Analysis of the 21st Century Cures Act on Reducing Clinician Burden Attributable to Health Information Technology & Electronic Health Records
I. Executive summary
The Health Information Technology for Economic and Clinical Health (HITECH) Act invested over $37 billion of incentives to hospitals and providers to implement electronic health records (EHRs) through the Meaningful Use Program and promoted the adoption of value-based care. Though, as the healthcare environment rapidly changed under pressure from aggressive timelines, another crisis brewed: clinician burnout.
Documentation burden, the usability of EHRs, and a lack of interoperability were all identified as EHR-related factors that contribute to burnout. Stakeholders commonly cited Evaluation and Management (E/M) codes as outdated and contribute to documentation burden. A focus on EHR implementation through HITECH incentives crippled the efforts in designing user-friendly EHRs. The lack of interoperability formed information silos, both at the point of care and across organizations, frequently translated to manual data entry and unnecessary clicks.
The Cures Act outlines many burden-reduction provisions. Section 4001 tasked the ONC to formulate a strategy to reduce administrative burden attributable to health IT and EHRs. Section 4002 aimed to improve usability through the use of an EHR reporting program, the United States Core Data for Interoperability, and application programming interfaces (APIs). Section 4003 redefined interoperability and set forth a framework that will scale existing health information exchanges to achieve nationwide interoperability.
Enactment of the Cures Act is a landmark piece of legislation that can address all three levels of NAM’s clinician burnout model: external environment, health care organization, and frontline care delivery. However, the effectiveness of its key provisions will be profoundly reliant on crucial factors that will dictate the magnitude of its success. While there is still ambiguity in how the final CMS and ONC rules will impact burnout, especially amidst the ongoing COVID-19 pandemic, the initiatives spawned from the Cures Act most certainly have had an indirect effect on reducing burden attributable to HIT and EHRs.
II. Summary of how capstone project addresses personal MPH goals
As an informatics pharmacist who configures EHRs, my priorities and projects are frequently dictated by EHR upgrades. In turn, the EHR upgrades are heavily influenced by federal regulations, various quality improvement programs, and end-user feedback. Given the impact of HITECH on transforming the HIT and EHR landscape, I sought to better understand how health IT policy is formulated, influenced, and analyzed. Moreover, as a former pharmacist end-user of EHRs, I am very interested in how we can better design and implement them in a way that assists, rather than disrupt, the workflows of my colleagues. This capstone helps me accomplish my personal MPH goals by providing me the opportunity to thoroughly explore the implications of a major federal initiative on clinician burnout.
III. Introduction
The vision of safer healthcare systems through quality and transparency was conveyed through two Institute of Medicine (now National Academy of Medicine) reports: To Err is Human: Building a Safer Health System1 and Crossing the Quality Chasm: A New Health System for the 21st Century.2 In 2009, this vision was realized through the rapid adoption of electronic health records (EHR) and the simultaneous transition towards value-based care. The HITECH Act, as part of the American Recovery and Reinvestment Act of 2009,3 invested over $37 billion of incentives to hospitals and providers to implement EHRs through the Medicare and Medicaid EHR Incentive Program,4 popularly known as Meaningful Use, while the Patient Protection and Affordable Care Act of 2010,5 promoted adoption of value-based care. These legislative measures, coupled with the advent of EHRs, revolutionized the United States in how patients receive care, how providers deliver care, and how care is regulated. Though, as the healthcare environment rapidly changed under pressure from aggressive timelines to meet reimbursement criteria, another crisis brewed: clinician burnout. Although the etiology of burnout is multi-factorial, EHRs and the increased administrative burdens borne from these changes, have been commonly identified as key contributors towards the growing epidemic.6
Burnout is a syndrome studied from as early as the 1970s and is characterized by emotional exhaustion, depersonalization, and reduced personal accomplishment.7 The Maslach Burnout Inventory (MBI) is a validated 22-item questionnaire that is considered the gold-standard for measuring burnout and is often used to quantify the issue.7,8 The prevalence of burnout has been estimated to be roughly 35 to 54% of physicians and nurses and between 45 to 60% for medical students and residents.9 Unsurprisingly, this has sparked calls to action from multiple physician groups10,11 and even 12 hospital CEOs in the United States.12
In December 2019, the National Academy of Medicine (NAM) published the results from their Taking Action Against Clinician Burnout: A Systems Approach to Professional Well-Being report that conceptualized burnout by three levels: frontline care delivery, health care organization, and the external environment.9 The first level of frontline care delivery refers to the interactions whereby students, clinicians, and patients all interact. The second level of health care organizations refers to its culture, its management, and the various policies that govern how that entity functions. Lastly, the third level is the external environment and it refers to all of the forces (e.g. political, societal, professional) that may influence, be it constrain or expand, the other two levels. Given the ubiquitous adoption of EHRs, the 21st Century Cures Act of 2016 presents a unique opportunity to influence the burnout crisis as it touches on all three levels in NAM’s conceptual framework.
Enactment of the 21st Century Cures Act of 2016,13 herein referred to as the “Cures Act”, contains multiple provisions to address the clinician burnout crisis. One of the key burden-reduction initiatives outlined by the Cures Act is Section 4001, which amended the HITECH Act of 2009 to add section 13103, “Assisting doctors and hospitals in improving quality of care for patients”. This section called on the Health and Human Services (HHS) to provide a strategy towards reducing administrative and regulatory burden related to EHRs and identified multiple areas of focus which include: federal EHR incentive programs, value-based payment models, certification of health IT program, implementation of standards, and improvements in clinical documentation. Initiatives to improve usability and functionality are subsequently described in Section 4002. These include the establishment of an EHR reporting program to increase consumer transparency and the adoption of APIs. Lastly, section 4003 drafts the framework for nationwide interoperability. Thus, the Cures Act has immense potential in responding to the current burnout situation. However, execution is key and will be dependent on how HHS translates the law of the land. As of March 9, 2020, the Centers for Medicare and Medicaid (CMS) and the Office of the National Coordinator for Health Information Technology (ONC) finalized the two historic rules that will fulfill the Cures Act.14,15
The purpose of this report is to review the implications of the Cures Act and what is known about its impact on reducing clinician burden. This will be accomplished via three objectives. First, a literature search will be conducted surrounding clinician burnout attributable to health IT and EHRs. Second, the burden-reduction initiatives of Cures will be reviewed and summarized. Third, the regulations stipulated by Cures will be critiqued on its potential effectiveness.
IV. Review literature on consensus, disagreement, and gaps in clinician burnout
Methods
A literature review was conducted to identify articles that evaluated clinician burnout associated with HIT or EHRs. PubMed was the database used and only full-text articles published within the last five years were included. The specific query used was as follows: ("Electronic Health Records"[Mesh] OR "Information Technology"[Mesh] OR "American Recovery and Reinvestment Act"[Mesh] OR "Medical Informatics"[Mesh]) AND ("Burnout, Psychological"[Mesh] OR "Burnout, Professional"[Mesh]) AND ("2014/12/04"[PDat] : "2019/12/02"[PDat]), which resulted in 54 unique results. After a preliminary review of the title and abstracts, 41 of the articles were included for full-text review. To expand the search, references were reviewed to identify additional articles of interest. Two recent reports were included from authoritative organizations such as the ONC and the National Academy of Medicine.4,9 Every article was analyzed to determine if there were any associations between EHRs and burnout and whether there were any specific attributes of EHRs that were more predictive of burnout than others. Since this paper is a policy analysis, added attention was given towards the implications of previous policy decisions on burnout. Lastly, following Bardach’s Eightfold Path for Policy Analysis16, the next few sections will group the evidence into areas of consensus, disagreement, and gaps.
Documentation burden
Documentation burden is one of the most commonly cited predictors in the burnout crisis and likely a primary driver of EHR dissatisfaction.17 As we transition to value-based care, federal incentive programs (e.g. Meaningful Use) have markedly increased the minimal amount of documentation required for patient care. In fact, ever since the enactment of HITECH, clinical notes in the United States have doubled in length.16 Even when compared against non-US countries using the same EHR, the mean length of notes in the United States is still four times as long.16 Unusually, EHR satisfaction around the globe, as assessed by the Arch Collaborative, appear to be the same between the United States and non-US health systems.18 The authors of that report suggest that this is largely due to the amount of regulatory burden, likely driven by payors, that exists in the United States. They also further hypothesize that the EHR satisfaction in countries outside of the US would likely decrease if the regulatory burden was similar to that of the US.18 These regulatory requirements underpin NAM’s third level of the burnout model in which federal regulations, while well-intentioned, can introduce unnecessary burden on clinicians. Our current methods of billing may be outdated as well. Aside from documentation of care for medical record-keeping, state and federal regulations require specific documentation that justifies the level of care a patient requires. Evaluation and management (E/M) visit codes, a set of billing codes used for patient visits since 1995, is frequently cited as being outdated and a source of burden.4 These E/M codes, which reflect the paper charting paradigms of the past, still require the provider to document certain data elements (e.g. history and exam) even if they already exist elsewhere in the EHR. Considering these codes have not been updated in over 25 years,19,20 stakeholders believe there is much opportunity to better leverage our electronic environment to mitigate these challenges and revise the E/M codes to better align with current technology.4
As the cost of healthcare continues to increase, so has the use of prior authorizations by payers to limit the unnecessary and inappropriate use of medications and procedures. Unfortunately, the criteria for prior authorizations and its associated documentation are different across payers, frequently change, and often need to be completed by clinicians to justify their use. In a study by academic physicians, prior authorizations were among three of the most burdensome tasks with the other two being ambulatory clinical documentation and medication reconciliation. Yet, of the three, prior authorization was determined to be the only one of least value and more than half of the physicians in the survey felt as though the task could be delegated.21 Perhaps most importantly, documentation burden has constrained and diminished the patient-provider relationship. One study that used EHR event-log data demonstrated that providers spent 5.9 hours of an 11.4-hour workday, both during and after clinic hours, on the EHR.22 It has been estimated that for every one hour physicians spend in direct patient care, up to two hours would be spent on EHR tasks.23,24 This stresses the importance of well-designed and well-implemented EHRs to minimize the chance of it detracting from the patient-provider relationship, and subsequently, increased workload and burnout.9,25
Despite these documentation challenges, it is worthwhile to note that the majority of clinicians favor EHRs over paper charts.26 In a report published by Stanford Medicine in 2018, over two-thirds of primary care physicians see the value in EHRs, but also believe there is room for improvement.27 This perspective is also shared by the collective findings from the National Academy of Medicine when EHRs are well-implemented.9 In comparison to their former predecessors, well-implemented EHRs provide more accurate and efficient workflows than paper charts when it comes to entering orders and documenting medical histories.9 Further, the culmination of data in EHRs have opened up an unprecedented opportunity for productivity gains into researching the cures and diseases of today. Thus, documentation burden generated from EHRs should be viewed as both an improvement over paper charts, but also an area of much needed improvement as we move forward.26
Usability
Lack of EHR usability is another area of agreement found in the literature. Poorly designed user interfaces and information overload can easily lead to misaligned workflows that do not meet the needs of clinicians.28 Additional steps that are often cumbersome and do not add value in the care of a patient both intensify frustration and compounds the documentation burden. To address the issue, one must understand some of the reasons why the lack of EHR usability may be occurring. At the center of these reasons were the HITECH incentives and disincentives that focused primarily on EHR implementation.10 Ambitious timelines imposed on eligible providers and hospitals crippled the efforts in designing user-friendly EHRs.29,30 Even though the importance of user experience was stressed early on in the implementation,31 it quickly became a major issue that led to an AMIA task force on usability in 201332 and a requirement for certification in the ONC’s certified electronic health record (CEHRT) program in 2015 that mandated user-centered design (UCD) during EHR development. Despite these efforts, usability is still a common complaint10 and criticism is typically directed at the health IT vendors.
In the last few years, local site implementations have been identified as another factor in usability discussions.9,33 Despite implementation of certified EHR products, which are required to have a user-centered design, customization of local implementations can still deviate from its original certification that had consistent layouts, workflows, and presentation of information that was developed with the clinical end-user in mind.33 In a study that evaluated the usability and safety of the two largest EHR vendors (i.e. Epic & Cerner) across four health systems, wide variability between the organizations in the number of clicks, task completion time, and error rates was found.34 Some of the differences in click burden amounted up to an eight-fold difference in the number of clicks and a nine-fold difference in time taken, on average.34
Perhaps more importantly, patient safety can be jeopardized when EHRs are not well-designed.9 In a systematic review of nurses’ experience with EHRs, a lack of usability led to workflow workarounds that bypass the checks embedded within EHRs.35 Even performing simple patient care tasks such as retrieving patient information was difficult.35 Keeping the clinical end-user in mind in all phases of the project lifecycle, especially during local implementations, can help streamline EHR activities such as documentation, chart review, and computerized order entry (CPOE).36 In the face of more stringent regulation on documentation requirements, the amount of information overload generated likely exacerbates and further contributes to less user-friendly interfaces and decreased EHR satisfaction.36,37
Interoperability
While not overtly discussed in the evidence gleaned in the literature search,28,38–41 but certainly a consensus in expert opinion, the lack of interoperability across EHRs was another common theme that was described. In fact, it was one of the key burden-related themes referenced by the National Academy of Medicine9 and the ONC.4 Information silos, spawned by a spectrum of political, cultural, and technical factors, introduce unnecessary burden for clinicians in the form of manual data entry.9,42 This in turn causes direct patient care activities that manifest in the form of manual data input from one information system to another to ensure data is consistent, accurate, and complete.9 Examples include the transcription of patient information (e.g. vital signs) or the manual programming of medical devices like smart pumps, which can be susceptible to human error.43 Unsurprisingly, the need for effortless data exchange has spawned an entire industry dedicated to proprietary integration technology in which vendors compete for the business of healthcare organizations. In a report from West Health Institute in 2013, it was estimated that $36 billion dollars could be saved in inpatient settings alone if widespread medical device interoperability was established.44 These conditions make it less of an incentive for health IT vendors to share data, practices, or solutions as it gives them a competitive advantage in the marketplace.42
Effortless exchange of information across organizations45 is also needed for decision making at the point of care. One example use case is the regulation that requires prescribers to query medication histories from a state-run prescription drug monitoring program (PDMP) prior to prescribing an opioid. While supportive of combatting the ongoing opioid epidemic, the current lack of integration between EHRs and PDMPs translates into unnecessary clicks for the prescribers and frequently requires them to log into a separate system.4 The technical standards required for the exchange of opioid-related information between EHRs, pharmacies, and PDMPs further complicates the issue as they are not consistent. For example, a majority of state PDMPs are implemented through the National Information Exchange Model (NIEM), EHRs and pharmacies typically use the NCPDP Script Standard, and the exchange of information between state PDMPs is often conducted using proprietary solutions.4,46 Prescribers are also further challenged with disruptions introduced by two-factor authentication, which is required for electronic prescribing of controlled substances (EPCS) as it is not often well-integrated into the prescribing workflow.47 Although the adoption of EPCS is still currently low at 24% nationally, the SUPPORT for Patients and Communities Act will mandate this adoption in January 2021 for medications covered under Medicare Part D.
Association between burnout, patient outcomes & EHRs
While there has been a numerous amount of literature that has been published in the last decade associating burnout and patient outcomes or burnout and EHRs,10,23,48,49 there has also been evidence refuting such associations.50–52 One of the most compelling arguments came from a systematic review that looked at the association between burnout and patient outcomes.51 Their most surprising finding was that associations between burnout and patient outcomes came predominantly from studies that incorporated physician perception.51 Studies that included the clinical chart, however, found no such relationship.51 While this systematic review did not completely refute that there is no association, the authors did conclude that the relationship between burnout and patient outcomes may not be as overt as originally speculated. Moreover, studies that have attempted to characterize the amount of burnout attributable directly to EHRs6 have also been directly refuted due to underlying methodological concerns.52 In light of these findings, we should continue to conduct well-designed research to advance our understanding of these associations.50
V. Review burden-reduction initiatives from Cures Act
Most of the burden-reduction initiatives from the Cures Act are laid out in Title IV - Delivery. This section will review each of these initiatives along with its associated proposed and/or finalized regulation.
Section 4001: Assisting doctors and hospitals in improving quality of care for patients.
Report on Reducing Regulatory and Administrative Burden
One of the primary burden-reduction initiatives is the requirement that the HHS create a plan that will reduce the administrative and regulatory burdens for our frontline providers per section 4001 of the Cures Act. To fulfill this goal, HHS solicited feedback in 2017 directly from stakeholders through a variety of mediums (e.g. listening sessions, town hall meetings, webinars, and a notice of proposed rulemaking) in addition to conducting literature reviews of their own. In November 2018, the ONC published the draft Strategy on Reducing Regulatory and Administrative Burden Relating to the Use of Health IT and EHRs based on the feedback. The report categorizes the issues into four areas of focus: clinical documentation, health IT usability and the user experience, EHR reporting, and public health reporting. After a 60-day public comment period and revision of the report, the ONC released a final report on February 21, 2020.4 The report provides strategies and recommendations to multiple stakeholders and has led to the launch of multiple initiatives.
Patient’s Over Paperwork initiative
In response to the ONC’s report,4 CMS, in collaboration with the ONC, launched the Patients Over Paperwork initiative in 2017.53 The goals of the program are to reduce unnecessary burden, increase efficiencies, and improve the beneficiary experience.54 While there are multiple strategies implemented through this program, one of the most significant involves the revisions to the outpatient Evaluation and Management (E/M) Codes, the first in over 25 years, that providers use for billing visits.20 In concert with CMS, recommendations for the revisions came through a workgroup established by the American Medical Association (AMA) that includes the Current Procedural Terminology (CPT) Editorial Panel and the AMA/Specialty Society RVS Update Committee (RUC).20 On November 1, 2018, some of the E/M revisions were finalized through the calendar year (CY) 2019 Physician Fee Schedule (PFS)4,20,55 which included the following key provisions:56,57
Providers are no longer required to document on required data elements if it already exists in the chart and would instead acknowledge that it was reviewed
Documentation of chief complaint and history of present illness is now allowed to be delegated to ancillary staff instead of being limited to only the provider for both new and established patients
More notable and larger modifications to the E/M codes were delayed until CY 2021 due to stakeholder concerns.56,57 These changes will result in the following:58,59
For established patients, retainment of 5 levels of coding
For new patients, reduction to 4 levels of coding for office and outpatient E/M visits
Performance of history and exam will only be required as medically appropriate
Revision of the times and medical-decision making process for all office-based E/M codes will be revised
Providers are now able to choose either medical decision making (MDM) or time when selecting E/M visit levels
As of October 29, 2019, results from the Patients Over Paperwork Initiative are estimated to have saved $6.6 billion through the reduction of nearly 42 million hours of burden through 2021.60
Section 4002: Transparent reporting on usability, security, and functionality
Electronic Health Record Reporting Program
The ONC was tasked with the development of a national EHR reporting program that would be included in the certified EHR technology (CEHRT) program and whose data would be collected as a requirement of certification and maintenance per Section 4002 of the Cures Act.13 For the new program $15,000,000 would be appropriated and would address critical areas that include security, usability and user-centered design, interoperability, conformance to certification testing, and other categories, as appropriate in measuring EHR technology.13 In August 2018, the ONC contracted with the Urban Institute to determine the specific reporting criteria that should be included in the program.61,62 The data from the EHR reporting program will assist providers and healthcare organizations in selecting CEHRT that meets a standard of usability, safety, and interoperability as determined by the ONC.63 However, in testimony before the US Senate in October 31, 2017, the ONC Deputy National Coordinator at the time, Jon White, stated that the ONC would be unable to move forward with the EHR reporting program64 due to the proposed budget cuts that would decrease funding by $22 million.65 As noted by the final rule published by the ONC on March 9, 2020, the EHR reporting program has not been established and future rulemaking will be utilized to fulfill Section 4002 of the Cures Act.15
United States Core Data for Interoperability
The United States Core Data for Interoperability (USCDI) is a standardized set of health data classes and data elements for nationwide, interoperable health information exchange. Within USCDI, a “data class” is defined as a grouping of data elements for a specific use case and a “data element” is the smallest unit in which a piece of data is exchanged.66 As of March 9, 2020, USCDI replaced the Common Clinical Data Set (CCDS) as a standard in the 2015 Edition Certification Criteria and expanded the minimum baseline of data classes that were available for interoperable data exchange.15 Continual expansion of the data shared through USCDI will occur through a systematic process established by ONC that is predictable, transparent, and collaborative with a consensus-driven approach. Health IT developers will also be able to take advantage of certifying their products to newer versions of USCDI, without waiting for rulemaking, through a process called “Standards Version Advancement Process” (SVAP).15 Two notable changes in the final ONC rule, from its proposed rule during NPRM, is the 1) alignment with HL7 Fast Healthcare Interoperability Resources (FHIR) and 2) inclusion of additional data elements in the patient demographics patient class to promote patient matching.47
Standards-based API certification criterion
The use of a standards-based API, specifically the HL7 FHIR Release 4.0.1 (herein referred to as HL7 FHIR) standard, was adopted as a new certification criterion for the 2015 Edition Cures Update for patient and population services as of March 9, 2020.15,48 Use of the HL7 FHIR standard was also required by CMS-regulated payers in the Patient Access and Provider Directory API, except Qualified Health Plan (QHP) issuers on the Federally-facilitated Exchanges (FFEs), in the CMS final rule.49,50 The Patient Access API will allow patients easier access to their claims data and the Provider Directory API will allow multiple groups, including third-party vendors, patients, and providers, to easily identify provider information.50
Section 4003 - Interoperability
Definition of interoperability
Section 4003 of the Cures Act amended Section 3000 of the Public Health Service Act (PHSA) by defining interoperability as health information technology that “enables the secure exchange of electronic health information with, and use of electronic health information from, other health information technology without special effort on the part of the user; allows for complete access, exchange, and use of all electronically accessible health information for authorized use under applicable State or Federal Law; and does not constitute information blocking as defined in section 3022(a)”.13 This definition, along with a few other key provisions in Section 4003, provides a foundation for advancing interoperability across all stakeholders that include patients, providers, payers, and other entities.
Trusted Exchange Framework and Common Agreement
The Trusted Exchange Framework and Common Agreement (TEFCA) is an initiative established by Section 4003 of the Cures Act that called on the National Coordinator to establish a common agreement by which information could be easily exchanged across disparate health information networks (HIN).67 The first draft (i.e. TEF Draft 1) was released by the ONC in January 2018 followed by draft 2 on April 19, 2019, after a period of public comments.68 The impetus for TEFCA was primarily derived from the deficits in the existing agreements that allowed HINs to share data with organizations within the network, but prevented exchange of information across HINs, usually due to competitive interests.69 To enable data exchange across providers, payers, patients, and various healthcare organizations, TEFCA aims to accomplish three overarching goals:69
Establish a single “on-ramp” to nationwide connectivity
Enable electronic health information to securely follow the patient
Allow nationwide scalability
It is important to note that it is the combination of two components, the Trusted Exchange Framework (TEF) and the Common Agreement, that will serve as the technical and legal requirements for enabling nationwide information exchange. The TEF provides a common set of principles (standardization; transparency; cooperation and non-discrimination; privacy, security, and patient safety; access; and data-driven accountability) that are designed to facilitate trust between the HINs and the Common Agreement specifies the minimum set of exchange modalities and Exchange Purposes for sending and receiving electronic health information.69 In August 2019, the ONC awarded The Sequoia Project a 4-year contract to serve as the Recognized Coordinating Entity (RCE) in charge of developing, updating, implementing, and maintaining the Common Agreement outlined in TEF.70,71 As of the publication of the final rules from both the CMS and ONC, TEFCA has not been finalized. Consequently, the CMS rule did not finalize that CMS-payers (i.e. MA organizations, Medicaid managed care plans, and CHIP managed care entities and QHP issuers on the FFEs) would be required to participate in TEFCA citing the lack of a mature agreement.72
Establishment of a Health Information Technology Advisory Committee
The Health Information Technology Advisory Committee (HITAC) was established by Section 4003 of the Cures Act via amendment of Section 3002 of the PHSA and replaces the former HIT Policy Committee (HITPC) and the HIT Standards Committee (HITSC).13 The HITAC would be tasked with providing the National Coordinator recommendations on a policy framework that advances nationwide interoperability and sets the priority for the efforts involved.13
VI. Discussion of Cures Act Impact on Clinician Burnout
This section will review the implications of the Cures Act on the specific components of burnout identified from the literature review.
Uncertainty in reducing documentation burden
The modifications to the E/M codes, strongly supported by the medical community,73 will likely contribute the most towards reducing documentation burden. However, the magnitude of its impact will be driven by a couple of key factors. The first of which is the adoption of the new code modifications by commercial payers, which represent 67.7% of insured individuals in the United States.74 Commercial payers may be reluctant to adopt the new codes, there are historic examples of this in the past,56 as it would then require updates to fee schedules, contracts, and pricing.75 In this scenario, frontline providers may actually experience an unintended increase in documentation workload that may increase burnout due to the stress of adhering to multiple coding guidelines stipulated by payers.56 In a survey of the largest commercial payers, Anthem and UnitedHealthcare intend to adopt the new codes, Humana is undecided, and Aetna and Cigna did not respond.76,77 Secondly, while the E/M code changes enacted through the CY 2019 Physician Fee Schedule likely had an immediate impact in alleviating redundant documentation, the more significant changes won’t take effect until January 1, 2021. Thus, both the success and impact of the major E/M code changes will be largely contingent on its implementation by providers, coders, and payers.78 This underscores the importance of educating stakeholders and aligning informatics resources to support effective adoption.78
Usability may improve, but largely unaddressed
Product usability, as assessed by the system usability scale (SUS), remained stagnant between 2014 - 2015 in a study of 70 EHR vendors.79 The delayed implementation of the EHR reporting program, per section 4002 of Cures, and confirmed by the recently finalized ONC rules, is an unfortunate loss for advancing EHR usability and improving clinician job satisfaction. Though, while the EHR reporting program would have enabled more transparency in the existing EHR marketplace and established more formal usability evaluations from vendors, it is questionable whether the reporting criteria instituted would have actually helped alleviate usability shortcomings. As discussed in the literature review, issues pertaining to the design and user experience needs to be addressed at the local level as variations will most certainly occur, even if institutions are using the same EHR.33,34 The challenge will be how best to extract that level of detail without duplicating existing usability metrics80 and without further overloading providers with reporting requirements.81 Despite these drawbacks, some momentum was gained in the final ONC rule that fulfilled Section 4002 of Cures by prohibiting EHR vendors from requiring authorization from healthcare organizations to share screenshots of their products. Although variations due to site-specific configurations likely represent more of the current usability challenges, the ability for end-users to share EHR product information will enable more opportunities to conduct usability and safety research.82
Potential in reducing burden through interoperability
Although unlikely to be immediately impactful in the short-term, the interoperability provisions outlined in Cures have arguably the most potential in addressing burnout attributable to EHRs. Underpinning this argument is the required deployment of APIs, specifically HL7’s Fast Healthcare Interoperability Resources (FHIR) version 4.0.1.83 across a broad set of use cases. While initiatives such as the Patient Access API, Provider Directory API, and the API Certification Criterion for health IT vendors do not directly address the burnout concern, they create a path towards exchange of information, without special effort from the user, that can potentially mitigate burdensome reporting requirements across all three conceptual levels outlined by NAM. Adoption of HL7 FHIR as the foundational standard across stakeholders will enable a level of data liquidity that is unprecedented.84 Moreover, as CMS and ONC continue to consolidate redundant measures across various quality incentive programs, recognition of common data elements by stakeholder consensus can be incorporated into USCDI to further facilitate a reduction in administrative burden.
Though, it is doubtful that these benefits will be realized by frontline providers in the interim as it will take time for providers, payers, and health IT vendors to implement them. Timelines are as short as six months for health information exchanges (HIE) and between twelve to twenty-four months for EHR vendors.85 Immaturity of TEFCA and removal of the proposed requirement for payers by CMS will further extend the agenda for nationwide interoperability. Perhaps more importantly, the advent of the COVID-19 pandemic threatens the original deadlines established by HHS and an extension in adopting the final rules are being considered.86,87
Informatics Training: A Missed Opportunity
To assist the nation in implementing EHRs, HITECH provided $120 million in funding towards training health informatics professionals.88 Unfortunately, it would appear as though the existing informatics workforce fails to meet the expectations and demands of our current electronic environment.88,89 By the same token, one may question whether we are ready to effectively tackle documentation burden, usability, and interoperability given the inadequacy of our existing workforce. The complete omission of this issue within the ONC report is also quite concerning. Albeit, creating and designing informatics curricula is not a simple task and developing competent healthcare informaticians is even more difficult. While there are many challenges that can be discussed, three are worthy to mention. The first of which is defining the core competencies required of health informatics professionals.89 As evidenced by multiple groups attempting to tackle this issue like the Technology Informatics Guiding Education Reform (TIGER), the ONC, and the American Medical Informatics Association (AMIA) to name a few, this issue still persists.89 Secondly, the pace at which technology advances adds to this complexity. Lastly, one of the key challenges is the heterogeneity of the trainees’ knowledge and skills.88 While information technology professionals may possess technical skills, they lack clinical competencies. Similarly, while clinicians possess medical knowledge, they lack the technical skills. Even if different tracks are created to better align with a trainees’ background, the current vendor-dominated landscape makes it difficult to allow practical training opportunities in which the vendor’s software could be used for practice and skills development.88 While there have been monumental and directed efforts towards reforming reimbursement policy and vendor solutions, there have been an extremely dismal amount of attention towards increasing the knowledge, skills, and education of the individuals that build, maintain, and optimize these information systems. This appears to be a missed opportunity and one that will hopefully be incorporated and addressed in future policy decisions.
VII. Conclusion
Enactment of the Cures Act is a landmark piece of legislation that can address all three levels of NAM’s clinician burnout model: external environment, health care organization, and frontline care delivery.9 However, the effectiveness of its key provisions will be profoundly reliant on crucial factors that will dictate the magnitude of its success. While there is still ambiguity in how the final CMS and ONC rules will impact burnout, especially amidst the ongoing COVID-19 pandemic, the initiatives spawned from the Cures Act most certainly have had an indirect effect in reducing burden attributable to HIT and EHRs.
References
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