Notice2021-23583
Establishing a TRICARE Childbirth and Breastfeeding Support Demonstration
Primary source
Metadata and text below are from the Federal Register, a public-domain U.S. government work. Always verify the official published version before relying on it for any legal matter.
Published
October 29, 2021
Issuing agencies
Defense Department
Abstract
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.
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<title>Federal Register, Volume 86 Issue 207 (Friday, October 29, 2021)</title>
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[Federal Register Volume 86, Number 207 (Friday, October 29, 2021)]
[Notices]
[Pages 60006-60011]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[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.
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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,
<a href="/cdn-cgi/l/email-protection#3f5a4d565c5e115c11595a4d4d5051115c56497f525e565311525653"><span class="__cf_email__" data-cfemail="fa9f8893999bd499d49c9f88889594d499938cba979b9396d4979396">[email protected]</span></a>.
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\
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\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 <a href="https://www.commonwealthfund.org/publications/issue-briefs/2020/nov/maternal-mortality-maternity-care-us-compared-10-countries">https://www.commonwealthfund.org/publications/issue-briefs/2020/nov/maternal-mortality-maternity-care-us-compared-10-countries</a>.
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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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\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 <a href="https://www.commonwealthfund.org/publications/issue-briefs/2020/nov/maternal-mortality-maternity-care-us-compared-10-countries">https://www.commonwealthfund.org/publications/issue-briefs/2020/nov/maternal-mortality-maternity-care-us-compared-10-countries</a>.
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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.
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\6\ <a href="http://DoulaTraining.net">DoulaTraining.net</a>. (2021). Types of Doulas. Retrieved March
19, 2021, from <a href="http://www.doulatraining.net/types-of-doulas">http://www.doulatraining.net/types-of-doulas</a>.
\7\ American Pregnancy Association. (2021, February 05). Labor
and birth. Retrieved March 19, 2021, from <a href="https://americanpregnancy.org/health-pregnancy/labor-and-birth/">https://americanpregnancy.org/health-pregnancy/labor-and-birth/</a>.
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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\
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\8\ Hayes, Inc. ``Impact of Doulas on Birth Related Outcomes.''
Long Hayes Technology Assessment, November 16, 2020.
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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\
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\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.
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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\
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\11\ Doulas of North America. (2021, March 04). Become a birth
doula--certification. Retrieved March 19, 2021, from <a href="https://www.dona.org/become-a-doula/birth-doula-certification/">https://www.dona.org/become-a-doula/birth-doula-certification/</a>.
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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\
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\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 <a href="https://www.cdc.gov/breastfeeding/about-breastfeeding/why-it-matters.html">https://www.cdc.gov/breastfeeding/about-breastfeeding/why-it-matters.html</a>.
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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.
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\14\ U.S. Breastfeeding Committee. ``Lactation Support Providers
Descriptors Table.'' Accessed online on 3/21/21 at <a href="http://www.usbreastfeeding.org/page/lsp-descriptor-table">http://www.usbreastfeeding.org/page/lsp-descriptor-table</a>.
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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:
<bullet> 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.
<bullet> 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
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