ONC & CMS Proposed Rules | Part 2: Interoperability


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 21st 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. You can find Part 1 of the series here


In 2016, Congress enacted the 21st Century Cures Act with specific goals to “advance interoperability and support the access, exchange and use of electronic health information.” The purpose was to spur innovation and competition in health IT while ensuring patients and providers have ready access to the information and applications they need.

The free flow of data and the ability for applications to connect and exchange it “without special effort” are central to and supported by a combination of rules proposed by ONC and CMS. These rules address both technical requirements and expected behaviors. In this article, we look at specific technical and behavioral requirements for interoperability. Future articles will examine data blocking and other behavioral issues.

Compatible “Plugs and Sockets”

The proposed rules explicitly mandate the adoption and use of application programming interface (API) technology (or a successor) for a simple reason: APIs have achieved powerful, scalable and efficient interoperability across much of the digital economy. Put simply, APIs provide compatible “plugs and sockets” that make it easy for different applications to connect, exchange data and collaborate. They are an essential foundation for building the next generation of health IT applications. (Note: readers who want to go deeper into APIs can do so at the API Learning Center).

APIs are versatile and flexible. This makes them powerful but can also lead to wide variations in how they work. Therefore, ONC is proposing that certified health IT applications use a specific API based on the Fast Healthcare Interoperability Resources (FHIR) specification. FHIR is a consensus standard developed and maintained by the standards development organization (SDO) Health Level–7 (HL7). Mandating the use of the FHIR standard API helps to ensure a foundational compatibility and basic interoperability. This gives API technology suppliers (like EHR vendors) a clear set of standards to follow in order to fulfill the API requirement. It also ensures “consumers” of that API (like hospitals and health IT developers), have consistency when integrating applications.

Data for Interoperability

Using APIs to connect applications removes many hurdles to achieving interoperability by making it easy to connect applications. But “plugging in” is of little value if the data needed is not available. That’s why ONC has also proposed, “Adoption of the United States Core Data for Interoperability (USCDI) as a standard [that] would establish a set of data classes and constituent data elements that would be required to be exchanged in support of interoperability nationwide.”

The mandated combination of FHIR APIs and USCDI provides a solid technical underpinning for the next generation of interoperability by efficiently supporting the exchange of a standard data set. This will be a huge improvement over the hodge-podge of current legacy integration technology which is expensive, brittle, difficult to scale and suffers from a lack of enforced standards.

Interoperability for Innovation

Congress and ONC wisely recognized that today’s challenges with interoperability are due to a combination of technical barriers and behaviors. Adoption of APIs and standards, like FHIR and USCDI, solve many technical challenges but do not address behaviors which may be counter-productive. In response, ONC and CMS have crafted interlocking rules to promote a level playing field and regulate stakeholder behaviors believed to inhibit the free flow of data, innovation and competition.

Much of this is addressed in the proposed rules on information blocking, a subject we will explore in a future article. But, ONC also proposes rules related to the access and use of API technology. These API Conditions of Certification address transparency, permitted fees, and openness and pro-competitive conditions. For example, API technology suppliers must treat all API “consumers” (like hospitals and health IT developers) the same. They can’t limit access or charge differently for competitors. Documentation must be readily available, and fees must be published and based on recovery of reasonable costs.

These particular rules are intended to keep API tech suppliers from abusing market power by monetizing access to data or limiting the entry of competing products. And they come with enforcement “teeth.” Failure to comply may lead ONC to “ban a health IT developer from the program or terminate the certification of one or more of its health IT modules.” Suspected information blocking violations may be referred to the Office of the Inspector General and can result in hefty fines.

The adoption of a FHIR standard API that delivers the USCDI provides a powerful, technical solution. The proposed ONC rules build on this by encouraging behaviors that promote competition on a level playing field. This powerful combination of technical and behavioral requirements will play a key role in advancing interoperability in health care for the benefit of patients and care-givers alike.

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.

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New THCB site coming MONDAY! (It’ll be down this weekend)

I’m thrilled to tell you that after a lot of work by Zoya Khan, Dan Kogan and his tech whizzes, there’ll be a new THCB site up on Monday. Hopefully you’ll notice the changes and think it’s an improvement!

But while we do the switch (to a new server, template, host, et al) the site will be down this weekend starting Friday night PT.  So go outside and enjoy some fresh air and we’ll be back Monday morning!  Thanks!  — Matthew Holt

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Healthcare Must Open More Doors to Mental Health Patients


If someone we love has a physical ailment, we can list a variety of places for them to seek care: a clinician’s office, a pharmacy, an urgent care clinic, a school health clinic, an emergency department — the list goes on.

And, in every case, we would feel confident the clinicians in those places would know how to handle the case — or at least know where to send the patient if they need more intensive or specialized care.

But, sadly, the same isn’t true for a loved one with a mental health or substance misuse need, even thought mental health problems are more prevalent than many physical conditions.

As deaths of despair from drug or alcohol misuse or suicide continue to rise, we need a comprehensive, coordinated “no wrong door” approach that fully integrates mental health into the health care system and beyond. We need to transform our clinical practice, creating more options for care and putting mental health and substance use patients’ best interests first. Policy and payment reform must happen to make this new vision of care possible.

Consider that there are an estimated 44 million U.S. adults with mental illness, and more than half  — 24 million — did not get treatment in the past year. Among the 1 in 5 adults who did seek treatment, many did not receive the optimal, evidence-based care they needed. Even worse, 6 in 10 young people with severe depression received no treatment, a risk factor for depression in adulthood. Imagine if half the people with broken arms just had to figure out a way to manage it on their own.

There are many reasons people don’t get adequate mental health care or any at all, from stigma to lack of health insurance coverage. But another major barrier, which gets less attention, is the actual design of our health care system — it doesn’t make things easy.

In terms of how we provide them and how we pay for them, we’ve segregated mental health and substance misuse services from other medical services. Yet, we know that mental and physical health are inextricably linked. For example, having diabetes boosts the likelihood someone will have depression, and vice versa. Having both conditions increases the risk of a host of physical complications.

We can — and must — change the system to better reflect this knowledge. We can catch mental illnesses and substance use disorders before they become full-blown crises. Just as we monitor blood pressure every time someone goes to their primary care office, we can ensure that wherever people go for help — whether in an emergency or for a regular check-up — they are connected to mental health support on the spot.

It’s a tall order, but it has to be done for the good of our nation. Some first steps include:

  • Integrating mental health and substance use services into primary care. This includes embedding mental health clinicians into primary practices and creating standardized care pathways that enable physicians to better address common conditions, like depression, anxiety, ADHD and insomnia.
  • Employing digital solutions. Health care systems are piloting ways to provide psychiatric care via apps and other digital means.
  • Acknowledging emergency departments as the first point of entry for many people with mental health care needs. Across the nation, some leading health systems are integrating behavioral health in emergency departments and the community.
  • Looking for upstream solutions. Health systems and community partners can work together to redistribute mental health throughout all entry points, including schools, places of worship and workplaces.

Everybody, everywhere should have their mental health needs identified and treated. We can achieve this goal if we stop shuttling mental health patients through a separate door and instead redesign our systems to ensure better coordination.

Dr. Arpan Waghray is chief medical officer for Well Being Trust and system medical director for behavioral health at Swedish Health Services in Seattle.

Dr. Benjamin F. Miller is chief strategy officer for Well Being Trust, a foundation established by Providence St. Joseph Health to advance the mental, social and spiritual health of the nation. 

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Health in 2 Point 00, Episode 73 | Mergers, Medicaid, & Money

Today on Health in 2 Point 00, Jess and I power through a whopping six questions. In this episode, Jess asks me about the merger between Cambia Health Solutions and Blue Cross NC, Alex Azar getting grilled by Rep. Joe Kennedy on Medicaid work requirements, Omada Health adding connected blood pressure and glucose monitors, 23andMe’s new Type 2 Diabetes predisposition test, and raises by Akili Interactive and MAP Health Management. —Matthew Holt 

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Come Together.Health, Right Now…Over Me


At HIMSS19, the year-old ‘Digital Health Collaborative’ announced its relaunch as ‘Together.Health.’ More than just a feel-good name, the new moniker is indicative of how the organization is literally trying to help the health innovation world ‘get its #%&! together.’

“We’re building a hub-and-spoke model,” says Stephen Konya of the US Office of the National Coordinator for Health IT (ONC).

He and Nick Dougherty of MassChallenge Health Tech are founding co-chairs for Together.Health and the pair have managed to build a roster of more than 40 different partners – including almost every digital health accelerator and incubator in the country. Add into the mix  some of the biggest health innovation investors in the biz, the usual healthcare incumbents, and a number of different government organizations and economic development groups with local, regional, and federal reach and one begins to clearly see how Together.Health is filling a void for ‘spokes’ that were definitely missing the connecting power of a ‘hub.’

But, what’s the real value of all this together-ness? According to Konya and Dougherty, faster uptake for innovation in healthcare.

For example, the organization’s first project is the development of a standard Business Associates Agreement (BAA) for startups and health systems to use to streamline the onerous paperwork process required before piloting or deploying new solutions. This is a process that currently takes 9-12 months and varies by health system. Together.Health thinks they can shorten that timeframe to 2-3 months just by getting the right people into the room and agreeing to keep 80% of the questions in the assessment in a standard format. The idea is meant to help prevent startups from ‘running out of runway’ (and their health system champions from simply ‘running away’ in frustration), while everyone waits for the necessary paperwork to make its way through Legal.

The pragmatism doesn’t stop there. Listen in to my interview with Stephen Konya to hear about the two other challenges Together.Health is taking on this year: putting together a common curriculum for health accelerator programs and mapping the US Health Innovation Ecosystem.

Want to get a jump on learning what’s happening in some of those health innovation pockets in the US? I had the opportunity to interview 10 ecosystem leaders at the Together.Health Spring Summit at HIMSS and the variety of conversations (and concerns) they share is pretty remarkable.

You can check out the whole Together.Health playlist here, or wait for a few of my favs (and their dishy gossip!) to make an appearance here on THCB over the next week.

Get a glimpse of the future of healthcare by meeting the people who are going to change it. Find more WTF Health interviews here or check out www.wtf.health

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Health Care Price Tags Won’t Find You the Best Doctor

By MICHAEL L. MILLENSON Michael Millenson

Say you want to know which baseball players provide the most value for the big dollars they’re being paid. A Google search quickly yields analytics. But suppose your primary care physician just diagnosed you with cancer. What will a search for a “high value” cancer doctor tell you?

Not much.

Public concern over bloated and unintelligible medical bills has prompted pushback ranging from an exposé by a satirical TV show to a government edict that hospitals list their prices online. But despite widespread agreement about the importance of high-value care, information about the clinical outcomes of individual physicians, which can put cost into perspective, is scarce. Even when information about quality of care is available, it’s often unreliable, outdated, or limited in scope.

For those who are sick and scared, posting health care price tags isn’t good enough. The glaring information gap about the quality of care must be eliminated.

“When people are comparison shopping, knowing the price of something is not enough,” notes Eric Schneider, a primary care physician and senior vice president of policy and research at the Commonwealth Fund. “People want to know the quality of the goods and services they’re buying.”

While Medicare officials play up the need for transparency about prices, the information on Medicare’s Physician Compare website contains little more than professional credentials. Commercial websites have similar flaws, as does the information coming from state governments and nonprofit organizations.

Perhaps the most ambitious attempt to link the names of individual surgeons with hard data on their patients’ quality of care is the Surgeon Scorecard website hosted by the investigative journalism group ProPublica. Working with academic partners and using Medicare data available to researchers, ProPublica has published surgeon-specific complication rates for eight elective procedures, adjusted for how sick patients were to begin with. Unfortunately, the Surgeon Scorecard hasn’t been updated since 2015, although a new version is in the works.

ProPublica also showed how unreliable information can flourish when solid information is scarce. One of its reporters, a non-physician, was granted a Top Doctor award by a company whose profit model comes from selling plaques.

Since the mid-1990s, New York state has published risk-adjusted mortality rates of hospitals and individual physicians for a small number of cardiac procedures — one of the few states to do so. But those data are three to four years old and buried in reports whose bland titles, such as “Cardiac Surgery and PCI (Angioplasty) Outcomes Reports in New York State,” give no hint they contain names of individual doctors and hospitals.

The Society of Thoracic Surgeons offers both the best risk-adjustment and the most recent information (about seven months old). The group partners with Consumer Reports and has a public reporting website. But the information covers a limited number of procedures, and it comes only from medical groups that join the society’s national database and voluntarily choose to report their surgical outcomes to the public. The public-facing ratings cover only hospitals or surgical groups; even cardiologists can’t see outcomes for individual surgeons.

In cancer, the information contained in several registry programs is rich in detail. But it’s confidential, so patients can’t use the outcomes data to determine quality of care. That leaves cancer centers free to spend tens of millions of dollars on print and TV ads dangling the lure of “beat the odds” cures. Unfortunately, as with so many other advertisements, what consumers are being told is “deceptive,” according to a Truth In Advertising analysis.

The playwright Oscar Wilde once quipped, “A cynic is a man who knows the price of everything, and the value of nothing.” A good place to begin combating health care cynicism would be supporting the research needed to generate the detailed outcomes information patients urgently need for what can be life-and-death choices.

If you’re fortunate, your employer or health plan may have used its clout to get data for a “Center of Excellence” for some procedures, as Walmart and others have done.

Even though some believe that value ratings for individual doctors are a vain hope, a recently published University of Virginia study suggests a path toward developing them. Researchers crunched nine years of data from surgeons at their medical center, then assigned each surgeon a numerical score based on risk-adjusted death and complication rates in relationship to care costs. The quality of care and cost analysis was useful “for surgeons performing a certain volume of cases,” the study concluded, although greater detail on patient characteristics and the supporting hospital teams was needed “for more fairly attributing cost and quality to individual surgeons.”

Tellingly, while entrepreneurs promising price transparency are pulling in millions in funding, the Virginia researchers had to rely on mostly volunteer labor, lead investigator Dr. R. Scott Jones, a former senior official with the American College of Surgeons, said in an interview. The team is hoping for grants in order to continue.

Seema Verma, the administrator of the Centers for Medicare and Medicaid Services, recently waxed enthusiastic about the potential of price transparency in an article on the website of a health care pricing startup. Verma praised the way American “shoppers” demand “value” and promised “to pull every lever in her power” to give patients the information they need.

There’s no greater value in health care than a human life. Responsible consumerism can’t cynically focus only on price. The government and providers themselves must make it at least an equal priority to give us the timely, reliable, and complete information about the quality of care upon which our lives depend.

Michael L. Millenson is president of Health Quality Advisors LLC and adjunct associate professor of medicine at Northwestern University Feinberg School of Medicine. This article originally appeared on STAT here

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Reducing Burnout and Increasing Efficiency with Telepsychiatry



Telepsychiatry is now an established form of mental health care. Many studies demonstrate that it meets all appropriate standards of psychiatric care and may be better than in-person consultations for certain groups of patients, such as children, adults with PTSD or anxiety disorders, or those who find it hard to leave their homes. At UC Davis all patients are now offered the option of either seeing their psychiatrist in person, online at home, or in any private setting. Many patients now choose to receive their care in a hybrid manner that can be significantly better than being seen exclusively in the clinic office for numerous reasons.

From the patient’s perspective it is more convenient, allowing them to fit their consultations into their lives, rather than having to take several hours out to travel and attend a clinic. Many patients also find this form of care to be more intimate and less threatening, with the slightly increased “distance” from the therapist allowing them to feel safer talking about stigmatized or embarrassing topics, such as trauma and abuse. We also know from numerous satisfaction studies that patients like being treated using video. In fact some groups, such as children and young adults, prefer this to conventional methods.

What has not been examined scientifically in as much detail is the impact telepsychiatry has on providers, although the latter are voting with their feet. Latest figures suggest that up to 15% of psychiatrists are now using video with their patients  There are numerous advantages for psychiatrists and it is becoming clear that treating patients in a hybrid manner using telepsychiatry, as well as other technologies like messaging and secure email, may be a major response to the problem of physician burnout, making providers both more efficient and clinically effective.

So what are the advantages of telemedicine for mental health providers?

First, telemedicine consults save time for the provider in two ways. It is easier to type notes at the same time as talking to the patient using telemedicine because it is socially more appropriate to do this while maintaining eye contact via video. This can save several minutes of provider time per consult, allowing more time to be spent with patients, and/or less time completing notes after hours for the physician.  Our studies show that the time saved of 5 and 7 minutes per consultation makes a massive difference to provider efficiency and reduces stress markedly over the course of a single day.

Flexibility of time and workplace is also important for providers.  Working from home, even part time, and offering consults in the evening or weekends, enables a better work life balance. There are also cost savings for clinics as a decrease in patients means less administrative and rooming work, and the potential to use rooms for patients who need to be physically seen.

Improved clinical quality through teamwork is another big advantage of telepsychiatry. Many psychiatrists can work more easily with primary care physicians, who may join the consults on video, and with patients’ families, especially when the patients are seen at home. I often ask patients to give me a virtual tour of their homes, which enables me to learn more about a patient than if they were seen in the office.

Finally some psychiatrists use telepsychiatry to develop panels of patients who are in alignment with their specialty interest, perhaps working in a number of different health systems to see patients with very specific disorders in which they are expert. Other providers like the extra safety that comes with video consults, especially if dealing with potentially dangerous patients such as in correctional systems.

So how does all this connect with physician burnout, currently affecting 15-20% of all physicians, a rate that is twice as high as non-physician professionals?

There are three proven approaches that reduce burnout. The first is to increase physician resilience, and while this is important, physicians are highly resilient people. It is hard to get through medical school and residency if you are not. More important than resilience is to increase physician efficiency and support their sense of meaning of their work. Telepsychiatry and the process of hybrid care enable physicians to have more flexibility, choice, and time savings. This allows them to increasingly enjoy treating patients, about whom they learn more through the processes of improved teamwork and the use of virtual visits.

Involving the use of many varying technologies should be the new standard of care in psychiatry, and in other medical specialties, because it is good for patients and improves clinician wellbeing. If clinicians don’t look after themselves, they cannot look after their patients as effectively. Ultimately hybrid care is an obvious path for us to use to improve outcomes for all our patients.

The big question now is how best can virtual health technologies be fully integrated into routine care workflows in a patient focused manner that reduces clinician burnout and improves clinical efficiency, quality, outcomes and patient safety. Continue the conversation with me and my colleagues at ATA19, April 14-16 in New Orleans.

Peter Yellowlees is Chief Wellness Officer and Professor of Psychiatry at the University of California, Davis. He has an international reputation in telemedicine and long distance health and education delivery. 

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