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HHS Solicits Comments on Proposed E-prescribing Standards

Healthcare and standards representatives to meet with key government official

New York, Feb 05, 2005

A February 4 Federal Register notice issued by the Centers for Medicare & Medicaid Services of the U.S. Department of Health and Human Services has announced a proposed rule affecting potential standards for an electronic prescription drug program under Title I of the Medicare Prescription Drug Improvement and Modernization Act of 2003 (MMA).

Included in the Act’s provisions is a requirement that certain drug prescriptions and other information transmitted electronically comply with final uniform standards adopted by the HHS Secretary under an electronic prescription drug program, once the final standards for those transaction are effective.

The MMA called upon the National Committee on Vital and Health Statistics (NCVHS) to develop recommendations for uniform standards for e-prescribing to promote patient safety and quality health care. From March to September 2004, NCVHS heard testimony from 65 witnesses and other industry experts including all stakeholder groups identified in the MMA, as well as e-prescribing networks, demonstration projects, software developers, and consumer advocacy organizations.

The proposed “foundation standards” would represent the first step in an incremental approach to adopting final uniform standards that are consistent with the MMA objectives of patient safety, quality of care, and efficiencies and cost savings in the delivery of care. In this proposed regulation, foundation standards “would not need to be pilot tested because adequate industry experience with those standards already exists.”

To assess industry experience, the Centers for Medicare and Medicaid Services is soliciting comments on the proposed standards based on these criteria:

  • The standard is American National Standards Institute (ANSI) accredited. [We] propose this criterion because the ANSI accreditation process is open and based upon consensus, so accredited standards are more likely to adequately address, and effectively respond to, industry needs.

  • The standard generally has been implemented by entities to which the final standard will be applied in multiple e-prescribing programs with more than one external health care partner. [We] propose this criterion because it demonstrates that the standard can be successfully implemented, the experience can be replicated, and the standard is interoperable between organizations as well as within an organization.

  • The standard is recognized by key industry stakeholders as the industry standard. [We] propose this criterion so that we do not adopt a standard in a situation where there are competing industry standards and the industry is divided over which one should be selected. The Secretary has determined that pilot testing is not required for the standards proposed in this regulation because they meet the criteria for adequate industry experience. The need for pilot testing of future standards will be determined when additional standards are recommended.
Recently, President Bush has been vocal in urging the use of electronic health records to reduce medical errors and costs. In late January, the Bush administration informed Congress that it would restore $50 million to the 2005 budget for the Office of the National Health Information Technology Coordinator, Dr. David J. Brailer. The funds had been diverted by Congress in November during budget cuts precipitated by federal deficit concerns. [See related article: Electronic Health Record (EHR) Update: Public Input Sought for National Health Information Network and EHR Standard] The $50 million will be used to support pilot programs that demonstrate the advantages of electronic health records, development of technical standards, and study of policies to encourage investment.

On February 16, Dr. Brailer will be meeting in Dallas, TX, with representatives of several key stakeholders including ANSI and its Healthcare Informatics Standards Board, the American Dental Association, the National Council for Prescription Drug Programs, the National Institute of Standards and Technology, ASTM International, International Organization for Standardization (ISO) Technical Committee 215 (Health informatics), and others.

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