My name is Jean Narcisi. I am the Director of the Office of Electronic Medical Systems for the American Medical Association (AMA). It is my pleasure to appear today on behalf of the AMA before the Workgroup on Computer-based Patient Records of the National Committee on Vital and Health Statistics (NCVHS). I would like to thank you for the opportunity to testify.
My statement summarizes the views and concerns of the AMA on issues related to uniform data standards for, and electronic transmission of, patient medical record information, as well as the appropriate role for the federal government in addressing these issues. AMA policy with regard to computer-based patient records includes the following:
The following steps will allow the AMA to act as a source of physician input to the revolutionary developments in computer-based medical information applications, as a coordinator, and as an educational resource for physicians. The AMA will: (1) Provide leadership on these absolutely critical and rapidly accelerating issues and activities. (2) Work, in cooperation with state and specialty associations, to bring computer education and information to physicians. (3) Work to define the characteristics of an optimal medical record system; the goal being to define the content, format and functionality of medical record systems, and aid physicians in evaluating systems for office practice computerization. (4) Focus on the CPR aspect of human-computer interaction (the physician data input step) and work with software venders on the design of facile interfaces. (5) Provide guidance on the use of computer diagnosis and therapeutic support systems. (6) Continue to be involved in national forums on issues of electronic medical data control, access, security, and confidentiality. (7) Continue to work to ensure that issues of patient confidentiality and security of data are continually addressed with implementation resolved prior to the implementation and use of a computer-based patient record. (H-480.971)
The following comments will address the questions we were asked to discuss as well as other issues of concern to the AMA.
1.How do you interpret the Congressional instruction?
The responsibilities of the NCVHS to evaluate and recommend patient medical record standards, which includes clinical information standards, are addressed within Section 263 of the Health Insurance Portability and Accountability Act (HIPAA) of 1996 (P.L.104 -191). Section 263 states that the NCVHS “shall study the issues related to the adoption of uniform data standards for patient medical record information and the electronic exchange of such information; and shall report to the Secretary [DHHS] not later than 4 years [August 2000] after the date of the enactment of the Health Insurance Portability and Accountability Act of 1996 recommendations and legislative proposals for such standards and electronic exchange.”
It is important to note that NCVHS’ responsibilities on this issue are fundamentally different than those for HIPAA administrative transactions. There is no federal legislation requiring implementation of medical record standards. Moreover, it is not at all clear if the HIPAA model for administrative transaction standards, which is intended to address inter-enterprise communication, is fully applicable to medical record standards that involve a large intra-enterprise focus.
HIPAA is intended to improve “…the efficiency and effectiveness of the health care information system through the establishment of standards and requirements for the electronic transmission of certain health information.” Since the NCVHS was asked to study the issues relating to the adoption of uniform data standards for patient medical record information and the electronic interchange of such information, the AMA believes that the NCVHS should also continue to study and identify privacy, security, and access measures to protect individually identifiable health information in an environment of electronic networking and multiple uses of data. These measures must be in place to assure a secure and ethically principled electronic environment for patient data.
Because the Secretary of the Department of Health and Human Services (HHS) is likely to rely on the advice of the NCVHS, it is essential that your recommendations be carefully evaluated and thoroughly deliberated with these protections in mind.
2.What factors or issues are preventing or delaying the development and widespread implementation of uniform standards for patient medical record information and its electronic transmission?
A recent AMA survey indicated that only 14% of physicians have electronic patient medical record systems in their primary practice. The survey did not define an electronic patient medical record; therefore, this number could actually be lower. In general, the frequency and extent of use of electronic patient medical record systems by physicians practices has been related to the size of the practice; the larger the practice the more likely it is to be automated. It has been reported that less than 5% of ambulatory patient records were completely computerized in early 1997. In addition, only 22% of group practices (with 20 or more physicians) and 25% of hospitals have computerized their patient records.
These data imply that there is great potential for the health care community to acquire health information systems in the future. Although there are numerous efforts underway to standardize key elements of an electronic patient medical record system, we cannot over-emphasize the critical need for physician input. Without this input, electronic patient medical record systems will be "modified" in an attempt to fit physician's applications rather than developed specifically for the profession that is key to their creation and use.
The AMA realizes that one of the biggest barriers in health care information technology relates to the current status of standards. Standards for electronic patient medical record systems need further work in a number of areas, including, but not limited to, medical vocabulary, common identifiers, data exchange, and privacy and confidentiality. In addition, standards are lacking in the categories of authentication, system interfaces and interoperability. This latter deficiency is especially troublesome because the underlying technology and infrastructure of an electronic patient medical record system must incorporate the ability to communicate between one system and another.
Although, many organizations are addressing standards and issues related to electronic patient medical record systems, no organization is focusing on the necessity for vendors to incorporate the specific needs of the practicing physician in the ambulatory care setting. Since there are no agreed upon standards for electronic patient medical record systems, the vendor community is creating a variety of electronic patient medical record systems that are often incompatible. This situation leaves little guidance for physicians in selecting systems.
This incompatibility is especially acute because clinical efficiency often demands that multiple programs be available on a single workstation. Physicians often use multiple computerized programs in an ambulatory setting. Unfortunately, vendors have not effectively dealt with this need for multiple systems and physicians must often switch from program to program in a cumbersome fashion. In addition, many physicians have expressed concerns about data input inefficiencies. For an electronic patient medical record system to become a success, it must facilitate direct data entry in a time-efficient manner.
The AMA believes that a true private sector approach to standards development is needed, with the role of the federal government much more sharply limited than has been the case with the development of administrative transactions standards. The federal government could play a useful role, however, in helping to identify any gaps in standards, as well as helping to facilitate and prioritize standards development. At the same time, we state emphatically that the AMA does not believe that federally mandated standards are likely to be an appropriate or productive course.
Cost may be an obstacle for delaying the widespread implementation of electronic patient medical record systems. The costs for installing ambulatory physician practice electronic medical record systems vary substantially depending on the size of the installation. In addition to these purchase and installation expenditures, physicians could also expect an initial increase in administrative costs as well as an initial decrease in productivity while physicians and staff adjust to the newly installed system. Over time, however, an installed electronic patient medical record system is predicted to lower costs in the following areas: clerical labor support, transcription of notes, storage, and supplies.
3. Is the private sector able to address these problems satisfactorily? In your opinion, what is the role of government for assisting the private sector in the guidance, development, coordination, and implementation of standards for patient medical record data and their electronic transmission? How might the government help to improve the standards processes?
It is clear that physicians and their patients can derive important benefits from broader use of electronic patient medical record systems that adequately address their needs. At the same time, the AMA recognizes that there are important issues related to potential impact on physician time, cost, patient care, and confidentiality. In addition, the AMA realizes that current electronic patient medical record systems are not fully supporting patient or physician needs.
As indicated previously, the AMA believes that standards will evolve and should be allowed to do so in the private sector. Automation of clinical data will occur at different rates throughout the health care industry. Larger health care delivery systems, such as hospitals, integrated health networks, and managed care organizations will continue to lead the trend in automation. This trend will be slower in the ambulatory setting, with the larger practices automating first. Although the requirements of institutional systems often overlap with those of non-institutional and physicians’ systems, they are not identical. Therefore, electronic patient medical record systems should be continually evaluated in order to meet the specific needs of physicians and patients.
Despite the slow penetration into the ambulatory practice, physicians are interested in electronic patient medical record systems, in part due to anticipated improvements in technology and software. In fact, information technology spending on physician-oriented systems is predicted to increase substantially within the next few years.
Based on the current environment and obstacles, the AMA believes that it is premature for the NCVHS to suggest specific standards for electronic patient medical record systems, particularly in the context of potential privacy and security federal legislation and subsequent regulations. At the same time, there is a need for accelerated progress in the electronic patient medical record systems by the vendor community. This progress should address the areas of system interfaces and interoperability. Perhaps it should also focus on developing a framework for the specification of a clinical data architecture as it applies to the application data interface of health care information systems. As stated previously, interoperability is an especially important feature for physicians because electronic patient medical record systems must have the ability to communicate between one system and another to assure continuity of quality patient care.
4. Which standards related to patient medical record information and its electronic transmission would:
(E) Add the most value for improving the quality and efficiency of health care for the nation? Why?
(F) Be most important to the business or goals of your organization? Why?
(G) What is the business case for more rapid standards development and implementation?
As stated previously, the AMA believes that standards are deficient for electronic patient medical record system in a number of areas, including, but not limited to, medical vocabulary, common identifiers, data exchange and privacy and confidentiality. The AMA believes that there is no single solution to the vocabulary needs for computerized patient records. We see, consistent with previous NCVHS discussion, the need for interlocking code sets with each code set addressing different aspects of the vocabulary issue.
As you know, we are working to develop the next generation of CPT (i.e., CPT-5) and have taken initial steps, with the National Library of Medicine and the College of American Pathologists, to map CPT-4 to SNOMED. CPT-5 is explicitly designed to meet the HIPAA criteria for a longer term procedure code set for administrative and financial transactions and a promising and integral element of the coding sets needed for computer-based patient records.
The CPT-5 project is examining the need to:
The CPT-5 project is structured to capture input from a variety of sources. Participation on the project Workgroups include coding, payment and health systems experts from a variety of backgrounds including clinical, data management, and research from both the public and private sectors. Representatives from the National Center for Health Statistics (NCHS) and the Agency for Health Care Policy and Research (AHCPR), as well as a liaison from the National Library of Medicine (NLM), also participate in the Workgroups. There are currently six topic-specific workgroups involved in the CPT-5 project: Managed Care, Research, Nonphysician Practitioners, Maintenance and Education, Sites of Service, and Structure and Hierarchy.
The AMA recommends that the CPT-5 code set be designed to meet the diverse needs of its various users, including clinicians, payers, managed care plans, and researchers. In addition, the AMA believes that data content standards for claims, encounters and attachments should adhere to the recommendations of the National Uniform Claim Committee (NUCC), the National Uniform Billing Committee (NUBC) the National Council for Prescription Drug Programs (NCPDP) and the American Dental Association (ADA). It is essential to recognize that data formats for electronic transmission of claims/encounters can best be viewed as messaging standards that serve as electronic envelopes into which appropriate data are placed. We believe strongly, however, that groups like the NUCC and NUBC should make data content decisions.
In the future, the NUCC will determine if the appropriate data elements are included in the data sets to support the performance measurement applications that are being developed in today’s environment. There clearly are needs for the collection of data for health care applications, including clinical care, administrative reimbursement, practice management, and statistical reporting. Since no standards exist for the computer-based patient record, claims data will continue to be used to capture some of this detail. The NUCC is currently revising its protocol and expanding its membership to include the public health and research community, as well as the Health Level 7 (HL7) standards developing organization, in order to meet some of these diverse needs.
The AMA is highly supportive of the NUCC’s activities. NUCC efforts have resulted in the development of a standard data set, with complete and unambiguous data definitions, for an electronic environment but applicable to evolving paper claim form standards. The current NUCC data set defines the set of data elements that physicians and other health care professionals should submit with claim or encounter transactions and that payers should be prepared to accept as sufficient.
The NUCC data set is a uniform data set that represents a workable compromise among the providers, payers and others represented on the NUCC. It could provide a “blueprint” for vendors to build into their electronic patient medical record systems. It clarifies to providers what is required on a claim for all payers. It also provides guidelines to clearinghouses and payers on the standardized components of a claim. The data set, and the NUCC process for its maintenance, should provide physicians with effective protection against arbitrary and/or excessive data requirements by payers and others, while enabling them to communicate key clinical, financial, and administrative information to payers and managed care organizations.
Besides recommending the CPT-5 code set and the NUCC data set as clinical data standards for current and future HIPAA applications, the AMA realizes that HL7 is widely used in current health care software systems, especially in the hospital environment. Therefore, the AMA recommends that HL7 should be a key standard used by vendors when building electronic patient medical record systems. However, as stated previously, the AMA believes that standards will evolve and should be allowed to do so in the private sector.
13. Do you agree with our emphasis on the four focus areas listed above? Explain.
The AMA believes that the four focus areas identified by the NCVHS Subcommittee on Standards and Security are extremely critical areas to be studied. However, as stated previously, in addition to studying the issues relating to the adoption of uniform data standards for patient medical record information and the electronic interchange of such information, the AMA believes that the NCVHS should also continue to study and identify privacy, security, and access measures to protect individually identifiable health information in an environment of electronic networking and multiple uses of data.
Thank you for this opportunity to present the views of the American Medical Association. I would be pleased to respond to any questions that you might have.