McKesson Corporation is the world's largest pharmaceutical supply management and healthcare information technology company. McKesson provides pharmaceutical supply management and information technologies across the entire continuum of healthcare, including market-leading businesses in pharmaceutical and medical-surgical distribution, information technology for healthcare providers, services for payors and outsourcing. McKesson Information Solutions provide enterprise-wide patient care, clinical, financial and strategic management software solutions, as well as Internet-based and networking technologies, electronic commerce, outsourcing and other services to healthcare organizations throughout the world. With revenues of $42 billion for the fiscal year ended March 31, 2001, McKesson ranks No. 35 in the 2001 Fortune 500.
Charles C. Meyer
Informatics Standards Liaison
McKesson Information Solutions
Director, Health Level Seven, Inc.
Co-chair, X12N/TG3 Transaction Coordination and Modeling
Member:ANSI
ANSI Health Informatics Standards Board
ASTM E31
IEEE
NCPDP
US TAG to ISO TC215
Mr. Chairman, members of the subcommittee, I am Chuck Meyer, Informatics Standards Liaison for McKesson Information Solutions. We greatly appreciate this opportunity to address the subcommittee regarding PMRI message format standards. McKesson has long been a supporter of comprehensive healthcare informatics standards and believes that the ultimate adoption of standards specific to the capture, exchange, and maintenance of patient medical record information will go far toward improving the quality and safety of patient care.
The list of standards included with the invitation to address the subcommittee is comprehensive; however, with the exception of HL7, none address the full spectrum of message exchange relevant to PMRI.
While the IEEE standard is unparalleled in its ability to communicate patient telemetry data, its purview is limited to those scenarios requiring automated patient monitoring. This standard does not, nor was it ever intended to, address the exchange of information necessary for patient administration and scheduling, order entry and management, observation reporting in the general sense, or medical records management. The IEEE standard fills a unique niche in the conglomerate of information that forms the patient medical record.
The CORBAmed standard from OMG is without a doubt the leader in component-based healthcare messaging. However, by its very definition it is limited to client/server applications and, once again, does not support the full and essential exchange of information necessary to qualify as a PMRI messaging standard. Further, OMG is not an ANSI accredited standards development organization (SDO). Beyond facilitating portal operations, CORBAmed has achieved little penetration as a messaging standard in the healthcare environment.
The DICOM standard is used widely for the exchange of radiological images, but it is a very complex standard and restricted in scope to the exchange of such images. We have seen little or no penetration of the general healthcare market by DICOM nor would we expect any enhancements to the standard to rectify that situation.
It is interesting to note that ASTM is only represented by two “enabling” standards, which in reality do not serve to enable a higher standard of interoperability. These draft standards, now in ballot for final approval, are incomplete clones of the HL7 Clinical Document Architecture. They profess to be CDA compliant, which seems synonymous with a proprietary approach to structured documents based on CDA. We question why an ASTM working group is trying to replicate an ANSI accredited standard without the infrastructure necessary to support its implementation. In the overall scheme of things, ASTM E31 standards have not received wide spread industry support. We do not expect these documents to fare any better.
Finally we consider the NCPDP SCRIPT standard for a prescriber-pharmacist interface. This standard, although well conceived, designed and documented, is constrained by its definition and domain. NCPDP represents the standard in use for all retail pharmacy transactions in the United States. We believe this standard will be adopted for that domain as well. However, it is obviously not a workable solution for the full gambit of medication information exchange necessary to the support of the patient medical record. HL7 has a robust medication information messaging structure supporting all facets of such information exchange. NCPDP and HL7 are currently negotiating a cooperative messaging development agreement.
This brings us to HL7, the only viable messaging standard relevant to the exchange of patient medical records information. McKesson has long relied on HL7 as our integration tool of choice. It is broadly implemented within our extensive library of health information technology applications. This is mirrored by the general industry acceptance of HL7 as the standard of choice for clinical content. Beyond the domain of the provider-payor, HL7 is far and away the industry leader in health information exchange with implementations reaching well beyond the traditional acute care arena.
We need only look at the current organizational structure of HL7 to recognize its wide acceptance, both nationally and internationally. HL7 now has 18 International Affiliates and is being used in such diverse applications as Home Health, public health reporting of proscribed laboratory results, and the CDC immunization registries project. At last week’s HL7 meeting it was reported that the New Zealand Health Services’ Ambulatory Care Service is based entirely on HL7 messaging.
As a vendor of health information technology McKesson Information Solutions is largely market driven, the high demand for HL7 expressed by our customers over the last decade has led to our extensive involvement in the development and use of the HL7 messaging standard. We have implemented literally thousands of HL7 V2.x interfaces and contend that it is the de facto standard for the exchange of patient medical record information. Based on the number of non-McKesson ancillary systems we have completed HL7 interfaces for it’s apparent that the rest of the industry supports that position.
Given its current wide spread use, the designation of HL7 V2.x as the national PMRI messaging standard would not, in our opinion, prove to be too much of a burden to the healthcare industry. However, we do not believe that such a decision would ultimately benefit the quality and safety of patient care.
In its current iteration HL7 V2.x represents a specification that still requires significant negotiation to resolve its ambiguities. Many vendors, including McKesson, have a long history of conducting such negotiations and have developed mechanisms to speed the process. Nonetheless it is a time consuming and expensive exercise. Even though HL7 has committed to continue to develop V2.x standards as long as the industry demands it, there is little to console the V2 veteran given the issue of ‘backwards compatibility.” It should also be recognized that, to a large extent, the insistence of continued V2.x enhancements is driven by the International Affiliates.
It is interesting that you have chosen the designation V2.x, given that the current ANSI accredited version is V2.4. Hopefully this is directly related to the large number of earlier versions of the standard still in use. It was apparent by the selection of the standard transactions and code sets, that is was not the intent of administrative simplification to turn the industry on its ear. This would certainly accommodate the installed industry base. It may also recognize that there may well be later V2 iterations that should be considered when designating a national standard. I applaud such forward thinking.
However, we contend that it is not forward thinking enough. McKesson has made significant commitments of time and personnel to further the HL7 Version 3 effort. We believe that V3 represents a quantum leap in integration technology. Based on a common reference information model (RIM), well-defined methodology, and a comprehensive tool set; V3 should not be considered as just the next version of HL7. It is the next generation of healthcare messaging standards; easily extensible to cover all facets of healthcare data interchange requirements.
Rather than tie the industry to a given version of a standard, we believe that the process should support the designation of an SDO, in this case HL7, as the producer of the national standard and allow the adoption of any ANSI accredited version of their standard. Such an approach would further validate the dual track approach supported by HL7 and foster systems enhancements to support the next generation of the standard.
Our experience with the process of adopting standards for administrative simplification has produced some trepidation. We share a concern with the industry that a methodology must be adopted that improves the timeliness of this process. We do not believe that the recommendation of a standard should result in the mandated adoption of one that is at that point obsolete.
McKesson has already made commitments to incorporate the V3 process into its product development cycle. While awaiting accredited messaging standards, we have instituted a process of basing data exchange and integration on the RIM and quasi-proprietary refined message information models (R-MIM). I say quasi-proprietary due to the fact that our R-MIM may differ slightly from the one actually balloted by HL7. Wherever possible we use proposed components and stand ready to convert to the accredited messages once available.
In summary:
Thank you again for your time and attention. I will be available to address any questions you may have about this testimony following the panel’s presentations.