[Federal Register Volume 63, Number 169 (Tuesday, September 1, 1998)]
[Proposed Rules]
[Pages 46538-46555]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 98-22560]
[[Page 46537]]
_______________________________________________________________________
Part V
Department of Health and Human Services
_______________________________________________________________________
42 CFR Parts 5 and 51c
Designation of Medically Underserved Populations and Health
Professional Shortage Areas; Proposed Rule
Federal Register / Vol. 63, No. 169 / Tuesday, September 1, 1998 /
Proposed Rules
[[Page 46538]]
DEPARTMENT OF HEALTH AND HUMAN SERVICES
42 CFR Parts 5 and 51c
RIN 0906-AA44
Designation of Medically Underserved Populations and Health
Professional Shortage Areas
AGENCY: Health Resources and Services Administration, DHHS.
ACTION: Proposed rules.
-----------------------------------------------------------------------
SUMMARY: The rules proposed below would consolidate the processes for
designating medically underserved populations (MUPs) and health
professional shortage areas (HPSAs), designations that are used in
several DHHS programs. The purpose is to improve the way underserved
areas are designated by incorporating up-to-date measures of health
status and access barriers and eliminating inconsistencies and
duplication of effort. The intended effect is to reduce the effort and
data burden on States and communities by simplifying and automating the
design process as much as possible, while maximizing the use of
technology. The proposed rules involve major changes to both the MUP
and the primary care HPSA designation criteria, which have the effect
of making primary care HPSAs a subset of the MUPs. No changes are
proposed with respect to the criteria for designating dental and mental
health HPSAs. Podiatric, vision care, pharmacy, and veterinary care
HPSA designations would be abolished under the rules proposed below.
DATES: Comments on this proposed rule are invited, and, to be
considered, must be submitted on or before November 2, 1998.
ADDRESSES: Comments should be submitted in writing to: Office of Policy
Coordination, Bureau of Primary Health Care, Room 7-1D1, 4350 East-West
Highway, Bethesda, MD 20814.
FOR FURTHER INFORMATION CONTACT: Richard Lee, 301-594-4280.
SUPPLEMENTARY INFORMATION: The Secretary of Health and Human Services
proposes below a consolidated, revised process for designation of
Medically Underserved Populations (MUPs) pursuant to section 330 of the
Public Health Service Act (as amended by the recent Health Centers
Consolidation Act of 1996, Pub. L. 104-299), 42 U.S.C. 254c, and for
designation of Health Professional Shortage Areas (HPSAs) pursuant to
section 332 of the Act, 42 U.S.C. 254e. Currently, regulations at 42
CFR Part 5 govern the procedures and criteria for designation of HPSAs,
while designation of MUPs has been carried out under the Community
Health Center regulations at 42 CFR Part 51c, Subpart A, and
implementing Federal Register notices. The proposed rules below would
replace the existing Part 5 with regulations governing both MUP and
HPSA designation, and would make conforming changes to Part 51c.
Together, these changes would meet the MUP designation requirements of
the new legislation and the HPSA designation requirements of existing
legislation, while consolidating the two processes to a great degree.
(Note that the abbreviation MUP used here includes not only
population group designations but also the populations of designated
geographic areas, also known as medically underserved areas or MUAs.
Similarly, the abbreviation HPSA includes not only geographic area
designations but also population group and facility designations.)
I. Current Uses of Designations
The MUP and HPSA designations are currently used in a number of
Departmental programs. MUP designations are used in the community
health center (CHC) program as a basis for eligibility for funding
under section 330(e) of the Act. Health professionals placed through
the National Health Service Corps (NHSC) can be assigned only to
designated HPSAs. Other health centers not funded by section 330 grants
but otherwise meeting the definition of a community health center,
including service to a MUP, may be certified by the Health Care
Financing Administration (HCFA) upon the recommendation of the Health
Resources and Services Administration (HRSA) as federally qualified
health centers (FQHCs), eligible for reasonable cost-based Medicaid and
Medicare reimbursement. Clinics in rural areas designated either as an
MUA or as a geographic or population group HPSA, and which use nurse
practitioners and/or physician assistants, may be certified by HCFA as
Rural Health Clinics (RHCs); these RHCs are also eligible for
reasonable cost-based Medicaid and Medicare reimbursement. Physicians
delivering services in areas designated as geographic HPSAs are
eligible for Medicare incentive payments of an additional 10 percent
above the Medicare reimbursement they would otherwise receive. In
addition, a number of health professions programs funded under Title
VII of the Public Health Service Act are required to give preference to
applicants placing graduates in medically underserved communities,
defined to include both HPSA and MUPs. For most of the programs using
the designations, designation of the area or population to be served is
a necessary but not sufficient condition for allocation of program
resources, in that other eligibility requirements must also be met,
and/or there is competition among eligible applicants for available
resources.
II. Purposes of Revising the Designation Mechanisms
The current HPSA criteria date back to 1978; their predecessor, the
``Critical Health Manpower Shortage Area'' or CHMSA criteria date back
to the 1971 legislation creating the National Health Service Corps. The
current MUA/P criteria date back to 1973 and 1975, when legislation was
enacted creating grants for Health Maintenance Organizations and
Community Health Centers, respectively.
The original CHMSA criteria were based on a simple population-to-
primary care physician ratio; the HPSA criteria expanded this to
require a lower ratio for areas with high needs indicated by high
poverty, infant mortality or fertility, and for population groups with
access barriers. The original MUA/P criteria, still in effect, employ a
four-variable Index of Medical Underservice, including percent with
incomes below poverty, population-to-primary care physician ratio,
infant mortality rate and percent elderly, but poverty has tended to
predominate (partly because it was available at subcounty levels).
Since the time these designations were developed, other programs
have been required to use these designations, such as the Rural Health
Clinic program, the Medicare Incentive Program, and the J-1 visa waiver
program, and various Bureau of Health Professions programs now have
preferences for applicants serving designated areas. In addition, there
has been an evolution both in the types of requests for designation
received and the application of the HPSA criteria. Instead of
relatively simple geographic area requests, such as whole counties and
rural subcounty areas, more and more requests have been received for
urban neighborhoods and population group designations. The availability
of census data on poverty, race and ethnicity down to the census tract
level enabled the delineation of urban service areas based on their
economic and race/ethnicity characteristics; thus areas with
concentrations of poor, minority and/or linguistically isolated
populations could achieve area or population group HPSA designations
based on limited access to physicians serving other parts of their
metropolitan areas. As a result, many
[[Page 46539]]
HPSA designations actually represent underserved populations within
larger areas that may have reasonable population-to-practitioner
ratios; the distinction between HPSA and MUA/P designations has become
less sharp. Furthermore, Congress has explicitly identified indicators
for identifying HPSAs with the greatest shortages to include not only
provider-to-population ratio but also rates of low birth weight births,
infant mortality, and poverty as well as access to primary health
services.
Generally, the literature indicates that, despite increases in the
total number of physicians practicing in the United States, including
increases in numbers of primary care physicians, anticipated
``diffusion'' of these physicians into frontier and other remote rural
areas has been limited. At the same time, while some areas have
improved their population-to-practitioner ratios, the nature of the
unmet need has shifted to populations with certain characteristics.
Reflecting this evolution, the combined methodology proposed below
includes both population-to-practitioner ratios and demographic and
other factors associated with access problems. The designation
processes and criteria are being revised to accomplish several goals
and alleviate problems associated with the existing methods of
designation. These purposes include: (a) To consolidate the two
existing procedures, two sets of primary care-related criteria, and two
overlapping lists of designations, one of which has been updated
regularly while the other has not, into one procedure with consistent
criteria that generates an integrated list, updated regularly; (b) to
make the system more proactive, better able to identify new, currently
undesignated areas of need and areas no longer in need; (c) to automate
the scoring process as much as possible, making maximum use of national
data and reducing the effort at State and community levels associated
with information gathering for designation and updating; (d) to expand
the State role in the designation process, with special attention to
the State role in definition of rational service areas; (e) to reduce
the need for time-consuming population group designations, by
specifically including indicators representing access barriers
experienced by these groups in the criteria applied to area data; (f)
to incorporate better measures or correlates of health status; (g)
among the selected indicators of underservice/shortage, to improve
equity by more heavily weighting the more common attributes, while
giving less weight to factors that apply only to subsets of underserved
areas/populations; and (h) to ensure that current services to
underserved populations are not disrupted in the transition to a new
system. These purposes are explained more fully below.
A. Consolidation and Simplification
The separate statutes authorizing MUP and HPSA designations address
fundamentally the same policy concern: that is, the identification of
those areas and populations which have unmet needs for personal health
services, for the purpose of determining eligibility for certain
Federal health care resources. Some of these areas and populations have
shortages of health professionals to deliver the health services; in
others, the problem is lack of access to existing resources. The
legislative requirements for the two are similar in many respects, but
the designation processes have, up to now, been largely separate. The
rules proposed below attempt to establish a unitary procedure and
consistent criteria, insofar as is legally permissible, both to
simplify the designation process for agencies, communities, entities,
and individuals involved in it and to increase the efficient and
effective use of Departmental resources. Thus, all the legislatively
mandated elements of both statutes are included in the proposed
procedures. Further, in redesigning the criteria, common definitions
are used for MUPs and HPSAs. In addition, the criteria are structured
so that primary care HPSAs become a subset of MUPs, the subset with
particular shortages of health professionals.
B. Proactivity and C. Automation
The proposed methodology is also designed to enable a more
automated process for designation, through a simpler method for scoring
areas and for updating the scores when data updates occur. The new
method makes considerable use of census variables for which data are
available not only at the county level but also at subcounty levels
(e.g., for census tracts and census divisions), so that a wide variety
of State- and community-defined service areas can be evaluated for
possible designation. The intent is to minimize the effort required by
States, communities, and other entities to designate an area or update
its designation. It should also enable more universal application of
the designation criteria, so that applicant familiarity with the
designation process will be less of a factor and independent data
collection by applicants will be less of a barrier than previously. At
the same time, States and communities will continue to have the
opportunity to challenge federally-provided data.
D. Increased State Role
The proposed approach seeks to foster increased partnership between
the various levels of government involved in designation, including a
significantly larger State and local role in defining service areas,
underserved population groups and unusual local conditions. The new
criteria are significantly less prescriptive in terms of travel time
and mileage standards for defining service areas. Each State will be
encouraged to define, with community input and in collaboration with
the Secretary, a complete set of rational service areas covering its
territory. Once developed, these service areas will be used in
underservice/shortage area designations unless new census data or other
changes require further area boundary changes. It is also the agency's
intention to ask States to provide information on their practitioner
data sources and their methods for evaluating access to service area
and contiguous area resources; where States have reliable data sources
and analysis procedures, the time required for case-by-case review will
be significantly reduced.
E. Reduce the Need for Population Group Designations
Designation of population groups is typically more resource-
intensive than designation of geographic areas, both from the
standpoint of data collection (since obtaining data for a particular
population is often more difficult than for the area as a whole) and in
terms of review. As discussed below, specific indicators included in
the proposed approach represent the access barriers of low income,
racial minority or Hispanic ethnicity, and linguistic isolation. It is
hoped that the inclusion of these indicators in the proposed index will
reduce the need for specific population group designations for these
population groups, by increasing the probability of designation of
geographic areas with concentrations of these groups.
F. Incorporate Better Measures or Correlates of Health Status
Both designation statutes speak of inclusion of indicators of
health status. However, the only specific measure of health status
mentioned in either statute or included in the existing designation
criteria is infant mortality rate. Both infant mortality rate and low
live birthweight rate are nationally available for all counties and for
a limited number of subcounty areas (generally, for places
[[Page 46540]]
of population 10,000 or more), and these measures are both
incorporated. As discussed further below, other direct measures of
health status could not be included at this time; however, a number of
indirect measures were included as proxies, because they are correlated
with low health status.
G. Improve Equity Through Weighting
Experience in designation of both MUA/Ps and HPSAs has indicated
that the most common characteristics of shortage/underserved areas
involve high population-to-practitioner ratios and a high proportion of
the population in poverty or with low incomes. Both these indicators
figure prominently in the current HPSA and MUA/P designation
approaches; both were considered logical candidates for high relative
weighting in any new index. Other indicators of access barriers and low
health status are being included, but with lower weights representing
their less general applicability as underservice indicators.
H. Avoid Disruption
An improved system will not generate the exact same designations as
the old system, or it would represent no change/improvement. However,
in the transition to a new system, which will involve updating many MUP
designations that have not been updated for some time, care must be
taken to ensure that vulnerable underserved populations, identified
under previous criteria and now being served by projects based on the
existing designations, do not suffer an inappropriate disruption of
services. This involved testing the new criteria against the database
of currently-designated service areas and active projects.
III. Development of the New Methodology
The development of the proposed new methodology was initiated in
the fall of 1992 through discussions with academic researchers and
Federal experts in relevant fields, as well as representatives of State
health departments and others involved in and affected by the
designation process. These discussions covered problems with the
current methods, and issues involved in developing better needs
assessment/designation methods; the basic goals listed above were
identified. A wide variety of potential shortage/underservice
indicators and methodological approaches were discussed.
Particular attention was given to health status indicators.
Morbidity and mortality rates, including those relevant to primary
health care, are generally available only at the county level. This is
a problem, because only about one-third of current designations cover
whole counties (40 percent are subcounty areas, 22 percent are
population groups, and 6 percent are facilities). Also considered were
health status indicators based on ``ambulatory care sensitive
conditions.'' However, since such data are currently available for less
than half the States, their inclusion was not feasible. Developments in
this field will be monitored for possible future inclusion of such
indicators.
A third group of health status and utilization indicators
identified as potentially useful in designation are those collected as
part of the National Center for Health Statistics' Health Interview
Survey (HIS). However, the surveying/sampling techniques used in
collecting these data were originally designed to obtain conclusions
valid at national, not local, levels. Efforts to develop a method to
allow prediction of the indicators from local demographic data are
underway, but have not yet been successful.
Based on the recommendations of various experts consulted and the
gaps in data availability noted above, it was decided to pursue
development of a new index using demographic proxies for those access
and health status indicators that are not yet widely available. The
literature was reviewed to identify additional candidate variables,
potential variables were evaluated to establish a test data base, and
correlation analysis was applied to identify which indicators could be
treated as independent variables and which combinations of indicators
would tend to over-represent the same underlying variables.
As a result of this process, some indicators considered were not
selected for inclusion in the proposed new methodology. For example,
the percentage of the population with incomes below 100 percent of the
poverty level is not used as an indicator of ability-to-pay; instead,
the percentage with incomes below 200 percent of poverty (which is very
highly correlated with the proportion below poverty) was selected,
since this low-income population is the prime target population of the
CHC and NHSC projects which use the designations. Another indicator not
ultimately included was educational level. Educational level is quite
highly correlated with income; since percent of population with low
income is being included in the new methodology, and is highly
weighted, it was felt that educational level need not also be included.
The percentage of the population which is uninsured was not included,
because these data are generally available only at the State level. An
indicator of health status, trimester of entrance into prenatal care,
was likewise not used, because of concerns that these data are often
unreliable.
Impact testing and analysis were conducted to ensure that variables
most indicative of need were incorporated, that the scaling and
relative weighting of the indicators identified areas of known high
need, and that the transition to the new methodology would cause
minimal disruption to projects already serving the underserved based on
past designation methods. The proposed new methodology was discussed
with a variety of academic and government experts and State partners in
the designation process during 1995 and revised. As revised, the
proposed methodology has been outlined in presentations to national and
regional meetings of State and community primary care organizations and
others.
IV. Description of the Proposed Regulations
A. Procedures
The proposed approach to processing both MUP and HPSA designation
requests, set forth in proposed Subpart A below, is an adaptation of
the HPSA designation procedures currently in effect, as codified at 42
CFR Part 5. The proposed procedures have been modified to include the
particular comment and consultation requirements of the MUP
legislation, but otherwise closely follow the present HPSA designation
procedures, including those specifically required by statute.
As before, the procedures involve an interactive process between
the Secretary, the States, and individual applicants. Any individual,
community group or State or other agency may apply for designation of a
geographic area or population group MUP and/or HPSA, or for a facility
HPSA; the Secretary may also propose such designations. Such requests
are reviewed both at State and federal levels, including a 30-day
comment period for Governors, State health agency contacts, State
primary care associations (i.e. organizations representing community
health centers and other providers of primary care), and appropriate
medical, dental or other health professional societies.
[[Page 46541]]
Annually, the Secretary will review all designations, with emphasis
on those for which new data have not been submitted during the previous
three years; this extends to MUA/Ps the review process previously used
for HPSAs. In such reviews, the latest data from national sources on
already-designated areas are provided by the Secretary to State
entities and others for review and correction; if no corrections are
provided, the national data are used as the Secretary's basis for
decisions. The national data will normally be used for census-collected
variables, and for infant mortality and low birth weight rates, but
national data for practitioner counts and for population groups is
typically updated during the designation process using State and local
sources. State and local data are normally more up-to-date and accurate
regarding provider locations and are the only source for accurate full-
time-equivalency data on those practitioners practicing less than full
time or splitting their time between two or more different areas.
There is also a section describing procedures that would operate
during the transition from the current system to the new system. These
procedures include a process for resolution of any overlapping
boundaries that may exist between currently-designated HPSAs and MUA/Ps
at the time the new regulations go into effect, and allow that any HPSA
or MUA/P designation for which new data was submitted and approved
under the old criteria may continue in effect for three years from the
approval date. This is to relieve States, communities and others from
having to provide updated data on all designations during the first
year the new regulations go into effect.
B. MUP Criteria
The criteria for designating MUPs are set out in Subpart B. In
brief, areas to be designated must be rational areas for the delivery
of primary care services. For each area so defined and considered for
designation, the Secretary will determine the area's score on its Index
of Primary Care Shortage (IPCS). As discussed below, the IPCS is a
composite of partial scores on a number of variables that reflect and
incorporate statutory requirements. An area may be designated if its
composite score for all variables equals or exceeds the designation
threshold determined by the Secretary. (This approach is structurally
quite similar to the approach previously used to designate MUA/Ps.)
C. Rational Service Areas
The proposed rules would continue to require that each area
proposed for designation be a rational area for the delivery of primary
care services. See, proposed Sec. 5.103(a). Optimally, each State will
develop a State-wide system that subdivides the territory of the State
into rational service areas; criteria for such a State-wide system are
specified. A definition of the term rational service area is included
which allows for considerable flexibility of interpretation by States.
Until a State develops such a State-wide system of areas, provisions
for determining individual rational service areas would apply. These
provisions allow for inclusion of service areas currently designated,
whether made up of whole counties or portions thereof; of counties or
county-equivalents; and of other areas meeting the regulation's
definition of a rational service area. To deal with cases where the
boundaries of currently designated MUA/Ps and HPSAs overlap but do not
coincide, transition procedures allow the appropriate State official to
define which area will be considered to be the rational service area
for designation purposes.
D. IPCS Approach
The proposed rules provide that, for each area defined as a
rational service area and considered for a primary care shortage/
underservice designation, the Secretary will determine the area's score
on a new Index of Primary Care Shortage (IPCS). See, proposed
Sec. 5.103(b). The IPCS is a composite of seven variables that reflect
need for and lack of access to primary care services, including those
factors that are legislatively mandated: (1) The population- to-primary
care practitioner ratio, (2) the percentage of the population with
incomes below 200 percent of the poverty level, (3) the infant
mortality or low birthweight rate, (4) the percentage of the population
that is racial minority, (5) the percentage of the population of
Hispanic ethnicity, (6) the percentage of the population that is
linguistically isolated, and (7) low population density. The basis for
inclusion of these variables in the index is discussed below.
1. Population-to-Primary Care Practitioner Ratio
This ratio is the best available measure of primary care resources
available within a particular area, is historically accepted as the
prime indicator of primary care practitioner shortage, and reflects the
resource decisions central to the NHSC and CHC programs. Also,
inclusion of this measure is legislatively required for HPSAs, and
meets the MUP legislative requirement for a measure of availability.
2. Percentage of the Population With Income Below 200 Percent of the
Poverty Level
This variable represents the economic access barrier faced by many
underserved populations, including Medicaid-eligibles and those working
poor and Medicaid-ineligibles who tend to be uninsured or underinsured.
It also closely approximates the target population of CHC/NHSC
projects, which are required to provide care on a sliding fee scale to
patients with incomes below 200 percent of poverty level, and fulfills
the legislative requirement for a factor indicative of ability-to-pay.
Furthermore, low income is highly correlated with low health status.
See, for example, George Davey Smith, et al., ``Socioeconomic
Differentials in Mortality Risk among Men Screened for the Multiple
Risk Factor Intervention Trial,'' Am. J. Public Health, 1996:86:486-
504.
3. Infant mortality rate or low birthweight rate
These two variables are both indicators of adverse birth outcomes.
Consideration of infant mortality rate (deaths per thousand live
births) is statutorily required; it has also been used historically as
a measure of negative health status, and/or as an indicator of
inadequacy of the health care system. Low live birthweight rate
(percentage of live births below 2500 grams) is a statistically more
robust indicator, since there are more events, and it better reflects
access to prenatal care. The highest of the partial scores for each of
these two indicators would be used in computing an area's overall IPCS
score.
4. Percentage of the Population That Is a Racial Minority
This variable (defined in the census as including blacks, Asian and
Pacific Islanders, Native Americans, and other non-whites) is included
partly because various minority groups display higher prevalence of
certain diseases than the population at large, and lower health status
generally, and partly because of access barriers due to discrimination
in some cases and cultural barriers in others. The literature indicates
that these effects are independent of income. (See, for example,
Gornick et al., ``Effects of Race and Income on Mortality and Use of
Services among Medicare Beneficiaries,'' New England
[[Page 46542]]
Journal of Medicine, Vol. 335, No. 11, pp. 791-799, Sept. 12, 1996;
Commonwealth Fund, National Comparative Survey of Minority Health Care,
1995.) Also, a high percentage of the CHC/NHSC patient population are
minorities.
5. Percentage of the Population of Hispanic Ethnicity
This census variable is included because many persons of Hispanic
ethnicity experience negative health status effects and discriminatory
and cultural barriers, independent of income, while persons of Hispanic
ethnicity are not included in the census variable ``racial minority''
unless they self-identify themselves as ``other non-white.'' (For
reference relevant to both indicators (4) and (5), see, for example,
Lillie-Blanton and Alfaro-Correa, Joint Center for Political and
Economic Studies Project on the Health Care Needs of Hispanics and
African-Americans, 1995.) Also, a high percentage of the underserved
populations served by existing CHC/NHSC programs is Hispanic.
6. Percentage of the Population That Is Linguistically Isolated
This variable (defined in the census as the percentage of the
persons in households in which no one over the age of 14 speaks English
well) is used as a direct measure of those persons with a severe
language barrier, as distinct from those of foreign origin who speak
English well.
7. Low Population Density
This variable is included as a proxy for the long distances and
high travel times to care experienced by frontier and other isolated
rural communities.
E. Scoring
For a given area, partial scores are computed for each of the above
variables; these partial scores are then summed to obtain the total
IPCS score. An area will receive non-zero partial scores only for those
variables which have, in that area, values worse than a normative level
for that variable, if available, or the 1996 national rate, where no
norm was available.
In the case of the population-to-primary care practitioner ratio,
the normative floor level for scoring being used is 1250:1. This
corresponds to the lower end of the acceptable range for supply of
primary care providers recognized by the Council on Graduate Medical
Education (COGME) after adjusting for inclusion of obstetrician-
gynecologists and nonphysician providers. A range of 60-80
``generalist'' physicians per 100,000 population was recognized by the
Council on Graduate Medical Education (COGME) as adequate for primary
care in its Eighth Report (see U.S. DHHS Report No.HRSA-P-DM 95-3,
revised Nov. 1996, pp. 8-12). Since COGME's definition of
``generalist'' physicians encompasses only those physicians in Family
Practice, General Practice, General Internal Medicine and Pediatrics,
while the definition of Primary Care Practitioners (PCPs) in the MUP/
HPSA criteria proposed herein also includes physicians in Obstetrics
and Gynecology as well as nurse practitioners, physician assistants and
certified nurse midwives, the COGME lower level of 60 per 100,000 was
adjusted upward by the ratio of all U.S. PCPs to all U.S. generalists,
yielding a level of 80 PCPs per 100,000 population or 1250 persons per
PCP.
In the case of infant mortality and low live birthweight, the
normative floor levels correspond to the Healthy People 2000 national
targets of no more than 7 infant deaths per thousand live births and no
more than 5 percent low birthweight births, respectively. In the case
of the census-related variables, the 1996 national rates are used as
the floor for scoring.
There is a maximum number of points for each variable, and scales
for each variable have been devised which relate to its distribution
across all U.S. counties. (For example, for a census variable given a
maximum score of five points, the values of the variable which divide
all counties above its national rate into five equal groups are used as
breakpoints.) The scales proposed to be used are shown in Tables 1-7
below; following consideration of comments, they will be republished
(with any changes made in response to comments) with the final rule.
The IPCS approach provides that certain variables are more heavily
weighted than others, in determining an area's IPCS score. See,
Sec. 5.103(b). The weighting scheme chosen was designed to enhance
equity by more heavily weighting common attributes of shortage areas,
while giving less weight to factors that identify population subgroups
with particular access problems. The population-to-primary care
practitioner ratio and percentage of population with incomes below 200
percent of the poverty level variables are most heavily weighted
(maximum 35 points each). The percentage of population that is
linguistically isolated, percentage minority and percentage Hispanic
variables are less heavily weighted (maximum 5 points each). Similarly,
the infant mortality rate and low birthweight rate variables are scored
at a maximum of 5 points each; the highest of these two scores is
included in the total IPCS score. To address the isolation and
distance-related access problems of rural populations, the low-
population-density variable is weighted on a 10-point scale. These
seven partial scores are combined to obtain the total IPCS score, which
thus has a maximum value of 100 points.
Table 1.--IPCS Partial Score for Population-to-Primary Care Practitioner
Ratio (R) 1
------------------------------------------------------------------------
Partial
Range score
------------------------------------------------------------------------
R 9,000:1........................................ 35
9000:1 > R 7000:1................................ 34
7000:1 > R 5000:1................................ 33
5000:1 > R 4500:1................................ 32
4500:1 > R 4000:1................................ 31
4000:1 > R 3800:1................................ 30
3800:1 > R 3500:1................................ 29
3500:1 > R 3400:1................................ 28
3400:1 > R 3300:1................................ 27
3300:1 > R 3200:1................................ 26
3200:1 > R 3100:1................................ 25
3100:1 > R 3000:1................................ 24
3000:1 > R 2800:1................................ 23
2800:1 > R 2600:1................................ 22
2600:1 > R 2500:1................................ 21
2500:1 > R 2400:1................................ 20
2400:1 > R 2300:1................................ 19
2300:1 > R 2200:1................................ 18
2200:1 > R 2100:1................................ 17
2100:1 > R 2000:1................................ 16
2000:1 > R 1950:1................................ 15
1950:1 > R 1900:1................................ 14
1900:1 > R 1850:1................................ 13
1850:1 > R 1800:1................................ 12
1800:1 > R 1750:1................................ 11
1750:1 > R 1700:1................................ 10
1700:1 > R 1650:1................................ 9
1650:1 > R 1600:1................................ 8
1600:1 > R 1550:1................................ 7
1550:1 > R 1500:1................................ 6
1500:1 > R 1450:1................................ 5
1450:1 > R 1400:1................................ 4
1400:1 > R 1350:1................................ 3
1350:1 > R 1300:1................................ 2
1300:1 > R 1250:1................................ 1
R < 1250:1................................................... 0
------------------------------------------------------------------------
1 For areas or population groups where the number of FTE primary care
practitioners equals zero, the appropriate ratio R for entering this
table is computed as follows: R = adjusted population + 1250.
Table 2.--IPCS Partial Score for Percent of Pop. With Incomes Below 200%
of Poverty Level (P)
------------------------------------------------------------------------
Partial
Range score
------------------------------------------------------------------------
P 65%............................................ 35
65% > P 60%...................................... 34
60% > P 57%...................................... 33
57% > P 55%...................................... 32
[[Page 46543]]
55% > P 52%...................................... 31
52% > P 50%...................................... 30
50% > P 49.5%.................................... 29
49.5% > P 49%.................................... 28
49% > P 48.5%.................................... 27
48.5% > P 48%.................................... 26
48% > P 47%...................................... 25
47% > P 46%...................................... 24
46% > P 45%...................................... 23
45% > P 44.5%.................................... 22
44.5% > P 44%.................................... 21
44% > P 43.5%.................................... 20
43.5% > P 43%.................................... 19
43% > P 42%...................................... 18
42% > P 41%...................................... 17
41% > P 40%...................................... 16
40% > P 39.5%.................................... 15
39.5% > P 39%.................................... 14
39% > P 38.5%.................................... 13
38.5% > P 38%.................................... 12
38% > P 37%...................................... 11
37% > P 36%...................................... 10
36% > P 35%...................................... 9
35% > P 34.5%.................................... 8
34.5% > P 34%.................................... 7
34% > P 33.5%.................................... 6
33.5% > P 33%.................................... 5
33% > P 32.5%.................................... 4
32.5% > P 32%.................................... 3
32% > P 31%...................................... 2
31% > P 30%...................................... 1
P < 30%...................................................... 0
------------------------------------------------------------------------
Table 3.--IPCS Partial Score for Infant Mortality Rate (IMR)--or--Low
Birth Weight Rate (LBWR)
------------------------------------------------------------------------
Partial
Range score
------------------------------------------------------------------------
Deaths/1000 Birth
------------------------------------------------------------------------
IMR 15.0......................................... 5
15.0 > IMR 12.0.................................. 4
12.0 > IMR 11.0.................................. 3
11.0 > IMR 10.0.................................. 2
10.0 > IMR 7.0................................... 1
IMR < 7.0.................................................... 0
------------------------------------------------------------------------
LBW births as % of live births
------------------------------------------------------------------------
LBWR 9.0......................................... 5
9.0 > LBWR 8.0................................... 4
8.0 > LBWR 7.5................................... 3
7.5 > LBWR 7.0................................... 2
7.0 > LBWR 5.0................................... 1
LBWR < 5.0................................................... 0
------------------------------------------------------------------------
The highest of the IMR and LBWR scores is to be used.
Table 4.--IPCS Partial Score for Percent Pop. Racial Minority (M)
------------------------------------------------------------------------
Partial
Range score
------------------------------------------------------------------------
M 50%............................................ 5
50% > M 40%...................................... 4
40% > M 30%...................................... 3
30% > M 25%...................................... 2
25% > M 20%...................................... 1
M < 20%...................................................... 0
------------------------------------------------------------------------
Table 5.--IPCS Partial Score for Percent Pop. of Hispanic Ethnicity (H)
------------------------------------------------------------------------
Partial
Range score
------------------------------------------------------------------------
H 40%............................................ 5
40% > H 25%...................................... 4
25% > H 15%...................................... 3
15% > H 11%...................................... 2
11% > H 8.8%..................................... 1
H < 8.8%..................................................... 0
------------------------------------------------------------------------
Table 6.--IPCS Partial Score for Percent of Pop. Linguistically Isolated
(LI)
------------------------------------------------------------------------
Partial
Range score
------------------------------------------------------------------------
LI 10.0.......................................... 5
10.0 > LI 7.0.................................... 4
7.0 > LI 5.0..................................... 3
5.0 > LI 4.0..................................... 2
4.0 > LI 3.0..................................... 1
LI < 3.0..................................................... 0
------------------------------------------------------------------------
Table 7.--IPCS Partial Score for Population Density (D)
[persons/sq. mi.]
------------------------------------------------------------------------
Partial
Range score
------------------------------------------------------------------------
D < 3........................................................ 10
3 D < 7.......................................... 9
7 D < 10......................................... 8
10 D < 15........................................ 7
15 D < 20........................................ 6
20 D < 25........................................ 5
25 D < 30........................................ 4
30 D < 35........................................ 3
35 D < 40........................................ 2
40 D < 50........................................ 1
D 50............................................. 0
------------------------------------------------------------------------
F. Designation Threshold
A county or other rational service area will be designated if its
composite IPCS score for all variables equals or exceeds the
designation threshold determined by the Secretary. This rule proposes
to set this threshold at a level which does not cause a major
disruption at the time of implementation in the number of counties with
some designation, reduces the total population in designated areas
somewhat, and, by keeping the threshold constant, allows for future
decreases in the number and population of designated areas as
conditions improve. The threshold level proposed is 35, approximating
the current median of all U.S. county IPCS scores--i.e., the score
which would, based on 1996 data, separate the highest-scoring 50
percent of counties nationwide from the remaining counties.
Use of a designation threshold set at the median county value is
consistent with past practice for designating MUA/Ps, and testing
indicates it would result in a total U.S. underserved population of
about 64 million, approximately 10 percent lower than the unduplicated
population of currently-designated MUA/Ps and HPSAs, 72 million. The
difference is primarily attributable to improvements since the time of
the last major MUA/P update.
G. Degree of Shortage; Relationship of Designations to Interventions;
Types of Shortage Lists
An important issue in the preparation of these regulations was
whether those practitioners who are present in designated areas as a
result of interventions based on the designations should be included in
computations when updating the designations. One school of thought
emphasizes concerns about potential ``yo-yo'' effects, in which an area
is designated, a CHC or NHSC intervention occurs as a result of the
designation, those practitioners are then counted resulting in a loss
of the designation, the intervention is removed, the area again becomes
eligible for designation, and the cycle repeats itself. Another school
of thought reflects concerns about carrying on the list of designations
areas whose needs have been met through CHC and/or NHSC interventions.
This can lead to such eventualities as waiver of J-1 visa physicians'
return-home requirements in return for service in a designated area or
certification of a new Rural Health Clinic in a designated area,
although that area's needs are already being met by CHC, NHSC, and/or
previously waived J-1 visa providers.
To deal with these concerns it is proposed to publish a two-tiered
list of designations. Each designated MUP or HPSA will be identified as
having either a first or second degree of shortage. First degree of
shortage designations will be those which continue to be designatable
even when resources placed in the area through CHC and/or NHSC
interventions are counted; second degree of shortage designations will
be those which are designatable only when
[[Page 46544]]
resources placed through CHC and/or NHSC interventions are excluded.
Both types of designations would be eligible for CHC and NHSC
resources, but other programs would be encouraged to concentrate their
resources on first degree of shortage areas. For primary care HPSAs,
these two degrees of shortage would replace the previously defined
degree of shortage groups.
Some have suggested that the second group should also include areas
that would remain designatable if physicians whose J-1 visa return-home
requirements have been waived were not counted. This has not been done,
since J-1 waiver physicians are not equivalent to those placed or
supported by HRSA: they are not required to serve patients regardless
of ability to pay, and for many, there is no monitoring system in
place. However, public comment on this issue is invited.
H. Data Definitions
The proposed rules spell out the data needed to determine the score
for each of the IPCS variables for an area. See, proposed
Sec. 5.103(c).
1. Population and Practitioner Counts
The population and practitioner count variables are to be
calculated in essentially the same way as now provided for HPSAs under
the existing Part 5. Like the present Part 5, the proposed rules
anticipate adjustment of population by age/sex; however, rather than
including these adjustments in the regulation as before, the proposed
rules provide that the table for making such adjustments will be
published by notice from time to time in the Federal Register, so that
updated data on age/sex utilization rates can be used as it becomes
available. The age-adjustment table proposed to be used initially is
shown as Table 8 below; it will be republished (with any changes made)
in the preamble to the final rules.
Table 8.--Age Adjustment of Population
[Based on 1992 Health Interview Survey data]
------------------------------------------------------------------------
-------------------------------------------------------------------------
Number of physician contacts =
malepop < 1 yr * 5.9 + femalepop < 1 yr * 5.9
malepop 1-4 * 5.9 + femalepop 1-4 * 5.9
malepop 5-17 * 3.0 + femalepop 5-17 * 3.0
malepop 18-44 * 3.5 + femalepop 18-44 * 5.4
malepop 45-64 * 3.5 + femalepop 45-64 * 5.4
malepop 65-74 * 5.5 + femalepop 65-74 * 7.1
malepop > 74 * 11.1 + femalepop > 74 * 11.1
Adjusted population = Number of physician contacts/5.3 (here, 5.3 is the
national average number of physician contacts per year)
Population-to-primary care practitioner ratio (R, for Table 1) =
Adjusted population / number of FTE primary care practitioners
------------------------------------------------------------------------
The practitioner count requirements are similar to those in the
current Part 5, although they are reorganized for clarity and some
important changes have been made. Foreign medical graduates who are
citizens or permanent residents or are on J or H visas are to be fully
counted unless they have restricted licenses. Practitioners providing
medical services under a federal service obligation or as an employee
of a federal grantee are counted for first degree of shortage
designations but are excluded for second degree of shortage
designations; see, discussion above. It should be noted that, although
the proposed rules would allow NHSC and grant-hired practitioners to be
excluded from the practitioner count for second degree of shortage
designation purposes, these practitioners are included by the
Department in making decisions as to how to allocate additional NHSC
assignees and health center grant resources. Also, the current HPSA
provision allowing the discounting of physicians with restricted
practices on a case-by-case basis is proposed to be eliminated;
experience has shown that this provision is not useful as a practical
matter.
2. Non-Physician Primary Care Practitioners
Significant interest has been expressed in including nurse
practitioners (NPs), physician assistants (PAs), and certified nurse-
midwives (CNMs) in counts of primary care practitioners for designation
purposes, particularly where they practice as effectively independent
providers of care and particularly given the role of these
practitioners in the Rural Health Clinic program. However, controversy
exists as to whether the available data will permit them to be counted
accurately and how they should be weighted relative to primary care
physicians. There are several related issues involved. First,
significant differences exist among the States as to the modes of
practice allowed for these practitioners, including the extent to which
they are allowed to work independently, and what medical tasks they are
legally allowed to perform. This means that it has been difficult or
impossible to incorporate their contributions in a consistent way
across all States. Second, there are significant limitations to the
national databases currently available on these practitioners as
compared with the national data available for M.D.s and D.O.s. While
some States have accurate data on the number, location and practice
characteristics of these practitioners, others do not; however, if
incorporation of these practitioners were made dependent on use of
State data, those States willing and able to provide the data would
effectively be penalized relative to those States which could not or
did not provide it, since inclusion of more practitioners decreases the
likelihood of designation. Finally, for those States in which
nonphysician practitioners can legally provide many of the same
services as primary care physicians, exactly how they complement
physicians, and therefore how they should be weighted relative to
physicians, is not well-defined.
The proposed rules below include these nonphysician practitioners
by requiring that all of them be counted as equivalent to 0.5 FTE. Some
have suggested that different equivalencies be used in different
States, depending on the degree of independence allowed by the
different State laws, or that the equivalency be different in areas
without physicians as compared to areas where physician and
nonphysician providers are teamed together. This has not been done,
both to avoid further complexity and to avoid penalizing those States
where nonphysician providers are effectively used; however, public
comment on the equivalency issue is solicited. The rules provide that
the proposed relative weight of 0.5 may be revised upward by Federal
Register notice, if the Secretary determines that national practice
data support a higher weight. Please note that the 0.5 relative
weighting is proposed only for purposes of estimating primary care
practitioner counts for shortage area designation purposes; it should
not be construed as representing the relative cost of these providers'
services compared to physician services. However, its use is consistent
with productivity standards currently used by HCFA for RHCs and FQHCs,
which are 2100 visits per year for NPs and PAs as compared with 4200
visits per year for physicians.
A national database for these practitioners will be constructed
from those data available from national sources on NPs, PAs and CNMs.
Data from this national database will be used
[[Page 46545]]
as a first approximation, but States will be encouraged to provide more
accurate State data, if available. In this way, States with better data
should not be penalized.
Methods for computing the remaining IPCS variables are also
included in Subpart B below. The proposed rules specify the type of
data to be used, so as to achieve, insofar as possible, uniformity and
comparability of designations. It should be noted that HRSA plans to
initially compute the IPCS scores for county-equivalents and existing
HPSAs and MUPs from national data, providing them to the States and
other interested parties for review.
I. Population Group Designations
The inclusion in the proposed IPCS of a number of variables
representing the access barriers and/or negative health status
experienced by certain at-risk populations, and its use in geographic
area designations, is likely to decrease the need for specific
population group designations, which are more difficult procedurally
for both applicants and reviewers to deal with. However, the proposed
rules continue to provide for population group designations within
geographic areas which, taken as a whole, do not meet the criteria for
designation. See, proposed Sec. 5.104(a). These generally build on the
criteria for designating geographic areas, with several key
differences. First, the proposed rules recognize certain additional
types of areas as rational areas for the delivery of primary care
services for specific population groups (e.g., reservations for Native
American population groups). See, proposed Sec. 5.104(a). Second, there
are particular minimum population size requirements applicable to the
designation of low income population groups. See, proposed
Sec. 5.104(b). Finally, each variable in the IPCS is to be calculated
based on data for the population group for which designation is sought,
as nearly as possible, rather than on the population of the area as a
whole. See, proposed Sec. 5.104(a). However, where the definition of a
population group requested for designation essentially coincides with
one of the variables used in the index (e.g., a low-income population
group, defined as the population with incomes below 200 percent of the
poverty level), the total IPCS score could be distorted by
automatically assigning the maximum possible score to one variable. To
avoid this, it is proposed that the variable involved not be considered
in scoring the requested population group; instead, its weight would be
distributed among the other variables.
J. Designation of Primary Care HPSAs
1. Criteria and Procedures
The criteria and procedures for designating primary care HPSAs are
set out in proposed Subpart C. They build upon and are integrally
related to the criteria and procedures for designating MUPs set out in
Subpart B; to be considered for primary care HPSA designation, areas
and population groups must first achieve the same minimum IPCS score
used in MUP designation. However, to clearly identify those underserved
areas and population groups with practitioner shortages, consistent
with past HPSA practice the proposed new primary care HPSA designation
criteria also require a specific minimum population-to-practitioner
ratio, not required for designation of an MUP. See, proposed
Secs. 5.202(c) and 5.203(b)(4). Thus, under the rules proposed below,
the geographic area and population group primary care HPSAs will be a
subset of the MUPs.
2. HPSA Designation Threshold
The threshold population-to-primary care practitioner ratio for
primary care HPSA designation of this subset (within the group of all
areas above the threshold for MUA/P designation) is proposed to be set
at 3,000:1. In effect, this maintains current practice with regard to
the HPSA threshold. A threshold of 3,000:1 is currently used for HPSA
designation of population groups and of ``high need'' geographic areas,
which are identified based on criteria including proportion of the
population with low incomes, infant mortality and fertility rates, and
indicators of insufficient primary care capacity. Under the proposed
regulation, all areas considered for HPSA designation will first have
been identified as ``high need'' by achieving an IPCS score of 35 or
more, using similar criteria which include proportion of the population
that is low income or minority, infant mortality or low birthweight
rates and low population density.
Public comments are specifically requested on whether the proposed
3,000:1 threshold or some alternative threshold would best serve to
identify those areas and population groups with shortages of primary
care health professionals.
As with the other thresholds mentioned above, there are no plans to
change this level once set; therefore, the number of designated areas
should decrease as the national provider distribution improves. Note
also that this level is not being identified as an adequacy level but
as a shortage level.
3. HPSA Designation of ``Special Medically Underserved Populations.''
The proposed provisions for population group HPSAs allow for HPSA
designation of the ``special'' populations defined by section 330 of
the PHS Act (as recently amended by Pub. L. 104-299), which are not
required to be designated as MUPs. For example, the provisions for
designation of migrant/seasonal farmworker population groups as primary
care HPSAs allow the use of agricultural areas as the service area unit
of analysis. Although no particular special requirements are specified
for designation of homeless populations as primary care HPSAs, they can
be considered for designation either in similar fashion to or in
combination with poverty or low-income populations, i.e. by utilizing
the ratio of the total number of persons in the population group to the
total FTE primary care practitioners serving them, together with data
for the other IPCS variables representing as closely as possible their
values for the population group being considered. Similarly, a project
serving a public housing project can be considered for primary care
HPSA designation by either assessing its geographic area for a
geographic area HPSA designation or assessing its low income population
for a population group HPSA designation.
K. Designation of Facility Primary Care HPSAs
1. Correctional Facility HPSAs
The criteria and methodology for designating correctional
facilities as primary care HPSAs are essentially unchanged from the
current Part 5. They have no MUP counterpart, since the statute does
not provide for designation of facility MUPs.
2. Other Public or Private Non-Profit Facilities as HPSAs
These criteria are proposed to be simplified. Under the proposed
rules, such a facility will be considered for primary care HPSA
designation only if it is serving one or more designated geographic or
population group HPSAs but is not located within a designated
geographic HPSA or within the area of residence of a designated
population group HPSA. To be designated, the facility would then need
to demonstrate from patient origin data that a majority of its services
are being provided to residents of designated areas or to designated
population groups; travel
[[Page 46546]]
time would not be a consideration. Second, as before, the facility
would need to show that it has insufficient capacity to meet the
primary care needs of the designated areas or population groups served.
However, instead of showing that two of four criteria for insufficient
capacity are met, as in the past, only one criterion would be used:
more than 6,000 outpatient visits per year per FTE primary care
physician on the staff of the facility. The two previously-used waiting
time criteria were difficult to document but almost always
automatically met, while the indicator ``excessive use of emergency
rooms for non-emergent care'' was not well-defined.
L. Dental and Mental Health HPSAs
The proposed procedures in Subpart A would apply to the designation
of dental and mental health HPSAs as well. The criteria currently in
use for these types of HPSA designations are contained in Appendices B
and C of the current part 5. Appendix B (dental HPSAs) would be
redesignated as Appendix A, and Appendix C (mental health HPSAs) would
be redesignated as Appendix B, but no other changes to the appendices
are proposed at this time.
M. Podiatry, Vision Care, Pharmacy and Veterinary Care HPSAs
The HPSA regulations now in use at part 5 also contain, in
appendices D, E, F, and G, criteria for the designation of vision care,
podiatric, pharmacy, and veterinary care HPSAs. These were originally
developed for use in student loan repayment programs for individuals in
those health professions which are no longer authorized or funded.
Consequently, the proposed rule would abolish these types of
designation by revoking these appendices.
N. Transition provisions
The proposed rules also include transition provisions. See,
proposed Sec. 5.5. These would allow existing designations of MUA/Ps
and primary care HPSAs which were made or updated under the previous
criteria within the past three years to remain in effect while older
designations are updated under the new criteria, unless the State
itself indicates that it would like to revise them earlier. The intent
is to review all designations under the same schedule used under the
previous HPSA procedures; i.e., each year those designations which are
more than three years old must be updated, while review of more recent
designations is optional. The proposed rules also set out a procedure
for resolving situations where MUA/P and primary care HPSA boundaries
overlap.
O. HPSAs of Greatest Shortage Determinations
Section 333A of the Public Health Service Act provides that
priority in the assignment of NHSC members be given to entities that,
in addition to meeting certain other requirements, serve HPSAs ``of
greatest shortage,'' and lists the factors to be used in determining
which HPSAs qualify as such. At present, the ``HPSA of greatest
shortage'' score is calculated under criteria published in the Federal
Register, 56 FR 41363-41365, Aug. 20, 1991, and uses population-to-
primary care physician ratio, percent of population below the poverty
level, infant mortality rate or low birthweight rate, and travel time
or distance to care.
Although the regulations proposed below were developed to implement
requirements of sections 330 and 332 of the Act and thus do not
directly address the additional ``HPSA of greatest shortage''
determinations required by section 333A, the agency's intent is to use
the new IPCS variables in making those determinations for geographic
and population group primary care HPSAs in the future. Section 333A(b)
requires that certain exclusive factors be considered in determining
HPSAs of greatest shortage: the ratio of available health professionals
to the population, the rate of low birthweight births, the infant
mortality rate, the ``rate of poverty,'' and ``access to primary health
services, taking into account the distance to such services.'' In the
agency's view, these required factors are captured by the proposed
IPCS. ``Rate of poverty'' in the statute is represented by the percent
of the population with incomes below 200 percent of the poverty line,
and ``access to primary health services, taking into account the
distance to such services' in the statute is represented by the
combination of four access variables--percent linguistically isolated,
percent minority, percent Hispanic ethnicity, and low population
density. All these factors represent access barriers; furthermore, the
low population density variable in particular represents and is
correlated with excessive travel distance to care. Therefore, the
agency intends to use the IPCS variables in determining relative
shortage for the purposes of making HPSA of greatest shortage
determinations under section 333A for primary care HPSAs. The precise
method for doing so will be published following publication of the
final rules.
P. Impact Analysis
The agency has conducted an analysis of the impact of the new
designation methodology on counties, existing geographic HPSAs, and
existing MUAs. It is important to note that the agency's impact
analysis was done using national data for all variables in the IPCS;
therefore, it could not reflect the use of State and local data which
is normally obtained during the back-and-forth activity of the actual
designation process. Accordingly, the results of the impact analysis
for particular areas are not definitive; in fact, the scoring based on
national data would represent only the first step in an exchange with
State and local partners in the actual designation process. However,
the aggregate results of this impact analysis (in terms of total
numbers of areas designated or dedesignated nationally) represent a
conservative approximation to the likely results of the real
designation process--conservative since more corrective feedback is
likely to be received from areas which the national data would tend to
dedesignate than from areas which it would newly designate or continue
in designation.
The U.S. has 3,141 counties (including D.C., but excluding Puerto
Rico and other non-States). Under the existing designation system, 703
counties have been wholly-designated as both MUA and HPSA; 700 others
as whole-county MUAs; and 202 others as whole-county HPSAs, for a total
of 1,605 counties wholly-designated. In addition, 1,063 other counties
contain either a part-county MUA designation, a part-county geographic
HPSA designation or both. The 35 unduplicated population of all
designated HPSAs and MUAs is 72 million.
The agency's impact analysis indicates that, under the new system,
approximately 1,600 counties would be wholly designated, and about 750
other counties partially designated, with a total designated population
of 64 million. Thus, there would be a net decrease of about 300
counties with some designation, and 8 million fewer persons living in
designated areas. The percentage of counties containing some type of
designation would decrease from 85 percent to 76 percent.
The impact analysis also indicates that nationally 23 percent of
existing MUAs (counting each designated whole county and each separate
subcounty area as one MUA) would lose their designation, while only
nine percent of existing HPSAs would lose designation. Most of the
anticipated net decrease in counties wholly or partially designated
[[Page 46547]]
corresponds to the anticipated old MUA dedesignations, which in turn
relates to the fact that many MUAs have not been updated for 15 years
and underservice-relevant conditions in some of these have improved.
Of the 3,141 U.S. counties, 2,134 are rural, while 1,007 are urban;
447 have large minority (non-white) populations, while 260 have large
Hispanic populations. As shown in Table 9, the impact analysis
indicates that approximately 78 percent of the rural counties, 65
percent of the urban counties, 92 percent of the high-minority
counties, and 88 percent of the high-Hispanic counties would continue
to be at least partially designated. The table shows other relevant
statistics for these groups of counties; for example, two percent of
both rural and urban counties would gain designation, while 11 percent
of rural counties and 12 percent of urban counties would lose their
designation. Another nine percent of rural counties and 21 percent of
urban counties which previously contained no designations would remain
undesignated.
Table 9.--Impact by Type of County
[in percents]
----------------------------------------------------------------------------------------------------------------
High High
Total Rural Urban Minority Hispanic
(3141) (2134) (1007) (447) (260)
----------------------------------------------------------------------------------------------------------------
Remain Designated........................................ 74 78 65 92 88
Gain Designation......................................... 2 2 2 1 6
Lose Designation......................................... 11 11 12 5 3
Remain Undesignated...................................... 13 9 21 2 3
----------------------------------------------------------------------------------------------------------------
It should be emphasized that these numbers approximate the national
overall impact, based on the use of national data only. It is
impossible to predict the actual final impact on specific communities
and States because of the iterative process built into the system. As
described in section IV.A above, State and local officials will have
the opportunity to examine the data used to develop these first
approximations during the actual designation process, and to correct
inaccurate provider and other data. In addition, they will have the
opportunity to reconfigure service areas so as to more closely identify
the boundaries of areas where shortages now exist, which may have
changed since some of these service areas were constructed
(particularly the MUAs). We believe this is a major strength of the
proposal, since States and communities know best their service areas
and provider supplies. At the same time, it makes it difficult to
predict precisely the impact of the new method at the local level,
since the data used will be altered by State and local input.
The impact of the proposal on projects and providers in existing
MUPs and HPSAs has also been considered by HRSA. Estimates indicate
that most of the former MUA/Ps that would be dedesignated are not ones
that are currently served by CHCs. This is because the CHC grant
program employs further tests of need in the grant application process;
current grantees are generally serving areas and population groups
which would remain designatable under the new process. In those few
cases where a grantee is serving an area which would be dedesignated
under the new process, it is anticipated that an appropriate population
group will be designatable under the new process.
Although it is estimated that the total number of HPSAs will not
change appreciably, some particular HPSAs will lose designation either
because their IPCS score does not reach 35 or because the counting of
NPs, PAs and CNMs results in their population-to-practitioner ratio
falling below 3,000:1. The effect on existing NHSC sites will be muted
because NHSC assignees serving HPSAs that are dedesignated after they
arrive are allowed to complete their tours of duty; however, such sites
would not be able to ``backfill'' such assignees once they leave. HRSA
will examine this effect in more detail during the comment period.
No national database on location of physicians who have obtained J-
1 visa waivers currently exists, so a detailed analysis of the
potential impact on that program is not immediately available. However,
once such physicians obtain waivers, they can complete their obligation
in the area for which they were waived even if the area loses its
designation.
HRSA and HCFA will collaboratively analyze the combined impact of
the proposed new criteria and relevant provisions of the Balanced
Budget Act of 1997 on Rural Health Clinics during the comment period.
(See also section V below.)
Public comments on the anticipated effects of the proposal on these
various programs are specifically solicited.
Q. Technical and Conforming Amendments
Minor technical and conforming amendments to the CHC regulations at
42 CFR Part 51c are proposed. These amendments refer to Part 5 for
definition of designated medically underserved populations, and for
factors to be considered in assessing the needs of populations to be
served by grantee projects. In addition, they amend the definitions
section of the CHC regulations to include a definition of ``special
medically underserved populations'', which refers to language in the
statute as amended by Pub. L. 104-299. This definition states that such
populations are not required to be designated pursuant to part 5; this
is consistent with their treatment under prior legislation. Finally,
the amendments add a provision explicitly stating that a grantee which
was serving a designated MUA/P at the beginning of a project period
will be assumed to be serving an MUP for the duration of the project
period, even if that particular designation is withdrawn during the
project period.
V. Economic Impact
Executive Order 12866 requires that all regulations reflect
consideration of alternatives, costs, benefits, incentives, equity, and
available information. Regulations must meet certain standards, such as
avoiding unnecessary burden. Regulations which are ``significant''
because of cost, adverse effects on the economy, inconsistency with
other agency actions, budgetary impact, or novel legal or policy
issues, require special analysis. The Department has determined that
this rule will not have an annual effect on the economy of $100 million
or more and does not otherwise meet the definition of a ``significant''
rule under Executive Order 12866.
[[Page 46548]]
The Regulatory Flexibility Act requires that agencies analyze
regulatory proposals to determine whether they create a significant
impact on a substantial number of small entities. ``Small entity'' is
defined in the Regulatory Flexibility Act as ``having the same meaning
as the terms `small business,' `small organization,' and `small
governmental jurisdiction'.''
``Small organizations'' are defined in the Regulatory Flexibility
Act as not-for-profit enterprises which are independently owned and
operated and not dominant in their field. The small organizations
relevant to this regulation would be the Community Health Center
grantees. While we cannot predict actual impact at the community level,
for reasons discussed in section IV.P above, the similarity between the
need component of the funding criteria for CHCs and the elements of the
new designation methodology suggest that very few CHC service areas
would lose designation. In addition, because of the provision that
projects whose designation is lost will nevertheless be considered as
serving an MUA/P for the duration of the project period, any negatively
affected CHC will have time to submit an alternate type of designation
request (such as population group or Governor's) or to make the
transition to unfunded status.
With regard to small businesses, while the designation process may
affect some small profit-making health care-related businesses, it is
unlikely that it could have a significant economic impact (five percent
or more of total revenues) on three percent or more of all such small
businesses. Physician practices can obtain a 10 percent Medicare
Incentive Payment bonus for those services delivered in HPSAs; however,
this would be unlikely to amount to five percent of their total
revenues.
Rural Health Clinics already certified based on an MUA or HPSA
designation have not been adversely affected by dedesignations in the
past since the legislative authority for them has had a grandfather
clause; once certified, the RHC certification could not be withdrawn
based on loss of designation. However, recent legislation (the Balanced
Budget Act of 1997) has changed that; effective January 1, 1999, RHCs
in areas that have lost designation may lose their RHC certification.
On the other hand, the same legislation also provides that RHC
certifications can be retained if it is determined that the RHC is
essential to the delivery of primary care services in its area.
Therefore, dedesignation will not automatically decertify an RHC.
``Small governmental jurisdictions'' are defined by the Regulatory
Flexibility Act to include governments of those cities, counties,
towns, townships, villages, or districts with a population of less than
50,000. Of the 3,141 counties in the U.S., 2,134 are rural and 1,007
are urban. Our impact analysis indicated that 11 percent of all
counties could lose a designation, including 12 percent of urban
counties and 11 percent of rural counties. This would suggest that a
substantial number of small government jurisdictions could be affected.
However, it is unlikely that the economic impact on these jurisdictions
would be significant, i.e. that they would lose more than 5 percent of
their federal funding, as discussed in more detail below.
The impact on particular jurisdictions of loss of designation can
take one or more of three forms: loss of grant funding for primary care
services, loss of a source of clinicians to provide primary care
services, or loss of a more favorable level of Medicaid and/or Medicare
reimbursement. (941 counties have CHC and/or other BPHC funding, and/or
have NHSC resources.) The first of these types of impact would occur
only in the case of a Community Health Center (CHC) which, at the
beginning of a new project period, had been unable to identify a
Medically Underserved Population in the area it proposed to serve.
Typically, grant funding forms 30 percent of the income to a CHC; it is
possible that such a health center would be able to continue in
operation without this revenue. Moreover, dedesignation would indicate
that not only provider availability but also the income of the area's
population had increased. As a result, the percentage impact on the
economy of the area involved would likely be relatively low.
The second of these types of impact corresponds to an area which,
due to loss of its HPSA designation, is no longer eligible for NHSC
clinicians, once the tour of duty of any NHSC personnel already placed
there is completed. Given that the area will have recently been
dedesignated, there must have been an increase in the number of
providers in the area and/or a decreased population and/or improved
demographics, so that loss of NHSC clinicians will be unlikely to have
a major economic effect on the area.
The third type of impact applies in the case of FQHCs and/or RHCs
which lose eligibility for cost-based reimbursement, and private
physicians in former geographic HPSAs which lose the 10 percent
Medicare bonus. None of these entities would actually cease receiving
Medicare or Medicaid reimbursement; they simply would receive a lower
level of reimbursement. In the latter case, it is a loss of 10 percent,
but it is unlikely that it would amount to 5 percent of the physician's
total revenue. In the FQHC/RHC case, there could be a 20-30 percent
decrease in reimbursement to the provider in question, but again this
would not necessarily be a major economic loss to the county or other
jurisdiction as a whole.
It should also be noted that, to the extent that the proposed
regulation ultimately results in some areas losing designation while
others gain designation, and some areas therefore losing program
benefits which go to designated areas while others gain such benefits,
the benefits available in a particular fiscal year will have been
better targeted to the neediest areas, because the criteria will have
been improved and will have been applied to more current data.
The Department nevertheless requests comments on whether there are
any aspects of this proposed rule which can be improved to make the
designation process proposed more effective, more equitable, or less
costly.
VI. Information Collection Requirements Under Paperwork Reduction
Act of 1995
Sections 5.3 and 5.5 of the proposed rule contain information
collection requirements as defined under the Paperwork Reduction Act of
1995 and implementing regulations. As required, the Department of
Health and Human Services is submitting a request for approval of these
information collection provisions to OMB for review. The collection
provisions are summarized below, together with a brief description of
the need for the information and its proposed use, and an estimate of
the burden that will result.
Title: Information for use in designation of MUA/Ps and HPSAs.
Summary of Collection: These regulations revise existing criteria
and processes used for designation of Medically Underserved Areas/
Populations (MUA/P) and Health Professional Shortage Areas (HPSA). As
discussed above, service to an area or population group with such a
designation is one requirement for entities to obtain Federal
assistance from one or more of a number of programs, including the
National Health Service Corps and the Community and Migrant Health
Center Program.
In order to initially obtain such a designation, a community,
individual or State agency or organization must request the designation
in writing.
[[Page 46549]]
Requests must include data showing that the area, population group or
facility meets the criteria for designation, although these data need
not necessarily be collected by the applicant, but may be based on data
obtained from a State entity or data available from the Secretary. If
the request is made by a community or individual, the State entities
identified in the regulation are given an opportunity to review it,
which implies maintenance by these State entities of some recordkeeping
on designations previously made or commented upon by the State. These
requirements apply under both current rules and the proposed rule.
Once a designation has been made, it must be updated periodically
(at least once every three years) or it will be removed from the list
of designations. Although in the past this requirement applied only to
HPSA designations, the proposed rule would extend the regular periodic
update requirement to MUA/P designations, in response to concerns
raised by the GAO and Congressional committees, among others. The
update process involves the Secretary each year informing State (and/or
community) entities as to which of their designations require updates,
and providing these entities with the most current data available to
the Secretary for the areas, population groups and facilities involved,
with respect to the data elements used in designation. The State
entities are then asked to verify whether the designations are still
valid, using the data furnished by the Secretary together with any
additional, more current or more accurate data available to the State
entity (in consultation with the communities involved as necessary). In
the past, this has generally meant that the State (or community)
entities have needed to verify primary care physician counts in the
areas involved, especially for subcounty areas, since only county-level
physician data have been available from national sources; national
population data have been largely limited to decennial census data and
official Census Bureau intercensus county-level updates, so that State
population estimates were sometimes necessary; other relevant data have
generally been available from national sources. Under the proposed new
process, the data furnished by the Secretary will include provider data
and population estimates for subcounty areas as well as counties, in an
easily accessible database, and these data from national sources may be
used without further collection and analysis if acceptable to the State
and community involved. This should reduce the burden on States and
communities, except where the Secretary's data suggest withdrawal of a
designation, in which cases the State or community will still need to
obtain local data to support continued designation. In such cases the
inclusion of nonphysician providers under the proposed new rules will
increase the burden on those States or communities which wish to
challenge provider data furnished by the Secretary.
Need for the information. The information involved is needed in
order to determine whether the areas, populations and facilities
involved satisfy the criteria for designation, and are therefore
eligible for the programs for which these designations are a
prerequisite. While furnishing such information is purely voluntary,
failure to provide it can prevent some needy communities from becoming
eligible for certain programs. The Secretary will make a proactive
effort to identify such communities using national data, but feedback
from State entities and others with appropriate data is vital to
ensuring that the designation/need determination process is accurate
and current.
Likely respondents. The entities that generally submit this
information to DHHS are the State Primary Care Offices (within State
Health Departments) or the State Primary Care Associations (non-profit
associations of health centers and other organizations rendering
primary care). The total burden placed on these entities will be
determined by the number of applications they submit, review or update
each year, and, therefore, will vary from State to State. Updates of
all designated areas will not be required immediately when the new
method is initiated; State entities will be given the opportunity to
spread out updates of previously designated areas over a 3-year period
following implementation of the proposed regulation.
Burden estimate. The overall public reporting and record keeping
burden for this collection of information is estimated to be reduced
under the new method. This is primarily because, while the new method
will require some data collection from the same sources utilized in the
previous MUA/P and HPSA designation procedures, and will also require
MUA/Ps to undergo an updating process which was not previously
required, it eliminates the need to submit separate requests for the
two types of designation and allows the use of national data where
acceptable to the State and community. We also plan to allow electronic
submission of data.
The burden for compiling a request for new designation (including
supporting data) or for update of an existing designation, under the
existing system, was estimated by consulting with State entities who
prepare such requests/updates about the amount of time required for the
various aspects of request preparation, varying these estimates for
requests with several different levels of difficulty, and then
factoring in the approximate frequency of that type of request. Similar
estimates for the new system were then made, revising the contributing
factors to account for those aspects that would require more or less
effort under the new approach. These estimates also assume that some
applications are State-prepared, while others involve both an applicant
and a State consultation or review; the estimates include both parties'
time where two parties are involved. Under the new method States and
communities may use data provided by the Secretary, as mentioned above;
however, some may wish to provide their own data for primary care
physicians, while others may wish to provide data for both primary care
physicians and for the nonphysician primary medical care providers
which are included in the new system (Nurse Practitioners, Physician
Assistants, and Certified Nurse Midwives). Use of State and/or
community data will be more likely in those cases where the national
data suggest dedesignation; the estimates below include consideration
of the extent to which such local data collection will likely be
necessary.
The resulting burden estimates are as follows:
------------------------------------------------------------------------
Average
time to
Type of request compile
(in
hours)
------------------------------------------------------------------------
Current system:
MUA/P application--urban area/pop group..................... 11.5
MUA/P application--rural area/pop group..................... 4.7
HPSA application--urban area/pop group...................... 44.9
HPSA application--rural area/pop group...................... 14.9
HPSA facility application................................... 2.6
Average time per application--all types....................... 24.5
New system:
MUA/P/HPSA application--urban area/pop group................ 27.4
MUA/P/HPSA application--rural area/pop group................ 10.9
HPSA facility application................................... 2.6
Average time per application--all types....................... 15.4
------------------------------------------------------------------------
[[Page 46550]]
Thus the reporting burden per application is reduced by 9.1 hours, or
37 percent.
Purpose of comments: Comments by the public on this proposed
collection of information will be considered in (1) evaluating whether
the proposed collection of information is necessary for the proper
performance of the functions of the Department, including whether the
information will have a practical use; (2) evaluating the accuracy of
the Department's estimate of the burden of the proposed collection of
information, including the validity of the methodology and assumptions
used; (3) enhancing the quality, usefulness, and clarity of the
information to be collected; and (4) minimizing the burden of
collection of information on those who are to respond, including
through the use of appropriate automated electronic, mechanical, or
other technological collection techniques or other forms of information
technology; e.g., permitting electronic submission of responses.
Address for comments: Any public comments specifically regarding
these information collection requirements should be submitted to the
Office of Information and Regulatory Affairs, OMB, New Executive Office
Building, Washington, DC 20503, Attn: Desk Officer for DHHS, and to
Susan Queen, HRSA Reports Clearance Officer, Room 14-36, Parklawn
Building, 5600 Fishers Lane, Rockville, MD 20857. Comments on the
information collection requirements will be accepted by OMB throughout
the 60-day public comment period allowed for the proposed rules, but
will be most useful to OMB if received during the first 30 days, since
OMB must either approve the collection requirement or file public
comments on it by the end of the 60-day period.
List of Subjects
42 CFR Part 5
Health facilities, Health professions, Health statistics, Manpower,
Mental health programs, Reporting and recordkeeping requirements.
42 CFR Part 51c
Grant programs--health, Health care, Health facilities, Reporting
and recordkeeping requirements.
Dated: December 16, 1997.
Claude Earl Fox,
Acting Administrator, Health Resources and Services Administration.
Approved: April 6, 1998.
Donna E. Shalala,
Secretary, Department of Health and Human Services.
For the reasons set out in the preamble, parts 5 and 51c of title
42, Code of Federal Regulations, are proposed to be amended as follows:
PART 5--DESIGNATION OF MEDICALLY UNDERSERVED POPULATIONS AND HEALTH
PROFESSIONAL SHORTAGE AREAS
1. The heading for part 5 is revised as set forth above.
2. The authority citation for part 5 is revised to read as follows:
Authority: 42 U.S.C. 216, 254c, 254e.
3. The table of contents for part 5 is revised to read as follows:
Subpart A--General Procedures for Designation of Medically Underserved
Populations and Health Professional Shortage Areas
Sec.
5.1 Purpose.
5.2 Definitions.
5.3 Procedures for designation and withdrawal of designation.
5.4 Notice and publication of designation and withdrawals.
5.5 Transition provisions.
Subpart B--Criteria and Methodology for Designation of Medically
Underserved Populations
5.101 Applicability.
5.102 Criteria for designation of populations of geographic areas
as MUPs.
5.103 Methodology for designation of geographic areas as MUPs.
5.104 Criteria for designation of population groups as MUPs.
5.105 Requirements for designation of MUPs recommended by State and
local officials.
Subpart C--Criteria and Methodology for Designation of Primary Care
Health Professional Shortage Areas
5.201 Applicability.
5.202 Criteria for designation of geographic areas as primary care
HPSAs.
5.203 Criteria for designation of population groups as primary care
HPSAs.
5.204 Criteria for designation of medical and other public
facilities as primary care HPSAs.
Appendix A to Part 5--Criteria for Designation of Areas Having
Shortages of Dental Professionals
Appendix B to Part 5--Criteria for Designation of Areas Having
Shortages of Mental Health Professionals
4. The existing text is designated as subpart A; a subpart heading
is added; and newly designated subpart A is revised to read as follows:
Subpart A--General Procedures for Designation of Medically
Underserved Populations and Health Professional Shortage Areas
Sec. 5.1 Purpose.
This part establishes criteria and procedures for the designation
and withdrawal of designations of medically underserved populations
pursuant to section 330 of the Public Health Service Act and of health
professional shortage areas pursuant to section 332 of the Act.
Sec. 5.2 Definitions.
As used in this part:
(a) Act means the Public Health Service Act, as amended (42 U.S.C.
201 et seq.).
(b) FTE means full-time equivalent.
(c) Governor means the Governor or other chief executive officer of
a State.
(d) Health professional shortage area (or ``HPSA'') means any of
the following which the Secretary determines in accordance with this
part has a shortage of health professionals:
(1) An urban or rural area;
(2) A population group; or
(3) A public or private nonprofit medical facility or other public
facility.
(e) Medical facility means a facility for the delivery of health
services and includes:
(1) A health center (such as a community health center, migrant
health center, health center for the homeless, or a health center for
residents of public housing), public health center, facility operated
by a city or county health department, outpatient medical facility, or
a community mental health center;
(2) A hospital, State mental hospital, facility for long-term care,
or rehabilitation facility;
(3) An Indian Health Service facility, or a health program or
facility operated under the Indian Self-Determination Act by a
federally recognized tribe or tribal organization;
(4) A facility for delivery of health services to inmates in a U.S.
penal or correctional institution (under section 323 of the Act) or a
State correctional institution;
(5) Any medical facility used in connection with the delivery of
health
[[Page 46551]]
services under section 320, 321, 322, 324, 325, or 326 of the Act;
(6) Any other federal medical facility.
(f) Medically underserved population or MUP means:
(1) The population of an urban or rural area designated by the
Secretary in accordance with this part as having a shortage of personal
health services (also called a medically underserved area or ``MUA'');
or
(2) A population group designated by the Secretary in accordance
with this part as having a shortage of such services.
(g) Metropolitan statistical area means an area which has been
designated by the Office of Management and Budget as a metropolitan
statistical area. All other areas are ``non-metropolitan areas.''
(h) Poverty level means the current poverty line issued by the
Secretary pursuant to 42 U.S.C. 9902.
(i) Secretary means the Secretary of Health and Human Services and
any other officer or employee of the Department to whom the authority
involved has been delegated.
(j) State includes, in addition to the several States, the District
of Columbia, Guam, the Commonwealth of Puerto Rico, the Northern
Mariana Islands, the U.S. Virgin Islands, American Samoa, Palau, the
U.S. Outlying Islands (Midway, Wake, et al.), the Marshall Islands, and
the Federated States of Micronesia.
Sec. 5.3 Procedures for designation and withdrawal of designation.
(a)(1) Any agency or individual may request the Secretary to
designate (or withdraw the designation of) a particular area,
population group, or facility as an MUP or HPSA, as applicable. The
Secretary will forward a copy of each such request to the agencies,
officials, and entities listed below, with a request that they review
the request and offer their recommendations, if any, to the Secretary
within 30 days:
(i) The Governor;
(ii) The appropriate State health agency or agencies;
(iii) Appropriate county or other local health officials within the
State;
(iv) The State primary care association or other State
organization, if any, that represents a majority of community health
centers in the State;
(v) State medical, dental, or other appropriate health professional
societies; and
(vi) Where a public facility (including a federal medical facility)
is proposed for designation or withdrawal of designation, the chief
administrative officer of such facility.
(2) The Secretary may propose the designation, or withdrawal of the
designation, of an area, population group, or facility under this part.
Where such a designation or withdrawal is proposed, the Secretary will
notify the agencies, officials, and entities described in paragraph (a)
of this section and request comment as therein provided.
(b) Using data available to the Secretary from national and State
sources and based upon the applicable criteria in the remaining
subparts and appendices to this part, the Secretary will annually
prepare listings (by State) of currently designated MUPs and HPSAs,
relevant data available to the Secretary, and an identification of
those MUPs and HPSAs within the State whose designations, because of
age or other factors, are required to be updated. Such listings shall
distinguish between first and second degree-of-shortage MUPs and HPSAs,
as determined in accordance with Sec. 5.103. The Secretary will provide
the listing for the State and a description of any information needed
to the appropriate entities described in paragraphs (a)(1) (ii) and
(iv) of this section in each State and request review and comment
within 90 days.
(c) The Secretary will furnish, upon request, an information copy
of a request made pursuant to paragraph (a) of this section or the
materials provided pursuant to paragraph (b) of this section to other
interested persons and groups for their review and comment. Comments or
recommendations may be provided to the Secretary, the Governor, the
appropriate State agency(ies), or any other contact designated by the
Governor.
(d) In the case of a proposed withdrawal of a designation, the
Secretary shall afford, to the extent practicable, other interested
persons and groups in the affected area an opportunity to submit data
and information concerning the proposed action, including entities
directly dependent on the designation and primary care associations and
State health professional associations.
(e)(1) The Secretary may request such further data and information
deemed necessary to evaluate particular proposals or requests for
designation or withdrawal of designation under paragraph (a) of this
section. Any data so requested must be submitted within 30 days of the
request therefor, unless a longer period is approved by the Secretary.
(2) If the information requested under paragraph (b) or (e)(1) of
this section is not provided, the Secretary will evaluate the proposed
designation (including continuation of designation) or withdrawal of
designation of the areas, population groups, and/or facilities for
which the information was requested on the basis of the information
available to the Secretary.
(f) After review and consideration of the available information and
the comments and recommendations submitted, the Secretary will
designate those areas, population groups, and facilities as MUPs and/or
HPSAs, as applicable, which have been determined to meet the applicable
criteria under this part and will withdraw the designation of those
which have been determined no longer to meet the applicable criteria
under this part.
Sec. 5.4 Notice and publication of designations and withdrawals.
(a) In the case of a request under Sec. 5.3(a)(1), the Secretary
will notify the individual or agency requesting the designation or
withdrawal of designation of the determination made.
(b) The Secretary will give written notice of a designation (or
withdrawal of designation) under this part on, or not later than 60
days from, the effective date of the designation (or withdrawal) to:
(1) The Governor of each State in which the designated or withdrawn
MUP or HPSA is located in whole or in part;
(2) The State health department of the affected State or States and
any other State agency(ies) deemed appropriate by the Secretary; and
(3) Other appropriate public or nonprofit private entities which
are located in or which the Secretary determines have a demonstrated
interest in the area designated or withdrawn, including entities
directly dependent on the designation and primary care associations and
State health professional associations.
(c) The Secretary will periodically, but not less than annually,
publish updated lists of designated MUPs and HPSAs in the Federal
Register, by type of designation and by State. Such listings shall
identify the degree-of-shortage of each MUP or HPSA determined pursuant
to Sec. 5.103 of this part.
(d) The effective date of the designation of an MUP or HPSA shall
be the date of the notification letter provided pursuant to paragraph
(a) or (b) of this section or the date of publication in the Federal
Register, whichever occurs first.
(e) The effective date of the withdrawal of the designation of an
MUP or HPSA shall be the date of the notification letter provided
pursuant to
[[Page 46552]]
paragraph (a) or (b) of this section, the date on which notification of
the withdrawal is published in the Federal Register, or the date of
publication in the Federal Register of an updated list of designations
of the type concerned which does not include the designation, whichever
occurs first.
Sec. 5.5 Transition provisions.
(a) Revision of MUPs and primary care HPSAs. (1) The Secretary
will, after [date of publication of final rule in the Federal
Register], submit to the entities in each State identified pursuant to
Sec. 5.3(a)(1) and (2) a listing of the Index of Primary Care Services
(IPCS) scores computed under Sec. 5.103(b) for each currently
designated MUP and primary care HPSA within its boundaries, based on
the data and information available to the Secretary.
(2) The State health agency or other designee of the Governor shall
have 90 days from receipt of such listing, or such longer time period
as the Secretary may approve, to provide comments to the Secretary.
Such comments should take into account the effects on local communities
and any comments by affected entities and may include recommendations
on the following topics:
(i) Where the boundaries of a currently designated MUP and primary
care HPSA overlap but do not coincide --
(A)(1) Which area boundaries the State recommends be continued in
effect; and
(2) Whether the State proposes to have any remaining area
separately designated, either on its own or as part of another area; or
(B) If the State wishes to designate a new area instead of either
area currently designated, a request for such designation in accordance
with the applicable subpart or appendix of this part;
(ii) Any other area boundaries that the State recommends be
revised; and
(iii) Accuracy of the FTE primary care practitioner data and other
data used in scoring.
(b) Continuation of currently designated MUPs and primary care
HPSAs. (1) Except as otherwise provided in this section, the
designation of a MUP or a primary care HPSA designated in the period up
to three years prior to [the date of publication of the final rule in
the Federal Register] will remain in effect for three years from the
date of designation, unless part of the area covered by the designation
is revised under this part.
(2) Where a current MUP and a primary care HPSA designation
overlap, and the State makes an election under paragraph (a)(2)(i)(A)
of this section, the MUP or primary care HPSA that is not selected will
be deemed to be automatically withdrawn.
(3) If part of the area of a currently designated MUP or primary
care HPSA is revised under this part and the State does not request
designation of the remaining area, the current designation covering the
remaining area will be deemed to be automatically withdrawn.
(4) If a State does not provide recommendations to resolve
overlapping area situations under paragraph (a) of this section, the
Secretary may revise the areas involved, based on the applicable
criteria and data and information available.
(5) Subparts B and C are added to read as follows:
Subpart B--Criteria and Methodology for Designation of Medically
Underserved Populations
Sec. 5.101 Applicability.
The following criteria and methodology shall be used to designate
populations of geographic areas and population groups as medically
underserved populations (or ``MUPs'') under section 330(b) of the Act.
Sec. 5.102 Criteria for designation of populations of geographic areas
as MUPs.
The population of an urban or rural area will be designated as a
medically underserved population, pursuant to section 330(b) of the
Act, if it is demonstrated, by such data and information as the
Secretary may require, that the area meets the following criteria:
(a) The area meets the requirements for a rational service area for
the delivery of primary medical care services under Sec. 5.103(a); and
(b) The area's Index of Primary Care Shortage (IPCS) score,
computed in accordance with Sec. 5.103(b), equals or exceeds the
designation threshold specified under Sec. 5.103(b)(4).
Sec. 5.103 Methodology for designation of geographic areas as MUPs.
(a) Rational service areas for the delivery of primary care
services--(1) State-wide system. Each State is encouraged to develop a
State-wide system which divides the territory of the State into
rational service areas for the delivery of primary care services within
the State.
(i) A ``rational service area'' is a geographic area that--
(A) Is composed of one or more contiguous census tracts (CTs),
block numbering areas (BNAs), or census divisions and does not include
partial CTs or BNAs;
(B) The boundaries of which do not overlap with the boundaries of
another rational service area defined by the State;
(C) In which travel time from the population center of the area to
the population center of each contiguous area is typically greater than
30 minutes but less than 60 minutes, except where the circumstances in
any of the following subparagraphs of this paragraph are shown to
exist:
(1) Travel time from the population center of the area to the
population center of a contiguous area may exceed 60 minutes in a
frontier or other sparsely populated area, where topography, market,
transportation, or other conditions and patterns lead to utilization of
providers at greater distances;
(2) Travel time from the population center of the area to the
population center of a contiguous area may be less than 30 minutes
where established neighborhoods and communities within metropolitan
statistical areas display a strong self-identity (as indicated by a
homogeneous socioeconomic or demographic structure and/or a tradition
of interaction or interdependence), have limited interaction with
contiguous areas, and, in general, have a population density equal to
or greater than 100 persons per square mile; or
(3) The State has defined a different travel time standard for use
in its State, has provided a rationale for use of this travel time
standard, and the travel time standard proposed is accepted by the
Secretary as reasonable; and
(D) In which contiguous area resources are not reasonably available
to the population of the area at the time of submission of the area for
consideration as a rational service area. Contiguous area resources are
deemed not reasonably available if any of the following conditions
exists:
(1) Primary care practitioner(s) in the contiguous area are more
than 30 minutes travel time from the population center(s) of the area;
(2) The contiguous area population-to-FTE primary care practitioner
ratio is in excess of 1,500:1; or
(3) Primary care practitioner(s) in the contiguous area are
inaccessible to the population of the area because of specific access
barriers, such as--
(i) Significant differences between the demographic (or socio-
economic) characteristics of the area and those of the contiguous area
indicative of isolation of the area's population from
[[Page 46553]]
the contiguous area, such as language differences; or
(ii) A lack of economic access to contiguous area resources,
particularly where a very high proportion of the area population is
poor (i.e., where more than 20 percent of the population or the
households have incomes below the poverty level or more than 40 percent
have incomes below 200 percent of the poverty level), and Medicaid-
covered or public primary care services are not available in the
contiguous area.
(ii) Each State-wide system of rational service areas shall be
developed in collaboration with the Secretary and be approved by the
State health department or other designee of the Governor.
(2) Non-statewide system. Until a State develops a State-wide
system of rational service areas pursuant to paragraph (a)(1) of this
section, the following areas will be considered to be rational service
areas for the delivery of primary care services:
(i) Currently designated HPSA or MUP service areas, consistent with
the requirements of Sec. 5.5;
(ii) A county or a political subdivision equivalent to a county,
such as a parish in Louisiana; and
(iii) Any other area that the Secretary determines meets the
requirements set out at paragraph (a)(1)(i) of this section.
(b) Index of Primary Care Shortage (IPCS). (1) The IPCS score for
an area is the sum of the area's score with respect to the scales for
each of the following seven variables, with the following maximum
scores:
(i) Population-to-primary care practitioner ratio (35 points);
(ii) Percentage of the population with incomes below 200 percent of
the poverty level (35 points);
(iii) Percentage of the population consisting of racial minorities
(5 points);
(iv) Percentage of the population that is Hispanic (5 points);
(v) Percentage of the population that is linguistically isolated (5
points);
(vi) The greater of the area's score for--
(A) Infant mortality rate (5 points); or
(B) Low birthweight births rate (5 points);
(vii) Low population density (10 points).
(2) Scales for each variable comprising the IPCS are determined by
giving zero points to areas having values for the variable below a
normative level for that variable, or below the 1996 national rate,
where no norm is available, and allocating breakpoints between zero and
the above maximum scores proportionally based on the number of counties
with values above the norm or national rate.
(3) IPCS scores will be computed in accordance with paragraph (c)
of this section and will be determined on both a first degree-of-
shortage basis and a second degree-of-shortage basis.
(4) The threshold for designation of an MUP is an IPCS score of 35.
(c) Calculation of specific IPCS variables--(1) Population count.
The population of an area is the total resident civilian population,
excluding inmates of institutions, based on the most recent U.S. Census
data, adjusted for increases/decreases to the current year using the
best available intercensus projections, and making the following
adjustments, as appropriate:
(i) Adjustments to the population for the differing health service
requirements of various age/sex population groups of the area shall be
computed using a table based on national utitilization rates by age/sex
provided by the Secretary and published from time to time in the
Federal Register.
(ii) Migratory workers and their families may be added to the
adjusted resident civilian population, if significant numbers of
migratory workers are present in the area, using the latest Migrant
Health Atlas or best available federal or State estimates. Estimates
used must be adjusted to reflect the percentage of the year that
migratory workers are present in the area.
(iii) Where seasonal residents significantly affect the effective
total population of an area, seasonal residents (not including
tourists) may be added to the adjusted resident civilian population, if
supported by acceptable State, Chamber of Commerce, or other local
estimates. Estimates used must be adjusted to reflect the percentage of
the year that seasonal residents are present in the area.
(2) Counting of primary care practitioners. (i) In determining an
area's IPCS for designation as having a first degree-of-shortage,
practitioners shall be counted as follows:
(A) Practitioners included. All non-Federal doctors of medicine
(M.D.) and doctors of osteopathy (D.O.) who provide direct patient care
and practice principally in one of the four primary care specialties
(general or family practice, general internal medicine, pediatrics, and
obstetrics and gynecology) shall be counted in terms of FTEs, to the
extent possible. In computing the number of FTE primary care
physicians, the following adjustments shall be made:
(1) Each intern or resident counts as 0.1 FTE physician;
(2) Each graduate of a foreign medical school who is a citizen or
lawful permanent resident of the United States but does not have an
unrestricted license to practice medicine counts as 0.5 FTE physician;
(3) Hospital staff physicians practicing in organized outpatient
departments and primary care clinics, shall be counted on an FTE basis,
calculated as provided for in paragraph (c)(2)(iii) of this section;
(4) Practitioners who are semi-retired, who operate a reduced
practice, or who provide patient care services to the residents of the
area only on a part-time basis shall be counted on an FTE basis,
calculated as provided for in paragraph (c)(2)(iii) of this section;
and
(5) Each nurse practitioner, physician's assistant, or certified
nurse midwife counts as 0.5 FTE. The Secretary may revise this weight
upward if, based on such national practice data as the Secretary
considers reliable, the Secretary determines that a higher weight
better represents the average contribution of such practitioners.
(B) Practitioners excluded. The following shall be excluded from
primary care practitioner counts under paragraph (c)(2)(i) of this
section:
(1) Physicians who are engaged solely in administration, research,
or teaching;
(2) Hospital staff physicians involved exclusively in inpatient
and/or in emergency room care; and
(3) Physicians who are suspended under provisions of the Medicare-
Medicaid Anti-Fraud and Abuse Act, during the period of suspension.
(ii) In determining an area's IPCS for designation as having a
second degree-of-shortage, practitioners shall be counted as provided
for under paragraph (c)(2)(i) of this section, except that the
following practitioners shall also be excluded:
(A) Primary care practitioners who are providing medical services
pursuant to a federal scholarship or loan repayment program obligation,
such as obligations under sections 338A, 338B, 338I, and 338L of the
Act; and
(B) Primary care practitioners who are employed by a federal
grantee under section 330 of the Act.
(iii) Counting of FTEs. FTEs shall be computed as follows: for
practitioners working less than a 40-hour week, every four hours (or
\1/2\-day) spent providing patient care, in either ambulatory or
inpatient settings, counts as 0.1 FTE, and each practitioner providing
patient care 40 or more hours a week counts as 1.0 FTE. Numbers
obtained for FTEs shall be rounded to the nearest 0.1 FTE.
(3) Computation of other variables. (i) Data for the IPCS variables
at paragraphs (b)(1)(ii) through (b)(1)(v) of this section
[[Page 46554]]
for an area shall be aggregated from the most recent available U.S.
Census data for the counties, census tracts, and/or census divisions
which comprise the area; more recent national updates thereof may be
used, if available.
(ii) The IPCS variables at paragraph (b)(1)(vi) of this section
shall be calculated based on the latest available five-year average for
the county of which the service area is a part, unless the area is a
subcounty area and statistically significant five-year average
subcounty data on these variables are available for the subcounty area.
For service areas which cross county lines, a population-weighted
combination of the rates for the counties involved shall be used.
(iii) The IPCS variable at paragraph (b)(1)(vii) of this section
shall be calculated using U.S. Census TIGRE data or the equivalent for
the specific service area involved.
Sec. 5.104 Criteria for designation of population groups as MUPs.
(a) A population group may be designated as an MUP under section
330(b) of the Act, if it is demonstrated, by such data and information
as the Secretary may require, that the following criteria are met, as
applicable:
(1) The area in which the population group resides--
(i) Meets the requirements for a rational service area under
Sec. 5.103(a); or
(ii) In the case of a American Indian or Alaska Native population
group, is an Indian reservation; or
(iii) In the case of a health center population group, is the
catchment area of the health center, as defined by its application
under section 330 of the Act;
(2) The rational service area in which the population group resides
does not meet the criteria for designation as a geographic area MUP
under Sec. 5.102;
(3) There are access barriers that prevent the population group
from accessing primary medical care services available to the general
population of the area, as demonstrated by an IPCS score for the
population group that equals or exceeds the currently applicable
designation threshold, as provided for by Sec. 5.102(b). In calculating
the IPCS score for a population group:
(i) The IPCS variables shall be calculated based as nearly as
possible on their values for the applicable population group and
service area, using such methodology as the Secretary may require; and
(ii) If the type of population group for which designation is
sought is one for which one variable automatically achieves the maximum
possible score, the point value assigned to that variable shall be
distributed among the other variables, using such methodology as the
Secretary may require.
(b) The following types of population groups may be designated as
MUPs only if the applicable criteria of this section are met, as shown
by such data and information as the Secretary may require:
(1) Low income population group: at least 1,500, or 30 percent, of
the area's population, whichever is less, have annual incomes below 200
percent of the poverty level;
(2) American Indian or Native Alaskan tribal population group: the
tribe is listed in the current listing of Federal Register by the
Department of the Interior.
Sec. 5.105 Requirements for designation of MUPs recommended by State
and local officials.
The population of a service area that does not meet the criteria at
Sec. 5.102(b) or Sec. 5.104 may be designated as an MUP, if the
following requirements are met:
(a) The area is recommended for designation by the Governor of the
State in which the area is located and by at least one local official
of the area. A ``local official'' for this purpose may be--
(1) The chief executive of the local governmental entity which
includes all or a substantial portion of the requested area or
population group (such as the county executive of a county, mayor of a
town, mayor or city manager of a city); or
(2) A city or county health official (such as the head of a city or
county health department) of the local governmental entity which
includes all or a substantial portion of the requested area or
population group.
(b) The request for designation is based on the presence of unusual
local conditions, not covered by the criteria at Secs. 5.102(b) and
5.104, which are a barrier to access to or the availability of personal
health services in the area or for the population group for which
designation is sought.
(c) The request for designation contains such documentation as the
Secretary may require.
Subpart C--Criteria and Methodology for Designation of Primary Care
Health Professional Shortage Areas
Sec. 5.201 Applicability.
The following criteria and methodology in this subpart shall be
used to designate geographic areas, population groups, and facilities
as primary care HPSAs under section 332 of the Act.
Sec. 5.202 Criteria for designation of geographic areas as primary
care HPSAs.
An urban or rural geographic area may be designated as a primary
care HPSA where the following criteria are met:
(a) The area is a rational service area under Sec. 5.103(a);
(b) The area's IPCS score equals or exceeds the designation
threshold specified under Sec. 5.103(b)(4); and
(c) The area's population-to-primary care practitioner ratio, as
determined in accordance with Sec. 5.103(c), equals or exceeds 3,000:1.
Sec. 5.203 Criteria for designation of population groups as primary
care HPSAs.
(a) The following types of population groups may be designated as
primary care HPSAs:
(1) A population group designated under Sec. 5.104;
(2) A migrant and/or seasonal farmworker population, as defined in
section 330(g) of the Act;
(3) A homeless population, as defined in section 330(h) of the Act;
and
(4) A public housing resident population, as defined in section
330(i) of the Act.
(b) A population group specified in paragraph (a) of this section
may be designated as a primary care HPSA where the following criteria
are met:
(1) The area in which the population group resides--
(i)(A) Meets the requirements for a rational service area under
Sec. 5.104(a); and
(B) In the case of a public housing resident population group, the
rational service area includes public housing, as defined under section
330(i)(1) of the Act; or
(ii) In the case of a migrant and/or seasonal farmworker population
group, is an agricultural area, as defined by the Secretary;
(2) The area in which the population group resides does not meet
the criteria for designation as a geographic area HPSA under
Sec. 5.202;
(3) The criteria in Sec. 5.104, as appropriate to the type of
population group under consideration, are met; and
(4) The population-to-primary care practitioner ratio determined in
accordance with Sec. 5.104(a)(3) equals or exceeds 3,000:1.
Sec. 5.204 Criteria for designation of medical and other public
facilities as primary care HPSAs.
A public or private nonprofit medical facility or other public
facility will be designated as a primary care HPSA, if the following
criteria are met:
[[Page 46555]]
(a) Federal and State correctional institutions. (1) Medium to
maximum security Federal and State correctional institutions and youth
detention facilities will be designated as primary care HPSAs, if both
of the following criteria are met:
(i) The institution has at least 250 inmates; and
(ii) The ratio of the number of internees per year to the number of
FTE primary care practitioners, determined in accordance with
Sec. 5.103(c)(2)(iii), serving the institution is at least 1,000:1. For
purposes of this paragraph, the number of internees shall be determined
as follows:
(A) If the number of new inmates per year and the average length-
of-stay are not specified, or if the information provided does not
indicate that intake medical examinations are routinely performed upon
entry, then the number of internees equals the number of inmates;
(B) If the average length-of-stay is specified as one year or more,
and intake medical examinations are routinely performed upon entry,
then the number of internees equals the average number of inmates plus
the product of 0.3 multiplied by the number of new inmates per year; or
(C) If the average length-of-stay is specified as less than one
year, and intake examinations are routinely performed upon entry, then
the number of internees equals the average number of inmates plus the
product of 0.2 multiplied by (1 + ALOS/2) multiplied by the number of
new inmates per year. ``ALOS'' is the average length of stay, in
fractions of a year.
(2) Physicians permanently employed by the Federal Bureau of
Prisons or by States to provide services to Federal or State prisoners
shall be counted based on the FTE services they provide, calculated as
provided for in Sec. 5.103(c)(2)(iii).
(b) Public or non-profit private medical facilities--(1) Criteria.
Public or non-profit private medical facilities will be designated as
primary care HPSAs, if the following criteria are met:
(i) The facility is providing primary medical care services to one
or more areas and/or population groups designated under this subpart as
a primary care HPSA but is not located within a designated geographic
area HPSA or within the rational service area for a designated
population group HPSA; and
(ii) The facility has insufficient capacity to meet the primary
care needs of the designated area(s) or population group(s) served.
(2) Methodology. In determining whether public or non-profit
private medical facilities or other public facilities meet the criteria
established by paragraph (b)(1) of this section, the following
methodology will be used:
(i) A facility will be considered to be providing services to one
or more designated areas or population groups, if a majority of the
facility's primary care services are being provided to residents of
geographic areas designated as primary care HPSAs under this subpart or
members of population groups designated as primary care HPSAs under
this subpart.
(ii) A facility will be considered to have insufficient capacity to
meet the primary care needs of the designated area(s) and/or
population(s) it serves, if there are more than 6,000 outpatient visits
per year per FTE primary care physician on the staff of the facility.
Appendices A, D, E, F, G [Removed]
6. Appendices A, D, E, F, and G of part 5 are removed.
Appendix B [Redesignated as Appendix A and Amended]
7. Appendix B of part 5 is redesignated as new Appendix A of part 5
and the appendix heading is revised to read as follows:
Appendix A to Part 5--Criteria for Designation of Areas Having
Shortages of Dental Professionals.
Appendix C [Redesignated as Appendix B and Amended]
8. Appendix C of part 5 is redesignated as new Appendix B of part
5.
PART 51c--GRANTS FOR COMMUNITY HEALTH SERVICES
9. The authority citation for part 51c is revised to read as
follows:
Authority: 42 U.S.C. 216, 254c.
10. Section 51c.102 is amended by revising paragraph (e) and adding
paragraph (k) to read as follows:
Sec. 51c.102 Definitions.
* * * * *
(e) Medically underserved population means the population of an
urban or rural area which is designated as a medically underserved
population by the Secretary under part 5 of this chapter.
* * * * *
(k) Special medically underserved population means a population
defined in section 330(g), 330(h), or 330(i) of the Act. A special
medically underserved population is not required to be designated in
accordance with part 5 of this chapter.
11. Section 51c.104 is amended by revising paragraph (b)(3) and
adding paragraph (d) to read as follows:
Sec. 51c.104 Applications.
* * * * *
(b) * * *
(3) The results of an assessment of the need that the population
served or proposed to be served has for the services to be provided by
the project (or in the case of applications for planning and
development projects, the methods to be used in assessing such need),
utilizing, but not limited to, the factors set forth in Sec. 5.103(b)
of this chapter.
* * * * *
(d) If an application funded under this part demonstrates that the
grantee would serve a designated medically underserved population at
the time of application, then the grantee will be assumed to be serving
a medically underserved population for the duration of the project
period, even if the designation is withdrawn during the project period.
12. Section 51c.203 is amended by revising paragraph (a) to read as
follows:
Sec. 51c.203 Project elements.
* * * * *
(a) Prepare an assessment of the need of the population proposed to
be served by the community health center for the services set forth in
Sec. 51c.102(c)(1), with special attention to the need of the medically
underserved population for such services. Such assessment of need
shall, at a minimum, consider the factors listed in Sec. 5.103(b) of
this chapter.
* * * * *
[FR Doc. 98-22560 Filed 8-31-98; 8:45 am]
BILLING CODE 4160-15-P