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CMS and ONC Issue Regulations Proposing "Meaningful Use" Definition, Setting EHR Certification Standards

30 December 2009

Today the Centers for Medicare & Medicaid Services (CMS) and the Office of the National Coordinator for Health IT (ONC) released two regulations relating to the Medicare and Medicaid incentives authorized by the American Recovery and Reinvestment Act of 2009 (ARRA).  Both rules have public comment periods of 60 days and are scheduled to be published in the Federal Register on January 13, 2010.  Final rules are expected to be issued in the spring of 2010.

EHR Incentives for “Meaningful Use”

The CMS Proposed Rule defines the criteria for “meaningful use” of certified electronic health record (EHR) technology. “Eligible professionals” (EPs) and hospitals that meet this criteria will be eligible for incentive payments beginning in 2011.

CMS proposes to phase in meaningful use criteria in three stages. The Proposed Rule focuses on the Stage 1 criteria, and CMS plans to propose Stage 2 and Stage 3 criteria in future rulemaking, with a goal of issuing proposed Stage 2 standards by the end of 2011 and proposed Stage 3 standards by the end of 2013. 

For Stage 1, which begins in 2011, CMS has proposed 25 objectives, or measures, for EPs and 23 objectives for eligible hospitals, all of which must be met in order for a provider to be deemed a meaningful EHR user.

Standards, Implementation and Certification Criteria

The ONC Interim Final Rule sets forth initial standards, implementation specifications and certification criteria for EHR technology.  These provisions specify the capabilities and related standards that certified EHR technology must include in order to support the proposed Stage 1 requirements for meaningful use.  This Rule goes into effect 30 days after publication in the Federal Register.

According to ONC, the standards set forth in the Rule “rely heavily on existing standards for the interoperability of health information technologies, including those established and/or promoted by Health Level 7 (HL7), the National Institute of Standards and Technology (NIST) and Integrating the Healthcare Enterprise (IHE).”  The standards, which fall into the categories of vocabulary, content exchange, transport and privacy/security, also rely upon classification and nomenclature systems such as SNOMED CT, ICD-9 and 10, X12, LOINC, NCPDP and RxNorm. 

ONC will issue a separate Notice of Proposed Rulemaking relating to the testing and certification process for EHRs and EHR Modules in early 2010. 

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