Response to Comments on Revised Geographic Eligibility for Federal Office of Rural Health Policy Grants, 2418-2420 [2021-00443]
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Federal Register / Vol. 86, No. 7 / Tuesday, January 12, 2021 / Notices
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Health Resources and Services
Administration
Response to Comments on Revised
Geographic Eligibility for Federal
Office of Rural Health Policy Grants
Health Resources and Services
Administration (HRSA), Department of
Health and Human Services (HHS).
ACTION: Revised definition of rural area;
final response to comments.
AGENCY:
HRSA’s Federal Office of
Rural Health Policy (FORHP) is
modifying the definition it uses of rural
for the determination of geographic
areas eligible to apply for or receive
services funded by FORHP’s rural
health grants. This notice revises the
definition of rural and responds to
comments received on proposed
modifications to how FORHP designates
areas to be eligible for rural health grant
programs published in the Federal
Register on September 23, 2020. After
consideration of the public comments
received, FORHP is adding Metropolitan
Statistical Area (MSA) counties that
contain no Urbanized Area (UA)
population to the areas eligible for rural
health grant programs.
DATES: All proposed changes will go
into effect for new rural health grant
opportunities anticipated to start in
Fiscal Year 2022.
FOR FURTHER INFORMATION CONTACT:
Steve Hirsch, Public Health Analyst,
FORHP, HRSA, 5600 Fishers Lane,
Mailstop 17W59D, Rockville, MD
20857. Phone: (301) 443–0835. Email:
ruralpolicy@hrsa.gov.
SUPPLEMENTARY INFORMATION: FORHP
published a notice in the Federal
Register on September 23, 2020, (85 FR
59806) seeking public comment on
proposed modifications to how it
designates areas eligible for its rural
health grant programs. FORHP proposed
a data-driven methodology connected to
existing geographic identifiers that
could be applied nationally and be
applicable to the wide variation in rural
areas across the U.S.
FORHP uses the Office of
Management and Budget (OMB)’s list of
counties designated as part of a MSA as
the basis for determining eligibility to
apply for, or receive services funded by,
its rural health grant programs.
Currently, all areas within non-metro
counties (both Micropolitan counties
and counties with neither designation)
are considered rural and eligible for
rural health grants. FORHP also
designates census tracts within MSAs as
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SUMMARY:
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rural for grant purposes using RuralUrban Commuting Area (RUCA) codes
from the Economic Research Service
(ERS) of the U.S. Department of
Agriculture (USDA). These include all
census tracts inside MSAs with RUCA
codes 4–10 and 132 large area census
tracts with RUCA codes 2 and 3. The
132 MSA census tracts with RUCA
codes 2–3 are at least 400 square miles
in area with a population density of no
more than 35 people per square mile.
Information regarding FORHP’s
designation of rural is publicly available
on its website at: https://www.hrsa.gov/
rural-health/about-us/definition/
index.html and https://data.hrsa.gov/
tools/rural-health.
In the Federal Register notice
published in September 2020, FORHP
proposed modifying its existing rural
definition by adding outlying MSA
counties with no UA population to its
list of areas eligible to apply for and
receive services funded by FORHP’s
rural health grants. UAs are defined by
the Census Bureau as densely settled
areas with a total population of at least
50,000 people.
FORHP received 67 comments in
response to the Federal Register notice.
Following is a summary of the
comments received.
Over three quarters of the comments
received supported the proposal to add
outlying MSA counties with no UA
population to the list of areas eligible for
rural health grants. While most
comments supported the proposal,
several advised against adoption of the
proposal. There were also several
commenters who neither supported nor
opposed the proposal.
The comments in favor of the
proposal agreed with FORHP that
proximity to a Metropolitan area does
not mean a county is not rural in
character and that shifts in employment
and job creation have drawn people to
commute to jobs in MSAs even though
they still live in rural areas. Many
commenters noted that FORHP’s
proposal appropriately identified
populations that were rural in character
and did not include areas or
populations that were not rural in
character.
Those who opposed the proposed
modification did so for a variety of
reasons. These included:
1. There are limited resources
currently available for rural
populations. Increasing the number of
people and areas eligible will dilute the
resources available.
2. The proposed modification does
not include some areas that used to be
considered rural, and still should be,
but are now part of MSAs.
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3. The proposal is too limited and
should more expansively define what is
rural.
4. The proposal, and the current
definition of what is eligible for rural
health grants, is too expansive and
includes areas that are not truly rural.
5. Determination of need in rural
areas should include whether areas are
‘‘underserved,’’ alternatively, the
determination should factor in
unemployment as another criteria.
Response to Comment 1: FORHP
understands commenters concerns that
expanding the number of areas eligible
to apply for rural health grants has the
potential to dilute available resources
for existing rural areas. At the same
time, it is important to identify the
entire rural population as objectively
and accurately as possible so that
resource allocation decisions can be
based on complete and accurate
information. The modification is
intended to more accurately identify
rural populations within MSAs.
Response to Comment 2: After every
Census, there is a process to identify
areas where population has increased or
decreased. Urban Clusters, which have
increased in population above the
49,999 limit, are re-designated as UA
and, vice versa, some UA may lose
population and be re-designated as
Urban Clusters. FORHP’s intent, with
the use of RUCA codes and this
proposed modification for counties with
no UA population, is to correctly
identify rural populations inside of
MSAs.
Response to Comment 3: FORHP is
proposing clear, quantitative criteria
using nationally available data for an
expansion of areas eligible for rural
health grants. FORHP has not identified
clear, quantitative criteria beyond what
was proposed.
Response to Comment 4: FORHP will
continue to use the best available means
it can to define rural areas.
Response to Comment 5: FORHP is
modifying its identification of rural
areas with this notice, consistent with
its program authority to award grants to
support rural health and rural health
care services. While rural areas are
frequently underserved and may
experience shortages of health care
providers, rurality and underservice are
not the same thing. Unemployment is
also a factor that does not determine
rurality since a rural area could have
high or low unemployment. Both could
be used as factor in grant awards, given
programmatic goals, but do not indicate
rurality.
Many of the commenters, both those
who supported and those who opposed
the proposed FORHP modifications,
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Federal Register / Vol. 86, No. 7 / Tuesday, January 12, 2021 / Notices
also suggested further modifications or
adjustments to the way FORHP defines
rural areas.
Comment: The most common
suggestion was that FORHP identify
difficult and mountainous terrain
because travel on roads through such
terrain is more difficult and timeconsuming.
Response to Comment: FORHP
recognizes that travel in difficult and
mountainous terrain, along with
distance, are often barriers to access to
health care.
The ERS of U.S. Department of
Agriculture was charged with
researching the feasibility of identifying
census tracts with difficult and
mountainous terrain in Senate Report
116–110—Agriculture, Rural
Development, Food and Drug
Administration, and related Agencies
Appropriations Bill, 2020. ERS
produces the RUCA codes that FORHP
uses to identify rural areas insides
MSAs. ERS has greater experience and
resources to analyze geography than
FORHP does. If ERS does add identifiers
for difficult and mountainous terrain to
the RUCA codes, FORHP will examine
the feasibility of using this information
to designate rural census tracts in
MSAs.
Comment: Many commenters
suggested specific Metropolitan
counties by name that they believed
should be designated as rural.
Response to Comment: Consistent
with other federal geographic standards,
FORHP seeks only to use appropriate
objective data to assess a geographic
unit to determine whether a place meets
those standards. FORHP cannot define
individual counties as rural without
having clear, data-driven criteria that
can be equitably applied.
Comment: Many commenters
suggested that FORHP consider
expanding eligibility to urban health
centers that primarily serve rural
populations.
Response to Comment: FORHP
implemented this suggestion after the
Coronavirus Aid, Relief, and Economic
Security Act (the CARES ACT, Pub. L.
116–136) reauthorized the Rural Health
Care Services Outreach, Rural Health
Network Development, and Small
Health Care Provider Quality
Improvement grant programs created by
Section 330A of the Public Health
Service Act (42 U.S.C. 254c). The
CARES Act changed the statutory
authority for Rural Health Care Services
Outreach and Rural Health Network
Development grants and expanded
eligibility to allow urban entities to
apply as the lead applicant for these
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rural health grants as long as they serve
eligible rural populations.
Comment: Some commenters
suggested that FORHP should accept
state government-designated rural areas
for the purpose of eligibility for rural
health grant programs.
Response to Comment: FORHP
understands and supports the right of
states to develop definitions of rural that
meet their specific needs. In
determining eligibility for a federal
grant program that is national in scope,
the challenge for FORHP is having
consistent and objective standards that
can be applied consistently across the
entire country. For that reason, FORHP
uses quantitative standards that can be
applied nationally and consistently in
an administratively efficient manner.
Comment: Some commenters
suggested that FORHP allow individual
counties to request designations as
rural.
Response to Comment: FORHP
applies consistent quantitative
standards to identify rural areas and
populations across the nation as a
whole. An exception process for
individual counties would yield
inconsistent results.
Comment: Commenters suggested that
all providers with specific certifications
or special payment designations (e.g.,
Rural Health Clinics, Critical Access
Hospitals, etc.) from the Centers for
Medicare & Medicaid Services (CMS)
should be designated as eligible for rural
health grant programs and that FORHP
should coordinate the definition of rural
with CMS.
Response to Comment: Many of the
providers identified as ‘‘rural’’ by CMS
are classified using different standards
that are specific to each special
designation. In addition, some
designated providers are no longer
located in rural areas due to population
growth over time. They have maintained
their status due to reclassification or
grandfathering provisions specific to
those certification and payment
programs. In contrast, the purpose of
FORHP grants is to provide services to
the rural population, as determined by
a consistent, quantitative standard.
FORHP notes that hospitals or clinics
that have the CMS rural designation can
still apply for FORHP rural health grant
funding as long as they propose to serve
an eligible rural population. This
change was part of the recent reauthorization of the Section 330A
programs described above. FORHP
believes this change will address some
of the concerns raised by commenters.
Comment: Several commenters
suggested grandfathering providers, as
legacy rural sites of care which would
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2419
enable those organizations to apply for
rural health grants even if they were no
longer located in a rural area.
Response to Comment: This comment
is similar, but not precisely the same as
the earlier comment that FORHP should
accept all providers with specific
certifications or special payment
designations from CMS as eligible for
rural health grants. The change in
statutory authority for the Section 330A
programs will allow these providers to
continue to apply for rural health grants
as long as they continue to serve rural
populations. Identifying and tracking
legacy rural sites of care would be
administratively unworkable and is not
needed to target services to rural
populations.
Comment: Several commenters
suggested that FORHP remove
incarcerated people from the total
population that makes up the UA core
of a MSA in cases where the UA
population would fall below the floor of
50,000.
Response to Comment: FORHP has
not identified a data source to
consistently determine the populations
of incarcerated people within the UA
boundaries. Without a standard,
national data source, FORHP cannot
calculate the number of incarcerated
people for every UA and determine
whether removal of this population
from a UA core would reduce the total
population below 50,000. In addition,
prison populations can fluctuate year to
year and there are administrative
challenges in validating data from local
sources.
Comment: Several commenters
suggested that FORHP remove college
students from UA population totals.
Response to Comment: As with the
population of incarcerated people
mentioned above, FORHP does not have
a national data source to identify the
student population of an UA. Students
are also able to access health care
resources in the community. Without a
standard, national data source, FORHP
cannot calculate the number of college
students for every UA and determine
whether removal of this population
from a UA core would reduce the total
population below 50,000. In addition,
there are administrative challenges in
validating data from local sources.
Comment: Several commenters
suggested that if FORHP does adopt the
proposed modification and increases the
number of people eligible to be served
by rural health grants, FORHP should
increase the funding available for grants.
Response to Comment: The level of
resources available for any federal
program is determined by Congress.
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Federal Register / Vol. 86, No. 7 / Tuesday, January 12, 2021 / Notices
Comment: Several Tribal
organizations wrote comments objecting
to the modification. They suggested that
all Tribal lands be defined as rural and
that funds be set aside solely for awards
to Tribal health providers.
Response to Comment: The statutory
authority for rural health grant programs
directs services at rural areas and
populations. FORHP understands the
unique challenges faced by Tribal
entities. Rural health grants can be and
have been awarded to Tribal
organizations located in rural areas.
With the changes in the authorization
for 330A programs, urban Tribal
providers can also apply for rural health
grants to serve rural populations.
FORHP cannot change rural health
funding to direct it to urban
populations, even if they are
underserved, or specify funding setasides for Tribal organizations.
Comment: Different commenters
suggested that FORHP use a
combination of population density,
travel time or distance, geographic
isolation, and access to resources to
designate rural areas, or that FORHP use
Frontier and Remote Area (FAR) Codes
to determine rurality.
Response to Comment: Commenters
did not suggest data sources that would
combine population density, travel time
or distance, geographic isolation, and
access to resources to provide a
consistent, nationally standard
definition of rural areas. FAR Codes
utilize population density and travel
time to designate different levels of
‘‘frontier’’ or remoteness. However,
much of the rural U.S. that is currently
eligible for rural health grants is not
designated as frontier and remote and
would lose eligibility if only FAR codes
were used.
FORHP thanks the public for their
comments. After consideration of the
public comments we received, FORHP
is implementing the modification as
proposed to expand its list of rural
areas. FORHP will add MSA counties
that contain no UA population to the
areas eligible for rural health grant
programs. Using the March 2020 update
of MSA delineations released by OMB,
295 counties will meet this criteria as
outlying MSA counties with no UA
population. The expanded eligibility
will go into effect for new rural health
grants awarded in fiscal year 2022.
FORHP will ensure information about
the expanded eligibility is available to
the public and update the Rural Health
Grants Eligibility Analyzer at https://
data.hrsa.gov/tools/rural-health for
fiscal year 2022 funding opportunities.
These changes reflect FORHP’s desire to
accurately identify areas that are rural in
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character using a data-driven
methodology that relies on existing
geographic identifiers and utilizes
standard, national level data sources.
sanitizers.1 The agency acknowledged
‘‘that some consumers and health care
personnel are currently experiencing
difficulties accessing alcohol-based
hand sanitizers,’’ and that some were
Thomas J. Engels,
relying on home-made hand sanitizers
Administrator.
as a result.2 FDA issued the guidance in
[FR Doc. 2021–00443 Filed 1–11–21; 8:45 am]
response to requests from ‘‘certain
BILLING CODE 4165–15–P
entities that are not currently regulated
by FDA as drug manufacturers’’ that
nevertheless rose up to meet this public
DEPARTMENT OF HEALTH AND
health need.3 FDA stated it ‘‘does not
HUMAN SERVICES
intend to take action against firms that’’
produce hand sanitizer products during
the COVID–19 Public Health
[Docket No. FDA–2020–N–2246]
Emergency, provided the firm’s
Notice That Persons That Entered the
activities are consistent with the
Over-the-Counter Drug Market To
guidance.4
Supply Hand Sanitizer During the
The guidance, which FDA amended
COVID–19 Public Health Emergency
after the Coronavirus Aid, Relief, and
Are Not Subject to the Over-theEconomic Security Act (‘‘CARES Act’’),
Counter Drug Monograph Facility Fee
Public Law 116–136, 134 Stat. 281
(March 27, 2020) became law, contains
AGENCY: Food and Drug Administration
no mention of user or facility fees.
(FDA), Department of Health and
FDA’s website on Hand Sanitizers and
Human Services (HHS).
COVID–19, contains a sub-bullet under
the link to the guidance announcing that
ACTION: Notice.
‘‘the facility fee applies to all OTC hand
SUMMARY: The Department of Health and sanitizer manufacturers registered with
Human Services is issuing this Notice to FDA, including facilities that
clarify that persons that entered into the manufacture or process hand sanitizer
products under this temporary policy,’’
over-the-counter drug industry for the
but that language was added about the
first time in order to supply hand
same time as the aforementioned
sanitizers during the COVID–19 Public
withdrawn Notice was published in the
Health Emergency are not persons
Federal Register.5 Entities that began
subject to the facility fee the Secretary
producing
hand sanitizers in reliance on
is authorized to collect under section
the guidance were understandably
744M of the Food, Drug, and Cosmetic
surprised when FDA contacted them to
Act.
collect an establishment fee in excess of
DATES: January 12, 2021.
$14,000.6
FDA’s purported authority for these
FOR FURTHER INFORMATION CONTACT:
facility fees comes from the CARES Act.
David Haas, Office of Financial
In section 3862 of the CARES Act,
Management, Food and Drug
Congress provided the Secretary with
Administration, 4041 Powder Mill Rd.,
the authority to assess user and facility
Rm. 61075, Beltsville, MD 20705–4304,
fees from ‘‘each person that owns a
240–402 4585.
facility identified as an OTC drug
SUPPLEMENTARY INFORMATION: On
monograph facility on December 31 of
December 29, 2020, FDA published a
the fiscal year or at any time during the
Notice in the Federal Register entitled
preceding 12-month period.’’ FD&C Act
Fee Rates Under the Over-the-Counter
744M(a)(1)(A), 21 U.S.C. 379j–
Monograph User Fee Program for Fiscal
Year 2021. 85 FR 85646. The
1 FDA, Temporary Policy for Preparation of
Department since withdrew that Notice
Certain Alcohol-Based Hand Sanitizer Products
because it was not approved by the
During the Public Health Emergency (COVID–19)
Guidance for Industry (Mar. 2020; updated Aug. 7,
Secretary. For the reasons provided
below, the Department is clarifying that 2020).
2 Id. at 3.
persons that entered the over-the3 Id.
counter drug market to supply hand
4 Id.
sanitizer products in response to the
5 An archived version of the website shows the
COVID–19 Public Health Emergency are language at issue was not on the website as late as
December 29, 2020. See: https://web.archive.org/
not subject to the facility fee the
web/20201229105739/https://www.fda.gov/drugs/
Secretary is authorized to collect under
coronavirus-covid-19-drugs/hand-sanitizers-covidsection 744M of the Food, Drug, and
19.
6 This surprise, coupled with the guidance’s
Cosmetic Act (FD&C Act).
silence on facility fees, raises reliance interests
In March 2020, FDA issued a
concerns under the Supreme Court’s decision in
temporary policy to enable increased
Department of Homeland Security v. Regents of the
production of alcohol-based hand
University of California, 140 S. Ct. 1891 (2020).
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]]>Agencies
[Federal Register Volume 86, Number 7 (Tuesday, January 12, 2021)]
[Notices]
[Pages 2418-2420]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2021-00443]
[[Page 2418]]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Health Resources and Services Administration
Response to Comments on Revised Geographic Eligibility for
Federal Office of Rural Health Policy Grants
AGENCY: Health Resources and Services Administration (HRSA), Department
of Health and Human Services (HHS).
ACTION: Revised definition of rural area; final response to comments.
-----------------------------------------------------------------------
SUMMARY: HRSA's Federal Office of Rural Health Policy (FORHP) is
modifying the definition it uses of rural for the determination of
geographic areas eligible to apply for or receive services funded by
FORHP's rural health grants. This notice revises the definition of
rural and responds to comments received on proposed modifications to
how FORHP designates areas to be eligible for rural health grant
programs published in the Federal Register on September 23, 2020. After
consideration of the public comments received, FORHP is adding
Metropolitan Statistical Area (MSA) counties that contain no Urbanized
Area (UA) population to the areas eligible for rural health grant
programs.
DATES: All proposed changes will go into effect for new rural health
grant opportunities anticipated to start in Fiscal Year 2022.
FOR FURTHER INFORMATION CONTACT: Steve Hirsch, Public Health Analyst,
FORHP, HRSA, 5600 Fishers Lane, Mailstop 17W59D, Rockville, MD 20857.
Phone: (301) 443-0835. Email: [email protected].
SUPPLEMENTARY INFORMATION: FORHP published a notice in the Federal
Register on September 23, 2020, (85 FR 59806) seeking public comment on
proposed modifications to how it designates areas eligible for its
rural health grant programs. FORHP proposed a data-driven methodology
connected to existing geographic identifiers that could be applied
nationally and be applicable to the wide variation in rural areas
across the U.S.
FORHP uses the Office of Management and Budget (OMB)'s list of
counties designated as part of a MSA as the basis for determining
eligibility to apply for, or receive services funded by, its rural
health grant programs. Currently, all areas within non-metro counties
(both Micropolitan counties and counties with neither designation) are
considered rural and eligible for rural health grants. FORHP also
designates census tracts within MSAs as rural for grant purposes using
Rural-Urban Commuting Area (RUCA) codes from the Economic Research
Service (ERS) of the U.S. Department of Agriculture (USDA). These
include all census tracts inside MSAs with RUCA codes 4-10 and 132
large area census tracts with RUCA codes 2 and 3. The 132 MSA census
tracts with RUCA codes 2-3 are at least 400 square miles in area with a
population density of no more than 35 people per square mile.
Information regarding FORHP's designation of rural is publicly
available on its website at: https://www.hrsa.gov/rural-health/about-us/definition/ and https://data.hrsa.gov/tools/rural-health.
In the Federal Register notice published in September 2020, FORHP
proposed modifying its existing rural definition by adding outlying MSA
counties with no UA population to its list of areas eligible to apply
for and receive services funded by FORHP's rural health grants. UAs are
defined by the Census Bureau as densely settled areas with a total
population of at least 50,000 people.
FORHP received 67 comments in response to the Federal Register
notice. Following is a summary of the comments received.
Over three quarters of the comments received supported the proposal
to add outlying MSA counties with no UA population to the list of areas
eligible for rural health grants. While most comments supported the
proposal, several advised against adoption of the proposal. There were
also several commenters who neither supported nor opposed the proposal.
The comments in favor of the proposal agreed with FORHP that
proximity to a Metropolitan area does not mean a county is not rural in
character and that shifts in employment and job creation have drawn
people to commute to jobs in MSAs even though they still live in rural
areas. Many commenters noted that FORHP's proposal appropriately
identified populations that were rural in character and did not include
areas or populations that were not rural in character.
Those who opposed the proposed modification did so for a variety of
reasons. These included:
1. There are limited resources currently available for rural
populations. Increasing the number of people and areas eligible will
dilute the resources available.
2. The proposed modification does not include some areas that used
to be considered rural, and still should be, but are now part of MSAs.
3. The proposal is too limited and should more expansively define
what is rural.
4. The proposal, and the current definition of what is eligible for
rural health grants, is too expansive and includes areas that are not
truly rural.
5. Determination of need in rural areas should include whether
areas are ``underserved,'' alternatively, the determination should
factor in unemployment as another criteria.
Response to Comment 1: FORHP understands commenters concerns that
expanding the number of areas eligible to apply for rural health grants
has the potential to dilute available resources for existing rural
areas. At the same time, it is important to identify the entire rural
population as objectively and accurately as possible so that resource
allocation decisions can be based on complete and accurate information.
The modification is intended to more accurately identify rural
populations within MSAs.
Response to Comment 2: After every Census, there is a process to
identify areas where population has increased or decreased. Urban
Clusters, which have increased in population above the 49,999 limit,
are re-designated as UA and, vice versa, some UA may lose population
and be re-designated as Urban Clusters. FORHP's intent, with the use of
RUCA codes and this proposed modification for counties with no UA
population, is to correctly identify rural populations inside of MSAs.
Response to Comment 3: FORHP is proposing clear, quantitative
criteria using nationally available data for an expansion of areas
eligible for rural health grants. FORHP has not identified clear,
quantitative criteria beyond what was proposed.
Response to Comment 4: FORHP will continue to use the best
available means it can to define rural areas.
Response to Comment 5: FORHP is modifying its identification of
rural areas with this notice, consistent with its program authority to
award grants to support rural health and rural health care services.
While rural areas are frequently underserved and may experience
shortages of health care providers, rurality and underservice are not
the same thing. Unemployment is also a factor that does not determine
rurality since a rural area could have high or low unemployment. Both
could be used as factor in grant awards, given programmatic goals, but
do not indicate rurality.
Many of the commenters, both those who supported and those who
opposed the proposed FORHP modifications,
[[Page 2419]]
also suggested further modifications or adjustments to the way FORHP
defines rural areas.
Comment: The most common suggestion was that FORHP identify
difficult and mountainous terrain because travel on roads through such
terrain is more difficult and time-consuming.
Response to Comment: FORHP recognizes that travel in difficult and
mountainous terrain, along with distance, are often barriers to access
to health care.
The ERS of U.S. Department of Agriculture was charged with
researching the feasibility of identifying census tracts with difficult
and mountainous terrain in Senate Report 116-110--Agriculture, Rural
Development, Food and Drug Administration, and related Agencies
Appropriations Bill, 2020. ERS produces the RUCA codes that FORHP uses
to identify rural areas insides MSAs. ERS has greater experience and
resources to analyze geography than FORHP does. If ERS does add
identifiers for difficult and mountainous terrain to the RUCA codes,
FORHP will examine the feasibility of using this information to
designate rural census tracts in MSAs.
Comment: Many commenters suggested specific Metropolitan counties
by name that they believed should be designated as rural.
Response to Comment: Consistent with other federal geographic
standards, FORHP seeks only to use appropriate objective data to assess
a geographic unit to determine whether a place meets those standards.
FORHP cannot define individual counties as rural without having clear,
data-driven criteria that can be equitably applied.
Comment: Many commenters suggested that FORHP consider expanding
eligibility to urban health centers that primarily serve rural
populations.
Response to Comment: FORHP implemented this suggestion after the
Coronavirus Aid, Relief, and Economic Security Act (the CARES ACT, Pub.
L. 116-136) reauthorized the Rural Health Care Services Outreach, Rural
Health Network Development, and Small Health Care Provider Quality
Improvement grant programs created by Section 330A of the Public Health
Service Act (42 U.S.C. 254c). The CARES Act changed the statutory
authority for Rural Health Care Services Outreach and Rural Health
Network Development grants and expanded eligibility to allow urban
entities to apply as the lead applicant for these rural health grants
as long as they serve eligible rural populations.
Comment: Some commenters suggested that FORHP should accept state
government-designated rural areas for the purpose of eligibility for
rural health grant programs.
Response to Comment: FORHP understands and supports the right of
states to develop definitions of rural that meet their specific needs.
In determining eligibility for a federal grant program that is national
in scope, the challenge for FORHP is having consistent and objective
standards that can be applied consistently across the entire country.
For that reason, FORHP uses quantitative standards that can be applied
nationally and consistently in an administratively efficient manner.
Comment: Some commenters suggested that FORHP allow individual
counties to request designations as rural.
Response to Comment: FORHP applies consistent quantitative
standards to identify rural areas and populations across the nation as
a whole. An exception process for individual counties would yield
inconsistent results.
Comment: Commenters suggested that all providers with specific
certifications or special payment designations (e.g., Rural Health
Clinics, Critical Access Hospitals, etc.) from the Centers for Medicare
& Medicaid Services (CMS) should be designated as eligible for rural
health grant programs and that FORHP should coordinate the definition
of rural with CMS.
Response to Comment: Many of the providers identified as ``rural''
by CMS are classified using different standards that are specific to
each special designation. In addition, some designated providers are no
longer located in rural areas due to population growth over time. They
have maintained their status due to reclassification or grandfathering
provisions specific to those certification and payment programs. In
contrast, the purpose of FORHP grants is to provide services to the
rural population, as determined by a consistent, quantitative standard.
FORHP notes that hospitals or clinics that have the CMS rural
designation can still apply for FORHP rural health grant funding as
long as they propose to serve an eligible rural population. This change
was part of the recent re-authorization of the Section 330A programs
described above. FORHP believes this change will address some of the
concerns raised by commenters.
Comment: Several commenters suggested grandfathering providers, as
legacy rural sites of care which would enable those organizations to
apply for rural health grants even if they were no longer located in a
rural area.
Response to Comment: This comment is similar, but not precisely the
same as the earlier comment that FORHP should accept all providers with
specific certifications or special payment designations from CMS as
eligible for rural health grants. The change in statutory authority for
the Section 330A programs will allow these providers to continue to
apply for rural health grants as long as they continue to serve rural
populations. Identifying and tracking legacy rural sites of care would
be administratively unworkable and is not needed to target services to
rural populations.
Comment: Several commenters suggested that FORHP remove
incarcerated people from the total population that makes up the UA core
of a MSA in cases where the UA population would fall below the floor of
50,000.
Response to Comment: FORHP has not identified a data source to
consistently determine the populations of incarcerated people within
the UA boundaries. Without a standard, national data source, FORHP
cannot calculate the number of incarcerated people for every UA and
determine whether removal of this population from a UA core would
reduce the total population below 50,000. In addition, prison
populations can fluctuate year to year and there are administrative
challenges in validating data from local sources.
Comment: Several commenters suggested that FORHP remove college
students from UA population totals.
Response to Comment: As with the population of incarcerated people
mentioned above, FORHP does not have a national data source to identify
the student population of an UA. Students are also able to access
health care resources in the community. Without a standard, national
data source, FORHP cannot calculate the number of college students for
every UA and determine whether removal of this population from a UA
core would reduce the total population below 50,000. In addition, there
are administrative challenges in validating data from local sources.
Comment: Several commenters suggested that if FORHP does adopt the
proposed modification and increases the number of people eligible to be
served by rural health grants, FORHP should increase the funding
available for grants.
Response to Comment: The level of resources available for any
federal program is determined by Congress.
[[Page 2420]]
Comment: Several Tribal organizations wrote comments objecting to
the modification. They suggested that all Tribal lands be defined as
rural and that funds be set aside solely for awards to Tribal health
providers.
Response to Comment: The statutory authority for rural health grant
programs directs services at rural areas and populations. FORHP
understands the unique challenges faced by Tribal entities. Rural
health grants can be and have been awarded to Tribal organizations
located in rural areas. With the changes in the authorization for 330A
programs, urban Tribal providers can also apply for rural health grants
to serve rural populations. FORHP cannot change rural health funding to
direct it to urban populations, even if they are underserved, or
specify funding set-asides for Tribal organizations.
Comment: Different commenters suggested that FORHP use a
combination of population density, travel time or distance, geographic
isolation, and access to resources to designate rural areas, or that
FORHP use Frontier and Remote Area (FAR) Codes to determine rurality.
Response to Comment: Commenters did not suggest data sources that
would combine population density, travel time or distance, geographic
isolation, and access to resources to provide a consistent, nationally
standard definition of rural areas. FAR Codes utilize population
density and travel time to designate different levels of ``frontier''
or remoteness. However, much of the rural U.S. that is currently
eligible for rural health grants is not designated as frontier and
remote and would lose eligibility if only FAR codes were used.
FORHP thanks the public for their comments. After consideration of
the public comments we received, FORHP is implementing the modification
as proposed to expand its list of rural areas. FORHP will add MSA
counties that contain no UA population to the areas eligible for rural
health grant programs. Using the March 2020 update of MSA delineations
released by OMB, 295 counties will meet this criteria as outlying MSA
counties with no UA population. The expanded eligibility will go into
effect for new rural health grants awarded in fiscal year 2022. FORHP
will ensure information about the expanded eligibility is available to
the public and update the Rural Health Grants Eligibility Analyzer at
https://data.hrsa.gov/tools/rural-health for fiscal year 2022 funding
opportunities. These changes reflect FORHP's desire to accurately
identify areas that are rural in character using a data-driven
methodology that relies on existing geographic identifiers and utilizes
standard, national level data sources.
Thomas J. Engels,
Administrator.
[FR Doc. 2021-00443 Filed 1-11-21; 8:45 am]
BILLING CODE 4165-15-P
