THE FORUM OF END-STAGE RENAL DISEASE NETWORKS, Mr. JOHN J. SALMON, DEAR MR. SALMON: On behalf of the Forum of ESRD Networks, I am submitting five copies of this written statement for inclusion in the printed record of the House Ways and Means Subcommittee on Oversight's hearing of April 22, 1982 relative to: "The proposed regulations governing reimbursement under the Medicare ESRD Program." Although it is our understanding that the Subcommittee will hear testimony on network activities later this year, this statement specifically addresses the proposed regulations and the relationship of networks relative to their proper administration and evaluation. The Health Care Financing Administration's (HCFA) proposal for implementing Congress' mandated dual composite rate structure will have an immediate impact on the majority of ESRD facilities in this country. How the providers of care will adjust to these new rates is not fully understood. Congress has the responsibility for evaluating these changes and their impact on patient care. Networks are the only mechanism currently in place which have the data and professional expertise necessary to assist Congress in assuring that renal patients are not adversely or unjustly penalized as a result of these Congressional and Administrative changes in the reimbursement policy. It is unfortunate that HCFA has recommended the elimination of networks at a time when their functions are absolutely critical to the continued health and safety of over 68,000 renal patients. Members of Congress have been reviewing carefully the total ESRD program in order to determine the most effective mechanism for controlling costs without endangering the quality and appropriateness of care delivered to ESRD patients. While a consensus exists relative to the soundness of this objective, there is strong disagreement with respect to the most appropriate mechanism. Previous public laws and regulations aimed at encouraging less expensive treatment modalities have not been successful. The current proposal regulations have been met with criticism and fear by both providers and patients. The Forum believes that Congress is forced by HCFA to formulate legislation without the benefit of complete, accurate and timely ESRD data, the absence of which is referenced throughout the proposed regulations and emphasized by those who criticize them. The Forum asks that the Subcommittee give careful consideration to the critical need for accurate data, the historical inability of the national ESRD-Medical Information System (MIS) to provide such data, and the current role of networks in data-related activities. The national ESRD-MIS, plagued with problems since the onset of the program, has been unable for nearly a decade to produce the data necessary for proper program management and administrative decision making. When networks were funded in 1978, they were told that the MIS would support their data needs relative to the performance of their required medical review functions. Recognizing that medical review without data is impossible, networks independently, and often in conflict with HCFA directives, developed their own manual patient data collection systems. It was, in fact, the access to data at the network level that led to identification of specific problems in the MIS. As a result, effective January 1, 1981, HCFA assigned to networks full responsibility for the collection, validation and submission of all non-reimbursement MIS forms. This was in addition to their responsibility for the Semi-Annual MIS Facility Survey and the MIS Patient Census. Just last year HCFA permitted networks to establish access to computerized data processing. Since that time the majority of networks have converted from manual to automated data systems. The Forum regrets that HCFA has not made an effort to coordinate data activities between networks, nor have they requested our reports for your review. All activities now underway relative to providing a meaningful exchange and sharing of information between networks has been initiated by individual networks and coordinated via the Forum. The Forum itself was organized voluntarily by network chairpersons to meet this need for communication between networks. In March, the Forum asked each network to send copies of the 1980 and 1981 MIS Semi-Annual Facility Survey forms to one network for compilation. Networks have been responsible for collecting and forwarding these forms to HCFA for the past three years. HCFA rarely publishes the data in a timely fashion and to our knowledge has not yet published any 1981 reports. Enclosed for your review are copies of the reports published by one network in less than a month. Please recognize that these data were produced primarily for network use, and thus several titles require clarification in order to be fully understood by a broader based audience. Also, network numbers have been omitted from some tables. I have sent you a copy of the packet especially developed for my local network area, and thus you will find "Network 4" identified and underlined on most of the tables. These tables are being sent to you because the Forum is impressed by the quality of the data and the timeliness in which they could be produced by a cooperative effort of 32 networks acting without HCFA assistance. Many of these tables, such as the ones on new patients per million population and mortality of dialysis patients, have never been produced by the HCFA's MIS. In previous Congressional testimony, the Forum stated that if networks were continued in 1982 they would be able to provide data that characterize the dialysis and transplant patient population. Samples of such data are now available for your review and include socio-demographic characteristics, morbidity factors, and incidence, prevalence, and mortality rates. Unfortunately, the ESRD-MIS has not provided comparable data for the nation, even though networks have met their responsibility relative to the collection and submission of MIS forms. Patients and providers have expressed their concerns relative to HCFA's plan for monitoring the impact of the proposed regulations on the quality of care rendered to patients. Serious questions have been raised as to what measures are planned to assure that appropriate care is provided in a fair and equitable manner. Networks and their Medical Review Boards (MRBs) represent the only mechanism ready to respond to these concerns. Since 1978, MRBs nationwide have performed activities relative to their regulatory functions, which are summarized below: (See Section 405.2113, Federal Register, June 6, 1976): "Monitoring and assessing the appropriateness of patients for the proposed treatment modalities; "Evaluating the performance of facilities and physicians based on aggregate data for at least the following three areas: appropriateness of the proposed treatment modality; morbidity; and mortality; "Performing medical care evaluation studies, which include the development of criteria and standards, data collection and display, interpretation of the findings, institution of corrective action, and reperformance of any study which indicates a problem; "Performing in-depth studies as indicated; "Offering recommendations for improvements and reporting inappropriate or substandard care to the Secretary". Medical Review Boards have met their responsibilities relative to these functions. The majority of networks have conducted studies on the appropriate selection of patients for home dialysis, and can update these studies as necessary. Criteria sets and the results of these studies are available for your review at any time. The range of topics selected by networks for in-depth study is impressive. The enclosed booklet developed by the Forum provides a listing of these studies and other related activities performed by networks during 1981. HCFA has stated that "continuous ambulatory peritoneal dialysis (CAPD) is the preferred treatment for many patients." Currently, there is no medical evidence to support this position as long-term clinical experience is just beginning. In addition, data are not available to support a conclusion that CAPD is a less costly treatment option. Although networks do not collect actual cost data, they are conducting studies which will help determine how this treatment modality compares to other forms of dialysis in medical effectiveness and cost by taking into account the rate and duration of hospitalization. This is but one example of how networks simultaneously evaluate the effectiveness of care and associated costs. HCFA is required to report annually to Congress on the total ESRD program, including the role of networks. In order to prepare this report, HCFA requires networks to submit an annual report documenting all activities. Unfortunately, network achievements have, for the most part, been omitted from HCFA's report to Congress. Members of the Forum have had the opportunity to review the draft copy of HCFA's 1980 ESRD Report to Congress and compare it to the final document. During the revision process, HCFA omitted key sentences including the following on the role of networks relative to data: "The efforts (networks role in collecting and submitting MIS forms) culminated in 100 percent compliance in Facility Survey forms, resulting in increased validity and accuracy of the ESRD patient data base. "The data (collected by networks for their individual patient data systems) supplement the national MIS data, making possible profile analysis on an individual network basis in areas such as incidence, prevalence and survival rates by treatment modality, age/sex distribution of patients, primary diagnosis statistics, and facility capacity reports." Because the Forum believes that Congress is not receiving from HCFA an adequate or honest summary of network achievements, we prepared the enclosed booklet, which highlights network activities in 1981. We feel confident that you will be impressed by its content, and as puzzled as we are when you compare it to reports from HCFA. Recently, Dr. Carolyne Davis, Administrator of HCFA, was asked to testify on the ESRD Program before a Subcommittee of the House Government Operations Committee. When asked how HCFA monitored the quality of care, she responded that this was the function of networks. She was then asked if HCFA had recommended the elimination of networks, and she responded yes. When asked why HCFA recommended the elimination of networks, she stated because (1) the networks had not shown that they were successful enough to warrant their cost, and (2) the networks' planning role is hampered by the individuals' conflicts of interest. These reasons clearly demonstrate HCFA's lack of understanding of the network program. First, the total network budget for 1982 was $4.5 million, or less than .3 percent of the estimated $1.8 billion total annual ESRD program budget. Considering network achievements relative to data collection, validation and application for assuring the quality of patient care, it seems unreasonable to recommend the elimination of networks for reasons of cost. Secondly, networks have never had any authority relative to the planning process. Networks provide information, such as incidence and prevalence data, to those local and regional agencies legally responsible for health planning. The Forum believes Dr. Davis has misled Congress as to the functions and cost-effectiveness of the network program. In conclusion, networks comprise a relatively inexpensive, functioning system that has already demonstrated the ability to generate meaningful data impacting on the quality of care, cost control, and the effective administration of the total program. No other system exists for carrying out these functions and the interruption of network activities would prove disastrous to the management of the ESRD program. The Forum urges your thoughtful consideration of this statement as you review comments submitted by those who are concerned as to the impact of the proposed regulations on the patients with end-stage renal disease. We are optimistic that you will recommend denial of HCFA's proposal to eliminate networks. If you have any questions or wish to review documents cited in this statement, please feel free to contact me. Sincerely, Enclosures. DOMINICK E. GENTILE, M.D., Chairman, Forum of ESRD Networks. |