Healthcare Innovation attorneys Carrie Nixon and Rebecca Gwilt show the connection between National Security and Healthcare Innovation—and why this critical issue needs to be addressed

Subscribe on Apple Podcasts, Spotify, Buzzsprout, or follow the podcast on LinkedIn for new episode drops.

In this episode you’ll discover:

• When we aren’t actively facilitating healthcare innovation, we put our national security at risk. Think about how long it took people to get a telehealth visit for chronic or acute conditions during the first months of the pandemic. If we can’t keep our people healthy, how secure are we?

• If telehealth reimbursement passed in 1997, why did it take until 2020 for the first nationwide, full-service telehealth provider to expand its medical services to include Medicare Part B coverage?

• Regulations that protect patient safety are important, but need to facilitate innovation. We’ll talk about a few resources for this, as well as how far we still have to go.

Keep scrolling for a transcript of this episode.

Learn more from Carrie and Rebecca: 

Healthcare insights (monthly email) | Telehealth/Virtual Care Mgmt Update (biweekly LinkedIn update)

Website | Carrie on LinkedIn | Rebecca on LinkedIn | NGL on LinkedIn

Learn More Here

The FDA’s Digital Health Center of Excellence, which aims to facilitate partnerships to accelerate digital health advancements, share best practices, and provide oversight in a less burdensome, efficient way. Still, there is no explicit coordination with CMS, the agency that connects reimbursement to these innovations.

Doctor On Demand, a San Francisco, CA-based virtual care provider, announced it is the first nationwide, full-service telehealth provider to expand its medical services to include Medicare Part B coverage.

Read the transcript:

Carrie Nixon (00:00):

Regulations protect patient safety. That's incredibly important, but we absolutely cannot allow the regulatory landscape in healthcare to stifle innovation.

Announcer (00:12):

You're listening to Decoding Healthcare Innovation with Carrie Nixon and Rebecca Gwilt, A podcast for novel and destructive healthcare business leaders seeking to transform how we receive and experience healthcare.

Carrie Nixon (00:25):

Hi everyone. It's good to be here. All right, so today we're going to talk about national security. That is probably a bit of a surprise for some of you who have tune tuned in to hear about healthcare innovation because that's what this podcast is supposed to be about. But the truth of the matter is that healthcare innovation is actually a matter of national security. So why is that? Well, national security is really the safe safekeeping of our nation as a whole, and this includes protecting the health of our people. So when we aren't actively facilitating healthcare innovation, our national security is at risk. We saw a prime example of this during covid 19 where we had to scramble crazy to figure out how to connect people with their doctors when they couldn't see them in person. It was insane. We saw people who we saw large health systems who were unable to quickly pivot and facilitate telehealth visits.

(01:30):

We saw small medical practices who had absolutely no idea what to do. I experienced this personally when my father had a medical appointment that we had literally been waiting months to have. We were supposed to have it I think it was around April 9th in 2020, and this was with a large medical system, a health system, and I reached out to them and said, Hey, I know things are crazy. I'm really glad that we know now we are allowed to do telehealth, and I'm really looking forward to doing this visit via telehealth and being on there with my dad and connecting with you that way because I wanted to make sure we were still set to go, and they went, we're going to have to postpone. We're really not prepared to do telehealth, and we're still trying to figure it out, and so we're really backed up and we're going to have to just reschedule. So it wasn't until two months later in June that we were able to have that appointment. That's not acceptable and it's not good for our national security.

Rebecca Gwilt (02:39):

So I remember when that happened, Carrie, and at the same time, we had several clients that were unprepared despite us talking to them for years about how to integrate these kinds of tools into their practices and those who were able to pivot quickly survived, and those that couldn't didn't had a really, really tough time. And I know that we have one client that was very willing to be innovative. They were an outsourced emergency services physician group that worked with a very large health system in our area. They were ready and the hospital, they couldn't accommodate it. Their IT department couldn't accommodate the change. Their legal department was taking too long to sort of say yay or nay on it. And I imagine that a lot of other Americans have the same kind of story.

Carrie Nixon (03:29):

Yeah, exactly. So when we're reading the news today, the general news as well as sort of the healthcare trade press, people are talking about telehealth as innovation, and that just seems absurd to me. We have had telehealth and the ability to be reimbursed for telehealth through Medicare since 1997. That was when the legislation passed that allowed Medicare to reimburse for telehealth services in certain limited circumstances. That was only when provided at an originating site, like a clinic for people in rural areas. At that time, the technology was new it was somewhat limited and the whole focus of telehealth at that time was providing people who were living in rural areas access to expert medical care that was in the big cities. So they didn't have to travel a long ways. Very understandable. Today in 2021, the technology has improved immensely, right? We don't have to have special video cameras that are set up in a clinic to video the patient and to video the provider on the other end. Everyone has a webcam on their phone or on their computer. So telehealth and technology advanced, but the laws and regulations around it remain the same. And this meant that medical practices and large health systems simply were not adopting telehealth technology.

Rebecca Gwilt (05:12):

Much of this goes back to, we say policy. What we're really talking about is reimbursement policy. There are certainly regulations making sure that the services are delivered in a high quality way, that the people delivering the services are appropriately licensed. But really what unleashed all the change that we've seen over the last year was CMS relenting and allowing for reimbursement for a broader swath of patients. So that in particular was patients who they stopped a limitation on patients who were in rural area. Okay, let me start again. Let me again. Okay. And really when we're talking about policy and the limitations of policy, what we're talking about is reimbursement policy. There are other laws that apply to the delivery of services via telemedicine that have to do with the quality of care, the licensure of the doctors making sure that it's safe and that patients aren't hurt in the process.

(06:26):

But really what we saw during 2020 was an explosion in the use of telemedicine and other remote and virtual care services only because the ability to bill for them had changed. Providers were no longer restricted to billing for services, telemedicine services for only rural patients for instance, under Medicare which sets a lot of the policies that the commercial insurers follow behind. It is shocking to me that it took till May of 2020 for the first sort of 50 state telehealth provider to start billing to Medicare. They just couldn't do it before that. And that meant that 33 million Medicare beneficiaries who couldn't pay cash for services were only able to access them, setting aside those that lived in rural areas who could make it to an office in that rural area. They couldn't get it from home at that time that it took till May, 2020 to open up that market. And what we've seen since then is that the care was good. The people like it and they're asking for more.

Carrie Nixon (07:32):

Yeah, that's right. And I think you're referring to Doctor on Demand. That's right. That's a company that had a national presence. As soon as Medicare said, Hey, we're going to allow reimbursement for this, they pivoted to get enrolled in Medicare. But it's still a process, and it took longer than it should. And in the meantime, as you very rightly point out, there were many, many, many Americans that were left without access to good care. So you know, and I know very well that healthcare is the most highly regulated industry in the nation, and that's for a lot of good reasons. Regulations protect patient safety. That's incredibly important. But we absolutely cannot allow the regulatory landscape in healthcare to stifle innovation in that place, in that space. Instead, we really need to be encouraging legislation and regulation that actually actively, proactively facilitates innovation. We know that the Covid pandemic really shown a spotlight on healthcare as a matter of national security.

(08:46):

And thankfully, I think we are seeing some progress now. Right? One example is the FDA's new Digital Health Center of Excellence that was announced I believe back in late 2020. And the goal of the Digital Health Center of Excellence is really to facilitate partnerships to accelerate digital health advancements to share best practices, and importantly, to provide oversight, but in theory, at least in a less burdensome way than has previously been done. Importantly for those of us who work with clients very frequently who are formulating their business models, FDA is not coordinating with CMS, right? The other agency that is involved, that frankly provides the reimbursement for these innovative devices, services, et cetera. And as you mentioned before, if something's not paid for in the healthcare industry, it's not done. So we have seen implications for lack of coordination between FDA and CMS in the past. I would like to see some very explicit coordination with CMS and with FDA in recognition that those two agencies really have to be working hand in hand in order to avoid giving sort of conflicting or contrary or non coordinated guidance and advice to the people who are out there innovating.

Rebecca Gwilt (10:27):

Yeah,

Carrie Nixon (10:28):

You've probably seen some other examples of things that have worked and things that haven't.

Rebecca Gwilt (10:33):

So as some of you may know, my experience goes back to the implementation of the Affordable Care Act. There were many instances there of the left hand not working with the right hand. I have a number of stories that I could go into, but we don't have enough time for that today. I absolutely think that coordination between federal agencies is vital. It is also very, very difficult to do and this administration is in the process of transitioning as they do that stakeholders in the industry and folks like me and Carrie are going to absolutely be there to support them and to help them in that coordination effort. If you'd like to ask us more about how we're doing that, please contact us. We're happy to share, and we'd love to bring a larger coalition to the issue. What I also want to talk about is in addition to the reimbursement changes that we need to see call your congressperson to ask them to support the Connect for Health Act, that's absolutely a place to start.

(11:38):

In addition to that, what we're seeing from the Centers for Medicare and Medicaid innovation, which was largely dormant during the last administration, is very strong words about the revivifying of the payment models that were in place including bundled payment initiatives, accountable care organizations behavioral health integration. There are a number of models out there. What we've experienced is that when those models work, and by that I mean when they're paying dividends they're large sort of financial benefits to the folks participating in them. They continue. When there aren't large financial benefits, those folks are dropping out of those models. And the problem is, models were created to increase quality and to reduce costs in the industry across the board. And so when individual players can choose to opt out, when for instance, it doesn't work out for them for one reason or another, it really impacts the ability for our federal agencies to, on a national level, move the needle. And so the head of CMMI, Liz Fowler has said that we should keep an eye out for some of those models becoming mandatory so that there's no option to opt out of them. And that value-based payment and value-based principles are going to be a mandatory requirement for all organizations that want to participate in the Medicare program. I think that's pretty huge.

Carrie Nixon (13:05):

I agree, and I think it's necessary. I mean, we have tried sort of the sole carrot approach for a while now. We thought that it might be enough to really move the needle and make the change happen. We thought we've seen some progress, but I think what we know now is that we need sort of a carrot and a steak approach. The last thing I'll say about sort of ongoing efforts around innovation in the space is we are seeing some innovation contests being put out by the government, right by ONC, these innovation challenges. And I think that's terrific. We need more of those. We need to broaden the ability for people to know of them and to participate in them. I think there's some good stuff to come out of that. So I'm encouraged by that. But as we wrap up, I'm going to circle back to telehealth and not because it is sort of the only healthcare innovation far, far from it but it's a really good example of a course of action. We don't want to repeat. We don't want to get to reimbursement for virtual care services only to have them so limited that no one actually again starts using them. So I'm going to circle back to healthcare, and we've, we're seeing a lot of legislation out there, but a lot of that legislation does not include payment parody. And that means that there's no requirement that telehealth be reimbursed at the same amount as the equivalent in-office visit. And frankly, that is less of an incentive for providers to encourage telehealth.

(14:52):

And that, without a doubt increases. We know that telehealth increases the access to care and reduces overall cost to the system as a result. So there are some really easy and smart things that I think the government can be doing looking to telehealth, sort of as an example. So anyway, as we conclude, I just want to urge everyone to think about and to talk about healthcare innovation as a matter of national security. As Rebecca said, talk to your legislators, talk to your policy makers. Help frame this as an issue of national security, the safekeeping of our nation that with respect to their healthcare needs and their overall health. I think it's a message that we don't hear enough, they don't hear enough, and I think it's a message that really should resonate. So thanks for the time today for tuning in, and we'll talk to you soon. Bye everyone.