Since the passage of the American Recovery and Reinvestment Act (ARRA or the Act) in February 2009, the U.S. health care community has anxiously awaited guidance regarding the definition of “meaningful use” of electronic health records (EHRs) that will be key to the receipt of financial incentives established under the Act for providers who have adopted EHR technology.

An initial glimpse of what the term will mean was afforded by the Health IT (HIT) Policy Committee this week, although the process to finalize the definition will be a long, arduous road. Providers and vendors must stay abreast of developments and become proactive to ensure an implementable definition surfaces at the earliest possible date. Otherwise, providers will not have time to prepare adequately for early-round incentives and may never be able to catch up.

On June 16, 2009, the HIT Policy Committee (a federal advisory committee to the Office of the National Coordinator for HIT (ONC) created under the Act) released its preliminary draft of recommendations to the ONC for what constitutes meaningful use. A second iteration is due on July 16, 2009, the day the committee reconvenes.

Meanwhile, the U.S. Department of Health & Human Services (HHS) has opened a 10-day comment period, with responses limited to 2,000 words, due by June 26, 2009, seeking input regarding the draft description of meaningful use.

These efforts are merely steps along the way to a final definition of meaningful use, which will be embodied in regulations expected to be proposed by the Centers for Medicare and Medicaid (CMS) before the end of 2009 and made final early in 2010.

However, health care providers and EHR developers and vendors are well advised to stay abreast of these developments because by the time meaningful use is finally dictated, it may well be too late for them to be ready to take advantage of the first round of incentives. As noted below, they could fall victim to having to play catch-up throughout the incentives period.

Moreover, providers and vendors should take every opportunity to influence the development of a practical, achievable definition through the comment process or risk a repeat of the disappointing EHR donation regulations that have proved impractical and unhelpful for many providers attempting to deploy EHRs on a broad basis.

What’s at stake?

As is well known, the ARRA provides financial incentives under Medicare and Medicaid to health care providers who can demonstrate meaningful use of certified EHR. (For more information about reimbursement incentives and disincentives, see our “Carrots and Sticks” advisory.) The Act itself provides only a basic framework for meaningful use, and it defers to the Secretary of Health and Human Services to establish a definition or standards for meaningful use under the Act.

HIT Policy Committee recommendations

The HIT Policy Committee’s first draft of meaningful use recommendations is driven by its vision of enabling “significant and measurable improvement in population health through a transformed health care delivery system.” (The committee’s introductory commentary is available here.)

The committee’s draft identifies five major health outcome priorities that provide a conceptual and aspirational basis for transforming our nation’s health care delivery system. These health system goals are (1) improving quality, safety, and efficiency and reducing health disparities; (2) engaging patients and families; (3) improving care coordination; (4) improving population and public health; and (5) ensuring adequate privacy and security protection for personal health information.

The committee has developed a matrix of specific care goals for providers that advance its systemic health policy priorities through measurable clinical conditions and use of EHR technology. The specific objectives and measures for providers change over time, beginning in 2011, and increase in scope and complexity in 2013 and 2015. The evolving parameters are intended to improve the quality of health care, and the health care delivery system as a whole, as demonstrated by the achievement of measurable outcomes.

The progression begins in 2011 with the initial goal of electronically capturing in coded format and reporting health information and using that information to track key clinical conditions. In 2013, the meaningful use objectives expand toward guidance and support of care processes and care coordination. Finally, in 2015, the objectives focus on achieving and improving performance and supporting care processes and on measuring key health system outcomes.

Measurements

Perhaps the most critical aspect of the committee’s recommendations are those with the most yet to be determined—the measurements that will determine whether a provider has achieved meaningful use.

To the extent that the 2011 “measurement” is actually a question of whether or not this information is being captured electronically and reported (without requiring providers to undertake chart review to assess the level of electronic data capture), the specific information identified by the committee may not be daunting.

However, for the long-term purposes of data analysis and quality assessment regarding health care delivery, the definitions put into place initially must continue in use over time. In 2013 and 2015, this same data may become the basis for measuring processes and outcomes in order for providers to receive financial incentives, so the details become increasingly important for providers.

Accordingly, additional clarity is required to establish common terminology, sources of information, measurement methodologies and the frequency of measurements. For example, one proposed quality measure in 2011 is the percentage of hypertensive patients with blood pressure under control.

This one proposed measurement contains multiple unknowns. An initial question is, What pool of patients is the basis for the percentage? Do you include patients that record on the high end of blood pressure parameters, or only patients with documented hypertension diagnoses? Do you report on all your patients who are hypertensive or only those whom you treat directly for hypertension? Further, what does “under control” mean, and who makes that determination? And how often is this data captured and reported? These details will have to be carefully delineated to provide useful guidance to providers.

The committee’s matrix sets forth certain meaningful use measures in 2013 and 2015 that are, as yet, articulated only at a conceptual level. In 2013, “additional quality reports” will be required, and in 2015, “clinical outcome measures, efficiency measures and safety measures” will be required—but each of these broadly described measures is still to be determined.

Although the committee may rightfully focus on the most immediate deadlines given the accelerated schedule advanced by the ARRA, the future standards for meaningful use currently are generic placeholders for the specific objectives that providers will have to work to meet. Additional questions will have to be addressed regarding the overall assessment of performance against these measurements. What target performance levels will be specified for each of the quality measures reported? What mix of performance across the various measures will be considered sufficient to demonstrate meaningful use?

A further conceptual issue that requires consideration as the meaningful use definition becomes outcomes-based is the impact of issues outside of providers’ control. While providers can prescribe courses of treatment, whether a patient follows through—taking prescribed medicine consistently, coming in for testing and/or treatment, improving diet and the like—is ultimately out of providers’ hands, and therefore providers should be not penalized for choices made by patients.

In the HIT Policy Committee meeting on June 16, the committee clarified that the progressive definition of meaningful use would not apply based on a provider’s year of adopting certified EHR technology, but that there would be a single definition effective for all providers at any one time, regardless of their status in implementing EHR technology or when they first accomplish meaningful use.

The practical effect, then, of the progression of the meaningful use requirement is to place even greater emphasis on being able to demonstrate meaningful use at the earliest possible time. The greatest promise of this progressive definition is to encourage continual forward movement for early-adopting providers.

However, because the requirements become increasingly more difficult to meet over time, providers that don't successfully implement them within the initial time frame will be continually playing catch-up as the requirements increase. And, while the dollar value of incentives goes down, this will likely have the unintended effect of shutting some providers out of the incentives process and causing financial penalties of reduced reimbursement payments in the out years.

What’s next?

We anticipate that these recommendations will form the basis of interim, proposed rulemaking and, after notice and opportunity for public comment, the final rules that are required under the Act to be established early in 2010. We recommend that providers and vendors take advantage of the current and future comment opportunities to bring practicality and reality to the requirements for achievement of meaningful use of certified EHR technology. For this first comment period, the deadline for submissions is June 26, 2009, and the length limit is 2,000 words.

Electronic responses to the draft description of meaningful use are preferred and should be addressed to:

MeaningfulUse@hhs.gov

Subject line: “Meaningful Use”

Written comments may also be submitted to:

Office of the National Coordinator for Health Information Technology

200 Independence Ave, SW

Suite 729D

Washington, D.C. 20201

Attention: HIT Policy Committee Meaningful Use Comments