Extension of the Comprehensive Autism Care Demonstration for TRICARE Eligible Beneficiaries Diagnosed With Autism Spectrum Disorder
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Abstract
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.
Full Text
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<title>Federal Register, Volume 87 Issue 149 (Thursday, August 4, 2022)</title>
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[Federal Register Volume 87, Number 149 (Thursday, August 4, 2022)]
[Notices]
[Pages 47731-47733]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[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 (<a href="https://clinicaltrials.gov/ct2/show/study/NCT04078061">https://clinicaltrials.gov/ct2/show/study/NCT04078061</a>). 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
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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
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