Might CMS Move to Implicitly Mandate Health Data Exchange at Discharge, at the Federal Level? | Mark Hagland | Healthcare Blogs Skip to content Skip to navigation

Might CMS Move to Implicitly Mandate Health Data Exchange at Discharge, at the Federal Level?

April 26, 2018
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CMS officials make broad hints about data-sharing in their release of a new proposed rule

Tuesday’s announcement on the part of the federal Centers for Medicare and Medicaid Services (CMS) that the agency is planning to drastically overhaul the meaningful use program, even to the extent of changing its name, was a big one. As Healthcare Informatics Managing Editor Rajiv Leventhal noted in his report two days ago, “In a press release, the federal agency said that it will be proposing to re-name the meaningful use program to ‘Promoting Interoperability.’ CMS said 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.”

Further, Leventhal noted, “The meaningful use (Medicare and Medicaid EHR Incentive Programs) program has been around since 2011 with the intent to encourage eligible providers to demonstrate meaningful use of certified EHR (electronic health record) technology. Seven years later, with nearly all hospitals and most physician practices having implemented a certified EHR, CMS is proposing a shakeup of the initiative with a rethinking of industry priorities.  Broadly,” he wrote, “the proposed rule issued today proposes 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). According to CMS, the policies in the IPPS and LTCH PPS proposed rule ‘would further advance the agency’s priority of creating a patient-driven healthcare system by achieving greater price transparency and interoperability—essential components of value-based care— while also significantly reducing the burden for hospitals so they can operate with better flexibility and patients have the information they need to become active healthcare consumers.’”

Among other things, Leventhal wrote, “The proposed policies begin implementing core pieces of the government-wide MyHealthEData initiative through several steps to strengthen interoperability or the sharing of healthcare data between providers.” And his report included the statement made by CMS Administrator Seema Verma that was contained in the announcement. “We seek to ensure the healthcare system puts patients first,” Verma a statement. “Today’s proposed rule demonstrates our commitment to patient access to high quality care while removing outdated and redundant regulations on providers. We envision a system that rewards value over volume and where patients reap the benefits through more choices and better health outcomes. Secretary Azar has made such a value-based transformation in our healthcare system a top priority for HHS, and CMS is taking important, concrete steps toward achieving it.”

What’s more, as Leventhal and Healthcare Informatics Associate Editor Heather Landi reported this morning in their follow-up article, “CMS is proposing to re-name the meaningful use program, now calling it “promoting interoperability.” But just how far the federal agency will go beyond “promotion” remains to be seen. For instance, deep inside the rule, CMS wrote that it is seeking public comment, via an RFI (request for information) on whether participation in the 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.”

Their story notes that “Those who have been close to the early meetings on TEFCA—which is the Office of the National Coordinator’s (ONC’s) plan to jolt the sluggish pace of progress on interoperability between providers— have praised the fact that provider participation in the initiative is currently voluntary. But,” they note in their article from this morning, “Jeff Smith, vice president of public policy at AMIA (the American Medical Informatics Association), believes that providers might actually be forced to participate after all.” Indeed, Smith told them, “One of the really interesting things is that nestled away [in the RFI] is that it says CMS 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 that would require them to transfer medically necessary information upon a patient discharge or transfer to do so electronically. A few other phrases are [also] in there, such as requiring hospitals to send discharge information to a community provider via electronic means, if possible, and requiring hospitals to make information available to patients, or a specific third-party application via electronic means, if requested.”

Further, they report, “[E]ven more thought-provoking, adds Smith, is TEFCA possibly counting as an HIE measure and objective in the new program.” In fact, he told them, “This could be wildly overblown, but one of the critiques of TEFCA is that it is voluntary and if you make it too hard, [no one] will do it. I always thought that was flawed logic, as the ONC EHR [electronic health record] certification program is voluntary, but nobody treats it like it’s voluntary if they want to be part of this world.”

And, though Smith told them that he had always assumed that TEFCA participation would be “voluntary,” the government would figure out a way to encourage participation. “If you think about TEFCA as essentially requiring all these [activities], if they were to try to make Conditions of Participating align with the general outline of TEFCA, that would be a pretty strong motivation to participate. It sure seems to me that what’s outlined here—making information available to other facilities upon transfer or discharge, requiring discharge information go to community providers, and making sure that information is available to patients or third-party apps—is pretty much a large swath of what TEFCA is trying to accomplish,” he said.

Using the modifications to the IMPACT Act to compel data exchange?

So, now comes a question: might CMS officials end up, down the road, creating an implicit mandate for inpatient hospitals to participate in de facto health information exchange in routine discharges from inpatient stays, as a condition of participation in the Medicare and Medicaid programs, via modifications made to the IMPACT Act, above and beyond potentially giving providers “credit” for such data-sharing at the point of discharge, as part of the renamed “Promoting Interoperability” program? The question is a provocative one, but we’ll have to do some digging and pondering here.

It’s right there, on pages 1474-1477 of the proposed rule:

“In light of the widespread adoption of EHRs along with the increasing availability of health information exchange infrastructure predominantly among hospitals, we are interested in hearing from stakeholders on how we could use the CMS health and safety standards that are required for providers and suppliers participating in the Medicare and Medicaid programs (that is, the Conditions of Participation (CoPs) Conditions for Coverage (CfCs), and Requirements for Participation (RfPs) for Long Term Care Facilities) to further advance electronic exchange of information that supports safe, effective transitions of care between hospitals and community providers.  Specifically, CMS might consider revisions to the current CMS CoPs for hospitals such as: requiring that hospitals transferring medically necessary information to another facility upon a patient transfer or discharge do so electronically; requiring that hospitals electronically send required discharge information to a community provider via electronic means if  possible and if a community provider can be identified; and requiring that hospitals make  certain information available to patients or a specified third-party application (for example, required discharge instructions) via electronic means if requested.

On November 3, 2015, we published a proposed rule (80 FR 68126) to implement the provisions of the IMPACT Act and to revise the discharge planning CoP requirements that hospitals (including short-term acute care hospitals, long-term care hospitals (LTCHs), inpatient rehabilitation hospitals (IRFs), inpatient psychiatric hospitals (IPFs), children’s hospitals, and cancer hospitals), critical access hospitals (CAHs), and home health agencies (HHAs) must meet in order to participate in the Medicare and Medicaid programs.  This proposed rule has not been finalized yet. However, several of the proposed requirements directly address the issue of communication between providers and between providers and patients, as well as the issue of interoperability:

  • Hospitals and CAHs would be required to transfer certain necessary medical information and a copy of the discharge instructions and discharge summary to the patient’s practitioner, if the practitioner is known and has been clearly identified;
  • Hospitals and CAHs would be required to send certain necessary medical information to the receiving facility/post-acute care providers, at the time of discharge; and
  • Hospitals, CAHs and HHAs, would need to comply with the IMPACT Act requirements that would require hospitals, CAHs, and certain post-acute care providers to use data on quality measures and data on resource use measures to assist patients during the discharge planning process, while taking into account the patient’s goals of care and treatment preferences.

We published another proposed rule (81 FR 39448), on June 16, 2016, that updated a number of CoP requirements that hospitals and CAHs must meet in order to participate in the Medicare and Medicaid programs. This proposed rule has not been finalized yet.  One of the proposed hospital CoP revisions in that rule directly addresses the issues of communication between providers and patients, patient access to their medical records, and interoperability.  We proposed that patients have the right to access their medical records, upon an oral or written request, in the form and format requested by such patients, if it is readily producible in such form and format (including in an electronic form or format when such medical records are maintained electronically); or, if not, in a readable hard copy form or such other form and format as agreed to by the facility and the individual, including current medical records, within a reasonable timeframe.  The hospital must not frustrate the legitimate efforts of individuals to gain access to their own medical records and must actively seek to meet these requests as quickly as its record keeping system permits.”

Now, there are alternative ways of reading this. The most passive reading would be a kind of “blue-sky” reading: that senior CMS officials see some future opportunity to make changes to the IMPACT Act that would promote “Promoting Interoperability,” and those officials want to let everyone know that they’re “blue-sky”-ing that thought right now.

But really, that would be a rather Pollyanna-ish view, to be honest. After all, those officials went to the trouble of spilling three pages of (electronic) ink on the idea, in the proposed rule modifying what has been meaningful use, on Tuesday morning. Which means they’re very actively thinking about it.

So my interpretation, as of this moment, is that Seema Verma and her fellow senior CMS officials this week have signaled to hospital senior executives and other leaders that actively sharing key data with the appropriate post-acute-care providers at the point of discharge from inpatient stays, may come to be mandated, in effect, either through explicit changes to what had been called the Meaningful Use program and is now called the Promoting Interoperability program, or, more likely based on the text I’ve shared above from the new proposed rule, instead through rulemaking in the IMPACT Program. Certainly, all of this is supported by all the comments that senior federal healthcare officials have been making in recent months, and certainly is supported by the comments that Administrator Verma made in March at HIMSS18 in Las Vegas, when she announced the creation of the MyHealthEData initiative. So all of it hangs together conceptually, as well as, potentially, policy-wise.

And while all of this is “envisioned” right now in late April 2018, things that are “envisioned” by CMS officials often become concrete requirements quite soon. So, stay tuned—all of this is about to get even more interesting, sooner rather than later.

 

 

 

 

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/news-item/interoperability/directtrust-touts-2018-growth-data-exchange-volume-participants

DirectTrust Touts 2018 Growth in Data Exchange Volume, Participants

January 23, 2019
by Rajiv Leventhal, Managing Editor
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DirectTrust, a nonprofit organization that supports health information exchange via the Direct message protocols, has announced continued steady growth in the number of healthcare organizations using its interoperability services during 2018.

The organization also noted an upsurge in the number of Direct message transactions, patient use, and addresses. According to year-end 2018 metrics:

  • There were nearly 274 million Direct message transactions between DirectTrust addresses in 2018, a 63-percent increase over the 2017 total of 168 million transactions. There were more than 110 million Direct messages transmitted during the fourth quarter of 2018 alone.
  • The number of patients/consumers involved using Direct increased approximately 35 percent to nearly 248,000.
  • The number of healthcare organizations served by DirectTrust accredited health information service providers (HISPs) increased 30 percent to nearly 139,000, compared with approximately 107,000 at year-end 2017.
  • The number of trusted DirectTrust addresses able to share PHI across the DirectTrust network increased 16 percent to more than 1.8 million since the end of 2017.
  • Eleven healthcare organizations joined DirectTrust during 2018, bringing the organization’s total membership to 115.

Last July, 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.

He told Healthcare Informatics at the time that his organization could make more headway by engaging with the EHR (electronic health record) 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,” Stuewe said.

Stuewe also noted that DirectTrust’s technical trust framework is about “stretching the highest security mechanism across identity-proofed endpoints,” which, he said, “is kind of a unique model.”

A recent data brief from the Office of the National Coordinator for Health IT (ONC) revealed that about four in 10 surveyed hospitals participated in more than one nationwide health information exchange network, such as Surescripts, the e-Health Exchange, DirectTrust, CommonWell, or Carequality. Surescripts was the most commonly network used; 61 percent of hospitals participated. The next highest participation rates were in DirectTrust and the e-Health Exchange; about a quarter of hospitals participated in each.

 

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Hospitals Outline Agenda to Accelerate Interoperability

January 22, 2019
by Heather Landi. Associate Editor
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Hospitals and health systems are making progress in sharing health information, with 93 percent making records available to patients online, but collaboration across many private and public sector entities, including technology vendors and policymakers, is necessary to achieve comprehensive interoperability, according to a new report from national hospital associations.

The report reviews the current state of interoperability, which show promises but is still a patchwork system, as well as outlines current challenges and provides an agenda for steps to take to improve interoperability among health IT systems. The report was compiled by seven national hospital associations—America’s Essential Hospitals, American Hospital Association (AHA), Association of American Medical Colleges, Catholic Health Association of the United States, Children’s Hospital Association, Federation of American Hospitals and the National Association for Behavioral Healthcare.

“We see interoperability in action all around us. Mobile phones can call each other regardless of make, model, or operating system. The hospital field has made good headway, but it’s time to complete the job. We are united in calling for a truly interoperable system that allows all providers and patients to benefit from shared health records and data, leading to fully informed care decisions,” AHA President and CEO Rick Pollack said in a statement.

“For the best care today, it’s the data stupid. Quality care depends on having the right information at the right time, so our patient’s records need to be available in the hospital or wherever our patients receive care. Hospitals are joining together to support improving interoperability because it is the key to assuring the best for our patients,” Federation of American Hospitals President and CEO Chip Kahn said in a prepared statement.

The report highlights that hospitals and health systems are making progress in sharing health information, with 93 percent making records available to patients online, up from 27 percent in 2012. What’s more, 88 percent of hospitals are sharing records with ambulatory care providers outside their system, up from 37 percent in 2012. And, 87 percent of hospitals enable patients to download information from their health record, up from 16 percent in 2012.

“We are inching closer to, but still short of, the ideal of seamless interoperability. In health care, this refers to the capacity to send and receive a patient’s health information from multiple sources between different systems and locations with its integrity intact,” the report authors wrote. “The information communicated must be useful to the receiving care provider, patients and families, and result in the care decisions that are best for them. Today, interoperability is a partially-achieved aim, working well in some but not all settings.”

The report authors note that the key to leveraging health data’s full potential for improving patient care is the establishment of a framework for compatible technical and linguistic (semantic) standards adopted by all parties that “lead us to a generic, vendor-neutral data exchange platform.” “We currently lack universally agreed upon ways of sharing and using information — “rules-of-the-road” that make possible the uncorrupted transfer of patient data between differing (and often proprietary) health record systems,” the report authors wrote.

Looking at progress made to date, hospitals and health systems have invest hundreds of billions over the past decade in electronic health records (EHRs) and other IT systems that record, store and transfer patient data securely among medical professionals. In 2017 alone, hospitals and health systems invested $62 billion in these IT systems.

According to the Office of the National Coordinator for Health Information Technology (ONC), the vast majority of hospitals use multiple mechanisms to share health information, and more than half must use four or more. Furthermore, most hospitals devote significant resources to manually matching patient records, since we do not have a national patient identifier, the report states.

And, according to 2010 AHA survey data, only 16 percent of hospitals had a basic EHR system in place. By 2017, 97 percent of surveyed hospitals had adopted a certified EHR system.

What’s more, hospitals and health systems have made efforts to link via health information exchanges (HIEs), however, the report notes while HIEs do deliver on some of the promises of interoperability, the exchangeable data is often limited to a regional or statewide scale. “In addition, some HIEs cannot reliably carry out full data exchange within a health system among different source technologies, or data

 

 

exchange across health systems including ambulatory or post-acute settings,” the report authors wrote. Also, HIEs may not enable individual patients to access their data.

The report authors also outline the ongoing barriers to comprehensive interoperability. According to an AHA analysis on barriers to health data exchange and interoperability, 63 percent of respondents cited the lack of capable technology as the biggest barrier. That survey also identified difficulties matching or identifying the correct patient between systems also as additional costs to send or receive data with care settings and organizations outside their system as significant interoperability barriers as well.

“Barriers to interoperability must be addressed in order to support the level of electronic sharing of health information needed to provide the best care, engage people in their health, succeed in new models of care, and improve public health. Doing so requires collaboration across many private and public sector entities, including hospitals and health systems, technology companies, payers, consumers, and federal and state governments,” the report authors wrote.

The report also outlines “pathways” to advance interoperability with a particular focus around privacy, security, standards and infrastructure as well as industry stakeholders committing to share best practices and lessons learned.

Among the report’s recommendations, new standards are needed to overcome the significant gaps making communication difficult between systems. “For example, APIs (application programming interfaces), including those based on the FHIR (Fast Healthcare Interoperability Resources) standard, allow for more nimble approaches to accessing needed data. Health care will benefit most from use of standard, secure, non-proprietary APIs that minimize the added costs associated with proprietary solutions and gatekeeping. API access should support both patient access to information from providers and other stakeholders, and the use of trusted third-party tools to support clinical care,” the report authors wrote.

“While we have made much progress, at present, we have the incomplete outline of a national data-sharing system in place, one that lacks the agreed upon rules of the road, conformance, technical standards and standardized implementations to ensure that all HIE platforms can communicate correctly with each other,” the report authors concluded.

The report authors note that true interoperability that advances improved health care and outcomes is within reach with effective federal policies and key stakeholders doing their part. The report calls on health systems to use their procurement power to drive vendors toward compatibility in systems design and lend a voice to the development process.

EHR and IT vendors, in turn, should commit to more field testing and consistent use of standards, the report authors wrote, and avoid pricing models that create a “toll” for information sharing. Vendors also should offer alternatives to expensive, labor-intensive workarounds that drain providers’ time and energy.

 

Related Insights For: Interoperability

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HL7 Model Identifies Clinical Genomics Workflows, Use Cases

January 16, 2019
by David Raths, Contributing Editor
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Domain Analysis Model covers pre-implantation genetic diagnosis, whole-exome sequencing, RNA sequencing and proteomics

HL7’s Clinical Genomics Work Group has published an HL7 Domain Analysis Model (DAM) to identify common workflows and use cases to facilitate scalable and interoperable data standards for the breadth of clinical genomics scenarios.

The Domain Analysis Model (DAM), which has underdone a rigorous ISO/ANSI-compatible balloting process, covers a myriad of use cases, including emerging ones such as pre-implantation genetic diagnosis, whole-exome sequencing, RNA sequencing and proteomics.

The effort “builds on the DAM Clinical Sequencing work that is already being used to design precision medicine workflows at hospitals across the country,” said Gil Alterovitz, Ph.D., an HL7 Clinical Genomics Work Group co-chair, in a prepared statement. He also serves as a Harvard professor with the Computational Health Informatics Program/Boston Children’s Hospital.

The Clinical Sequencing DAM fueled the design of FHIR Genomics, the subset of HL7’s FHIR standard designed to communicate clinical genomic information. “By extending to broader domains, it can serve as a standard going forward to aid in the design of workflows, exchange formats as well as other areas,” Alterovitz added,

The document presents narrative context and workflow diagrams to guide readers through the stages of each use case and details steps involving the various stakeholders such as patients, health care providers, laboratories and geneticists. This contextual knowledge aids in the development and implementation of software designed to interpret and communicate the relevant results in a clinical computer system, especially a patient's electronic health record.

The HL7 Clinical Genomics Work Group developed several new applications and refinements in the Domain Analysis Model beyond its original scope of clinical sequencing. One notable addition is the analysis of the common workflows for pre-implantation genetic diagnosis (PGD). For those undergoing in-vitro fertilization, advanced pre-implantation genetic screening has become increasingly popular as it avoids the implantation of embryos carrying chromosomal aneuploidies, a common cause of birth defects. Implementers can follow the workflow diagram and see the context for each transfer of information, including the types of tests performed such as blastocyst biopsy and embryo vitrification.

As the clinical utility of proteomics (detecting, quantifying and characterizing proteins) and RNA-sequencing increases, the DAM also outlines clinical and laboratory workflows to capitalize on these emerging technologies.

HL7 notes that future challenges arise from uncertainty about the specific storage location of genomic data, such as a Genomics Archive and Computer/Communication System (GACS), as well as the structure of a patient’s genomic and other omics data for access on demand, both by clinicians and laboratories. Best practices in handling such considerations are being formulated within HL7 and include international input from across the spectrum of stakeholders. In parallel, the HL7 Clinical Genomics Work Group has been preparing an implementation guide for clinical genomics around many of these use cases, to be leveraged alongside the newly published HL7 FHIR Release 4 standard.

 

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