Below are the first 10 and last 10 pages of uncorrected machine-read text (when available) of this chapter, followed by the top 30 algorithmically extracted key phrases from the chapter as a whole.
Intended to provide our own search engines and external engines with highly rich, chapter-representative searchable text on the opening pages of each chapter.
Because it is UNCORRECTED material, please consider the following text as a useful but insufficient proxy for the authoritative book pages.
Do not use for reproduction, copying, pasting, or reading; exclusively for search engines.
OCR for page 89
~-
Appendix B
Final Version of
National Guidelines for Health Planning
(March 28, 1978)
- B1
OCR for page 90
- 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 hospitals—Occupancy rate.
121.203 Obstetrical services.
121.204 Neonatal special care units.
121.205 Pediatric inpatient services Number of beds.
121 .206 Pediatric inpatient services—Occupancy 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
OCR for page 91
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.
§ 121.4—Applicability 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.
OCR for page 92
- 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
OCR for page 93
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 population—than 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.
OCR for page 94
- 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
OCR for page 95
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.
§121.202—General 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.
OCR for page 96
- 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.
§121.203—ObstetrIcal 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
OCR for page 97
- 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.
OCR for page 98
- 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.
OCR for page 99
- 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
OCR for page 100
- 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. ~~ alar—ant 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
OCR for page 101
- 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
OCR for page 102
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
OCR for page 103
- 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.)
OCR for page 104
- 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
OCR for page 105
- 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.
OCR for page 106
Representative terms from entire chapter:
state health
