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April 25, 2011

Sorting Out Meaningful Use
By Elizabeth S. Roop
For The Record
Vol. 23 No. 8 P. 14

Many hospitals remain puzzled and challenged by the requirements for meaningful use quality reporting.

To demonstrate the meaningful use of HIT and qualify for incentive funds under the HITECH Act, eligible hospitals are required to utilize certified EHR technology to collect and report clinical quality measures for the Centers for Medicare & Medicaid Services (CMS). Hospitals must report on 15 quality measures, a requirement that, on the surface, may not appear to be onerous.

However, the reality is that even technically advanced provider organizations and their vendors are finding that compliance presents several challenges that could delay qualification. Among the most significant is ensuring that the multiple systems in place throughout a facility can aggregate the comprehensive data necessary to comply with reporting requirements. Another concern is the ability to address expanded technology and workflow enhancements.

The issue “is about what is the appropriate strategy to make sure we are collecting the data and getting them to the certified quality reporting portion of the EHR, ideally in a way that doesn’t require manual extraction or entry,” says Mark Segal, PhD, vice president of government and industry affairs at GE Healthcare IT. “It’s about building a collection of workflow strategies that take into consideration the system … in place to support the measure.”

Core measures that must be reported to the CMS focus on ischemic or hemorrhagic stroke, venous thromboembolism (VTE), anticoagulation overlap therapy, platelet monitoring, and emergency department (ED) throughput. All quality measures must be reported for all patients, with zeros reported if there are no applicable patients.

Hospitals are also required to attest to the use of certified EHR technology to capture the data and calculate and report the results, and to the accuracy and completeness of the numerators, denominators, and exclusions for each.

Certified Systems Not Enough
The challenge is not with the measures themselves or the act of reporting them since most hospitals have been doing that for years. The issue for many will be ensuring that systems can be linked to enable comprehensive real-time collection and that the processes are in place for proper transmission to the CMS.

“Keep in mind that we’ve been recording core measures and quality for a long period of time,” says Charles E. Christian, FCHIME, vice chair of the College of Healthcare Information Management Executive’s policy steering committee and chief information officer at Good Samaritan Hospital in Vincennes, Ind. “The issue is that the quality measures at Good Samaritan have always been collected retrospectively vs. automatically generated. [The challenge is] making certain that we are gathering the data points needed and that we have the systems in place to hit the magic button, produce the data, and transmit it. We have to make sure we have the standards down pat that we will use to transmit that data.”

Exacerbating the problem is that the data elements necessary for compliant reporting are often collected across multiple systems, not all of which are subject to or eligible for HITECH certification. In other cases, hospitals are using add-on modules that may not be certified to ensure they have the full functionality they need outside of meaningful use.

As such, providers must find ways to push data from these often-disparate systems into the certified EHR from which reports must be transmitted.

“The ability to do that is paramount,” says Christian. “You can have a lot of systems that are gathering data, so it’s a matter of what is classified as certified technology. It could be certified modules. ONC [Office of the National Coordinator for Health Information Technology] says if all modules are certified, then by aggregation they are all certified. The issue is if a vendor is only certified as a complete EHR and you’re using pieces of that or pieces from two different vendors, you can’t qualify. That’s where the self or site certification comes into play. We’ve scratched our heads about that a lot.”

The system challenges confronting Good Samaritan and other hospitals were dubbed the “hidden functional requirements” by CSC in its August 2010 report “Hospital Quality Reporting: The Hidden Requirements of Meaningful Use.” CSC deconstructed the 15 quality measures to examine the set of unique data elements required to capture the information necessary to comply with stage 1. Each data element was assigned to a source within the EHR, which incorporated core hospital applications such as registration/admission/discharge/transfer and laboratory system; specific functional requirements such as computerized physician order entry (CPOE), problem, and allergy lists; and typical inpatient EHR modules.

Researchers found deceptive the appearance that quality measures would be a simple percentage calculation. Rather, each measure actually includes multiple pieces of information in the numerator and denominator to determine which patients to include and exclude and, if the recommended care was provided or desired, the outcomes achieved.

For example, deconstruction of the VTE prophylaxis measure found that inclusion criteria required three data elements, exclusion required 15, and outcomes required eight. Further, the information was provided by six different sources and needed to address ED and postadmission care or care both in the acute care units and the surgical suites.

The report ultimately concluded that simply meeting stage 1 functional requirements for data capture will cover only 35% of the unique data elements needed for the 15 required quality measures. The remaining data elements will come from CPOE for nonmedication orders (8%), physician documentation (29%), electronic medication administration (13%), nursing documentation (6%), discharge instructions (8%), medication list (1%), and other documentation (1%).

“The most problematic of these ‘hidden’ requirements is undoubtedly the need for physician documentation and medication administration in addition to the other software upgrades and application rollouts already in the queue for stage 1 meaningful use,” the researchers wrote, noting that a recent survey found that just 12% of U.S. hospitals have implemented electronic physician notes. “Because data elements for quality reporting must be structured (coded), even many of these early adopters are likely to require some optimization of current practices in order to capture necessary information.”

The implication, they concluded, is that “even after hospitals have met the explicit stage 1 meaningful use requirements, there will be many gaps between what data elements are available electronically and what is needed to meet the requirement for quality reporting from the EHR.”

Unanticipated Burdens
The unexpected addition of the ED to the scope of data-capture requirements in the final rules is an excellent example of another challenge confronting hospitals: the need to add or enhance systems and/or functionality beyond the basics necessary to comply with meaningful use requirements.

The ED requirement in particular is problematic because, according to figures from HIMSS Analytics, 36% of hospitals lack any ED information system. Of the 64% that do have ED systems, it is unclear whether all the necessary clinical information is captured and can be integrated with inpatient care information for reporting purposes.

As a result, the requirement will force some eligible hospitals to upgrade or implement ED systems. It will also require them to reconfigure workflows and work with vendors to identify data points that, upon entry, will trigger the capture and reporting of appropriate data.

The ED requirement was “put back in because CMS is using point of service to create that cohort of reportable patients. But do we include everyone who comes into the ED or just those who are admitted as inpatients?” Christian asks. “With those choices, we now have decision points that we have to come up with and that the vendors will have to code so they will know exactly when to give us the option and choice of who is to be included.”

Christian also points to the gaps in technology and processes that remain even after certified systems are deployed, gaps that, left unfilled, will impact a hospital’s ability to comply with reporting requirements. Specifically, while many facilities will focus first on CPOE deployment due to the attestation requirements, electronic order entry on its own is insufficient.

“You have to put in the reporting piece so you can actually extract data,” says Christian. “Even more important is going to be the process change necessary to identify those elements we need to include as part of the documentation process so we can extract and report. The worst thing is doing without documenting because if you fail on one point, you don’t qualify.”

More Clarification, Time
Although the CMS has issued some clarifications to the reporting requirements, hospitals and vendors alike are calling for additional refinements to address issues that arise as compliance efforts get under way. For example, the patient demographic data requirement could be interpreted as considering data incomplete if a cause of death is not indicated. There are also data that patients can and often do refuse to provide that are required for compliance.

“If we were reading it literally, hospitals could only report on those patients who died in the hospital,” says Christian. “You have to have a mechanism to identify the exceptions both from having to gather the data and from the population upon which we have to report.”

Equally important as refining the requirements is providing hospitals and vendors with sufficient time to incorporate the changes they trigger. This is particularly true when clarifications issued after initial regulations or measure specifications require additional changes to technology and/or workflow.

According to Segal, vendors and their customers have been focused on ensuring that their systems enable compliance by aligning data collected by EHRs with the specific elements or variables of individual quality measures included in the final rules. When clarifications issued by the CMS impact that alignment, vendors must reconfigure systems and hospitals must redo workflow planning. Further, midstream changes with no accommodations in the compliance time frame cut into the ability to conduct comprehensive validity testing before systems or upgrades are rolled out for meaningful use.

“For exactly this reason, one of the things we’ve suggested as part of our comments on the meaningful use ‘straw man’ was to not add new quality standards for stage 2 because we found that quality reporting is almost a shadow or parallel form of meaningful use,” says Segal. “Implementing specific measures requires data to be collected and workflows to be adjusted. It’s a great benefit of EMRs but to make sure the system is set up to report on quality measures is a big undertaking. Our approach is to ask CMS and ONC to focus on perfecting the quality reporting that was established in stage 1 rather than adding the burden of a lot of new measures, particularly given the tight regulatory timeframe for stage 2.”

— Elizabeth S. Roop is a Tampa, Fla.-based freelance writer specializing in healthcare and HIT.


Required Quality Measures
Eligible professionals must report on the following core measures:

• Hypertension: Blood Pressure Measurement

• Preventive Care and Screening Measure Pair

a. Tobacco Use Assessment

b. Tobacco Cessation Intervention

• Adult Weight Screening and Follow-Up

If the denominator for any core measure is zero, eligible professionals must instead report on some/all of the following alternate core measures:

• Weight Assessment and Counseling for Children and Adolescents

• Preventive Care and Screening: Influenza Immunization for Patients > 50 Years Old

• Childhood Immunization Status

Eligible hospitals must report on the following 15 core measures:

• Emergency Department [ED] Throughput — admitted patients Median time from ED arrival to ED departure for admitted patients

• Emergency Department Throughput — admitted patients Admission decision time to ED departure time for admitted patients

• Ischemic stroke — Discharge on antithrombotics

• Ischemic stroke — Anticoagulation for A-fib/flutter

• Ischemic stroke — Thrombolytic therapy for patients arriving within 2 hours of symptom onset

• Ischemic or hemorrhagic stroke — Antithrombotic therapy by day 2

• Ischemic stroke — Discharge on statins

• Ischemic or hemorrhagic stroke — Stroke education

• Ischemic or hemorrhagic stroke — Rehabilitation assessment

• VTE [venous thromboembolism] prophylaxis within 24 hours of arrival

• Intensive Care Unit VTE prophylaxis

• Anticoagulation overlap therapy

• Platelet monitoring on unfractionated heparin

• VTE discharge instructions

• Incidence of potentially preventable VTE



EPs Face Own Set Of Unique Challenges
For eligible professionals (EPs), meaningful use rules require reporting on three core and three non-core measures. If the denominator for any of the three core measures, composed of hypertension, preventive care, and adult weight screening and monitoring, is zero, EPs must also report on an alternate core measure. Conversely, a zero denominator for a non-core measure is acceptable provided the EP does not have an applicable population.

Meeting these requirements presents several unique challenges for physician groups. In particular, “Eligible professionals may need new workflows for consistent capture of data defined in a particular way. The actual calculation of the measures is straightforward, but it’s making sure you have the right data associated with the right elements of the measures [that is challenging]. If it’s a practice that has been doing quality measures for a while, it will be ahead of the game,” says Mark Segal, PhD, vice president of government and industry affairs for GE Healthcare IT.

Another make-or-break issue for physician practices is gaining physician buy-in. It’s a challenge faced even by those already operating in a primarily electronic environment or that have been participating in quality reporting programs like the Physician Quality Reporting Initiative, according to Sandra Regenye, billing and operations manager for Horizon Eye Care, a 10-physician ophthalmology practice in New Jersey that has been utilizing the NextGen Ambulatory EHR since 2001.

She notes that Horizon will soon file for its incentive funds, something that is possible so early primarily because it secured top-down support for its meaningful use strategy.

“You really do have to have that buy-in because you are going to have a dramatic impact on data gathering,” Regenye says. “There is a lot of up-front work on the data gathering, including hardware, software, and physician workflow. You can have all that but if the physician doesn’t buy in, you’re not going to [qualify].”

Regenye recommends that practices designate a team to take responsibility for assessing what will be needed to meet reporting requirements, including gaining any clarification necessary for compliance. In Horizon’s case, the team was able to tap into NextGen Healthcare’s meaningful use support group to answer many of its questions. They also participated in webinars and Centers for Medicare & Medicaid Services events designed to educate providers on achieving meaningful use.

This information was used to educate practice executives and physicians on what was required and the benefits of doing so as well as for designing and implementing its strategy for complying with reporting requirements.

“We took it in steps. We registered, implemented the certified EMR, and identified the data and where it resides. Next, we’ll debug the new application and then start reporting,” says Regenye. “There is no point in waiting, but one advantage we have is that it’s not written that we have to report on all physicians at once. We’ll test on one or two.”

One challenge Horizon doesn’t face, compared with others, is managing reporting when data are collected in more than one system or when data aren’t collected at all regardless of how many systems are in use.

“This would be true, for instance, if the physician notes were not captured in coded form and if there was no coded electronic immunization record, neither of which is required for stage 1 of meaningful use,” says Erica Drazen, managing partner of emerging practices for CSC. “In fact, meeting all the stage 1 requirements for meaningful use only will capture 50% of the data elements required by all the quality measures.”

She recommends practices decide up front which quality measure they plan to report, “deconstruct those measures to identify all the data elements required, and then assess what is missing and to fill the gaps.”