CMS and ONC Issue Meaningful Use Rules

On July 13, 2010, Kathleen Sebelius, secretary of the US Department of Health and Human Services, announced 2 final rules that will implement the electronic health records (EHRs) incentive program under the Health Information Technology for Economic and Clinical Health (HITECH) Act. The rules were issued under the auspices of the Centers for Medicare & Medicaid Services (CMS) and the Office of the National Coordinator for Health Information Technology (ONC).

The HITECH Act is part of the American Recovery and Reinvestment Act of 2009. It encourages the adoption of EHRs by providing financial incentives administered by CMS to hospitals and clinicians who demonstrate “meaningful use” certified EHR technology.

In making the announcement, Secretary Sebelius said, “For years, health policy leaders on both sides of the aisle have urged adoption of electronic health records throughout our healthcare system to improve the quality of care and ultimately lower costs. Today, with the leadership of the president and Congress, we are making that goal a reality.”

The new CMS rule outlines the objectives that providers (professionals, hospitals, and critical access hospitals) must meet in 2011 and 2012 in order to qualify for incentive payments; the ONC rule specifies the technical capabilities that EHR technology must demonstrate to be certified and to help providers meet the meaningful use objectives.

The final CMS rule includes core criteria that all providers are required to meet to qualify for payments as well as a set of menu items of additional criteria that providers can select (see sidebar). The criteria for meaningful use outlined in the current rule are based on technological capabilities that are currently available as well as providers’ practice experience. As technologies and capabilities change, CMS will identify graduated criteria for meaningful use in future rules.

The ONC rule sets initial standards, specifications for implementation, and certification criteria for EHR technology under the incentive program. It also coordinates the standards required of EHR systems with the meaningful use requirements for professionals and hospitals. The ONC standards will ensure that the certified EHR technology adopted by providers will be able to perform the necessary functions to comply with the CMS meaningful use requirements as well as other administrative requirements of Medicare and Medicaid to qualify for the incentive payments.

The HITECH Act stresses that the adoption of EHR technology is not an end unto itself; the use of EHRs to achieve health and efficiency levels is the goal. The meaningful use criteria are designed to achieve 5 healthcare goals: (1) improve the quality, safety, and efficiency of care while reducing disparities; (2) engage patients and families in their care; (3) promote public and population health; (4) improve care coordination; and (5) promote the privacy and security of EHRs.

The 2 rules announced in July complement 2 other recent rules. In late June, ONC published a final rule that established a temporary certification program for health information technology, and on July 8, the Office for Civil Rights announced a proposed rule that would expand privacy, security, and enforcement protections under the Health Insurance Portability and Accountability Act of 1996.

In combination, the 4 rules are the key components of the regulatory structure needed to administer the EHR program and meet the goals of the HITECH Act.

David Blumenthal, MD, national coordinator for health information technology said, “This is a turning point for electronic health records in America, and for improved quality and effectiveness in healthcare. In delivering on the goals that Congress called for, we have sought to provide the leadership and coordination that are essential for a large, technology-based enterprise. At the same time, we have sought and received extensive input from the healthcare community, and we have drawn on their experience and wisdom for produce objectives that are both ambitious and achievable.”—Tori Socha