December 20, 2005
The Honorable Michael O. Leavitt
U.S. Department of Health and Human Services
200 Independence Avenue, S.W.
Washington, D.C. 20201
Dear Secretary Leavitt:
The National Committee on Vital and Health Statistics (NCVHS) is requested by the Medicare Prescription Drug, Improvement, and Modernization Act of 2003 (MMA) to develop recommendations for uniform standards to enable electronic prescribing (e-prescribing) in ambulatory care. Additionally, 42 CFR Part 423 Medicare Program; E-Prescribing and the Prescription Drug Program; Final Rule (on page 67579) asks “the NCVHS to assess new versions of standards as they are developed, obtain input from Standards Development Organizations (SDOs) and other organizations, and provide recommendations to the Secretary regarding whether the new versions should be adopted.” We have sent you two previous letters (September 2, 2004 and March 4, 2005) with our recommendations. As a result of hearings we conducted on December 7, 2005, to receive an update on the industry’s development of e-prescribing standards, we have two additional recommendations.
Background and Discussion
About a year ago, we heard testimony that improvements to the National Council for Prescription Drug Programs (NCPDP) SCRIPT standard were in process. We asked NCPDP to keep us informed of these improvements and report back as progress was being made. Specifically, we asked NCPDP to show us the differences between the implementation guidance found in SCRIPT Standard Implementation Guide Version 5.0 (SCRIPT 5.0) and in the new SCRIPT Standard Implementation Guide Version 8.1 (SCRIPT 8.1). On December 7, 2005, we learned that the rapid progress made by the industry working through NCPDP has resulted in improvements to the standard we originally recommended (SCRIPT 5.0) and that you adopted as one of the e-prescribing foundation standards.
A newer version (SCRIPT 8.1) was approved by NCPDP and the American National Standards Institute, and published in October 2005. This newer version of the SCRIPT standard includes all functions of the foundation standard plus the ability to transmit medication history information. Furthermore, it provides additional clarification for use of the standard. We also learned that the industry generally has not implemented SCRIPT 5.0 and actually is implementing SCRIPT 8.1 to gain its benefits.
Based on the information we received from NCPDP and input from industry representatives on December 7, 2005, NCVHS concludes that the SCRIPT 8.1 standard is backward compatible for the core functions in SCRIPT 5.0.
The preamble of the E-Prescribing Final Rule (in Section 10 of Federal Register, 70:214, 67579-80) describes a process by which the Secretary may “waive notice and comment rulemaking under an Administrative Procedure Act exception to the requirement for notice and comment rulemaking.” The implementation of SCRIPT 5.0 is mandated for e-prescribing beginning January 1, 2006. Without adoption by the Secretary of SCRIPT 8.1 for foundation standard functions, however, the industry is held back from implementing SCRIPT 8.1 for e-prescribing.
We learned from recent testimony and information from the industry that SCRIPT 8.1 contains slightly more functionality than SCRIPT 5.0, but does not incorporate significant changes from SCRIPT 5.0. Further, SCRIPT 8.1 preserves the core functions of SCRIPT 5.0 and is backward compatible. Finally, SCRIPT 8.1 has received the necessary SDO and ANSI accreditation, as required by the November final rule.
For these reasons, NCVHS recommends the Secretary allow the use of SCRIPT 8.1 in addition to the previously adopted version SCRIPT 5.0 for meeting the e-prescribing transaction standards for Part D prescriptions. This means that use of either version of NCPDP SCRIPT (5.0 or 8.1) would constitute compliance with e-prescribing standards under the MMA. However, use of SCRIPT 8.1 would be voluntary at this time. It further allows the flexibility requested by the industry and the assurance that implementing SCRIPT 8.1 is considered compliant.
Because time is of the essence for permitting the industry to implement SCRIPT 8.1, NCVHS also recommends the Secretary waive notice and comment rulemaking under an Administrative Procedure Act exception for the adoption of SCRIPT 8.1 for the foundation standard functions so that it may be implemented as rapidly as is feasible.
NCVHS is pleased to support the process by which the Department of Health and Human Services can improve the efficiency and effectiveness of eprescribing.
Simon P. Cohn, M.D., M.P.H., Chairman
National Committee on Vital and Health Statistics
cc: DHHS Data Council co-chairs