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Rule Roundup: Health IT Groups Respond to CMS’ Promoting Interoperability Proposal

June 27, 2018
by Rajiv Leventhal
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Industry stakeholders seem mixed on CMS’ impactful proposal around the possibility of requiring electronic data exchange to avoid being forced out of Medicare

Health IT associations have sent in their public comments on the Centers for Medicare & Medicaid Services’ (CMS) meaningful use rebranding proposed rule, with a key focus of the remarks centering around the government’s proposal to consider interoperability as a condition of Medicare participation.

A Review of the Proposal

For background, in late April, CMS proposed updates to Medicare payment policies and rates under the Inpatient Prospective Payment System (IPPS) and the Long-Term Care Hospital (LTCH) Prospective Payment System (PPS). Included in the proposal was a re-naming of the meaningful use program to “Promoting Interoperability.” CMS said at the time that the goals of the new program will be to: make it more flexible and less burdensome; emphasize measures that require the exchange of health information between providers and patients, and incentivize providers to make it easier for patients to obtain their medical records electronically. 

Drilling down, however, the proposed rule has several interoperability elements to it beyond just a name change—some of which would have a significant impact on providers. For instance, as Healthcare Informatics reported at the time of the rule’s release,  CMS wrote that it would be seeking public comment, via an RFI (request for information) on whether participation in the Office of the National Coordinator’s (ONC’s) Trusted Exchange Framework and Common Agreement (TEFCA) should be considered a health IT activity that could count for credit within the health information exchange objective in lieu of reporting on measures for this objective.

Indeed, deep inside the rule, the federal agency suggested that it may consider revising the current CMS “Conditions of Participation” [which were originally proposed in the IMPACT Act and might be changed for future purposes] for hospitals, with the possibility of requiring providers to transfer medically necessary information upon a patient discharge or transfer to do so electronically.

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What this means, according to experts who have analyzed the rule in depth, such as Jeff Smith, vice president of public policy at AMIA (the American Medical Informatics Association), who spoke to Healthcare Informatics in April, is that while the proposal does away with the meaningful use patient data access objective (view, download and transmit), “what this RFI [on the possibility of revising Conditions of Participations to revive interoperability] seems to be signaling is that they are not saying it’s not important to allow patients to view, download and transmit their information, but quite the opposite. CMS is signaling that they think it’s more important than participating in this little program that could cost you a percentage point or two in reimbursement. They think it’s so important that you don’t get participate in Medicare [if you don’t meet the Conditions of Participation],” Smith said at the time.

Stakeholders Respond

Health IT trade groups had until June 26 to send in their public comments on the rule, and after reviewing the remarks, there seems to be varied responses as it relates to requiring interoperability as a condition to participate in Medicare.

For one, the Ann Arbor, Mich.-based College of Healthcare Information Management Executives (CHIME) attested that CMS is taking the wrong approach. CHIME wrote in their comments, “Simply imposing regulatory requirements that make electronic data exchange a condition for providers to receive Medicare payment does not address the root issues at play. Addressing ongoing barriers is needed to speed greater progress around interoperability. Importantly too, a distinction must be drawn between speeding and increasing data exchange among providers and achieving a true state of interoperability. The two should not be conflated.”

The Chicago-based EHR (electronic health record) Association (EHRA) had similar sentiments as CHIME, noting that “We question the utility of new Conditions of Participation for Medicare around data sharing, especially in light of 21st Century Cures ongoing regulatory implementation. Further regulatory action on data sharing and interoperability should wait until the rulemaking mandated by 21st Century Cures is complete. For example, a CoP related to information blocking is contingent on ONC’s definitions on safe harbors.” EHRA added, “It is additionally unclear how interoperability expectations in the CoPs would be evaluated and audited, but it seems likely that evaluation and auditing of these items would generate additional hospital burden.”

The aforementioned AMIA, the Bethesda, Md.-based organization which sent in 38 pages of comments, pondered if CMS were to propose a new CoP standard to require electronic exchange of medically necessary information, would this help to reduce information blocking? In response to this question, AMIA wrote that it believes that clinicians do want to send important data and receive important data, but they acknowledge “this isn’t occurring consistently.” AMIA continued, “We recommend that CMS garner experience and insights under the Information Blocking rule, once finalized, before deciding to modify COP/CfC/RfPs. Further, we recommend CMS focus its inquiry on provider-to-patient information flows and calibrate its policies to ensure that all entities receiving Medicare funds provide patients 24x7x365 access to their information in a persistent manner and without special effort. We find the concept of ‘medically necessary information’ somewhat abstract and very context-dependent.”

Similarly, the Washington, D.C.-based American Hospital Association (AHA) said that CMS should not “implement a CoP/CfC to increase interoperability across the continuum of care because post-acute care providers were not provided the resources or incentives to adopt health IT, and creating this requirement would put another unfunded mandate on these organizations. Such a requirement would only be workable if all facilities were afforded the same opportunity to acquire certified EHRs that actually conformed to standards that enable the kind of interoperability CMS envisions.”

However, there are a plethora of stakeholders that feel differently. A letter signed by more than 50 organizations, representing plans, providers, patient groups, ACOs (accountable care organizations) and health IT companies, has called on CMS to take more aggressive action to promote interoperability and advance health information exchange. Some of these signed groups include prominent industry names such as Beth Israel Deaconess Care Organization, Blue Shield of California, the New York eHealth Collaborative, and Aledade, just to name a few.

In the letter, these organizations wrote, “We believe that tying information sharing to Conditions of Participation would be a tremendous benefit to millions of Medicare and Medicaid patients across the country. In addition, we recognize that CMS has other levers that should be used to facilitate greater data sharing and interoperability, including requiring the use of 2015 Edition Certified EHRs and aligning requirements in the Quality Payment Program, the Promoting Interoperability program, and other quality programs such as STAR ratings.”

Other Noteworthy Comments

Beyond commenting on the possibility of revising Conditions of Participations to further promote interoperability, the trade groups weighed in on many other issues as well. The Washington, D.C.-based Pew Charitable Trusts noted that via the rule, CMS has opportunities to improve interoperability by addressing factors that affect the exchange and utility of health data, such as: better patient matching; the use of simple and transparent application programming interfaces (APIs); and standardized clinical terminologies.

Furthermore, EHRA stressed the need for better timelines and stronger alignment, noting that: any program changes must be communicated with enough lead time to allow for education, testing, implementation, roll out, and certification; and that while it appreciates the alignment of program names, “this does not address much more significant challenges, such as the challenge associated with capturing and calculating measures differently for the Medicare and Medicaid programs. To avoid burden in certification and software development, CMS must keep individual measures consistent between their Medicare and Medicaid programs, even if the scoring approach varies,” EHRA commented.

CHIME, meanwhile, thanked CMS for removing the “pass/fail” element in the new Promoting Interoperability program, while also showing appreciation that CMS has given providers more time in 2018 to install and begin using their 2015 CEHRT.CHIME does, however, recommend that CMS make the reporting period for all programs that require the use of 2015 CEHRT—beyond just Promoting Interoperability—be 90 days in 2019.

What’s more, AHA wrote that it opposes the use of Stage 3 requirements in FY 2019, as it believes “the level of difficulty associated with meeting all of the Stage 3 current measures is overly burdensome.”  The organization gave an example of how one Stage 3 objective requires the incorporation of patient-generated health data or data from a nonclinical setting for more than five percent of patients into an EHR. But as AHA noted, “The types of data to be integrated are not specified, the data sources range from social service organizations to consumer fitness devices, and the manner by which to incorporate the data into the EHR is not specified.”

AMIA’s other recommendations included: CMS should chart a course towards an end to numerator/denominator-driven measurement through the Promoting Interoperability program; CMS should abandon the construct of measure reporting in favor of an activity-based approach; and that CMS should initiate a broad and inclusive conversation regarding the contours and additional characteristics of acceptable IIAs (inpatient improvement activities).

It’s expected that a final rule will be published this fall.

 

 


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New DirectTrust CEO Sees Potential for Applying its Trust Framework in Other Healthcare Contexts

October 15, 2018
by David Raths, Contributing Editor
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Former Cerner exec Scott Stuewe seeks closer relationship with EHR vendors
DirectTrust CEO Scott Stuewe

In July the nonprofit DirectTrust named former Cerner executive Scott Stuewe its new CEO to replace founding CEO Dr. David Kibbe. In a recent interview with Healthcare Informatics, Stuewe spoke about working more closely with EHR vendors and expanded opportunities for his organization’s trust framework.

Stuewe spent 24 years at Cerner, including working on interfacing and systems integration. His last three years there were spent focused on the Commonwell Health Alliance and trying to convince Cerner clients to get more involved, so working on interoperability issues is not new to him.

In fact, the role at DirectTrust seems like a logical next step in his career. “I spent some of the most exciting years of my life working on systems integration efforts,” he said. The Commonwell effort gave him an opportunity to get to know key players in the interoperability space. He also participated in Carequality advisory group, where he got to know people at Epic and other places that had not been active in Commonwell.

I asked Stuewe what he had discovered about the strengths of DirectTrust in his first few months.

“I think what was new to me was the strength of the trust framework as a technical trust framework,” he said. Other interoperability groups have trust frameworks that are legal and policy documents. “Those documents are the bread and butter of what those organizations are about. DirectTrust has this technical trust framework. which is about stretching the highest security mechanism across identity-proofed endpoints, and that is kind of a unique model. That is the advantage of the trust framework that DirectTrust represents – that identity proofing process and technologies associated with it are hardened at a level that really nothing else at its scale can really point to.”

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When I interviewed Dr. Kibbe in June, he spoke about how DirectTrust was working with the Office of the National Coordinator on an extension of its trust framework to FHIR. I asked Stuewe if he saw that as an area with potential.

He replied that it is a huge opportunity for DirectTrust. He said something like SMART on FHIR uses the same technologies that are in use in Facebook and other social media platforms. But higher levels of trust need to be established in healthcare than has been used in social media, where there have been some very large-scale data breaches. “The way the FHIR community has so far imagined that connections will be made is that the end points, that is, the provider organizations, take the responsibility to ensure that the people who are able to get to their data are who they say they are and are appropriate,” Stuewe said. People do all sorts of secure transactions over the internet, but they do so using a public key infrastructure (PKI) of the sort that DirectTrust represents, he added. “I think there is great potential there. We have demonstrated it is doable, but it does require both the caller and receiver to make relatively small accommodations for the certificates that will enable that exchange. That is not the way FHIR has been rolled out so far.”

What are some other areas where DirectTrust needs to make progress?

Stuewe says the organization could make more headway by engaging with the EHR vendors who so far have not been very engaged with DirectTrust. “There are some gaps in features among the EHRs that frankly are the same gaps we saw in query-based exchange in Commonwell. There are usability problems; the way a given feature surfaces in one EHR is so different than another that you can’t even do the same work flow across the two systems.”

He noted the same was true in query-based exchange and it took three years of meetings with the EHR vendors showing each other their user interfaces to make progress. “That is what I believe we can get done in DirectTrust,” he said. “Our clinician work group issued a consensus statement on the features/functions required for Direct to be fully adopted by the clinical community. The problem is we don’t have enough of the EHR players as participating members to really stimulate that conversation. I am eager to reach out and point this out because we are actually not that far from being able to make tremendous headway. In fact, there are a ton of things we can do right now. We are already at 1.7 million addresses and 50 million transactions per quarter. It is really happening. But there are a whole lot of things DirectTrust could do that it can’t right now given the differences in the way the EHRs work.”

Stuewe said that by far the biggest opportunity for DirectTrust is to apply its trust framework in other contexts. “FHIR is one of them, but we look at some other healthcare communication vectors, and believe healthcare communication can be secured by our PKI regardless of what standards or technologies are used for those.”

He added that it would be important to identity-proof the consumer at scale to enable more comfort from provider organizations around the connections people are going to want to make to them. “We believe that has a huge value and I think given the entry of the large consumer-based organizations into the world of healthcare, that is the opportunity we have,” Stuewe explained. “If you combine FHIR, a trust framework and a major consumer player, then that is when you can make a lot of this stuff actually work. I am excited about it.”

 


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VA-DoD Leaders Signal Commitment to Achieving Interoperability, but What Uphill Challenges Will They Face?

October 15, 2018
by Heather Landi, Associate Editor
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"There is no precedent for this level of interoperability in healthcare,” says one industry thought leader
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The U.S. Secretaries of Veterans Affairs (VA) and Defense (DOD) have signaled their commitment to achieving interoperability between the two agencies by implementing a single, seamlessly integrated electronic health record (EHR), according to a joint statement published last week.

VA Secretary Robert Wilkie and Defense Secretary James N. Mattis signed a joint statement Sept. 26 pledging that their two departments will “align their plans, strategies and structures as they roll out a EHR system that will allow VA and DoD to share patient data seamlessly,” according to a press release about the joint statement.

“The Department of Defense and Department of Veterans Affairs are jointly committed to implementing a single, seamlessly integrated electronic health record (EHR) that will accurately and efficiently share health data between our two agencies and ensure health record interoperability with our networks of supporting community healthcare providers,” the joint statement from Wilkie and Mattis states. “It remains a shared vision and mission to provide users with the best possible patient-centered EHR solution and related platforms in support of the lifetime care of our Service members, Veterans, and their families.”

The VA and the DoD are both undertaking massive projects to modernize their EHR systems and both departments plan to standardize on Cerner’s EHR. The hope is that this will provide a more complete longitudinal health record and make the transition from DoD to VA more seamless for active duty, retired personnel and their dependents. Once completed, the project would cover about 18 million people in both the DoD and VA systems.

The VA signed its $10 billion contract with Cerner May 17 to replace VA’s 40-year-old legacy health information system—the Veterans Health Information Systems and Technology Architecture (VistA)—over the next 10 years with the new Cerner system, which is in the pilot phase at DoD.

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DoD began rolling out its EHR modernization project, called Military Health System (MHS) Genesis, in January 2017 at Fairchild Air Force Base and three other pilot sites in Washington State. The DoD EHR overhaul contract, which was awarded in 2015 to Cerner, Leidos and others, is currently valued at $4.3 billion. The new EHR system is expected to be deployed at every military medical facility in phases over the next five years.

“There is no precedent for this level of interoperability in healthcare, but one can hope the DoD-VA effort will drive the evolution of meaningful interoperability forward and benefit everyone,” says Dave Levin, M.D., chief medical officer at Sansoro Health and former chief medical information officer (CMIO) for Cleveland Clinic. Levin has been observing the VA-DoD interoperability efforts and has written several blogs pointing out the critical challenges facing the two agencies in these efforts.

“There is a long-standing need for the VA and the DoD to be on the same information database for service members and veterans. Cerner is a good product. I am hopeful that Cerner’s commitment to the FHIR (Fast Healthcare Interoperability Resources) standard and to process interoperability standards will be revealed to the general community and implemented wholeheartedly, because at the end of the day, it’s not what’s best for VA and DoD, it’s what’s best for veterans and service members as they consume care along their own personal pathways,” says Shane McNamee, M.D., who previously served as the clinical lead for the VA’s Enterprise Health Management Platform (eHMP) effort and also the VHA business lead for the development and deployment of the VA’s Joint Legacy Viewer. He is now the chief medical officer of Cleveland-based software company mdlogix.

In the press release, Wilkie said the joint statement represents “tangible evidence” of VA and DoD’s commitment. “The new EHR system will be interoperable with DoD, while also improving VA’s ability to collaborate and share information with community care providers. This will ease the burden on service members as they transition from military careers and will be supported by multiple medical providers throughout their lives.”

Wilkie also said the new EHR system will give health care providers a full picture of patient medical history and will help to identify Veterans proactively who are at higher risk for issues, such as opioid addiction and suicide, so health care providers can intervene earlier and save lives.

Specifically, the joint statement pledges that VA and DoD will develop an accountability mechanism to coordinate decision-making and oversight. “The importance, magnitude, and overall financial investment of our EHR modernization efforts demand alignment of plans, strategies and structure across the two departments,” the two agency leaders stated in the joint statement. “To this end, DoD and VA will institute an optimal organizational design that prioritizes accountability and effectiveness, while continuing to advance unity, synergy and efficiencies between our two departments.”

VA and DoD will construct a plan of execution that includes a new organizational structure that optimally coordinates clinical and business workflows, operations, data management and technology solutions and a more detailed implementation timeline.

"We are committed to partnering with the VA to support the lifetime care of our service members, Veterans and their families," Mattis said in the press release. "This modern electronic health record will ensure those who serve our nation have quality health care as they transition from service member to Veteran."

An Uphill Battle for Interoperability

Interoperability between the VA and DoD has been a long-standing goal for both agencies, and the past two decades has seen the agencies making strides to achieve interoperability between two separate health IT systems. However, progress on this front has been slowed by both operational and technical challenges.

Back in April 2016, the DoD and VA signed off on achieving one level of interoperability, after the VA implemented its Joint Legacy Viewer (JLV) the previous fall. The JLV is a web-based integrated system that combines electronic health records from both the DoD and the VA, which enables clinicians from both agencies to access health records.

However, as reported by Healthcare Informatics, during a congressional hearing in July 2016, a Government Accountability Office (GAO) official testified that in 2011, DoD and VA announced they would develop one integrated system to replace separate systems, and sidestep many of their previous challenges to achieving interoperability. “However, after two years and at a cost of $560 million, the departments abandoned that plan, saying a separate system with interoperability between them could be achieved faster and at less overall cost,” Valerie Melvin, director of information management and technology resources issues at the GAO, testified at the time.

Melvin said that the VA has been working with the DoD for the past two decades to advance EHR interoperability between the two systems, however, “while the department has made progress, significant IT challenges contributed” to the GAO designating VA as “high risk.”

And, Melvin summarized the GAO’s concerns about the VA’s ongoing modernization efforts. “With regard to EHR interoperability, we have consistently pointed to the troubled path toward achieving this capability. Since 1998, VA has undertaken a patchwork of initiatives with DoD. These efforts have yielded increasing amounts of standardized health data and made an integrated view of data available to clinicians. Nevertheless, a modernized VA EHR that is fully interoperable with DoD system is still years away,” Melvin said during that hearing two years ago.

Fast forward to June 2017 when then-VA Secretary David Shulkin announced that the department plans to replace VistA by adopting the same EHR platform as DoD. Six months later, Shulkin then said that the contracting process was halted due to concerns about interoperability. According to reports, VA leaders’ concerns centered on whether the Cerner EHR would be fully interoperable with private-sector providers who play a key role in the military health system. VA leaders finally signed the Cerner contract this past May.

The Pentagon also has hit some road bumps with its EHR rollout. In January 2018, DoD announced the project would be suspended for eight weeks with the goal to assess the “successes and failures” of the sites where the rollouts had already been deployed. This spring, a Politico report detailed that the first stage of implementations “has been riddled with problems so severe they could have led to patient deaths.” Indeed, some clinicians at one of four pilot centers, Naval Station Bremerton, quit because they were terrified they might hurt patients, or even kill them, the report attested.

Media reports this past summer indicated that the Cerner platform was up and running at all four initial DoD pilot sites, with federal officials saying the agency is still troubleshooting the platform at the initial facilities, but the overall adoption’s shown “measurable success.” This month, media reports indicated that DoD is moving onto a second set of site locations for its Cerner EHR rollouts, with three bases in California and one in Idaho.

According to the VA press release issued last week, collaborating with DoD will ensure that VA “understands the challenges encountered as DoD deploys its EHR system called MHS GENESIS; adapts an approach by applying lessons learned to anticipate and mitigate known issues; assesses prospective efficiencies to help deploy faster; and delivers an EHR that is fully interoperable.”

While both Levin and McNamee praise the VA-DoD interoperability efforts, they note the substantial challenges the effort faces. In a January blog post, Levin wrote at the heart of this VA-DoD interoperability challenge are two fundamental issues: “an anemic definition of interoperability and the inevitable short comings of a ‘one platform’ strategy.”

In response to the joint statement issued last week, Levin provided his observations via email: “DoD and VA will have separate instances of the Cerner EMR. They will not be on the same EMR with a single, shared record but rather on distinct and separate implementations of the same brand of EMR. The choice of language in the announcement is interesting: they are saying they will create a single EHR [author’s emphasis] through interoperability between these separate EMRs and with the EMRs in the civilian health system, which is essential since a lot care for active duty, Veterans, and dependents is rendered outside the military system. This will depend greatly on the extent and depth of interoperability between the different EMRs.”

Levin continued, “My second observation relates to interoperability between the EMRs, or EHR system, and the many other apps and data services within military health IT. For example, there is an emerging class of apps sometimes referred to as ‘wounded warrior’ apps. These are specially designed for this population. They will need to be effectively integrated into this new IT ecosystem or their value will be greatly diminished, if not lost.”

McNamee points out there are different layers of interoperability—data interoperability, or ensuring data flows back and forth (the Joint Legacy Viewer achieved this level of interoperability, he says), semantic interoperability, in which meaningful information is associated with the data, and then standards-based process interoperability.

The lack of standards-based process interoperability continues to be a roadblock for all healthcare providers, and this issue has yet to be solved by any one specific EHR vendor, many industry thought leaders note.

“The challenges that VA and DoD face are similar to what the rest of healthcare faces in this country,” McNamee says. “There’s more than 10 million patients between these two organizations, meditated across thousands of different sites and the inability to transfer information and process for the VA and the DoD is similar as the rest of the country.”

He continues, “If you talk to any informatics or health IT professional about the most challenging thing that they’ve ever had to do in their career it’s to install an EHR into their hospital; it’s incredibly disruptive and, if not done well, it can negatively impact patient care, reimbursement and morale. VA and DoD are attempting to do this across thousands of healthcare sites, with millions of patients, and hundreds of thousands of healthcare providers, in one project, that’s a daunting task, to do that well and do that seamlessly.”


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Carequality Seeks Input on FHIR-Based Exchange

October 12, 2018
by Rajiv Leventhal, Managing Editor
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Carequality is seeking input from the healthcare community as it looks to add support for FHIR (Fast Healthcare Interoperability Resource)-based exchange.

According to an announcement from Carequality—national-level, consensus-built, common interoperability framework to enable exchange between and among health data sharing networks—member and non-member stakeholders from across the healthcare continuum are encouraged to participate in the new FHIR Implementation Guide technical and/or policy workgroups. The former will concentrate more on specifications and security, while the latter will focus on the “rules of the road,” officials said.

With much of the healthcare industry either starting to implement FHIR at some level, or planning to do so, the Carequality community is thinking ahead to the type of broad, nationwide deployments that Carequality governance can enable, officials noted.

The new policy and technical workgroups are expected to work in concert with many other organizations contributing to the maturity and development of FHIR, and officials attest that the workgroups will not duplicate the work that is underway on multiple fronts, including defining FHIR resource specs and associated use case workflows. Instead, the workgroups will focus on the operational and policy elements needed to support the use of these resources across an organized ecosystem. 

“Carequality has demonstrated the power of a nationwide governance framework in connecting health IT networks and services for clinical document exchange,” said Dave Cassel, executive director of Carequality.  “We believe that the FHIR exchange community will ultimately encounter some similar challenges to those that Carequality has helped to address with document exchange, and likely some new ones as well.  We’re eager to engage with stakeholders to map out the details of FHIR-based exchange under Carequality’s governance model.”

Cassel added, “We believe that adoption of FHIR in the Carequality Interoperability Framework can advance all of these goals by improving the availability of useable clinical information, expanding the scope of exchange, and significantly lowering the costs of participating in interoperable exchange.”

In August, Carequality and CommonWell, an association providing a vendor-neutral platform and interoperability services for its members, announced they had started a limited roll-out of live bidirectional data sharing with an initial set of CommonWell members and providers and other Carequality Interoperability Framework adopters.

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