At one time it was said the federal definition and criteria for the “meaningful use” of electronic health-record systems would be released by mid-December, but that milestone will be passed today at noon.
In fact, the federally chartered Health Information Technology Policy Committee took the time Tuesday to parse some recommendations from one of its work groups on what to do about standards for electronic laboratory orders. The policy committee then hustled up a vote to accept the eleventh-hour recommendations so they still could be considered by rulemakers before the first round of meaningful-use criteria are published. The CMS, which will administer the subsidy program, also will do the rule writing.
The American Recovery and Reinvestment Act of 2009 called for creation of the HIT Policy Committee to advise HHS' Office of the National Coordinator for Health Information Technology on a host of subjects. Committee members have spent a significant portion of their time since the group was launched in May dealing with meaningful-use recommendations.
The act, also known as the stimulus law, provides an estimated $34 billion in federal subsidies to hospitals and physicians for the purchase of EHR systems.
One catch in the Medicare portion of the subsidy program is that the law requires providers to first meaningfully use their EHRs before they get reimbursed for their purchases. The law only sketchily defines "meaningful use" as the use of certified EHRs for electronic prescribing, information exchange and the reporting of quality measures, the latter of which are to be selected by HHS.
The law requires HHS to publish rules for standards for certification of EHRs by Dec. 31.
Earlier this year, the HIT Policy Committee made several suggestions to the ONC on the meaning of "meaningful use."
It recommended three tiers of increasingly more stringent criteria lasting for periods of two years each. The years 2011, 2013 and 2015 were chosen as the starting and ratcheting up dates to coincide with break points in the subsidy payment regime. Physicians who qualify for EHR subsidies will receive their maximum initial payments of $18,000 under Medicare if they start meaningfully using their EHRs in 2011 or 2012.
The recommendations the HIT Policy Committee voted on Tuesday came from its information exchange work group and specified standards for use by providers when electronically ordering laboratory tests for a patient.
Work group Co-chairman Micky Tripathi of the Massachusetts eHealth Collaborative said 70% to 80% of lab transactions are not performed using EHR systems. The failure of the healthcare industry to come together on a common set of messaging standards and their implementation guides for labs is “in many ways, the Achilles' heel of meaningful use,” he said.
“There are a lot of standards out there that are not used, and many standards that are used in various ways,” Tripathi said. In addition to 5,200 commercial labs, there are 8,500 hospital laboratories, 400 public health laboratories and 115,000 small laboratories in physician offices and clinics, Tripathi said.
A lack of consensus on laboratory standards has remained an intractable barrier to interoperability for multiple reasons, Tripathi said. Large national reference laboratories control 25% of the market, he said, but are only part of a contingent of commercial laboratories, all of which are ineligible for EHR subsidy payments under the stimulus law. Thus, they won't receive direct incentives to respond if laboratory standards are included in the meaningful use criteria.
Commercial labs are covered under the federal
Clinical Laboratory Improvements Amendments of 1988 or CLIA, but the law permits variance in regulation by the states. Many states require that lab results only be transmitted to the providers who ordered the tests, which precludes direct transmission to a patient through his or her personal health record, for example.
“Because labs are so decentralized, there are not one or two sharp policy things we can do,” to induce or coerce the entire industry to use a specific set of data standards in communicating with providers and other healthcare organizations.
Thus, Tripathi said, the ONC needs to work with the Food and Drug Administration to coordinate the movement of CLIA-regulated labs toward adoption of common standards. That way, electronic laboratory ordering as well as receipt of test results can be included in EHR certification programs and meaningful use criteria that providers can meet.
The policy committee addressed and voted to accept one of several recommendations from the work group specifically that “ONC should require national standards for messaging, vocabulary and measure codes and create means for widespread availability of authorized implementation guides and code sets.”
David Blumenthal, the physician who heads the ONC, said, his office needed “a little more time to digest” other work group recommendations and committee discussions that included a possible federal pre-emption of state lab laws, which might have legal implications.
The HIT Policy Committee also heard from Paul Egerman, the co-chairman of the certification and adoption workgroup of the HIT Policy Committee, who said that the Certification Commission for Health Information Technology could have a competitor.
Under the stimulus law, the ONC “shall keep or recognize a program or programs for the voluntary certification of health information technology.”
The Drummond Group, an Austin, Texas,-based software testing service provider, “threw their hat in the ring and want to become a certification organization,” Egerman said. “They are putting together a second certification organization emphasizing vendors that provide software to physicians groups, particularly small physician groups.”
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