CMS and ONC Issue Regulations Proposing a Definition of ‘Meaningful Use’ and Setting Standards for Electronic Health Record Incentive Program

The Centers for Medicare & Medicaid Services (CMS) and the Office of the National Coordinator for Health Information Technology (ONC) released regulations that lay a foundation for improving quality, efficiency and safety through meaningful use of certified electronic health record (EHR) technology. The regulations will help implement the EHR incentive programs enacted under the American Recovery and Reinvestment Act of 2009 (Recovery Act).

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.

CMS and ONC worked closely to develop the two rules and received input from hundreds of technical subject matters experts, health care providers, and other key stakeholders. Numerous public meetings to solicit public comment were held by three Federal advisory committees: the National Committee on Vital and Health Statistics (NCVHS), the Health IT Policy Committee (HITPC), and the Health IT Standards Committee (HITSC). HITSC presented its final recommendations to the National Coordinator in August 2009. These recommendations, along with all other input were considered to help inform the development of the regulations announced today.

The IFR 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 IFR 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 IFR calls for the industry to standardize the way in which EHR information is exchanged between organizations, and sets forth criteria required for an EHR technology to be certified. These standards will support meaningful use and data exchange among providers who must use certified EHR technology to qualify for the Medicare and Medicaid incentives.

Under the statute, HHS is required to adopt an initial set of standards for EHR technology by Dec. 31, 2009. 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. The Recovery Act established programs to provide incentive payments to eligible professionals and eligible hospitals participating in Medicare and Medicaid that adopt and make “meaningful use” of certified EHR technology. Incentive payments may begin as soon as October 2010 to eligible hospitals. Incentive payments to other eligible providers may begin in January 2011.

The proposed rule would define the term "meaningful EHR user" as an eligible professional or eligible hospital that, during the specified reporting period, demonstrates meaningful use of certified EHR technology in a form and manner consistent with certain objectives and measures presented in the regulation. These objectives and measures would include use of certified EHR technology in a manner that improves quality, safety, and efficiency of health care delivery, reduces health care disparities, engages patients and families, improves care coordination, improves population and public health, and ensures adequate privacy and security protections for personal health information.

The proposed rule would define meaningful use for the Medicare EHR incentive programs. It proposes one definition that would apply to eligible professionals participating in the Medicare fee-for-service and the Medicare Advantage EHR incentive programs as well as a proposed definition that would apply to eligible hospitals and critical access hospitals. These definitions also would serve as the minimum standard for eligible professionals and eligible hospitals participating in the Medicaid EHR incentive program. The rule proposes that states could request CMS approval to implement additional meaningful use measures, as appropriate, but could not request approval of fewer or less rigorous meaningful use measures than required by the rule.

This rule proposes a phased approach to implement the proposed requirements for demonstrating meaningful use. This approach would initially establish reasonable criteria for meaningful use based on currently available technological capabilities and providers’ practice experience. CMS will establish stricter and more extensive criteria for demonstrating meaningful use over time, as anticipated developments in technology and providers’ capabilities occur. CMS provides a 60-day comment period on the proposed rule.

The CMS proposed rule and fact sheets may be viewed at http://www.cms.hhs.gov/Recovery/11_HealthIT.asp

You can download the full 556-page document at http://www.federalregister.gov/OFRUpload/OFRData/2009-31217_PI.pdf

ONC’s interim final rule may be viewed at http://healthit.hhs.gov/standardsandcertification. 

In early 2010 ONC intends to issue a notice of proposed rulemaking related to the certification of health information technology.

CMS has proposed stages for the meaningful use criteria with Stage 1 meaningful use criteria focusing 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.

CMS officials recommend Stage 2 criteria proposed by the end of 2011 and the Stage 3 definition proposed by the end of 2013.

HealthCareITNews has published articles outlining the meaningful use criteria for providers and hospitals. To view the article on eligible provider meaningful use go to: http://www.healthcareitnews.com/news/eligible-provider-meaningful-use-criteria.

To view the article on eligible hospital meaningful use criteria go to: http://www.healthcareitnews.com/news/eligible-hospital-meaningful-use-criteria