Mission creep is the expansion of a project or mission beyond its original goals, often after initial successes. Mission creep is usually considered undesirable due to the dangerous path of each success breeding more ambitious attempts, only stopping when a final, often catastrophic, failure occurs.
Health Information Technology (HIT or health IT) is one of the few areas where there is bipartisan agreement on investment in American society. In this article, we ask if the expanding role of Meaningful Use (MU) regulations is taking current Obama administration health IT efforts beyond their foundation of agreement into the soft sands of partisan politics.
The American healthcare system has embarked on a process to encourage and accelerate adoption of electronic health records (EHRs) through a program of incentive payments to providers. This new initiative was authorized in law (the Health Information Technology for Economic and Clinical Health (HITECH) Act, contained in the American Recovery and Reinvestment Act, January, 2009).
The HITECH Act uses a regulatory approach to encourage adoption of EHRs by hospitals and by physicians and other providers in outpatient settings. Under Section 4101 of the Act (see page 353), to be eligible for incentive payments that can total as much as $44,000 for individual providers and incentives in the low-millions range to hospitals, and to avoid penalties beginning in 2015, hospitals and other providers must use certified EHR technology “in a meaningful manner,” including e-prescribing, the electronic exchange of information, and the submission of information on measures of clinical quality and other metrics as determined by the Secretary. While providing unprecedented funding for health IT, in the past three years the sparse language of the original bill has morphed into a complex set of evolving Federal regulations that seek to ensure that providers use government-approved EHRs in government-specified ways.
Mission Creep Toward Guidelines For Care
To implement HITECH, the Office of the National Coordinator for Health Information Technology (ONC) developed policies to define and promote MU of EHRs in three stages, with increasing levels of performance with all providers required to achieve yet-to-be-defined goals for Stage 3 by 2015. The framework for MU has grown to be much larger than the language of the statute. The adoption of EHRs is not only supposed to result in clinicians using HIT to care for individual patients, but also in changes in the content of any clinical encounter that could include: enhanced disease prevention activities; improving the “patient-centeredness” of care (through measures such as printing a summary of the visit for patients); and contributing data related to disease surveillance for public health purposes. In an interview, Federal Health IT Coordinator Dr. Farzad Mostashari suggested the scope of MU is all health reform, stating:
Meaningful use… is the roadmap for what they [providers] have to do to succeed with health reform and the delivery of more-coordinated higher-quality care…
Risks of expansion of MU come as regulations move from the Congressional intent of ensuring “use in a meaningful manner” to increasingly reflecting a requirement to use health IT in an “appropriate manner,” as specified by the ONC. The difference between “meaningful” and “appropriate” is critical. “Meaningful” would allow a much broader range of activities, tailored to the needs of the user of health IT. Use in an “appropriate” manner would move Federal MU regulations closer to specifying guidelines for care. Therefore, we must look at evolving MU regulations to examine the degree to which they have become de facto guidelines.
MU regulations have become highly complex. With the publication of the Notice of Proposed Rule Making for Stage 2 MU, the total body of regulations for MU is now over 1100 pages. While Stage 2 proposals have eliminated some of the more onerous requirements on specialists in the initial document, the problem of MU regulations coming progressively closer to government-mandated guidelines for practice has worsened. For eligible providers, Stage 2 increases the number and complexity of core measures to 17 and increases the thresholds to levels of use and reduces the number and flexibility of menu options. Similar changes are proposed for hospitals.
The evolution of MU regulations is clear: the regulations are not flexible checklists that allow providers and hospitals to demonstrate they that are using their IT systems in ways meaningful to them. Rather, the regulations are in fact guidelines on how providers and hospitals should appropriately use their IT systems.
Mission Creep Beyond Evidence-Based Practice
Compounding the problem, proposed regulations in Stage 2 go beyond the evidence for impacts of health IT adoption. For example, there is no study documenting that electronic transmission of a discharge summary or a consult request produces superior outcomes to transmission by fax (although this seems like a good idea). The process of creation of government regulations that have the force of law should at least conform to the present state of knowledge about how to develop evidence-based guidelines.
Unfortunately, most MU regulations cannot be easily mapped to graded evidence and there is minimal discussion of the evidence for or against each rule in the Notice of Proposed Rulemaking. Assessment of evidence for proposed rules is complicated by the paucity of randomized trial studies of the impacts of HIT enabled care. Hussain, in an article in the Annals of Internal Medicine, called for making MU more of a “bottom up” process focused on activities known to be useful and limited to proven clinical contexts. In an editorial response, that marked a considerable departure from the usual evidence-based medicine focus of this journal, the respondent claimed that rapid adoption of best practices for use of HIT was critical to the health of our patients.
In our opinion, best practices for care will be evidence-based, and government policies regulating the practice of medicine should not outstrip the bounds of scientific evidence. Therefore, we ask, “Why isn’t MU driven by evidence produced by pilots and demonstration projects similar to the work of the Center for Medicare and Medicaid Innovation?” and “Do we really need to move so quickly as to forgo a well-structured, evidence-based approach?”
Mission Creep Into Risks To Patients
The rapid pace of MU implementation, and the reductions in flexibility for providers proposed for Stage 2, might also pose risks to patients. As health IT departments and vendors struggle to implement MU requirements, new software systems and new workflows are created within existing systems. There is a growing literature suggesting that implementation of inadequately tested systems can have unintended negative consequences on care.
This is not so much an issue of ergonomics as of workflow and culture. For example, Ash and colleagues found that Computerized Patient Order Entry systems (required under Phase 2 MU) caused eight different (unanticipated) types of adverse consequences on care. Testing of computer software interfaces for tendencies to cause errors, and certification based on this criterion, has been advocated by ONC; however, errors can arise through complex social-cultural interactions, and “interface guideline” types of approaches may not be sufficient. Forced adoption of a business process in a computer system, to earn an incentive or to avoid a penalty, is hazardous because the adopter may fail to consider the social-cultural consequences.
For example, Strom and colleagues found unacceptable delays in clinical care with implementation of a specific decision support rule regarding a drug-drug interaction. Providers must be able to do things that make clinical sense in automation of clinical care processes. As currently structured, the Federal rule-making process is not sufficiently flexible to allow providers to modify implementation of “core” MU regulations. This could pose a risk to patients’ health. If clinicians disagree with the assessment of risk to benefit from implementing a particular aspect of the MU requirements in their computer system, they should have time to evaluate the tradeoffs. There should also be a mechanism to appeal specific requirements, if in the judgment of a clinician they might be considered as posing a risk to patient care.
Mission Creep Into Unknown Costs
More than a year after publication of stage 1 MU regulations, the Federal government does not know the costs of compliance with MU regulations. The Stage 2 NPRM (page 13701) states:
Information on the costs and benefits of adopting systems specifically meeting the requirements for the EHR Incentive Programs has not yet been collected and information on costs and benefits overall is limited.
These costs not only include the attestation process but also the costs of purchase of software upgrades and the labor required to implement the business processes required by MU. Each stage of MU requires a full development cycle from implementers. Not only do they need to purchase upgrades but they also have to assess how workflows should change to meet requirements, train users in new methods, and accept productivity losses during roll out. While there is some data on initial costs for compliance with stage 1, there is no way to compare the benefits of making investments in Stage 2 MU regulations with other opportunities to invest in health.
At the minimum MU policies should integrate with other government efforts to assess the comparative effectiveness of medical interventions and be judged by the same standards. Are MU regulations a cost-effective intervention?
Mission Creep Into Expanded Bureaucracy
One might anticipate that a federal government health IT adoption program, especially a program designed to provide a quick economic stimulus, would be created, mature, and eventually end with the end of the stimulus. However, the HITECH statute couples MU incentive payments during the initial phase of the program with penalties for failure to comply starting in 2015. Penalties begin at a 1 percent reduction of Medicare payments and can escalate to as much as 5 percent–a substantial amount. For many hospitals, a 1 percent penalty, for one year of non-compliance, will be greater than the total incentive payments they would have received under HITECH. Further, as a staged activity, with new rules issued on an ongoing basis, hospitals and providers have to meet progressively higher standards and to recertify compliance on a specified timetable.
This approach makes MU far more than an HIT adoption program. It is an ongoing regulatory program that significantly and permanently expands the federal role in healthcare and the federal bureaucracy. Accordingly, the ONC has created a Division (minimum size of 28 full time equivalents according to HHS regulations) to manage the growth of regulation on an ongoing basis, with an expanding staff of permanent federal employees. In short, what started off as a health IT adoption program is morphing into a permanent tool for regulation of medicine by federal rule-making. This takes MU beyond bipartisan areas of agreement on the role of government and possibly beyond the Obama administration’s own positions in other areas on the role of government regulation.
We question the wisdom of expanding the administration’s EHR adoption program into an ever-evolving program of regulations and rule-making. If requirements for the basic EHR functions that have been shown to improve quality and reduce costs were included in certification criteria, we would ask, “Is it necessary for the government to mandate the use of these features and to require physicians to document that they are using specific features of an EHR? Is all other use meaningless?” Incentive programs, such as those put forward by the Center for Medicare and Medicaid Innovation, should drive ongoing evolution and integration of health care and health IT, not regulations.
Wrapped in the sugar-coating of incentives for Stage 1, MU becomes a bitter pill starting in 2014 when compliance with Stage 2 requirements will bring only small marginal payments. Starting in 2015, MU is a penalty-based regulatory program. As structured in the stage 2 NRPM, MU regulations are moving further from use in a “meaningful way” to being closer to requirements to use health IT in a government- specified “appropriate way.” Moreover, as regulations move beyond evidence-based medicine and common sense safety practices to “good ideas” with unknown costs and benefits, mission creep threatens the administration’s health IT adoption program and the substantial progress already made.