Appendix C

Questions to the Defense Health Agency and Responses

April 22, 2024

Building network/enrolling providers

1. What factors does DHA ask contractors to use when making network design decisions?

   DHA Response: The Managed Care Support Contractors (MCSC) are required to establish and maintain networks of individual and institutional providers for TRICARE Prime and Select plans that produce the best quality clinical outcomes for TRICARE beneficiaries (TRICARE contract C.2.1.1.). Their network must be able to meet the TRICARE beneficiaries needs within the Access To Care (ATC) standards as required by federal regulation and as described in the attached.

2. If network design is determined by contractors, please provide additional information on which factors DHA uses to ensure network adequacy of ABA providers (e.g., size, location, needs assessments, network adequacy, etc.).

   DHA Response: The MCSCs use a proprietary formula that includes the size of the beneficiary population and staffing models plus historical utilization data to determine an adequate network. Once the Government accepts that model, the MCSCs develop

2. targets based on the formula and recruit providers to meet those targets, where providers are available in the community. This is done for all specialties and outlined in the MCSC Network Implementation Plan that DHA reviews and accepts. ABA is a subspecialty within the Behavioral Health network needs assessment. As of December 31, 2023, there are a total of 95,269 ABA providers nationwide (25,522 BCBAs, 1,497 assistant behavior analysts, 68,240 behavior technicians).
3. Beyond the educational criteria, licensure standards, NPI requirements, and background check outlined in the TRICARE Operations Manual (TOM), what criteria do the contractors use to assess providers when joining the network and on an ongoing basis? Are the contractors directed to assess any aspects of quality, cost, different ABA modalities provided, etc.?

   DHA Response: The TRICARE manuals set forth the DHA-approved provider eligibility requirements for the MCSCs to follow. Additionally, the MCSCs use their best business practices along with the elements required by the accrediting body, URAC (Utilization Review Accreditation Commission), to assess a provider before they are accepted. This includes a review of any action taken against their license. If there are any issues identified, the provider’s file is submitted to the Credentialing Committee who then evaluates the provider to assess the risk of bringing them in to the network. Once an ABA provider is certified, they must sign a participation agreement attesting to their compliance with the TOM and all applicable policies. Providers must be recertified every three years. The TOM provisions set forth the DHA-approved contractor responsibilities to develop a provider steerage model. These require that access to care be two of the three metrics for steering patients to authorized care. The third element is defined by the contractor’s best business practices.

4. What is the process for recruiting and enrolling providers?

   DHA Response: We understand this question to refer to recruiting and enrolling providers to the TRICARE network. Recruiting and enrolling providers is a function of the MCSCs. DHA cannot direct, influence, or interfere with the MCSCs’ provider network and processes. The MCSC contacts the providers and offers them an agreement to become a network provider as well as marketing on their website if any providers would like to join the network.

5. How often are ABA providers re-credentialed in TRICARE networks?

   DHA Response: Only authorized ABA supervisors are “credentialed.” They are “re-credentialed” every three years.

6. What processes, supports, and infrastructure are in place to ensure provider network information is up to date and accurate?

   DHA Response: Per the TRICARE Contract, paragraph C.2.1.3., the Contractor shall maintain an on-line directory of network providers with a minimum of 95% accuracy. “Accuracy” is defined as a directory entry that contains correct information for all of the following data elements: provider name, provider specialty, sub-specialty (if applicable), gender, work address, work fax number, and work telephone number for each service area. Although the directory shall indicate whether network providers are accepting new TRICARE patients, this data field is not included for purposes of accuracy calculations. The information in the on-line network provider directory shall be current and refreshed no less frequently than once every 24 hours when information has been submitted to the MCSC. DHA receives and tracks monthly audits reports from each MCSC that audits a random sample from each region and feedback of these findings is discussed with each MCSC monthly.

Access and adherence to services

7. What are the average wait times for connecting families with ABA services after enrollment in ACD?

   DHA Response: For calendar year 2023, the average number of days between a verified referral and the first date of services for an assessment is in the below table.

8. What percentage of families receive services within the 28-day requirement?

   DHA Response: In calendar year 2023, 68 percent of beneficiaries with authorized care accessed ABA services within the 28-day access to care requirement regardless of waiver status. Of note, 47 percent of the new referrals declined an available provider (waived access to care) in favor of waiting for a preference (location, provider, time of day).

9. What percentage of families who start do not complete the ACD enrollment process?

   DHA Response: In calendar year 2023, 8.66 percent of families who were referred to the ACD did not complete enrollment. Reasons for lack of completion include, but are not limited to, beneficiary did not meet ACD eligibility requirements (i.e., no diagnosis of ASD), beneficiary ineligible for TRICARE, or parents declined ABA services.

10. What steps are taken to ensure equitable service delivery across TRICARE regions?

    DHA Response: The TRICARE benefit is a uniform benefit for worldwide application. The contractors follow the TOM requirements set forth by DHA that specify the administration of the ACD. Any differences between the regions are likely related to provider practices (e.g., available staff, scope of competency, other business choices). Ultimately, services delivery is the responsibility of the authorized provider.

11. Are there hour limits on ABA services? Any variations on limits between regions and overseas? If so, please explain why.

    DHA Response: There are no benefit limits with regards to age, duration, or intensity. However, all ABA services must be clinically necessary and appropriate. Medically unlikely edits, the highest anticipated quantity of a procedure in one day that offers quality control edits to prevent accidental over reporting of a procedure for all CPT codes, are implemented to assist with daily or monthly utilization; however, there are no differences between regions including overseas.

12. What supports and resources are available to parents to support a higher level of engagement in services and treatment adherence?

    DHA Response: Neither the DHA nor the MCSCs are required to ensure treatment adherence. This is consistent with all other benefits under TRICARE. The authorized BCBAs are ethically responsible for providing the scope of services for which they are authorized. Executing authorized hours is the ethical responsibility of the ABA provider who recommended treatment and was subsequently authorized to render that care. It is the BCBA’s responsibility to ensure sufficient staff is hired to ensure compliance. Providers should not accept new patients for whom they cannot render all authorized hours for all patients. Regarding parent engagement specifically, DHA implemented a minimum parent engagement requirement due to the overall lack of parent participation as evidenced by claims data.

13. Are there additional or variations in supports for families who have multiple children with autism? Who have a parent that is deployed? Who are engaged in PCS moves?

    DHA Response: We understand the question to be asking if there are any variations in support to families participating in the ACD. As of January 1, 2025, all beneficiaries participating in the ACD will be assigned an Autism Services Navigator (ASN). The ASN provides beneficiary- and family-specific guidance for those beneficiaries assigned to ASNs in obtaining the care and services they uniquely need. For beneficiaries not enrolled in the ACD, they have access to case management services through the regular benefit.

14. Are results of the PSI/SIPA used to provide supports and resources to parents?

    DHA Response: At the MCSC level, no. Providing supports and resources to the parents as a result of findings on the PSI or SIPA at the MCSC level are not a contract requirement. However, at the individual level, it is the administering provider’s responsibility to make any appropriate referrals based on all assessments. Providers and families may also request that the ASN assist with locating identified or recommended resources.

15. Please comment on differences between Health Net Federal Services and Humana coverage for parent mediated programs

15. related to autism and the ACD position on parent mediated programs.

    DHA Response: Although the ACD references parent-mediated programs, the ACD does not oversee the execution of parent-mediated programs as those services are rendered by other TRICARE authorized providers (non-ABA providers). As a reminder, the ACD provides the authority for ABA providers to render only ABA services. Any other services fall under other authorities. It is unclear what is intended by the assumption that there are differences between the MCSCs. The TRICARE benefit is a uniform benefit worldwide. Any “differences” may be related to availability of services rather than benefit coverage. If eligible providers request to join the network, they may submit applications to their respective MCSC. DHA is concerned about parent engagement and included several provisions in the ACD to address knowledge, awareness, and engagement in the comprehensive treatment of their family member with autism. Parent-mediated programs offer options to families who may need or want other or adjunctive services.

Data collection practices/Engagement with beneficiaries

16. What information is provided to parents and/or individual patients on the purpose and use of inventories and indexes required by the ACD?

    DHA Response: Upon entry into the ACD, all parents are given, and continue to have access to, the “Parent Toolkit,” which provides not only information about the ACD but also specific information about the measures administered including their frequency and purpose. In addition to the Parent Toolkit, the DHA and the MCSCs address questions through various means such as posting FAQs or information flyers on relevant websites. Also, the ASNs speak directly with families and have the opportunity to address any questions about all of the measures. Finally, all providers should also obtain informed consent when administering any procedure to include describing a measure and its purpose to the parent and patient, where appropriate. Therefore, families receive multiple opportunities to obtain information about the ACD and the outcome measures.

17. Prior reports and testimony have referenced parent surveys in 2016 and 2018. Were these surveys administered? Are summaries of

17. results available? If so, please also include information about how the survey was administered, including when it was fielded and to whom, aggregate results data, response rate, etc.

    DHA Response: Yes, the surveys of 2016 and 2018 were administered. No formal reports were published; however, the following is a summary of findings from the 2016 analysis (the 2018 analysis summary was not archived). Survey recipients were identified by billing for ABA services or an ASD diagnosis code on two or more encounters. Caregivers of children in those households (approximately 15,000), including those with children participating in the Comprehensive Autism Care Demonstration and those with children with a diagnosis of ASD but not participating in the demonstration, received the survey. Overall, 22 percent of caregivers responded, including 24 percent among demonstration participants and 19 percent among non-participants. We determined participation status in the demonstration through administrative data at the time of sampling. The survey was designed to address the following topics:

    1. Caregivers’ perceptions of impairments and deficits in their children with a diagnosis of ASD;
    2. Choices made by caregivers regarding ABA services and other ASD-related services for their children;
    3. The degree of difficulty encountered by respondent caregivers in accessing ABA and other clinical services needed by their children; and
    4. Caregivers’ perceptions of and satisfaction with ABA services received

    Summary A) Caregivers’ perceptions of the severity of their children’s impairment or condition differed substantially between participants and non-participants. Almost 60 percent of caregivers of children participating in the demonstration rated their children’s condition as moderate or severe, whereas more than half of nonparticipants rated their children’s condition as mild. Most respondents in both groups stated that their children had at least one comorbid condition. Demonstration participants were more likely to report challenges with speaking and communication; otherwise, there were no significant differences in the symptom burden between the subgroups. Children not participating in the demonstration were more likely to be prescribed medications to manage ASD-related behaviors and challenges than were participants.

17. Summary B) Caregivers for more than 90 percent of demonstration participants reported that they have had ABA recommended by a physician for their children’s condition, compared with 60 percent among caregivers of children with an ASD diagnosis not participating in the demonstration. Health care use and perceptions varied somewhat by beneficiary group, with families from retiree or reservist personnel more likely to use civilian-run facilities than families of active duty personnel, while maintaining similar satisfaction levels with health plans and providers as civilian health care consumers.

    Summary C) All caregivers reported high family impact from their children’s diagnoses. Caregivers across demonstration participant and non-participant subgroups reported feeling physically or mentally unwell and having their normal activities limited by poor health at rates well above levels reported in both national data and data for the Military Health System. More than half of caregivers reported stopping work or reducing work hours to care for their children diagnosed with ASD, and about one-third reported financial hardship related to costs related to their children’s care. They also reported significant unmet needs for ASD-related services and supports, such as respite care, care management, and family supports; about half of respondents indicated five or more gaps in their current support system.

    Summary D) Caregivers of demonstration participants and nonparticipants had limited knowledge about the demonstration, their children’s eligibility for the demonstration, and their children’s participation status. The complex nature of the ASD diagnosis and the lack of information on causal relationships between ABA services and collected data limit the survey findings.

    2016 Survey Summary: Although the Comprehensive Autism Care Demonstration might have increased access to ABA services, there was no observed difference in respondents’ perceptions of health plans or providers.

18. Exit interviews with EFMP families were mentioned at the committee’s first meeting. Are summaries/analyses of these interviews available? If so, please also include information about how the survey was administered, including when it was fielded and to whom, aggregate results data, response rate, etc.

18. DHA Response: To clarify DHA’s statement at the first committee meeting, DHA contacted the Services’ Exceptional Family Member Program (EFMP) headquarters to inquire about whether or not they have any information on parents stating that they have left the military because of the ACD. DHA does not possess Service departure information. Any details about “exit interviews” should be directed to EFMP. This outreach was an informal ask to the Services’ EFMP offices. At the time, the Services stated they had no such feedback. To date, DHA has no other evidence to confirm this assertion.
19. What happens with data collected by the contractors regarding Autism Services when the new TRICARE contract changes over to another contractor?

    DHA Response: All TRICARE contract transition activities follow TOM, chapter 2, “Transitions” requirements.

Care management practices

20. What is the process to ensure coordination among case management services offered to military families through TRICARE contractors? Which entity is ultimately responsible for coordinating care navigation services?

    DHA Response: Case management (CM) services under the TRICARE program are provided on a voluntary basis. The ACD does not have jurisdiction over CM processes under the TRICARE Basic (i.e., medical) benefit. Under the ACD, the ASN is the primary point of contact. According to the ACD, both MCSCs have a responsibility in the transition of care; the losing MCSC collates and transfers, and the gaining MCSC receives and assists.

21. How does the role of Autism Services Navigator differ from prior supports to families?

    DHA Response: Clinical case management services have always been available on a voluntary basis under the TRICARE Basic (i.e., medical) benefit. Following the 2021 ACD policy update, beneficiaries entering the ACD were automatically assigned an ASN. As of January 1, 2025, all beneficiaries participating in the ACD will have an ASN. The ASN offers the family a dedicated point of contact

21. that helps facilitate referrals, transitions of care, and education to support the family. The ASN also develops a comprehensive care plan that consolidates the care and relevant information about the beneficiary and their family. Additionally, the ASN services are provided for the duration of the enrollment in the ACD.
22. What is the average case load for the Autism Services Navigators? Does this vary between East region and West region contractors?

    DHA Response: This information is proprietary to the MCSCs and therefore, DHA cannot answer this question.

23. What are the processes in place to ensure training requirements for the ASNs are being met? Is ABA training part of the training process? Are there any continuing education requirements in ABA or ASD?

    DHA Response: The MCSCs are required to employ ASNs in accordance with the requirements defined in TOM Chapter 18, Section 3, Paragraph 11.11 Autism Services Navigator (ASN):

    “An ASN must hold a current, valid, unrestricted license which include: a Registered Nurse (RN) with CM experience, clinical psychologist, LCSW, or other licensed mental health professionals who possess a certification in CM. The ASN must have clinical experience in: pediatrics, behavioral health, and/or ASD; a healthcare environment; and proven care management experience.”

    The ASN’s primary responsibilities focus on comprehensive case management/care coordination services that include supporting the families, developing a comprehensive care plan, facilitating transitions of care, and coordinating services beyond ABA for the identified patient. Additionally, as the beneficiary may often times have other healthcare needs to include comorbid conditions, the ASN facilitates other referrals or resources identified by treating providers to support the beneficiary. Training in ABA is not required as this role far exceeds the narrow scope of ABA. The ASN responsibilities are defined in TOM, Chapter 18, Section 4, Paragraph 6.0. Obtaining continuing education credits are the responsibility for licensed individual per their licensure requirements. Separate from the ASN, the MCSCs employ Board Certified Behavior Analysts (BCBAs) who are utilized in the clinical

23. necessity review process. In this requirement, the BCBAs review the submitted treatment plan and with use of a utilization management tool, address clinical recommendations including recommended hours and treatment progress.
24. How is DHA planning to assess the effectiveness of the Autism Services Navigators?

    DHA Response: As the ASN role is fairly new to the ACD, DHA is monitoring compliance measures according to the TOM. For example, DHA is collecting data on the number of days between a verified referral to the ACD and the first contact by the ASN to the family. Clinical outcome measures are not analyzed in relation to the ASN as the activities of the ASN are individualized to the patient’s needs. Additionally, assessing clinical outcomes is outside the role of the ASN responsibilities. The MCSCs may also implement best business practices to monitor ASN activities in accordance with the TOM requirements. These are not reported to DHA as they are not contract requirements. DHA could consider using a survey tool once approved.

Clinical effectiveness

25. What performance and process metrics is DHA collecting from the contractors? (e.g., denial rates, reasons for denial, treatment plan denials, plan reassessment, etc.) Please describe the methodologies used to collect these metrics, including frequency of collection. Please also describe how the metrics are used to assess contractor performance in administering the ACD.

    DHA Response: MCSC performance evaluation is defined per contract requirements. The DHA uses Contract Data Requirements Lists (CDRLs) to evaluate MCSC performance. For the ACD, there are two CDRLs, submitted quarterly and annually. This summary information is reported in the ACD annual reports to congress.

26. Do providers who issue referrals for ABA get information back about their referrals?

    DHA Response: Information regarding referrals from the military medical treatment providers is available in MHS GENESIS, the Military’s electronic health record, and via the MCSC provider portals.

26. Per TOM Chapter 8 Section 5, P 1.2.1: “The contractor shall provide a response to the referring provider and beneficiary.”
27. What is the rationale behind the two-year renewal process requiring an updated diagnostic checklist from the referring provider?

    DHA Response: The purpose of the DSM-5 Checklist at each referral interval is for documenting symptom presentation at periodic intervals. This requirement was included in the ACD as a recommendation from a group of military medical treatment facility developmental behavioral pediatricians. DHA agreed with the use of standardized documentation across all providers.

28. What does ACD consider the “baseline” for their data? The date of enrollment, the date of first service, or something else?

    DHA Response: The term “baseline” under the ACD is specific to the context of outcome measures. Therefore, “baseline” data is in reference to “before TRICARE ABA services begin.”

29. Does DHA or its contractors collect information on how ABA providers are using outcome measures to develop treatment plans and evaluate patient improvement?

    DHA Response: Per the TOM, ABA providers are required to document the findings of outcome measures in the treatment plans and incorporate these findings into the developed goals (see paragraphs 8.7.1.6 and 8.7.1.7). Following documentation, the MCSCs are required to complete clinical necessity reviews that incorporate findings from the outcome measures (see paragraphs 8.6.2.2.1, 8.6.3.1.3, 8.6.3.1.4 for references of MCSC responsibilities with regards to the review and inclusion of outcome measures). Clinical necessity reviews are completed by a BCBA or a master’s/doctoral level professional in a like-specialty (see paragraph 9.1.6) to ensure compliance and appropriateness of care.

30. Has the DHA conducted comparisons of ABA services to other treatment options available under the TRICARE basic benefit? If so, are summaries of comparisons available?

    DHA Response: No.

ACD administration

31. Please describe the staffing structure within the DHA that oversees the ACD. Please describe roles and responsibilities for staff involved.

    DHA Response: There is no unique staffing structure with regards to the ACD. Rather, as with all TRICARE program manuals, there is an established process. An Action Officer (AO) is assigned to lead the development or revision, followed by a review by multiple stakeholders of the proposed changes. As in the case of the March 2021 policy update, the Director, DHA signed a decision paper endorsing conceptual changes to the ACD. The AO then developed the revisions and through the coordination process, DHA stakeholders reviewed the proposed revisions. Those stakeholders included, but were not limited to, experts in: network development, case management, strategic communications, budgeting, law, healthcare operations, contracts, the military Services, and the TRICARE Health Plan.

32. Please describe the processes that DHA staff managing the ACD use to oversee contractor performance with respect to the ACD. (e.g., any processes for regular communication, process for communicating updates/changes to program, processes for providing feedback on contractor performance, etc.)

    DHA Response: The TRICARE contracts have established processes for contract oversight for all contract areas including network development, credentialing, strategic communication, claims payment, etc. These requirements are defined in the contract and are contract sensitive. Communication regarding any changes or updates to the TRICARE manuals are directed through the Contracting Office. The DHA uses CDRLs to evaluate MCSC performance.

33. Please describe the decision-making process when determining changes to the ACD. In particular, please comment on the process used to develop the ACD policy changes in 2021. Please also describe any scientific literature, best practices, or evidence basis used in determining these policy updates.

    DHA Response: DHA published comprehensive policy revisions to the ACD on March 23, 2021. These revisions were the result

33. of three years of work and feedback from various stakeholders and included lessons learned over the duration of this demonstration. Summaries of lessons learned can be found in the annual reports.

    The three years of work included:

    • An Industry Day in 2017 where DHA solicited feedback from provider groups, advocate organizations, and funding sources on best practices and program recommendations.
    • Incorporating years of feedback received via the DHA ACD email box from providers, families, and advocates.
    • Incorporating findings from literature reviews, reviews of commercial and Medicaid Plan benefit coverage, available advocacy publications, the Department of Defense Office of Inspector General Reports, and program audits including compliance reviews and medical records documentation.

    Each update was carefully evaluated to ensure the revisions aligned with the authority and goals of the demonstration. This update focused on improving the ACD overall by ensuring a comprehensive approach to care as well as providing enhanced beneficiary and family support, improving outcomes, enhancing parental involvement, providing more support to families, and improving utilization management controls. These revisions also improved management and accountability of both the MCSCs and the ABA providers. The DHA worked extensively with the DHA contracting office and the MCSCs prior to the publication to develop and execute a phased implementation timeline.

34. What is the approval chain for inventories and indexes used in the ACD? What documentation is available on how they were approved and will be used?

    DHA Response: Following publication of Senate Report 114–255, Page 205, to Accompany S. 2943, the National Defense Authorization Act for Fiscal Year 2017, which requested, among other things, that the Department report on health-related outcomes for beneficiaries participating in the ACD, the Department sought to identify appropriate outcome measures that would be responsive to this ask from Congress. The decision of which outcome measures to use had to balance large scale applicability, standardization, ability for aggregate analysis, repeatability, contractor

34. feasibility, and qualified provider types. DHA reviewed the literature, received feedback from various stakeholders, and evaluated the feasibility of application over time. While a robust list of measures across domains was identified, the aforementioned criteria for balance resulted in the decision of three clinical outcome measures. The selected measures are standardized, norm-referenced, valid, and reliable tools commonly referenced in ABA research. In the absence of any industry guidance, agreement was reached on three measures. The Vineland and the SRS were measures that were recommended by developmental behavioral pediatricians, and the Pervasive Developmental Disorder Behavior Inventory was recommended by the President of the Association of Professional Behavior Analysts. After review of the relevant materials, DHA concurred that these measures were standardized, valid, and reliable; replicable; and could be administered by a wide range of provider types. Other measures considered limited the range of eligible providers who would be able to administer the measures, and some were not for the purpose of repeat administrations. Ultimately, the collection of these outcome measures allows DHA to make observations about population level data. No determinations regarding effectiveness of ABA services have been made as DHA is not conducting research and this question is outside the scope of the ACD.

FOLLOW-UP QUESTIONS FOR DHA

September 26, 2024

Program Evaluation and Access to Services

35. It has been documented in several records that “the purpose of the Demonstration is to analyze and evaluate the appropriateness of the ABA services tiered delivery model under TRICARE (the medical benefit) in light of current and anticipated practice guidelines.” Is this still considered the purpose of the Comprehensive Autism Care Demonstration (ACD)? Have the demonstration objectives changed since the ACD introduction in 2014?

    DHA Response: Yes. The referenced language establishing the purpose of the ACD first appeared in the initial Federal Register Notice (FRN) creating the ACD in 2014, 79 Federal Register (FR) 37291, and most recently appeared in the latest extension of the ACD at 87 FR 47731. No changes to the purpose of the demonstration have been made.

36. Does DHA have a written evaluation plan for evaluating the appropriateness of the ABA services tiered delivery model under TRICARE? Or evaluating progress toward its objectives? If so, can the evaluation plan be shared with the committee?

    DHA Response: Yes, the FRNs include the goals of the demonstration (e.g., evaluating an appropriate reimbursement methodology and rate for ABA services) and are DHA’s written evaluation plan for the ACD. They are available on the federal register website for review. To clarify, DHA is not evaluating ABA services or the tiered model’s safety and effectiveness for treatment of ASD through the demonstration. Rather, DHA separately conducts such assessments through medical benefit determinations based on the hierarchy of reliable evidence. While DHA continues to monitor the literature, there have been no significant advances in ABA research with regards to defining dose-response (including intensity, frequency, or duration), and determining for whom ABA is most effective and what clinical outcomes could be expected as a result of ABA interventions. As of now, ABA services do not meet the TRICARE hierarchy of reliable evidence standard for proven medical care.

37. Please share any documentation regarding the determination that ACD activities, including those related to its analysis and evaluation, do not meet the federal definition of research. (For example, did DHA receive an IRB exemption for the ACD under 32 CFR Section 219.104(d)(5) or a determination by an agency head under 32 CFR 219.101(c) that the policy did not apply to ACD activities.)

    DHA Response: The ACD is not research, thus DHA does not have any documentation of an IRB exemption or other research-related inquiries. The ACD as it exists today, evolved out of prior authorities, all aimed at determining how the Department might cover ABA services for persons diagnosed with ASD. Documentation related to the intent behind the ACD authority may be found at 79 FR 37291, 80 FR 30664, 82 FR 58186, and 87 FR 47731. DHA separately continues to survey industry research to assess the safety and effectiveness of ABA as a treatment modality for ASD.

38. In making the determination that DHA is not conducting research, what steps were taken to ensure such judgment was exercised consistent with the ethical principles of the Belmont Report?

    DHA Response: Although the ACD is not research and not subject to the Belmont Report, DHA is committed to the ethical delivery of

38. benefits to its patient population. Regarding “Respect for Persons”, DHA has instituted protections for beneficiaries receiving ABA services under the ACD. For example, TRICARE excludes coverage of restraints in the practice of ABA. With respect to “Beneficence”, DHA, in contrast to most other payers, imposes no time, dollar amount, or frequency limitations to the provisions of ABA such that patients may receive however much care is clinically appropriate pursuant to their treatment plan. With regards to “Justice”, all TRICARE beneficiaries with ASD have access to the ACD.
39. How is the clinical information gathered from patients, families and providers and/or the observations about population level data used to make decisions for the ACD? How have they been used for the determination of appropriateness of ABA services tiered delivery model under TRICARE?

    DHA Response: Clinical information and observations of population level data are not used to make decisions about the ACD. Rather, DHA is currently reporting such observations following the collection of outcome measures as Congress requested. Decisions about clinical effectiveness are outside the scope of the ACD.

Access to Care

40. Regarding receiving an autism diagnosis, what is the purpose or rationale for requiring that the DSM criteria be documented in a DHA-approved checklist in the referral?

    DHA Response: The purpose of the DSM-5 checklist is to ensure standardized documentation across all beneficiaries who receive a diagnosis of autism. This checklist, consistent with any other conditions, provides a uniform document to capture each criterion, including symptom presentation, at any given time. The DSM-5 checklist was added based on a recommendation from the Developmental Behavioral Pediatricians within the military medical treatment facilities.

41. Please clarify why the TRICARE Overseas Program is excluded from some of the ACD requirements (for example, paragraphs 6.0 through 6.9 of operations manual) and not authorized for the tiered model.

    DHA Response: The TRICARE Overseas Program excludes some ACD requirements and does not include a tiered model of delivery

41. because oversight functions overseas do not resemble those available stateside. By regulation, the TRICARE program is not automatically implemented in all respects outside the United States.
42. In response to prior questions, DHA noted that all beneficiaries will be assigned an Autism Services Navigator (ASN) starting in 2025. How did the agency make the determination that it should expand the ASN assignment from new enrollees to all beneficiaries? What information was considered to determine the value of expanding such services?

    DHA Response: DHA expanded the assignment of ASNs to all beneficiaries enrolled in the ACD based on the literature on case management services. The purpose of ASN services is multi-fold: provide a dedicated resource, increase support to participating beneficiaries, improve patience experience, facilitate access to additional services, ensure the dedicated person is knowledgeable about the entire system (e.g., TRICARE, complex health care needs, navigating comorbid conditions), and facilitating transitions of care needs. The ASN ensures a “whole person” response to the beneficiary and their family. The addition of the comprehensive care plan allows for the consolidation of all related information.

43. We have heard that families would need to be reassigned a new ASN when they move. Is this true if they move within the same region? Or just if they move between TRICARE regions? What is the purpose of this reassignment? Has DHA considered mechanisms to support a single navigator or care coordinator for families throughout their participation in the ACD to ensure continuity of care?

    DHA Response: Not all moves will require reassignment of an ASN. ASNs are required to have specific knowledge of local resources available to assist a beneficiary and their family. If an ASN has expertise in both the location the family is moving from and moving to, the family may not need to be reassigned to a different ASN. The MCSCs make ASN reassignment determinations based on what is best for the beneficiary and based on their best business practices. In addition, a nationwide ASN is not possible. ASNs are employed by one of either of the two TRICARE MCSCs administering the benefit in the East and West regions. As a family moves across regions and their MCSC changes, they will need to be assigned an ASN employed by their receiving MCSC.

44. During the course of information gathering for this study, we have heard concerns in public sessions on the process of enrollment and required outcome measures from military families, ABA providers, researchers, and groups monitoring changes with the ACD. Does DHA still hold roundtables and provider information sessions to gather feedback from stakeholders?

    DHA Response: DHA paused the hosting of roundtables and provider information meetings while the National Academies analysis was underway as there was no intent of making any programmatic changes until after the National Academies’ analysis was complete. DHA has heard the feedback provided in the public forums hosted by the National Academies and are awaiting any recommendations made by the National Academies in their final report before making any changes.

45. The 2021 ACD changes were aimed at “providing enhanced beneficiary and family support, improving outcomes, encouraging parental involvement, improving utilization management controls. . . .” Have you seen progress toward these aims? If so, what information has DHA drawn on to determine progress?

    DHA Response: Yes, DHA has seen improvements in many areas as a result of the updates it made to the ACD in 2021. For example, access to care is a constant concern in light of the interest in early intervention. In the 2021 ACD policy update, the MCSC requirement of “Active Provider Placement” (APP) increased contractor oversight and provider accountability for ensuring beneficiaries have timely access to ABA services. APP requires the MCSC to identify an ABA provider that confirms they can provide ABA services within the specialty care ATC standard of 28 days. In most locations, families are able to access an available provider in a timely manner. Additionally, with the APP requirement, the MCSCs are able to collect more information about why access to care may not be met. Another example of program improvement is the monitoring of parent engagement. By requiring parent participation and reviewing claims data, the MCSCs are able to engage with the family to aide in overcoming any barriers to treatment.

46. Is DHA currently considering any changes to ACD operations?

    DHA Response: DHA is constantly reviewing program feedback and program outcomes, published literature, and lessons learned.

46. As noted earlier, the T5 contract does expand the ASN to all enrolled beneficiaries, but no other changes will be made until the National Academies’ analysis is complete.

TRICARE (Medical) Basic Benefit

47. What are the unknowns and barriers to authorizing coverage of ABA under the TRICARE basic benefit? What specifically are the downsides? Has DHA identified solutions for overcoming any barriers?

    DHA Response: To authorize coverage of ABA under the TRICARE Basic (i.e., medical) benefit, ABA must be found proven safe and effective through a review of literature from the hierarchy of reliable evidence. Barring separate statutory authority, the Department cannot cover ABA under the Basic (i.e., medical) benefit if it does not meet these criteria. Should DHA determine that ABA meets the TRICARE standard for proven medical care as a medical treatment for ASD, among the considerations that would need to be addressed are: (1) who the authorized providers of ABA would be and under what authority; (2) movement of ABA CPT codes off the No Government Pay List; and (3) the establishment of reimbursement rates consistent with other TRICARE benefits.

48. What statutory or regulatory barriers, if any, prevent coverage of ABA services under the TRICARE basic benefit?

    DHA Response: There is no separate statutory authority for TRICARE to cover ABA, thus in order for DHA to extend coverage under the TRICARE Basic (i.e., medical) benefit, DHA must determine that reliable evidence shows that ABA is medically or psychologically necessary and meets the threshold requirement of being proven safe and effective as required by existing TRICARE law.

49. If authorized, what steps need to be taken to put coverage of ABA under the TRICARE basic benefit?

    DHA Response: Any steps taken would depend on the specific authority granted. However, any coverage of ABA separately authorized by a new or amended statute would likely require notice- and-comment rulemaking followed by the writing of sub-regulatory guidance (i.e., TRICARE program manual entries) to the contractors for their implementation of the new benefit.

50. Please identify some of the recent demonstrations and pilot projects related to TRICARE. Did any become a basic benefit under TRICARE and what determinations were made in doing so?

    DHA Response: Other ongoing TRICARE demonstrations and pilot projects include DHA’s Evaluation of U.S. FDA non-approved Laboratory Developed Tests and the Childbirth and Breastfeeding Support Demonstration. A recent demonstration that was incorporated as a TRICARE benefit was the “Tobacco Free Me” tobacco cessation demonstration project. This demonstration was launched on May 8, 2006, to TRICARE Prime beneficiaries in Colorado, Kansas, Minnesota and parts of Missouri. The demonstration included a tobacco cessation counseling, web-based educational programs, and pharmacotherapy made available through the TRICARE Mail Order Pharmacy to determine if these were effective interventions for tobacco cessation. Recruitment for the demonstration continued through September 2007. Subsequently, Section 713 of the National Defense Authorization Act for Fiscal Year 2009 required DoD to enact a smoking cessation program under TRICARE. The current smoking cessation benefit now sits at 32 CFR 199.4(e)(30).