[Federal Register Volume 87, Number 149 (Thursday, August 4, 2022)]
[Notices]
[Pages 47731-47733]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2022-16742]


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DEPARTMENT OF DEFENSE

Office of the Secretary


Extension of the Comprehensive Autism Care Demonstration for 
TRICARE Eligible Beneficiaries Diagnosed With Autism Spectrum Disorder

AGENCY: Department of Defense.

ACTION: Notice of an extension of the Comprehensive Autism Care 
Demonstration (ACD) for all Applied Behavior Analysis (ABA) services 
for all TRICARE eligible beneficiaries diagnosed with Autism Spectrum 
Disorder (ASD).

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SUMMARY: This notice provides a five-year extension to the Military 
Health System's (MHS) demonstration project entitled Comprehensive ACD 
(the ``Demonstration''), which is authorized to render clinically 
necessary and appropriate ABA services for the core symptoms of ASD. 
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. In addition to a pending independent research study and a 
Congressionally-required independent National Academies of Sciences, 
Engineering, and Medicine analysis, based on the agency's experience in 
administering ABA services under the Demonstration (including 
engagements with beneficiaries, providers, advocates, associations, and 
other payers), more data collection and analysis is required to 
determine the appropriate structure of implementing ABA services as 
either a medical treatment or other modality, under the TRICARE program 
coverage requirements.

DATES: The Demonstration will continue through December 31, 2028.

ADDRESSES: Defense Health Agency, Health Plan Operations, 7700 
Arlington Boulevard, Suite 5101, Falls Church, Virginia 22042.

FOR FURTHER INFORMATION CONTACT: For questions pertaining to this 
demonstration project, please contact Ms. Valerie Palmer at (303) 676-
3557.

SUPPLEMENTARY INFORMATION: 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

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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. The Demonstration was 
implemented on July 25, 2014, with the original authority set to expire 
on December 31, 2018; however, an extension of the authority for the 
Demonstration until December 31, 2023, was granted, as documented via a 
FR notice published on December 11, 2017 (82 FR 58186). The notice 
stated that additional analysis and experience were required to 
determine the appropriate characterization of ABA services as a medical 
treatment, or other modality, under the TRICARE program coverage 
requirements. 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.
    ABA services are currently provided through the Demonstration and 
managed by existing TRICARE regional Managed Care Support Contractors 
(MCSCs). Under the Demonstration, the Department implemented a provider 
model that allows reimbursement for ABA services rendered by providers 
who are not otherwise eligible for reimbursement. Approximately 16,000 
beneficiaries diagnosed with ASD participate in the program annually 
with Demonstration enrollment continually fluctuating with new and 
terminating participants. Unlike the TRICARE Basic medical benefit, 
many TRICARE standards had to be modified and exceptions to policy made 
due to the unique and evolving nature of ABA service provision or 
Congressional direction, such as: diagnosis and referral procedures; 
ABA provider qualifications and credentialing/certification; 
utilization management reviews; and reimbursement rate methodology. 
Since implementation of the Demonstration, Congress directed the agency 
to add outcome measures as a requirement to the program. Outcome 
measures were implemented on January 1, 2017, and are aimed at 
assessing individual progress for each beneficiary, as well as 
evaluating program effectiveness with the beneficiary population 
participating in the Demonstration. Preliminary outcome findings for 
one of three outcome measures were first reported in Quarter 1, Fiscal 
Year (FY) 2019. Subsequent quarterly and annual reports continued to 
highlight findings based on only one outcome measure. Inconsistencies 
in data collection methods and reporting from participating providers 
limited the Department's ability to analyze the other two outcome 
measures.
    In addition to the Demonstration's outcome measures, a grant was 
awarded under the Congressionally Directed Medical Research Program 
(CDMRP) to the University of Rochester in September 2018 that is 
evaluating traditional intensive ABA services compared to a modified 
ABA service delivery model (https://clinicaltrials.gov/ct2/show/study/NCT04078061). Early intensive behavioral intervention (EIBI) for 
toddlers and preschoolers diagnosed with ASD typically involves 20 or 
more hours per week of individualized instruction based on ABA 
principles. Although research to date does not yet meet TRICARE's 
hierarchy of reliable evidence standards for proven medical care, 
research suggests that EIBI accelerates development of cognitive and 
adaptive skills in many children diagnosed with ASD. However, the 
evidence base has significant gaps, notably a shortage of randomized 
controlled trials (RCTs), limited data on whether EIBI reduces ASD 
symptoms, and few studies on outcomes of EIBI in community settings 
such as private agencies where most children with ASD receive services. 
Recently, research suggests that less intensive, time limited ABA 
interventions can effectively target specific core and associated 
features of ASD. The investigators in the CDMRP study are evaluating if 
combining targeted interventions via an individualized, adaptive, and 
modular ABA (MABA) approach (10 hours per week) could be at least as 
effective as EIBI (20 hours per week) over the course of a 24-week RCT 
at follow-ups conducted 24 weeks after intervention and 90 weeks after 
intervention.
    It is anticipated that the results of the CDMRP study will not only 
further the Department's understanding of the impact of ABA services 
delivered to the Demonstration participants, but also that findings 
from this study may benefit the larger community of individuals 
diagnosed with ASD and their families. The findings will leverage 
clinical outcomes while informing program development, structure, and 
long term impacts. Additionally, the findings may offer more clinical 
program choices to families, potentially identifying variables 
beneficial to clinical success. Findings may also lead to lowering 
costs to families and payers while also increasing access to effective 
and targeted ABA services. This study is scheduled to conclude at the 
end of 2023.
    Further impacting the Demonstration, Congress directed that, via 
enactment of the National Defense Authorization Act for FY 2022, 
Department of Defense enter into an agreement with the National 
Academies of Sciences, Engineering, and Medicine (``National 
Academies'') to conduct an analysis on the effectiveness of the ACD and 
develop recommendations for the Department based on such analysis. The 
analysis would include, among other goals, a review of the expected 
health outcomes for an individual who has received ABA services over 
time, and other analyses to measure the effectiveness of the 
Demonstration. At the conclusion of the study, the National Academies 
will develop and provide the Department a list of findings and 
recommendations related to the measurement, effectiveness, and 
increased understanding of the Demonstration and its effect on 
beneficiaries under the TRICARE program. The National Academies study 
will take significant time to complete, and the Department will then 
require additional time to evaluate the National Academies' 
recommendations and make any appropriate and authorized changes.
    Experience from administering the Demonstration to date informed 
the Department's ability to publish a significant policy update (March 
23, 2021) to address the clinical needs of the beneficiary population 
as well as revise program oversight requirements. This policy update 
focused on providing enhanced beneficiary and family support; improving 
clinical outcomes; encouraging parental involvement; and improving 
utilization management controls. These revisions are anticipated to 
improve the quality of, and access to, clinically necessary and 
appropriate care and services, and will also improve management and 
accountability of both the MCSCs and ABA providers.
    Based on the above factors, at this time, making any determination 
regarding the efficacy of ABA services as a medical benefit, or other 
coverage options, under TRICARE is premature, and it is necessary for 
the Department

[[Page 47733]]

to extend the Demonstration beyond its expiration on December 31, 2023. 
While much information has been learned about ABA while administering 
services under the Demonstration authority, the Department needs time 
to further evaluate the goals of the Demonstration, collect and 
evaluate outcome measures, incorporate the results of the CDMRP study 
award, and address recommendations from the National Academies. In 
addition, by extending the Demonstration, the Department will not only 
be able to fully implement the program improvements, but also will 
continue to gain greater insight and understanding of the effectiveness 
of ABA services being delivered to TRICARE beneficiaries based on 
outcome data.
    As the Department is pending a benefit determination, this 
extension will determine whether the Demonstration meets its stated 
purpose and will provide the Department with consistent and reliable 
information necessary to make a formal decision regarding the provision 
of the ABA services benefit. The Demonstration continues to be 
authorized by Title 10, United States Code, Section 1092.

    Dated: July 29, 2022.
Aaron T. Siegel,
Alternate OSD Federal Register Liaison Officer, Department of Defense.
[FR Doc. 2022-16742 Filed 8-3-22; 8:45 am]
BILLING CODE 5001-06-P