The expanding collaboration between the Centers for Medicare & Medicaid Services (CMS) and the U.S. Food and Drug Administration (FDA) is an important signal that developers would be smart to heed. It’s creating a new playbook for how products move from development to care, and critically, how patients can access them in a timely and sustainable way.
Breakthrough designation accelerated development, but access has remained uneven
The FDA’s Breakthrough Devices Program has accelerated the development and review of novel technologies through earlier engagement with regulators, more flexible study design, and shorter time to authorization for many high-impact devices.
A growing body of analysis, including tracking from STAT, shows that while the number of designated devices has increased rapidly, far fewer have reached patients at scale.
Addressing this gap between breakthrough and bedside is at the heart of our mission here at DiMe.
For many products, the period following FDA authorization determines whether they become part of routine care. Coverage timelines, payment pathways, clinical workflow integration, and patient uptake each influence whether a device that performs well in studies is ultimately used in practice. Efforts such as the Transitional Coverage for Emerging Technologies (TCET) pathway have improved aspects of this process, but have not kept pace with the scale of the Breakthrough program, and delays between approval and widespread access persist.
CMS and FDA are moving toward coordinated decision-making
The RAPID Coverage Pathway, announced just last week, reflects a more coordinated approach between CMS and FDA.
RAPID is designed to accelerate Medicare coverage decisions for certain FDA-designated Breakthrough Devices by aligning evidence expectations earlier in development and initiating coverage review at the time of FDA authorization.
Historically, the time between FDA authorization and a national coverage decision could extend for many months, often into years. RAPID is intended to shorten that interval, creating a more direct path from authorization to reimbursed use in clinical settings.
This approach has enormous potential to improve the speed with which Medicare beneficiaries can access new technologies. However, Payment adequacy, provider incentives, and workflow integration will continue to influence whether covered technologies are adopted in practice.
Evidence strategies must reflect the full set of decision-makers
Here at the Digital Medicine Society (DiMe), we have long argued that evidence generation should be designed with all relevant decision-makers in mind from the outset. These include regulatory authorities, who determine whether a product can enter the market; payers or buyers, who determine whether it will be covered; clinicians, who determine whether it will be used; and patients and individuals, who determine whether it will be adopted in real-world settings.
In many cases, these perspectives have been addressed sequentially. Products are developed to meet regulatory requirements, followed by additional studies to support coverage, and further work to understand real-world use. This approach increases cost, extends timelines, and places unnecessary burden on patients participating in multiple studies that could have been designed more efficiently.
An integrated evidence plan offers a more effective alternative. DiMe’s work on integrated evidence pathways provides a structured approach to designing studies that address multiple decision-making needs within a unified strategy.
Designing evidence that translates into use
An integrated approach requires careful alignment of outcomes and data collection.
Clinical outcomes must demonstrate effectiveness that are meaningful in real-world populations, including those covered by Medicare. Measures of resource utilization and care delivery can provide early insight into economic value. Patient-reported outcomes and usability data help determine whether a product will be used consistently outside controlled environments.
These considerations are particularly important for digital health and AI-enabled technologies.
A radiology algorithm may demonstrate strong performance in validation studies, but we know it will sit on the shelf if it cannot integrate into existing clinical workflows. A patient-facing application may meet high standards for privacy and security, but its impact will be limited if individuals cannot use it easily due to design constraints.
To support more consistent evaluation, DiMe developed the DiMe Seal, which assesses digital health products across evidence, privacy and security, and usability.
The DiMe Seal is now a recognized pathway for patient-facing applications seeking entry into the Medicare App Library, providing a clear example of how this integrated approach is applied in practice.
Implications for developers
A comprehensive evidence strategy has always supported a more efficient path to adoption and a stronger case for value.
As CMS and FDA move toward coordinated decision-making, this approach must become table stakes. Developers who continue to treat regulatory approval, coverage, and adoption as separate challenges are likely to encounter delays that can be addressed through more integrated planning.
Designing studies and evidence strategies that support aligned decisions across regulatory, coverage, clinical, and patient domains can reduce time to access and strengthen the case for sustained use.
Aligning innovation with patient impact
These policy developments reflect a broader effort to align innovation with patient outcomes.
At DiMe, we focus relentlessly on the ‘double bottom line’: Simultaneously achieving both commercial success and meaningful patient benefit. Products that function effectively in real-world settings for every person they could benefit are more likely to be adopted and sustained over time.
The deepening collaboration between CMS and FDA that RAPID, TEMPO, and other programs signal, encourages evidence generation that serves multiple decision-makers simultaneously and supports more consistent translation from development into care.
DiMe resources that can support the success of these policy developments
The system is moving toward a model in which evidence, access, and adoption are more closely connected. Developers who design with that model in mind will be better positioned to bring new technologies into care and ensure that patients benefit from them.
DiMe exists to support innovators – both developers and adopters – championing these strategies. Resources that you can access today include:
- DiMe’s Integrated Evidence Pathway tools and resources
- The DiMe Seal
- DiMe’s Digital Medicine Academy® crash course on building fit-for-purpose digital health technologies
We also welcome inquiries from organizations seeking more tailored support. Contact partnerships@dimesociety.org.
