Establishing a TRICARE Childbirth and Breastfeeding Support Demonstration, 60006-60011 [2021-23583]
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Federal Register / Vol. 86, No. 207 / Friday, October 29, 2021 / Notices
SUPPLEMENTARY INFORMATION:
DEPARTMENT OF DEFENSE
Office of the Secretary
[Docket ID: DoD–2021–OS–0112]
Proposed Collection; Comment
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Chief Information Officer (CIO),
Department of Defense (DoD).
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AGENCY:
In compliance with the
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clarity of the information to be
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respondents, including through the use
of automated collection techniques or
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DATES: Consideration will be given to all
comments received by December 28,
2021.
SUMMARY:
You may submit comments,
identified by docket number and title,
by any of the following methods:
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FOR FURTHER INFORMATION CONTACT:
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Title; Associated Form; and OMB
Number: System Authorization Access
Request Form; DD 2875; OMB Control
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Dated: October 25, 2021.
Aaron T. Siegel,
Alternate OSD Federal Register Liaison
Officer, Department of Defense.
[FR Doc. 2021–23549 Filed 10–28–21; 8:45 am]
BILLING CODE 5001–06–P
DEPARTMENT OF DEFENSE
Office of the Secretary
Establishing a TRICARE Childbirth and
Breastfeeding Support Demonstration
Defense Health Agency,
Department of Defense (DoD).
ACTION: Notice of demonstration project.
AGENCY:
The Assistant Secretary of
Defense for Health Affairs issues this
notice announcing the creation of a
demonstration to cover the services of
three new classes of extra-medical
TRICARE-authorized providers:
certified labor doulas (CLDs), certified
lactation consultants, and certified
lactation counselors. The demonstration
also adds childbirth support services,
provided by CLDs, as a benefit under
TRICARE and expands the existing
breastfeeding counseling benefit to
include group breastfeeding counseling
sessions. The demonstration will
SUMMARY:
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commence January 1, 2022, and will be
conducted for a period of 5 years
covering eligible beneficiaries in the 50
United States and District of Columbia.
Eligible beneficiaries in overseas
locations will be covered under the
demonstration beginning January 1,
2025, until termination of the
demonstration project.
FOR FURTHER INFORMATION CONTACT:
Erica Ferron, 303–676–3626,
erica.c.ferron.civ@mail.mil.
SUPPLEMENTARY INFORMATION:
A. Background
The purpose of the demonstration is
to study the impact of adding these
providers and services on cost, quality
of care, and maternal and fetal outcomes
for the TRICARE population, as required
by Section 746 of the William M. (Mac)
Thornberry National Defense
Authorization Act for Fiscal Year 2021
(NDAA–2021). The demonstration will
also study the appropriateness and
administrative feasibility of making
coverage under the TRICARE Program
permanent.
In the NDAA–2021, enacted January
1, 2021 (Pub. L. 116–283), Congress
directed the Secretary of Defense to
carry out a demonstration project to
evaluate the cost, quality of care, and
impact on maternal and fetal outcomes
of using extra-medical maternal health
providers under the TRICARE Program,
and to determine the appropriateness of
making coverage of such providers
under TRICARE permanent. Extramedical maternal health care providers
under the demonstration include doulas
and lactation consultants and
counselors not otherwise TRICAREauthorized providers (that is, that are
not also physicians, registered nurses,
certified nurse midwives, etc.).
In a recent Report to Congress (RTC),
DoD reported on maternal and infant
mortality rates. Military Health System
(MHS) data reflects that from January
2009 to June 2018, the pregnancyrelated mortality ratio (PRMR),1
including the direct care (DC) and
private sector care (PC) systems, was
7.40 deaths per 100,000 live births and
statistically significantly lower than the
benchmark data from National Perinatal
Information Center (NPIC) 2 with a
comparative rate of 11.3 deaths per
100,000 live births. During that same
period, the infant mortality rate was
2.51 deaths per 1,000 live births and
1 PRMR is defined as CDC as the death of a
woman while pregnant or within one year of
pregnancy from any cause related to or aggravated
by pregnancy or its management, but not from
accidental or incidental causes.
2 The NPIC is a nationwide voluntary obstetric
quality improvement database.
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was statistically significantly below the
NPIC rate of 4.76 per 1,000 live births.
Despite generally lower rates of
maternal and infant mortality compared
with the United States overall and with
NPIC member facilities, the MHS
continues to actively work to decrease
infant and maternal mortality.3
Nationally, and worldwide the rates of
maternal morbidity are increasing
related to postpartum bleeding, high
blood pressure, infection and mental
health disorders. The U.S. maternal
mortality rate is greater than 10 other
high-income countries and the U.S. is
the only developed country in the world
where the maternal mortality rate has
been steadily increasing. In 1987, the
maternal mortality rate was 7.2 deaths
per 100,000 live births. By 2018, the
maternal mortality rate had increased to
17.4 per 100,000 live births, compared
with 3.2 deaths per 100,000 in Germany,
or 6.5 deaths per 100,000 in the United
Kingdom.4
The risk of maternal mortality is not
limited to labor and delivery. The three
months immediately following birth,
sometimes referred to as the ‘‘fourth
trimester,’’ account for more than half
(52 percent) of pregnancy-related deaths
in the U.S. (one-third of deaths occur
during pregnancy and 17 percent occur
on the day of delivery). Of the maternal
deaths that occur postpartum, 19
percent occur one to six days
postpartum and another 21 percent
occur within six weeks of birth. Twelve
percent are considered late maternal
deaths, occurring later than six weeks
post-delivery.5 Doulas and lactation
consultants and counselors provide
services during pregnancy and the
critical fourth trimester, potentially
impacting outcomes for both the parent
giving birth and the infant.
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1. Childbirth Support and Doulas
Doulas are support personnel; while
there are many types of doulas, some
maternity related, some not, this
demonstration will be limited to the
3 Office of the Secretary of Defense. ‘‘Maternal
and Infant Mortality Rates in the Military Health
System.’’ July 2019. RefID 8–0153FF6.
4 Tikkanen, R., Gunja, M. Z., FitzGerald, M., &
Zephyrin, L. (2020, November 18). Maternal
mortality and maternity care in the United States
compared to 10 other developed countries.
Retrieved March 19, 2021, from https://
www.commonwealthfund.org/publications/issuebriefs/2020/nov/maternal-mortality-maternity-careus-compared-10-countries.
5 Tikkanen, R., Gunja, M. Z., FitzGerald, M., &
Zephyrin, L. (2020, November 18). Maternal
mortality and maternity care in the United States
compared to 10 other developed countries.
Retrieved March 19, 2021, from https://
www.commonwealthfund.org/publications/issuebriefs/2020/nov/maternal-mortality-maternity-careus-compared-10-countries.
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services of labor doulas. Labor doulas,
often referred to as birth doulas or labor
assistants, provide guidance to the
parent giving birth and family through
the labor and birthing process, and
attend to the needs of the family shortly
before delivery; during the birth,
whether it be vaginal, or C-section; and
immediately after delivery.6 Labor
doulas are not medical personnel and
are not qualified to provide medical
services, such as examination of the
cervix or prescription of medications,
and do not give medical advice.7 Rather,
the labor doula provides physical and
emotional support, coaching, and
guidance. While doulas do not provide
medical services, evidence increasingly
suggests health benefits may be
associated with the use of childbirth
support services.
DoD commissioned a technology
assessment from Hayes, Inc., in late
2020 in anticipation of this
demonstration that evaluated the impact
of doula services on maternal and fetal
outcomes. The results provided insight
into areas for the Defense Health Agency
(DHA) to explore in analysis of this
demonstration. In particular, the
evidence indicates that doula services
might have a positive impact on
shortened duration of labor, decreased
epidural anesthesia, decreased anxiety
during labor, decreased rate of stillbirths
and low Apgar score in infants, and
increased maternal feelings of coping
well with labor and feeling that the birth
experience was good. Additionally,
some outcomes with mixed results, such
as emergent C-section rate, warrant
further study.8
In 2019, the American College of
Obstetricians and Gynecologists (ACOG)
published a committee opinion in
which they recognized the value of
labor doulas, stating ‘‘evidence suggests
that, in addition to regular nursing care,
continuous one-to-one emotional
support provided by support personnel,
such as a doula, is associated with
improved outcomes for women in
labor.’’ 9 The opinion highlights the
benefits of using doula support
personnel including: Shortened labor,
6 DoulaTraining.net. (2021). Types of Doulas.
Retrieved March 19, 2021, from https://www.doula
training.net/types-of-doulas.
7 American Pregnancy Association. (2021,
February 05). Labor and birth. Retrieved March 19,
2021, from https://americanpregnancy.org/healthpregnancy/labor-and-birth/.
8 Hayes, Inc. ‘‘Impact of Doulas on Birth Related
Outcomes.’’ Long Hayes Technology Assessment,
November 16, 2020.
9 ACOG. ‘‘ACOG Committee Opinion No. 766:
Approaches to Limit Intervention During Labor and
Birth.’’ Obstet Gynecol. 2019 Feb;133(2):e164–e173.
doi: 10.1097/AOG.0000000000003074. PMID:
30575638. ACOG piece.
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decreased need for analgesia, fewer
operative deliveries (C-sections), and
fewer reports of dissatisfaction with the
experience of labor. The ACOG opinion
noted that one analysis, looking at birthrelated outcomes for Medicaid
recipients who received prenatal
education and childbirth support from
trained doulas, suggested that paying for
such personnel might result in
substantial cost savings annually.10
Labor doulas are not currently
licensed in any state and are not
recognized by Medicare, although a few
state Medicaid programs cover doula
services. Medicaid reimburses doulas
for their services in Oregon, Minnesota,
Nebraska, and Indiana, with other states
considering legislation. New York has a
pilot program for doula services,
launched in early 2019. Some state
Medicaid programs recommend and
recognize certification from approved
private certifying organizations, whose
certification qualifies a doula to receive
Medicaid payment, while others offer
their own certification. As of 2018, there
were over 100 independent
organizations offering some form of
doula training or certification.
Requirements for certification vary but
typically include some combination of
training workshops, reading lists,
training in breastfeeding and basic
childbirth education, networking to
develop a doula business, and hands-on
support for expectant mothers and their
partner/spouse.11
2. Breastfeeding Support, Lactation
Consultants, and Lactation Counselors
The U.S. Preventive Services Task
Force (USPSTF) recommends
breastfeeding counseling as a preventive
service for pregnant women, new
mothers, and their children, and
recommends interventions both during
pregnancy and after birth to support
breastfeeding.12 According to the
Centers for Disease Control and
Prevention (CDC), breastfeeding can
reduce the risk of infants developing:
Asthma, obesity, type-1 diabetes, severe
lower respiratory disease, acute otitis
media (ear infections), sudden infant
death syndrome, gastrointestinal
infections, and necrotizing enterocolitis
for preterm infants. Breastfeeding may
impact maternal health by lowering the
10 Kozhilmannil KB, Hardeman RR, Attanasio LB,
Blauer-Peterson C, O’Brien M. Doula care, birth
outcomes, and costs among Medicaid beneficiaries.
Am J Publish Health 2013; 103;e113–21.
11 Doulas of North America. (2021, March 04).
Become a birth doula—certification. Retrieved
March 19, 2021, from https://www.dona.org/
become-a-doula/birth-doula-certification/.
12 U.S. Preventive Services Task Force. (2016).
Final Recommendation Statement Breastfeeding:
Primary Care Interventions (Rep.). USPSTF.
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they provide treatment for either the
mother or the infant.
risk of: High blood pressure, type-2
diabetes, ovarian cancer, and breast
cancer.13
B. Description of Demonstration
As a result of section 706 of the
National Defense Authorization Act for
Fiscal Year 2015 (NDAA–2015),
TRICARE beneficiaries have access to
up to six breastfeeding/lactation
counseling sessions per birth event.
These sessions are authorized in
addition to any breastfeeding/lactation
counseling services received as part of
an inpatient maternity stay or outpatient
obstetrical or well-child visit.
Breastfeeding counseling must be
provided by an already-authorized
TRICARE provider, such as a physician,
physician assistant, nurse practitioner,
certified nurse midwife, registered
nurse, outpatient hospital, or clinic.
Despite the expanded breastfeeding
benefit, internal analysis found fewer
than five percent of TRICARE mothers
in FY20 used breastfeeding counseling
services in the 12 months following
delivery. Low use of this service may be
due in part to our current regulatory
requirement that all services be
provided by a TRICARE-authorized
provider, as many lactation consultants
and counselors do not have a health
profession-related degree or license, and
those that do are unlikely to focus on
providing lactation services. Low
utilization may have been further
impacted by the failure to create a new
provider class of lactation consultant/
counselor, which meant this type of
provider cannot be specifically searched
for in TRICARE provider directories.
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According to the U.S. Breastfeeding
Committee, an independent nonprofit
coalition, lactation consultants and
counselors are the most educated of four
lactation specialties (the other two are
breastfeeding peer counselors and
lactation educators).14 Lactation
consultants and counselors are health
care professionals who have received
specialized training to aid in
breastfeeding and passed a certification
exam. Lactation consultants and
counselors are not licensed in most
states; while some are also licensed
medical professionals (such as
registered nurses), many are not.
Lactation consultants and counselors do
not diagnose or assess illnesses, nor do
13 CDC. ‘‘Breastfeeding: Why it Matters.’’
Retrieved March 25, 2020, from https://
www.cdc.gov/breastfeeding/about-breastfeeding/
why-it-matters.html.
14 U.S. Breastfeeding Committee. ‘‘Lactation
Support Providers Descriptors Table.’’ Accessed
online on 3/21/21 at https://www.usbreast
feeding.org/page/lsp-descriptor-table.
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1. Overall Demonstration Details
The demonstration is designed to
evaluate the following hypotheses:
(1) Access to doulas will have a
positive and measurable impact on
maternal and fetal outcomes.
(2) Access to lactation consultants and
lactation counselors will have the same
or better impact on maternal and fetal
outcomes when compared to the same
services provided by other TRICAREauthorized providers.
(3) The cost of providing access to
such providers is justified by the impact
of the providers on maternal and fetal
outcomes.
(4) It is feasible to administer the new
provider classes and the services they
provide.
In order to evaluate the
demonstration, it is divided into two
distinct parts: A childbirth support
benefit and a breastfeeding support
benefit. This division recognizes that
the impact on maternal and fetal
outcomes, costs, and administrative
feasibility must be studied separately for
the two benefits (that is, the evaluation
may find a positive impact on outcomes
for one part of the demonstration but
not the other). Each provision adds a
new class of extra-medical provider,
while the childbirth support portion
also adds a new type of benefit. An
extra-medical provider as defined in the
regulations (Title 32 Code of Federal
Regulations (CFR), Part 199.6(c)(iv)) is
an individual professional provider who
provides ‘‘counseling or nonmedical
therapy and whose training and
therapeutic concepts are outside the
medical field.’’ Other extra-medical
providers include certified marriage and
family therapists, pastoral counselors,
supervised mental health counselors,
and Christian Science practitioners and
Christian Science nurses.
a. Demonstration Scope
The demonstration will be limited to
services occurring in PC. TRICARE
statutory and regulatory restrictions on
providers, from which the NDAA–2021
demonstration offers relief, apply to care
administered under PC. By contrast,
Military Medical Treatment Facilities
(MTFs) under DC are not prevented
from hiring such providers under
existing statutory and regulatory
requirements. Some MTFs already have
lactation consultants on staff, from
whom beneficiaries are eligible to
receive services. As of the drafting of
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this decision paper, no MTFs had
doulas on staff; however, many MTFs
do permit beneficiaries to bring a doula
with them during labor, whether that
doula be a volunteer, paid for by the
family, or reimbursed under another
program. The evaluation of maternal
and fetal outcomes will not be impacted
by the limitation of the demonstration to
PC.
b. Beneficiary Eligibility
The demonstration will be available
to TRICARE Prime and TRICARE Select
beneficiaries who receive care in PC
under the managed care support
contractors (MCSCs). TRICARE
Overseas beneficiaries will be eligible to
participate in the demonstration
beginning January 1, 2025, when the
demonstration expands to overseas
locations. Not included in the
demonstration will be TRICARE for Life,
United States Family Health Plan
(USFHP), and Continued Health Care
Benefit Program (CHCBP) beneficiaries.
Excluding beneficiaries not under the
MCSCs or the Oversea Program
(beginning January 1, 2025) reduces the
administrative burden of the
demonstration without having a
meaningful impact on the
demonstration’s results (the hypothesis
regarding administrative feasibility
refers primarily to the management of
the new provider categories and
benefits, and not to the administrative
variations under different TRICARE
contracts, which are a known variable
that does not require evaluation). Any
potential permanent expansion would
revisit inclusion of beneficiary
categories excluded under the
demonstration.
Beneficiaries will be enrolled in the
demonstration automatically when
accessing one or more covered services
from a provider authorized under this
demonstration. The contractor will
record the beneficiary’s enrollment by
marking the claims with a special
processing code for either the childbirth
support or breastfeeding counseling
portion of the demonstration.
Beneficiaries who are interested in
participating in the demonstration will
be able to contact the contractor for their
area to express interest in participating
and receive information on the
demonstration requirements and help
locating a provider, but such early
contact will not be required.
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2. Childbirth Support and Doulas
The childbirth support benefit both
adds certified labor doulas (CLDs) as
TRICARE-authorized providers and
childbirth support services as a benefit.
In order to be a CLD under this
demonstration, doulas must be at least
18-years-old and have:
(a) A current certification as a labor
doula by one of the following
organizations:
i. BirthWorks International
ii. Doulas of North America (DONA)
International
iii. Childbirth and Postpartum
Professional Association (CAPPA)
iv. International Childbirth Education
Association (ICEA)
v. toLabor
(b) Attended a training curriculum of
at least 24 hours that includes the
physiology of labor, labor doula
training, antepartum doula training, and
postpartum doula training.
(c) Attended one or more
breastfeeding courses.
(d) Attended one or more childbirth
education courses (e.g., Lamaze).
(e) Within the past three years,
provided continuous labor support for
at least three childbirths as the primary
labor doula supporting the birthing
parent, with a minimum of 15 hours
over the three childbirths. At least two
of the births must have been a vaginal
birth.
(f) Within the past three years,
provided antepartum and postpartum
support for at least one birth.
(g) A current child, infant, and adult
cardiopulmonary resuscitation (CPR)
certification.
(h) A state license or certification if
one is offered by the state, even if such
a license or certification is optional.
(i) A national provider identification
number (NPI).
A doula cannot use experience gained
from their own childbirth experience, to
include the labor and any associated
classes, to qualify as an authorized
provider under TRICARE.
The requirements for doulas selected
under the demonstration were based on
an analysis of over 150 doula training
and certification bodies. The
certification bodies selected for
inclusion had a time-limited
certification and were well-established
with a wide-ranging footprint (i.e.,
national or international); included
classroom training and workshops in
labor physiology and other childbirth
topics; required doulas to have
completed at least two deliveries prior
to certification; required evaluations
from health care professionals for
services provided during labor support
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or a comprehensive examination; and
had an established scope of practice,
code of ethics, code of conduct, or
similar by which the doula is required
to agree to abide. Some of our
requirements for CLDs may duplicate
those under the required certification;
this is due to differences in certification
requirements for the five selected
certification bodies and to ensure a
minimum level of education and
experience for all CLDs under this
demonstration. DoD recognizes that
there may be some doulas and doula
certification bodies concerned they do
not meet inclusion criteria. If DoD
determines it is appropriate to move
forward with permanent coverage of
CLDs under the TRICARE Program at
the conclusion of this demonstration,
interested individuals and organizations
will be invited to provide feedback
during notice and comment rulemaking.
TRICARE will cover up to six total
antepartum and postpartum CLD visits.
One continuous labor support encounter
per birth event will be authorized
regardless of the location of the
childbirth (hospital, birthing center,
home delivery, etc.). The birthing parent
must be at least 20 weeks pregnant to be
eligible for services, and the maternity
episode-of-care must be overseen by a
TRICARE-authorized provider (that is,
childbirth support services are ineligible
for reimbursement if the delivery is
performed or planned to be performed
by other than a TRICARE-authorized
provider; e.g., a lay midwife, except in
emergency circumstances). No
additional reimbursement will be
provided for travel to the delivery
location or if the doula moves with the
patient from an initial location (the
home or birthing center) to another
location (a hospital), for long or difficult
deliveries, or for false labor. Doula
services will be eligible whether the
labor is completed via vaginal birth or
C-section, and whether or not the labor
results in a live birth (doula services are
excluded for elective abortions not
otherwise covered by TRICARE).
Childbirth support reimbursement
under the demonstration is as follows:
• Antepartum/Postpartum visits (up
to six total): The six authorized
antepartum or postpartum visits will be
reimbursed at a rate of $46.00 per visit
(for Calendar Year (CY) 2021), wage
adjusted and updated annually. These
visits will be untimed and no more than
one visit will be eligible for
reimbursement per day.
• Continuous Labor Support:
Continuous labor support will be
reimbursed at a national rate of 15 times
the rate of the antepartum/postpartum
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visit rate, or $690.00 for CY 2021, wage
adjusted and updated annually.
CLDs will be reimbursed the lower of
the billed charge or the rates listed
above. A CLD who advertises their rate
at a rate lower than the TRICARE
reimbursement amount but bills
TRICARE for the reimbursement rate
listed above (i.e., charges TRICARE
beneficiaries more than they charge
other clients) may be subject to the
administrative remedies for fraud,
waste, and abuse, pursuant to 32 CFR
199.9 and referral to the appropriate
program integrity authority. Additional
coding and reimbursement information
will be published in the TRICARE
manuals prior to the start of the
demonstration, and may be updated
periodically upon approval of the
Director, DHA.
3. Breastfeeding Support, Lactation
Consultants, and Lactation Counselors
The breastfeeding support portion of
the demonstration creates two new
classes of extra-medical providers:
Certified lactation consultants and
certified lactation counselors. Certified
lactation consultants under the
demonstration will have a current
International Board of Lactation
Consultant Examiners (IBLCE)
certification as an International Board
Certified Lactation Consultant or a
current Academy of Lactation Policy
and Practice (ALPP) certification as an
Advanced Nurse Lactation Consultant
or an Advanced Lactation Consultant.
Certified lactation counselors must hold
a current certification from ALPP as a
Certified Lactation Counselor. Both
classes of provider will be required to be
at least 18-years-old; to maintain a
current adult, child, and infant CPR
certification; to be licensed or certified
in the state in which they practice even
if such a licensure or certification is
optional; and to bill under an NPI. If
DoD determines it is appropriate to
move forward with permanent coverage
of lactation consultants and/or lactation
counselors under the TRICARE
Program, interested individuals and
organizations will be able to provide
feedback on qualification and other
requirements during notice and
comment rulemaking.
The breastfeeding support benefit
under this demonstration conforms with
the requirements of the existing
breastfeeding counseling benefit as
found in the TRICARE Policy Manual,
Chapter 8, Section 2.6, paragraph 4.3,
which authorizes coverage of up to six
outpatient breastfeeding/lactation
counseling sessions per birth event
using current procedural terminology
(CPT) codes 99401 to 99404. Cost-
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shares, copays, and deductibles do not
apply to covered breastfeeding/lactation
counseling services rendered on or after
December 19, 2014. This demonstration
adds coverage of group breastfeeding
counseling, which may include prenatal
breastfeeding education. Such services
shall be included in the six total
breastfeeding counseling visits currently
authorized under the benefit.
Group lactation counseling/classes
will be billed under CPT code 99411
Preventive Counseling, Group, 30 min,
and 99412 Preventive Counseling,
Group, 60 min. These codes will be paid
at the TRICARE non-physician, nonfacility CHAMPUS Maximum Allowable
Charge (CMAC) rate ($17.80 and $22.24,
respectively, for FY21). Individual
lactation counseling sessions will be
reimbursed at the non-physician, nonfacility CMAC under the existing CPT
codes 99401 through 99404.
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C. Implementation Details
The DHA will publish additional
details on implementation of the
demonstration in the TRICARE manuals
prior to start of the demonstration.
Providers interested in participating in
the demonstration should contact the
appropriate TRICARE contractor for
their area during this period. While
interested providers are not required to
be network providers to participate in
the demonstration, all providers must
meet the eligibility requirements under
the demonstration to have their services
cost-shared. Provider networks overseas
will begin development prior to the start
of the demonstration expansion.
Beneficiaries do not need to enroll or
otherwise sign up to participate in the
demonstration, but must meet eligibility
criteria for the demonstration (e.g., must
be at least 20 weeks pregnant for
childbirth support services).
D. Beneficiary Survey
The NDAA–2021 mandated the
Secretary administer a survey by
January 1, 2022, and annually thereafter
for the duration of the demonstration.
The survey is required to gather
information on:
(1) How many members of the Armed
Forces or spouses of such members give
birth while their spouse or birthing
partner is unable to be present due to
deployment, training, or other mission
requirements; how many single
members of the armed forces give birth
alone; and how many members of the
Armed Forces or spouses of such
members use doula, lactation
consultant, or lactation counselor
support.
(2) The race, ethnicity, age, sex,
relationship status, Armed Force,
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military occupation, and rank, as
applicable, of each member surveyed.
(3) If individuals surveyed were
members of the Armed Forces or the
spouses of such members, or both.
(4) The length of advanced notice
received by individuals surveyed that
the member of the Armed Forces would
be unable to be present during the birth;
if applicable.
(5) Any resources or support that
individuals surveyed found useful
during the pregnancy and birth process,
including doula, lactation consultant,
and lactation counselor support.
The DoD intends to ask additional
questions in the survey to aid in
evaluation of the demonstration. Results
of the survey will be reported to
Congress.
E. Cost Assessment
The demonstration is anticipated to
cost $51.16M in health care and
administrative costs, with an additional
$4.3M estimated for evaluation of the
demonstration over the five-year period.
Increased costs to the TRICARE Program
for breastfeeding counseling are
estimated at $7.05M, while $40.18M are
estimated for the childbirth support
benefit. The childbirth support benefit
estimate includes a calculation for
offsets from C-section reductions. There
is substantial uncertainty surrounding
the estimate, given that no commercial
insurers and only a few Medicaid
programs reimburse for childbirth
support services. The estimate includes
approximately $3.93M for
administrative costs related to
credentialing, billing, and contractor
reporting requirements.
F. Demonstration Analysis
The DoD will evaluate the success of
the demonstration project and report to
Congress on the results annually. DoD
intends to use an outside firm to assist
in its analysis. In order to measure
maternal and fetal outcomes, DoD will
compare outcomes and use of services:
(1) With historical data; (2) between
those who choose not to use a service
and those who do; and, (3) with
nationwide statistics. The analysis will
evaluate the childbirth support benefit
by reviewing information obtained from
claims data, such as C-section rates and
use Pitocin, and comparing it to the
same outcomes from before the
demonstration started (pre/post-test),
with beneficiaries who do not use the
childbirth support benefit, and with
national statistics. To evaluate the
breastfeeding support benefit, the
analysis will evaluate outcome
measures (such as ear infections for
infants) for beneficiaries receiving
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Fmt 4703
Sfmt 4703
services provided from a lactation
consultant/counselor compared to the
same outcome for services from an
otherwise-authorized TRICARE
provider, and when compared to
beneficiaries who choose not to use the
breastfeeding counseling benefit. The
analysis will also compare outcomes to
historical data and nationwide statistics.
Additionally, we will ask questions on
the beneficiary survey to assist in
evaluating the quality of care received.
The effectiveness of the demonstration
will be evaluated by the impact of the
demonstration on outcomes, the
availability of providers under the
demonstration, and beneficiary
satisfaction with the providers. Cost will
be evaluated by reviewing the overall
cost of the demonstration, but also by
capturing cost-savings due to
improvements in maternal and fetal
outcomes (for example, the cost savings
associated with avoiding C-sections).
Throughout the demonstration, we
will evaluate the effectiveness of the
qualification requirements for providers
and the reimbursement methodology.
We will also evaluate the administrative
feasibility of continuing the
demonstration and/or implementing
permanent coverage under the TRICARE
Program. Such feasibility analysis will
include: the extent to which TRICARE’s
contractors are able to build networks,
the extent to which TRICARE
beneficiaries access the benefit, whether
providers under the demonstration are
able to file claims for services and
otherwise comply with program
requirements, the presence of any
provider quality concerns, and the cost
for TRICARE’s contractors to maintain
the benefit. The DoD will add, remove,
or revise outcome measures under study
as needed to ensure a robust evaluation
of the demonstration.
Because the providers under this
demonstration are not medical
providers, but instead are support
personnel who work outside the
medical field, no clinical care will be
provided as part of this demonstration.
Neither doulas nor lactation
consultants/counselors are qualified to
provide clinical care, and both will be
required to refer the beneficiary to a
qualified medical professional if they
identify a medical issue requiring a
change to the patient’s clinical care.
DoD’s evaluation will be limited to deidentified evaluation of claims records
and survey responses. The ASD(HA) has
determined that the demonstration is
exempt from the requirements for
human subjects research, pursuant to
the authority provided by 45 CFR
46.104(d)(5) exempting demonstration
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projects by Federal Departments that
evaluate public benefit programs.
Dated: October 25, 2021.
Aaron T. Siegel,
Alternate OSD Federal Register Liaison
Officer, Department of Defense.
[FR Doc. 2021–23583 Filed 10–28–21; 8:45 am]
BILLING CODE 5001–06–P
DEPARTMENT OF EDUCATION
[Docket No.: ED–2021–SCC–0096]
Agency Information Collection
Activities; Submission to the Office of
Management and Budget for Review
and Approval; Comment Request;
Education Stabilization Fund—
Elementary and Secondary School
Emergency Relief Fund (ESSER I/
ESSER II/ARP ESSER Fund) Recipient
Data Collection Form
Office of Elementary and
Secondary Education (OESE),
Department of Education (ED).
ACTION: Notice.
AGENCY:
In accordance with the
Paperwork Reduction Act of 1995, ED is
proposing a revision of a currently
approved collection.
DATES: Interested persons are invited to
submit comments on or before
November 29, 2021.
ADDRESSES: Written comments and
recommendations for proposed
information collection requests should
be sent within 30 days of publication of
this notice to www.reginfo.gov/public/
do/PRAMain. Find this information
collection request by selecting
‘‘Department of Education’’ under
‘‘Currently Under Review,’’ then check
‘‘Only Show ICR for Public Comment’’
checkbox. Comments may also be sent
to ICDocketmgr@ed.gov.
FOR FURTHER INFORMATION CONTACT: For
specific questions related to collection
activities, please contact Gloria Tanner,
202–453–5596.
SUPPLEMENTARY INFORMATION: The
Department of Education (ED), in
accordance with the Paperwork
Reduction Act of 1995 (PRA) (44 U.S.C.
3506(c)(2)(A)), provides the general
public and Federal agencies with an
opportunity to comment on proposed,
revised, and continuing collections of
information. This helps the Department
assess the impact of its information
collection requirements and minimize
the public’s reporting burden. It also
helps the public understand the
Department’s information collection
requirements and provide the requested
data in the desired format. ED is
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SUMMARY:
VerDate Sep<11>2014
18:17 Oct 28, 2021
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soliciting comments on the proposed
information collection request (ICR) that
is described below. The Department of
Education is especially interested in
public comment addressing the
following issues: (1) Is this collection
necessary to the proper functions of the
Department; (2) will this information be
processed and used in a timely manner;
(3) is the estimate of burden accurate;
(4) how might the Department enhance
the quality, utility, and clarity of the
information to be collected; and (5) how
might the Department minimize the
burden of this collection on the
respondents, including through the use
of information technology. Please note
that written comments received in
response to this notice will be
considered public records.
Title of Collection: Education
Stabilization Fund—Elementary and
Secondary School Emergency Relief
Fund (ESSER I/ESSER II/ARP ESSER
Fund) Recipient Data Collection Form.
OMB Control Number: 1810–0749.
Type of Review: A revision of a
currently approved collection.
Respondents/Affected Public: State,
Local, and Tribal Governments.
Total Estimated Number of Annual
Responses: 14,652.
Total Estimated Number of Annual
Burden Hours: 2,051,280.
Abstract: Under the current
unprecedented national health
emergency, the legislative and executive
branches of government have come
together to offer relief to those
individuals and industries affected by
the COVID–19 virus under the
Coronavirus Aid, Relief, and Economic
Security (CARES) Act (Pub. L. 116–136)
authorized on March 27, 2020, and
expanded through the Coronavirus
Response and Relief Supplemental
Appropriations (CRRSA) Act, and the
American Rescue Plan (ARP) Act. The
ESSER Fund awards grants to SEAs and
for the purpose of providing local
educational agencies (LEAs), including
charter schools that are LEAs, as well as
Outlying Areas, with emergency relief
funds to address the impact that Novel
Coronavirus Disease 2019 (COVID–19)
has had, and continues to have, on
elementary and secondary schools
across the Nation.
This information collection requests
approval for a revision to a previously
approved collection that includes
annual reporting requirements to
comply with the requirements of the
ESSER program and obtain information
on how the funds were used by State
and Local Education Agencies. In
accordance with the Recipient’s
Funding Certification and Agreements
executed by ESSER grantees, the
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60011
Secretary may specify additional forms
of reporting. This collection has 4 fewer
grantee respondents than the originally
approved version, as information
reported from Outlying Areas will be
obtained through a separate collection.
The information collection also includes
directed questions, in Attachment A, on
which the Department is requesting
public input.
Dated: October 26, 2021.
Juliana Pearson,
PRA Coordinator, Strategic Collections and
Clearance, Governance and Strategy Division,
Office of Chief Data Officer, Office of
Planning, Evaluation and Policy
Development.
[FR Doc. 2021–23640 Filed 10–28–21; 8:45 am]
BILLING CODE 4000–01–P
DEPARTMENT OF EDUCATION
Applications for New Awards;
Transitioning Gang-Involved Youth to
Higher Education Program
Office of Postsecondary
Education, Department of Education.
AGENCY:
ACTION:
Notice.
The Department of Education
(Department) is issuing a notice inviting
applications (NIA) for fiscal year (FY)
2021 for the Transitioning GangInvolved Youth to Higher Education
Program, Assistance Listing Number
84.116Y. This notice relates to the
approved information collection under
OMB control number 1894–0006.
SUMMARY:
Applications available: October
29, 2021.
Deadline for transmittal of
applications: November 29, 2021.
DATES:
For the addresses for
obtaining and submitting an
application, please refer to our Common
Instructions for Applicants to
Department of Education Discretionary
Grant Programs, published in the
Federal Register on February 13, 2019
(84 FR 3768), and available at
www.govinfo.gov/content/pkg/FR-201902-13/pdf/2019-02206.pdf.
ADDRESSES:
FOR FURTHER INFORMATION CONTACT:
Jymece Seward, U.S. Department of
Education, 400 Maryland Avenue SW,
Room 2B159, Washington, DC 20202–
4260. Telephone: (202) 453–6138.
Email: Jymece.Seward@ed.gov.
If you use a telecommunications
device for the deaf (TDD) or a text
telephone (TTY), call the Federal Relay
Service (FRS), toll free, at 1–800–877–
8339.
SUPPLEMENTARY INFORMATION:
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]]>Agencies
[Federal Register Volume 86, Number 207 (Friday, October 29, 2021)]
[Notices]
[Pages 60006-60011]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2021-23583]
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DEPARTMENT OF DEFENSE
Office of the Secretary
Establishing a TRICARE Childbirth and Breastfeeding Support
Demonstration
AGENCY: Defense Health Agency, Department of Defense (DoD).
ACTION: Notice of demonstration project.
-----------------------------------------------------------------------
SUMMARY: The Assistant Secretary of Defense for Health Affairs issues
this notice announcing the creation of a demonstration to cover the
services of three new classes of extra-medical TRICARE-authorized
providers: certified labor doulas (CLDs), certified lactation
consultants, and certified lactation counselors. The demonstration also
adds childbirth support services, provided by CLDs, as a benefit under
TRICARE and expands the existing breastfeeding counseling benefit to
include group breastfeeding counseling sessions. The demonstration will
commence January 1, 2022, and will be conducted for a period of 5 years
covering eligible beneficiaries in the 50 United States and District of
Columbia. Eligible beneficiaries in overseas locations will be covered
under the demonstration beginning January 1, 2025, until termination of
the demonstration project.
FOR FURTHER INFORMATION CONTACT: Erica Ferron, 303-676-3626,
[email protected].
SUPPLEMENTARY INFORMATION:
A. Background
The purpose of the demonstration is to study the impact of adding
these providers and services on cost, quality of care, and maternal and
fetal outcomes for the TRICARE population, as required by Section 746
of the William M. (Mac) Thornberry National Defense Authorization Act
for Fiscal Year 2021 (NDAA-2021). The demonstration will also study the
appropriateness and administrative feasibility of making coverage under
the TRICARE Program permanent.
In the NDAA-2021, enacted January 1, 2021 (Pub. L. 116-283),
Congress directed the Secretary of Defense to carry out a demonstration
project to evaluate the cost, quality of care, and impact on maternal
and fetal outcomes of using extra-medical maternal health providers
under the TRICARE Program, and to determine the appropriateness of
making coverage of such providers under TRICARE permanent. Extra-
medical maternal health care providers under the demonstration include
doulas and lactation consultants and counselors not otherwise TRICARE-
authorized providers (that is, that are not also physicians, registered
nurses, certified nurse midwives, etc.).
In a recent Report to Congress (RTC), DoD reported on maternal and
infant mortality rates. Military Health System (MHS) data reflects that
from January 2009 to June 2018, the pregnancy-related mortality ratio
(PRMR),\1\ including the direct care (DC) and private sector care (PC)
systems, was 7.40 deaths per 100,000 live births and statistically
significantly lower than the benchmark data from National Perinatal
Information Center (NPIC) \2\ with a comparative rate of 11.3 deaths
per 100,000 live births. During that same period, the infant mortality
rate was 2.51 deaths per 1,000 live births and
[[Page 60007]]
was statistically significantly below the NPIC rate of 4.76 per 1,000
live births. Despite generally lower rates of maternal and infant
mortality compared with the United States overall and with NPIC member
facilities, the MHS continues to actively work to decrease infant and
maternal mortality.\3\ Nationally, and worldwide the rates of maternal
morbidity are increasing related to postpartum bleeding, high blood
pressure, infection and mental health disorders. The U.S. maternal
mortality rate is greater than 10 other high-income countries and the
U.S. is the only developed country in the world where the maternal
mortality rate has been steadily increasing. In 1987, the maternal
mortality rate was 7.2 deaths per 100,000 live births. By 2018, the
maternal mortality rate had increased to 17.4 per 100,000 live births,
compared with 3.2 deaths per 100,000 in Germany, or 6.5 deaths per
100,000 in the United Kingdom.\4\
---------------------------------------------------------------------------
\1\ PRMR is defined as CDC as the death of a woman while
pregnant or within one year of pregnancy from any cause related to
or aggravated by pregnancy or its management, but not from
accidental or incidental causes.
\2\ The NPIC is a nationwide voluntary obstetric quality
improvement database.
\3\ Office of the Secretary of Defense. ``Maternal and Infant
Mortality Rates in the Military Health System.'' July 2019. RefID 8-
0153FF6.
\4\ Tikkanen, R., Gunja, M. Z., FitzGerald, M., & Zephyrin, L.
(2020, November 18). Maternal mortality and maternity care in the
United States compared to 10 other developed countries. Retrieved
March 19, 2021, from https://www.commonwealthfund.org/publications/issue-briefs/2020/nov/maternal-mortality-maternity-care-us-compared-10-countries.
---------------------------------------------------------------------------
The risk of maternal mortality is not limited to labor and
delivery. The three months immediately following birth, sometimes
referred to as the ``fourth trimester,'' account for more than half (52
percent) of pregnancy-related deaths in the U.S. (one-third of deaths
occur during pregnancy and 17 percent occur on the day of delivery). Of
the maternal deaths that occur postpartum, 19 percent occur one to six
days postpartum and another 21 percent occur within six weeks of birth.
Twelve percent are considered late maternal deaths, occurring later
than six weeks post-delivery.\5\ Doulas and lactation consultants and
counselors provide services during pregnancy and the critical fourth
trimester, potentially impacting outcomes for both the parent giving
birth and the infant.
---------------------------------------------------------------------------
\5\ Tikkanen, R., Gunja, M. Z., FitzGerald, M., & Zephyrin, L.
(2020, November 18). Maternal mortality and maternity care in the
United States compared to 10 other developed countries. Retrieved
March 19, 2021, from https://www.commonwealthfund.org/publications/issue-briefs/2020/nov/maternal-mortality-maternity-care-us-compared-10-countries.
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1. Childbirth Support and Doulas
Doulas are support personnel; while there are many types of doulas,
some maternity related, some not, this demonstration will be limited to
the services of labor doulas. Labor doulas, often referred to as birth
doulas or labor assistants, provide guidance to the parent giving birth
and family through the labor and birthing process, and attend to the
needs of the family shortly before delivery; during the birth, whether
it be vaginal, or C-section; and immediately after delivery.\6\ Labor
doulas are not medical personnel and are not qualified to provide
medical services, such as examination of the cervix or prescription of
medications, and do not give medical advice.\7\ Rather, the labor doula
provides physical and emotional support, coaching, and guidance. While
doulas do not provide medical services, evidence increasingly suggests
health benefits may be associated with the use of childbirth support
services.
---------------------------------------------------------------------------
\6\ DoulaTraining.net. (2021). Types of Doulas. Retrieved March
19, 2021, from https://www.doulatraining.net/types-of-doulas.
\7\ American Pregnancy Association. (2021, February 05). Labor
and birth. Retrieved March 19, 2021, from https://americanpregnancy.org/health-pregnancy/labor-and-birth/.
---------------------------------------------------------------------------
DoD commissioned a technology assessment from Hayes, Inc., in late
2020 in anticipation of this demonstration that evaluated the impact of
doula services on maternal and fetal outcomes. The results provided
insight into areas for the Defense Health Agency (DHA) to explore in
analysis of this demonstration. In particular, the evidence indicates
that doula services might have a positive impact on shortened duration
of labor, decreased epidural anesthesia, decreased anxiety during
labor, decreased rate of stillbirths and low Apgar score in infants,
and increased maternal feelings of coping well with labor and feeling
that the birth experience was good. Additionally, some outcomes with
mixed results, such as emergent C-section rate, warrant further
study.\8\
---------------------------------------------------------------------------
\8\ Hayes, Inc. ``Impact of Doulas on Birth Related Outcomes.''
Long Hayes Technology Assessment, November 16, 2020.
---------------------------------------------------------------------------
In 2019, the American College of Obstetricians and Gynecologists
(ACOG) published a committee opinion in which they recognized the value
of labor doulas, stating ``evidence suggests that, in addition to
regular nursing care, continuous one-to-one emotional support provided
by support personnel, such as a doula, is associated with improved
outcomes for women in labor.'' \9\ The opinion highlights the benefits
of using doula support personnel including: Shortened labor, decreased
need for analgesia, fewer operative deliveries (C-sections), and fewer
reports of dissatisfaction with the experience of labor. The ACOG
opinion noted that one analysis, looking at birth-related outcomes for
Medicaid recipients who received prenatal education and childbirth
support from trained doulas, suggested that paying for such personnel
might result in substantial cost savings annually.\10\
---------------------------------------------------------------------------
\9\ ACOG. ``ACOG Committee Opinion No. 766: Approaches to Limit
Intervention During Labor and Birth.'' Obstet Gynecol. 2019
Feb;133(2):e164-e173. doi: 10.1097/AOG.0000000000003074. PMID:
30575638. ACOG piece.
\10\ Kozhilmannil KB, Hardeman RR, Attanasio LB, Blauer-Peterson
C, O'Brien M. Doula care, birth outcomes, and costs among Medicaid
beneficiaries. Am J Publish Health 2013; 103;e113-21.
---------------------------------------------------------------------------
Labor doulas are not currently licensed in any state and are not
recognized by Medicare, although a few state Medicaid programs cover
doula services. Medicaid reimburses doulas for their services in
Oregon, Minnesota, Nebraska, and Indiana, with other states considering
legislation. New York has a pilot program for doula services, launched
in early 2019. Some state Medicaid programs recommend and recognize
certification from approved private certifying organizations, whose
certification qualifies a doula to receive Medicaid payment, while
others offer their own certification. As of 2018, there were over 100
independent organizations offering some form of doula training or
certification. Requirements for certification vary but typically
include some combination of training workshops, reading lists, training
in breastfeeding and basic childbirth education, networking to develop
a doula business, and hands-on support for expectant mothers and their
partner/spouse.\11\
---------------------------------------------------------------------------
\11\ Doulas of North America. (2021, March 04). Become a birth
doula--certification. Retrieved March 19, 2021, from https://www.dona.org/become-a-doula/birth-doula-certification/.
---------------------------------------------------------------------------
2. Breastfeeding Support, Lactation Consultants, and Lactation
Counselors
The U.S. Preventive Services Task Force (USPSTF) recommends
breastfeeding counseling as a preventive service for pregnant women,
new mothers, and their children, and recommends interventions both
during pregnancy and after birth to support breastfeeding.\12\
According to the Centers for Disease Control and Prevention (CDC),
breastfeeding can reduce the risk of infants developing: Asthma,
obesity, type-1 diabetes, severe lower respiratory disease, acute
otitis media (ear infections), sudden infant death syndrome,
gastrointestinal infections, and necrotizing enterocolitis for preterm
infants. Breastfeeding may impact maternal health by lowering the
[[Page 60008]]
risk of: High blood pressure, type-2 diabetes, ovarian cancer, and
breast cancer.\13\
---------------------------------------------------------------------------
\12\ U.S. Preventive Services Task Force. (2016). Final
Recommendation Statement Breastfeeding: Primary Care Interventions
(Rep.). USPSTF.
\13\ CDC. ``Breastfeeding: Why it Matters.'' Retrieved March 25,
2020, from https://www.cdc.gov/breastfeeding/about-breastfeeding/why-it-matters.html.
---------------------------------------------------------------------------
As a result of section 706 of the National Defense Authorization
Act for Fiscal Year 2015 (NDAA-2015), TRICARE beneficiaries have access
to up to six breastfeeding/lactation counseling sessions per birth
event. These sessions are authorized in addition to any breastfeeding/
lactation counseling services received as part of an inpatient
maternity stay or outpatient obstetrical or well-child visit.
Breastfeeding counseling must be provided by an already-authorized
TRICARE provider, such as a physician, physician assistant, nurse
practitioner, certified nurse midwife, registered nurse, outpatient
hospital, or clinic. Despite the expanded breastfeeding benefit,
internal analysis found fewer than five percent of TRICARE mothers in
FY20 used breastfeeding counseling services in the 12 months following
delivery. Low use of this service may be due in part to our current
regulatory requirement that all services be provided by a TRICARE-
authorized provider, as many lactation consultants and counselors do
not have a health profession-related degree or license, and those that
do are unlikely to focus on providing lactation services. Low
utilization may have been further impacted by the failure to create a
new provider class of lactation consultant/counselor, which meant this
type of provider cannot be specifically searched for in TRICARE
provider directories.
According to the U.S. Breastfeeding Committee, an independent
nonprofit coalition, lactation consultants and counselors are the most
educated of four lactation specialties (the other two are breastfeeding
peer counselors and lactation educators).\14\ Lactation consultants and
counselors are health care professionals who have received specialized
training to aid in breastfeeding and passed a certification exam.
Lactation consultants and counselors are not licensed in most states;
while some are also licensed medical professionals (such as registered
nurses), many are not. Lactation consultants and counselors do not
diagnose or assess illnesses, nor do they provide treatment for either
the mother or the infant.
---------------------------------------------------------------------------
\14\ U.S. Breastfeeding Committee. ``Lactation Support Providers
Descriptors Table.'' Accessed online on 3/21/21 at https://www.usbreastfeeding.org/page/lsp-descriptor-table.
---------------------------------------------------------------------------
B. Description of Demonstration
1. Overall Demonstration Details
The demonstration is designed to evaluate the following hypotheses:
(1) Access to doulas will have a positive and measurable impact on
maternal and fetal outcomes.
(2) Access to lactation consultants and lactation counselors will
have the same or better impact on maternal and fetal outcomes when
compared to the same services provided by other TRICARE-authorized
providers.
(3) The cost of providing access to such providers is justified by
the impact of the providers on maternal and fetal outcomes.
(4) It is feasible to administer the new provider classes and the
services they provide.
In order to evaluate the demonstration, it is divided into two
distinct parts: A childbirth support benefit and a breastfeeding
support benefit. This division recognizes that the impact on maternal
and fetal outcomes, costs, and administrative feasibility must be
studied separately for the two benefits (that is, the evaluation may
find a positive impact on outcomes for one part of the demonstration
but not the other). Each provision adds a new class of extra-medical
provider, while the childbirth support portion also adds a new type of
benefit. An extra-medical provider as defined in the regulations (Title
32 Code of Federal Regulations (CFR), Part 199.6(c)(iv)) is an
individual professional provider who provides ``counseling or
nonmedical therapy and whose training and therapeutic concepts are
outside the medical field.'' Other extra-medical providers include
certified marriage and family therapists, pastoral counselors,
supervised mental health counselors, and Christian Science
practitioners and Christian Science nurses.
a. Demonstration Scope
The demonstration will be limited to services occurring in PC.
TRICARE statutory and regulatory restrictions on providers, from which
the NDAA-2021 demonstration offers relief, apply to care administered
under PC. By contrast, Military Medical Treatment Facilities (MTFs)
under DC are not prevented from hiring such providers under existing
statutory and regulatory requirements. Some MTFs already have lactation
consultants on staff, from whom beneficiaries are eligible to receive
services. As of the drafting of this decision paper, no MTFs had doulas
on staff; however, many MTFs do permit beneficiaries to bring a doula
with them during labor, whether that doula be a volunteer, paid for by
the family, or reimbursed under another program. The evaluation of
maternal and fetal outcomes will not be impacted by the limitation of
the demonstration to PC.
b. Beneficiary Eligibility
The demonstration will be available to TRICARE Prime and TRICARE
Select beneficiaries who receive care in PC under the managed care
support contractors (MCSCs). TRICARE Overseas beneficiaries will be
eligible to participate in the demonstration beginning January 1, 2025,
when the demonstration expands to overseas locations. Not included in
the demonstration will be TRICARE for Life, United States Family Health
Plan (USFHP), and Continued Health Care Benefit Program (CHCBP)
beneficiaries. Excluding beneficiaries not under the MCSCs or the
Oversea Program (beginning January 1, 2025) reduces the administrative
burden of the demonstration without having a meaningful impact on the
demonstration's results (the hypothesis regarding administrative
feasibility refers primarily to the management of the new provider
categories and benefits, and not to the administrative variations under
different TRICARE contracts, which are a known variable that does not
require evaluation). Any potential permanent expansion would revisit
inclusion of beneficiary categories excluded under the demonstration.
Beneficiaries will be enrolled in the demonstration automatically
when accessing one or more covered services from a provider authorized
under this demonstration. The contractor will record the beneficiary's
enrollment by marking the claims with a special processing code for
either the childbirth support or breastfeeding counseling portion of
the demonstration. Beneficiaries who are interested in participating in
the demonstration will be able to contact the contractor for their area
to express interest in participating and receive information on the
demonstration requirements and help locating a provider, but such early
contact will not be required.
[[Page 60009]]
2. Childbirth Support and Doulas
The childbirth support benefit both adds certified labor doulas
(CLDs) as TRICARE-authorized providers and childbirth support services
as a benefit. In order to be a CLD under this demonstration, doulas
must be at least 18-years-old and have:
(a) A current certification as a labor doula by one of the
following organizations:
i. BirthWorks International
ii. Doulas of North America (DONA) International
iii. Childbirth and Postpartum Professional Association (CAPPA)
iv. International Childbirth Education Association (ICEA)
v. toLabor
(b) Attended a training curriculum of at least 24 hours that
includes the physiology of labor, labor doula training, antepartum
doula training, and postpartum doula training.
(c) Attended one or more breastfeeding courses.
(d) Attended one or more childbirth education courses (e.g.,
Lamaze).
(e) Within the past three years, provided continuous labor support
for at least three childbirths as the primary labor doula supporting
the birthing parent, with a minimum of 15 hours over the three
childbirths. At least two of the births must have been a vaginal birth.
(f) Within the past three years, provided antepartum and postpartum
support for at least one birth.
(g) A current child, infant, and adult cardiopulmonary
resuscitation (CPR) certification.
(h) A state license or certification if one is offered by the
state, even if such a license or certification is optional.
(i) A national provider identification number (NPI).
A doula cannot use experience gained from their own childbirth
experience, to include the labor and any associated classes, to qualify
as an authorized provider under TRICARE.
The requirements for doulas selected under the demonstration were
based on an analysis of over 150 doula training and certification
bodies. The certification bodies selected for inclusion had a time-
limited certification and were well-established with a wide-ranging
footprint (i.e., national or international); included classroom
training and workshops in labor physiology and other childbirth topics;
required doulas to have completed at least two deliveries prior to
certification; required evaluations from health care professionals for
services provided during labor support or a comprehensive examination;
and had an established scope of practice, code of ethics, code of
conduct, or similar by which the doula is required to agree to abide.
Some of our requirements for CLDs may duplicate those under the
required certification; this is due to differences in certification
requirements for the five selected certification bodies and to ensure a
minimum level of education and experience for all CLDs under this
demonstration. DoD recognizes that there may be some doulas and doula
certification bodies concerned they do not meet inclusion criteria. If
DoD determines it is appropriate to move forward with permanent
coverage of CLDs under the TRICARE Program at the conclusion of this
demonstration, interested individuals and organizations will be invited
to provide feedback during notice and comment rulemaking.
TRICARE will cover up to six total antepartum and postpartum CLD
visits. One continuous labor support encounter per birth event will be
authorized regardless of the location of the childbirth (hospital,
birthing center, home delivery, etc.). The birthing parent must be at
least 20 weeks pregnant to be eligible for services, and the maternity
episode-of-care must be overseen by a TRICARE-authorized provider (that
is, childbirth support services are ineligible for reimbursement if the
delivery is performed or planned to be performed by other than a
TRICARE-authorized provider; e.g., a lay midwife, except in emergency
circumstances). No additional reimbursement will be provided for travel
to the delivery location or if the doula moves with the patient from an
initial location (the home or birthing center) to another location (a
hospital), for long or difficult deliveries, or for false labor. Doula
services will be eligible whether the labor is completed via vaginal
birth or C-section, and whether or not the labor results in a live
birth (doula services are excluded for elective abortions not otherwise
covered by TRICARE).
Childbirth support reimbursement under the demonstration is as
follows:
Antepartum/Postpartum visits (up to six total): The six
authorized antepartum or postpartum visits will be reimbursed at a rate
of $46.00 per visit (for Calendar Year (CY) 2021), wage adjusted and
updated annually. These visits will be untimed and no more than one
visit will be eligible for reimbursement per day.
Continuous Labor Support: Continuous labor support will be
reimbursed at a national rate of 15 times the rate of the antepartum/
postpartum visit rate, or $690.00 for CY 2021, wage adjusted and
updated annually.
CLDs will be reimbursed the lower of the billed charge or the rates
listed above. A CLD who advertises their rate at a rate lower than the
TRICARE reimbursement amount but bills TRICARE for the reimbursement
rate listed above (i.e., charges TRICARE beneficiaries more than they
charge other clients) may be subject to the administrative remedies for
fraud, waste, and abuse, pursuant to 32 CFR 199.9 and referral to the
appropriate program integrity authority. Additional coding and
reimbursement information will be published in the TRICARE manuals
prior to the start of the demonstration, and may be updated
periodically upon approval of the Director, DHA.
3. Breastfeeding Support, Lactation Consultants, and Lactation
Counselors
The breastfeeding support portion of the demonstration creates two
new classes of extra-medical providers: Certified lactation consultants
and certified lactation counselors. Certified lactation consultants
under the demonstration will have a current International Board of
Lactation Consultant Examiners (IBLCE) certification as an
International Board Certified Lactation Consultant or a current Academy
of Lactation Policy and Practice (ALPP) certification as an Advanced
Nurse Lactation Consultant or an Advanced Lactation Consultant.
Certified lactation counselors must hold a current certification from
ALPP as a Certified Lactation Counselor. Both classes of provider will
be required to be at least 18-years-old; to maintain a current adult,
child, and infant CPR certification; to be licensed or certified in the
state in which they practice even if such a licensure or certification
is optional; and to bill under an NPI. If DoD determines it is
appropriate to move forward with permanent coverage of lactation
consultants and/or lactation counselors under the TRICARE Program,
interested individuals and organizations will be able to provide
feedback on qualification and other requirements during notice and
comment rulemaking.
The breastfeeding support benefit under this demonstration conforms
with the requirements of the existing breastfeeding counseling benefit
as found in the TRICARE Policy Manual, Chapter 8, Section 2.6,
paragraph 4.3, which authorizes coverage of up to six outpatient
breastfeeding/lactation counseling sessions per birth event using
current procedural terminology (CPT) codes 99401 to 99404. Cost-
[[Page 60010]]
shares, copays, and deductibles do not apply to covered breastfeeding/
lactation counseling services rendered on or after December 19, 2014.
This demonstration adds coverage of group breastfeeding counseling,
which may include prenatal breastfeeding education. Such services shall
be included in the six total breastfeeding counseling visits currently
authorized under the benefit.
Group lactation counseling/classes will be billed under CPT code
99411 Preventive Counseling, Group, 30 min, and 99412 Preventive
Counseling, Group, 60 min. These codes will be paid at the TRICARE non-
physician, non-facility CHAMPUS Maximum Allowable Charge (CMAC) rate
($17.80 and $22.24, respectively, for FY21). Individual lactation
counseling sessions will be reimbursed at the non-physician, non-
facility CMAC under the existing CPT codes 99401 through 99404.
C. Implementation Details
The DHA will publish additional details on implementation of the
demonstration in the TRICARE manuals prior to start of the
demonstration. Providers interested in participating in the
demonstration should contact the appropriate TRICARE contractor for
their area during this period. While interested providers are not
required to be network providers to participate in the demonstration,
all providers must meet the eligibility requirements under the
demonstration to have their services cost-shared. Provider networks
overseas will begin development prior to the start of the demonstration
expansion. Beneficiaries do not need to enroll or otherwise sign up to
participate in the demonstration, but must meet eligibility criteria
for the demonstration (e.g., must be at least 20 weeks pregnant for
childbirth support services).
D. Beneficiary Survey
The NDAA-2021 mandated the Secretary administer a survey by January
1, 2022, and annually thereafter for the duration of the demonstration.
The survey is required to gather information on:
(1) How many members of the Armed Forces or spouses of such members
give birth while their spouse or birthing partner is unable to be
present due to deployment, training, or other mission requirements; how
many single members of the armed forces give birth alone; and how many
members of the Armed Forces or spouses of such members use doula,
lactation consultant, or lactation counselor support.
(2) The race, ethnicity, age, sex, relationship status, Armed
Force, military occupation, and rank, as applicable, of each member
surveyed.
(3) If individuals surveyed were members of the Armed Forces or the
spouses of such members, or both.
(4) The length of advanced notice received by individuals surveyed
that the member of the Armed Forces would be unable to be present
during the birth; if applicable.
(5) Any resources or support that individuals surveyed found useful
during the pregnancy and birth process, including doula, lactation
consultant, and lactation counselor support.
The DoD intends to ask additional questions in the survey to aid in
evaluation of the demonstration. Results of the survey will be reported
to Congress.
E. Cost Assessment
The demonstration is anticipated to cost $51.16M in health care and
administrative costs, with an additional $4.3M estimated for evaluation
of the demonstration over the five-year period. Increased costs to the
TRICARE Program for breastfeeding counseling are estimated at $7.05M,
while $40.18M are estimated for the childbirth support benefit. The
childbirth support benefit estimate includes a calculation for offsets
from C-section reductions. There is substantial uncertainty surrounding
the estimate, given that no commercial insurers and only a few Medicaid
programs reimburse for childbirth support services. The estimate
includes approximately $3.93M for administrative costs related to
credentialing, billing, and contractor reporting requirements.
F. Demonstration Analysis
The DoD will evaluate the success of the demonstration project and
report to Congress on the results annually. DoD intends to use an
outside firm to assist in its analysis. In order to measure maternal
and fetal outcomes, DoD will compare outcomes and use of services: (1)
With historical data; (2) between those who choose not to use a service
and those who do; and, (3) with nationwide statistics. The analysis
will evaluate the childbirth support benefit by reviewing information
obtained from claims data, such as C-section rates and use Pitocin, and
comparing it to the same outcomes from before the demonstration started
(pre/post-test), with beneficiaries who do not use the childbirth
support benefit, and with national statistics. To evaluate the
breastfeeding support benefit, the analysis will evaluate outcome
measures (such as ear infections for infants) for beneficiaries
receiving services provided from a lactation consultant/counselor
compared to the same outcome for services from an otherwise-authorized
TRICARE provider, and when compared to beneficiaries who choose not to
use the breastfeeding counseling benefit. The analysis will also
compare outcomes to historical data and nationwide statistics.
Additionally, we will ask questions on the beneficiary survey to assist
in evaluating the quality of care received. The effectiveness of the
demonstration will be evaluated by the impact of the demonstration on
outcomes, the availability of providers under the demonstration, and
beneficiary satisfaction with the providers. Cost will be evaluated by
reviewing the overall cost of the demonstration, but also by capturing
cost-savings due to improvements in maternal and fetal outcomes (for
example, the cost savings associated with avoiding C-sections).
Throughout the demonstration, we will evaluate the effectiveness of
the qualification requirements for providers and the reimbursement
methodology. We will also evaluate the administrative feasibility of
continuing the demonstration and/or implementing permanent coverage
under the TRICARE Program. Such feasibility analysis will include: the
extent to which TRICARE's contractors are able to build networks, the
extent to which TRICARE beneficiaries access the benefit, whether
providers under the demonstration are able to file claims for services
and otherwise comply with program requirements, the presence of any
provider quality concerns, and the cost for TRICARE's contractors to
maintain the benefit. The DoD will add, remove, or revise outcome
measures under study as needed to ensure a robust evaluation of the
demonstration.
Because the providers under this demonstration are not medical
providers, but instead are support personnel who work outside the
medical field, no clinical care will be provided as part of this
demonstration. Neither doulas nor lactation consultants/counselors are
qualified to provide clinical care, and both will be required to refer
the beneficiary to a qualified medical professional if they identify a
medical issue requiring a change to the patient's clinical care. DoD's
evaluation will be limited to de-identified evaluation of claims
records and survey responses. The ASD(HA) has determined that the
demonstration is exempt from the requirements for human subjects
research, pursuant to the authority provided by 45 CFR 46.104(d)(5)
exempting demonstration
[[Page 60011]]
projects by Federal Departments that evaluate public benefit programs.
Dated: October 25, 2021.
Aaron T. Siegel,
Alternate OSD Federal Register Liaison Officer, Department of Defense.
[FR Doc. 2021-23583 Filed 10-28-21; 8:45 am]
BILLING CODE 5001-06-P
