By JONATHON S. FEIT

If ideas presented in essays on The Health Care Blog and other healthcare forums are meant to be rhetorical, without intention of turning notions into reality on behalf of patients who need genuine, intimate, desperate help…then feel free to ignore this essay entirely. 

Some among us—the State of Washington’s Co-Responder Outreach Alliance; Lisa Fitzpatrick’s Grapevine Health, which specializes in “street medicine” and advocacy in and around Washington, D.C.; Thorne Ambulance Service, an inspirational ambulance entrepreneur bringing both emergency and nonemergency medical transportation to underserved rural spaces (and more) across South Carolina; and the RightCare Foundation in Phoenix, a firefighter-driven organization dedicated to ensuring that patients’ needs and wishes are honored during critical moments, spring fast to mind—are stretching hands across the care continuum while pounding the table for interoperability at scale because PEOPLE. ARE. FALLING. THROUGH. THE. CRACKS. AND. DYING.  

Thatincludes responders who run toward the crises; into alleys; who risk their own lives, health, psyches, families, and futures because, as Josh Nultemeier—Chief Paramedic and Operations Manager of San Francisco’s King-American Ambulance, and a volunteer firefighter in the Town of Forestville—put it so simply in a social media post: “People could get hurt.” Moral override—that matter-of-fact willingness to risk himself for strangers who lack any other path to save themselves—is what makes Josh (and others who believe as he does) heroic.

Solving problems like substance use disorder—coupled with an increasing awareness of the lack of interoperability with prescription drug monitoring programs (PDMPs), many of which are run by Bamboo Health, which today imports zero data regarding out-of-hospital overdoses—is urgent. If an overdose is reversed in an alley, an abandoned home, a tent or “under the bridge downtown,” by an ambulance, fire, or police service pumping Narcan to get breathing going again, the agency’s lifesaving efforts get zero “credit” in the data. The downstream effects of this information sharing breakdown make it difficult to settle for less-than-bona fide interoperability: there is neither time to waste nor margin of error, yet hospitals and healthcare systems cannot even “see” the tip-of-the-tip-of-the-spear.

A similar emotionality makes it difficult to tolerate lamentations about information sharing when states like California—and the federal Office of EMS, inside the National Highway Traffic Safety Administration—are transforming interoperability into a standard operating procedure. As a listener to the “Health Tech Talk Show” since its start, I have struggled with hearing Lisa Bari and Kat McDavitt deride whether interoperability is “real.” It is real. It is happening, and has been automated for years—for example, with both the Quality Health Network and Contexture (formerly CORHIO) in Colorado—empowering agencies of all sizes to care for patients experiencing healthcare emergencies, and those who have children with Duchenne’s Muscular Dystrophy and other diseases. Such efforts should be celebrated for their meaningful impact on patients who rely on ambulance services to get them the care that they need—and sometimes to get them to the care that they need. 

Yet no panel at the national conference for CIVITAS was dedicated to interoperability to or from ambulances, despite that some of America’s most active health information exchanges—coast to coast—have automated interoperability involving Fire, EMS, Non-Emergency / Interfacility Medical Transport, Critical Care, and Community Paramedicine. No mention highlighted widespread efforts to make POLST forms accessible to Mobile Medical professionals, thanks to prioritization of the ethical treatment of medically frail patients after COVID-19 and a New York Times piece called “Filing Suit for Wrongful Life.”

Critical document registries are now built into several large HIEs but these are generally invisible to Mobile Medical professionals. No less an enabler of interoperability than Amazon Web Services has acknowledged that caring for underserved patients must incorporate Mobile Medicine because the poorest in America get much of their care from ambulance services. Leading medical directors and the executive director of National POLST have cited interoperability as a key to empowering Responders to best care for our loved ones when seconds count. Yet when the “Health Tech Talk Show” hones in on discussions about public insurance and safety net medicine—“I heard ‘Medicaid is hard,’ more times than I can count. Public health? Barely a word…

Individuals on Medicaid and the underserved make up nearly 25% of the country. Public health? SUD is a public health issue. Behavioral health is a public health issue. Maternal health is a public health issue. CANCER Is [sic] a public health issue. Public health is more than covid tests and flinging around vaccines and we should treat it as such.”—ambulances are not mentioned once. 

Fire and ambulance services are successfully closing information sharing gaps, but they remain left out of the advocacy efforts—and worse, they end up as an unintended target. Mobile Medicine could be a case study in the power of sharing clinical insights in real-time to do what is best for the patient and the healthcare ecosystem simultaneously. Instead, advocacy efforts in the name of interoperability have traversed a path—twice, now—that risks blocking Mobile Medical professionals from participating in the modern healthcare ecosystem, to the detriment of patients, families and the agencies themselves.

This first such instance occurred when the “Health Tech Talk Show” fanned the flames of the Health Data Utility (HDU) movement. In America and globally, ambulance services are unique, as the only health care providers that routinely engage Unknown Patients (patients who need care while unconscious, unable to communicate, and/or “altered mental status” so one cannot trust their self-assessment). Mobile Medical professionals routinely engage patients in places like alleyways and in abandoned basements. It is worth noting that none of the above pertains necessarily to emergency care, as Mobile Medical professionals engage the most severely ill and underserved chronic care patients wherever they are, and that frequently is on the streets. 

Estimates of the size of the non-emergency medical transport sector range from par to double that of emergency medical transportation. Yet Mobile Medical professionals are largely shut out of the national healthcare data interoperability discussion because they don’t document in HL7-based data systems; they use a different, essential, standard called the National EMS Information System. 

The Office of the National Coordinator of Healthcare IT (ONC) has focused on bringing Mobile Medical data into the broader health data fold, including most recently by holding the second EMS data summit concurrently with the 2023 ONC annual meeting. The movement toward implementation of Health Data Utilities (HDU) risks undoing this critical progress to date, careening Mobile Medical professionals toward second-class status. The advocates of this approach do not appear to be considering its downstream effects: HDUs risks devolving Mobile Medical professionals into shoppers on Christmas Day who are forced to watch sales happening inside the store, while standing outside in the snow. 

Put another way: “Where the HDUs do not currently consume Mobile Medical data, the ambulance, fire and CP/MIH agencies will stay shut out until outsized pressure forces a change (say, an adverse encounter that could that have avoided if the crew had had real-time access to the more complete information in real-time).”

More recently, the Health Tech Talk Show team has begun advancing the notion that America needs a “Chief Patient Officer” (they even went so far as to propose a candidate). Like the HDU concept, this proposal is risky for Mobile Medicine professionals, which is why this author is speaking up. It obviates the reality that, for many, ambulance-based care is nothing short of a lifeline—an entryway to the healthcare ecosystem where no other exists. In their article for The Health Care Blog, Lisa Bari and Kat McDavitt write that “Because of this lack of access, resources, and representation, and because there is no single senior staff member in the federal government dedicated to ensuring the voice of the patient is represented, the needs and experiences of patients are deprioritized by corporate interests.” What about Americans whose needs and challenges are so basic, fundamental, and neglected over time that they’re utterly irrelevant to corporate interests?

There are many such people, and they deserve attention. 

They receive it from caregivers who work in ambulances.

Put another way: What realistic hope is there for a white, educated, socioeconomically “just fine,” city (or countryside) dwelling caregiver hope to muster sufficient empathy for the reality of being a single parent of color, whose child has a major disability, who lives far away from everything that they need to care for their kid? What does it feel like to be a Black woman, who is pregnant, short of breath, living in a one room apartment that smells of feces, whose doctor is all the way over there while she’s in an ambulance going nowhere in rush hour traffic? (Note: this is no theoretical situation—I did a ridealong with just such a patient in Pittsburgh, Pennsylvania). How can one person purport to represent America’s “So Many Patients”, channeling the challenges of race, lack of access to care, language, disability, religion, understanding of healthcare, fear of maltreatment, and more?

If one purports to advocate seriously for a Chief Patient Officer…where will they come from? Will they speak English as a second (or third) language? Will they have a child, spouse, or parent with a mortal disability (or must they have already lost one or more of the above)? Will they be straight, gay, intersex, or transgender? Must they have processed an end-of-life medical order for themselves or for a loved one, to know what it’s like to contemplate the ethics of demise? Must they have an implant that failed, or “get” why patients use ambulances as doctor’s offices? 

“We need a Chief Patient Officer” makes a catchy bumper sticker message, just like “QHINs aren’t real” makes a snazzy alien-themed shirt. But in reality, lightheartedness about life-and-death issues can feel disrespectful of the minutes, hours, and lifetimes that are being invested in making such necessities a reality. The varieties of human experience are so diverse that to suggest enough empathy can be found in one person—anywhere but in a committee of Chief Patient Officers—denigrates the struggle that ambulance-based care providers face in their mission to bring care to patients, families, and communities that lack options but face critical needs. 

Worse yet is that Mobile Medical professionals can end up with the short end of the stick: not just kept outside the glass, pining for a seat at Healthcare’s Table at the Future, but indeed, being blamed for the lack of such tools, made to look like Luddites. This author hopes we will collectively adjust our investments of time and passion into spreading ideas that make things easier—more effective in terms of time and medicine—for those who work to deliver care, with fewer resources than they need, to those who lack the basics.

Jonathan Feit is the CEO of Beyond Lucid Technologies

CEO Steve Yaskin takes on the tough job giving us a brief overview of TEFCA (the Trusted Exchange Framework and Common Agreement) which is meant to establish once-and-for-all a common ground for data interoperability. Then, we get into QHINs – a specially designated group of “qualified health information networks – and how his business is applying for this certification to further build “the bridge” between the public sector and the private sector and what’s needed to achieve compliance for data exchange.

Phew! No wonder this startup has landed nearly $80 million dollars in funding! We talk about the basis for the business model – but, more importantly, the real market need – and find out what’s in store for all of us in the next chapter of data interoperability.

Particle Health’s CEO Troy Bannister stops by to not only talk about the API platform company’s $25M Series B, but to also explain exactly what’s going on in that patient data ‘exchange-standardize-and-aggregate’ space that, these days, looks poised to pop as the 21st Century Cures Act Information Blocking Rule stands ready to make hospitals share data like never before.

Troy calls Particle a “network of networks” and what that means is that their API pulls patient records from organizations and businesses that are already aggregating them (so aggregating the aggregators) to get all the lab data and medical data a clinician would want to in order to have a more complete picture of their patient. For clients like One Medical or Omada Health, who deliver value-based care and take on risk, having such a robust historic data set on patients – along with a more complete picture of their comorbidities – helps improve decision making and outcomes.

So, how is Particle Health working now – and what will change – as the Information Blocking Rule gets implemented? Troy’s written about this for Forbes, and explains what has him fired up here too. Turns out their model has room to accommodate a big pivot: giving patients access to their own ‘network of networks’ record. Find out what sets Particle off in this new B2B2C direction and how they will be using that Series B funding to build out deeper analytical tools to help everyone make better sense of what the data in all those records can show us.

Link to Troy’s Forbes piece on Anti Information Blocking Rules

Link to Jess’s chat with Micky Tripathi, the National Coordinator for Health Information Technology at HHS, on Anti Information Blocking & TEFCA:

By KIM BELLARD

I really wasn’t expecting to write about the Metaverse again so soon, after discussing it in the context of Roblox last March, which itself followed a look at Epic Games CEO Tim Sweeney’s vision for the Metaverse last August.  But darn that Mark Zuckerberg!

Not many noticed when Mr. Zuckerberg told Facebook employees in June that the company would become focused on building a metaverse, but he got some attention when he expanded on his vision for The Verge in late July.  Then last Monday Andrew Bosworth, Facebook’s head of AR/VR, confirmed a product group had been formed to bring it about.  And, finally, in an earnings call last Wednesday, Mr. Zuckerberg and his executive team couldn’t stop gushing about the importance of the metaverse to the company, and the world.

So, yeah, the metaverse is in the news.  And, once again, I worry healthcare is going to be late to the party. 

I won’t go into too much detail about what the metaverse is; for those who want a deep dive, there’s Matthew Ball’s nine part primer, or you could just read Ready Player One.  Mr. Zuckerberg described it to The Verge as follows: “you can think about the metaverse as an embodied internet, where instead of just viewing content — you are in it.”  In the earnings call, he clarified: “The defining quality of the metaverse is presence – which is this feeling that you’re really there with another person or in another place.” 

Depending on your age/preferences, the concept of “an embodied internet” is either chilling or thrilling.  Maybe both.   

It’s potentially a big deal.  Gene Marks, writing in Forbes, says, “business interactions will forever change.”  The Conversation’s Beth Daley goes further, stating “creating a virtual world for users to interact with their friends and family is not just a fancy vision, it is a commercial necessity.”

It’s not VR, it’s not AR, it’s not 3D internet, although all those may be part of it.  It’s not gaming, it’s not entertainment, it’s not social network, although all of those will be part of it too.  Mr. Zuckerberg promises: “It’s going to be accessible across all of our different computing platforms; VR and AR, but also PC, and also mobile devices and game consoles.”  Not to overstate it, but he sees the Metaverse as the “next generation of the internet.”  Mr. Zuckerberg also described it as “the next computing platform.”

He is openly telling people that the goal is for Facebook to transition to a metaverse company, “within the next five years or so.”  Analysts on the earnings call pressed Facebook to confirm an estimate of a $5b investment, but only got an admission that, yes, the investment was “billions.”

Significantly, for Facebook, Mr. Zuckerberg believes: “this is going to be not something that one company builds alone, but I think it is going to be a whole ecosystem that needs to develop.”   As Mr. Zuckerberg said in The Verge interview, “Hopefully in the future, asking if a company is building a metaverse will sound as ridiculous as asking a company how their internet is going.”

This will require interoperability; “People are going to want to reach the people they care about no matter what service they’re on and be able to move between these.” In other words, “it has to have the sense of interoperability and portability.”   These are not the kind of sentiments words we’re used to hearing from Facebook.

Nobody, not even Mr. Zuckerberg, thinks we’re going to see a metaverse right away – perhaps five years, maybe ten, possibly more — and no one is really sure where the money will be.  It may become a “huge economy,” with “entirely new types of work” and plenty of virtual goods, as Mr. Zuckerberg predicts, but, admittedly, the concept is still not well defined.  The Next Web warns: “The hype train has arrived.”  

That article, by Thomas Macaulay, goes on to add:

There is some merit to the hype. Technological advances in fields like VR and AI are rapidly making virtual worlds more immersive and layered. Their escapist appeal has also grown during pandemic restrictions.

In the short term, however, buzzwords rarely live up to the hype. But once the underlying tech matures, effective strategies develop, and realistic objectives emerge? It has the potential to be truly transformational. Just don’t expect it to happen overnight.

Tech companies, you see, are deathly afraid of missing “the next big thing.”  They’ve been the beneficiaries of previous next big things, and they know both how fragile their perch is and how quickly a newcomer can ride that next wave past them.  Just ask AOL, MySpace, Netscape, Kodak, Nokia, or Wang, to name a few. 

Microsoft famously was late to realize the importance of the Internet, Google was flummoxed by the introduction of the iPhone, Facebook didn’t take mobile seriously enough initially, and Apple is still well behind its peers in cloud computing.  Each survived, even prospered, but none wants to miss the metaverse too.

Not so much in healthcare, though.  The incumbents just keep rolling along.  For all the adoption of EHRs, they still are not living up to the promise of better care and shared data.  For all the ballyhooed gains of telehealth during the pandemic, they’re already starting to dissipate.  For all the investment in digital health, there’s no real sign that it saves money or improves health.   Healthcare takes new technologies and kludges them into submission. 

Let’s face it: healthcare was late to computers (well, at least to PCs).  It was late to the internet.  It was late to mobile.  It still doesn’t understand the importance of social media or gaming.  It isn’t even thinking about the metaverse. 

I don’t know what health care might be in the metaverse.  I doubt anyone does.  But, for example:

• Your digital twin could see your doctor’s avatar (or an A.I. doctor!), for a virtual in-person visit;
• You could connect with others with similar conditions/interest in a much more personal and robust way than Zoom or Facebook allow;
• You could immersively educate yourself about health (and other) topics of interest.

More importantly, new uses will be found as people get used to the technology, just as we found new uses for smartphones and the internet as more people started using them.  This will happen in health care too.

Ignore it at your own risk. 

Kim is a former emarketing exec at a major Blues plan, editor of the late & lamented Tincture.io, and now regular THCB contributor.

“This pandemic highlights why we need that free flow of healthcare data. So that we can make better decisions sooner.”

In the way that Covid-19 has proven the utility of telehealth as a means for health systems to reach their patients, has the pandemic also become the final argument for healthcare data interoperability? Has this pandemic been the worst case scenario we needed to make our best ‘case-in-point’ for why U.S. healthcare needs a national health data infrastructure that makes it possible for hospitals to share information with one another and government health organizations?

Interoperability advocates have been clamoring for this for years, but Dan Burton, CEO of data-and-analytics health tech company, Health Catalyst, says this public health crisis has likely created an inflection point in the interoperability argument.

“What [Covid-19] has exposed is gaps beyond the health system setting. If you ‘click up’ a level to the state level or the national level, we have a digital patchwork today with many, many gaps that exist from health system to health system.”

“It’s so consequential the fact that we haven’t had precision as it relates to our digital health infrastructure and, as a result, have had to make high-level, broad-brush policy decisions that have had really dramatic economic consequences.”

“In the future, we want to be better equipped to be more precise in our response and you can do that if you have a large enough data set and you have it in in the moment that you need that data so that you can make better decisions.”

What decisions can health data help inform? Dan shares all the ways Health Catalyst is leveraging its Touchstone health data repository — which includes 80-million de-identified patient records from hospital systems across the country — to help inform everything from covid-19 treatment options to vaccine clinical trial recruitment and even the most optimal ways to re-open financially fragile hospitals for elective procedures.

“Covid-19 highlights the need for a national [health data] repository, a national digital infrastructure, says Dan. “And we are hopeful that that will be a learning that persists and that there will be some investment at the national and state level to make sure that individual health systems are connecting in an interoperable way, and in an effective way, with a strong, scalable infrastructure backing it up.”

A few weeks ago, WTF Health took the show on the road to Australia’s digital health conference, HIC 2019. We captured more than 30 interviews (!) from the conference, which is run by the Health Informatics Society of Australia (hence the HISA Studio branding) and I had the opportunity to chat with most of the Australian Digital Health Agency’s leadership, many administrators from the country’s largest health systems, and a number of health informaticians, clinicians, and patients. I’ll be spotlighting a few of my favorites here in a four-part series to give you a flavor of what’s happening in health innovation ‘Down Under.’ For much more, check out all the videos on the playlist here.  

I’d like to kick off the series with my interview on all things interoperability with arguably the most famous Australian in health tech, Grahame Grieve. 

Grahame Grieve, “the Father of FHIR” architected healthcare’s best shot at EMR data interoperability when he founded HL7’s Fast Healthcare Interoperability Resources (FHIR), but have you heard what prompted Grahame to pursue creating a common standard for electronic health data exchange in the first place? Grahame shares the surprisingly personal and emotional story and weighs in how he thinks FHIR adoption is going so far. If your business has anything to do with health IT, EMR, or healthcare’s play in big data, be sure to tune in to find out what’s next for FHIR, whether or not Big Tech’s new role in healthcare can help speed up adoption, and if Grahame thinks we’ll ever finally solve healthcare’s interoperability problem.

Filmed in the HISA Studio at HIC 2019 in Melbourne, Australia, August 2019.

By CLAUDIA WILLIAMS

Robust exchange of health information is absolutely critical to improving health care quality and lowering costs. In the last few months, government leaders at the US Department of Health and Human Services (HHS) have advanced ambitious policies to make interoperability a reality. Overall, this is a great thing. However, there are places where DC regulators need help from the frontlines to understand what will really work. 

As California’s largest nonprofit health data network, Manifest MedEx has submitted comments and met with policymakers several times over the last few months to discuss these policies. We’ve weighed in with Administrator Seema Verma and National Coordinator Dr. Don Rucker. We’ve shared the progress and concerns of our network of over 400 California health organizations including hospitals, health plans, nurses, physicians and public health teams. 

With the comment periods now closed, here’s a high-level look at what lies ahead: 

CMS is leading on interoperability (good). Big new proposals from the Centers for Medicare and Medicaid Services (CMS) will set tough parameters for sharing health information. With a good prognosis to roll out in final form around HIMSS 2020, we’re excited to see requirements that health plans give patients access to their claims records via a standard set of APIs, so patients can connect their data to apps of their choosing. In addition, hospitals will be required to send admit, discharge, transfer (ADT) notifications on patients to community providers, a massive move to make transitions from hospital to home safe and seamless for patients across the country. Studies show that readmissions to the hospital are reduced as much as 20% when patients are seen by a doctor within the first week after a hospitalization. Often the blocker is not knowing a patient was discharged. CMS is putting some serious muscle behind getting information moving and is using their leverage as a payer to create new economic reasons to share. We love it.

ONC wants to crack-down on information blocking (hopeful). Leveraging their role as a regulator, the Office of the National Coordinator (ONC) is proposing new penalties to stop technology companies, information networks and providers from hoarding health data. I’m hopeful that this program will help break down silos that stop patients and providers from receiving crucial information. However, there are exceptions for “reasonable and necessary costs” and other possible work-arounds could be exploited to maintain the status quo.  

TEFCA v2 would slow national connectivity (bad). Designed as a framework for achieving nationwide connection between local health data networks through a “network of networks,” we fear the complex new Trusted Exchange Framework and Common Agreement (TEFCA) will do the opposite. By proposing novel approaches and definitions—and requiring that every node build new technology functions to segment data and rewrite contracts with participants—TEFCA risks slowing down or stopping exchange that is now finally occurring across networks, counter to the intent of Congress. 

The Cures Act specifies that TEFCA “shall take into account existing trusted exchange frameworks and agreements used by health information networks to avoid the disruption of existing exchanges between participants of health information networks.” We believe TEFCA in its current form would disrupt hundreds of millions of existing exchanges between hundreds of thousands of participants in health information networks.  

We agree with the goal of TEFCA and believe it is already being achieved in the market today. We urge ONC to put a hold on rolling out the proposed approach and focus effort on implementing the information sharing and blocking regulations. These rules are critically important to furthering the nation’s interoperability, and we support them. They represent a fundamental paradigm shift in how health care entities exchange information, and it will take stakeholders time to work through implementation and develop new organizational policies. Adding the complex structure of TEFCA on top of these regulatory obligations will hamper progress. 

We’re looking forward to continuing the rapid growth of our California network with tailwind provided by the best of these new policy actions. We’re confident the voices of California healthcare have been heard in DC and that our community will be prepared to leverage these policies to advance information sharing in 2020.

Claudia Williams is CEO of Manifest MedEx and the former senior advisor for health innovation and technology at the White House, where she helped lead  data sharing, care transformation, and precision medicine efforts under the Obama administration.

This post originally appeared on LinkedIn here.

By DAVE LEVIN, MD and NIKKI KENT

The Office of the National Coordinator (ONC) and the Centers for Medicare and Medicaid (CMS) have proposed final rules on interoperability, data blocking, and other activities as part of implementing the 21^st Century Cures Act. In this series, we will explore ideas behind the rules, why they are necessary and the expected impact. Given that these are complex and controversial topics are open to interpretation, we invite readers to respond with their own ideas, corrections and opinions.

Interventions to Address Market Failures

Many of the rules proposed by CMS and ONC are evidence-based interventions aimed at critical problems that market forces have failed to address. One example of market failure  is the long-standing inability for health care providers and insurance companies to find a way to exchange patient data. Each has critical data the other needs and would benefit from sharing. And, as CMS noted, health plans are in a “unique position to provide enrollees a complete picture of their clams and encounter data.” Despite that, technical and financial issues, as well as a general air of distrust from decades of haggling over reimbursement, have prevented robust data exchange. Remarkably, this happens in integrated delivery systems which, in theory, provide tight alignment between payers and providers in a unified organization.

With so much attention focused on requirements for health IT companies like EHR vendors and providers, it is easy to miss the huge impact that the new rules is likely to have for payers. But make no mistake, if implemented as proposed, these rules will have a profound impact on the patient’s ability to gather and direct the use of their personal health information (PHI). They will also lead to reduced fragmentation and more complete data sets for payers and providers alike.

Overview of Proposed CMS Rules on Information Sharing and Interoperability

The proposed CMS rules affect payers, providers, and patients stating that they:

• Require payers to make patient health information available electronically through a standardized, open application programming interface (API)
• Promote data exchange between payers and participation in health information exchange networks
• Require payers to provide additional resources on EHR, privacy, and security
• Require providers to comply with new electronic notification requirements
• Require states to better coordinate care for Medicare-Medicaid dually eligible beneficiaries by submitting buy-in data to CMS daily
• Publicly disclose when providers inappropriately restrict the flow of information to other health care providers and payers

These rules apply to:

• Health care providers
• State Medicaid and Children’s Health Insurance Program (CHIP) agencies
• Insurers that offer qualified health plans (QHPs)
• Medicare Advantage plans
• Medicaid and CHIP managed care plans

While, the broader commercial market, employer-sponsored health insurance, and stand-alone dental plans are currently exempted from these rules, the hope is that some will still adopt these new approaches.

Data Exchange Requirements for Payers CMS has proposed substantial data exchange requirements that define both the types of information to be shared and, where appropriate, the technical approach and standards to be followed. One key requirement is to implement and maintain an open API that allows third-party applications (some with approval from the patient) to easily retrieve a variety of information as shown in the table below:

Other key data management provisions include:

• Payers must be able to exchange data elements outlined in the United States Core Data for Interoperability (USCDI) standards.
• Payers must incorporate received data into their own records.
• When a patient (member) requests it, the payer must (1) accept data from a patient’s prior health plan for up to five years, (2) send data to other health plans for up to five years, (3) send data to a recipient designated by the patient for up to five years.

Importantly, the rules also specify response times where possible:

• Claims, encounter, and clinical data must be available through the API no later than one business day after a claim is processed or the data is received by the payer.
• Provider directory data must be updated within 30 business days of changes to the directory.
• No specific timeframe for submitting pharmacy directory or formulary information.

A key issue will be the payer’s dependence on providers sharing data with them in a timely manner so the payer can meet these requirements. CMS is urging payers to consider whether their contracts with providers should include timing standards regarding the submission of claims and encounter data.

API Standards for Payers

CMS and ONC have been moving in tandem to address interoperability and information blocking. It’s no surprise CMS will require payers to comply with a separate ONC proposed rule to use APIs to meet certain technical standards and address standardized content and vocabulary for data available through the API. They also address behaviors that can limit interoperability or lead to information blocking. A good example is the requirement to deliver clinical data which mandates USCDI be available via a standard FHIR API. Other requirements specify (among other things) that:

• The API must be publicly accessible on a payer’s website and accompanied by documentation on technical aspects (such as API syntax, function names, and various other parameters).
• Payers cannot require a reader to pay a fee to access the documents, receive a copy via email, or agree to receive future communications before making the documentation available.
• Payers can deny or discontinue a third party’s connection to their API if the payer determines—using objective, verifiable criteria —that the connection threatens the security of protected health information (PHI).
• Payers can make non-standardized data available through their APIs but are required to ensure that their API documentation provides enough information to developers to handle this information.

Economic Impact on Payers

In general, the rules proposed by CMS and ONC are subject to a Regulatory Impact Analysis (RIA) to estimate the costs and benefits of specific rules. Interestingly, CMS suggests that promoting data exchange between payers and participating in a trusted health information exchange may qualify as “quality improvement activities” for purposes of an insurer’s medical loss ratio. This is an important consideration for payers since these costs

could be counted against the requirement to spend 80 or 85 percent of premium revenue on claims and quality improvement.

This is Getting Real – Real Fast

CMS has proposed specific time lines and actions for payers to meet the new requirements as illustrated below:

It seems likely payers will object to the January and July 2020 deadlines and that CMS and ONC will accommodate some delay, given the current timelines.

Data Must Flow for the Benefit of the All.

An overarching theme of the proposed rules is that patient data should flow freely and at the direction of the patient unless there is a compelling, common-sense exception (seven of which are spelled out in detail). The proposed rules for payers reflect this theme and directly address the long-standing failure of market forces to encourage robust information sharing. They also hold the real promise of benefiting patients, health care providers and payers by enabling better care at a lower cost.

____________

Dave Levin, MD is co-founder and Chief Medical Officer for Sansoro Health where he focuses on bringing true interoperability to health care. You can follow him @DaveLevinMD or email Dave.Levin@SansoroHealth.com

Nikki Kent, SVP of Operations at Sansoro Health, is an accomplished health care executive having specialized in Operations, Human Capital and Sales for Payer and Provider organizations.

Today, THCB is spotlighting Lygeia Ricciardi. As the former Director of Consumer e-Health at the ONC, Lygeia tells us about patient access to health data and the ONC and CMS’s new rules on interoperability. But now, she’s the CTO of Carium Health, going from a “consumer activist consultant-type” to actually working with a startup. Carium provides a platform for consumer empowerment and engagement, helping to guide individuals through their health care and wellness journeys.

By DAVE LEVIN, MD and GRANT BARRICK

The Office of the National Coordinator (ONC) and the Centers for Medicare and Medicaid (CMS) have proposed final rules on interoperability, data blocking, and other activities as part of implementing the 21^st Century Cures Act. In this series, we will explore the ideas behind the rules, why they are necessary and the expected impact. Given that these are complex and controversial topics open to interpretation, we invite readers to respond with their own ideas, corrections, and opinions. In part five of this series, we look at how competition unlocks innovation, and how the proposed rules may disrupt the balance between innovation, intellectual property (IP), and supporting business models.  

____________

The recent publication of proposed rules by ONC and CMS set off a flurry of activity. In anticipation of their implementation, the health care industry is wrestling with many questions around business models. What practices inhibit competition and innovation? How do we balance the need for competition while protecting legitimate intellectual property rights? How can vendors ensure profit growth when pricing is heavily regulated? In this article, we will examine how competition unlocks innovation and the possible disruptions the proposed rules may bring for innovation, intellectual property (IP) and supporting business models.

Unlocking Innovation via Competition

In most markets, innovation is driven forward by competition. Businesses compete on equal footing, and their investment in R&D drives innovation forward. Innovation in health care has been dramatically outpaced by other markets, leading to an urgent need for both disruptive and evolutionary innovation.

What is inhibiting health care innovation? The rules identify a combination of tactics employed in health care that restrict the free flow of clinical data, such as:

• NDAs
• Confidentiality Clauses
• Hold-harmless Agreements
• Licensing Language

These tactics slow innovation by contributing to an environment where stakeholders resist pushing the boundaries — often because they are contractually obligated not to. The legislation and proposed rules are designed to address the ongoing failure of the market to resolve these conflicts.

As the rules are finalized, we will continue to monitor whether the ONC defines these practices as innovation stifling and how they will implement regulations — both carrot and stick — to move the industry forward.

Protecting IP & Profit

Health IT (HIT) companies must be able to protect their intellectual property (IP). And, the proposed rules agree. There are four general areas of IP:

• Patents
• Trade Secrets
• Copyrights
• Trademarks

How can health IT (HIT) companies compete and protect their IP if we open the marketplace? The goal of the rules is to define what is reasonable in IP protection and limit the tactics discussed above, saying:

…a developer is not permitted to prohibit or restrict communications under the guise of copyright protection (or under the guise of a confidentiality or non-disclosure obligation) when the communication in question makes a use of the copyright material in a way that would qualify that use as a “fair use.”

The rules seek a balance between the need for free-flowing clinical data and IP protection. Further, the rules recognize that HIT companies should be able to generate profits.

There are two different pathways to profitability:

1. The ability to be profitable through pricing.
2. The exploration of new business models that maximize profits.

While they extend the definition of information blocking to include, “any fee that is likely to interfere with the access, exchange, or use of EHI.” They also acknowledge the potential negative impact on innovation. They go on to note that vendors can charge fees, but the fees must be tied to actual costs. This is intended to promote competition and the free flow of clinical data while also minimizing opportunistic pricing (“rent seeking”) and ensuring reasonable vendor profitability.

It is a good first step that guarantees HIT vendors a profit while encouraging clinical data exchange. However, it may not allow HIT vendors the opportunity to earn the profits needed to invest in R&D, which is necessary to promote innovation. HIT vendors may need to embrace new business models.

The Benefits of Innovation in Other Sectors

Apple has defined the business model for the new millennium. They embrace an open model, where developers can freely (within the confines of terms and limitations) exchange data and it has flourished. Their App Store revenue has grown by 28% in recent years, outpacing the rest of the company despite lowering developer fees in 2016. This example shows that an open environment can help revenue growth. Moreover, if lower pricing means greater access to participation–the more open the environment is, the faster it can grow.

In moving to a more open environment, the market will have access to far more data and insights, which is the goal of the proposed rules. Imagine the analytics and insights an electronic health record (EHR) could give their customers and developer partners, providing further value and strengthening all relationships in the industry.

Or, look at Airbnb as a disrupter in the hospitality industry. They proved you can be successful without owning property — having more listings than the five largest hotel brands combined.

In health care, we can compare this to clinical data ownership. It belongs to who it belongs to, and they can do with it as they please. However, by enabling the marketplace, you make room for dramatic growth.

Next Steps for Health IT

The proposed rules have raised a lot of questions around business models, innovation, and profitability. It will be interesting to see how much-needed competition will impact innovation in health care and the role free-flowing clinical data will play on that innovation. And, how these changes will take place while guaranteeing the rights of HIT vendors to protect IP and profits.

However, the proposed rules help us understand what the limitations and guide rails will be. If HIT looks outside of health care for inspiration, we may find that the open exchange of clinical data and healthy profits are possible while protecting IP.

Dave Levin, MD is co-founder and Chief Medical Officer for Sansoro Health where he focuses on bringing true interoperability to health care. Dave is a nationally recognized speaker, author and the former CMIO for the Cleveland Clinic.

Grant Barrick is the VP Marketing at Sansoro Health with decades of experience in guiding growth for health care companies in core and adjacent markets. He’s served in executive roles at 3M, MinuteClinic, Wolters Kluwer Health and ProVation.