Skip to main content

Paige Stocks, Director, Partnerships

There is immense promise in digital health’s ability to treat children and help their caregivers manage their condition, yet a lack of understanding stifles innovation and adoption.

The primary challenges? 

  • How to get the right digital tools into the hands of providers, their patients and their caregivers effectively
  • What regulations must be navigated, and when

First, it’s essential to understand the difference between non-prescription digital health tools and prescription digital therapeutics (PDTs). While not all digital health solutions require FDA clearance, PDTs do. 

The Prescription Digital Therapeutics Act of 2022, which should provide health systems with a much-needed framework, is still on Congress’s desk – for how long, who knows? 

In the meantime, health systems and payors should evaluate pediatric digital health tools that can help improve patient care and bottom lines. 

Let’s dive into the differences in detail and what vendors, health systems, and payors should know about these distinct scenarios. 

Pediatric PDTs 

Pediatric PDT is still a nascent market. EndeavorRx garnered significant media buzz in 2020 as the first video game approved by the FDA as a non-drug option for improving symptoms associated with ADHD. 

Diagnostic tools are perhaps less alluring to the mainstream but no less critical. In 2022, the FDA approved Cognoa autism assessments. The tool enables caregivers to capture videos and record different pieces about the patient. This is especially important because PCPs don’t typically specialize in autism, and in some locations this type of assessment and care may be inaccessible to families so it’s a valuable way to start pediatric patients on their care paths. 

Non-Prescription Pediatric DTx

On the other hand, many tools are available to providers and patients that require no FDA clearance or prescription. 

For example, Manatee is a smartphone app that provides therapy services for children in a gamified style similar to EndeavorRx, but it is unregulated. Families can sign up directly for the service, which offers insurance reimbursement, FSA/HSA, and is compatible with company mental health stipends.

The public needs to be aware of and reminded about these tools; providers must distribute them, and payors must cover them. 

While the road ahead is long, Xealth and our partners are making strides. We work with multiple children’s hospitals, including Children’s Wisconsin, to digitally engage patients and their families. 

It’s crucial for vendors to note that, even if their solutions are orderable and placed on a formulary, providers and health systems still have to build the awareness of these tools and ensure they are integrated into the provider workflow. It’s rarely as simple as “this tool is available”. Be aware of these pain points when approaching health systems and payors.

Understanding FDA Clearance: What Vendors Need It and Who Does Not? 

Xealth partners with several digital health and DTx vendors who have yet to go through the FDA and never plan to. They have a model allowing them to license their software or tool to a health system, and they have a different value proposition attached. They either offer insurance for the health system, or they will reduce staffing needs and operate like a professional service. Their care managers monitor the patients, not the health system. They might be using chronic care management (CCM) codes, or they might be using RPM billing codes.

In contrast, PDTs require FDA approval. Their value proposition is that using their tool is free for the health system and likely covered by the patient’s insurance. However, providers still need to know the tool exists. 

This evokes salient questions:

  • What are the EHR implications for the workflow?
  • What is the volume of patients in the local population or capture area for whom the tool is appropriate?
  • How does this top the list from a priority perspective for an IT team?
  • Will clinicians adopt the tool in their care delivery?

FDA Precedents

Welldoc, a Xealth partner, was the first true PDT with 501(k) clearance. If your solution is a new or novelty PDT, the route to pursue is De Novo classification. If you’re similar to existing prescription DTx, there are other FDA paths. 

Vendors looking to provide prescription DTx solutions must realize that the prescription component adds another layer of complexity that might make it more difficult to justify to health systems.

For example, Akili Interactive negotiates reimbursement directly with payors. However, they still face the challenges of facilitating discussions with health systems, raising awareness, and getting their tools used.

Staying the Course

Pediatric PDTs still have a long way to go but on the surface have a lot of potential to help patients and their caregivers. Imagine a world where we reach for an app instead of putting a young patient on medication or one where families are empowered with the information and tools they need to help navigate their kiddos care.

Vendors, providers, and health systems must understand the differences between non-prescription pediatric DTx and pediatric PDTs to embrace valuable patient care opportunities that can impact outcomes and drive adoption.

If you’d like to learn more about how we can work together to improve pediatric PDT adoption and access, request your demo today!

Download our Digital Health Formulary How-To Guide

Close Menu