WASHINGTON – The government delivered on Wednesday the long-awaited definition of meaningful use of electronic health record technology, and it came wrapped in about 700 pages of proposed regulation.

The ability to exchange health data among providers, security of that data, standard formats for clinical summaries and prescriptions and standard terms to describe clinical problems, procedures and tests are part of the package.

A proposed rule issued by CMS outlines proposed provisions governing the EHR incentive programs, including defining the central concept of “meaningful use” of EHR technology. An interim final regulation (IFR) issued by ONC sets initial standards, implementation specifications, and certification criteria for EHR technology.  Both regulations are open to public comment.

Phased approach

For providers, who have feared that "meaningful use" would be unreachable in 2010,CMS recommends phasing  the criteria in three stages. "Such a phased approach encompasses reasonable criteria for meaningful use based on currently available technology capabilities and provider practice experience, and builds up to a more robust definition of meaningful use, based on anticipated technology and capabilities development," the proposed rule says.

The Stage 1 meaningful use criteria focuses on electronically capturing health information in a coded format, using that information to track key clinical conditions and communicating that information for care coordination purposes. It also calls for implementing clinical decision support tools to facilitate disease and medication management and reporting clinical quality measures and public health information.

(A list of 25 Stage 1 criteria for eligible providers may be found here. The 23 Stage 1 criteria for eligible hospitals may be found here.)

CMS officials recommend Stage 2 criteria proposed by the end of 2011 and the Stage 3 definition proposed by the end of 2013. "Our goals for “Stage 3” meaningful use criteria represent overarching goals which, we believe, are attainable by the end of the EHR incentive programs," the proposed rule says.

CMS seeks comment

The IFR will go into effect 30 days after publication, with an opportunity for public comment and refinement over the next 60 days.  A final rule will be issued in 2010. A proposed rule regarding the certification of EHRs is in the works and expected "soon," according to ONC officials, declining to speculate on how the meaningful use criteria might impact products certified by the Certification Commission for Health Information Technology.

"Widespread adoption of electronic health records holds great promise for improving health care quality, efficiency, and patient safety,” said, National Coordinator for Health Information Technology David Blumenthal, MD. “The Recovery Act’s financial incentives demonstrate Congress’ and the Administration’s commitment to help providers adopt and make meaningful use of EHR technology so they can give better care and their patients’ experience of care will improve.  Over time, we believe the EHR incentive program under Medicare and Medicaid will accelerate and facilitate health information technology adoption by more individual providers and organizations throughout the health care system.”

The economic stimulus package has allotted $17.2 billion to reward Medicare and Medicaid providers who can prove they are using certified healthcare IT "in a meaningful way." At a press conference on Dec. 30 announcing the rules, CMS officials said the actual incentive payments could range anywhere from $14.1 billion on the low end, $27.3 billion on the high end. The actual amount, they say, depends on how many providers opt out of participating in the voluntary program, and of those who opt-in, how many will qualify for all payments.

The incentives are scheduled to take effect starting Oct. 1, 2011. Experts say providers should not waste time getting prepared because there is a shortage of change management experts available to help.

Foundation for boosting quality, efficiency

Officials from The Centers for Medicare & Medicaid Services and the Office the National Coordinator for Health Information Technology said the regulations lay a foundation for improving quality, efficiency, and safety through meaningful use of electronic health record technology.

“These regulations are closely linked,” said Charlene Frizzera, CMS acting administrator.  “CMS’s proposed regulation would define and specify how to demonstrate ‘meaningful use’ of EHR technology, which is a prerequisite for receiving the Medicare incentive payments.  Our rule also outlines the proposed payment methodologies for the Medicare and Medicaid EHR incentive programs.  ONC’s regulation sets forth the standards and specifications that will enhance the interoperability, functionality, utility and security of health information technology.”

The Interim Final Rule issued by ONC describes the standards that must be met by certified EHR technology to exchange healthcare information among providers and between providers and patients. This initial set of standards begins to define a common language to ensure accurate and secure health information exchange across different EHR systems. The rule describes standard formats for clinical summaries and prescriptions; standard terms to describe clinical problems, procedures, laboratory tests, medications and allergies; and standards for the secure transportation of this information using the Internet.

The regulations are aimed at implementing  the EHR incentive programs enacted under the Health Information Technology for Clinical and Economic Health (HITECH) Act, which was part of the American Recovery and Reinvestment Act of 2009, according to CMS. CMS said public comment on the regulations would be encouraged.