[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