The Centers for Medicare & Medicaid Services (CMS) and the Office of the National Coordinator for Health Information Technology (ONC) have issued two regulations regarding electronic health record (EHR) technology. The first is of particular significance, as it is the CMS proposed rule regarding the concept of "meaningful use" of EHR technology, which directly impacts the incentive programs under the American Recovery and Reinvestment Act of 2009 (Recovery Act). The agencies are encouraging public comment on the regulation.

The Recovery Act of 2009 signed into law earlier this year includes the Health Information Technology for Economic and Clinical Health Act (the "HITECH Act"). The HITECH act established programs under Medicare and Medicaid to provide incentive payments for the "meaningful use" of EHR technology.

The proposed rule CMS issued defines the central concept of "meaningful use." In the fact sheet CMS provides, the agency says its goal is for the definition of meaningful use to be "consistent with applicable provisions of Medicare and Medicaid law while continually advancing the contributions of certified EHR technology" to improve health care quality, efficiency, and patient safety.

The CMS proposed rule would implement criteria for demonstrating meaningful use in three phases, as the agency considers a phased approach most appropriate, based on public and stakeholder input.

The proposed rule states that 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 (whether that information is structured or unstructured, but in structured format whenever feasible); consistent with other provisions of Medicare and Medicaid law, implementing clinical decision support tools to facilitate disease and medication management; and reporting clinical quality measures and public health information."

For Stage 1, beginning in 2011, CMS proposes 25 objectives/measures for eligible professionals (EPs) and 23 objectives/measures for eligible hospitals that must be met to be deemed a meaningful EHR user. In 2011, EPs and hospitals would report all of the results for all objectives/measures to CMS, or in the case of Medicaid, report to the states, through attestation.

In 2012, CMS proposes requiring the direct submission of clinical quality measures to CMS (or to the states for Medicaid EPs and hospitals) through certified EHR technology.

The proposed rule states that Stage 2 meaningful use criteria expands upon the Stage 1 criteria to "encourage the use of health IT for continuous quality improvement at the point of care and the exchange of information in the most structured format possible, such as the electronic transmission of orders entered using computerized provider order entry (CPOE) and the electronic transmission of diagnostic test results (such as blood tests, microbiology, urinalysis, pathology tests, radiology, cardiac imaging, nuclear medicine tests, pulmonary function tests and other such data needed to diagnose and treat disease)." CMS may consider applying the criteria more broadly to both the inpatient and outpatient hospital settings.

The proposed rule states that Stage 3 meaningful use criteria, consistent with other provisions of Medicare and Medicaid law, will "focus on promoting improvements in quality, safety and efficiency, focusing on decision support for national high priority conditions, patient access to self management tools, access to comprehensive patient data and improving population health."

The ONC's interim final rule (IFR) describes the standards that must be met by certified EHR technology to exchange health care information among providers, and between providers and patients. The standards involve defining a common language for accurate and secure health information exchange across different EHR systems. The ONC says 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 is also advocating that the industry standardize how EHR information is exchanged between organizations, and submits criteria required for an EHR technology to be certified.

"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. in a CMS press release. "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, in the same release. "CMS's proposed regulation would define 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."

There are 60-day public comment periods on the ONC IFR and the CMS proposed rule. The final rules will be issued sometime in 2010.

Read more:

The CMS press release: http://www.hhs.gov/news/press/2009pres/12/20091230a.html

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

The ONC IFR can be accessed through: http://healthit.hhs.gov/portal/server.pt?open=512&objID=1153&mode=2

Comments may be submitted electronically by accessing http://www.regulations.gov and following the instructions on the home page.

Comments can also be submitted by regular mail to:

Centers for Medicare & Medicaid Services,
Department of Health and Human Services,
Attention: CMS-0033-P
P.O. Box 8013
Baltimore, MD 21244-8013