The “Point-Counterpoint” to End All Point-Counterpoints in the Healthcare IT Policy World? | Mark Hagland | Healthcare Blogs Skip to content Skip to navigation

The “Point-Counterpoint” to End All Point-Counterpoints in the Healthcare IT Policy World?

September 12, 2017
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The New England Journal’s op-ed face-off offers a surprising level of conceptual overlap

The New England Journal of Medicine, long known for providing a forum for the discussion of complex and thorny healthcare policy issues, has surpassed itself in its latest issue, dated September 7, by showcasing what might be the ultimate point-counterpoint of contrasting views of the meaningful use program under the HITECH (Health Information Technology for Economic and Clinical Health) Act.

In last week’s issue, the esteemed NEJM published facing Perspectives (op-ed articles) by, on the one hand, a team of the four most recent past National Coordinators for Health Information Technology; and on the other hand, two exceptionally well-known national healthcare IT leaders. Thus, on p. 904 began “The HITECH Era and the Path Forward,” authored by Vindell Washington, M.D., Karen DeSalvo, M.D., Farzad Mostashari, M.D., and David Blumenthal, M.D.; and beginning on p. 907, readers were offered “The HITECH Era in Retrospect,” authored by John D. Halamka, M.D., CIO of Beth Israel Deaconess Hospital in Boston, and Micky Tripathi, Ph.D., president and CEO of the Massachusetts eHealth Collaborative.

This face-off of healthcare IT policy titans did not disappoint. On the one hand, the two teams did present somewhat contrasting perspectives on the meaningful use program; on the other hand, there was a surprising level of consensus on some of the fundamentals, as well as on some of the particulars, in their arguments. Let’s look at both, and then analyze the confluence of perspectives.

First, Drs. Washington, DeSalvo, Mostashari, and Blumenthal provided a broad overview of the history of the meaningful use program under HITECH. There’s no need to reproduce that summary here in full, though certain passages are worth quoting.

For one thing, the former National Coordinators note, eight-and-a-half years after the Congress passed, and President Obama signed, the HITECH Act, as part of the ARRA (American Recovery and Reinvestment Act of 2009), “Today, almost all U.S. hospitals and nearly 80 percent of office-based practices use certified EHRs [electronic health records]. A majority of providers can share health information between systems, and 87% of patients report having access to their electronic health information. More important, of nearly 500 studies examining the use of health IT functionalities required for what the HITECH Act designated as “meaningful use,” 84 percent showed that deploying this technology had a positive or partially positive effect on care quality, safety, and efficiency.”

Still, the National Coordinators write, “Obstacles emerged with the rapid deployment of technology and the development of new sources and uses of health data. Primary policy goals were to foster health IT adoption and stimulate the economy. The ONC [Office of the National Coordinator for Health IT], for example, was originally structured as a coordinating entity rather than a regulatory agency, and HITECH only slightly adjusted that profile. Participation in the EHR incentive program and the vendor-certification program is voluntary. Other challenges included congressional expectations of rapid allocation of HITECH funds and development of IT programs. A short timeline meant that some organizations simply expanded existing, proprietary EHRs; the design was hampered as clinical documentation requirements were in competition with billing and compliance needs.”

Importantly, the former National Coordinators concede, “Health care providers, especially physicians, have borne the brunt of this transformation. Many are frustrated by poor EHR usability and the lack of actionable information generated by these systems. In part, such limitations are attributable to the decision to allow proprietary standards and data blocking in the market, which has led to suboptimal data sharing.” So what’s the answer? “As former national coordinators for health IT,” they write, “we believe that the culture surrounding access to and sharing of information must change to promote the seamless, secure flow of electronic information. Both patients and providers want health information to be sharable between systems. Relevant policy work has involved educating clinicians, technology developers, and patients about common misperceptions associated with privacy protections under the Health Insurance Portability and Accountability Act (HIPAA). It has also focused on empowering patients through efforts such as the Blue Button Initiative, which allows patients to view and download their personal health information.”

And the former National Coordinators spend nearly the entirety of the rest of their op-ed article promoting the idea of interoperability, in the context of internal healthcare system reform. One of the main goals they see is this one: “Health IT provides new opportunities to engage patients and caregivers and can empower patients to learn and communicate more easily about their health, engage in shared decision making, and manage their care in convenient and meaningful ways. Market innovations and government policies should soon allow patients to combine information from various sources to create a single resource with all their current and historical health information. Seamless interoperability,” they emphasize, will facilitate better monitoring of health outcomes, as well as efficient resource use and cost analysis, particularly for care provided in multiple systems and settings. An emerging public health model, Public Health 3.0, encourages various sectors to collaborate to use data to enhance the societal effects of public health efforts.” They also see interoperability as vital to efforts to create a “learning health system.”

Halamka and Tripathi Weigh In

Interestingly, John Halamka and Micky Tripathi agree with the former National Coordinators on some key points. For one thing, they begin their op-ed by stating that, “At a high level, the Health Information Technology for Economic and Clinical Health (HITECH) Act of 2009 accomplished something miraculous: the vast majority of U.S. hospitals and physicians are now active users of electronic health record (EHR) systems. No other sector of the U.S. economy of similar size (one sixth of the gross domestic product) and complexity (more than 5000 hospitals and more than 500,000 physicians) has undergone such rapid computerization.” That said, they immediately add that, “Along the way, however, we lost the hearts and minds of clinicians. We overwhelmed them with confusing layers of regulations. We tried to drive cultural change with legislation. We expected interoperability without first building the enabling tools. In a sense, we gave clinicians suboptimal cars, didn’t build roads, and then blamed them for not driving.”

The chief culprit, in their view? “Burdensome requirements imposed costs on providers and vendors without offering sustained benefit. These deficiencies were manifested in five key areas: usability, workflow, innovation, interoperability, and patient engagement.”

Not only that; Halamka and Tripathi “name names.” “The Centers for Medicare and Medicaid Services (CMS) and the Office of the National Coordinator for Health Information Technology (ONC) set ambitious requirements for ‘meaningful use’ of health information technology (IT) to ensure that Medicare and Medicaid would get value from their large investment on a fixed timeline,” they write. “But in the absence of business and clinical drivers for change (HITECH predated the Affordable Care Act by more than a year), meaningful use came to be used as a de facto vehicle for transforming health care delivery — a purpose for which, as a technology investment program, it was not adequate.”

The industry leaders go on to pillory the “avalanche of requirements” foisted upon clinicians in practice. And, importantly, they opine that, “Furthermore, meaningful use set unrealistic expectations for interoperability. Though it did not specify a nationwide patient-matching strategy, create a nationwide directory of provider electronic addresses, forge a single set of consent or privacy guidelines, or define governance for deciding who could exchange what for various purposes, it set requirements with the assumption that interoperability could somehow skip over such essentials.” They further contend that, “Instead of recognizing the work that needed to be done on these foundational items, some policymakers invented the myth of “information blocking” as the root cause for lack of data flow. Our 50-plus combined years in the health IT industry have taught us that when technology, policy, and business needs are aligned, data flow.”

Still, even with that, Halamka and Tripathi acknowledge that “HITECH has played an invaluable role in accelerating the adoption of EHRs throughout the country.” What’s next? “We believe that now is the time to step back and recalibrate the role of the federal government on the basis of lessons learned,” they write. And they believe that a few major policy shifts need to take place: “First, requirements related to meaningful use and the Merit-Based Incentive Payment System (MIPS) introduced by CMS could be dramatically simplified to focus on interoperability and a streamlined set of outcome-oriented quality measures. Second, EHR certification could focus exclusively on interoperability capabilities by setting up a public test server and reporting on EHR vendors’ success in reading and writing medical records on it.” And, “Third, interoperability could be encouraged by market action rather than by regulation. The ONC… and other federal agencies could actively encourage private-sector networks to connect with each other using open industry standards, much as wireless and automated-teller networks have done. Finally, we could offer incentives for the adoption of open industry application programming interface (API) standards, such as FHIR, for provider–patient, provider–provider, provider–payer, and payer–patient interactions.”

Some Points of Commonality

So what’s interesting here? What to me is the most interesting is that the Halamka/Tripathi team is not necessarily that far apart from the former National Coordinators in their broader perspective, in certain respects. Everyone agrees that interoperability needs to be the biggest focus of federal healthcare IT policy going forward. What’s especially interesting is that Donald Rucker, M.D., the new National Coordinator, shared his strong interest in market-driven interoperability progress, when he sat down with me at the SHIEC Conference last month in Indianapolis. And that means that, under a Republican administration, it’s highly likely now that some of what Halamka and Tripathi have argued for in their NEJM op-ed probably will work out more in the direction that they foresee than the direction that perhaps the former National Coordinators envision it—though, to be honest, the former National Coordinators write rather vaguely about how interoperability might come about from a policy and regulatory standpoint, anyway.

What’s more, Dr. Rucker hinted to me very strongly that ONC’s focus will shift going forward. Indeed, though he refused to say so explicitly, he did not push back when I stated that it appeared that any final “Stage 3” of meaningful use for hospitals appears to be fading as a prospect, leaving the distinct possibility that ONC will begin now focusing away from what many clinicians and administrators have seen as more coercive requirements, and more towards an emphasis on stimulating the healthcare IT market, something that would greatly please Halamka and Tripathi and those who share their overall viewpoint.

Indeed, Dr. Rucker, in his interview with me in Indianapolis, put a strong focus on a market-driven push for value. “The challenge around value is that we’ve moved purchasing in healthcare from the free market and free-market equilibrium where consumers and producers agree on price, to a situation where we now have proxy consumers, which is the federal government and all the payers, who are trying to imagine what the consumer would pay for,” he told me. “And we’re trying to get the consumer back into the equation. The biggest way to do that, of course, is high-deductible health plans and health savings accounts; but one of the ways we’re trying to do this is through consumer access to data liquidity. And payers are consumers, too; and they need access to this data. So it really is broader than simply provider-to-provider data-sharing.”

In other words, it looks as though, inevitably, things are going to shift now, going forward, towards less comprehensive regulation and instead more towards the federal agencies that have oversight over federal healthcare IT policy, working to stimulate the marketplace.

The open question in all this is whether such a shift will get us to comprehensive interoperability faster or not; the jury honestly is very much out on that.

What is likely, though, is that HHS (the Department of Health and Human Services) and CMS (the Centers for Medicare and Medicaid Services), and ONC, might reduce the volume of process-oriented outcomes that Medicare-participating physicians will have to report to the federal government under the MIPS (Merit-based Incentive Payment System) system and the various APM- (advanced payment model) based programs under the governance of the MACRA (Medicare Access and CHIP Reauthorization Act of 2015) law’s requirements. Halamka and Tripathi definitely have a point about a need to shift outcomes reporting towards truly meaningful clinical outcomes, over time. It’s also important to keep in mind that, at the helm of ONC, Dr. Rucker is someone who spent decades in medical practice, and also worked as a health system administrator and as a vendor executive. So the chances that he will try to lift some of the burden on practicing physicians that Halamka and Tripathi cite in their op-ed, are relatively very good.

In the end, then, what some might find surprising is this: while the juxtaposition of the two NEJM op-eds was meant to create a conceptual and rhetorical contrast, the extent of commonality between the two is striking.

And, as Halamka and Tripathi note in their piece, “The HITECH era was an important catalyst for EHR adoption, and the industry benefited from government intervention. If the post-HITECH era can return control of the agenda to customers, developers, and multi-stakeholder collaborations, we should be able to recapture the hearts and minds of our clinicians.” Only time will tell, but there is a good hope that there will be enough of a meeting of minds among all the factions sitting around the federal healthcare IT policy table, that something close to an ideal of an overall policy thrust and emphasis, can be found, going forward. Our industry certainly deserves to get as close to that ideal as possible.

 

 

 

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Study: Clinical Decision Support EHR Alerts Can Lower Health Costs, Complications

August 20, 2018
by Rajiv Leventhal
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When physicians follow the recommendations of context-specific clinical decision support at the point of care, clinical and financial outcomes should improve, according to new research.

Researchers, in the recent study, published in the American Journal of Managed Care, examined more than 26,000 patient encounters to determine whether utilization of clinical decision support (CDS) is correlated with improved patient clinical and financial outcomes. In the treatment group, the provider adhered to all CDS recommendations, while in the control group, the provider did not adhere to CDS recommendations.

The analysis examined the associations between adherence to recommendations from Choosing Wisely—a clinical decision support platform from Stanson Health—embedded into clinical decision support alerts, and four measures of resource use and quality.  They found and concluded:

  • Encounters in which providers adhered to all alerts had significantly lower total costs, shorter lengths of stay, a lower probability of 30-day readmissions, and a lower probability of complications compared with nonadherent encounters.
  • Full adherence to Choosing Wisely alerts was associated with savings of $944 from a median encounter cost of $12,940.
  • Health systems should consider real-time CDS interventions as a method to encourage improved adoption of evidence-based guidelines.

In 2012, the ABIM Foundation—a healthcare quality organization devoted to advancing medical professionalism—introduced the Choosing Wisely (CW) initiative, a voluntary effort by more than 70 physician subspecialty societies to identify commonly used low-value services, with the intent to stimulate provider–patient discussions about appropriate care and thereby reduce low-value tests and treatments. But initial research of the CW recommendations found that providers had difficulty interpreting guidelines and evaluating patient risk.

To this end, the researchers attested that an EHR (electronic health record) infrastructure could provide real-time computerized clinical decision support to inform healthcare providers when their care deviates from evidence-based guidelines. CDS comprises a variety of tools, including computerized alerts and reminders with information such as diagnostic support, clinical guidelines, relevant patient information, diagnosis-specific order sets, documentation templates, and drug–drug interactions.

For this study, CW recommendations were implemented in the EHR at a large academic health system in the form of 92 alert-based CDS interventions, both inpatient and ambulatory. When initiating a potentially inappropriate order, a provider received real-time notification of deviation from a CW recommendation. That provider then had the option to cancel, change, or justify the order, if he or she agreed with the alert’s recommendation in the context of the individual patient.

It should be noted that two of the study’s authors are employed by Optum, which is a licensed reseller of Stanson Health, including its Choosing Wisely alert content evaluated in this study. What’s more, another of the authors is employed by Cedars-Sinai, which is the major shareholder of Stanson Health.

In the end, the researchers recommended that health systems consider real-time CDS interventions as a method to encourage improved adoption of CW and other evidence-based guidelines. A meta-analysis of CDS systems concluded that by providing context-specific information at the point of care, the odds of providers adopting guideline recommendations are 112 times higher.

They concluded, “Our findings contribute to the evidence base surrounding the use of CDS and improvements in patient clinical and financial outcomes. Formal prospective cohort studies and randomized CDS intervention trials, perhaps randomizing providers assigned to receive CDS interventions, should be prioritized to help guide future provider strategies in regard to reducing low-value care.”

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Study: Many U.S. Hospitals won’t Reach HIMSS Stage 7 Until 2035

August 14, 2018
by Rajiv Leventhal
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Unless the healthcare IT ecosystem experiences major policy changes or leaps in technological capabilities, many hospitals will not reach Stage 7 of HIMSS Analytics’ Electronic Medical Record Adoption Model (EMRAM) until 2035, according to new research.

The study, published in the August edition of the Journal of Medical Internet Research, analyzed Healthcare Information and Management Systems Society (HIMSS) Analytics’ EMRAM data from 2006 to 2014.

HIMSS Analytics is the research arm of the Healthcare Information and Management Systems Society (HIMSS). HIMSS Analytics developed the EMRAM in 2005 as a methodology for evaluating the progress and impact of electronic medical records on health systems around the world. Tracking their progress in completing eight stages (0-7), hospitals can review the implementation and utilization of information and technology applications culminating with Stage 7, which represents an advanced electronic patient record environment. Other Stage 7 requirements include: leveraging an external HIE (health information exchange); use of a data warehouse; and having robust data analytics functions.

The researchers of this study noted that the meaningful use (MU) program has promoted electronic health record (EHR) adoption among U.S. hospitals. And while studies have shown that EHR adoption has been slower than desired in certain types of hospitals; generally, the overall adoption rate has increased among hospitals.

However, the researchers continued, these studies have neither evaluated the adoption of advanced functionalities of electronic health records (beyond meaningful use,) nor forecasted EHR maturation over an extended period in a holistic fashion. “Additional research is needed to prospectively assess U.S. hospitals’ electronic health record technology adoption and advancement patterns,” the researchers stated.

The HIMSS EMRAM data set was used to track historic uptakes of various EHR functionalities considered critical to improving healthcare quality and efficiency in hospitals. A technology diffusion model was then used to predict the technological diffusion rates for repeated EHR adoptions where upgrades undergo rapid technological improvements. The forecast used EMRAM data from 2006 to 2014 to estimate adoption levels to the year 2035.

In 2014, more than 5,400 hospitals completed HIMSS’ annual EMRAM survey (86 percent of total U.S. hospitals). Back in 2006, the majority of the U.S. hospitals were in EMRAM Stages 0, 1, and 2. But by 2014, most hospitals had achieved Stages 3, 4, and 5, the study noted.

The researchers found that in 2006, the first year of observation, peaks of Stages 0 and 1 were shown as EHR adoption precedes HIMSS’ EMRAM. By 2007, Stage 2 reached its peak. Stage 3 reached its full height by 2011, while Stage 4 peaked by 2014. This forecast indicates that Stage 5 should peak by 2019 and Stage 6 by 2026, according to the data revealed in the study.

The researchers noted, “Although this forecast extends to the year 2035, no peak was readily observed for Stage 7. Overall, most hospitals will achieve Stages 5, 6, or 7 of EMRAM by 2020; however, a considerable number of hospitals will not achieve Stage 7 by 2035.” They concluded, “These results indicate that U.S. hospitals are decades away from fully implementing sophisticated decision support applications and interoperability functionalities in electronic health records as defined by EMRAM’s Stage 7.”

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HHS OIG Fines eClinicalWorks $132,500 For Violating Corporate Integrity Agreement

August 1, 2018
by Heather Landi
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The Health and Human Services (HHS) Office of Inspector General (OIG) fined electronic health record (EHR) vendor eClinicalWorks $132,500 for failing to report patient safety issues to the regulatory body as reportable events in a timely manner.

According to the OIG website, eClinicalWorks paid the fine July 18. The EHR vendor is required to report these patient safety issues to OIG as part of its corporate integrity agreement (CIA) with the agency.

eClinicalWorks entered into a CIA back in May 2017 as part of a settlement with the U.S. Department of Justice to resolve a False Claims lawsuit. According to the DOJ’s case, the company allegedly violated federal law by misrepresenting the capabilities of its software and for allegedly paying kickbacks to certain customers in exchange for promoting its product, according to the U.S. Department of Justice. As part of that settlement, eClinicalWorks also paid a $155 million settlement over the allegations.

The five-year CIA requires, among other things, that the company retain an Independent Software Quality Oversight Organization to assess eClinicalWorks’ software quality control systems and provide written semi-annual reports to OIG documenting its reviews and recommendations. The company must provide prompt notice to its customers of any safety related issues and maintain on its customer portal a comprehensive list of such issues and any steps users should take to mitigate potential patient safety risks.

Further, the agreement also requires eClinicalWorks to allow customers to obtain updated versions of their software free of charge and to give customers the option to transfer their data to another EHR software provider, without penalties or service charges. The vendor must also retain an Independent Review Organization to review its arrangements with healthcare providers to ensure compliance with the Anti-Kickback Statute.

 

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