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Health 2.0: Why I’m (Freaking) Excited…and a (Bit) Concerned

By DAVE LEVIN, MD

The 2019 Health 2.0 conference just wrapped up after several days of compelling presentations, panels, and networking. As in the past, attendees were a cross section of the industry: providers, payers, health IT (HIT) companies, investors, and others who are passionate about innovation in healthcare.

Tech-enabled Services

One of the more refreshing themes of the conference was an emphasis on how health IT can enable the delivery of services. This is a welcome perspective as too often organizations believe that simply deploying technology will solve their problems. In my 30+ years in healthcare, I’ve never seen that work. What does work is careful attention to the iron triad of people, process, and technology. Neglect one of these and you will fall short of your goals. Framing opportunities as services that are enabled and enhanced by technology helps us avoid the common pitfall of believing “Tech = Solution” and forces us to account for process and people.

Provider Burn-out and Health IT

Several sessions focused on the impact technology is having on end-users, especially clinicians. One session featured a “reverse-pitch” where practicing physicians “pitched” to health IT experts on the challenges they face, especially with EHRs, and what they need in order to do their job and have a life. This was summed up elegantly by a physician participant as, “Please make all the stupid sh*t stop!” There’s increasing evidence that the deployment of EHRs is a major factor for clinician burnout and the impassioned pleas of the attendees resonated throughout the conference.

Other sessions explored how to we might address these problems with improvements in user-interface design, workflow, and interoperability. Demonstrations of advanced technologies like voice-driven interfaces, artificial intelligence, enhanced communications, and smart devices show where we are headed and hold out the promise of a more efficient and pleasing HIT for providers and patients.

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ONC & CMS Proposed Rules – Part 6: Payer Data Requirements

Nikki Kent
Dave Levin

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 21st 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

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ONC & CMS Proposed Rules – Part 5: Business Models

Grant Barrick
Dave Levin

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 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. 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.  

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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.

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ONC & CMS Proposed Rules – Part 3: Data Requirements

Matt Humphrey
Dave Levin

By DAVE LEVIN, MD and MATT HUMPHREY

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. In part three of this series, we look at how the new USCDI draft helps foster innovation.  

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The U.S. Core Data for Interoperability (USCDI) draft is a step forward toward expanding the 21st Century Cures Act. The Cures Act was helpful in moving the needle for interoperability and defining data blocking. The latest draft of the USCDI is meant to further specify what data should be shared freely.

In this article, we’ll look at the data added to the Common Clinical Data Set (CCDS) used for ONC certification. We’ll walk through the proposed plan to add more data over time. And we’ll explore why this is a step in the right direction toward increased data sharing.

New Shared Data

The bulk of the datasets in the USCDI comes from the Common Clinical Data Set (CCDS), which was last updated in 2015. The new USCDI draft adds two types of data:

  • Clinical notes: both structured and unstructured. EHRs store these notes differently, but both are important and helpful in data analysis.
  • Provenance:  an audit trail of the data, showing where it came from. It is metadata, or information about the data, that shows who created it and when.

The Fast Healthcare Interoperability Resources (FHIR) have created standards around APIs used to access health care data. APIs developed under the FHIR standard aligns with the USCDI to meet the proposed certification rules. The USCDI draft recommends using a FHIR compliant API to access the data.

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ONC & CMS Proposed Rules | Part 2: Interoperability

By DAVE LEVIN MD 

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

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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.

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Interoperability and Data Blocking | Part 1: Fostering Innovation

By DAVE LEVIN MD 

The Office of the National Coordinator (ONC) and the Centers for Medicare and Medicaid (CMS) have published proposed final rules on interoperability and data blocking 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, controversial topics, and open to interpretation, we invite readers to respond with their own ideas, corrections, and opinions.

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Health IT 1.0, the basic digitalization of health care, succeeded in getting health care to stop using pens and start using keyboards. Now, Health IT 2.0 is emerging and will build on this foundation by providing better, more diverse applications. Health care is following the example set by the rest of the modern digital economy and starting to leverage existing monolithic applications like electronic health records (EHRs) to create platforms that support a robust application ecosystem. Think “App Store” for healthcare and you can see where we are headed.

This is why interoperability and data blocking are two of the biggest issues in health IT today. Interoperability – the ability of applications to connect to the health IT ecosystem, exchange data and collaborate – is a key driver of the pace and breadth of innovation. Free flowing, rich clinical data sets are essential to building powerful, user-friendly applications.  Making it easy to install or switch applications reduces the cost of deployment and fosters healthy competition. Conversely, when data exchange is restricted (data blocking) or integration is difficult, innovation is stifled.

Given the importance of health IT in enabling the larger transformation of our health system, the stakes could hardly be higher. Congress recognized this when it passed the 21st Century Cures Act in 2016. Title IV of the act contains specific provisions designed to “advance interoperability and support the access, exchange, and use of electronic health information; and address occurrences of information blocking”. In February 2019, ONC and CMS simultaneously published proposed rules to implement these provisions.

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Innovation Amidst the Crisis: Health IT and the Opioid Abuse Epidemic | Part 4 – Resource Allocation and Access

By COLIN KONSCHAK, FACHE and DAVE LEVIN, MD 

Dave Levin

Colin Konschak

The opioid crisis in the United States is having a devastating impact on individuals, their families, and the health care industry. This multi-part series will focus on the role technology can play in addressing this crisis. Part one of the series proposed a strategic framework for evaluating and pursuing technical solutions.

A Framework for Innovation

In part one of our series, we declared the opioid crisis an “All Hands-On Deck” moment and made the case that health IT (HIT) has a lot to offer. Given the many different possibilities, having a method for organizing and prioritizing potential IT innovations is an important starting point. We have proposed a framework that groups opportunities based on an abstract view of five types of functionality. In this article, with an assist from Dr. Marv Seppala, Chief Medical Officer at the Hazelden-Betty Ford Foundation and Dr. Krista Dobbie, Palliative Care physician at the Cleveland Clinic, we will explore allocation of resources and access to care and the role that technology can play.

Resource Allocation and Access for Opioid Management

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Innovation Amidst the Crisis: Health IT and the Opioid Abuse Epidemic | Part 3 – Clinical Decision Support

By COLIN KONSCHAK, FACHE and DAVE LEVIN, MD

Dave Levin

Colin Konschak

The opioid crisis in the United States is having a devastating impact on individuals, their families, and the health care industry. This multi-part series will focus on the role technology can play in addressing this crisis. Part one of the series proposed a strategic framework for evaluating and pursuing technical solutions.

A Framework for Innovation

As noted in part one of our series, we believe the opioid crisis is an “All Hands-On Deck” moment and health IT (HIT) has a lot to offer. Given the many different possibilities, having a method for organizing and prioritizing potential IT innovations is an important starting point. We have proposed a framework that groups opportunities based on an abstract view of five types of functionality. In this article we will explore the role of technologies that provide clinical decision support.

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Innovation Amidst Crisis: Health IT and the Opioid Abuse Epidemic | Part 2 – Fostering Situational Awareness

By COLIN KONSCHAK, FACHE and DAVE LEVIN, MD

Dave Levin

Colin Konschak

The opioid crisis in the United States is having a devastating impact on individuals, their families, and the health care industry. This multi-part series will focus on the role technology can play in addressing this crisis. Part one of the series proposed a strategic framework for evaluating and pursuing technical solutions. 

A Framework for Innovation

Deaths from drug overdoses in the United States jumped nearly 10 percent last year, according to recent estimates by the Centers for Disease Control. One major reason for the increase: more Americans are misusing opioids.

Health IT (HIT) can play a pivotal role in addressing the opioid-abuse epidemic. To maximize impact, however, we believe it’s essential to organize and prioritize IT innovations and approaches. In part one of this series, we proposed a conceptual framework that sorts opportunities based on five types of functionality. In this article, we will explore one of these categories: technologies that enhance situational awareness.

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Innovation Amidst the Crisis: Health IT and the Opioid Abuse Epidemic | Part 1 – A Strategic Framework

Colin Konschak

Dave Levin

By COLIN KONSCHAK, FACHE and DAVE LEVIN, MD

The opioid crisis in the United States is having a devastating impact on individuals, their families, and the health care industry. This multi-part series will focus on the role technology can play in addressing this crisis. In this article, we propose a strategic framework for evaluating and pursuing technical solutions. Future articles will explore specific areas and solutions within this framework.

A Full-Blown Crisis

One of the authors recently had the opportunity to participate in a multi-stakeholder workshop in Cleveland, OH dedicated to finding new, collaborative approaches to addressing the nation’s opioid abuse epidemic. While Ohio might be considered ground zero for this epidemic, the evidence is clear that this is a national crisis and it is getting worse. The numbers are frightening, especially the 2016 estimate that 2.1 million people misused opioids for the first time.

Given the statistics, it is likely that many of you have been personally touched by the epidemic.

In our experience, successful improvement efforts in health care almost always address the role of people, process and technology. Strategic innovations aimed at the opioid abuse crisis should account for all three of these in a holistic manner. Innovation should be pursued as a series of practical experiments that address current gaps, result in near-term improvement, provide insights for future tests of change, and lead to a set of sustainable and scalable solutions that will be essential to ensuring long-term success in addressing this enormous problem.

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