GAO report says CMS' rule on quality reporting system may be too vague

A new CMS rule on clinical data registries aimed at boosting participation in its Physician Quality Reporting System could be too vague to provide meaningful data but, according to a new U.S. Government Accountability Office report (PDF), one solution could be to require electronic health-record vendors to develop products that make it easier to extract the data that registries use.

Some viewed the flexible approach the CMS took in developing its rule on the clinical data registry program as increasing the opportunities for physicians—specialists in particular—to participate in the PQRS. But the GAO said otherwise.

The new rule was in response to congressional mandates included in the last-minute deal reached to avert the fiscal cliff last year. That legislation, the American Tax Relief Act of 2012 also ordered the GAO to study how registries could improve healthcare quality and efficiency.

The GAO reviewed studies assessing the impact of registries, interviewed officials from organizations operating existing registries, convened an expert panel to discuss registry requirements and oversight, and reviewed documents and interviewed officials from the CMS and HHS' Office of the National Coordinator for Health Information Technology.

The agency concluded that the flexible approach may “provide minimal impetus to (clinical data registries) to take full advantage of their specific opportunities to promote the quality and efficiency of care.” Also, the GAO said, the CMS did not provide details on how it would interpret or enforce the program's requirements.

By collecting large amounts of standardized clinical data over long periods of time, clinical data registries can track and interpret healthcare trends and assess physician performance. For example, the Society of Thoracic Surgeons' national database, which has been collecting data since 1989, has shown that increased use of guideline-recommended treatments has led to lower rates for mortality and postoperative stroke.

However, the GAO said, exclusive use of clinical data has correlated to a lack of studies that examine efficiency and costs. To address that problem, according to the report, privacy concerns must be addressed so that clinical registry data can be linked to payers' administrative data.

One exception cited is a Blue Cross and Blue Shield of Michigan report showing how the use of a regional surgical registry led to 2,500 fewer patients suffering surgical complications each year, which translated into an annual savings of $20 million.

Standardizing data sets collected by EHRs could help. The GAO noted that different EHRs may not differentiate between occasional and heavy smokers. Sometimes the word “pneumonia” may not appear in an EHR, so manual analysis of x-rays, stethoscope breath sounds and other data is required for inputting into a clinical data registry.

“If CDRs could receive and aggregate electronically extracted data from EHR systems, the need for manual abstraction by trained professional staff could be reduced or eliminated,” the GAO wrote. “Reducing the burden of manual data abstraction could have a number of long-term benefits, including reducing costs for physicians to participate in the CDR, reducing the amount of time a practice spends on CDR data collection activities, and increasing overall participation of physicians in CDRs.”

Through its meaningful-use program, the GAO recommends that HHS “influence the extent to which EHR systems are designed and implemented to collect data needed by CDRs to assess physician performance.”

Unless clinical data registries can overcome variations in content, storage and other specifications, they will not be able to take full advantage of an EHR's ability to collect and transmit data, the GAO concluded.

“Changes to EHR capabilities that would enable them to collect such data within existing standards are clearly feasible, but are not high priorities for providers and IT vendors because they are not included in the current set of meaningful use requirements for the EHR incentive program,” the GAO wrote. “As HHS determines what the next cycle of meaningful-use requirements should comprise, identifying data elements for measures commonly needed by CDRs and including them in meaningful-use requirements could substantially assist qualified CDRs in adapting health IT to make data collection less costly and more timely.”

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