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~- Appendix B Final Version of National Guidelines for Health Planning (March 28, 1978) - B1

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- B2 Health Planning and Resources Development Part 121 - National Guidelines for Health Planning Subpart A General Provisions See. 121.1 121.2 121.3 121.4 121.5 121.6 Definitions. Purpose and scope. Applicability of national guidelines to Health Systems Plans. Applicability of national guidelines to State health plans. Responsi bi I ity of health systems agencies. Adjustment of standards for particular Health Systems Plans. Subpart B National Health Planning Goals (Reserved) Subpart 4:: Standards Respecting the Appropriate Supply, Distribution, and Organization of Health Resources 121.201 General hospitals- Supply. 121.202 General hospitalsOccupancy rate. 121.203 Obstetrical services. 121.204 Neonatal special care units. 121.205 Pediatric inpatient services Number of beds. 121 .206 Pediatric inpatient servicesOccupancy rates. 121.207 Open heart surgery. 121.208 Cardiac catheterization. 121.209 Radiation therapy. 121.210 Computed tomographic scanners. 121.211 End-stage renal disease (ESRD). Authority: Section 1501 of the Public Health Service Act, 88 Stat. 2227 (41 U.S.C. 300k-1~. Appendix B

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B3 - SUBPART A GENERAL PROVISIONS 121.1- DefinitIons. Terms used herein shall have the meanings given them in 42 CER 122.1 . 121.2 Purpose and scope. Section 1501 of the Public Health Service Act requires the Secretary to issue, by regulation, national guidelines for health planning. The guidelines are to include national health planning goals (section 1501 (b)~21) and standards respecting the supply, distribution, and orga- nization of health resources (section 1501(b)~1~. This subpart includes general provisions applicable to such goals and standards; subpart B of this part sets forth specific national health planning goals; and subpart C sets forth specific standards respecting the supply, distribution, and or- ganization of health resources. 121.3 Applicability of national guidelines to Health Systems Plans. Section 1513(b)~2) of the Act requires health systems agencies, in the development of their Health Systems Plans, to give "appropriate consid- eration" to the national guidelines for health planning. Health Systems Plans must also '`take into account" and be "consistent with" the standards respecting the supply, distribution, and organization of health resources set forth in subpart C. (a) Meaning of "consistent with." A Health Systems Plan will be con- sidered "consistent with" a standard set forth in subpart C where it (1 ) es- tablishes a target level which is not in excess of the level set forth in the standard where that level is stated as a maximum, or not less than the level set forth in the standard where that level is stated as a minimum, except where a specific ad justment is justified in accordance with subpart C or 121.6 of this subpart, and (2) includes plans which, if implemented, are reasonably calculated to achieve that target level within five years. (b) Effective date. Health Systems Plans established after December 31, 1978, must be "consistent with" each standard set forth In subpart C. 121.4Applicability of national guidelines to State health plans. Each State's State health plan developed under Title XV of the Act must be "made up of" the Health Systems Plans of the health systems agencies within the State, revised as found necessary by the Statewide Health Coordinating Council to achieve their appropriate coordination with each other or to deal more effectively with Statewide health needs. (Section 1524(c)~2~(A) of the Act.) Since Health Systems Plans must individually give appropriate consideration to the national guidelines for health planning and take into account and be consistent with the standards respecting the supply, distribution, and organization of health resources, the State health plan will accordingly reflect the guidelines.

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- B4 121.5 Responsibility of health systems agencies. Subject to the authority of the Statewide Health Coordinating Council to require the revision of Health Systems Plans under section 1524(c)~2~(A) of the Act, each health systems agency is responsible for analyzing the needs and conditions in its health service area and applying the national guidelines for health planning in the development of its Health Systems Plan, including the need for adjustments. 121.6 Adjustments of standards for particular Health Systems Plans. Subpart C of this part includes provisions for adjustment of individual standards. I n addition: (a) Health systems agencies must make such adjustments as may be necessary: (1) to take into account special needs and circumstances of Health Maintenance Organizations; (2) to take into account services available to local residents from Federal health care facilities; and (3) to take into account higher minimum target levels and lower maximum levels that are established for State Certificate-of-Need and related programs. (b) Whenever a health systems agency concludes, on the basis of a detailed analysis, that development of a Health Systems Plan consistent with one or more of the standards set forth in subpart C would result in: (1 ) residents of the health service area not having access to necessary health services; (2) significantly increased costs of care for a substantial number of patients in the area; or (3) the denial of care to persons with special needs resulting from moral and ethical values; and that result cannot be avoided through use of the adjustments specifically provided for in the standard or in paragraph (a) of this section, the agency may include in the Health Systems Plan a special adjustment of the standard or standards which will avoid this result. Whenever a special adjustment is so included, the plan must also contain a detailed justification fG the adjustment and documentation of the circumstances that are the basis of the justification. In the case of an adjustment included on the basis of (1 ) or (2) above, the plan must further include an analysis indicating whetherthe need for such an adjustment is permanent. If it is, the supporting rationale must be documented and if it not, an estimate must be included of how long inclusion of the adjustment will be required along with a detailed justification for that length of time. (c) Any proposed adjustment under this section and the analyses supporting it must be reviewed by the State health planning and devel- opment agency in its preparation or review of the preliminary State health plan under section 1523(a)~2) of the Act and by the Statewide Health

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B5 - Coordinating Council in its preparation or review of the State health plan under section 1524(c)~2) of the Act. On the basis of that review, and consistent with Statewide health needs and the need to coordinate Health Systems Plans as determined by the Statewide Health Coordinating Council, the adjustment may be made part of the State health plan. The Statewide Health Coordinating Council shall report its comments on and disposition of the proposed adjustments to the Secretary under section 1524(c)~1) of the Act. SUBPART B NATIONAL HEALTH PLANNING GOALS (Reserved) SUBPART C STANDARDS RESPECTING THE APPROPRIATE SUPPLY, DISTRIBUTION, AND ORGANIZATION OF HEALTH RESOURCES 121.201 General Hospitals Bed Supply (a) Standard. There should be less than four non-Federal, short-stay hospital beds for each 1,000 persons in a health service area except under extraordinary circumstances. For purposes of this section, short-stay hospital beds include all non-Federal short-stay hospital beds (including general medical/surgical, children's, obstetric, psychiatric, and other short-stay specialized beds). Conditions which may justify adjustments to this ratio for a health service area include: (1 ) Age: Individuals 65 years of age and older have a higher hospital utilization rate up to four times that of the general populationthan any other age group. Bed-population ratios for health service areas in which the percentage of elderly people insignificantly higher tmorethan 12%of the population) than the national average may be planned at a higher ratio, based on analyses by the HSA. (2) Seasonal population fluctuations: Large seasonal variations in hospital utilization may justify higher ratios. Plans should reflect vacation and recreation patterns as well as the needs of migrant workers and other factors causing unusual seasonal variations. (3) Rural areas: Hospital care should be accessible within a reasonable period of time. For example, in rural areas in which a majority of the residents would otherwise be more than 30 minutes travel time from a hospital, the HSA may determine, based on analyses, that a bed- population ratio of greater than 4.0 per 1,000 persons may be justified. (4) Urban areas: Large numbers of beds in one part of a Standard Metropolitan Statistical Area (SMSA) may be compensated for by fewer beds in other parts of the SMSA. Health service areas which include a part of an SMSA may plan for bed-population ratios higher than 4.0 per 1,000 persons reflecting existing patterns if there is a joint plan among all HSAs serving the SMSA which provides for less than 4.0 beds per 1,000 persons in the SMSA as a whole.

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- B6 - (5) Areas with reforral hospitals: In the case of referral institutions which provide a substantial portion of specialty services to individuals not residing in the area, the IdSA Nay exclude from its computation of bed-population ratio the beds utilized by referred patients who reside outside both the SMSA and the HSA in which the facility is located. (b) Discussion. There is general agreement that the number of general hospital beds in the United States is significantly in excess of what is needed and that utilization of acute in-patient care resources is often higher than necessary. Excess bed capacity and use contribute to the high cost of hospital care with little or no health benefits. Empty beds are often filled by patients who could be cared for as well or better in less expensive ways, such as ambulatory care or home care. The Institute of Medicine's Report on "Controlling the Supply of Hospital Beds" in 1976 recommended that the nation should achieve at least a 10% reduction in the bed-population ratio in the next five years and further significant reductions thereafter. The Institute statement noted: '`This would mean a reduction from the current national average of approximately 4.4 non-Federal short-term general hospital beds Per 1,000 population to a national average of approximately 4.0 in five years and well below that in the years to follow." Similarly a study reported by InterStudy of Minneapolis, Minn. the same year concluded that a 10% reduction in hospital bed supply would be a desirable and reasonable first step toward reducing excess hospital capacity. As part of the process for determining this standard, the Department reviewed projections in State health facilities planning plans. Such plans have set targets for future hospital bed supply that, on an aggregate nationwide basis, project just under 4.0 beds per thousand. Many States set lower targets. Health Maintenance Organizations and similar groups have shown that high quality care can be provided with less than 3.0 beds per 1,000 population. Thus, 4.0 beds per 1,000 population is a ceiling, not an ideal situation. HSAs are expected to identify the desirable local ratio, working closely with the State Health Planning and Development Agency and the Statewide Health Coordinating Council. It is anticipated that in subsequent plans HSAs will be required to indicate how they will reach a bed-population ratio of less than 3.7 per 1,000 population except under extraordinary circumstances. HSAs whose areas are now below the 4.0 per 1,000 level are urged to attempt to decrease bed-population ratios below 3.7 per 1,000 population. In areas where Federal medical facilities and Health Maintenance Organizations provide substantial services to local residents, lower ratios should be readily achievable. Population growth must be carefully analyzed; in many cases, this factor alone will bring the area below the target level if no unnecessary additional beds are built. Under some conditions, a higher target ceiling may be justified by the HSA. Travel distance to the nearest hospital is one of the most important

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B7 - factors to be analyzed, especially in rural areas. A planning criteria of 30 minutes has been set, in line with the policies of many local and State health planning agencies around the country. In analyzing ways of reducing bed supply, it should be recognized that Pleater savings will be achieved when entire facilities are considered. In developing such plans, priority consideration should be given to maintaining and strengthening resources that are emphasizing acitivites indentitied as national health priorities in Section 1502 of the Act. 121.202General Hospitals-Occupancy Rate (a) Standard. There should be an average annual occupancy rate for medically necessary hospital care of at least 80% for all non-Federal, short-stay hospital beds considered together in a health service area, except under extraordinary circumstances. Conditions which may justify an adjustment to this standard for a health service area include: (1) Seasonal population fluctuations: In some areas, the influx of people for vacation or other purposes may require a greater supply of hospital beds than would otherwise be needed. Large seasonal variations in hospital utilization which can be predicted through hospital and health insurance records may justify an average annual occupancy rate lower than 80% based on analyses by the HSA. (2) Rural areas: Lower average annual occupancy rates are usually required by small hospitals to maintain empty beds to accommodate normal fluctuations of admissions. In rural areas with significant numbers of small (fewer than 4,000 admissions per year) hospitals, an average occupancy rate of less than 80% may be justified, based on analyses by the HSA. (b) Discussion. There is substantial evidence that excess capacity and use contribute significantly to high hospital costs. The ~ 976 report by the Institute of Medicine, for example, found that "there is a growing concern that the surpluses of hospital beds are contributing significantly to the recent rise of health care costs at a rate well beyond that of general inflation. This concern has not only to do with the cost of maintaining unused hospital bed capacity, but also with the unnecessary and inappropriate uses of hospital beds, especially those in the short-term care category." Occupancy rates currently average about 75% nationwide. Many hospital capacity studies, including those by InterStudy and the Bureau of Hospital Administration of the University of Michigan, indicate that an average hospital occupancy rate exceeding 80% is a reasonable target. In addition, many State and local health planning agencies have estab- lished higher occupancy targets. For example, health planning agencies in Illinois, New Jersey, New York, Massachusetts, Michigan and Wisconsin have recommended occupancy rates higher than 80% for larger hospitals. Higher averages have been advocated, especially for medical-surgical units.

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- B8 While past studies typically apply these rates to individual institutions, the Department, in line with the objectives of community-wide planning, has extended this concept to apply on an area-wide basis. Within local health service areas, hospitals of varying size and circumstances will have varying occupancy rates; a collective rate exceeding 80% on an area-wide basis is a reasonable, achievable goal except in rural areas and when situations present extraordinary circumstances. Increases are to be attained through constrained capacity growth and improved planning and management. It is not, of course, intended that increased rates be achieved through unnecessary hospital admissions or stays. 121.203ObstetrIcal Services - (a) Standard. (1 ) Obstetrical services should be planned on a regional basis with linkages among all obstetrical services and with neonatal services. (2) Hospitals providing care for complicated obstetrical problems (Levels ll and 111) should have at least 1,500 births annually. (3) There should be an average annual occupancy rate of at least 75% in each unit with more than 1,500 births per year. (b) Discussion. The importance of developing regional systems of care for maternal and perinatal health services has been broadly recognized. The Committee on Perinatal Health, representing the American Academy of Family Physicians, American Academy of Pediatrics, American College of Obstetricians and Gynecologists, and the American Medical Association issued a report in 1976, "Toward Improving the Outcome of Pregnancy". The report identified opportunities to reduce rates of maternal, fetal and neonatal mortality as well as to improve deployment of scarce resources, especially those needed to provide comprehensive services for high-risk patients. The impact on quality of care of both under-utilization and over-utilization was emphasized. The report states: "A systematized, cohesive regional network including a number of differentiated resources is the approach most likely to achieve the objective. Each component of the regional system must provide the highest quality care, but the degree of complexity of patient needs determine where, and by whom, the care should be provided." Level I hospitals provide services primarily for uncomplicated maternity and newborn cases. Level 11 hospitals provide services for uncomplicated cases and for the majority of complicated problems, and certain specialized neonatal services. Level 111 hospitals are able also to handle all the serious types of illness and abnormalities. Established arrangements should provide for early access of high-risk pregnant women and prompt referrals among levels of care as appropriate. Regional planning should include a cooperative, coordinated network of hospitals, physicians and other health care professionals, providing (1 ) expert consultation and referral, (2) basic and continuing education for

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- B9 health professionals ano consumers, A) transport of selectee parents IO facilities possessing more specialized maternal and neonatal services, (4) a continuing evaluation of the effectiveness and costs of regionalized programs. In 1972 the American College of Obstetrics and Gynecology identified a minimal target of 1,500 births per year for facilities in communities of 100,000 population or more to provide a full range of obstetrical services in an efficient manner. In 19:74, this figure was revised: "The experience of many obstetric departments indicate that the size, equipment, services and personnel adequate to maintain a consistently high standard of ordinary obstetrical care and a reasonably economic operation generally require more than 2,000 deliveries." (Standards for Obstetrical and Gynecological Services, Committee on Professional Standards of the American College of Obstetrics and Gynecologists, 1974.) The Commit- tee on Perinatal Health also identified the 2,000 minimum figure for facilities identified as Level 11 facilities. In determining the 1,500 target, the Department took into considera- tion these reports as well as the comments received from the public and from members of the expert advisory panel, particularly the criticism that a 2,000 target was too high. The 1,500 level is in line with the policies of many local and State health planning agencies and can help assure more economic use of specialized resources while avoiding inappropriate utilization of such facilities. The Department also recognizes that there are substantial differences among facilities which provide different ranges of services, and there are circumstances, such as those involving special moral and ethical preferences, which may necessitate the HSA providing an adjustment to this standard. In addition, in order to promote more economical use of resources the Department has established the 75% minimum occupancy rate in Level 11 and 111 facilities. The 75% figure was derived from an analysis of various occupancy rate figures in a number of source documents, whose recommendations range from 50% to over 80%. The Hill-Burton program recommended an occupancy level for obstetrical units of at least 75%. The Department anticipates that institutions operating at Levels 11 and 111 will usually be able to exceed this level. In keeping with the national priority set forth in Section 1502 of the Act for the consolidation and coordination of institutional health services, the consolidation of multiple, small obstetrical units with low occupancy rates should be undertaken unless such action is undesirable because of needs to assure ready access and sensitive care. 121.204 Neonatal Special Care Units (a) Standard (1) Neonatal services should be planned on a regional basis with linkages with obstetrical services.

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- B10 (2) The total number of neonatal intensive and intermediate care beds should not exceed 4 per 1,000 live births per year in a defined neonatal service area. An adjustment upward may be justified when the rate of high-risk pregnancies is unusually high, based on analyses by the HSA. (3) A single neonatal special care unit (Level 11 or 111) should contain a minimum of 15 beds. An adjustment downward may be justified for a Level 11 unit when travel time to an alternate unit is a serious hardship due to geographic remoteness, based on analyses by the HSA. (b) Discussion. For this standard, the Department has adopted the widely endorsed concept of regionalization, involving various levels of care. Under this concept, Level 111 units arestaffed end equipped forthe intensive care of new-borns as well as intermediate and recovery care. Level 11 units provide intermediate and recovery care as well as some specialized services. Level I units provide recovery care. Neonatal special care is a highly specialized service required by only a very small percentage of infants. The Department believes that four neonatal special care beds for intensive and intermediate care per 1,000 live births will usually be adequate to meetthe needs, taking into account the incidence of high risk pregnancies, the precentage of live births requiring intensive care, and the average length of stay. ("Bed" includes incubators or other heated units for specialized care, and bassinettes.) In addition, the Department has established a minimum of 15 beds per unit for Levels 11 and 111 as the minimum number necessary to support economical operation for these services. Both standards are supported and recommended by the American Academy of Pediatrics. The American Academy of Pediatrics has noted that "the best care will be given to high risk and seriously ill neonates if intensive care units are developed in a few adequately qualified institutions within a community rather than within many hospitals. Properly conducted, early transfer of these infants to a qualified unit provides better care than do attempts to maintain them in inadequate units." This regionalized approach is reflected in the minimum size standard which is designed to foster the location of specialized units in medical centers which have available special staff, equipment, and consultative services and facilities. Since perinatal centers which include neonatal units will serve th patient load resulting from a representative population of more than one million, a defined neonatal service area should be identified by the relevant HSAs in conjunction with the State Agency. Special attention should also be given to ensure adequate communication and transporta- tion systems, including joint transfers of mother and child and maintenance of family contact. Hospitals with such units should have agreements with other facilities to serve referred patients. The regional plan should include a structured ongoing system of review, including assessment of changes in health status indicators.

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- B11 121~205- Pediatric InpatIent Services Number of Beds (a) Standard. There should be a minimum of 20 beds in a pediatric unit in urbanized areas. An adjustment downward may be justified when travel time to an alternate unit exceeds 30 minutes for 10% or more of the population, based on analyses by the HSA. (b) Discussion. Pediatric services should be planned on a regionalized basis with linkages among hospitals and other health agencies to provide comprehensive care. The 1977 report of the Committee on Implications of Declining Pediatric Hospitalization Rates for the National Research Council states that "for a policy of housing children separately to be effective, certain minimum services and facilities are needed, thus requiring bed capacity utilization to make provision for these cervices and facilities economically feasible." This standard was developed by the Department in this context. A number of sources support a minimum unit size of 20 pediatric beds, including planning agencies in California, Massachusetts, Ohio, Penn- sylvania, and Wisconsin. Consolidation of pediatric care in units of at least 20 beds in urbanized areas will promote the concentration of nursing and support staff with special pediatric knowledge and skills, the increased training of staff, and the provision of special treatment and other ancillary facilities which meet the special needs of children. (A pediatric inpatient unit is a specific section, ward, wing, hospital or unit devoted primarily to the care of medical and surgical patients usually less than 18 years old, not including special care for infants.) The criteria of 30 minutes travel time reflects interest in ensuring that children remain close to their homes, family, and friends. Frequent visits to hospitalized children are highly desirable and can be an aid to improvement and recovery. The American Academy of Pediatrics has recommended to its State Chapters that child health plans should provide that primary care for children should be available within 30 minutes. This access standard is consistent with those of many local and State plan- ning agencies such as those in Massachusetts, New York, Pennsylvania, and Wisconsin. 121.206- Pediatric Inpatient Services Occupancy Rates (a) Standard. Pediatric units should maintain average annual occupan- cy rates related to the number of pediatric beds (exclusive of neonatal special care units) in the facility. for a facility with 20-39 pediatric beds, the average annual occupancy rate should be at least 65%; for a facility with 40-79 pediatric beds, the rate should be at least 70%; for facilities with 80 or more pediatric beds, the rate should be at least 75%. (b) Discussion. Variable occupancy rates are designed to reflect the need for smaller units to maintain the capacity to accommodate normal day-to-day fluctuations in admissions and to set aside pediatric beds for particular ages and types of cases. Such scheduling problems are less severe in pediatric units of a greater capacity. Moreover, large units are

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- Bl2 able to sustain higher occupancy rates because they are frequently associated with regional centers which serve patients needing types of care that can be scheduled on a more flexible basis. It is not intended, of course, to encourage unnecessary admissions or stays to achieve these levels. This standard is identical to that recommended by the American Acedemy of Pediatrics. 121.207 Open Heart Surgery (a) Standard. (1 ) There should be minimum of 200 open heart procedures performed annually, within three years after initiation, in any institution in which oDen heart surgery is performed for adults. (2) There should be a minimum of 100 pediatric heart operations annually, within three years after initiation, in any institution in which pediatric open heart surgery is performed, of which at least 75 should be open heart surgery. (3) There should be no additional open heart units initiated unless each existing unit in the health service areats) is operating and is expected to continue to operate at a minimum of 350 open heart surgery cases per year in adult services or 130 pediatric open heart cases in pediatric services. (b) Discussion. Open heart surgery for congenital and acquired heart and coronary artery disease represents a marked advance in patient care. Highly specialized open heart procedures require very costly, highly specialized manpower and facility resources. Thus, every effort should be made to limit duplication and unnecessary resources related to the performance of open heart procedures, while maintaining high quality care. Minimum case loads are essential to maintain and strong then skills. (Open heart surgery procedures are defined as procedures which use a heart-lung bypass machine to perform the functions of circulation during surgery.) A minimum of 200 adult open heart surgery procedures should be per- formed annually within an institution to maintain quality of patient care and make most efficient use of resources. This standard Is based on recommendations of the Inter-Society Commission on Heart Disease Resources. In order to prevent duplication of costly resources which are not fully utilized, the opening of new units should be contingent upon existing units operating, and continuing to operate, at a level of at least 350 procedures per year. The 350 level assumes an average of 7 ~ ~ _ ~~ _^ _ ~~ ~~_~r~~~c. ~~ alarant is operations a week, a schedule that In Ine uepar~n1~ll~ ~uuyl,,~,,` = feasible in most institutions providing these services. In units that provide services to children, lower targets are indicated because of the special needs involved. The established level for pediat- ric units is consistent with the recommendation of the Pediatric Cardiol- ogy Section of the American Academy of Pediatrics. In determining the utilization target of 130 pediatric open heart cases the Department used

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- B13 the same ratio as for adult units. In the case of units that provide serv- ices to both adults and children, at least 200 open heart procedures should be performed, including 75 for children. In some areas, open heart surgical teams, including surgeons and specialized technologists, are utiliz ng more than one institution. For these institutions, the guidelines may be applied to the combined number of open heart procedures performed by the surgical team where an adjustment is justifiable in line with Section 121.6(B) and promotes more cost-effective use of available facilities and support personnel. In such cases, in order to maintain quality care a minimum of 75 open heart procedures in any institution is advisable, which is consistent with recommendations of the American College of Surgeons. Data collection and quality assessment and control activities should be part of all open heart surgery programs. 121.208 Cardiac Catheterization (a) Standard. (1 ) There should be a minimum of 300 cardiac catheterizations, of which at least 200 should be intracardiac or coronary artery catheterizations, performed annually in any adult cardiac catheterization unit within three years after initiation. (2) There shoula be a minimum of 150 pediatric cardiac cathsteriza- tions performed annually in any unit performing pediatric cardiac catheterizations within three years after initiation. (3) There should be no new cardiac catheterization unit opened in any facility not performing open heart surgery. (4) There should be no additional adult cardiac catheterization unit opened unless the number of studies per year in each existing unit in the health service areats) is greater than 500 and no additional pediatric unit opened unless the number of studies per year in each existing unit is greater than 250. (b) Discussion. The modern cardiac catheterization unit requires a highly skilled staff and expensive equipment. Safety and efficacy of laboratory performance requires a case load of adequate size to main- tain the skill and efficiency of the staff. In addition, the underutilized unit represents a less efficient use of an expensive resource and frequently reflects unnecessary duplication. Based on recommendations from the Inter-Society Commission on Heart Disease Resources, the Department believes that a minimum level of 300 catheterizations per year is indicated to achieve economic use of resources. Several State health planning agencies, such as New~lersey, suggested a higher minimum level and the Department will be consid- ering whether a higher level should be established in the future. The Department has also determined the existing units should be per- forming more than 500 cardiac catheterizations or 250 pediatric cardiac catherizations before a new unit is opened. The 500 level is based on an

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B14 - average of two catheterizations a day, a rate that is in the Department's judgment readily achievable in most institutions providing these serv- ices and that will foster more effective use of current resources prior to the development of additional resources. More than 600 procedures are performed annually in some institutions. Pediatric cardiac catheterizations require special facilities and sup- port services. Lower target numbers are presented in these cases because of the special conditions and needs of children. The estab- lished levels are consistent with the recommendations of the Section on Cardiology of the American Academy of Pediatrics and the Inter- Society Commission on Heart Disease Resources. The patient studied in the cardiac catheterization unit is frequently recommended for open heart surgery. While acceptable inter- institutional referral patterns exist in some areas, cardiac catheterization units should optimally be located within a facility in which cardiac surgery is performed. 121.209 Radiation Therapy (a) Standard. (1 ) A megavoltage radiation therapy unit should serve a population of at least 150,000 persons and treat at least 300 cancer cases annually, within three years after initiation. (2) There should be no additional megavoltage units opened unless each existing megavoltage unit in the health service areats) is per- forming at least 6,000 treatments per year. (~) Adjustments downward may be justified when travel time to an alternate unit is a serious hardship due to geographic remoteness, based on analyses by the HSA. (b) Discussion. While various types of radiation are indicated and used for tumors with different characteristics, megavoltage equipment is accepted as the most efficacious for treatment of deep-seated tumors. Megavoltage equipment is expensive to purchase, install, and support on a continuing basis. Every effort should thus be made to avoid unnecessary duplication of this costly resource. Established standards should provide needed treatment capabilities while preventing unneces- sary duplication of radiation therapy units and underutilization of existing capacity. A unit refers to a single megavoltage machine or energy source. The most common types of units to deliver megavoltage therapy are cobalt 60 and linear accelerators. Treatments are meant to be the same as patient visits. A treatment or visit averages 2.2 fields, according to reports from the American College of Radiology. It also reports that about half of new cancer patients require megavoltage radiation ther- apy, and that many require subsequent courses of treatment. The American College of Radiology has indicated that at least 300 cancer cases annually are a reasonable minimum load for a megavol- tage radiation therapy unit in order to maintain an efficient high quality

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- B15 - operation. Based on the information and recommendations of the College, as well as comments received from the public and from members of the expert advisory panel which reviewed the standard, the Department has set a minimum standard of at least 300 cancer cases per unit per year. In t974, the Department commissioned a study of the use of radiation therapy units. A committee appointed by the American College of Radiology and the American Society of Therapeutic Radiology to review that study suggested that economical operation of radiation units would call for existing units to do 5,000-8,700 treatments per year. The 7,500 level was included in the September 23, 1977 NPRM. This target would have required units to treat an average of 30 patients per day. Based on comments received from the profession and the general public, the Department has adjusted the standard downwards to 6,000 treatments per year, an average of about 25 patients per day, to take into account variations in patient mix and work schedules. Since many institutions meet and exceed these targets, this standard in the Department's judgment represents an attainable, efficient level of operation. The indicated target levels are minimal and should generally be exceeded. Dedicated special purpose and extra high energy machines which have limited but important applications may not perform 6,000 treat- ments per year and should be evaluated individually by HSAs in the de- velopment of Health Systems Plans. 121 .210 Computed Tomographic Scanners (a) Standard. (1 ) A Computed Tomographic Scanner (head and body) should operate at a minimum of 2,500 medically necessary patient procedures per year, for the second year of its operation and thereafter. (2) There should be no additional scanners approved unless each existing scanner in the health service area is performing at a rate greater than 2,500 medically necessary patient procedures per year. (3) There should be no additional scanners approved unless the operators of the proposed equipment will set in place data collection and utilization review systems. (b) Discussion. Because CT scanners are expensive to purchase, maintain and staff, every effort must be made to contain costs while providing an acceptable level of service. Intensive utilization of existing units, regardless of location, will prevent needless duplication and limit unnecessary health care costs. Estimates and surveys for efficient utilization of CT scanners range from 1,800 to over 4,000 patient procedures a year. (One patient procedure includes, during a single visit, the initial scan plus any necessary additional scans of the same anatomic area of diagnostic interest.)

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- B16 - The Institute of Medicine, the Office of Technology Assessment and others have carefully reviewed these data and the capabilities of various available units. The Department has reviewed these analyses as well as the extensive literature that has been developed on GT scanners. In arriving at a standard for the use of these machines, the Department has considered a variety of factors, including the difference in time required for head scans and body scans, the need for multiple scans in some patient examinations, variations in patient-mix, the special needs of children, time required for maintenance, and staffing requirements. Moreover, tine Department considered the actual operating experience of hospitals and institutions reflected in reports on the use of CT scanners. The standard set in the Department's guidelines is intended to assure- effective utilization and reasonable cost for CT scanning. These ma- chines are expensive, and therefore must be used at levels of high efficiency if excessive costs are to be limited. The Department recognizes that the cost of some machines is declin- ing, particularly those that perform only head scans which require less time. For machines that do predominantly head scans, the standard represents an efficient but more easily attainable level of utilization. For scanners capable of pertc~rm~ng both head and body scans, it is imperative that they be effectively used in order to spread the high capital expenditures over as much operating time as possible. As the Institute of Medicine report stated, "The high fixed cost of operating a scanner argue for as high a volume of use as the equipment allows without jeopardizing the quality of care." The Department believes that a 50-55 hour operating week is both consistent with the actual operating experience of many hospitals and a reasonable target. Based on reported experience forthe time required for both head scans and body scans, the Department estimated that a patient mix of about 60% head scans and about 40% body scans, making allowance for the other factors identified above, would allow a CT scanner to perform about 2,500 patient procedures per year if it is efficiently used about 50-55 hours per week. This estimate assumes a higher percent of body scans than is currently being performed. If fewer than 40/0 body scans are performed, then 2,500 patient procedures would involve even less than 50-55 hours per week. Basing the standard on a higher percentage of body scans also takes account of current trends toward increased proportions of such scans. The Department believes that sharing arrangements in the use of CT scanners is desirable, in line with the national health priorities of Section 1502. Individual institutions or providers should not acquire new machines until existing capacity is being well utilized. In planning for CT scanners, the HSA should take into consideration special circumstances such as: 1) an institution with more than one scanner where the combined average annual number of procedures is

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- B17 greater than 2,500 per scanner although the unit doing primarily body scans is operating at less than 2,500 patient procedures per year; 2) units which are, or will be, devoting a significant portion of time to fixed protocol institutionally approved research projects and 3) units which are, or will be, servicing predominantly seriously sick or pediatric patients. A summary of the data collected on CT scanners should be submitted by the operators to the appropriate HSA to enable it to adequately plan the distribution and use of CT scanners in the area. The data to be collected should include information on utilization and a description of the operations of a utilization review program. 121.211 End-Stage Renal Disease (ESRD) (a) Standard. The Health Systems Plans established by HSAs should be consistent with standards and procedures contained in the DHEW regulations governing conditions for coverage of suppliers of end-stage renal disease services, 20 CFR Part 405, Subpart U. (b) Discussion. The ESRD Program was created pursuant to Section 2991 of the Social Security Amendments of 1972 (Publ. L. 92-603), which extends Medicare benefits to any individual who has end-stage renal disease requiring dialysis or transplantation, provided that such individual: (1 ) is fully or currently insured or entitled to monthly benefits under Title 11 of the Social Security Act; or (2) is the spouse or dependent child of an individual so insured or entitled to such monthly benefits. In order for an ESRD facility to qualify for reimbursement under the program, the facility must meet the conditions for coverage of suppliers of end-stage renal disease services as established by regulation. These conditions incorporate standards which relate to supply, distribution, and organization of ESRD facilities. The standards were developed by the Department of Health, Education, and Welfare and were based on extensive consultation with professionals and other persons knowledge- able in the areas of nephrology and transplant surgery. Because these standards are already published as regulations, they are not republished here. The regulations do not try to encourage any particular type of dialysis setting. It is widely recognized that self-care dialysis can significantly contain costs without impairing the quality of care of the suitably chosen patient. The organization of resources to support self- care dialysis is therefore encouraged to the maximum extent practicable.

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