Q&A: The status of the Access to Prescription Digital Therapeutics Act

The Access to Prescription Digital Therapeutics Act, initially introduced in the U.S. Senate in 2022 and reintroduced in March of this year, aims to amend the Social Security Act to provide Medicare and Medicaid coverage and reimbursement for prescription digital therapeutics. 

Jennifer Mathieu, senior vice president of professional and government affairs at the Academy of Managed Care Pharmacy (AMCP), sat down with MobiHealthNews to provide an update on the bill’s passage and how lawmakers respond to the legislation. 

MobiHealthNews: The act was initially introduced in March 2022, but much has changed in digital therapeutics and digital health. Pear Therapeutics has gone bankrupt, there’s been a substantial decrease in investment in digital health and more. Has the bill itself been reshaped as the digital health environment has changed?

Jennifer Mathieu: Actually, surprisingly maybe, the bill has not changed at all, except for tiny [changes], dates obviously. We’ve had to adjust some things for it being a whole entire year later, but otherwise, the bill is exactly the same, identical as it was when it was introduced in 2022.  

I am pleased to say that it’s bipartisan, it’s bicameral. It has the same original cosponsors from the Senate side. We did actually get a new, obviously there was a change in majority in the House this year, and so we do have a new original cosponsor lead on the House side.

MHN: Who is that?

Mathieu: It’s Kevin Hern, and so he’s now leading the charge on the House side. As you may recall, the lead Republican in the House, Representative McKinley, did not win his primary. So he has left the House. So they needed a new Republican, and one thing that I think is an added, is kind of a boost for the bill in having Representative Hern as the lead, is he is a pretty well-known fiscal conservative. So, the fact that he is leading the charge on the bill this year on the House side, I think that speaks to his support for digital health, as well as has helped to assuage some of the concerns around the cost of the bill, particularly since we are still working to get that CBO score on it. 

His Democratic counterpart still remains Representative Mike Thompson from California. We also have some, you know, additional support, particularly in California, with Representative Matsui being in support of the bill, and quite a few other House cosponsors. The Senate side remains the same, with Senator Shaheen leading for the Democrats and Senator Moore Capito leading for the Republicans. 

One thing that we did this year in June is AMCP with the support of the Digital Therapeutics Alliance, we actually held a demo day on Capitol Hill on the House side, and it was our House sponsor, if you will, was Representative Hern. We held it in the Ways and Means Committee staff room, and we had about 200 staffers come through. We had ten manufacturers on-site, seven of whom have fully FDA-reviewed and cleared products. Then, we had three who are in the investigational stage. 

When we last spoke, I mentioned education is really one of the biggest hindrances thus far, and, you know, I’m really happy to say that we’ve seen the dial shift a little bit. We’ve seen the pendulum shift a little bit on the House side in that folks are more comfortable with their understanding, and so we hope to replicate the same on the Senate side.

MHN: So you’ve seen more lawmakers privy to digital therapeutics and the digital health space?

Mathieu: Between us, the Digital Therapeutics Alliance (DTA), and also we have our PDT coalition, which is led by AMCP and DTA. It includes all of the PDT manufacturers who have cleared products as well as investigational products. We have really been making a concerted push since the bill was reintroduced in March on Capitol Hill, really to bring that education, to bring manufacturers into meetings one-on-one, you know, to do these demo days. 

The question that we get now more so, as opposed to “Oh, what is a digital therapeutic or a prescription digital therapeutic?” now we get more questions around, “Oh, I’ve heard of those. Can you help explain the differentiation between a prescription digital therapeutic and a nonprescription digital therapeutic?” So we’re moving the dial ever so slightly, but it has definitely been noticeable, for us at least, a noticeable shift.

MHN: What are some of the concerns you’re hearing among lawmakers?

Mathieu: I think, as with most digital products, we have questions around data security and privacy. And we, as a coalition, are working to address those concerns proactively with the FDA. I wouldn’t say that the FDA and CMS [Centers for Medicare and Medicaid Services] are entirely ready to turn their attention to those types of questions just yet. We are still striving to get this benefit category first. We have shared some recommendations with the FDA, with CMS, you know, around those guidelines. 

AMCP is actually going to be hosting, in very early 2024, we’re going to be hosting a focus group amongst our members, amongst manufacturers that are really going to dig into those security and privacy questions as well as, I would say, the other kind of big topic that we get a lot of questions around is clinical evidence. How is the FDA evaluating these products? How are payers evaluating these products?

And so that’s a big question that we’re working across the board to answer. We don’t have a definitive recommendation yet, but we are exploring a baseline clinical-evidence standard and the possibility of incorporating that into future guidance, future hearings and whatnot. So those are probably the two big things: the privacy and security, and the clinical evidence baseline.  

I think also we’re now to the point where we’re doing less education on what a prescription digital therapeutic is and more on how many there are. There’s a bit of a misconception that there are hundreds and hundreds of products, and this bill has the potential to be incredibly expensive. We’re going in and course-correcting a little, saying, well, actually, we’re only talking about 15 max right now. Not a lot of them. So, you know, we’re not talking billions of dollars as a price tag, but a much smaller subset of products, and so that’s also been very helpful on the Hill about what these are and what exactly the scope of our bill is.

MHN: What are the next steps?

Mathieu: Yeah, so, like I mentioned earlier, we are exploring hosting a demo day on the Senate side. We obviously want to be respectful of the competing interests, particularly this month, with government funding. So we’re looking a little bit later, October/November, to be respectful of everyone’s attentions on the Hill. 

We are also in the process of working with DTA and the PDT coalition members on pulling together data and evidence for the Congressional Budget Office.  

We’re right now, actually, in the midst of meetings amongst all the manufacturers. Obviously, we represent the payer perspective to pull together as much data as we have to allow CBO to publish as accurate a score as possible. So that’s really where our attention is focused right now. And we’re hoping, we’re really hoping … we know that a year-end omnibus is likely, and we’re hoping that we’ll have that CBO score, and we’ll be able to include the bill as part of that year-end package.

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