelerate the implementation and utilization of APIs for patients, providers, and other payers, similar to the Blue Button 2.0 and Data at the Point of Care APIs released by CMS?"
"How interested are payers and providers in EHR technology advances that enable bulk extraction of clinical quality data from EHRs to payers to allow them to do the calculations instead of the provider-side technology?"
Tech Vendors, Data Providers, and Networks
"What short term (in the next 2 years) and longer-term steps can CMS take to stimulate developer interest in building digital health products for Medicare beneficiaries and caregivers?"
"How can CMS better encourage use of open, standards-based, publicly available APIs over proprietary APIs?"
"What new opportunities and advancements could emerge with APIs providing access to the entirety of a patient’s electronic health information (EHI)?"
Value-Based Care Organizations
"What incentives could encourage APMs such as accountable care organizations (ACOs) or participants in Medicare Shared Savings Program (MSSP) to leverage digital health management and care navigation products more often and more effectively with their patients? What are the current obstacles preventing broader digital product adoption for patients in ACOs?"
"What are essential health IT capabilities for value-based care arrangements?"
"How can key themes and technologies such as artificial intelligence, population health analytics, risk stratification, care coordination, usability, quality measurement, and patient engagement be better integrated into APM requirements?"
Click here for a full list of the questions in the RFI. You can find them on pages 9-24.
Action Steps: How to Respond (And Why You Should)
- Deadline: ~June 15, 2025 (30 days from Federal Register publication)
- Submit at: Regulations.gov
- Reference file code: CMS-0042-NC
What to include:
- Your product or service in plain English
- The patient population you serve
- Specific operational and regulatory barriers you’ve faced
- What policy changes would unlock scale and sustainability
TL;DR: If You Want CMS to Support What You're Building, Tell Them Now
Digital health founders have spent years (with our help!) trying to fit groundbreaking innovation into outdated payment and compliance structures. This RFI flips the script. CMS is finally asking you how the system needs to change. If you’re building tech that connects providers, supports care teams, and helps patients navigate the system—this is your chance to be heard.
Need help crafting a submission that makes an impact? Elevare is advising clients right now on how to respond strategically—and persuasively. Let’s talk.
We’ve seen what works. We’ve seen what’s blocked. Now CMS wants to hear about both—from you.
Like our insights? Subscribe to our newsletter for more strategic advice.
Informed by:
Centers for Medicare & Medicaid Services. (2025, May 16). Request for Information; Health Technology Ecosystem (CMS-0042-NC). Federal Register. Retrieved from https://public-inspection.federalregister.gov/2025-08701.pdf:contentReference[oaicite:3]{index=3}