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Meaningful Use And EHR Standards: The Final Rule



July 13th, 2010
by John Halamka

Editor’s Note: For more on electronic health records and meaningul use requirements, see the April issue of Health Affairs, “Health IT: The Road To ‘Meaningful Use’“.

This morning, the Centers for Medicare and Medicaid Services (CMS) and the Office of the National Coordinator (ONC) for Health Information Technology released the final rules that will guide electronic health record (EHR) rollouts for the next five years. CMS and ONC released final “meaningful use” requirements, spelling out how hospitals, physicians, and other medical professionals must use EHRs to improve care, in order to be eligible for Medicare and Medicaid financial incentives under the “HITECH” Act. ONC also released final rules governing standards that vendors of EHRs must meet and the process for certification of EHRs.

Key resources include information from the Depeartment of Health and Human Services on the final meaningful use and standards and certification regulations, as well as an overview of the regulations in the New England Journal of Medicine authored by national health IT coordinator David Blumenthal and CMS Principal Deputy Administrator Marilynn Tavenner.

Differences betwen final and proposed regulations. Both the meaningful use regulations and the standards regulations had earlier been issued in proposed form. Here’s my analysis of the key changes between the final and proposed meaningful use rules.

1. HHS has adopted the recommendation of the HIT Policy Committee – a group of private-sector individuals (including me) appointed to advise HHS — to frame meaningful use in terms of core requirements and discretionary requirements. This responds to the concern that the proposed rules had set up an “all or nothing” approach, in which hospitals and professionals who failed to meet any one of the requirements were ineligible for funding.

By adopting a framework of core and discretionary requirements, HHS has reduced the total number of requirements and introduced choice. In the notice of proposed rulemaking (NPRM) there were 25 requirements for Eligible Professionals and 23 for hospitals. In the Final Rule there are 15 core requirements for Eligible Professionals and 14 for hospitals. For both hospitals and professionals, there are 10 discretionary requirements from which five must be chosen.

2. Thresholds have been reduced in many cases.  For example, under the NPRM, 80 percent of orders for eligible professionals and 10 percent of orders for hospitals had to utilize computerized physician order entry (CPOE). The language in the final rule focuses on order entry of medications and requires that 30 percent of patients with medication orders have at least one medication order entered electronically.  This requirement applies to both eligible professionals and hospitals.    

3. Administrative simplification, which addresses formats for the exchange of information among different systems, has been postponed to Stage 2.

4. Only one clinical decision support rule must be included under the final rule, down from five in the proposed rule.

5. Required clinical quality measures have been reduced to 6 for professionals and 15 for hospitals.   For professionals, there are 3 core measures required, 3 alternative core measures, and a choice of 3 from a pool of discretionary measures.  Reporting by attestation is required in 2011, electronic reporting is required in 2012. Clinical quality measurements for specialists have been eliminated for stage 1. There has been great effort to align meaningful use with the measures tracked through CMS’ Physician Quality Reporting Initiative.

6. The NPRM did not include the recording of advanced directives or a provision for providing patients with educational materials.  The final rule includes these as discretionary meaningful use requirements.

Overall, the final rule maintains a balance between the policy objectives sought and the technology changes that are achievable now. There will still be three stages of meaningful use and later stages will be more demanding. All the Stage 1 requirements included in the NPRM will still be part of meaningful use by Stage 2.

In January of 2011, the clinicians may begin the 90 day process of using a certified record per meaningful use requirements. Attestation of this use begins in April 2011.   CMS payments will begin May 2011.

Standards and certification. ONC also released the final rule on standards and certification today. They have done a remarkable job of adding detailed implementation guidance specificity for patient care summaries, public health laboratory reporting, syndromic surveillance, and immunizations.  It’s a tricky balance to provide enough specificity to test and certify EHRs and modules for interoperability, while at the same time encouraging innovation. The final rule issued today achieves that balance perfectly, ensuring that only mature implementation guides are specified, leaving room for innovation in such areas as how to transport data from point to point via NHIN Direct and other demonstration projects.

Overall, a very good day for ONC, HHS and stakeholders. The final rule ensures meaningful use will be achievable by many. The standards and the process to certify their use are sufficiently specific. I’m impressed.

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2 Responses to “Meaningful Use And EHR Standards: The Final Rule”

  1. annecarroll Says:

    This is a good example of a “race to the bottom” in systems development. It is predictable when there are too many cooks in the kitchen–aka “stakeholders”–each with their own proprietary recipe. The idea that users of what is supposed to be a system that shares and integrates patient and public health data can pick “one from column A and one from column B,” like some generic Chinese menu, is the very antithesis of the idea of “standards.” It remains to be seen whether any of the goals of the NHIN or the PHIN can or will be achieved, in the lifetime of anyone alive now, by this lowest common denominator design, driven by the private sector with its special access to, and interlocking relationships with, the decision-makers in the public sector.

    What is also predictable is the pushback by vendors at each succeeding “stage.” Once each company has changed its business model to adjust to the requirements of the current stage, and once each company has an interest in the outcome of the design of the current stage, objections to the expense of time and money on implementing successive stages and changes are predictable. When taxpayers complain that “the government can’t do anything right,” what they really mean is that their contractors have guaranteed a less-than-optimal outcome based on self-interest alone.

    Why the ONC hasn’t just adopted the VA’s system, which has won awards for its patient-centered functionality, its integrated design (much more than an EMR), its data and process standards, and its focus on data collection for quality and patient safety improvement and research, is a question that hasn’t been answered. Or, perhaps the industry has an answer to that that includes the term “government crowd-out” or maybe even “socialism.”

    And it’s still a mystery why most providers in the US haven’t availed themselves of the VA system’s open source code, with its already-existing standards, like providers and governments in other countries have done, to their benefit. When it comes to inefficiency and ineffectiveness, just look to the US for the definitions, which is used to fielding a healthcare system that is the most expensive in the world but has the worst health outcomes and lowest patient satisfaction ratings in the industrialized world. It seems that the HIT community is hell-bent on replicating that result.

    Other industries have had these issues solved, or at least mitigated, for years. It’s hard to posit that a healthcare information system is any more complicated than a Wall Street arbitrage system. The healthcare industry is like an early stage in mammal evolution when it comes to HIT, and it keeps insisting, using the PR spin of terms like “innovation”, on becoming an evolutionary dead-end.

  2. docsitejohn Says:

    great summary. Looks as if elements associated with evidence of improving care stayed in. Glad to see there is room for evolving standards, care interactions and workflow. The experience in Vermont and elsewhere hooking registry (www.docsite.com) with exchanges (www.ge.com) in Vermont and EHRs (www.allscripts.com or http://www.epic.com) suggest that 1) Care can improve 2) True interoperability remains an evolving concept in the real world. These rules should help to focus industry effort.

    John Haughton

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