Earlier this year, Sen. Jeanne Shaheen (D-N.H.) introduced the Prescription for Digital Therapeutics Act, which would provide for Medicare and Medicaid coverage of prescription digital therapeutics and establish a payment methodology through the Centers for Medicare and Medicaid Services.
The nascent digital therapeutics sector, which uses prescription and non-prescription software to deliver interventions to patients, has evolved significantly in the past few years. Megan Coder, chief policy officer and founding member of the Digital Therapeutics Alliance, joined Modern Healthcare to discuss why the industry group is lobbying for the legislation and why she sees additional regulation as a necessity.
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Digital therapeutics is still a fairly new sector: The alliance launched in 2017. What is the reasoning behind categorizing a wellness product and an ingestible sensor—to name a few examples of the tools—under the same umbrella?
When we first launched the Digital Therapeutics Alliance, we needed to identify what a digital therapeutic is and create the methodology and the frameworks around that foundation for the industry. We’re realizing the need to further explain the ecosystem we operate within as it grows. Digital therapeutics operate within the entirety of the [healthcare] ecosystem, alongside products used for diagnosis, monitoring, wellness, clinical decision support and other needs.
You’re personally based in Europe, but the organization is largely focused on the U.S. market. How does that work when you’re attempting to lobby Congress?
The United States is a really big market. We know there’s a lot of attention to what it could be. So the potential for the U.S. market is huge. Our staff members are generally based in the United States. We are set up as a 501 (c)(6) organization in the United States. So, by that fact alone, we are a U.S.-based organization.
Right now, private payers are much more likely to engage with digital therapeutics, while the public payer segment has been much more challenging. Medicare doesn’t have a benefit category.
In Europe, I’m starting to see public payer systems begin to take this matter on. It’s happening in Asia as well. It has been fascinating to see such a different approach than what’s going on in the United States. While you are correct—the alliance’s focus is very much on the U.S.—I think it would be very one-sided if we didn’t have this comparison with what’s going on in the international community and [the opportunity to be] educated. The U.S. can import a lot of these ideas, while exporting a lot of their own practices too, so there’s bidirectionality to benefit from.
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Why is your group asking for additional regulation?
We are pushing for the appropriate level of regulation. In many cases, that is full regulation [of digital therapeutics] as a medical device.
It’s up to regulatory agencies, as we know, to determine the level of risk of each product and whether it is being submitted to a full regulatory review pathway. We also know [digital therapeutics] is a category of medicine. We know that it’s been used alongside of—or sometimes in place of—medications or in-person therapies. These technologies need to be seen as what they are: medical devices that are being used to impact patient disease states.
Regulation for digital therapeutics will likely be different than what’s going to be [appropriate] for pharmaceutical [products], but the same principles apply.
What’s your message to a skeptical hospital CEO or health system executive hesitant to adopt these technologies?
I would acknowledge to them that this is still likely a very challenging ecosystem to navigate. If you are new to this, I think the idea of knowing which products are the right ones to be looking at—which ones have the evidence, credibility, certifications and regulatory acceptance—can be very challenging.
The idea of a fit-for-purpose evaluation is critical too: Not just assuming digital therapeutics need to meet the exact same methodology and rigor of every single pharmaceutical that’s out there. Digital therapeutics have their own sets of rigor and trial designs appropriate to their style. So, it may not be a one-to-one identical relationship [from one therapeutic to another]. But it is important to be able to say: “Let’s look at what the study design is, what they’re trying to achieve, what they’ve accomplished, and what the rigor of this study is.”
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The alliance recently released a guide to help define digital therapeutics. What happens next for that toolkit, the industry and your organization if the Access to Prescription Digital Therapeutics Act passes?
Our next phase is going to be making sure that the [toolkit] materials and things that we’ve created are delivering on their impact: That they have the credibility they need from payers’ and decision-makers’ perspectives, but also usability. So really, the next phase is dissemination and engaging with a wide variety of stakeholders to really make sure that impact is optimized.
This interview has been edited for length and clarity.
