Health-E Law Podcast Ep. 11
CURES and Beyond: Reining in the Long Tail of Healthcare
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Listen to the podcast released July 18, 2024, here: https://www.sheppardmullin.com/multimedia-578
Welcome to Health-e Law, Sheppard Mullin's podcast exploring the fascinating health tech topics and trends of the day. In this episode, Gregory Stein, Founder, Chief Executive Officer, and Director of Shadowbox, joins us to discuss how the 21st Century Cures Act could impact interplay within the healthcare industry, particularly interoperability as a means of addressing what has become, according to recent testimony before the U.S. Senate Budget Committee, a $950 billion administrative burden.
About Gregory A. Stein
Gregory A. Stein is the Founder, Chief Executive Officer, and Director of Shadowbox, a venture funded healthcare software company whose mission is to elevate patient care by making patient data easy to access and safe to share no matter where it resides.
A former legislative aide on Capitol Hill, Greg was an original investor in Millennium Health and previously served as the company’s Vice President of Strategic and Community Affairs, helping it grow to over 1,500 employees and $1.8BN in enterprise value. Beyond the boardroom, Greg has dedicated his career to community service. He co-founded the Safe Homes Coalition to battle prescription drug abuse and served as Chairman of the San Diego County Taxpayers Association for seven years, leading the charge for better government efficiency.
About Sara Shanti
A partner in the Corporate Practice Group in the Sheppard Mullin's Chicago office and co-lead of its Digital Health Team, Sara Shanti’s practice sits at the forefront of healthcare technology by providing practical counsel on novel innovation and complex data privacy matters. Using her medical research background and HHS experience, Sara advises providers, payors, start-ups, technology companies, and their investors and stakeholders on digital healthcare and regulatory compliance matters, including artificial intelligence (AI), augmented and virtual reality (AR/VR), gamification, implantable and wearable devices, and telehealth.
At the cutting edge of advising on "data as an asset" programming, Sara's practice supports investment in innovation and access to care initiatives, including mergers and acquisitions involving crucial, high-stakes and sensitive data, medical and wellness devices, and web-based applications and care.
About Phil Kim
A partner in the Corporate and Securities Practice Group in Sheppard Mullin's Dallas office and co-lead of its Digital Health Team, Phil Kim has a number of clients in digital health. He has assisted multinational technology companies entering the digital health space with various service and collaboration agreements for their wearable technology, along with global digital health companies bolstering their platform in the behavioral health space. He also assists public medical device, biotechnology, and pharmaceutical companies, as well as the investment banks that serve as underwriters in public securities offerings for those companies.
Phil also assists various healthcare companies on transactional and regulatory matters. He counsels healthcare systems, hospitals, ambulatory surgery centers, physician groups, home health providers, and other healthcare companies on the buy- and sell-side of mergers and acquisitions, joint ventures, and operational matters, which include regulatory, licensure, contractual, and administrative issues. Phil regularly advises clients on matters related to healthcare compliance, including liability exposure, the Stark law, anti-kickback statutes, and HIPAA/HITECH privacy issues. He also provides counsel on state and federal laws, business structuring formation, employment issues, and involving government agencies, including state and federal agencies..
Transcript:
Sara Shanti:
This is Health-e Law, a podcast dedicated to the exciting and sometimes explosive interaction between technology and law in the healthcare space.
Phil Kim:
Hosted by Sheppard Mullin's digital health team. Each episode covers innovations that impact healthcare, like AI, virtual reality, and even wearable devices.
Sara Shanti:
We'll dive into the legal implications of health tech you should know about, visit with trailblazing players in the industry and have a little bit of fun along the way.
Phil Kim:
So let's get to it.
Sara Shanti:
Welcome to Health-e Law.
Phil Kim:
Today's episode explores the 21st Century Cures Act and how it may impact the industry and the interplay between the players.
Sara Shanti:
I'm Sara.
Phil Kim:
And I'm Phil.
Sara Shanti:
We're your hosts. We want to thank you for joining us today.
Phil Kim:
We're so pleased to have Greg Stein join us today. Greg is the CEO of Shadowbox, a healthcare software company whose mission is to elevate patient care by making patient data easy and accessible and safe to use, and to share no matter where it resides.
Sara Shanti:
Yeah, Greg began his career as a legislative aide on Capitol Hill before serving as an executive at a large independent diagnostic laboratory where he experienced firsthand the costs, delay and clinical challenges due to integration of technologies. The result being that 9 out of 10 providers still use fax to order ancillary services, as in facsimiles.
Shadowbox has since patented a powerful software tool that dramatically expands interoperability and workflow automation opportunities, especially for long tail healthcare.
Phil Kim:
So Greg, thanks so much for joining us today. Can you start off by telling us a little more about your company's software and how you see the impact, the overall effects on the long tail of healthcare?
Greg Stein:
Well, first of all, Phil, Sara, thank you very much for allowing me to participate in this podcast and to speak with you and your listeners. It's an honor. I am very excited to talk about Shadowbox as a technology and its origin story, which really is as Sara mentioned in the intro, came out of the challenges that we saw in the laboratory space primarily, but really across all of healthcare and specifically ancillary service providers where there's data for patients that live in electronic health record systems, a broad term for the systems of record where patient data evolved. And in order for those providers, those clinicians to properly diagnose and treat their patients, they often have to provide the information that lives in their EHR to other ancillary service providers, or other referring partners that don't have direct electronic access to that data.
And the traditional method of doing point-to-point integration or even hub-and-spoke integration where you have programmers at the EHR and programmers at the ancillary or some third party intermediary was very costly, very time-consuming. Because of the variability in the various practices in terms of the number of patients being served, the number of tests being ordered, the payer mix of those patients being served, very, very often my experience had been that we would invest in developing these integrations. They would go live, but they wouldn't pencil out.
Now there's been advances of course, and we'll talk a lot more about it. Now, Shadowbox essentially was designed to create a new modality or a new way to access patient data that lives in an EHR in a secure and compliant way, and avoid the cost delay and inaccuracies related to all of the various technologies that were currently available.
Sara Shanti:
That's great, Greg. Thank you. So maybe talk a little bit about how recent regulation, framework of the industry, not only from the regulatory, but kind of traditional business arrangements and evolving business arrangements have affected how your software can come into play and serve those customers, and what hurdles you're seeing and how easy it is to navigate that.
Greg Stein:
Well, Sara, this brings us right to the 21st Century Cures Act, which is a massive piece of legislation and it addressed all kinds of things that are not related at all to interoperability, but Title IV is specifically about interoperability and addressing what has become, according to relatively recent testimony at the Senate Budget Committee, a $950 billion a year administrative burden, which that's more money spent on administrative burden than is being spent on cancer care. I mean, there's other things that contribute to it, like the complexity of prior authorizations and so on, but all of that has to do with the movement of data from point A to point B, C, D and E.
So the Cures Act, once implemented, has been a game changer, and it's really inspired and through regulation, the larger entities to move towards and address standardization. So in terms of data standards and encoding standards and so on, which have already been in progress, but have been now moving towards being able to move that data at a level that is effective.
So today, the large hospital systems, the large health systems, the large provider groups are transacting billions and billions of transactions through traditional HL7 messages, through FHIR-based data standards and FHIR APIs. Now, there are SMART on FHIR applications which are enabling outside folks and insular service providers new technologies to access those large systems. But that's the large systems, then there's everybody else. So when you think about health disparities or access to care, care in rural areas or care in underserved areas, the challenge is that those large systems can't still under the existing technologies efficiently, cost-effectively and appropriately create that ecosystem of data transmission, and that's the long tail.
So think about it in several ways. The long tail of healthcare relates to, like I said, small practices, ancillary service providers who are trying to connect to those small practices, referring providers for new specialty services that are live outside the hospital. These are all sort of outside the happy path of interoperabilities that stands today. And what I found to be exciting about the Cures Act is that it didn't just say use APIs and this is the standard how you will connect. It said use APIs and "successor technology." So that enabled technologies like Shadowbox to be able to come to market and to find an opportunity to really address that long tail in a way that hadn't been done previously.
Phil Kim:
Moving forward, what do you see as the progress and the direction that the health IT vendor industry is moving towards in terms of adapting to the various Cures Act requirements?
Greg Stein:
So ONC is directed to establish standards, and those standards, if they are met, enable a EHR provider, or more broadly speaking, health IT vendor to become a certified health IT organization, and that's wonderful. Like I said, the large organizations, the Epic's, the Cerner's, the big EHRs that are out there are advancing rapidly, and that has enabled them and is enabling them to connect into the HIEs, the TEFCA, these types of interoperability plans, and it's really exciting.
But the challenge, however, is that there's a whole universe that lives outside of the certified health IT world, and they really fall into sort of three or four different buckets. One bucket is the specialty EHR that is really tailored to a very small group of users where advancing to those standards just doesn't pencil up. There's just not enough users to sustain a certified health IT program. The second set are those EHRs that live outside of the standard healthcare services market that never had access to the incentive programs that really drove EHR adoption. Then you have another section in the universe, which is all of those ancillary service provider systems, their systems are rapid. Think about it like a lab information management system or a radiology information system. Some of the brand new and exciting AI tools that are being used in radiology and so on, they're typically not certified.
Then the last group I think is really an important one that has not yet been contemplated effectively at all in the current regulation or legislation, at least at the federal level, is the vast universe of social service providers that are in effect providing a form of healthcare. So you've got this idea and public health objective to address the complete continuum of care so that a person has the best possible care with the most information about that person wherever they may need receiving care, whatever that care may look like are outside of the regulatory confines of what are called certified health IT, which is defined in the terms.
Sara Shanti:
So Greg, knowing that there's this bucket of those that are outside of the certified IT and that this might have direct impact on patient care, patient access, especially in more vulnerable communities, rural health, can you talk about what other gaps you're seeing and how this differentiation between those that are inside the regulatory framework and outside potentially could cause additional gaps in the industry for not only just how technology works, but the proliferation of access and quality care?
Greg Stein:
Yeah, Sara, I mean, your point is extremely well taken. It's not about the technology, it's about getting the best possible care to the greatest amount of people at the lowest possible cost. So when you have these disparities, meaning you have a significant portion of the health IT vendors that are out there, that live outside of the controls and standardization around certified health IT, you get several challenges.
One is if you don't get good clinical data out of a system effectively, meaning if a non-certified health IT vendor is information blocking, meaning that they're preventing the access or use of a patient's information for the provision of health care services, that forces several things. It forces you to use the facts, that 9 out of 10 providers are still using facsimile to order ancillary services. That forces to fax.
When you use a fax, you are automatically introducing delay, but what's worse than that is that let's say it's a diagnostic test and let's say the diagnostic test does not include all of the appropriate criteria, the data elements that are necessary for a good clinical report, now you're providing an inaccurate diagnostic result. And that's the key is that when you have bad information ineffectively transmitted, you're not only delaying care, but you are providing potentially incorrect responses to those requests.
Sara Shanti:
What other gaps do you see from your perspective?
Greg Stein:
So some of the gaps, and I touched on it a little bit earlier, include the amazing innovation that's coming out throughout the health ecosystem in terms of using technology to advance patient care. If we don't have a clear playing field and a roadmap for how those technologies can effectively interact either at the practice level, at the ancillary service level, or even at the health system level in a way that is effective, then those amazing technologies may never take hold.
There's a second piece of it, which isn't really about the Cures Act, so much as a lot of these new technologies don't have a specific CPT code that can be built against. So whereas they might be proving out the improved outcomes, they might be proving out increased throughput, they might be proving out increased productivity and reduced friction, in order for them to live within that paradigm of not a lot of revenue coming into the organization with this new technology, and then having to go out and be blocked from accessing the patient data that's necessary in order for them to provide those services unless they pay at EHRs potentially high fees, and the delay that I've already described in what the traditional methodology is, that could kill these technologies that are so important to improving healthcare across the board.
Phil Kim:
Yeah, I mean, leveraging these technologies to just increase access to care and drive down costs, and as you mentioned, ultimately saving lives, all of that seems like it's an exciting time for innovation right now, and it's also a challenging time for sustainability and adoption and utilization, right? So when it comes to legislators and addressing some of these gaps that you've identified, how would you recommend that they go about doing that?
Greg Stein:
Perhaps most importantly, Congress could expand the information blocking regulations beyond simply the certified health IT. So I believe that any health IT system that contains patient data that is funded in or in part by Medicare, Medicaid, DOD, VA, etc, should require that holder of that data to abide by the information blocking rules.
I think that there's more things that can be done now without legislation too as we work through that. So the Office of the National Coordinator, Department of Health and Human Services is responsible for implementing the Cures Act, has a website where vendors and patients and providers and others can complain about perception or reports of information blocking by health IT vendors. However, if the health IT vendor is not certified, then the case will just simply drop. So I think that ONC could do more than simply drop. They could reach out to the non-certified health IT vendor, advise them that a complaint has been made, share with them the resources and support that are available already through various programs to support the certification of that IT, and to keep that complaint on file for future reference.
Additionally, the Office of the Civil Rights, which is really designed to address the information blocking between a patient and their provider. So I'm a provider and I'm not going to give you as a patient your records, they are very active in addressing that, but that's between a provider and a patient. Although others can file complaints for information blocking on behalf of patients in that paradigm, the patient can say to the Office of Civil Rights that my provider is requesting information from an EHR vendor or health IT vendor for a service that supports my treatment, and that health IT vendor is interfering or blocking or preventing the use of my patient data for that service. So it's a nuance in that it's coming from the patient, regarding the provider, accessing the EHR and there's a third party complaint. But I think that ONC could expand that in a way that enhances the ability and the awareness and the support for driving more effective interoperability and workflow automation.
Another item that could be done is that there are already dollars out there that are appropriated through HHS, and Congress can certainly appropriate more for the education of providers and patients about the importance of utilizing certified health IT. There are probably many, many other things we could do, but those are just some that come to the top of mind.
Phil Kim:
Greg, thank you so much for joining us on this episode of Health-e Law. Thank you all for listening, and until next time, we'll see you then.
Greg Stein:
Thank you both.
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