• The Wait is Over: ONC and CMS Issue Regulations Regarding the Definition of "Meaningful Use" and Standards for Electronic Health Records
  • January 8, 2010 | Authors: Steven "Steve" D. Gravely; Erin S. Whaley
  • Law Firm: Troutman Sanders LLP - Richmond Office
  • On December 30, 2009, the Centers for Medicare and Medicaid Services (CMS) and the Office of the National Coordinator for Health Information Technology (ONC) simultaneously issued two new rules related to meaningful use of electronic health records.  CMS issued a notice of proposed rulemaking which outlines provisions governing the EHR incentive programs and defines the central concept of "meaningful use" of EHR technology.   In addition, ONC issued an interim final regulation, which establishes initial standards, implementation specifications, and certification criteria for electronic health record (EHR) technology.  ONC's interim final rule and CMS' proposed rule aim to provide guidance regarding the implementation of the EHR incentive programs that were included in the American Recovery and Reinvestment Act of 2009 (ARRA).  According to CMS acting administrator Charlene Frizzera, the two sets of regulations are "closely linked," as "CMS' proposed regulation would define and specify how to demonstrate 'meaningful use' of EHR technology, which is a prerequisite for receiving the Medicare incentive payments," while the ONC interim final rule "sets forth the standards and specifications that will enhance the interoperability, functionality, utility and security of health information technology."

    Under ARRA, programs have been created 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."  CMS' proposed rule defines (i) who is a "meaningful EHR user" (i.e. eligible professionals and eligible hospitals) and (ii) what constitutes "meaningful use" for the Medicare and Medicaid EHR incentive programs.  To implement the proposed requirements for demonstrating meaningful use, CMS' proposed rule provides a phased approach, which includes 3 stages.  Stage 1, which begins in 2011, establishes "reasonable criteria for meaningful use based on currently available technological capabilities and providers' practice experience."  Such criteria will focus on:

    • electronically capturing health information in a coded format;
    • using that information to track key clinical conditions;
    • communicating that information for care coordination purposes; and
    • initiating the reporting of clinical quality measures and public health information.

    For measuring whether eligible professionals and eligible hospitals have met the “meaningful use” requirements, the proposed rule includes 25 benchmarks that eligible professionals and 23 benchmarks that eligible hospitals must meet.  Given that incentive payments may commence in October 2010 for eligible hospitals and in January 2011 for other eligible providers, hospitals and providers should now examine the steps that they have taken to demonstrate their meaningful use of EHR technologies to take advantage of these incentive programs. 

    In an effort to ensure that accurate and secure health information is exchanged between various EHR systems, the ONC interim final rule provides standards that certified EHR technologies must meet in order to exchange healthcare information among providers and between providers and patients.  Specifically, the interim final rule 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 interim final rule will go into effect 30 days after its January 13, 2010 publication in the Federal Register, with an opportunity for public comment and refinement over the next 60 days.  A final rule will be issued in 2010.

    We will be further evaluating these rules over the next few weeks and will provide helpful information on what they will mean for all healthcare providers.

    ONC’s interim final rule may be viewed at http://healthit.hhs.gov/portal/server.pt?open=512&objID=1153&mode=2.

    The CMS proposed rule and fact sheets, may be viewed at http://www.cms.hhs.gov/Recovery/11&under;HealthIT.asp.