March 3, 2005

Centers for Medicare & Medicaid Services
Department of Health and Human Services
Attention: CMS-0011-P
P.O. Box 8014
Baltimore, MD 21244-8014

Via: http://www.cms.hhs.gov/regulations/ecomments

The National Committee on Vital and Health Statistics (NCVHS) was called upon 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. The initial recommendations were delivered September 2, 2004. The Committee is very pleased to find that these recommendations were helpful in drafting the Medicare Program E-Prescribing and the Prescription Drug Program Proposed Rule. This letter includes the NCVHS comments in response to the Proposed Rule in the response format requested.

BACKGROUND

A. Statutory Basis

NCVHS recognizes that the HHS Proposed Rule must be consistent with the wording in MMA, including the wording, “e-prescribing standards apply only to information regarding Part D eligible individuals enrolled in Part D plans.” However, NCVHS also believes that HHS should ensure that e-prescribing standards are not only appropriate for Medicare Part D users but also consistent with the standards for all types of prescribers, dispensers, and public and private sector payers. This is necessary to avoid barriers to interoperability across healthcare domains. To achieve this, e-prescribing standards for Medicare Part D should also be compatible with those adopted as HIPAA and CHI standards, and with those recommended in November 2003 by NCVHS for clinical data terminologies, especially with those pertaining to RxNorm.

F. Evolution and Implementation of an Electronic Prescription Drug Program

There are lessons learned from HIPAA regarding both the value of standards and the need for flexibility to respond to industry requirements and technology changes. There are a number of approaches that could be considered to provide the industry greater flexibility and ability to advance, while maintaining standardization of messages and data. For example, CHI has set a precedent for this by adopting a version of its clinical information standards as a baseline, from which new versions may be adopted by the industry when ready; even though this process is different from the process required for standards adopted under HIPAA. HHS should work with the industry in its rulemaking process to determine how best to afford flexibility in keeping standards in pace with the needs of the industry, including standards for HIPAA and e-prescribing transactions. For example, HHS might consider recognizing new versions of standards, without a separate regulation, if they are backward compatible.

PROVISIONS

C. Proposed Requirements for Part D Plans

The NCVHS recommendation relative to e-prescribing standards adoption within “closed” environments is different from the HIPAA transaction requirements where the Rule applies to both “closed” and “open” environments. NCVHS observes that HL7 is commonly used to communicate medication orders within a hospital, and with clinical pharmacies within an enterprise. Coordination of the HL7 data elements for order entry messages with the NCPDP SCRIPT Standard data elements for e-prescribing messages (which are used to communicate prescriptions to community and retail pharmacies) would result in functions being more seamless across healthcare environments. This would remove a major barrier to adoption of electronic medication ordering and prescribing. HL7 and NCPDP have already begun this coordination by mapping the data elements in their respective standards that support common functions. NCVHS believes that HHS should recognize the exchange of prescription transactions within the same enterprise[1]as outside the scope of MMA e-prescribing standard specifications. However, HHS should require that prescription orders sent using HL7 messages within an enterprise be translated to NCPDP SCRIPT message format if the message is being transmitted to a dispenser outside of the enterprise. HHS also should require that any retail pharmacy within an enterprise be able to receive prescription transmittals via NCPDP SCRIPT from outside the enterprise.

E. Proposed Standards

1. Prescription

NCVHS observes an apparent inconsistency in the description of the proposed standards to be adopted regarding the Prescription Fill Status Notification Transaction. On page 50 of the text version of the Proposed Rule, the Prescription Fill Status Notification Transaction (and its three business cases) are correctly excluded from the foundation standards. However, on page 53 of the text version of the Proposed Rule it incorrectly states that there is industry experience with the Fill Status Notification Transaction. The sentence on page 53 that needs to be corrected is: “More specifically, the NCPDP SCRIPT Standard transactions we propose for adoption have been used extensively for messaging between prescribers and retail pharmacies for new prescriptions, prescription refill requests, prescription fill status notifications, and cancellation notifications, as part of the Consolidated Health Informatics (CHI) Initiative.”

E. Proposed Standards

2. Eligibility

NCVHS supports the adoption of the ASC X12N 270/271 transactions for conducting eligibility and benefits inquiries between prescribers and Part D sponsors and the NCPDP Telecommunication Standard for conducting eligibility transactions between dispensers and Part D sponsors. NCVHS would like to emphasize the importance of the note within the proposed rule that “the level of detail returned on the 271 by the Part D sponsor must match the level of detail in the inquiry made by the prescriber in the 270 request, to the extent that the Part D sponsor’s system is capable of handling this request.” In addition, the proposed rule indicated that “if standards are updated and newer versions are developed, HHS would evaluate the changes and consider the necessity of requiring the adoption of new updates to the standards.” NCVHS believes the process of potentially accepting as compliant different versions of the standards that are backward compatible is critical to keeping the e-prescribing process current. This should apply to all applicable standards, including, for instance, the X12 278 Prior Authorization standard and others.

NCVHS is pleased to provide these comments in support of advancing the principles and purposes of e-prescribing.

Sincerely yours,

/s/

Simon P. Cohn, M.D., M.P.H.
Chairman, National Committee on Vital and Health Statistics

Cc: HHS Data Council Co-Chairs

[1] NCVHS recognizes that properly defining “enterprise” may be complex. NCVHS encourages the Secretary to clarify the definition in rulemaking.