[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]


-----------------------------------------------------------------------

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.
---------------------------------------------------------------------------

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 http://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 http://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