GAO turns critical eye to MU program

Cites lack of clear goals, strategy
By Bernie Monegain
01:00 AM
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The GAO recently called three government agencies – HHS, CMS and ONC – to task over the Meaningful Use EHR Incentive Program, saying it lacked sorely needed strategy. In a 75-page March report, the government watchdog urged the agencies to establish a plan in order to achieve program goals, especially those aimed at improving care.

Specifically, GAO called for developing a method to better ensure the reliability of clinical quality measures, or CQMs, and collected using EHRs. GAO also called for the agencies to develop and use outcome oriented performance measures to monitor progress toward goals.

Controversy has swirled around clinical quality reporting, with many providers struggling to do as required under meaningful use Stage 2.

As Pamela McNutt, senior vice president and CIO of Methodist Health System in Dallas, told Healthcare IT News in a recent interview: “This notion that we're going to extract every piece of data that we need to do clinical quality reporting solely from the electronic medical record is folly."

CMS is calling not only for electronic submission of quality metrics, but also for all the information to be entered and reported via the EHR, she explained. She and other CIOs contend that EHRs are not there yet.

John Halamka, MD, CIO at Beth Israel Deaconess Medical Center in Boston, elaborated on the topic in a recent blog.

“The clinical quality measures are certainly one of the problem spots, using standards that are not yet mature, and requiring computing of numerators and denominators that are not based on data collected as part of the clinical care workflow," wrote Halamka, who serves as vice chair of the federal Health IT Standards Committee.

GAO found "the lack of a comprehensive strategy limits HHS's ability to ensure the department can reliably use the clinical quality measures collected in certified EHRs for quality measurement activities."

"Reliability issues persist," GAO added. "Although CMS and HHS's Office of the National Coordinator for Health Information Technology have made efforts to address concerns. For example, different providers may report CQMs based on and tested to different requirements depending on whether their EHRs have incorporated technical updates. Without a comprehensive strategy, efforts to address reliability issues (in accordance with the internal control standard requiring relevant and reliable information) and improve quality and efficiency may be limited."

Strategy, strategy, strategy

GAO was emphatic in calling for a strategic approach.

“Although CMS officials told us that they were beginning to develop an approach to validate CQM data generated from EHRs, HHS has not yet developed a comprehensive strategy to address concerns with the reliability of CQMs collected using certified EHRs.”

GAO suggested there are several critical practices to help agencies implement effective government programs.

“A comprehensive strategy would establish objectives, steps to achieve results, priorities, and milestones and identify the steps necessary to achieve desired results. Addressing the concerns is important to ensure that the CQM data can be reliably used for CMS’s quality measurement activities as well as providers’ quality improvement activities.”

The GAO team made three recommendations. The first was for HHS to direct CMS and ONC to develop a “comprehensive strategy for ensuring that CQM data collected and reported using a certified EHR are reliable.”

In its response, HHS agreed that reliability and validity of clinical quality data is “of paramount importance,” and noted that as part of the 2014 certification of EHRs, the systems are tested with an HHS-developed tool called Cypress, in order to ensure reliability of clinical quality data.

GAO’s second and third recommendations called on HHS to direct CMS and ONC to develop performance measures to assess outcomes of the EHR programs and their effect on care quality, efficiency and patient safety. GAO recommended the agencies use the information to make adjustments to the programs as warranted.

HHS agreed, and noted that ONC oversees five major programs established by the HITECH Act. The interim results of evaluations of programs are available on the ONC website, HHS said.

As required by the HITECH Act that established the programs, the GAO did the following:

  • Assessed the extent of current and expected participation in the EHR programs;
  • examined information reported by providers and others to measure meaningful use in the EHR technology are reliable programs;
  • evaluated HHS efforts to ensure EHR data can be reliably used to measure quality of care;
  • evaluated HHS efforts to assess the effect of the EHR programs on program goals related to adoption and meaningful use of EHRs and improved outcomes.

GAO analyzed data from CMS and other sources; reviewed applicable statutes, regulations and guidance, and interviewed officials from HHS and stakeholder groups.

GAO found that programs increased substantially from their first year in 2011 to 2012. For hospitals, participation increased from 45 percent of those eligible for 2011 to 64 percent of those eligible for 2012. For physicians, participation increased from 21 percent of those eligible for 2011 to 48 percent of those eligible for 2012.

The report concludes: "Although HHS expects that the use of EHRs can help achieve improved outcomes and support other efforts that are also intended to improve care, that result is not yet assured. CMS and ONC may lack critical information necessary to establish program priorities and subsequently make program adjustments based on progress toward outcomes."