SUPPLEMENTARY INFORMATION:

A. Background

Section 746 of the William M. (Mac) Thornberry National Defense Authorization Act for Fiscal Year 2021 directed the Secretary of Defense to establish a five-year demonstration project under TRICARE to evaluate the cost, quality of care, and impact on maternal and fetal outcomes of covering the services of doulas and lactation consultants or counselors not otherwise TRICARE-authorized, and to determine whether it would be appropriate to implement permanent coverage. On October 29, 2021, the ASD(HA) published a Federal Register Notice (FRN) announcing the CBSD (86 Federal Register (FR) 60006), which began nationwide in the United States (U.S.) on January 1, 2022, and will expand to include overseas beneficiaries and locations on January 1, 2025.

The FRN announced that the CBSD was 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.

The FRN specified that coverage would be provided under private sector care and excluded care provided in direct care within Military Medical Treatment Facilities (MTFs). To participate, beneficiaries were required to be enrolled in Prime or Select with one of the managed care support contractors (MCSCs). TRICARE for Life, the Uniformed Services Family Health Plan, the Continued Health Care Benefit Program beneficiaries were excluded from participation. Beginning January 1, 2025, beneficiaries in Prime (including Prime Remote) and Select enrolled to the TOP contractor will be eligible to participate. The demonstration created a new benefit category (childbirth support services) and added three new extra-medical maternity care provider classes (Certified Labor Doulas (CLDs), Certified Lactation Consultants, and Certified Lactation Counselors). It also created qualification criteria for the new provider classes, established benefit limitations, added group breastfeeding counseling sessions to the existing individual breastfeeding counseling benefit, and established reimbursement methodologies.

B. Maternity Care Under the TOP

Each year, approximately 60,000 beneficiaries give birth under the MCSCs in private sector care facilities in the United States. The number of beneficiaries who give birth overseas under the TOP program is comparatively very small. Based on claims data for calendar year (CY) 2022, TRICARE beneficiaries enrolled with the TOP contractor gave birth 1,093 times in private sector care facilities in 41 countries. Over half of those deliveries occurred in Germany, with the next most frequent locations for deliveries being Italy, South Korea, the U.S. (TOP beneficiaries electing to deliver in one of the 50 states or District of Columbia), Puerto Rico, and Japan. These six locations accounted for 87 percent of deliveries under TOP. Of the 34 remaining countries, 13 had only one delivery, and another nine only had two deliveries in 2022. In 2021, the top six locations were the same, but there were 14 countries that had a delivery in 2021 that did not have one in 2022 while there were births in 15 countries in 2022 for which a birth was not recorded in 2021. In other words, there is a small group of countries within which the DoD can reliably expect most TOP deliveries to occur and a larger number of countries in which a small number of deliveries may occur. Expansion of the demonstration overseas accounts for this variability as well as the overall smaller number of deliveries overseas.

C. CBSD Modifications for Implementation Overseas

This FRN notifies the public that the DoD intends to modify the CBSD for overseas implementation by way of guidance to be published to the TRICARE manuals (found at manuals.health.mil). These changes are expected to impact some or all of the requirements published in the initial CBSD FRN and are intended to facilitate the DoD's ability to measure the CBSD hypotheses. The DoD's focus for overseas implementation will be testing ( printed page 50851) the fourth hypothesis, that is, is it feasible to administer the new provider classes and the services they provide in overseas locations? The other three hypotheses will be measured primarily using the larger beneficiary population already receiving services under the CBSD in the U.S.

As a worldwide benefit, the TRICARE Basic ( i.e., medical) benefit recognizes that cultural differences unique to health care practices and services in overseas locations necessitate allowances for variations in care delivery from how the program is administered in the U.S. in order to ensure a robust benefit (see the TRICARE Policy Manual (TPM), Chapter 12, Section 1.1). Such uniquities and cultural differences are expected to impact care provided under the CBSD, such that deviating from the CBSD requirements will be required. The requirements for the three classes of providers under the CBSD are likely to need adjustment in some or all locations to ensure applicability in the many countries in which TRICARE beneficiaries may give birth each year. These modifications will be enacted prior to the start of the CBSD overseas, but additional modifications may occur during the two-year overseas period. While the DoD selected certification bodies that had an international component, these bodies may be less available outside of the U.S. and Western Europe, such that additional bodies are required. The overseas CBSD modifications will extend to the extra-medical maternity provider classes approved under the CBSD in the U.S., but will not include new classes of extra-medical maternity providers. Additionally, we anticipate modifying reimbursement rates for CBSD services overseas, commensurate with how reimbursement is typically modified for overseas delivery of the TRICARE Basic ( i.e., medical) benefit (see the TRICARE Reimbursement Manual, Chapter 1, Section 34 and 35 for examples of such variances).

Finally, the DoD also anticipates that it may be necessary to add an enrollment requirement. The lack of an enrollment process in the U.S. was facilitated by known, uniform provider requirements such that both beneficiaries and providers could be assured that requirements were met prior to the receipt of services. Given that the DoD may need to approve changes to provider requirements consistent with care delivery in other countries, beneficiaries may not have the same ability to independently verify the qualifications of a provider without interacting with the TOP contractor. As such, an enrollment requirement would ensure beneficiaries understand the requirements for the CBSD in their location.

These and other modifications necessary to ensure DoD's ability to evaluate the CBSD hypotheses overseas will be published to the TRICARE Operations Manual, which is publicly available at http://manuals.health.mil. Additionally, the DoD will continue to publish information about the CBSD on its website (see tricare.mil/cbsd) and social media accounts.

D. Modification to the Demonstration Evaluation

Separately, the ASD(HA) is notifying the public of a change to the evaluation of the CBSD. The DoD stated in the October 29, 2021, FRN that we intended to use an independent contractor to evaluate the CBSD, at an estimated cost of $4.3M. Due to a constrained financial environment, the DoD may use internal DoD staff and resources to perform some or all of this evaluation. More information on the evaluation will be reported in the annual reports to Congress.