As part of its review of the evidence, the committee gathered information on relevant legislative, statutory, and regulatory definitions and requirements as well as public notices pertaining to the Comprehensive Autism Care Demonstration (ACD). Collected below is the complete or excerpted text of these various definitions and authorities. The information is laid out in the following sections: United States Code, Code of Federal Regulations, Federal Register Notices, and Congressional Reports.
United States Code (U.S.C.) is the official codification of the general and permanent federal statutes of the United States. It contains 53 titles. Title 10 of the U.S.C. outlines the role of the U.S. Armed Forces, including the roles, missions, and organization of each of the services and the U.S. Department of Defense (DoD). Below are excerpts from several parts of Title 10, including 10 U.S.C. § 1079, which outlines the statutory authority behind benefits under the Extended Care Health Option (ECHO) program; 10 U.S.C. § 1086, which outlines contracts for health benefits for certain members of the military, former members of the military, and their dependents; and 10 U.S.C. § 1092, which outlines the authority for studies and demonstration projects relating to delivery of health and medical care in the Military Health System.
Title 10, section 1079 of the U.S.C. outlines the statutory authority behind benefits under the ECHO program. The following excerpt describes the ECHO program benefits:
Extended benefits for eligible dependents under subsection (d) may include comprehensive health care services (including services necessary to maintain, or minimize or prevent deterioration of, function of the patient) and case management services with respect to the qualifying condition of such a dependent, and include, to the extent such benefits are not provided under provisions of this chapter other than under this section, the following:
The following excerpt from 10 U.S.C. § 1086 outlines contracts for health benefits for certain members of the military, former members of the military, and their dependents:
Contracts for health benefits for certain members, former members, and their dependents
The following excerpt from 10 U.S.C. § 1092 outlines the authority for studies and demonstration projects relating to delivery of health and medical care in the Military Health System:
Title 10, Chapter 55, Section 1092 of the United States Code covers studies and demonstration projects related to the delivery of health and medical care. The Secretary of Defense, in consultation with other administering Secretaries, conducts these projects to improve the quality, efficiency, convenience, and cost effectiveness of health care services. Section 1092 defines a demonstration as “a project of limited duration designed to test a different method for the finance, delivery or administration of health care activities for the uniformed services” (32 CFR 199.1(o)(3)). Demonstrations are authorized by statutory provisions. The DHA director has the authority to waive or alter any of the requirements of the TRICARE Basic Benefit in conducting the demonstration, except where alterations are prohibited by law.
The United States Code of Federal Regulations (C.F.R.) is the codification of the general and permanent regulations created by the executive departments and agencies of the federal government. There are 50 titles. Title 32 of the C.F.R. outlines regulations pertaining to national defense. Below are excerpts from several sections of Title 32 § 199, including 32 C.F.R. § 199.1(o), which contains language implementing the demonstration authority found in U.S.C., Title 10, Section 1092; 32 C.F.R. § 199.2,
which contains definitions used throughout Title 32, some of which apply to the administration of the ACD; 32 C.F.R. § 199.4, which outlines Basic Program benefits within TRICARE; and 32 C.F.R. § 199.5, which outlines regulations for TRICARE ECHO.
“(1) Authority. The Director, OCHAMPUS may waive or alter any requirements of this regulation in connection with the conduct of a demonstration project required or authorized by law except for any requirement that may not be waived or altered pursuant to 10 U.S.C. chapter 55, or other applicable law.
(2) Procedures. At least 30 days prior to taking effect, OCHAMPUS shall publish a notice describing the demonstration project, the requirements of this regulation being waived or altered under paragraph (o)(1) of this section and the duration of the waiver or alteration. Consistent with the purpose and nature of demonstration projects, these notices are not covered by public comment practices under DoD Directive 5400.9 (32 CFR part296) or DoD Instruction 6010.8.
(3) Definition. For purposes of this section, a ‘demonstration project’ is a project of limited duration designed to test a different method for the finance, delivery or administration of health care activities for the uniformed services. Demonstration projects may be required or authorized by 10 U.S.C. 1092, any other statutory provision requiring or authorizing a demonstration project or any other provision of law that authorizes the activity involved in the demonstration project.”
The following definitions of “medical,” “medically or psychologically necessary,” and “reliable evidence” are defined as follows:
“The generally used term which pertains to the diagnosis and treatment of illness, injury, pregnancy, and mental disorders by trained and licensed or certified health professionals. For purposes of CHAMPUS, the term ‘medical’ should be understood to include ‘medical, psychological, surgical, and obstetrical,’ unless it is specifically stated that a more restrictive meaning is intended.”
“The frequency, extent, and types of medical services or supplies which represent appropriate medical care and that are generally accepted by qualified professionals to be reasonable and adequate for the diagnosis and treatment of illness, injury, pregnancy, and mental disorders or that are reasonable and adequate for well-baby care.”
“(1) As used in § 199.4(g)(15), the term reliable evidence means only:
(2) The hierarchy of reliable evidence of proven medical effectiveness, established by (1) through (5) of this paragraph, is the order of the relative weight to be given to any particular source. With respect to clinical studies, only those reports and articles containing scientifically valid data and published in the refereed medical and scientific literature shall be considered as meeting the requirements of reliable evidence. Specifically not included in the meaning of reliable evidence are reports, articles, or statements by providers or groups of providers containing only abstracts, anecdotal evidence or personal professional opinions. Also not included in the meaning of reliable evidence is the fact that a provider or a number of providers have elected to adopt a drug, device, or medical treatment or procedure as their personal treatment or procedure of choice or standard of practice.”
Title 32 C.F.R. § 199.4 outlines Basic Program benefits within TRICARE. Title 32 C.F.R. § 199.4(g)(15) specifically addresses how the standards for reliable evidence as defined in 32 C.F.R. § 199.2 are considered when determining whether a medical treatment or procedure is unproven and thus excluded from the coverage under the TRICARE Basic Program.
(15) Unproven drugs, devices, and medical treatments or procedures. By law, CHAMPUS can only cost-share medically necessary supplies and
services. Any drug, device, or medical treatment or procedure, the safety and efficacy of which have not been established, as described in this paragraph (g)(15), is unproved and cannot be cost-shared by CHAMPUS except as authorized under paragraph 199.4(e)(26) of this part.
Title 32 C.F.R. § 199.5 outlines the ECHO program, which operates as a supplement to the TRICARE Basic Program.
The Federal Register is the official journal of the U.S. federal government in which agency rules, proposed rules, and public notices are published. The Federal Register has published several public notices regarding the ACD, including notice of its creation and extensions to the program. The relevant Federal Register notices were published in 2014, 2015, 2017, and 2022.
Title 79 FR 34291 contains the public notice that announced the creation of the ACD. Of importance, this notice contains the overarching goals and evaluation plan for the ACD, which are detailed in the excerpt below:
B. Description of the Autism Care Demonstration
The Department’s continued evaluation of ABA for ASD must be accomplished while ensuring continuity of care for children currently receiving ABA and those who will be diagnosed with ASD and then seek treatment. Specific Autism Care Demonstration goals include:
The Autism Care Demonstration will offer comprehensive ABA for all TRICARE eligible beneficiaries with an ASD when diagnosed by an appropriate provider. Under the Autism Care Demonstration, a Board Certified Behavior Analyst (BCBA) or Board Certified Behavior Analyst-Doctorate (BCBA-D) referred to as an “ABA Supervisor” will plan, deliver and/or supervise an ABA program. The BCBA or BCBA-D is supported by Board Certified Assistant Behavior Analysts (BCaBA) and/or paraprofessional Behavioral Technicians who work one-on-one with the beneficiary with ASD in the home and community setting to implement the ABA intervention protocol designed, monitored and supervised by the BCBA or the BCBA-D. A BCaBA and/or Behavioral Technician working within the scope of their training, practice, and competence may assist the BCBA or BCBA-D in various roles and responsibilities as determined appropriate by the BCBA or BCBA-D and delegated to the BCaBA and/or Behavioral Technician, and consistent with the BACB Guidelines (2012) and BACB certification requirements. As such, the Autism Care Demonstration will specifically require that BCaBAs and Behavioral Technicians work under the supervision of a BCBA or BCBA-D. ABA delivered solely by BCBAs or BCBA-Ds is also covered by the Autism Care Demonstration and will provide a comparative assessment of providing ABA services delivered solely by master’s level providers or under the ABA tiered delivery model in terms of access, quality, and cost. The Department will also compare naturally occurring utilization data of PT, OT, SLP and pharmacotherapy services without ABA to those also receiving ABA sole provider and tiered model services.
[. . .]
K. Evaluation of the Autism Care Demonstration
The Autism Care Demonstration will assist the Department in evaluating: The aspects of the ABA tiered-delivery model that are medical, educational, or other characterization; whether the provision of the ABA tiered-delivery model can effectively offset the difficulty parents have in using ABA interventions collaboratively, consistently, and intensely when interacting with their children who have an ASD; whether the use of BCaBAs and Behavioral Technicians creates more cost-effective access to ABA based on the limited number of BCBAs and BCBA-Ds, while maintaining the quality of ABA; the appropriateness of requirements for providers, referral, authorization, treatment planning, assessment, testing, reimbursement, cost-sharing, discharge planning, and oversight to increase access to ABA for TRICARE beneficiaries with an ASD, while ensuring appropriate progress and utilization.
To collect necessary data to achieve the goals outlined for the Autism Care Demonstration, two parental surveys will be administered: The first at the mid-period of the Autism Care Demonstration (2016) and a second upon its conclusion (2018). These parental surveys will contain questions regarding: The reasons why parents avail themselves of the ABA tiered-delivery model, BCBA-only ABA, or no ABA; the perceived impairment(s) of their child with ASD; their degree of difficulty in accessing ABA and other clinical services with ASD; and, their overall satisfaction and perceived benefit regarding the ABA services provided.
The Autism Care Demonstration will provide the Department the opportunity to continue evaluating the provision of ABA under TRICARE while avoiding disruption of potentially therapeutic ABA interventions that could greatly benefit TRICARE beneficiaries with ASD. This information will be essential for determining it and how ABA should be delivered under TRICARE if the clinical community and accumulated evidence clearly indicates that ABA is a reliably evidence-based medical intervention for the treatment of ASD.
“The purpose of the ACD is to further analyze and evaluate the appropriateness of the ABA delivery model under TRICARE in light of current and anticipated guidelines and best practices from the Behavior Analyst Certification Board (BACB) and other resources. The demonstration seeks to determine the appropriate provider qualifications for the proper diagnosis of ASD and the provision of ABA, refine the beneficiary cost-sharing requirements and provider reimbursement rates for the treatment of ASD, determine the appropriate patient safety and fraud prevention measures to implement regarding coverage of ABA for ASD, and develop more efficient and appropriate means of increasing access and delivering ABA services under TRICARE while creating a viable economic model and maintaining administrative simplicity.”
“The initial purpose of the Autism Care Demonstration (ACD) was to further analyze and evaluate the appropriateness of the ABA services tiered delivery model under TRICARE (the medical benefit) in light of current and anticipated Behavior Analyst Certification Board guidelines. Based on the agency’s experience in administering ABA services under the ACD, including engagement with beneficiaries, providers, advocates, associations, and other payers, much more analysis and experience is required in order to determine the appropriate characterization of ABA services as a medical
treatment, or other modalities, under the TRICARE program coverage requirements—to include further research and evaluation of the results, whether Board Certified Behavior Analysts may appropriately be recognized and treated as independent TRICARE authorized providers of a proven medical benefit, and what authorities are required to add ABA services as a permanent benefit under the TRICARE program—whether as a proven medical benefit or otherwise.
The Department of Defense published a notice in the Federal Register (FR) (79 FR 34291), as amended by 80 FR 30664 (May 29, 2015), of a TRICARE demonstration to further analyze and evaluate the appropriateness of the ABA tiered delivery model under TRICARE. The initial purpose of the demonstration was to determine the appropriate provider qualifications for the proper diagnosis of ASD and for the provision of ABA services, assess the feasibility and advisability of establishing a beneficiary cost share for ABA services for the treatment of ASD, and develop more efficient and appropriate means of increasing access to and delivering of ABA services under TRICARE while creating a viable economic model and maintaining administrative simplicity.”
“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.
On June 16, 2014, Department of Defense published a Notice in the Federal Register (FR) (79 FR 34291), as amended by 80 FR 30664 (May 29, 2015), of a TRICARE demonstration to further analyze and evaluate the appropriateness of the ABA tiered delivery model under TRICARE. The purpose of the Demonstration was to determine the appropriate provider qualifications for the proper diagnosis of ASD and for the provision of ABA services, assess the feasibility and advisability of establishing a beneficiary cost share for ABA services for the treatment of ASD, and develop more efficient and appropriate means of increasing access to and delivery of ABA services under TRICARE while creating a viable economic model and maintaining administrative simplicity[. . .] While much has been learned about ABA services administration under the TRICARE program, additional data are required to support a final determination regarding the appropriate provider qualifications for the proper diagnosis of ASD and for the provision of ABA services, the individual characteristics for patient/beneficiary improvement, and the appropriate clinical ABA services under the TRICARE benefit.”
Through the National Defense Authorization Act legislation, Congress made several requests for analysis and reporting on the ACD to ensure military-connected families had access to early and appropriate intervention and fair reimbursement practices. It also asked for reports on lessons learned and identification of any new legislative authorities required to improve the provision of services for autistic individuals.
As of this writing, DoD has issued eight annual reports on the results of the ACD (DoD, 2016, 2017b, 2018a, 2019a, 2020a, 2021b, 2023c, 2024b) in response to Senate Report 114-49, S. 1376, pp. 157–158, and 24 quarterly reports in response to Senate Report 114-255, S. 2943, p. 205 starting from FY 2017 Quarter 1 through FY 2022 Quarter 4. Relevant excerpts from Senate Report 114-255 and Senate Report 114-49 are included as are the Defense Health Agency’s reports to Congress which reference the 2021 policy revisions.
The annual reports to Congress include “a discussion of the evidence regarding clinical improvement of children with ASD receiving ABA therapy and a description of lessons learned to improve administration of the demonstration program” and the quarterly reports are to include, by state, “(1) the number of new referrals for services under the program; (2) the number of total beneficiaries enrolled in the program; (3) the average wait-time from time of referral to the first appointment for services under the program; (4) the number of providers accepting new patients under the program; (5) the number of providers who no longer accept new patients for services under the program; (6) the average number of treatment sessions required by beneficiaries; and (7) the health-related outcomes for beneficiaries under the program” (Senate Report 114-255, S. 2943, p. 205).
“The joint explanatory statement accompanying section 732 of the Duncan Hunter National Defense Authorization Act for Fiscal Year 2009 (Public Law 110–417) required a semi-annual report, without end date, on the status of implementation of the TRICARE autism demonstration project then in progress. That project ended in 2014, and the expanded TRICARE Comprehensive Autism Care Demonstration, which incorporates Applied Behavior Analysis (ABA) policies into a single program for all TRICARE beneficiaries with Autism Spectrum Disorder (ASD), succeeded it. [. . .]
The committee remains keenly interested in the Department of Defense’s response to the needs of children with ASD and directs the Secretary of Defense to report no later than April 1, 2016, and annually thereafter for the duration of the program, on the results of the program. No additional semi-annual reports on the initial TRICARE autism demonstration project are required. The newly required annual report should include a discussion of the evidence regarding clinical improvement of children with ASD receiving ABA therapy and a description of lessons learned to improve administration of the demonstration program. In the report, the Department should also identify any new legislative authorities required to improve the provision of autism services to beneficiaries with ASD.”
“The committee remains concerned about beneficiaries’ access to care for services provided under the TRICARE Comprehensive Autism Care Demonstration program. Beginning not later than July 1, 2016, and continuing through the duration of the demonstration program, the committee directs the Secretary of Defense to provide quarterly reports, by letter, to the Committees on Armed Services of the Senate and the House of Representatives on access to care and the effectiveness of care among military dependents participating in the program. The Secretary shall report, at a minimum, the following information by state: (1) the number of new referrals for services under the program; (2) the number of total beneficiaries enrolled in the program; 3) the average wait-time from time of referral to the first appointment for services under the program; (3) the number of providers accepting new patients under the program; (4) the number of providers who no longer accept new patients for services under the program; (5) the average number of treatment sessions required by beneficiaries; and (6) the health-related outcomes for beneficiaries under the program. This provision would improve data reporting on the demonstration program and ensure that military dependents with autism spectrum disorder have timely access to effective care.”
“[T]he DHA is continuously evaluating beneficiary progress in the ACD as well as steps to improve the program to ensure the best possible outcomes for all TRICARE beneficiaries receiving services under the ACD. To date, ABA services under TRICARE continue to grow exponentially in cost with no data that demonstrates that TRICARE beneficiaries diagnosed with ASD
are improving in their core deficits of ASD. In part due to this concerning finding, DHA is proposing significant changes to the ACD. These proposed comprehensive changes will provide an opportunity to improve support to beneficiaries and their families by providing more information about ASD and potential services, linking beneficiaries to the right care at the right time, and increasing services to eligible family members (especially parents). The improvements will create a beneficiary and parent-centered model of care and support that encompasses all of the beneficiary and family’s needs into one comprehensive approach. This manual change will incorporate all needed services (including but not limited to ABA services) into one treatment plan, and empowering parents to have a greater role in determining the most appropriate services for their child. The change will also include the option for treatment team meetings with participation by all providers treating the child and participation by the family (and when appropriate, the beneficiary). This comprehensive change aims to move the ACD from the current ABA-centric model to one focused on the beneficiary and family with the goal of helping the beneficiary diagnosed with ASD reach their maximum potential.”
“Since the beginning of the ACD, the DHA has made significant improvements to the program, such as increased access, implementation of audits in response to the Department of Defense Office of Inspector General audits, and collection and evaluation of outcomes measures. Additionally, DHA has worked with experts in the field of autism care, both in and out of the MHS, including ABA providers, advocates, MHS providers, commercial plans, and leading researchers to develop a comprehensive revision of the ACD.
The comprehensive review of the ACD will evolve the program to a more beneficiary and family-centric model. These changes aim to not only improve the quality of, value, and access to care and services for beneficiaries diagnosed with ASD and their families, but also to improve management and accountability of both the MCSCs and the ABA providers. These changes have been informed by a review of the data collected in the program, ongoing reviews of research evidence into the treatment of ASD, and discussions with experts in the field of autism care. These changes will focus on providing enhanced beneficiary and family support, improving outcomes, encouraging parental involvement, improving utilization management controls, and revising coverage of Adaptive Behavior Services (ABS) for the delivery of ABA services to TRICARE eligible beneficiaries
diagnosed with ASD. Major areas of improvement and program revisions will include: