ANSI - American National Standards Institute
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Medicare E-prescribing Rule to Require Standards from ANSI-accredited SDOs

New York, Nov 17, 2005

The Centers for Medicare and Medicaid Services (CMS) of the Department of Health and Human Services (HHS) has issued a final rule governing the adoption of standards for an electronic prescription drug program under the Medicare Prescription Drug Improvement and Modernization Act of 2003 (MMA). [See related article: HHS Solicits Comments on Proposed E-prescribing Standards].

The final rule issued in a November 7 Federal Register notice requires that standards for certain electronic prescriptions be developed by standards development organizations accredited by the American National Standards Institute (ANSI). CMS supported its reasoning in the February 4 proposed rule stating that “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 requirement is one of three criteria established by the National Committee on Vital and Health Statistics (NCVHS) to assess standards for adequate industry experience. The other criteria include the implementation of a standard among multiple partners to ensure interoperability and recognition by key stakeholders. Relevant, efficient, consensus-based e-prescription standards are critical to the MMA objectives of providing quality health care and patient safety.

To reach these requirements, HHS solicited recommendations from the NCVHS, which consulted a wide range of experts including standards-setting organizations, physicians, pharmacists, hospitals, e-prescribing experts, and federal agencies. The regulations adopted by the final rule will go into effect January 1, 2006, when Prescription Plan (PDP) sponsors and organizations offering certain Medicare plans will be required to comply with the final standards.

“We proposed adopting foundation standards that are ANSI a means of facilitating interoperability for Electronic Health Records (EHRs),” the CMS Federal Register notice states. Many commenters, who responded to the measures, “specifically favored the requirement for ANSI accreditation.”

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