April 24, 2025 • 12 mins
In this episode, Andy Molnar, CEO of the Digital Therapeutics Alliance discusses reimbursement for digital therapeutics and the pharmacists role in digital care delivery.
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Episode Transcript
Available transcripts are automatically generated. Complete accuracy is not guaranteed.
(00:03):
Welcome to the First Fill My name is KatieMeyer,
and I serve as the SeniorDirector of Content Creation at APhA.
This monthwe did something a little bit different
and provided visiting resident BobbyChristodoulopoulos
with the opportunityto interview our subject matter expert.
He chose the topic of regulatory
and reimbursement pathways for digitaltherapeutics and welcomed guest
(00:25):
Andy Molnar, the CEO of DigitalTherapeutics Alliance.
the opportunity to speak on this topic.
This podcast was recordedin Nashville at APhA 2025.
So with that, I’ll let Bobby take it away.
All right,can you start by introducing yourself
and sharing
how you broke into the digital healthspace and what you and your team do over
(00:47):
at the Digital HealthTherapeutics Alliance
our listeners who might not be familiarwith the organization.
Sure thing.
Thanks for having me.
Andy Molnar, the CEO of the DigitalTherapeutics Alliance.
I'm also an advisor on the FDA'sDigital Health Advisory Committee.
I broke into digital healthwhen I first heard
about Pear Therapeutics back in 2017.
I had a friend who worked there andI thought that was the future of medicine.
(01:11):
And so I applied for a joband the rest is history, really.
Now what we focus on with my teamand this sort of
stemmed from what we started at PearTherapeutics
was buildingthe infrastructure for an industry, right.
We needed to we started a governmentaffairs and lobbying work
with CMSto have proper coding and coverage.
(01:31):
And that evolved into my passionfor create,
creating the baseline for the industry,which is that the Digital Therapeutics
Alliance is specifically focused onon policy work and legislative work
and bringing stakeholderstogether to drive things forward
because it truly people say it a lot.
but it is true
that a rising tide lifts all boats,and that's the way I look at this.
(01:53):
So in our part one,we kind of talked a little bit
about the primary regulatorypathways, de novo,
and then also the different classesof approval for digital therapeutics.
Can you give us kind of a brief overviewof those
and maybe dive into some examplesthat you've seen in practice? Sure.
You know, from a regulatoryperspective, it if you're used to
medical devices,it does act very similarly.
(02:15):
So if you're familiar with the denovo process and the 510 K process, that
that is the same.
There are only a few class three devicesbecause those of are riskier.
So there's, I believe, a product that
affects your insulin pump.
And so if that doesn't work,that can cause major issues.
(02:36):
So that is higher risk.
But typically we see things come throughas class two.
We also see quite a few productsgo through the enforcement
discretion pathway,which I didn't see listed here.
Some of some of the products thatthe FDA states this on their website too.
It's like mindfulness and meditation.
And that is not something that you'regoing to want to put through the FDA.
So that falls either under enforcement
discretionor outside of regulation entirely.
(03:00):
So could you share some of the most commonreimbursement pathways pharmacists
and digital healthinnovators should be aware of,
particularly related to Medicaid, Medicareand private insurance?
Sure.
So in the last six months, we've hada couple of really big advancements.
The first one being in the 2025physician fee
schedule, CMS had put out codesfor within Medicare
(03:21):
for the reimbursement of digital mentalhealth treatment devices.
These cover some of the earliest productslike Pear therapeutics reset
and reset o for substance use disorder,as well as Sleepio and SleepioRx
for insomnia and a product for majordepressive disorder called Rejoin.
It's a really great advancementbecause we can start showing utilization
(03:41):
in the real world and collectreal world evidence with patients.
We also talk a lot about prescription druguse related software, PDRS
which is a guidance
put out by the FDA where digitaltherapeutics can accompany drugs.
I actually think this will haveone of the biggest impacts on pharmacists
and talking to pharmacopeia earlierand how it kind of
(04:03):
cleans up the reimbursement pathwayto look at
to make that similarto the way that drugs are paid for.
Now we also have people using
a durable medical equipment pathway,which makes a lot of sense.
A lot of these digital devices
also have that hardware componentthat make the founder DME.
And I think and we also have the codeswith the American Medical Association
(04:26):
related to RTM and RPMand working to advance those.
So I think the point I'mtrying to make here is if you were to ask
that question three years ago,I'd give you a lot of vague answers
and saying we could try this,we could try this, we could try this.
And now it's become a lot more realitywhere your business,
what makes sense for your businessmodel as a company,
(04:47):
you can say this is the pathwayI want to go down.
Now there are some gaps within that.
You know, kind ofsounds like I've covered everything there.
So gaps withinwithin some of those pathways.
But now you can choose your businessmodel makes sense for that.
Before it was like, let's choosethe only pathway possible.
And so now it's opened up and it really isa completely different world
(05:09):
in 2025 because of the codes coming outand this new guidance from the FDA
kind of moving a little bit further along,what are some challenges
that you might see going forward,especially given the complexity
around reimbursement, like any challengesthat you might see for pharmacists,
specifically those breakinginto the digital therapeutic space?
What do you thinkthat they might face in the future?
Well,I think the biggest problems right now are
(05:32):
system issues, right?
So where we see pharmacistsgetting involved right now is basically in
specialty pharmacy and specialty pharmacythat does virtual type dispensation.
The larger retail chains,this isn't quite big enough
for them to invest the money to trainevery single one of their pharmacists.
They kind of it doesn't necessarilysound that complex to you.
(05:55):
And I was sitting here,but when you think of, okay,
what if a patient comes to a pharmacyand doesn't know how to download an app?
Pharmacies aren't really trained for that.
And so there is quite a lot of trainingthat has to come into place
if your CVS or your Walgreens right,
you're going to
you have to put quite a lot of investmentinto that space.
(06:17):
So with that, a lot of these productshave gone to either get or the company
to be the licensed to dispense medicaldevice themselves or have partnered with
with specialty pharmacy.
So the pharmacies that are currently
like really have their hands aroundthis are more in the specialty space,
even though you know that this doesn'tquite feel like a specialty product.
(06:38):
It's a unique dispensation.
And so it has to go through a workflowthat is designed specifically
for individual products.
Interesting.
And that'll evolve very quickly over time
because we see what they're doingin Europe and Asia.
Could you share some kind of
practical examplesor strategies that have helped pharmacists
or anyone really to successfully overcomethese reimbursement challenges?
(07:01):
Kind of here in the U.S.?
Yeah.
So, you know,I was thinking with the last book,
the last questionmore about how the pharmacists
are involved in the process,but the reimbursement complexity.
Any pharmacistthat is used to billing on the medical
benefit is it's a very complex process,even for drugs.
(07:21):
Right.
So if you're doing your typical lifestyle
and things like that, we're dispensing,yeah, that's all set.
Issues that we have faced in the pastis that but because the
coding infrastructureisn't quite built out yet
for a lot of these products and insurancecompanies are still working with how
they want to cover these products,whether it be on a new benefit
or covered on pharmacy benefitor something else
(07:44):
is that the pharmacist will billand if you don't get that real time
benefits verificationthat that were used to make,
it may take time a week even a monthto find out if the patient has coverage.
And so with that,I think the hardest part is particularly
because the pharmacistsits between the patient
and the insurance companytrying to explain that to the patient
(08:06):
and ensuring that they understandthat this price is going to help them.
But it may not.
But they can’tdispense it to them right now
because they don't knowhow much their co-pay is going to be.
So that coding
aspect and I worked so hard to streamline
is certainly getting in the way of thisbeing streamlined for pharmacists.
And I cannot take that overnight.
(08:27):
More of a long term issue for sure.
So with that is moving.
Yeah.
Long term goals with that in mind,kind of moving into the future,
how do you see the regulatoryand reimbursement landscape
for digital therapeuticsevolving over the next couple of years?
You said that you could see itgetting bigger,
but kind of expand on that a little bit.Tell me more. Sure.
So we're once again seeing the PBMs
(08:48):
look into creating their formularyfor digital health products.
We saw this happen about, I want to say,six, five, six years ago now as well.
But it wasn't necessarily focusedon the clinically validated
and FDA regulated products.
They were looking at those products thatwere like a step up from mobile health,
maybe had some clinical validation,but weren't making claims.
(09:11):
And now I think we're seeingall those organizations
move towards that clinically validateddigital therapeutics.
And so we'll see that evolve.
But again, I'll bring up PDRS, the
prescription drug use related software,which will allow digital therapeutics
to be dispensed alongside drugs,and that will start seeing expansion
of the various CPT and HCPCS codesto kind of start to fill in those gaps.
(09:35):
But what we really need is for the peoplethat are really putting this product
on the ground to push,
you know, we want to get these productsinto the hands of patients.
We need these real practical examplesto make case to the CMS.
And so with these new digital healthmental health codes,
we'll see that real world evidencethat can allow then allow us to make
to put efforts forth to expand them intoother areas outside of just mental health
(09:57):
or to even expand within mental health,because those codes, for example,
don't cover issues with like tissuesand things like that
that are really triggerbecause of mental health issues.
And irritable bowel syndrome, for example,is triggered through mental health
a lot of times triggered their anxiety,not every time,
but there's products that treat that.
If there's productsthat treat fibromyalgia
(10:19):
and they aren't coveredwithin these mental health
treatment codes, even thoughthey're mental health products.
Coming to the end of our time here,what kind of practical advice
would you offer pharmacistswho want to effectively advocate
for better reimbursement for digitaltherapeutics in their practices?
Yeah.
So the best thing they can do is workwith the associations like APhA
(10:40):
and the Digital TherapeuticsAlliance and organizations like Advamed
and the Consumer TechnologyAssociation and AMCP.
And now I love NCPDP,but they're good with workflow.
They don't advocate on the Hill.
But this these trade associationsthat do lobby
and work with Congress on their behalfis the best way to move this forward
(11:00):
as well as,
of course, the provider associations likethe American Psychological Association.
Those are the folks
that are going to really stand upfor the industry on Capitol Hill.
So if you're going to say, hey,we all need this to move forward,
that makes sense.
APhA,the American Academy of Pediatrics, AAP.
Right. Get them.
(11:20):
You need to get them all involved.
It's not something that, you know,I think a standard pharmacist
would be just ready to do in theirspare time because it's a lot of work.
So the best thing is to have your voicebe heard
in these large groups like likewe have right here at this conference.
Thank you so much for your time.
I really appreciate youcoming on the First Fill.
Yeah, really appreciate it.Thank you. Thanks for having me.
Welcome to the First Fill My name is KatieMeyer,
and I serve as the SeniorDirector of Content Creation at APhA.
This monthwe did something a little bit different
and provided visiting resident BobbyChristodoulopoulos
with the opportunityto interview our subject matter expert.
He chose the topic of regulatory
and reimbursement pathways for digitaltherapeutics and welcomed guest
(00:25):
Andy Molnar, the CEO of DigitalTherapeutics Alliance.
the opportunity to speak on this topic.
This podcast was recordedin Nashville at APhA 2025.
So with that, I’ll let Bobby take it away.
All right,can you start by introducing yourself
and sharing
how you broke into the digital healthspace and what you and your team do over
(00:47):
at the Digital HealthTherapeutics Alliance
our listeners who might not be familiarwith the organization.
Sure thing.
Thanks for having me.
Andy Molnar, the CEO of the DigitalTherapeutics Alliance.
I'm also an advisor on the FDA'sDigital Health Advisory Committee.
I broke into digital healthwhen I first heard
about Pear Therapeutics back in 2017.
I had a friend who worked there andI thought that was the future of medicine.
(01:11):
And so I applied for a joband the rest is history, really.
Now what we focus on with my teamand this sort of
stemmed from what we started at PearTherapeutics
was buildingthe infrastructure for an industry, right.
We needed to we started a governmentaffairs and lobbying work
with CMSto have proper coding and coverage.
(01:31):
And that evolved into my passionfor create,
creating the baseline for the industry,which is that the Digital Therapeutics
Alliance is specifically focused onon policy work and legislative work
and bringing stakeholderstogether to drive things forward
because it truly people say it a lot.
but it is true
that a rising tide lifts all boats,and that's the way I look at this.
(01:53):
So in our part one,we kind of talked a little bit
about the primary regulatorypathways, de novo,
and then also the different classesof approval for digital therapeutics.
Can you give us kind of a brief overviewof those
and maybe dive into some examplesthat you've seen in practice? Sure.
You know, from a regulatoryperspective, it if you're used to
medical devices,it does act very similarly.
(02:15):
So if you're familiar with the denovo process and the 510 K process, that
that is the same.
There are only a few class three devicesbecause those of are riskier.
So there's, I believe, a product that
affects your insulin pump.
And so if that doesn't work,that can cause major issues.
(02:36):
So that is higher risk.
But typically we see things come throughas class two.
We also see quite a few productsgo through the enforcement
discretion pathway,which I didn't see listed here.
Some of some of the products thatthe FDA states this on their website too.
It's like mindfulness and meditation.
And that is not something that you'regoing to want to put through the FDA.
So that falls either under enforcement
discretionor outside of regulation entirely.
(03:00):
So could you share some of the most commonreimbursement pathways pharmacists
and digital healthinnovators should be aware of,
particularly related to Medicaid, Medicareand private insurance?
Sure.
So in the last six months, we've hada couple of really big advancements.
The first one being in the 2025physician fee
schedule, CMS had put out codesfor within Medicare
(03:21):
for the reimbursement of digital mentalhealth treatment devices.
These cover some of the earliest productslike Pear therapeutics reset
and reset o for substance use disorder,as well as Sleepio and SleepioRx
for insomnia and a product for majordepressive disorder called Rejoin.
It's a really great advancementbecause we can start showing utilization
(03:41):
in the real world and collectreal world evidence with patients.
We also talk a lot about prescription druguse related software, PDRS
which is a guidance
put out by the FDA where digitaltherapeutics can accompany drugs.
I actually think this will haveone of the biggest impacts on pharmacists
and talking to pharmacopeia earlierand how it kind of
(04:03):
cleans up the reimbursement pathwayto look at
to make that similarto the way that drugs are paid for.
Now we also have people using
a durable medical equipment pathway,which makes a lot of sense.
A lot of these digital devices
also have that hardware componentthat make the founder DME.
And I think and we also have the codeswith the American Medical Association
(04:26):
related to RTM and RPMand working to advance those.
So I think the point I'mtrying to make here is if you were to ask
that question three years ago,I'd give you a lot of vague answers
and saying we could try this,we could try this, we could try this.
And now it's become a lot more realitywhere your business,
what makes sense for your businessmodel as a company,
(04:47):
you can say this is the pathwayI want to go down.
Now there are some gaps within that.
You know, kind ofsounds like I've covered everything there.
So gaps withinwithin some of those pathways.
But now you can choose your businessmodel makes sense for that.
Before it was like, let's choosethe only pathway possible.
And so now it's opened up and it really isa completely different world
(05:09):
in 2025 because of the codes coming outand this new guidance from the FDA
kind of moving a little bit further along,what are some challenges
that you might see going forward,especially given the complexity
around reimbursement, like any challengesthat you might see for pharmacists,
specifically those breakinginto the digital therapeutic space?
What do you thinkthat they might face in the future?
Well,I think the biggest problems right now are
(05:32):
system issues, right?
So where we see pharmacistsgetting involved right now is basically in
specialty pharmacy and specialty pharmacythat does virtual type dispensation.
The larger retail chains,this isn't quite big enough
for them to invest the money to trainevery single one of their pharmacists.
They kind of it doesn't necessarilysound that complex to you.
(05:55):
And I was sitting here,but when you think of, okay,
what if a patient comes to a pharmacyand doesn't know how to download an app?
Pharmacies aren't really trained for that.
And so there is quite a lot of trainingthat has to come into place
if your CVS or your Walgreens right,
you're going to
you have to put quite a lot of investmentinto that space.
(06:17):
So with that, a lot of these productshave gone to either get or the company
to be the licensed to dispense medicaldevice themselves or have partnered with
with specialty pharmacy.
So the pharmacies that are currently
like really have their hands aroundthis are more in the specialty space,
even though you know that this doesn'tquite feel like a specialty product.
(06:38):
It's a unique dispensation.
And so it has to go through a workflowthat is designed specifically
for individual products.
Interesting.
And that'll evolve very quickly over time
because we see what they're doingin Europe and Asia.
Could you share some kind of
practical examplesor strategies that have helped pharmacists
or anyone really to successfully overcomethese reimbursement challenges?
(07:01):
Kind of here in the U.S.?
Yeah.
So, you know,I was thinking with the last book,
the last questionmore about how the pharmacists
are involved in the process,but the reimbursement complexity.
Any pharmacistthat is used to billing on the medical
benefit is it's a very complex process,even for drugs.
(07:21):
Right.
So if you're doing your typical lifestyle
and things like that, we're dispensing,yeah, that's all set.
Issues that we have faced in the pastis that but because the
coding infrastructureisn't quite built out yet
for a lot of these products and insurancecompanies are still working with how
they want to cover these products,whether it be on a new benefit
or covered on pharmacy benefitor something else
(07:44):
is that the pharmacist will billand if you don't get that real time
benefits verificationthat that were used to make,
it may take time a week even a monthto find out if the patient has coverage.
And so with that,I think the hardest part is particularly
because the pharmacistsits between the patient
and the insurance companytrying to explain that to the patient
(08:06):
and ensuring that they understandthat this price is going to help them.
But it may not.
But they can’tdispense it to them right now
because they don't knowhow much their co-pay is going to be.
So that coding
aspect and I worked so hard to streamline
is certainly getting in the way of thisbeing streamlined for pharmacists.
And I cannot take that overnight.
(08:27):
More of a long term issue for sure.
So with that is moving.
Yeah.
Long term goals with that in mind,kind of moving into the future,
how do you see the regulatoryand reimbursement landscape
for digital therapeuticsevolving over the next couple of years?
You said that you could see itgetting bigger,
but kind of expand on that a little bit.Tell me more. Sure.
So we're once again seeing the PBMs
(08:48):
look into creating their formularyfor digital health products.
We saw this happen about, I want to say,six, five, six years ago now as well.
But it wasn't necessarily focusedon the clinically validated
and FDA regulated products.
They were looking at those products thatwere like a step up from mobile health,
maybe had some clinical validation,but weren't making claims.
(09:11):
And now I think we're seeingall those organizations
move towards that clinically validateddigital therapeutics.
And so we'll see that evolve.
But again, I'll bring up PDRS, the
prescription drug use related software,which will allow digital therapeutics
to be dispensed alongside drugs,and that will start seeing expansion
of the various CPT and HCPCS codesto kind of start to fill in those gaps.
(09:35):
But what we really need is for the peoplethat are really putting this product
on the ground to push,
you know, we want to get these productsinto the hands of patients.
We need these real practical examplesto make case to the CMS.
And so with these new digital healthmental health codes,
we'll see that real world evidencethat can allow then allow us to make
to put efforts forth to expand them intoother areas outside of just mental health
(09:57):
or to even expand within mental health,because those codes, for example,
don't cover issues with like tissuesand things like that
that are really triggerbecause of mental health issues.
And irritable bowel syndrome, for example,is triggered through mental health
a lot of times triggered their anxiety,not every time,
but there's products that treat that.
If there's productsthat treat fibromyalgia
(10:19):
and they aren't coveredwithin these mental health
treatment codes, even thoughthey're mental health products.
Coming to the end of our time here,what kind of practical advice
would you offer pharmacistswho want to effectively advocate
for better reimbursement for digitaltherapeutics in their practices?
Yeah.
So the best thing they can do is workwith the associations like APhA
(10:40):
and the Digital TherapeuticsAlliance and organizations like Advamed
and the Consumer TechnologyAssociation and AMCP.
And now I love NCPDP,but they're good with workflow.
They don't advocate on the Hill.
But this these trade associationsthat do lobby
and work with Congress on their behalfis the best way to move this forward
(11:00):
as well as,
of course, the provider associations likethe American Psychological Association.
Those are the folks
that are going to really stand upfor the industry on Capitol Hill.
So if you're going to say, hey,we all need this to move forward,
that makes sense.
APhA,the American Academy of Pediatrics, AAP.
Right. Get them.
(11:20):
You need to get them all involved.
It's not something that, you know,I think a standard pharmacist
would be just ready to do in theirspare time because it's a lot of work.
So the best thing is to have your voicebe heard
in these large groups like likewe have right here at this conference.
Thank you so much for your time.
I really appreciate youcoming on the First Fill.
Yeah, really appreciate it.Thank you. Thanks for having me.
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