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

The Centers for Medicare & Medicare Services (CMS) and the Office of the National Coordinator for Health Information Technology (ONC) encourage public comment on two regulations issued today 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.

"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, M.D., M.P.P. "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."

"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."

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.
"We strongly encourage stakeholders to provide comments on these standards and specifications," Dr. Blumenthal said.

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 definition and requirements for demonstrating meaningful use of EHR technology are proposals. CMS welcomes and will give serious consideration to comments that improve our proposal while achieving the
goals Congress established for the EHR incentive programs," Frizzera said.

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Process Begins to Define "Meaningful Use" of Electronic Health Records

Building on the historic $19 billion investment provided through the
American Recovery and Reinvestment Act of 2009 (Recovery Act), efforts
continued today to further the national adoption and implementation of
health information technology (HIT) -- an essential tool to modernize
the health care system and bring about improved health for all
Americans. The Health Information Technology (HIT) Policy Committee, a
Federal Advisory Committee (FACA) to the U.S. Department of Health and
Human Services (HHS), met today to begin the process of defining
"meaningful use" of electronic health records (EHRs). This meeting is a
first step for the department, as it investigates possible definitions
for meaningful use.

"We are moving fast to achieve the President's goal to improve the
health and well-being of every American through the on-going use of
health information technology," stated HHS' National Coordinator for
Health Information Technology David Blumenthal, M.D., M.P.P. "The work
of the policy committee is a first step toward assuring that technology
-- the electronic health record -- is used in a meaningful way to
provide better patient care."

The Recovery Act provides Medicare and Medicaid incentive payments to
eligible providers, such as physicians and hospitals, in order to
increase the adoption of EHRs. To receive the incentive payments,
providers must demonstrate "meaningful use" of a certified EHR.
Building upon the work done by the HIT Policy Committee, the Centers for
Medicare & Medicaid Services (CMS), along with the Office of the
National Coordinator for Health Information Technology (ONC), will be
developing a proposed rule that provides greater detail on the incentive
program and proposes a definition of meaningful use. CMS expects to
issue the proposed rule in late 2009, which will be followed by a
comment period.

The recommendations discussed today represent extensive work by the
Committee's Meaningful Use Workgroup to review and evaluate diverse
ideas and contributions from Workgroup members along with information
from a public hearing on meaningful use convened in April by the
National Committee on Vital and Health Statistics (NCVHS). The NCVHS
hearing brought together key healthcare and information technology
stakeholder groups. The workgroup also reviewed written comments from
additional diverse stakeholders.

A public comment period on today's recommendations will be open through
the close of business on Friday, June 26, 2009. Instructions on how to
submit public comment can be found at http://healthit.hhs.gov.

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