Criteria for Determining Maternity Care Health Professional Target Areas, 53324-53329 [2021-20855]
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Federal Register / Vol. 86, No. 184 / Monday, September 27, 2021 / Notices
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changed by the CARES Act.7 We are
aware that there have been scientific
developments in the time since the
proposed rule was issued including,
among other things, the publication of
two new studies on the absorption of
sunscreen active ingredients,8 both of
which reinforced the need for the
sunscreen ingredient data requested in
our proposed rule (and in the proposed
order). The comment period on this
proposed order affords an opportunity
for the public to submit information that
has become available since the closure
of the comment period on the 2019
Proposed Rule. This includes
information that has become available
regarding the eight sunscreen active
ingredients, identified above, that were
the subject of timely requests for
deferral in order to conduct studies to
generate data first identified as lacking
in the 2019 Proposed Rule. We note that
if at any time the available evidence
becomes sufficient to resolve the
uncertainty as to the GRASE status of a
sunscreen containing any of these
ingredients, FDA intends to proceed to
a revised final order reflecting our
conclusion as to its status. However, if
at the close of the comment period on
this proposed order, the available data
do not resolve the outstanding questions
about each of these ingredients, but the
Agency has received satisfactory
indication of timely and diligent
progress on the necessary studies for a
specific ingredient, FDA would be
prepared to initially defer issuance of a
revised final order on the GRASE status
of sunscreens containing that particular
active ingredient. Such a deferral would
be for a period of not more than 1 year,
with a possibility of extension
depending on further satisfactory
progress with the studies. However, if,
in FDA’s judgment, studies for any
active ingredient do not appear to be
proceeding in a timely manner or
otherwise do not appear to be
productive, the Agency expects that it
will proceed to a revised final order on
sunscreens containing such particular
ingredient after this initial deferral.
As noted above, the Agency also
received a significant number of
comments to the public docket during
the previous public comment period on
the proposals described in the 2019
Proposed Rule, which we continue to
7 See section 505G(k)(1) of the FD&C Act and 21
CFR 330.10(a)(4).
8 See ‘‘FDA in Brief: FDA Announces Results
From Second Sunscreen Absorption Study,’’
available at https://www.fda.gov/news-events/fdabrief/fda-brief-fda-announces-results-secondsunscreen-absorption-study, describing Matta, et al.
(2020) (Ref. 1), as well as a prior pilot study (Matta,
et al. 2019) (Ref. 2).
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review. FDA will consider all comments
that were submitted to the public docket
for the 2019 Proposed Rule within its
comment period to be constructively
submitted as comments on the proposed
order being issued today. To enable the
Agency to review and address these
comments (and future comments that
may be submitted on this proposed
order) as expeditiously as possible, we
request that commenters do not
resubmit comments on this proposed
order previously submitted on the
proposed rule. FDA believes that this
approach will allow us to efficiently
consider public input as the Agency
assesses the appropriate regulatory
requirements for nonprescription
sunscreens marketed without approved
new drug applications.
We emphasize in the proposed order,
and here, that the proposed order does
not represent a conclusion by FDA that
the sunscreen active ingredients
included in the 1999 Final Monograph,
but proposed in the order as needing
additional data, are unsafe for use in
sunscreens. Rather, we are requesting
additional information on these
ingredients so that we can evaluate their
GRASE status in light of changed
conditions, including substantially
increased sunscreen usage and exposure
and evolving information about the
potential risks associated with these
products since originally evaluated. As
in the 2019 Proposed Rule, this
proposed order also advances proposals
addressing the other conditions of use
for sunscreen drug products marketed
without an approved application,
including broad spectrum protection,
maximum SPF requirements, dosage
forms, labeling, final formulation testing
and recordkeeping, sunscreen-insect
repellent combinations, and more.
II. Paperwork Reduction Act of 1995
This proposed order is issued under
section 505G(b) of the FD&C Act.
Chapter 35 of title 44, United States
Code does not apply to collections of
information made under section 505G of
the FD&C Act (see section 505G(o) of the
FD&C Act).
III. Electronic Access
Persons may obtain the proposed
order at the OTC Monographs@portal at
https://www.accessdata.fda.gov/scripts/
cder/omuf/index.cfm or at https://
www.regulations.gov.
IV. References
The following references are on
display with the Dockets Management
Staff (see ADDRESSES) and are available
for viewing by interested persons
between 9 a.m. and 4 p.m., Monday
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through Friday; these are not available
electronically at https://
www.regulations.gov as these references
are copyright protected. Some may be
available at the website address, if
listed. FDA has verified the website
addresses, as of the date this document
publishes in the Federal Register, but
websites are subject to change over time.
1. Matta, M.K., J. Florian, R. Zusterzeel et al.,
‘‘Effect of Sunscreen Application on
Plasma Concentration of Sunscreen
Active Ingredients: A Randomized
Clinical Trial,’’ Journal of the American
Medical Association, vol. 323(3), pp.
256–267, 2020 (available at https://
jamanetwork.com/journals/jama/full
article/2759002), accessed August 12,
2021.
2. Matta, M.K., R. Zusterzeel, R.P. Nageswara
Matta et al., ‘‘Effect of Sunscreen
Application Under Maximal Use
Conditions on Plasma Concentration of
Sunscreen Active Ingredients: A
Randomized Clinical Trial,’’ Journal of
the American Medical Association, vol.
321(21), pp. 2082–2091, 2019 (available
at https://jamanetwork.com/journals/
jama/fullarticle/2733085), accessed
August 12, 2021.
Dated: September 21, 2021.
Lauren K. Roth,
Acting Principal Associate Commissioner for
Policy.
[FR Doc. 2021–20780 Filed 9–24–21; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Health Resources and Services
Administration
Criteria for Determining Maternity Care
Health Professional Target Areas
Health Resources and Services
Administration (HRSA), Department of
Health and Human Services (HHS).
ACTION: Request for public comment.
AGENCY:
In accordance with the
requirements of the Public Health
Service Act, HRSA, authorized by the
Secretary of HHS, shall establish the
criteria which will be used to determine
maternity care health professional target
areas (MCTAs) in existing primary care
Health Professional Shortage Areas
(HPSAs). This notice sets forth the
proposed criteria which will be used to
identify and score MCTAs.
DATES: Submit written comments no
later than November 26, 2021.
ADDRESSES: Written comments should
be submitted to SDMP@hrsa.gov.
FOR FURTHER INFORMATION CONTACT: Dr.
Janelle McCutchen, Chief, Shortage
Designation Branch, Division of Policy
SUMMARY:
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Federal Register / Vol. 86, No. 184 / Monday, September 27, 2021 / Notices
and Shortage Designation, Bureau of
Health Workforce, HRSA, 5600 Fishers
Lane, Rockville, Maryland 20857, (301)
443–9156.
SUPPLEMENTARY INFORMATION: Section
332 of the Public Health Service Act, 42
U.S.C. 254e, provides that HRSA shall
designate HPSAs based on criteria
established by regulation. HPSAs are
defined in section 332 to include (1)
urban and rural geographic areas which
HRSA determines have shortages of
health professionals, (2) population
groups with such shortages, and (3)
public or private medical facilities or
other public facilities with such
shortages. The required regulations
setting forth the criteria for designating
HPSAs are codified at 42 CFR part 5.
Section 332(k)(1) provides that HRSA
shall identify shortages of maternity
care services ‘‘within health
professional shortage areas.’’ Section
332(k)(1) further requires HRSA to
identify MCTAs and distribute
maternity care health professionals
within HPSAs using the MCTAs so
identified. HRSA must also collect and
publish data in the Federal Register
comparing the availability and need of
maternity care health services in HPSAs
and must seek input from relevant
provider organizations and other
stakeholders.
HRSA sought input regarding MCTA
scoring from relevant stakeholders via a
Request for Information issued in May
2020. HRSA received 24 comments from
a variety of stakeholders, including
State Primary Care Offices, Indian
tribes, Federally Qualified Health
Centers, and women’s health and public
health advocacy groups. The comments
addressed a wide range of maternity
care concerns, including social
determinants of health that impact
maternal health outcomes, women’s
access to prenatal care, prevalence of
chronic disease, maternity care health
professional provider types to be
included in MCTAs, and the maternity
care needs of women in rural areas and
among tribes and Alaska natives.
Several commenters also provided
suggestions on data sources that HRSA
could use to calculate MCTA scores.
HRSA has carefully reviewed and
considered all of the feedback provided.
HRSA proposes the following MCTA
scoring criteria, which will be used to
distribute certain currently eligible
National Health Service Corps (NHSC)
clinicians who provide maternity care
services. This includes obstetrician
gynecologists (OB/GYNs) and certified
nurse midwives (CNMs). The statute
does not expand discipline eligibility
for participation in the NHSC to health
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professionals who are not already
eligible for the NHSC. See section
332(k)(1).
Approach for Determining Maternity
Care Health Professional Target Areas
of Greatest Shortage
A MCTA score will be generated for
each primary care HPSA using the
HPSA’s service area. The following six
scoring criteria will be included in a
composite scale that will be used to
identify MCTAs with the greatest
shortage of maternity care health
professionals: (1) Ratio of females ages
15–44-to-full time equivalent maternity
care health professional ratio; (2)
percentage of females 15–44 with
income at or below 200 percent of the
federal poverty level (FPL); (3) travel
time and distance to the nearest
provider location with access to
comprehensive maternity care services;
(4) fertility rate; (5) the Social
Vulnerability Index; and (6) four
maternal health indicators (prepregnancy obesity, pre-pregnancy
diabetes, pre-pregnancy hypertension,
and prenatal care initiation in the first
trimester). Each of these six criteria will
be assigned a relative weight based on
the significance of that criteria relative
to all the others.
The weighted scores will be summed
to develop a composite MCTA score
ranging from zero to 25, with 25
indicating the greatest need for
maternity care health professionals in
the MCTA. Accordingly, the higher the
composite score, the higher the degree
of need for maternity care health
services.
Score for Population-to-Full-TimeEquivalent Maternity Care Health
Professional Ratio
HRSA is seeking public comment on
the proposed approach to measuring the
ratio of females ages 15–44-to-full time
equivalent (FTE) maternity care health
professional, as HRSA received
overwhelmingly positive stakeholder
feedback indicating that HRSA should
consider the population-to-provider
ratio as a component of the MCTA
score. Accordingly, population-toprovider ratio will measure the number
of women of childbearing age in the
service area compared to the number of
maternity care health professionals in
the service area. The population-toprovider ratio continues to be a
cornerstone in measuring the
availability of primary care resources
within a particular area. Based on the
available literature and
recommendations received, for purposes
of MCTA scoring, women of
childbearing age will be defined as
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women between the ages of 15–44 years
old and maternity care professionals
will be defined as Obstetrician/
Gynecologists and Certified Nurse
Midwives (CNMs).1 A population-toprovider ratio of 1,500:1 will be used as
a minimum requirement for a
population to be considered reasonably
served by Obstetrician/Gynecologists
and CNMs.2
Based on comments received,
research, and consultation with
stakeholders, HRSA did not include
General Surgeons, Anesthesiologists,
Pediatricians, Doulas, and Lactation
Specialists into the provider portion of
the population-to-provider ratio for
MCTA scoring, as these providers do
not typically provide full-scope
comprehensive maternity care.
Additionally, HRSA considered
including Family Medicine Physicians,
Physician Assistants, Advance Practice
Registered Nurses, and Registered
Nurses who provide Women’s Health
services or obstetric care into the
provider portion of the population-toprovider ratio for MCTA scoring. With
respect to Family Medicine Physicians,
research shows that family medicine
practitioners offering maternity care
services has been in decline in recent
years, and data demonstrating how
much time these providers spend
providing maternity care services is not
readily available.
Rayburn, Petterson, and Phillips
conducted an observational study from
2003 to 2010 in which they examined
the proportion of Family Physicians
who perform deliveries.3 The
proportion of Family Physicians
performing deliveries declined by 40.6
percent, from 17.0 percent in 2003 to
10.1 percent in 2009, with deliveries
being more common in nonmetropolitan
areas. The researchers concluded that
the proportion of Family Physicians
performing deliveries continues to
decline with most delivering Family
Physicians performing 25 or fewer
deliveries per year. In another study,
Makaroff, et al., evaluated factors that
are contributing to the decline of Family
1 Johantgen, M. et al. ‘‘Comparison of Labor and
Delivery Care Provided by Certified NurseMidwives and Physicians: A Systematic Review,
1990 to 2008.’’ Women’s Health Issues, vol. 22, no.
1 (2012): e73–e81, doi: 10.1016/j.whi.2011.06.005.
2 Rayburn, W.F. et al. ‘‘Distribution of American
Congress of Obstetricians and Gynecologists
Fellows and Junior Fellows in Practice in the
United States.’’ Obstet Gynecol, vol. 119, no. 5
(2012): 1017, doi: 10.1097/AOG.0b013e31824cfe50.
3 Rayburn, William F., Stephen M. Petterson, and
Robert L. Phillips. ‘‘Trends in Family Physicians
Performing Deliveries, 2003–2010.’’ Birth (Berkeley,
Calif.) 41.1 (2014): 26–32.
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Federal Register / Vol. 86, No. 184 / Monday, September 27, 2021 / Notices
Physicians providing maternity care.4
Makaroff, et al. evaluated American
Board of Family Medicine survey data
collected from every family physician
during application for the Maintenance
of Certification Examination to
determine the percentage of family
physicians that provided maternity care
from 2000 to 2010. This research team’s
findings are in line with the results of
the research conducted by Rayburn,
Petterson, and Phillips in that they also
found that maternity care provision by
family physicians declined from 23.3
percent in 2000 to 9.7 percent in 2010
(p <0.0001). Furthermore, in 2018, a
study from Goldstein, et al. shows that
the percentage of family practitioners
offering low and high volume maternity
care services continues to decline in
both the United States and Canada and
is now at less than 5 and 1 percent,
respectively. These findings are based
on data from the American Board of
Family Medicine Examination
questionnaires. The data specifically
showed that the number of family
practitioners who offered high volume
obstetric services has declined by 50
percent since 2009.5
Thus, while family physicians
continue to play an important role in
providing maternity care in many parts
of the United States, there is a
documented decline in the percentage
of family physicians providing
maternity care. HRSA recognizes the
important contribution all of these
professionals play in the delivery of
obstetric care. However, as there is also
not currently detailed nationwide data
readily available outlining the number
of hours individual providers provide
these services, HRSA did not have an
analytical basis for how to include them
consistently. HRSA will continue to
review the availability of these data
points to determine if additional
provider types (particularly Family
Medicine Physicians, but also including
General Surgeons, Anesthesiologists,
Pediatricians, Doulas, Lactation
Specialists, Physician Assistants,
Advance Practice Registered Nurses,
and Registered Nurses who provide
Women’s Health services) may be
incorporated into the MCTA scoring
criteria in the future. HRSA is especially
interested in recommendations for how
to determine the amount of time Family
Medicine Physicians spend providing
maternity care services, as they may be
the only providers of maternity services
in areas with no OB/GYNs or CNMs.
HRSA welcomes comments on how to
incorporate these providers into future
iterations of MCTA scoring, and any
detailed nationwide data that may be
available to do so.
HRSA is seeking feedback on the
assigned point values in the
distribution, which are proposed to be
as follows:
Population-to-provider ratio
Points
Ratio ≥6,000:1, or No CNMs or OB–GYNs and Population (Pop) ≥500 ............................................................................................
6,000:1 >Ratio ≥5,000:1, or No CNMs or OB–GYNs and Pop ≥400 .................................................................................................
5,000:1 >Ratio ≥3,000:1, or No CNMs or OB–GYNs and Pop ≥300 .................................................................................................
3,000:1 >Ratio ≥2,000:1, or No CNMs or OB–GYNs and Pop ≥200 .................................................................................................
2,000:1 >Ratio ≥1,500:1, or No CNMs or OB–GYNs and Pop ≥100 .................................................................................................
Ratio <1,500:1, or No CNMs or OB–GYNs and Pop <100 ................................................................................................................
Score for Percentage of Population With
Income at or Below 200 Percent of the
Federal Poverty Level
HRSA proposes to incorporate
poverty data from the U.S. Census
Bureau into the MCTA composite score,
as the majority of commenters
highlighted the disparities that women
living in poverty face in accessing
necessary maternity health services. The
percentage of people living in the
service area at or below 200 percent of
the FPL will be used to score MCTAs,
based on recommendations from
commenters and poverty data from the
U.S. Census Bureau. Maternal health
literature demonstrates a high
correlation between low income, low
health status, and poor maternal health
outcomes.6
HRSA is seeking feedback on the
assigned point values in the
distribution, which are proposed as
follows:
Population with income at or below 200% FPL ratio
Percentage of population with income at or below
55% >Percentage of population with income at or
50% >Percentage of population with income at or
45% >Percentage of population with income at or
40% >Percentage of population with income at or
35% >Percentage of population with income at or
Percentage of population with income at or below
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Score for Travel Distance/Time to
Nearest Source of Accessible Care
Outside of the MCTA
Several of the commenters
highlighted the barriers in travel time
and transportation that many women
face in accessing maternity care
4 Makaroff, Laura A. et al. ‘‘Factors Influencing
Family Physicians’ Contribution to the Child Health
Care Workforce.’’ Annals of family medicine 12.5
(2014): 427–431.
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200%
below
below
below
below
below
200%
FPL ≥55%
200% FPL
200% FPL
200% FPL
200% FPL
200% FPL
FPL <30%
5
4
3
2
1
0
Points
................................................................................................
≥50% ......................................................................................
≥45% ......................................................................................
≥40% ......................................................................................
≥35% ......................................................................................
≥30% ......................................................................................
................................................................................................
6
5
4
3
2
1
0
services, particularly in rural and
underserved areas. In keeping with this
feedback, HRSA will incorporate the
travel time and distance to the Nearest
Source of Care into the MCTA
composite score. The Nearest Source of
Care is defined as the closest provider
location where the residents of the area
or designated population have access to
comprehensive maternity care services.
Scientific literature presented by the
American Academy of Pediatrics
Committee on Fetus and Newborn and
the American College of Obstetricians
5 Goldstein, Jessica, et al., ‘‘Supporting Family
Physician Maternity Care Providers’’ Family
Medicine 50:9 (2018).
6 Aftab., et al. ‘‘Effects of Poverty on Pregnant
Women.’’ Department of Gynae and Obstetrics, Dow
University of Health Sciences, Lyari General
Hospital, Karachi, vol. 51, no.1 (2012). March of
Dimes, ‘‘Nowhere to Go: Maternity Care Deserts
Across the US,’’ (2018), available at https://
www.marchofdimes.org/materials/Nowhere_to_Go_
Final.pdf.
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and Gynecologists Committee on
Obstetric Practice established that an
individual’s proximity to care can affect
health outcomes.7 Specifically for
maternity care, the literature indicates
that decision-to-incision time for
emergency cesarean delivery is 30
minutes.8
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HRSA is seeking public comment on
the assigned point values in the
distribution, which are proposed as
follows:
Travel time and distance
Points
Time ≥105 min, or Distance ≥105 miles .............................................................................................................................................
105 min >Time ≥90 min or 105 miles > Distance ≥90 miles ..............................................................................................................
90 min >Time ≥75 min, or 90 miles > Distance ≥75 miles .................................................................................................................
75 min >Time ≥60 min, or 75 miles > Distance ≥60 miles .................................................................................................................
60 min >Time ≥45 min, or 60 miles > Distance ≥45 miles .................................................................................................................
45 min >Time ≥30 min, or 45 miles > Distance ≥30 miles .................................................................................................................
Time <30 min, and Distance <30 miles ..............................................................................................................................................
Score for Fertility Rate
HRSA proposes to include fertility
rate as a criteria for the MCTA score to
reflect the increased need for maternity
care services among populations which
experience a higher rate of births.
Women of childbearing age will be
derived from the American Community
Survey and births will be derived from
the National Vital Statistics System.
6
5
4
3
2
1
0
HRSA is seeking public comment on
the assigned point values in the
distribution, which are proposed as
follows:
Fertility rate
Points
Fertility Rate ≥90th Percentile .............................................................................................................................................................
90th Percentile >Fertility Rate ≥50th Percentile ..................................................................................................................................
Fertility Rate <50th Percentile .............................................................................................................................................................
Score for Social Vulnerability Index
Several MCTA commenters
highlighted associations between
adverse maternal health outcomes and
non-clinical factors such as poverty,
unemployment, lack of adequate
housing and transportation, minority
status, and English language
proficiency. The Agency for Toxic
Substances and Disease Registry’s
Geospatial Research, Analysis and
Services Program within the Centers for
Disease Control and Prevention (CDC)
created databases to help emergency
response planners and public health
officials identify and map communities
that will most likely need support
before, during, and after a hazardous
event. Per the CDC, Social Vulnerability
refers to the resilience of communities
when confronted by external hazards
such as natural or human-caused
disasters, or disease outbreaks.
One such database is the Social
Vulnerability Index (SVI), which uses
U.S. Census data to determine the social
vulnerability of every census tract based
on the following four themes:
Socioeconomic status, household
composition and disability, minority
status and language, and housing type
and transportation. Each tract receives a
separate percentile ranking which is
represented by a number between zero
and one for each of the four themes, as
well as an overall ranking. These themes
take into account various factors ranging
from educational attainment and
unemployment to multi-unit structures
and single parent households.
Public health literature supports the
correlation between low English
proficiency and late initiation of
prenatal care as well as adverse
perinatal outcomes due to lack of
communication between the provider
and patient.9 10 Currently, literature is
not available that evaluates the use of
the entire SVI to specifically quantify
maternal health outcomes. However,
2
1
0
many of the individual factors within
the SVI are known social determinants
of health. Social determinants of health
are the conditions in the environment in
which people are born, live, learn, work,
play, worship, and age that affect a wide
range of health, functioning, and
quality-of-life outcomes and risks. These
social determinants of health as
represented within the SVI, are critical
in understanding external factors that
affect the need for maternity care
services.
A score for overall social vulnerability
will be incorporated into the MCTA
composite score to reflect the increased
need for maternity care services among
populations which experience a higher
rate of social vulnerability using the
CDC’s SVI. HRSA is seeking public
comment on the assigned point values
in the distribution, which are proposed
as follows:
Social Vulnerability Index
Points
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Social Vulnerability ≥75th Percentile ...................................................................................................................................................
75th Percentile > Social Vulnerability ≥50th Percentile ......................................................................................................................
Social Vulnerability <50th Percentile ...................................................................................................................................................
7 Kilpatrick, Sarah J., et al. Guidelines for
Perinatal Care. 8th ed., American Academy of
Pediatrics, 2017.
8 Roa, Lina et al., ‘‘Travel Time to Access
Obstetric and Neonatal Care in the United States.’’
Obstetrics and Gynecology (New York. 1953) vol.
136, no. 3 (2020): 610–612.
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9 Pope, Charlene. ‘‘Addressing Limited English
Proficiency and Disparities for Hispanic Postpartum
Women.’’ Journal of Obstetric, Gynecologic &
Neonatal Nursing, vol. 34, no. 4, 2005, pp. 512–20.
Crossref, doi:10.1177/0884217505278295.
10 Vinson, Abigail, et al. ‘‘131: Maternal Language,
Severe Maternal Morbidity and Access to Prenatal
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Care.’’ American Journal of Obstetrics and
Gynecology, vol. 222, no. 1, 2020, pp. S99–100.
Crossref, doi:10.1016/j.ajog.2019.11.147.
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Score for Maternal Health Indicators
Many of the comments HRSA
received raised concerns about social
determinants of health that have an
impact on women’s health outcomes,
not only during and after pregnancy, but
also before and in between pregnancies.
In order to address these concerns,
HRSA is seeking public comment on the
use of maternal health indicators as
scoring criteria for MCTAs. MCTA
scores will consider health indicators
that are associated with poor maternal
health outcomes by looking at various
data points related to pre-pregnancy
health status and when prenatal care
began. Scores will consider prepregnancy obesity, diabetes, and
hypertension, as well as whether
prenatal care began in the first trimester,
as these are all conditions which may
require additional workforce capacity to
adequately address community needs.
Only women of childbearing age will be
considered for these indicators. HRSA
will use the National Vital Statistics
System as the data source to determine
the sub-score for each of these four (4)
maternal health indicators.
Public health literature demonstrates
that higher rates of obesity, diabetes, or
hypertension, and later onset of prenatal
care are all associated with poorer
maternal health outcomes and will help
identify the need for additional health
professionals. A 2018 Centers for
Disease Control and Prevention report
on preconception health surveillance
identified priority indicators for adverse
maternal health outcomes.11 The study
reviewed 50 preconception health
indicators and prioritized those
indicators that are most suitable for
surveillance purposes. Weight, diabetes,
and hypertension were all among the
top 10 preconception health indicators
recommended for surveillance.12
HRSA also considered incorporating
maternal mortality data into the MCTA
score. However, due to data suppression
for privacy reasons, this data is not
readily available publicly or to HRSA
below the state level. As both HPSAs
and MCTAs are designed to be able to
provide meaningful differentiation of
need between communities at a local
level, HRSA decided not to incorporate
maternal mortality data at this time. If
this data eventually becomes available
to HRSA at the county level or below,
HRSA may include it in future MCTA
score calculation.
HRSA is seeking public comment on
the proposed criteria and point scale
distributions below. Service areas may
receive one point each for meeting the
criteria.
• Pre-Pregnancy Obesity
Pre-pregnancy obesity is defined as
having a Body Mass Index of 30 or
higher. One point will be awarded if the
prevalence of pre-pregnancy obesity in
the area is greater than or equal to the
75th percentile among all counties in
the United States. If the prevalence of
pre-pregnancy obesity in the area is less
than the 75th percentile among all
counties, zero points will be awarded.
Pre-pregnancy obesity
Points
Prevalence of pre-pregnancy obesity ≥75th percentile .......................................................................................................................
Prevalence of pre-pregnancy obesity <75th percentile .......................................................................................................................
• Pre-Pregnancy Diabetes
One point will be awarded if the
prevalence of pre-pregnancy diabetes in
the area is greater than or equal to the
75th percentile among all counties in
the United States. If the prevalence of
1
0
pre-pregnancy diabetes in the area is
less than the 75th percentile among all
counties, zero points will be awarded.
Pre-pregnancy diabetes
Points
Prevalence of pre-pregnancy diabetes ≥75th percentile .....................................................................................................................
Prevalence of pre-pregnancy diabetes <75th percentile ....................................................................................................................
• Pre-Pregnancy Hypertension
hypertension among women in the area
is greater than or equal to the 75th
percentile among all counties in the
nation. If the prevalence of pre-
One point will be awarded if the
prevalence of pre-pregnancy
1
0
pregnancy hypertension among women
in the area is less than the 75th
percentile among all counties, zero
points will be awarded.
Pre-pregnancy hypertension
Points
Prevalence of pre-pregnancy hypertension ≥75th percentile ..............................................................................................................
Prevalence of pre-pregnancy hypertension <75th percentile .............................................................................................................
• Prenatal Care Initiation in the 1st
Trimester
initiate prenatal care in the first
trimester of their pregnancy is greater
than or equal to the 75th percentile
among all counties in the nation. Zero
points will be awarded if the prevalence
One point will be awarded if the
prevalence of women who did not
of women who did not initiate prenatal
care in the first trimester of their
pregnancy is less than the 75th
percentile among all counties.
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Prenatal care in first trimester
Points
Prevalence of No Prenatal Care in First Trimester ≥75th percentile ..................................................................................................
Prevalence of No Prenatal Care in First Trimester <75th percentile ..................................................................................................
11 Robbins, Cheryl L., et al. ‘‘Preconception
Health Indicators for Public Health Surveillance.’’
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12 Ibid.
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Federal Register / Vol. 86, No. 184 / Monday, September 27, 2021 / Notices
Diana Espinosa,
Acting Administrator.
SUPPLEMENTARY INFORMATION:
Invitation to comment: HRSA invites
comments regarding this notice. To
ensure that your comments are clearly
stated, please identify the section of this
notice that your comments address.
[FR Doc. 2021–20855 Filed 9–24–21; 8:45 am]
BILLING CODE 4165–15–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
described in [statute] related to the
purposes of the program.’’ 5 Home
visiting programs could not achieve the
standards described in the program’s
authorizing statute without the support
of home visiting models.
HRSA, in collaboration with ACF, has
developed a proposed transparent and
standardized process for assessing home
visiting service delivery model(s)
against statutory requirements to
determine model eligibility for
implementation through the MIECHV
Program. Through this notice, HRSA
seeks to provide public notice of the
proposed process and gather public
comment, including from stakeholders.
Since the establishment of this process
may affect critical decision-making, and
to better understand the implications of
these changes for various stakeholders,
HRSA seeks public comment on the
proposed process for assessing home
visiting models against the MIECHV
statutory requirements. HRSA will
consider these comments in finalizing
this process.
HRSA, in partnership with
the Administration for Children and
Families (ACF) within HHS, oversees
the MIECHV Program, which supports
voluntary, evidence-based home visiting
services during pregnancy and to
families with young children up to
kindergarten entry. HRSA proposes to
standardize a process for also assessing
Home Visiting Evidence of Effectiveness
(HomVEE)-approved home visiting
models against the MIECHV statutory
requirements for a model to determine
which of the HomVEE-approved models
can be used to implement the MIECHV
Program.
DATES: Comments on this request for
public comment should be received no
later than November 26, 2021.
ADDRESSES: Submit your comments to
homevisiting@hrsa.gov with ‘‘MIECHV
Model Eligibility’’ in the subject line.
1.0 Background
The MIECHV Program provides
voluntary, evidence-based home visiting
services to pregnant people and families
with young children up to kindergarten
entry living in at-risk communities.1
States, jurisdictions, certain non-profit
organizations, and Tribal entities are
eligible to receive funding from the
MIECHV Program to implement service
delivery model(s) that meet statutory
requirements, including HHS criteria for
evidence of effectiveness.2 3
The MIECHV authorizing statute
specifies that a model selected by an
eligible entity must include certain key
components, including that it ‘‘conform
to a clear consistent home visitation
model that has been in existence for at
least 3 years and is research-based,
grounded in relevant empirically-based
knowledge, linked to program
determined outcomes, associated with a
national organization or institution of
higher education that has
comprehensive home visitation program
standards that ensure high-quality
service delivery and continuous
program quality improvement.’’ 4 In
addition, the MIECHV-funded program
must adhere to statutory standards
applicable to model use, including
adherence ‘‘to a clear, consistent model
that satisfies the requirements of being
grounded in empirically-based
knowledge related to home visiting and
linked to the benchmark areas specified
in [statute] and the participant outcomes
Requirement
Standard used
REQUIREMENT (1): Model is appropriate for
voluntary service provision.
REQUIREMENT (2): The model conforms to a
clear consistent home visitation model.
REQUIREMENT (3): The model . . . has been
in existence for at least 3 years.
There is evidence of model effectiveness in a
voluntary setting.
The model conforms to HomVEE’s definition
of an early childhood home visiting model.
The model is currently active and was first developed at least 3 years ago;.
OR
The model is inactive and was first developed
at least 3 years before a model developer
stopped providing implementation support;
OR
The model was implemented as a demonstration project that lasted at least 3 years.
Social Security Act, Title V, § 511(e)(7)(A).
target families with pregnant people and children
from birth to kindergarten. Information about the
HomVEE review is at https://homvee.acf.hhs.gov/.
3 By law, state and jurisdictional awardees must
spend the majority of their MIECHV Program grants
to implement evidence-based home visiting models,
with up to 25 percent of funding available to
implement a model that conforms to a promising
and new approach to achieving the benchmark
areas specified in Social Security Act, Title V, § 511
(d)(1)(A) and the participant outcomes described in
Social Security Act, Title V, § 511 (d)(2)(B), has
been developed or identified by a national
organization or institution of higher education, and
will be evaluated through well-designed and
rigorous process.
4 Social Security Act, Title V, § 511(d)(3)(A)(i)
5 Social Security Act, Title V, § 511(d)(3)(B)
Health Resources and Services
Administration
Statutory Requirements and Process
Standardization: Maternal, Infant, and
Early Childhood Home Visiting
(MIECHV) Program Model Eligibility
Review
Health Resources and Services
Administration (HRSA), Department of
Health and Human Services (HHS).
ACTION: Request for public comment.
AGENCY:
SUMMARY:
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53329
1 The MIECHV Program is authorized by Social
Security Act, Title V, § 511; Section 50601 of the
Bipartisan Budget Act of 2018 (Pub. L. 115–123)
(BBA) extended appropriated funding for the
MIECHV Program through FY 2022.
2 In current practice, HHS uses the HomVEE
review to conduct a thorough and transparent
review of the home visiting research literature and
provide an assessment of the evidence of
effectiveness for home visiting program models that
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2.0 Process for Assessing Eligibility
Against Statutory Requirements for a
Home Visiting Model
This notice presents statutory
requirements for a MIECHV service
delivery model and the proposed
process to assess home visiting models
against each MIECHV statutory
requirement. Then, the notice will
present the proposed process, with
timeline, for collecting information to
assess whether the model(s) meet these
requirements and therefore can be used
to implement the MIECHV Program.
2.1
Model Eligibility Requirements
Statutory citation of requirement
Social Security Act, Title V, § 511(d)(3)(A)(i)(I).
Social Security Act, Title V, § 511(d)(3)(A)(i)(I).
E:\FR\FM\27SEN1.SGM
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[Federal Register Volume 86, Number 184 (Monday, September 27, 2021)]
[Notices]
[Pages 53324-53329]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2021-20855]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Health Resources and Services Administration
Criteria for Determining Maternity Care Health Professional
Target Areas
AGENCY: Health Resources and Services Administration (HRSA), Department
of Health and Human Services (HHS).
ACTION: Request for public comment.
-----------------------------------------------------------------------
SUMMARY: In accordance with the requirements of the Public Health
Service Act, HRSA, authorized by the Secretary of HHS, shall establish
the criteria which will be used to determine maternity care health
professional target areas (MCTAs) in existing primary care Health
Professional Shortage Areas (HPSAs). This notice sets forth the
proposed criteria which will be used to identify and score MCTAs.
DATES: Submit written comments no later than November 26, 2021.
ADDRESSES: Written comments should be submitted to [email protected].
FOR FURTHER INFORMATION CONTACT: Dr. Janelle McCutchen, Chief, Shortage
Designation Branch, Division of Policy
[[Page 53325]]
and Shortage Designation, Bureau of Health Workforce, HRSA, 5600
Fishers Lane, Rockville, Maryland 20857, (301) 443-9156.
SUPPLEMENTARY INFORMATION: Section 332 of the Public Health Service
Act, 42 U.S.C. 254e, provides that HRSA shall designate HPSAs based on
criteria established by regulation. HPSAs are defined in section 332 to
include (1) urban and rural geographic areas which HRSA determines have
shortages of health professionals, (2) population groups with such
shortages, and (3) public or private medical facilities or other public
facilities with such shortages. The required regulations setting forth
the criteria for designating HPSAs are codified at 42 CFR part 5.
Section 332(k)(1) provides that HRSA shall identify shortages of
maternity care services ``within health professional shortage areas.''
Section 332(k)(1) further requires HRSA to identify MCTAs and
distribute maternity care health professionals within HPSAs using the
MCTAs so identified. HRSA must also collect and publish data in the
Federal Register comparing the availability and need of maternity care
health services in HPSAs and must seek input from relevant provider
organizations and other stakeholders.
HRSA sought input regarding MCTA scoring from relevant stakeholders
via a Request for Information issued in May 2020. HRSA received 24
comments from a variety of stakeholders, including State Primary Care
Offices, Indian tribes, Federally Qualified Health Centers, and women's
health and public health advocacy groups. The comments addressed a wide
range of maternity care concerns, including social determinants of
health that impact maternal health outcomes, women's access to prenatal
care, prevalence of chronic disease, maternity care health professional
provider types to be included in MCTAs, and the maternity care needs of
women in rural areas and among tribes and Alaska natives. Several
commenters also provided suggestions on data sources that HRSA could
use to calculate MCTA scores.
HRSA has carefully reviewed and considered all of the feedback
provided. HRSA proposes the following MCTA scoring criteria, which will
be used to distribute certain currently eligible National Health
Service Corps (NHSC) clinicians who provide maternity care services.
This includes obstetrician gynecologists (OB/GYNs) and certified nurse
midwives (CNMs). The statute does not expand discipline eligibility for
participation in the NHSC to health professionals who are not already
eligible for the NHSC. See section 332(k)(1).
Approach for Determining Maternity Care Health Professional Target
Areas of Greatest Shortage
A MCTA score will be generated for each primary care HPSA using the
HPSA's service area. The following six scoring criteria will be
included in a composite scale that will be used to identify MCTAs with
the greatest shortage of maternity care health professionals: (1) Ratio
of females ages 15-44-to-full time equivalent maternity care health
professional ratio; (2) percentage of females 15-44 with income at or
below 200 percent of the federal poverty level (FPL); (3) travel time
and distance to the nearest provider location with access to
comprehensive maternity care services; (4) fertility rate; (5) the
Social Vulnerability Index; and (6) four maternal health indicators
(pre-pregnancy obesity, pre-pregnancy diabetes, pre-pregnancy
hypertension, and prenatal care initiation in the first trimester).
Each of these six criteria will be assigned a relative weight based on
the significance of that criteria relative to all the others.
The weighted scores will be summed to develop a composite MCTA
score ranging from zero to 25, with 25 indicating the greatest need for
maternity care health professionals in the MCTA. Accordingly, the
higher the composite score, the higher the degree of need for maternity
care health services.
Score for Population-to-Full-Time-Equivalent Maternity Care Health
Professional Ratio
HRSA is seeking public comment on the proposed approach to
measuring the ratio of females ages 15-44-to-full time equivalent (FTE)
maternity care health professional, as HRSA received overwhelmingly
positive stakeholder feedback indicating that HRSA should consider the
population-to-provider ratio as a component of the MCTA score.
Accordingly, population-to-provider ratio will measure the number of
women of childbearing age in the service area compared to the number of
maternity care health professionals in the service area. The
population-to-provider ratio continues to be a cornerstone in measuring
the availability of primary care resources within a particular area.
Based on the available literature and recommendations received, for
purposes of MCTA scoring, women of childbearing age will be defined as
women between the ages of 15-44 years old and maternity care
professionals will be defined as Obstetrician/Gynecologists and
Certified Nurse Midwives (CNMs).\1\ A population-to-provider ratio of
1,500:1 will be used as a minimum requirement for a population to be
considered reasonably served by Obstetrician/Gynecologists and CNMs.\2\
---------------------------------------------------------------------------
\1\ Johantgen, M. et al. ``Comparison of Labor and Delivery Care
Provided by Certified Nurse-Midwives and Physicians: A Systematic
Review, 1990 to 2008.'' Women's Health Issues, vol. 22, no. 1
(2012): e73-e81, doi: 10.1016/j.whi.2011.06.005.
\2\ Rayburn, W.F. et al. ``Distribution of American Congress of
Obstetricians and Gynecologists Fellows and Junior Fellows in
Practice in the United States.'' Obstet Gynecol, vol. 119, no. 5
(2012): 1017, doi: 10.1097/AOG.0b013e31824cfe50.
---------------------------------------------------------------------------
Based on comments received, research, and consultation with
stakeholders, HRSA did not include General Surgeons, Anesthesiologists,
Pediatricians, Doulas, and Lactation Specialists into the provider
portion of the population-to-provider ratio for MCTA scoring, as these
providers do not typically provide full-scope comprehensive maternity
care. Additionally, HRSA considered including Family Medicine
Physicians, Physician Assistants, Advance Practice Registered Nurses,
and Registered Nurses who provide Women's Health services or obstetric
care into the provider portion of the population-to-provider ratio for
MCTA scoring. With respect to Family Medicine Physicians, research
shows that family medicine practitioners offering maternity care
services has been in decline in recent years, and data demonstrating
how much time these providers spend providing maternity care services
is not readily available.
Rayburn, Petterson, and Phillips conducted an observational study
from 2003 to 2010 in which they examined the proportion of Family
Physicians who perform deliveries.\3\ The proportion of Family
Physicians performing deliveries declined by 40.6 percent, from 17.0
percent in 2003 to 10.1 percent in 2009, with deliveries being more
common in nonmetropolitan areas. The researchers concluded that the
proportion of Family Physicians performing deliveries continues to
decline with most delivering Family Physicians performing 25 or fewer
deliveries per year. In another study, Makaroff, et al., evaluated
factors that are contributing to the decline of Family
[[Page 53326]]
Physicians providing maternity care.\4\ Makaroff, et al. evaluated
American Board of Family Medicine survey data collected from every
family physician during application for the Maintenance of
Certification Examination to determine the percentage of family
physicians that provided maternity care from 2000 to 2010. This
research team's findings are in line with the results of the research
conducted by Rayburn, Petterson, and Phillips in that they also found
that maternity care provision by family physicians declined from 23.3
percent in 2000 to 9.7 percent in 2010 (p <0.0001). Furthermore, in
2018, a study from Goldstein, et al. shows that the percentage of
family practitioners offering low and high volume maternity care
services continues to decline in both the United States and Canada and
is now at less than 5 and 1 percent, respectively. These findings are
based on data from the American Board of Family Medicine Examination
questionnaires. The data specifically showed that the number of family
practitioners who offered high volume obstetric services has declined
by 50 percent since 2009.\5\
---------------------------------------------------------------------------
\3\ Rayburn, William F., Stephen M. Petterson, and Robert L.
Phillips. ``Trends in Family Physicians Performing Deliveries, 2003-
2010.'' Birth (Berkeley, Calif.) 41.1 (2014): 26-32.
\4\ Makaroff, Laura A. et al. ``Factors Influencing Family
Physicians' Contribution to the Child Health Care Workforce.''
Annals of family medicine 12.5 (2014): 427-431.
\5\ Goldstein, Jessica, et al., ``Supporting Family Physician
Maternity Care Providers'' Family Medicine 50:9 (2018).
---------------------------------------------------------------------------
Thus, while family physicians continue to play an important role in
providing maternity care in many parts of the United States, there is a
documented decline in the percentage of family physicians providing
maternity care. HRSA recognizes the important contribution all of these
professionals play in the delivery of obstetric care. However, as there
is also not currently detailed nationwide data readily available
outlining the number of hours individual providers provide these
services, HRSA did not have an analytical basis for how to include them
consistently. HRSA will continue to review the availability of these
data points to determine if additional provider types (particularly
Family Medicine Physicians, but also including General Surgeons,
Anesthesiologists, Pediatricians, Doulas, Lactation Specialists,
Physician Assistants, Advance Practice Registered Nurses, and
Registered Nurses who provide Women's Health services) may be
incorporated into the MCTA scoring criteria in the future. HRSA is
especially interested in recommendations for how to determine the
amount of time Family Medicine Physicians spend providing maternity
care services, as they may be the only providers of maternity services
in areas with no OB/GYNs or CNMs. HRSA welcomes comments on how to
incorporate these providers into future iterations of MCTA scoring, and
any detailed nationwide data that may be available to do so.
HRSA is seeking feedback on the assigned point values in the
distribution, which are proposed to be as follows:
------------------------------------------------------------------------
Population-to-provider ratio Points
------------------------------------------------------------------------
Ratio >=6,000:1, or No CNMs or OB-GYNs and Population 5
(Pop) >=500............................................
6,000:1 >Ratio >=5,000:1, or No CNMs or OB-GYNs and Pop 4
>=400..................................................
5,000:1 >Ratio >=3,000:1, or No CNMs or OB-GYNs and Pop 3
>=300..................................................
3,000:1 >Ratio >=2,000:1, or No CNMs or OB-GYNs and Pop 2
>=200..................................................
2,000:1 >Ratio >=1,500:1, or No CNMs or OB-GYNs and Pop 1
>=100..................................................
Ratio <1,500:1, or No CNMs or OB-GYNs and Pop <100...... 0
------------------------------------------------------------------------
Score for Percentage of Population With Income at or Below 200 Percent
of the Federal Poverty Level
HRSA proposes to incorporate poverty data from the U.S. Census
Bureau into the MCTA composite score, as the majority of commenters
highlighted the disparities that women living in poverty face in
accessing necessary maternity health services. The percentage of people
living in the service area at or below 200 percent of the FPL will be
used to score MCTAs, based on recommendations from commenters and
poverty data from the U.S. Census Bureau. Maternal health literature
demonstrates a high correlation between low income, low health status,
and poor maternal health outcomes.\6\
---------------------------------------------------------------------------
\6\ Aftab., et al. ``Effects of Poverty on Pregnant Women.''
Department of Gynae and Obstetrics, Dow University of Health
Sciences, Lyari General Hospital, Karachi, vol. 51, no.1 (2012).
March of Dimes, ``Nowhere to Go: Maternity Care Deserts Across the
US,'' (2018), available at https://www.marchofdimes.org/materials/Nowhere_to_Go_Final.pdf.
---------------------------------------------------------------------------
HRSA is seeking feedback on the assigned point values in the
distribution, which are proposed as follows:
------------------------------------------------------------------------
Population with income at or below 200% FPL ratio Points
------------------------------------------------------------------------
Percentage of population with income at or below 200% 6
FPL >=55%..............................................
55% >Percentage of population with income at or below 5
200% FPL >=50%.........................................
50% >Percentage of population with income at or below 4
200% FPL >=45%.........................................
45% >Percentage of population with income at or below 3
200% FPL >=40%.........................................
40% >Percentage of population with income at or below 2
200% FPL >=35%.........................................
35% >Percentage of population with income at or below 1
200% FPL >=30%.........................................
Percentage of population with income at or below 200% 0
FPL <30%...............................................
------------------------------------------------------------------------
Score for Travel Distance/Time to Nearest Source of Accessible Care
Outside of the MCTA
Several of the commenters highlighted the barriers in travel time
and transportation that many women face in accessing maternity care
services, particularly in rural and underserved areas. In keeping with
this feedback, HRSA will incorporate the travel time and distance to
the Nearest Source of Care into the MCTA composite score. The Nearest
Source of Care is defined as the closest provider location where the
residents of the area or designated population have access to
comprehensive maternity care services. Scientific literature presented
by the American Academy of Pediatrics Committee on Fetus and Newborn
and the American College of Obstetricians
[[Page 53327]]
and Gynecologists Committee on Obstetric Practice established that an
individual's proximity to care can affect health outcomes.\7\
Specifically for maternity care, the literature indicates that
decision-to-incision time for emergency cesarean delivery is 30
minutes.\8\
---------------------------------------------------------------------------
\7\ Kilpatrick, Sarah J., et al. Guidelines for Perinatal Care.
8th ed., American Academy of Pediatrics, 2017.
\8\ Roa, Lina et al., ``Travel Time to Access Obstetric and
Neonatal Care in the United States.'' Obstetrics and Gynecology (New
York. 1953) vol. 136, no. 3 (2020): 610-612.
---------------------------------------------------------------------------
HRSA is seeking public comment on the assigned point values in the
distribution, which are proposed as follows:
------------------------------------------------------------------------
Travel time and distance Points
------------------------------------------------------------------------
Time >=105 min, or Distance >=105 miles................. 6
105 min >Time >=90 min or 105 miles > Distance >=90 5
miles..................................................
90 min >Time >=75 min, or 90 miles > Distance >=75 miles 4
75 min >Time >=60 min, or 75 miles > Distance >=60 miles 3
60 min >Time >=45 min, or 60 miles > Distance >=45 miles 2
45 min >Time >=30 min, or 45 miles > Distance >=30 miles 1
Time <30 min, and Distance <30 miles.................... 0
------------------------------------------------------------------------
Score for Fertility Rate
HRSA proposes to include fertility rate as a criteria for the MCTA
score to reflect the increased need for maternity care services among
populations which experience a higher rate of births. Women of
childbearing age will be derived from the American Community Survey and
births will be derived from the National Vital Statistics System.
HRSA is seeking public comment on the assigned point values in the
distribution, which are proposed as follows:
------------------------------------------------------------------------
Fertility rate Points
------------------------------------------------------------------------
Fertility Rate >=90th Percentile........................ 2
90th Percentile >Fertility Rate >=50th Percentile....... 1
Fertility Rate <50th Percentile......................... 0
------------------------------------------------------------------------
Score for Social Vulnerability Index
Several MCTA commenters highlighted associations between adverse
maternal health outcomes and non-clinical factors such as poverty,
unemployment, lack of adequate housing and transportation, minority
status, and English language proficiency. The Agency for Toxic
Substances and Disease Registry's Geospatial Research, Analysis and
Services Program within the Centers for Disease Control and Prevention
(CDC) created databases to help emergency response planners and public
health officials identify and map communities that will most likely
need support before, during, and after a hazardous event. Per the CDC,
Social Vulnerability refers to the resilience of communities when
confronted by external hazards such as natural or human-caused
disasters, or disease outbreaks.
One such database is the Social Vulnerability Index (SVI), which
uses U.S. Census data to determine the social vulnerability of every
census tract based on the following four themes: Socioeconomic status,
household composition and disability, minority status and language, and
housing type and transportation. Each tract receives a separate
percentile ranking which is represented by a number between zero and
one for each of the four themes, as well as an overall ranking. These
themes take into account various factors ranging from educational
attainment and unemployment to multi-unit structures and single parent
households.
Public health literature supports the correlation between low
English proficiency and late initiation of prenatal care as well as
adverse perinatal outcomes due to lack of communication between the
provider and patient.9 10 Currently, literature is not
available that evaluates the use of the entire SVI to specifically
quantify maternal health outcomes. However, many of the individual
factors within the SVI are known social determinants of health. Social
determinants of health are the conditions in the environment in which
people are born, live, learn, work, play, worship, and age that affect
a wide range of health, functioning, and quality-of-life outcomes and
risks. These social determinants of health as represented within the
SVI, are critical in understanding external factors that affect the
need for maternity care services.
---------------------------------------------------------------------------
\9\ Pope, Charlene. ``Addressing Limited English Proficiency and
Disparities for Hispanic Postpartum Women.'' Journal of Obstetric,
Gynecologic & Neonatal Nursing, vol. 34, no. 4, 2005, pp. 512-20.
Crossref, doi:10.1177/0884217505278295.
\10\ Vinson, Abigail, et al. ``131: Maternal Language, Severe
Maternal Morbidity and Access to Prenatal Care.'' American Journal
of Obstetrics and Gynecology, vol. 222, no. 1, 2020, pp. S99-100.
Crossref, doi:10.1016/j.ajog.2019.11.147.
---------------------------------------------------------------------------
A score for overall social vulnerability will be incorporated into
the MCTA composite score to reflect the increased need for maternity
care services among populations which experience a higher rate of
social vulnerability using the CDC's SVI. HRSA is seeking public
comment on the assigned point values in the distribution, which are
proposed as follows:
------------------------------------------------------------------------
Social Vulnerability Index Points
------------------------------------------------------------------------
Social Vulnerability >=75th Percentile.................. 2
75th Percentile > Social Vulnerability >=50th Percentile 1
Social Vulnerability <50th Percentile................... 0
------------------------------------------------------------------------
[[Page 53328]]
Score for Maternal Health Indicators
Many of the comments HRSA received raised concerns about social
determinants of health that have an impact on women's health outcomes,
not only during and after pregnancy, but also before and in between
pregnancies. In order to address these concerns, HRSA is seeking public
comment on the use of maternal health indicators as scoring criteria
for MCTAs. MCTA scores will consider health indicators that are
associated with poor maternal health outcomes by looking at various
data points related to pre-pregnancy health status and when prenatal
care began. Scores will consider pre-pregnancy obesity, diabetes, and
hypertension, as well as whether prenatal care began in the first
trimester, as these are all conditions which may require additional
workforce capacity to adequately address community needs. Only women of
childbearing age will be considered for these indicators. HRSA will use
the National Vital Statistics System as the data source to determine
the sub-score for each of these four (4) maternal health indicators.
Public health literature demonstrates that higher rates of obesity,
diabetes, or hypertension, and later onset of prenatal care are all
associated with poorer maternal health outcomes and will help identify
the need for additional health professionals. A 2018 Centers for
Disease Control and Prevention report on preconception health
surveillance identified priority indicators for adverse maternal health
outcomes.\11\ The study reviewed 50 preconception health indicators and
prioritized those indicators that are most suitable for surveillance
purposes. Weight, diabetes, and hypertension were all among the top 10
preconception health indicators recommended for surveillance.\12\
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\11\ Robbins, Cheryl L., et al. ``Preconception Health
Indicators for Public Health Surveillance.'' Journal of Women's
Health, vol. 27, no. 4 (2018): 430-43.
\12\ Ibid.
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HRSA also considered incorporating maternal mortality data into the
MCTA score. However, due to data suppression for privacy reasons, this
data is not readily available publicly or to HRSA below the state
level. As both HPSAs and MCTAs are designed to be able to provide
meaningful differentiation of need between communities at a local
level, HRSA decided not to incorporate maternal mortality data at this
time. If this data eventually becomes available to HRSA at the county
level or below, HRSA may include it in future MCTA score calculation.
HRSA is seeking public comment on the proposed criteria and point
scale distributions below. Service areas may receive one point each for
meeting the criteria.
Pre-Pregnancy Obesity
Pre-pregnancy obesity is defined as having a Body Mass Index of 30
or higher. One point will be awarded if the prevalence of pre-pregnancy
obesity in the area is greater than or equal to the 75th percentile
among all counties in the United States. If the prevalence of pre-
pregnancy obesity in the area is less than the 75th percentile among
all counties, zero points will be awarded.
------------------------------------------------------------------------
Pre-pregnancy obesity Points
------------------------------------------------------------------------
Prevalence of pre-pregnancy obesity >=75th percentile... 1
Prevalence of pre-pregnancy obesity <75th percentile.... 0
------------------------------------------------------------------------
Pre-Pregnancy Diabetes
One point will be awarded if the prevalence of pre-pregnancy
diabetes in the area is greater than or equal to the 75th percentile
among all counties in the United States. If the prevalence of pre-
pregnancy diabetes in the area is less than the 75th percentile among
all counties, zero points will be awarded.
------------------------------------------------------------------------
Pre-pregnancy diabetes Points
------------------------------------------------------------------------
Prevalence of pre-pregnancy diabetes >=75th percentile.. 1
Prevalence of pre-pregnancy diabetes <75th percentile... 0
------------------------------------------------------------------------
Pre-Pregnancy Hypertension
One point will be awarded if the prevalence of pre-pregnancy
hypertension among women in the area is greater than or equal to the
75th percentile among all counties in the nation. If the prevalence of
pre-pregnancy hypertension among women in the area is less than the
75th percentile among all counties, zero points will be awarded.
------------------------------------------------------------------------
Pre-pregnancy hypertension Points
------------------------------------------------------------------------
Prevalence of pre-pregnancy hypertension >=75th 1
percentile.............................................
Prevalence of pre-pregnancy hypertension <75th 0
percentile.............................................
------------------------------------------------------------------------
Prenatal Care Initiation in the 1st Trimester
One point will be awarded if the prevalence of women who did not
initiate prenatal care in the first trimester of their pregnancy is
greater than or equal to the 75th percentile among all counties in the
nation. Zero points will be awarded if the prevalence of women who did
not initiate prenatal care in the first trimester of their pregnancy is
less than the 75th percentile among all counties.
------------------------------------------------------------------------
Prenatal care in first trimester Points
------------------------------------------------------------------------
Prevalence of No Prenatal Care in First Trimester >=75th 1
percentile.............................................
Prevalence of No Prenatal Care in First Trimester <75th 0
percentile.............................................
------------------------------------------------------------------------
[[Page 53329]]
Diana Espinosa,
Acting Administrator.
[FR Doc. 2021-20855 Filed 9-24-21; 8:45 am]
BILLING CODE 4165-15-P
