Hubert H. Humphrey Building

Room 705-A

200 Independence Avenue, SW

Washington, DC

Presented by: Doug Pratt

Lead Analyst for Systems Integration

SMS

On behalf of SMS and HL7, I want to thank you for the opportunity to testify before you today on the very important subject of the standardization of message formats for patient medical record information (PMRI).

During my testimony, I will share with you

• SMS’ commitment to industry standards,
• our view of patient medical record information,
• the role of data models in standardizing messages for comparable PMRI,
• an assessment of the health care industry’s progress to date developing these standards, with emphasis on HL7
• inhibitors to advancing industry standards development to achieve plug compatibility, and
• how the federal government can help the health care industry realize the enormous potential and cost savings of plug compatible interface standards for comparable PMRI.

SMS is firmly committed to supporting industry standard message formats and common vocabulary across its entire line of integrated solutions for the health care industry. We have actively participated in the development of these standards for over a decade, assuming a number of leadership roles during this time.

Our customers have realized significant benefits as a result. By providing a common starting point for negotiating interface specifications among a health care provider’s software vendors, messaging standards reduce the amount of time that it takes to deploy interfaces. This is positive for providers and vendors alike. Standards also reduce the likelihood of misinterpretation of the meaning of the various elements of comparable PMRI messages used for data exchange, especially when implementation guides are provided so that all participants implement a standard message in the same way with the same data content.

Computer-based patient medical record (CPR) information is electronically maintained information about an individual's lifetime health status and health care. It replaces the paper medical record as the primary source of information for health care, meeting all clinical, legal and administrative requirements. It necessarily encompasses all data related to the person's health care, including demographic, clinical and financial information. The data include text, numbers, sounds, images, signal tracings and full motion video, which are integrated so that any given view of health data may incorporate one or more of these structural elements. It is not merely a recreation of the paper medical record. It enables health care providers to reengineer the health delivery process because it makes information readily available to the care provider when care decisions are being made and, as a by-product, provides a source to aggregate data for outcomes analysis. (The individually identifiable data can be excluded from aggregated data for health studies.) Clinical and financial decision-making is data driven rather than empirically formed.

The essential model is a "vocabulary" model. It is this vocabulary that enables the diverse and fragmented elements of the health delivery system to operate as a whole, coherently serving all stakeholders in facilitating effective and efficient health outcomes across the care continuum.

Information that is meaningful, interoperable and shareable is the essential objective. This requires that the underlying vocabulary, and the format in which it is communicated, must be standard, and is key to achieving comparable PMRI.

The strategic goal of health information system providers such as SMS is the Computer-based Patient Record (CPR). Whatever the technical implementation, it must be a truly portable record that follows the patient, and it must assimilate medical logic modules that are models of "best practice".

The CPR is made possible by improvements in underlying technology, particularly the growing reach and throughput of electronic networks. The primary barrier to achieving a viable CPR is the lack of universal standards that allow data integration across diverse and fragmented health provider organizations and health networks, and the application of standard medical logic modules. Progress is being made, but much work remains to be completed.

Let’s examine the current state of HL7 messaging and where it is headed in the future.

HL7 Version 2 is the most current generally available version of this standard. SMS specifies HL7 Version 2 for most of its interfaces that exchange PMRI. There is no question that HL7 Version 2 has significantly improved systems integration over the past decade, prior to which there was no accepted industry standard. Nevertheless, it is universally agreed that HL7 Version 2 falls short of achieving so-called "plug and play" compatibility.

There are a number of reasons for this; among them:

• the lack of a common vocabulary pertaining to data elements whose values are derived from coding systems,
• the fact that a number of data elements are subject to broad interpretation, and
• an over use of the optional attribute for HL7 data elements.

As a result, health care providers who purchase products that are designed to interface in accordance with the Version 2 specification find that the products cannot work together without site specific negotiations. This has made it impossible to construct and perform any kind of meaningful certification testing.

HL7 Version 3 promises to enable interfaces that come much closer to delivering plug compatibility "out of the box." Whereas Version 2 provided a starting point for interface negotiations, Version 3 is expected to reduce the negotiations to resolving minor, site-specific requirements.

Version 3 messages will be derived from the formal, rigorous message models under development within the HL7 technical committees. These models greatly reduce the need to declare data element optional because messages are derived from use cases. Together with the contributions of the HL7 Vocabulary Special Interest Group, Version 3 will directly address the three major deficiencies identified in my discussion of HL7 Version 2.

However, much standards development work remains to be done before Version 3, as a full functional replacement for Version 2 can be balloted and interfaces written to it put into production.

Progress is being made. But progress could be much greater if "funding", in whatever form, allowed a more intensive effort. The HL7 membership comprises some of the most talented developers in our respective companies. Efforts to accelerate standards development compete with product development. Travel expenses, to a lesser but still significant degree, limit the number of people that can attend working group meetings.

Another component of the Industry’s challenge today is that their revenues are declining due to Medicare, Medicaid and managed care reduced reimbursements. At the same time, regulatory initiatives such as Medical Necessity and HIPAA are driving the need for new capital and operating investments. Thus, revenues are declining and expenses are rising, putting more pressure on available capital and discretionary spending. The Industry is now facing more severe trade-offs between improving their care delivery capabilities versus improving their information infrastructure.

How can the Government help?

First, we believe that the HIPAA legislation is a valuable initiative that will eventually help the Industry reduce the overall cost of administering Health Care. However, the investment spike to achieve the projected savings is significant and daunting to many. The challenge is not in the logic or value of HIPAA, the challenge is in how we can collectively afford to get there from here.

One mechanism that has worked in the past in American industry is the concept of targeted investment tax credit. If the Government would like us to achieve the benefits associated with using standards and efficient electronic communications, then helping guide the Industry’s investments would stimulate progress in a meaningful direction. We strongly believe that targeted tax incentives applied to meaningful investments on the part of the all parties of health care (providers, payers, suppliers, information systems and technology companies) will accelerate our collective ability to realize the benefits described throughout my testimony.

Second, the federal government should help the Healthcare Informatics Standards Board (HISB) develop and execute a stronger charter that provides real leadership in healthcare informatics. This group is chartered with coordinating the activities of the various standards development organizations. This is a critical function that, in our judgement, needs stronger leadership.

Third, the federal government should designate an independent agency or agencies to design and execute conformance testing. We feel that it is critical that this be done outside of the standards development organizations (which are dominated by competing vendors) in order to eliminate any possible conflict of interest. This also enables the standards development organizations to concentrate on developing standards.

SMS and our customers understand the monumental benefits of the computer-based patient record, and the critical role that messaging standards such as HL7 and X12 play in fully realizing these benefits. Towards that end we have committed significant resources towards the development of these standards. While progress has been satisfactory, we believe that there is much room for improvement. We believe that the federal government can best help by providing much-needed financial incentives to increase participation by the private sector.

Mr. Chairman and members of the committee, it has been an honor and a pleasure to deliver this testimony to you. Thank you very much for this opportunity.