处方数字疗法的最新进展

您正在收听《Podnosis》，医疗行业的脉搏。

You're listening to Podnosis, the pulse of the healthcare industry.

我是主持人安娜斯塔西娅·格里亚科夫斯卡。

I'm your host Anastasia Gliakovska.

处方数字疗法这几年风头正劲，从破产潮到报销政策变化再到人工智能进步。

It's been a buzzy few years for Prescription Digital Therapeutics from bankruptcies to reimbursement policy changes to AI advancements.

处方数字疗法在最佳状态下，能提供更个性化的护理体验，同时也更便捷、更具成本效益。

At their best, Prescription Digital Therapeutics can offer a more personalized care experience, one that is also more convenient and cost effective.

行业参与者正在密切关注，但要实现广泛采用仍有很长的路要走。

Industry players are paying attention, but there's still a long road ahead for widespread adoption.

还有哪些挑战存在？针对这些挑战正在采取什么措施？

What challenges remain and what's being done about them?

为了解释清楚，我采访了该领域的两位专家约瑟夫·帕拉库帕卡和安迪·莫尔纳。

To explain, I talked to two experts in the space, Joseph Parakupka and Andy Molnar.

乔是处方数字治疗公司FreeSpira的首席执行官。

Joe is CEO of prescription digital therapeutic company FreeSpira.

安迪是美国远程医疗协会的行业事务高级副总裁。

Andy is SVP of industry affairs for the American Telemedicine Association.

请继续收听。

Stick around.

很高兴两位能来参加。

It's great to have you both.

非常感谢你们抽空参与。

Thanks so much for making the time.

谢谢邀请我们。

Thanks for having us.

处方数字疗法这几年经历了不少波折。

So Prescription Digital Therapeutics have had an interesting few years.

我们简称其为DDX，这类应用通常用于诊断和治疗多种疾病，包括今天重点讨论的心理健康问题。

DDX, as we'll refer to them throughout the combo, are generally apps that are used to diagnose and treat a variety of diseases, including mental health, which we'll focus on today.

期间发生了高调破产案例、上市公司私有化以及保险政策变化。

There have been high profile bankruptcies, public companies being taken private insurance changes.

研究人员确实预测未来DTX用户将会增加，这是一个非常令人兴奋的领域。

And researchers do predict that there's gonna be an uptick in DTX users in the future, so it's a very exciting space.

但仍然存在挑战。

But still, there are challenges.

DDX的保险覆盖远未标准化，监管审批本身也是一道难关。

Insurance coverage is far from standard for DDX, and regulatory approval is its own kind of hurdle.

我想先了解一下，过去五年左右这个领域是如何发展的？

I just wanna start with how has the space evolved over the past, say, five years?

你对哪些方面感到兴奋？

And what are you excited about?

好。

Yeah.

那我就这个问题来回答吧，毕竟这五年我一直领导着行业协会。

So I'll jump in on that one since I've led the industry association through those five years.

安迪，也许你可以简单自我介绍一下，让大家熟悉你的声音。

And, Andy, maybe introduce yourself briefly just so folks can recognize your voice.

好的

Yeah.

当然

Absolutely.

再次感谢邀请我

Thanks again for having me.

我是安迪·莫尔纳

Andy Molnar.

我曾担任数字疗法联盟的首席执行官，该联盟是一个专注于全球数字疗法产品监管和报销的行业协会

I was the former CEO of the Digital Therapeutics Alliance, which was the trade association focused on regulatory and reimbursement for digital therapeutics products globally.

六个月前我们被ATA Action收购，该协会同时关注远程医疗和所有虚拟医疗服务

We were acquired six months ago by ATA Action, which is the association both focused on telehealth and telemedicine and all virtual care.

因此我们与新协会的使命完美契合，继续致力于将数字健康产品带给患者

So we fit very nicely into this new association with our continued mission of bringing digital health products to patients.

当我们回顾全球发展历程时，十年前曾有一个特定的应用案例

And as we think about what's happened globally, there was this one specific use case a decade ago.

当时有个构想：我们如何通过数字手段开发出具处方资质且能产生治疗效果的产品。

And there was this idea of how do we have a prescription product that offers a therapeutic outcome through digital means.

对吧？

Right?

通过电脑和智能手机实现医疗交付的理念其实已存在很长时间。

And it's been around for a very long time, the idea of delivering things through a computer and then through smartphones.

但如何证明其临床有效性呢？

But how do you say it's clinically validated?

我们实际上采用与药物相同的疗效声明方式，并将这些数字疗法交到患者手中。

We actually make claims the same way you would with a drug and get that into the hands of patients.

因此我们亲眼见证了这个行业彻底转型并演变成全新形态的过程。

And so we've actually seen this industry completely turn over and morph into something new.

现在必须认识到：数字化是填补医疗保健重大缺口的唯一解决方案。

Now what we have to remember is digital is the only solution for our major gaps in health care.

这意味着当前的发展态势表明：数字医疗不仅不会消失，反而正在确立其永久地位。

And so what this looks like and what this is becoming is does never means that this is going away.

数字健康将改变无数人的生活，无论你身处美国乡村、世界各地还是大城市，异步医疗都能通过数字健康进行管理。

Digital health is going to change so many people's lives in whether you're in rural America, whether you're living around the world, or whether you're in a major city, asynchronous care can be managed through digital health.

现在我们看到它以不同形式重新出现，无论是远程监护中的护理管理，还是远程患者监护平台。

And so now we've seen it just reemerge in different ways, whether it be care management within remote monitoring or remote patient monitoring platforms.

我们看到有产品与药物配合使用，成为药物的辅助治疗手段。

We see products that are going alongside drugs and being paired with drugs.

我们依然能看到最初的用途，即这些产品可以像乔即将谈到的那样被开具处方。

And we still also see that original use case, which is that these products can be prescribed much like what Joe will talk about.

因此，我们现在拥有更多样化的产品类型，这将对医疗系统产生惊人影响，无论是从成本角度还是患者疗效角度。

And so with that, we now have a wider variety of types of products, and it's just going to make a incredible impact onto the health care system, both from a cost perspective and a patient outcome perspective.

乔，让我邀请你加入讨论，如果可以的话请简单做个自我介绍。

Joe, let me bring you in and just give a brief intro if you might.

好的。

Sure.

再次非常感谢邀请我们来到这里。

And, again, thanks so much for having us here.

我们非常高兴能参与这次讨论。

We're really excited to be part of this discussion.

我叫乔·帕拉库卡。

My name is Joe Paracupka.

我是FreeSpear公司的CEO，我们是一家数字疗法公司，或者更准确地说，我们专注于为成人和青少年提供针对焦虑障碍的家庭心理健康治疗方案。

I'm the CEO of FreeSpear Incorporated, and we are a digital therapeutic, or we like to refer to ourselves as an at home mental health treatment focused on anxiety disorders for adults and adolescents.

我们主要关注恐慌症、创伤后应激障碍，同时也致力于解决青少年的压力和焦虑问题。

And we predominantly focus on panic disorder, PTSD, and we're also addressing stress and anxiety for adolescents.

从我们的角度来看，我想接着安迪的话说——展望医疗保健的未来时，我认为数字疗法必将成为其中不可或缺的部分，尤其在心理健康领域。目前我们看到的最大机遇是：虽然从报销角度来看进展缓慢，但像我们FreeSpira这样的公司已经成功度过了风暴。

From our perspective, and I'll kind of build off what Andy said, I look at it this way, when we look at the future of healthcare, I don't see a world where digital therapeutics are not part of that, especially in the mental health space, where I think the greatest opportunity that we're seeing right now is it's been a slow adoption, it's been slow from a reimbursement standpoint, but there are companies like FreeSpira and other organizations that have been able to kind of weather the storm.

我们正在市场展现出强大的韧性，而其他许多机构却未能坚持下来。

We're demonstrating our resiliency in the market despite the other organizations that have not been able to make it.

从我们的视角来看，我认为最令人振奋的进展是：CMS今年终于发布了远程患者监控指南。

So from our perspective, I think some of the most exciting things that are really occurring is CMS has finally taken notice earlier this year when they released the physician fee schedule for digital mental health treatments.

今年早些时候，，我们看到了两个重大声明。

Really saw that as a bold move forward and I think they made two huge statements.

第一点，我们认为这些治疗方案应当被纳入针对心理健康障碍患者的治疗范式中。

One is, alright, we believe that these therapeutic options should be incorporated into the treatment paradigm for individuals that are suffering with mental health disorders.

但第二点，对我来说真正有力的是其背后的动机——我们需要更早地整合这些方案。

But secondly, what is really powerful to me is the motivation behind it is we need to incorporate them earlier.

因此当临床医生在诊断并为患者制定治疗计划时，他们希望患者从一开始就讨论数字心理健康治疗在其治疗路径中可能发挥的作用，并围绕这一点构建报销策略。

So as the clinician is diagnosing and building out that treatment plan for the patient, they want them to actually begin to discuss the role that a digital mental health treatment can play in their treatment pathway from the beginning and they're building a reimbursement strategy around that.

我认为这很重要，因为它表明心理健康在这个国家确实至关重要，我们目前严重滞后，必须采取重大举措才能迎头赶上，开始提供人们所需的治疗。

I think that's important because it signifies that mental health is really important in this country, we're really behind the eight ball and we really have to take significant advances to actually get ahead of it and start giving the treatment that people need.

我们稍后会详细讨论医师费用表。

And we'll talk more about the physician fee schedule shortly.

现在让我们转向今年早些时候在国会重新提出的《处方数字治疗药物可及性法案》。

But let's turn to the access to prescription digital therapeutics act, which was reintroduced in congress earlier this year.

各位认为这项法案将如何推动相关进展？

What are you guys thoughts on how that might move the needle on some of this stuff?

是的。

Yeah.

我想说的是，《处方数字疗法获取法案》我们从2021年就开始推进这项工作，实际上可以追溯到2018年就在国会山推动相关立法。

So I would say the Access to Prescription Digital Therapeutics Act, we have been working on this since 2021, but actually back to 2018 working on legislation on Capitol Hill.

这项法案成为了后续所有其他报销机制出台的驱动力。

This was the driver for all of the other reimbursement mechanisms that had come forth.

通过这项法案，我们成功引起了广泛关注，教育了众多利益相关方，不仅从政策角度，还包括专业协会、医疗服务网络等等。

We were able through this bill to get so much attention to educate so many different stakeholders, both from a policy perspective, but also professional associations, provider networks, etcetera.

这一切之所以能实现，是因为我们拥有这份指导整个行业的处方数字疗法框架文件。

And that all came about because we had this access to prescription digital therapeutic deck that was guiding the entire industry.

所以现在出现在医生收费表上的这些编码，实际上源于我们2023年与筹款委员会人士的一次对话。

So these codes that came about in the physician fee schedule actually occurred because of a conversation that we had in 2023 with somebody in ways and means.

他们向我们推荐了多种可以立即纳入数字疗法的报销机制。

And they recommended different reimbursement mechanisms that we could already put digital therapeutics into.

要知道，软件类产品通常很难获得报销。

Like, software in general is so hard to reimburse.

但在这种情况下，如果我们能找到不同的领域来提取报销机制——比如医生收费表中的这些心理健康编码，或者将某些产品列入耐用医疗设备清单。

And in this case, if we could find different areas where we could pull out reimbursement mechanisms like these mental health codes within the physician fee schedule, like putting certain products into as to list them as durable medical equipment.

这一切的发生是因为《处方数字疗法获取法案》以两党两院制形式提出，让其他人得以了解并帮助我们找到最初的报销途径。

This all happened because the Access to Prescription Digital Therapeutics Act was introduced bipartisan and bicameral, allowing other folks or allowing other people to be educated and help us figure out where we can get these initial reimbursement.

该法案将创建一个新的医疗保险福利类别。

And the bill would create a new Medicare benefit category.

是这样吗？

Is that correct?

没错。

That is correct.

是的。

Yeah.

如果你回顾福利类别的发展，1965年医疗保险刚设立时，他们根本想不到2025年我们口袋里会装着超级计算机。

And if you think back to benefit categories, when Medicare was first started in 1965, they never thought we were gonna have a supercomputer in our pockets in 2025.

直到2000年代初，医疗保险才首次涵盖并创建了药房福利。

And it wasn't until the early two thousands that a pharmacy benefit was even covered, was created in Medicare.

而将软件纳入其中一直非常复杂。

And fitting in software has been really complex.

事实上，如果我们想简化流程并让患者更容易获得这些产品，新增一个福利类别将是最理想的解决方案。

And really, if we wanna streamline this and make these products accessible to patients, a new benefit category would be the ideal solution.

你认为这会鼓励商业保险公司为此提供报销吗？

Do you think that it would encourage commercial payers to reimburse for this?

是的。

Yes.

对。

Yeah.

我来插一句。

I'll jump in there.

没错。

Yeah.

绝对如此。

Absolutely.

我想说，从我们以往的经验来看，商业保险公司通常会等待CMS先采取行动，然后这就会开辟出一条道路。

I would say what we see traditionally on our side is it's commercial payers often wait for CMS to make the first move, and then that kinda creates the pathway.

我想再回到之前的话题。

And I do wanna go back.

我想花点时间强调一下安迪在推动PDT法案通过过程中所起的作用。

I do wanna take in a minute to highlight the role that Andy played in actually pushing the PDT bill through.

在安迪加入DTA并接任CEO之前，法案虽然有所进展，但缺乏同样的专注度和关注度。

Prior to Andy coming on board with the DTA and the role that he took over as CEO, it was moving along but not with the same focus and attention.

我认为安迪做得特别出色的是将其列为优先事项，并召集所有成员组织共同支持推进工作。他真正促成的是让大家抛开个人动机，作为一个团队齐心协力推动这项法案。

I think what Andy did exceptionally well was make that the priority and then pull in all of the member organizations to support the efforts to move this forward and really what he allowed to happen was, okay, let's remove individual motivations and let's actually come together as a group and let's focus on how do we push this bill together collectively for all of us.

不是每个人都能在第一轮就获胜，就像数字心理健康治疗代码的情况一样。但我们需要团结一致，推动这个老生常谈的道理——水涨船高。

And not everybody's gonna win out on that first round as you see with the digital mental health treatment codes, but we all need to be together and trying to drive what is the old thing, all boats rise in a high tide.

这就是安迪为DTA带来的协调能力。

And that's what Andy brought to the DTA in coordinating this.

但回到报销这个话题，确实是个挑战。

But kind of going back to the reimbursement piece, it's really a challenge.

正如安迪提到的，我认为我们需要这个新分类的原因是事情并不像人们想的那么简单。

As Andy was mentioning, think the reason we need this new category is it's not as simple as people think.

试图将我们正在开发的数字治疗类别项目硬塞进健康计划传统采用的三大分类中，这非常具有挑战性，对吧？

Trying to take what we're doing from a digital therapeutic category and fit us into one of the three big buckets that health plans are traditionally doing, it's very challenging, right?

我们既不完全符合药品福利类别，也不属于传统医疗器械类别，更不是供应商服务。

We don't quite fit into that pharmacy benefit category, we don't fit into the traditional medical device category and we're not a vendor service.

健康计划机构确实很头疼该如何制定合同来引入这些治疗方案，即便他们有意愿这么做。

Health plans really do struggle with how do they actually create a contract to bring in these treatments even if they want to.

因此我认为这项法案对我们至关重要。

So I do think the bill is going to be really important for us.

正如安迪所说，医师收费标准实际上是实现这个目标的第一步。

And as Andy mentioned, the physician fee schedule was actually that first step in making and accomplishing that goal.

嗯。

Yeah.

那我们详细聊聊医师收费标准以及规则包含哪些内容吧。

So let's talk more about the physician fee schedule and what is part of the rule.

安迪，不如你先开始？

Andy, why don't you go first?

好的。

Yeah.

当然。

Sure.

是的。

Yeah.

所以他们创建了这些编码，DMHTs即数字心理健康治疗编码，这些编码开始涵盖心理健康数字疗法。

So they created these codes, DMHTs or digital mental health treatment codes that that are starting to cover mental health digital therapeutics.

这些编码的设计初衷是为了适用于遵循RESET和RESET O所采用的监管路径的任何产品。

So what they were designed for was any product that followed in the regulatory pathway that RESET and RESET O followed.

RESET和RESET O是较早的一批产品，它们主要针对物质使用障碍。

The RESET and RESET o were some of the earlier products, and they focused on substance use disorder.

共有七款产品以RESET作为参照设备通过了FDA审批。

So there's seven total products that have used RESET as a predicate device to go through the FDA.

这些产品都符合这些编码的资格。

Those qualify for these codes.

这真是太棒了。

So that's great.

其中有一个针对重度抑郁症，两个针对失眠症，当然还有两个针对物质使用障碍。

There's one in major depressive disorder, there's two in insomnia, and of course, there's two in substance use disorder.

对医生收费表进行了非常深刻的更新。

Very profoundly update to the physician fee schedule.

CMS故意将它们限定得很窄。

CMS made them narrow on purpose.

对吧？

Right?

他们知道心理健康领域存在缺口。

They know there's a gap in mental health.

他们知道数字化手段可以有所帮助。

They know digital can help.

但我认为他们担心如果对所有情况都开放，成本将会变得过高。

But I think there was a worry that if it was opened up to everything that it would really be way too costly.

所以他们希望保持范围狭窄，并至少测试一年。

And so they wanted to keep it narrow and test it out for at least a year.

他们已经将ADHD纳入计划，将于明年生效。

They've already added ADHD to go into effect next year.

但当你查看自2021年以来获批的所有心理健康数字疗法时，我只是以此作为参考，因为我手头有些PPT资料。

But when you look at all of the mental health digital therapeutics that have been approved since 2021, I just use that as a reference because of some PowerPoints that I have.

实际上很多产品并不符合这些编码标准。

A lot of them actually don't fit into these codes.

所以我认为乔也可以谈谈这个问题，但这确实是个很好的起点。

And so I think Joe can talk about this a little bit as well, but this is a great starting point.

这使医疗系统和远程医疗公司能够采用这些产品，并通过医生收费计划让患者获得付费治疗。

It's allowing health systems and telehealth companies to adopt these products and get them into the hands of patients paid through the physician fee schedule.

但它显然没有对所有心理健康产品开放，所以仍存在一些我们正在努力解决的问题。

But it is certainly not opened up to every mental health product, so it still does have some issues that we're trying to resolve.

是的。

Yeah.

所以，我再次表示我非常支持这个举措。

And so, again, I think I'm incredibly supportive of this.

但说实话，FreeSpirit是不符合这些分类的产品之一。

But truth be told, FreeSpirit is one of the products that don't fit into these categories.

因为我们公司早在2013年就成立了。

Because our company was founded back in 2013.

我们当初获批的类别与这些新的数字疗法分类那时甚至还不存在。

The category that we were approved under versus these new digital therapeutic categories wasn't even around yet.

所以我们现在正处于一个需要扩展的阶段。

So we are now at a point where we're trying to expand this.

但在整个过程中，我参与其中并与安迪合作，这确实成为了讨论的一部分，现实情况是我们必须推进这件事。

But throughout this process, I was involved in this and working with Andy, and it it came up as part of the discussion and the reality was, hey, we have to push forward with this.

对吧？

Right?

所以我们会想办法在未来让FreeSpirit跟上节奏。

So we'll figure out how to bring FreeSpirit up to speed down the road.

但眼下，我们需要这场胜利，需要让人们获得报销，得到他们所需的帮助，这正是推动我们前进的动力。

But for the meantime, we need this win and we need to get people some reimbursement and get people the help they need and that was the driver of it.

从Free Spirit的角度来看，我们目前正尝试通过向CMS申请独特的HCPCS编码来开辟自己的道路，这将使我们能够为所做的工作获得报销。

From a free spirit standpoint, we're trying to find our own pathway currently now by applying to CMS to get a unique HCPCS code that will actually allow us to get reimbursement for what we do.

我认为我们在审视数字心理健康治疗编码时面临的问题是，它完全基于我们所说的SAMD产品，即纯软件。

And I think the issue that we look at with the digital mental health treatment codes is it's purely based on what we call SAMD products, software only.

还有一类产品，比如Freeze Beer，我们是硬件和软件的结合体。

There's a whole category of products where, like Freeze Beer, where we're hardware and software.

这很有趣，因为人们没有意识到的是，虽然我们有了这个很棒的新类别，但还有另一类产品无法完全归入其中。

So it creates it's interesting because what people don't realize is great, we've got this new category, it's awesome, but yet there's this other group of there's this other group of products that don't fit neatly into that box.

那么现在，我们如何为这些产品提供便利？

So now how do we accommodate for those products?

我们是扩展现有的可用编码吗？

Do we expand the current codes that are available?

Andy提到他们正在添加ADHD相关编码。

Andy mentioned they're adding ADHD.

还是我们必须真正开拓前行，找到一个适用于我们这类产品的不同编码？

Or do we have to or do we have to actually forge forward and find a different code that we can utilize for products like us?

是的。

Yeah.

你知道，回到2024年，我很高兴乔提出这个问题，因为我们在会员内部进行了一些非常激烈的讨论。

You know, back in 2024, I'm glad Joe brought this up because we had some really great heated discussions within our membership.

当时我们就指出这些编码并不能覆盖所有的心理健康产品。

And we said these codes don't cover every mental health product.

我们该怎么办？

What are we gonna do?

实际上我们得出了与乔暗示相同的结论，即这些代码未能纳入2025年医师收费标准的最终版本，是最糟糕的情况。

And we actually came to the conclusion with that Joe alluded to, which is the codes not going into the final version of the physician fee schedule in 2025 were the worst was the worst thing that could happen.

因此我们不愿冒险，尽管它原本只涵盖七种产品，但我们需要这些代码到位。

And so we didn't wanna necessarily put that at risk even though it only was gonna cover seven products because we need the codes in place.

我们需要展示真实世界证据，也需要呈现总成本，以便政府能进一步推进此事。

We need to show real world evidence, and we need to show that total cost so the government can figure out how to move this further.

所以这就是一个权衡取舍的问题，伙计们，我们可能最终一无所获。

And so it's that toss-up between, well, guys, we may end up with nothing.

这比能推动进展的某些方案更好吗？

Is that better than something that can help move the needle?

实际上，会员们达成共识，决定支持CMS提出的编码方案。

And really, the members came together and elected to support the codes that CMS had proposed.

嗯。

Yeah.

Joe，你刚才提到了硬件，我确实想简单谈谈可穿戴设备。

Joe, you just referenced hardware, and I did wanna talk about wearables for a second.

七月时，HHS部长小FK在一次听证会上发表声明，希望所有美国人未来四年内都能佩戴数字健康设备。

In July, HHS secretary FK junior gave a statement at a hearing that he hopes all Americans are gonna be wearing digital health devices within the next four years.

他承诺将围绕这个目标开展一项大规模的HHS宣传活动。

He promised to launch a really big HHS campaign around this.

显然，可穿戴设备与处方数字疗法不是一回事，但它们如何相辅相成？你对这个承诺声明有何看法？

Obviously, wearables are not the same thing as a prescription digital therapeutic, but how do they go hand in hand, and what are your thoughts about that promise statement there?

关于现任政府有很多不同看法，但如果你仔细审视，会发现它可能带来许多积极影响。

There's a lot of views about this current administration, but I think there are a lot of positives that can come out of it if you look at it.

我确实认为这可能是一件好事。

And I I do think this could be a positive.

我先说说积极的一面，然后再谈谈对可穿戴设备的担忧。

So I'll give you my positive view and then also the concern that comes along with wearables.

我认为如果使用得当，可穿戴设备可以带来益处。

So I would say wearables can be beneficial if utilized in the right way.

所谓得当，就是如何将这些信息传递给临床医生，让他们能根据数据采取行动。

And the right way is how do we get the information from that into the hands of the clinician, right, so that they can take action on the data that's there.

如果没有这种连接，那么所有数据就毫无意义，对吧？

Without that connection, then all that data, it doesn't really matter, right?

可穿戴设备的目标是收集关键生理参数，并传回给临床医生以便他们采取行动。

So the goal of the wearables is gathering key physiological parameters that can be sent back to the clinician so that they can take action.

这是很重要的一环，也引出了我要说的第二部分。

So that's a big piece of it and that leads me into the second part.

我最大的担忧在于数据部分。

The big concern I have is the data piece.

要知道，那些被记录和传输的敏感患者健康数据，我们必须确保有适当的防护措施来保护这些数据，这确实令人担忧。

You know, the sensitive patient health data that is being recorded and transmitted, we have to make sure that there are the proper guardrails in place to protect that data, and that's something that's really concerning.

而且我们收集了大量数据。

And we gather a lot of data.

我们对此非常重视，无论是在数据收集方式、数据保护措施还是数据传输过程上。

We take it very seriously, right, in terms of how we're gathering the data, how we protect that data, and how we're transmitting that data.

在急于给每个人都配备可穿戴设备之前，我们必须先解决数据保护问题，因为目前这方面还不完善。

Before we rush to get everybody a wearable, we have to address that data protection piece because it's not there yet.

不过，安迪，我不知道你对此有什么看法。

But, Andy, I don't know what your thoughts are on that.

确实。

Yeah.

可穿戴设备产生的健康数据不受HIPAA法案保护。

Health data from wearables isn't protected by HIPAA.

对吧？

Right?

不是的。

It's not.

哦，确实不是。

Oh, it isn't.

这非常可怕。

It's very scary.

请继续，安迪。

Go ahead, Andy, please.

确实如此。

It is.

是的。

Yeah.

所以我们主要涉及临床验证且受联邦监管的产品领域。

So we're very much in the realm of clinically validated federally regulated products.

现在想想我们在美国技术上能做到的事，对吧？将可穿戴设备数据与临床验证数据、远程监测相结合，连接到你的电子病历，收集医疗数据，实际提供数字疗法，通过远程医疗提供治疗。

Now if you think about what we're able to technically do within The United States, right, with combining wearable data with clinically validated data with remote monitoring, link it up to your EMR, collect health care data, actually deliver digital therapeutics, deliver therapy through telehealth.

从技术上讲，我们完全可以做到所有这些。

We could technically do all of that.

而且我们可以利用人工智能来帮助引导患者完成这一旅程。

And we can use artificial intelligence to help guide patients through that journey.

我们确实可以。

We could.

但基础设施还不完善。

But the infrastructure isn't there.

政策支持也还没到位。

The policy isn't there.

所以对我来说，并不是简单地给每个人都发个很棒的可穿戴设备就完事了。

And so it's not for me like giving give everybody wearable great.

好吧。

Okay.

为了什么目的？

For what purpose?

好吧。

Okay.

是为了监测血压吗？

Is it for blood pressure?

是为了了解你的心理健康状况吗？

Is it to understand your mental health?

是为了辅助所有医疗健康事项吗？

Is it to help with everything healthcare?

所以我认为我们必须明确界定这个目标，因为成本极其高昂。

So I think we have to get to a point where we're really defining that goal because that is incredibly costly.

对吧？

Right?

给每个人都配备可穿戴设备或强制每个人购买可穿戴设备，这在各方面都很昂贵。

Giving everybody a wearable or forcing everybody to purchase a wearable, that's expensive across the board.

那么我们如何才能实现真正改善群体健康的目标，而不是仅仅作为一个噱头？

So how do we really get to a place where we look at population health and this is making a difference and it's not just a gimmick?

同时还要确保其安全有效，因为我们刚刚目睹人们使用生成式AI治疗心理健康时遇到问题，这与经过临床验证的方法不同，生成式AI并未引导他们走向正确的方向。

And also that it's safe and effective because we have just seen people run into trouble using generative AI to treat their mental health as opposed to something that's clinically validated and that generative AI did not lead them down the right path.

是的。

Yeah.

完全正确。

Absolutely.

安迪，你这么说我真的很高兴。

And and I'm so glad you said that, Andy.

如果可以的话，我认为关键在于医疗行业在采用新技术方面的步伐非常缓慢。

And if I may, I think the big piece here is, right, health care moves at a very slow pace in terms of adopting new technology.

而最让我担忧的是，我们提出了这个概念，却没有明确的前进路径。

And I think what concerns me most is we throw that out there, but there's no clear pathway forward.

对吧？

Right?

因此我认为我们必须采取迭代步骤。

So I think what have to is take iterative steps.

太棒了。

So great.

让我们引入可穿戴设备，但要专注于特定人群。

Let's introduce wearables, but let's focus on a given group of individuals.

无论是糖尿病监测，还是像安迪说的血压监测，我们就从这里开始，因为问题有两个方面。

So whether it's diabetes or, like Andy said, blood pressure monitoring, let's start there because the problem is two things.

如果我们全面铺开让所有人都使用，就会让每位临床医生、每个医疗系统、每家支付方都淹没在数据洪流中，最终导致失败。

If we roll it out wholesale and everybody's got this, we're gonna flood every clinician, every health system, every payer with too much data and what'll happen is it'll ultimately fail.

但如果我们说，让我们从非常专注的领域开始，预先确定好观察指标、数据监测方式以及数据传递和利用的路径。

But if we say let's begin with a very narrow focus, a very a predetermined path in terms of what we're looking at, how we're gonna monitor the data and then how we're going to transmit and utilize that data.

这样我们才能取得成功。

Then we can have success.

让我们先验证这个试点项目，然后再以此为基础进行扩展。

Let's prove that pilot program out if you will and then use that to actually expand beyond that.

但我认为在没有这些参数的情况下贸然推进会出问题。

But I think throwing it out there without those parameters is gonna be a problem.

关于安迪提到的AI数据部分，我认为这是技术可能迅速失控的一个典型案例。

And the data piece Andy brought up AI, I think that's a great example of where technology can go awry pretty quickly.

我确实想再深入探讨一下AI这个话题。

I did wanna just get at the AI piece a little bit more.

AI在类似自由精灵这样的产品中扮演什么角色？

What role does AI play in, say, a free spirit or a similar product?

对于生成式AI这类技术，你们如何考虑设置防护栏？

And how do you think about guardrails around things like generative AI?

是的。

Yeah.

这个问题很有趣，我认为AI会发挥作用，但我对此有个非常明确的观点。

So it's interesting because I think AI is gonna play a role, but I think I have a very distinct opinion on this.

我认为我们高估了AI在医疗保健领域应用的广度和速度。

I think we're overestimating how broad and how quickly AI will be adopted into health care and our health care system now.

我认为它有趣之处以及我首先遇到的困惑是，我们完全忽视了数字疗法——这一我认为可能是医疗保健领域最具变革性的数字化进步，而直接跳到了AI。

I think what's interesting about it and where I struggle first is we're overlooking, we're jumping completely to AI and we're overlooking what I believe is really probably the most transformative piece or change in healthcare that we've seen that's digital therapeutics.

正如安迪提到的，我们现在有能力将经过FDA验证批准的产品直接送到患者家中。

As Andy mentioned, we now have the ability to deliver validated FDA cleared products to a patient at home.

这在以前是根本无法实现的。

We were never able to do that previously.

所以从AI的角度来看，我认为它最大的影响将体现在提升临床医生和后台办公的效率上，帮助他们腾出时间专注于本职工作——减少文书工作，增加面对患者的时间，确保患者获得所需治疗。

So I think from an AI perspective, I think where it's going to have the greatest impact is really efficiencies with the clinicians, back office, helping free up their time so they can do what they're supposed to do, which is spend less time on paperwork and more time on being patient facing and helping get patients the treatments they need.

首先，如果人工智能被使用，其软件作为医疗器械的一部分用于实现临床疗效，那这就是数字疗法。

So first of all, if artificial intelligence is used and its software is a medical device and it's part of delivering a clinical outcome, that is a digital therapeutic.

因此我要明确表示：如果在数字疗法中应用了AI，我们已开始为此类治疗奠定报销基础。

So I wanna make it very clear that if AI is used within a digital therapeutic, we have started to lay the groundwork for reimbursement for that.

若应用于心理健康领域，并以RESET和RESET作为基础设备，实际上可以纳入这些数字心理健康治疗代码的覆盖范围。

If it's done within mental health and it uses RESET and RESET o as a predicate device, it would actually be covered under these digital mental health treatment codes.

事实上，从福利类别角度来看，使用AI与其他软件目前尚未形成本质区别。

Like, the fact that it uses AI versus another software really is not necessarily different yet from a benefit category perspective.

随着时间的推移可能会有所改变。

It might be over time.

但从行政角度来看，我确实认为乔说得对。

But from an administrative perspective, I do think Joe's right there.

我们将会看到很多进展。

We're gonna see a lot there.

但我们已经从行政角度遇到了政策问题。

But we're already running into policy issues from an administrative perspective.

想想自动化预先授权流程。

Think about automating prior authorizations.

AI可以对所有人说不，并且能为每个拒绝决定提供理由。

Well, AI can say no to everybody and can give a reason to say no to every single patient.

而有人参与决策时会说：'你知道吗？'

Whereas a human in the loop would say, oh, you know what?

实际上这位患者需要治疗，因为x、y和z等原因。

Actually, this patient needs it because of x y and z.

因此我们正面临这样的疑问：在这种情况下人工智能是否失效了。

And so we're running into questions there about is AI not working in that case.

而人工智能在护理管理方面的沟通则非常出色，因为它可以全天候工作，花时间通过电话回答你的每一个问题，而你的医疗提供者不可能整天只和你通话。

Whereas AI talking somebody through care management is great because AI has all day long, and they can spend time on the phone with you and answer every single question, whereas your provider does not have all day long just to talk to you.

所以我们确实看到人工智能将在医疗保健领域产生影响的明确途径，同时也很快发现从政策角度我们仍有许多问题需要解决。

And so we're really seeing some clear ways where artificial intelligence is gonna make an impact in health care, and it's also very quickly become apparent that there's a lot we still have left to figure out from a policy perspective.

如果我可以接着这个话题说，现在观察人工智能，特别是在心理健康领域，情况非常令人担忧。

If I could just build on that, if you take a look right now about AI, and especially mental health, it's very concerning.

我知道我们遇到了一些问题，但值得庆幸的是，目前有四个州正在对人工智能在心理健康领域的应用设置重大障碍，我对此表示赞赏。

And I know we've had some issues, unfortunately, but there are four states currently that are putting up serious roadblocks to AI and mental health, and I do applaud that.

伊利诺伊州在这方面真正走在前列，他们现在明确规定除非有临床医生实时监督，否则人工智能不得用于任何心理健康治疗场景。

So Illinois is really leading their charge and what they're stating now is AI cannot be used in any mental health treatment capacity unless there is a clinician that's actually monitoring it.

我认为这非常重要，因为心理健康具有特殊性，特别是当我们看到美国民众面临的挑战时，在我看来将临床医生完全排除在这个过程之外是件坏事。

I think that's really important because mental health is unique and I think when we look at the challenges that people are facing in The United States specifically, removing a clinician from the entire process from my perspective I think is a bad thing.

所以我认为人们在美国往往忽略的是，技术固然伟大，但在医疗保健领域，我们把医学视为一门科学，几乎是一门精确科学，但实际上并非如此。

So I think AI, what people tend to forget I think unfortunately in The US, is that technology is great, but when it comes to healthcare, we look at medicine as a science, almost as an exact science, and it's really not.

医学中有很大一部分依赖于经验，依赖于患者的参与，你会发现当观察临床医生与患者的互动方式时，他们确实是天赋异禀的诊断专家。

There is a huge component of medicine that relies on experience, that relies on patient engagement, and what you find is when you look at clinicians and the way they work with patients, they're really gifted diagnosticians.

想想很神奇，去看医生时他们会说：'嘿，我觉得我们应该往这个方向考虑，可能是这个原因对吧？'

What's amazing, you think about it, go to your doctor and they're like, Hey, I think we're moving in this direction, it's probably this, right?

我们会根据经验给你诊断，然后开抗生素或其他药物。

We're gonna empirically diagnose you, we're going to provide an antibiotic or some other form of medication.

但经常他们会说：'我们还需要做些其他检查，因为在这个情况下有些情况我就是觉得不对劲'——而这正是人工智能未必能理解的，我认为正因如此必须保留人为因素，这种经验会带来巨大差异。

But oftentimes they're like, but we're gonna run some other test because something's just not adding up to me in that scenario and that's what AI doesn't necessarily get and I think you have to the human element involved because of that experience and it makes a huge difference.

特别是在心理健康领域，我认为患者可能传递的许多微妙线索是AI永远无法捕捉的，正是这些有趣的细微差别决定了一个人是得到治疗康复，还是走向另一个极端产生自杀念头，这确实是个可怕的后果。

And in mental health specifically, I think there are a lot more subtle cues that patients may deliver that AI just will never pick up and it's those interesting nuances that make the difference between an individual getting care, getting better, or ending up on the other side and potentially moving towards suicidal ideation, which is an frightening prospect.

嗯。

Yeah.

关于临床医生的接受度以及他们如何看待处方数字疗法和整体技术应用，我很好奇您的实际经验和相关对话内容，因为我们听到临床医生对AI或新技术引入工作流程存在很多合理顾虑，无论是患者隐私问题还是对诊疗流程中断的担忧。

Well, with clinician uptake and just how clinicians think about prescription digital therapeutics and technologies in general, I'm curious what your experience has been and what those conversations are like because we hear a lot of hesitancy from clinicians, understandably so, around AI or just introducing new technologies into the workflow, whether it's concerns about patient privacy or just concerns to disruption of care.

那么您如何看待当前临床医生对处方数字疗法的采纳现状？

So how do you think about where clinician adoption currently stands of prescription digital therapeutics?

有没有什么方法能让临床医生感到更安心，还是说他们已经适应了？

And are there things that could make clinicians feel more comfortable, or are they already comfortable?

这个问题问得太好了。

It's such a great question.

再次强调，我们专注于心理健康领域，我认为目前我们面临双重挑战。

Now, again, we reside in mental health, and I think when you look at it, we're fighting two challenges.

首先是技术首次真正进入这个领域，对吧？

One is this is the first time technology has actually entered that space, right?

其他专科比如心脏病学已经习惯使用设备，可植入设备，软件也是其中一部分，所以他们更容易接受。

So there are other specialties like cardiology where they're used to doing devices, implantable devices, software is part of those so they're a little more comfortable with it.

从心理健康的角度来看，这和他们惯常做法有着巨大差异。

From a mental health perspective it's a pretty vast shift in terms of what they're used to doing.

因此推广过程中的障碍和接受曲线要缓慢得多。

So the obstacles and adoption curves are a lot slower.

但我认为这首先是专业协会的责任，对吧？

But I think it's incumbent upon, one is the societies, right?

我们需要这些协会更快地接纳我们，对吧？

We need the societies to start embracing us faster, right?

所以无论是美国心理学会开始讨论他们在访谈和信息收集中看到的情况，这也是企业的责任。

So whether it's the American Psychological Association to start talking about what they see in interviewing and gathering information, and it's also incumbent upon the companies.

我们发现一个非常有趣的事情是帮助临床医生理解我们的价值所在。

One of the things that we found that's really interesting is helping clinicians understand the value that we are.

我们不是要取代他们。

We're not there to replace them.

FreeSpirit不是为了从他们那里抢走病人，也不是为了破坏他们现有的护理路径。

FreeSpirit is not there to take patients away from them or to disrupt the care pathway that they have.

我们是来补充这一点的，对吧？

We're there to supplement that, right?

所以我们实际上是他们与患者工作的延伸，我们会对患者进行28天的治疗。

So we're really an extension of what they're doing with the individual and what we do is we treat patients for twenty eight days.

治疗结束时，我们会将患者转回，并提供治疗结束报告。我们发现临床医生在最初与我们合作，他们的患者使用Frispira时会有一些犹豫，但当他们熟悉后，就能真正看到这种治疗的价值。

At the end of that treatment we pass the patient back, we give them an end of treatment report, and what we're finding is that there's some hesitancy initially with clinicians as they're working with us and their patients are utilizing Frispira, but after they get comfortable with it, they really see the value of this.

他们意识到的是，哇，通过使用像FreeSpira这样的数字疗法，我的患者获得了难以置信的体验。

What they realize is, wow, so by utilizing a digital therapeutic like FreeSpira, my patient has an incredible experience.

这正是我们真正关注的——确保患者旅程顺畅，让他们获得良好体验。

And that's something we're really focused on, is making sure that we have a great patient journey and the patient has a good experience.

当患者回到临床医生的办公室时，我们听到的反馈是：患者的体验如此之好，以至于他们带着重新聚焦于持续治疗和寻求更高层次护理的动力回来，而之前可能存在抵触情绪。

And when they go back to the clinician's office, what we're hearing from them is the patients have such a good experience that they come back with kind of a renewed focus on continuing the care and seeking out that next level of care where maybe there was resistance previously.

我们现在看到的是，真正采用FreeSpirit的临床医生都认识到了它的价值。

What we're seeing now is there's clinicians that are really adopting FreeSpirit, they see the value of it.

由于我们为患者提供28天的辅助治疗，患者在家中进行这个项目，临床医生将其视为个人医疗护理计划的延伸，同时这28天内也减轻了他们的负担——既能提供更全面的治疗方案，又无需全程主动参与。

It also, because we're helping them for twenty eight days, the patient's going through this other program at home, they see it as an extension of the health care treatment program that they have for the individual, but it also reduces the burden on them in that twenty eight days so that they're providing a more robust treatment program, but they don't have to actively be involved in it.

因此从这个角度看，这有很多好处，而认识到其价值的临床医生会更快地采用它。

So from that perspective, there's a lot of benefits, and the clinicians that see the value in that are adopting it faster.

嗯。

Yeah.

这很合理。

That makes sense.

那么在成本节约方面，能否谈谈您如何向支付方证明这项技术确实能带来投资回报？不仅要改善患者体验和治疗效果，还要预防后续成本增加？

And in terms of just cost savings, can you talk about maybe what case you make to payers who wanna see that this is really gonna have ROI, that this technology is gonna not only improve outcomes in the patient experience, but also prevent downstream costs?

是的，你提出了一个重要且具有挑战性的问题。

Yeah, you bring up an important point and it's a challenging thing.

我认为很不幸的是，即使在我与认识的人交谈时，他们也难以理解为何无法获得这种特定治疗。

And I think unfortunately, even as I talk to people I know, they struggle with the concept of why can't I get this particular treatment?

为什么我的保险公司不为此买单？

Why doesn't my insurance company pay for that?

归根结底，我们必须认识到支付方确实是风险规避型组织，临床效果如何对他们并不重要。

And at the end of the day, have to realize what we're realizing is payers are they're really risk averse organizations, and it doesn't matter clinically what your product looks like.

这其中还涉及其他风险，对吧？

There are other risks that are associated with it, right?

部分风险在于患者是否能获得良好体验？

And part of that is, will the patient have a good experience?

他们非常关注患者满意度评分，也就是他们所谓的会员满意度评分。

They're very focused on patient satisfaction scores or what they call member satisfaction scores.

但另一方面，也必须要有相关的成本节约。

But the other piece too is there has to be cost savings associated with it.

所以我们有已发表的数据与健康计划分享，帮助他们理解。

So we've got published data that we share with the health plans and help them understand.

此外，通过我们收集的数据，我们正在追踪每位加入FreeSpear项目的个体的成本指标。

We also, through our gathering of data, we're tracking cost metrics for every individual that enrolls in FreeSpear and goes out.

因此当我们审视自己的工作并试图鼓励健康计划时，有两个数据点非常重要。

So when we look at what we're doing and we're trying to encourage health plans, there are two data points that are really important.

首先是成本节约部分。

The first is the cost savings piece.

我们已发布的数据显示总医疗成本降低了35%，但更重要的是，我们看到急诊科使用率大幅下降了65%以上。

The data that we have published demonstrates a 35% reduction in total medical costs, but more importantly, we're seeing significant reductions upwards of 65% in emergency department utilization.

对吧？

Right?

所以这些对健康计划来说是重要驱动因素。

So these are big drivers for health plans.

这些方面涉及巨额成本。

There are big costs associated with them.

然后我们会引入现实世界的成本节约数据。

We then pull in real world cost savings data.

目前，我们与部分健康计划合作已积累了两年的数据。

We're now, with some health plans, we've got two years of data.

我们正在证明第一年实现的成本节约会延续到第二年，并向他们展示相较于FreeSpirit的成本，可能达到四比一的投资回报率。

We're demonstrating that the cost savings we achieve in year one continue into year two, and we're showing them potentially a four to one ROI versus the cost of FreeSpirit.

这是极具说服力的数据。

It's incredibly powerful data.

但第二个重要方面，特别是在心理健康领域，是我们采用的基于测量的护理指标。

But the second piece that's important, especially in mental health, is the measurement based care metrics that we use.

我们对每一位加入FreeSpirit并成为其患者的个体都百分之百地实施基于测量的护理。

We use measurement based care in one hundred percent of the individuals that enroll with FreeSpirit and become a FreeSpirit patient.

纵观行为健康领域，遗憾的是只有约20%的临床医生会常规性地开展基于测量的护理。

When you look at behavioral health, unfortunately, only about twenty percent of clinicians are actively doing measurement based care on a routine basis.

对于可能不太了解的听众，您指的是患者报告的结果问卷吗？

And just for folks who might not be familiar, are you talking about patient reported outcome questionnaires?

是的，患者报告的结果问卷，谢谢。

Yes, patient reported outcome questionnaires, thank you.

确保无论是用PHQ-9量表来测量抑郁症治疗前后的症状变化。

Making sure whether it's a PHQ-nine to measure what your symptomology is at the start of a treatment versus the end of treatment for depression.

我们使用的是恐慌症严重程度调查表和PCL-5量表来评估创伤后应激障碍。

For us, we're using panic disorder severity surveys and the PCL-five for PTSD.

这实际上是在测量患者在整个治疗过程中的改善情况，对吧？

And what it is is it's measuring how the patient improves through the treatment course, right?

当我们与医疗计划签约时，我们会进行季度业务审查，并与他们分享基于这些指标的汇总临床结果。

When we sign up with a health plan, we do quarterly business reviews and we're sharing with them aggregated clinical outcomes based on those metrics.

这是有史以来第一次，医疗计划真正看到了现实数据——比如你们治疗了100名患者，这是治疗前的平均水平，这些是临床结果。

And for the first time ever, health plans are actually seeing real life, like okay great, so you treated 100 patients, this was the average before and this is the clinical outcomes.

通过分享这些实际数据，不仅增强了他们对我们工作的信心，也真正促使他们继续扩大与我们的合作，因为这些指标非常重要，不仅仅是成本节约，还包括临床结果部分。

And by sharing with them that actual data, it provides confidence in what we're doing with them and really empowers them to actually continue to expand us in working with them because those metrics are really important, not just cost savings, but also the clinical outcomes piece.

这很有道理。

That makes sense.

那么Vrispira现在是由保险公司全额报销，还是有时需要患者自费？

And today is Vrispira, like, always reimbursed by a payer or sometimes folks pay out of pocket?

具体是怎么运作的呢？

How does that work?

唉，我倒希望总能报销呢。

Oh, boy, I wish it was always reimbursed.

这是个漫长的过程。

It's a long haul.

不过目前我们正逐个与保险公司洽谈。

But no, we're going payer by payer.

现在有两项进展：我们已向CMS提交申请获取专属HCPCS编码，这将为我们开通报销渠道，便于获得更多商业医保的全面报销。

Two things that are happening now: we are working we did submit to CMS to get a unique HCPCS code that would provide reimbursement and open up the channel for us to get more global reimbursement across commercial health plans.

目前我们已进入退伍军人医疗体系。

Currently, we're in the VA.