The College of American Pathologists (CAP) appreciates this opportunity to submit written comments to the National Committee on Vital and Health Statistics on the administrative simplification provisions of the Health Insurance Portability and Accountability Act of 1996 (HIPAA), Public Law 104-191. The CAP is a medical specialty society representing more than 15,000 physicians board certified in anatomic and/or clinical pathology. College members practice their specialty in community hospitals, independent clinical laboratories, academic medical centers, and federal and state health facilities.
As you are aware, the requirements of HIPAA for adoption and development of standards to facilitate the transfer of electronic health data information have the potential to drastically reshape the U.S. health care system. In theory, following implementation of the HIPAA standards requirements, transfer of health information in the U.S. will occur within the confines of a national, uniform, accessible and confidential health information system.
While the CAP recognizes the potential benefits of a national health information system, we remain concerned about the standards that will be adopted to accomplish this goal. Adoption and implementation of inappropriate standards has the potential to produce undue burdens on both health care providers and patients and thereby negate the Congressional intent of HIPAA, to improve the efficiency and effectiveness of the health care system.
The administrative simplification provisions of HIPAA clearly mandate the adoption and implementation of standards for the administrative and financial transfer of health information. Implicit in HIPAA is the creation of a comprehensive health information system expanding beyond the scope of administrative transactions to encompass all of the activities in the clinical environment. An effective information linkage between the administrative and clinical environments is necessary in order to improve patient care delivery. We define the clinical environment as the setting in which the total patient care process occurs, including the assessment of patient care outcomes. The CAP urges NCVHS and HHS to keep first and foremost in its recommendations the synergy between the administrative and clinical environments.
As NCVHS and HHS consider the medical and clinical coding and classification issues surrounding implementing the HIPAA requirements, the CAP offers the following in response to specific questions posed by the Committee.
What are the Medical/Clinical Codes and Systems Currently Used for Administrative Transactions?
The systems widely in use today for administrative transactions are ICD-9-CM and CPT-4. ICD-9-CM and CPT-4 are designed for coding diseases/diagnosis and reporting medical services and procedures. While both systems work well for their intended purposes, ICD-9-CM and CPT-4 lack the detail necessary to assess the quality of patient outcomes. Administrative coding systems are not designed for the clinical environment and do not fit all the needs of the clinical environment.
Furthermore, ICD-9-CM and CPT-4 are classification systems. In contrast, a comprehensive health information system requires the use of anomenclature. The problem is that the particular terms used for classification systems are not generated as a natural part of routine documentation of the health care process, but rather are more general terms that are separately coded or abstracted. Classification systems do not have sufficient detail necessary to capture all of the processes that occur in the clinical environment. For example, clinical guidelines are extremely specific regarding the extent of coronary artery disease for which coronary artery bypass surgery, coronary angioplasty, or medical management would be appropriate. The detail contained in a classification system is not sufficiently specific to make the necessary distinctions. Classification systems are required for statistical analysis of data whereas a nomenclature has the detail necessary to perform studies and assess patient outcomes.
A Description of the Systematized Nomenclature of Human and Veterinary Medicine (SNOMED)
While the CAP recognizes that no system captures all clinical concepts, independent studies have demonstrated the Systematized Nomenclature of Human and Veterinary Medicine (SNOMED) to be pragmatically one of the most complete systems in use today for the clinical environment. SNOMED, copyrighted and published by the CAP, is a comprehensive nomenclature system designed to encompass all of the terms used in medicine, including procedures and diagnoses. SNOMED is cross-referenced to ICD-9-CM and can readily be cross-referenced to other classification systems. Therefore, SNOMED and classification systems are synergetic systems. SNOMED provides a mechanism to capture the detail needed to support classification systems, and much more.
SNOMED can codify all the activities within the patient medical record; including medical diagnoses and procedures, nursing diagnoses and procedures, patient signs and symptoms, occupational history, and the many causes and etiologies of diseases including such things as infectious conditions, genetic and congenital conditions, and the physical causes of injury. In contrast, classification systems such as ICD-9-CM represent only pieces of the medical record.
The CAP has over 30 years of experience with SNOMED. The precursor to SNOMED, the Systematized Nomenclature of Pathology (SNOP), was conceived in the late 1950s by the CAP Committee on Nomenclature and Classification of Disease and was first published in 1965. The first major evolution from SNOP to SNOMED occurred in 1975 when a field trial edition with nomenclature that extended to all medicine was published and distributed for evaluation and testing in 250 test groups representing various health care settings. Today, SNOMED International, the third edition of SNOMED, has gained wide acceptance internationally and is used by both the private and public sectors, including the Centers for Disease Control and Prevention and the Department of Veterans Affairs.
One of the advantages of SNOMED is its ability to adapt to multi-purpose coding. For example, SNOMED has been selected by the Digital Image Communications standard (DICOM) for representing anatomical and other concepts in the reports that accompany images in electronic messages. In cooperation with the American Dental Association (ADA), SNOMED has been revised to incorporate the ADA's nomenclature, integrating the ADA's nomenclature with the SNOMED structure while ensuring lack of overlap. This cooperative effort also permits the ADA wide latitude in determining the content of dental diagnoses contained in SNOMED. Similarly, working with NANDA, its nursing vocabulary has been integrated into SNOMED. We are also working closely with LOINC to integrate its clinical and laboratory codes into the structure and content of SNOMED.
There are several professional specialty organizations, in addition to those previously mentioned, with which the CAP is working to improve the detail and clinical content coverage of SNOMED. The CAP is committed to continuing these many efforts to meet the needs of the users of clinical vocabulary.
What Specific Suggestions Would You Like to See Implemented Regarding Coding and Classification?
Given the impending implementation date of the HIPAA standards requirements, the CAP recommends that the administrative transaction systems currently in use be allowed to continue (CPT-4 and ICD-9-CM). These systems are well accepted and understood, and there is significant investment in the abilities of organizations and individuals to encode clinical information in these existing systems.
Simultaneously, the CAP recommends that NCVHS take steps to establish a standard clinical standard nomenclature system that can be used to perform utilization review, risk management, quality assessment and other administrative functions.
Ultimately, a convergence should occur between the administrative transaction systems and nomenclature systems that will accurately reflect the entire patient health care process.
What Versions of ICD Would You Recommend Using?
As indicated previously, ICD-9-CM is designed to facilitate administrative transactions and therefore is not appropriate for use in the clinical environment. However, the advantage of ICD-9-CM is that it is familiar system.
ICD-10 appears to have made important strides in the direction of providing additional clinical detail and appears to be more of a hybrid between a nomenclature system and the current ICD-9 classification system. However, ICD-10 will require considerable retraining of coding staff and health care professionals. Consequently, it may be more worthwhile to retrain the same individuals to understand a nomenclature system.
The CAP has reviewed draft versions of the pathology sections of ICD-10-PCS. The anatomic and clinical pathology sections are inadequate. Furthermore, the system is still new and needs to be extensively tested prior to adoption and use on a large scale.
The CAP believes that further studies and trials should be conducted on ICD-10-CM and ICD-10-PCS to establish the relative costs and benefits of these systems. It is not a foregone conclusion that these systems should be implemented.
How Should the Ongoing Maintenance of Medical/Clinical Codes Sets and Systems be Addressed?
It is important to define the concept "in the public domain." If the concept refers to public access to a single official version of clinical codes and systems controlled through a public entity, the CAP could possibly support code sets and systems being within the public domain.
However, this raises the issue of how the ongoing maintenance of the codes sets would be financed. If public domain also is intended to mean "free of charge," this would imply that the government would have to take responsibility for the costs of maintenance and updates. In any scenario, whether publicly financed or based on charges to the users, the CAP strongly recommends that health care professionals remain in control of and responsible for the content and structure of clinical terminology.
The CAP believes that there should be a public-private partnership in the ongoing maintenance of systems with substantial financial investment by the government. Ongoing updates should be made regularly using professional coders and health care experts to ensure that the terminology is grounded in sound scientific logic.
What Would be the Resource Implications of Changing From the Coding and Classification Systems Currently Used to Other Systems?
It is inevitable that costs will be incurred in moving from the current system to that of a comprehensive, uniform health information system. The costs will include those associated with the implementation of electronic information systems and education of health care professionals, health information management professionals and the public about the new system. It will be important to minimize these costs and to make the transition as efficient and effective as possible.
What are Your Concerns About the HHS Coding and Classification Implementation Team?
The CAP would like more detailed information about the process to be used by the implementation team in selecting and recommending the set of health vocabularies needed for full coverage of concepts in computer-based patient records and other types of health data. We recommend that this process be clearly described and open, and that there be ample opportunity for input from organizations such as the CAP.
What Additional Concerns and Suggestions do You have for Carrying Out the Requirements of HIPAA?
In addition to the medical/clinical coding and classification issues addressed in HIPAA, the CAP would like to briefly state its concerns related to implementing the HIPAA privacy and confidentiality standards. The confidentiality of patient health care information is a basic principle of medical ethics. For CAP members, the principle of the confidentiality of patient information is a cornerstone of the physician-patient relationship.
The CAP supports the need for policies and procedures designed to protect the privacy of individuals. The key, however, is to develop policies that will protect the privacy and confidentiality of health care data while not unnecessarily impeding important research that may lead to improved therapies and prevention of disease in humans. The CAP, therefore, recommends that standards to protect patient information and data address the following issues:
In closing, the CAP urges NCVHS and HHS to focus on the entire clinical environment as recommendations are developed to implement the administrative simplification provisions of HIPAA. Administrative transaction systems alone do not have the detail necessary to capture the processes that occur in the clinical environment nor are they designed for this purpose. A nomenclature system is necessary for patient quality assessments. The CAP recommends that efforts are made to move toward developing a comprehensive health information system that links the activities of the administrative environment and the clinical environment. Also, the CAP recommends that standards to protect patient information and data address issues related to the appropriate access, release and use of information for research purposes.
The CAP stands ready to offer its assistance in implementing the HIPAA standards requirements.