Rule2025-14206
TRICARE Coverage of Clinical Trials and Termination of Expanded Access Treatments
Primary source
Metadata and text below are from the Federal Register, a public-domain U.S. government work. Always verify the official published version before relying on it for any legal matter.
Published
July 28, 2025
Effective
August 27, 2025
Issuing agencies
Defense Department
Abstract
The Assistant Secretary of Defense for Health Affairs (ASD(HA)) issues this final rule regarding circumstances under which services and supplies related to emerging treatments may be covered under the TRICARE program. This rule finalizes provisions published in two interim final rules (IFRs) with request for comment, which temporarily added coverage for the treatment use of investigational drugs under U.S. Food and Drug Administration (FDA)-authorized expanded access (EA) programs when for the treatment of coronavirus disease 2019 (COVID-19) and permitted coverage of National Institute of Allergy and Infectious Disease (NIAID)-sponsored clinical trials for the treatment or prevention of COVID-19. This final rule discusses the DoD's decision not to make permanent the coverage of treatment use of investigational drugs under FDA EA programs while updating language for care associated with their administration and broadens the COVID-19 clinical trial benefit to include coverage of clinical trials sponsored or approved by any National Institutes of Health (NIH) Center or Institute to treat or prevent infectious diseases associated with a pandemic or epidemic. Lastly, the final rule expands TRICARE's clinical trial benefit by covering services and supplies provided in conjunction with Phase I, II, III, and IV clinical trials that are NIH-sponsored or approved and that involve a new treatment or cure for a specific condition or the treatment of a currently uncontrolled symptom or aspect of that condition, provided that the condition is severely debilitating, life- threatening, or a rare disease.
Full Text
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<title>Federal Register, Volume 90 Issue 142 (Monday, July 28, 2025)</title>
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[Federal Register Volume 90, Number 142 (Monday, July 28, 2025)]
[Rules and Regulations]
[Pages 35422-35434]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2025-14206]
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DEPARTMENT OF DEFENSE
Office of the Secretary
32 CFR Part 199
[Docket ID: DOD-2020-HA-0050]
RIN 0720-AB83
TRICARE Coverage of Clinical Trials and Termination of Expanded
Access Treatments
AGENCY: Defense Health Agency (DHA), Department of Defense (DoD).
ACTION: Final rule.
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SUMMARY: The Assistant Secretary of Defense for Health Affairs
(ASD(HA)) issues this final rule regarding circumstances under which
services and supplies related to emerging treatments may be covered
under the TRICARE program. This rule finalizes provisions published in
two interim final rules (IFRs) with request for comment, which
temporarily added coverage for the treatment use of investigational
drugs under U.S. Food and Drug Administration (FDA)-authorized expanded
access (EA) programs when for the treatment of coronavirus disease 2019
(COVID-19) and permitted coverage of National Institute of Allergy and
Infectious Disease (NIAID)-sponsored clinical trials for the treatment
or prevention of COVID-19. This final rule discusses the DoD's decision
not to make permanent the coverage of treatment use of investigational
drugs under FDA EA programs while updating language for care associated
with their administration and broadens the COVID-19 clinical trial
benefit to include coverage of clinical trials sponsored or approved by
any National Institutes of Health (NIH) Center or Institute to treat or
prevent infectious diseases associated with a pandemic or epidemic.
Lastly, the final rule expands TRICARE's clinical trial benefit by
covering services and supplies provided in conjunction with Phase I,
II, III, and IV clinical trials that are NIH-sponsored or approved and
that involve a new treatment or cure for a specific condition or the
treatment of a currently uncontrolled symptom or aspect of that
condition, provided that the condition is severely debilitating, life-
threatening, or a rare disease.
DATES: This rule is effective on August 27, 2025.
FOR FURTHER INFORMATION CONTACT: Jennifer Stankovic, Medical Benefits
and Reimbursement Section, 303-676-3742,
<a href="/cdn-cgi/l/email-protection#f5bf909b9b9c939087dbb9dba681949b9e9a839c96db969c83b59d909499819ddb989c99"><span class="__cf_email__" data-cfemail="f1bb949f9f98979483dfbddfa285909f9a9e879892df929887b19994909d8599df9c989d">[email protected]</span></a>.
SUPPLEMENTARY INFORMATION:
Discussion of Comments and Changes
The IFR titled ``TRICARE Coverage of Certain Medical Benefits in
Response to the COVID-19 Pandemic'' published in the Federal Register
on September 3, 2020 (85 FR 54914-54924), and public comments were
allowed for 60 days. A total of four comments were submitted. Two
comments were generally supportive of the provisions implemented in
that IFR; the DoD is grateful to the public for their support. Comments
specific to provisions of that IFR not covered in this final rule were
discussed in full in a final rule titled ``TRICARE Coverage and
Reimbursement of Certain Services Resulting From Temporary Program
Changes in Response to the COVID-19 Pandemic'' that published on June
1, 2022 (87 FR 33001-33015). In the IFR of September 3, 2020, the DoD
specifically asked for comments on potentially making coverage of
treatment use of investigational drugs under FDA EA programs for the
treatment of COVID-19 permanent and on permanently covering the drugs
for all diseases. No comments were received specific to the coverage of
treatment use of investigational drugs on a permanent basis, either for
the treatment of COVID-19 or for the treatment of other diseases. This
final rule clarifies the DoD's decision not to add permanent coverage
of investigational drugs authorized for treatment use under FDA EA
programs when prescribed for the treatment of COVID-19 or for other
diseases. This decision was based primarily on analysis discussed later
in this rule rather than the lack of comments received on this
provision. The COVID-19 national emergency terminated on April 10,
2023. As the DoD is not making the provision authorizing
investigational drugs for COVID-19 under FDA EA programs permanent,
this final rule will remove the temporary provision from Title 32, Code
of Federal Regulation (CFR), Part 199. This final rule also modifies
language in the note to Sec. 199.4(g)(15)(i)(A) by replacing the terms
``Treatment Investigational New Drugs (INDs)'' and ``Treatment INDs''
with ``investigational drugs authorized for treatment use under FDA
expanded access programs'' to better reflect updated practices and
terminology associated with FDA EA programs.
The IFR titled ``TRICARE Coverage of National Institute of Allergy
and Infectious Disease Coronavirus Disease 2019 Clinical Trials,''
which discussed temporary coverage of NIAID-sponsored clinical trials
for the treatment of COVID-19, published in the Federal Register on
October 30, 2020 (85 FR 68753-68758). Comments were accepted for 30
days, and the DoD received four comments. The DoD thanks all commenters
for their submissions. In the COVID-19 Clinical Trials IFR, the DoD
specifically solicited comments on the potential expansion of TRICARE's
clinical trial benefit beyond cancer clinical trials and NIAID-
sponsored COVID-19 clinical trials. Two comments were generally
supportive of expanding the clinical trial benefit, while the other two
comments discussed the TRICARE benefit in general. The DoD received one
comment discussing the importance of clinical trials in assisting with
the development of products to prevent COVID-19 cases, treat COVID-19
more efficaciously, and treat severe COVID-19 complications. This
comment also recommended covering expenses related to clinical trials
for other life-threatening conditions that impact a large number of
beneficiaries, such as cardiovascular diseases, to improve health
outcomes for beneficiaries, and to support the advancement of effective
clinical treatments. The DoD received one comment recommending that
coverage of COVID-19 clinical trials be made permanent.
Due in part to these comments and the DoD's comprehensive review of
TRICARE's clinical trials and other investigational treatment benefits,
which is discussed further in-depth within the Discussion and
Regulatory Impact Analysis sections of this final rule preamble, the
Department is making COVID-19 clinical trial provisions permanent. As
the COVID-19 national emergency terminated on April 10, 2023, before
the publication of this final rule, TRICARE will only cover routine
services and supplies associated with NIAID-sponsored COVID-19 clinical
trials for beneficiaries who enroll in eligible clinical trials after
the effective date of this rule or who previously enrolled in an
eligible clinical trial before April 11, 2023. Due to low enrollment in
this benefit and the fact that beneficiaries who enroll in eligible
clinical trials before the termination of the national emergency will
still have routine care associated with the clinical trial covered
after the termination of the national emergency, the Department expects
this temporary
[[Page 35423]]
gap in coverage to impact few, if any, beneficiaries.
The Department is also expanding the provisions to include coverage
of services and supplies provided in conjunction with clinical trials
sponsored or approved by any NIH Center or Institute for the treatment
or prevention of infectious diseases that cause a pandemic or epidemic
and result in a Government-recognized health emergency, rather than
continuing to only cover services and supplies provided in conjunction
with NIAID-sponsored clinical trials for treatment or prevention of
COVID-19. The DoD is promulgating this change to prepare for future
health emergencies caused by infectious diseases beyond the COVID-19
pandemic, as coverage for clinical trials investigating a novel
infectious disease is critical to both advancing initial research into
treatments and preventive measures and fostering beneficiary access to
emerging treatments. The Department is also expanding this benefit to
include all NIH Centers and Institutes except for the NIH Clinical
Center because NIH Centers and Institutes other than NIAID have begun
conducting research on COVID-19, particularly on how the disease
affects specific organ systems. Likewise, the DoD expects other NIH
Centers and Institutes to conduct research on previous, current, or
future pandemics and epidemics that result from infectious pathogens
and cause the declaration of a national emergency or public health
emergency (PHE). This change also adds authorization of NIH-approved
clinical trials where NIH serves as a collaborator, rather than only
NIH-sponsored clinical trials, in order to further expand access to
clinical trials for TRICARE beneficiaries. This expansion of TRICARE's
clinical trial benefit therefore includes coverage of NIH-sponsored or
approved clinical trials for the treatment or prevention of infectious
diseases that cause a pandemic or epidemic and result in a Government-
recognized health emergency, including COVID-19 clinical trials, rather
than just NIAID-sponsored COVID-19 clinical trials. If the Government-
recognized health emergency was declared before the effective date of
this rule, only services and supplies provided in conjunction with
eligible clinical trials after this rule's effective date may be
covered.
Lastly, the Department is expanding and modernizing the TRICARE
clinical trial benefit to cover services and supplies provided in
conjunction with NIH-sponsored or approved Phase I-IV clinical trials
that involve a new treatment or cure for a specific condition or the
treatment of a currently uncontrolled symptom or aspect of that
condition, provided that the condition or uncontrolled symptom of the
condition under study in the clinical trial is severely debilitating,
life-threatening, or a rare disease. This includes expanding coverage
of cancer clinical trials to National Cancer Institute (NCI)-sponsored
or approved Phase I-IV clinical trials, rather than only NCI-sponsored
Phase I-III clinical trials, as cancer is itself a life-threatening
condition. This expansion of TRICARE's clinical trial benefit conforms
to statutory authority and is supported by the DoD's review into the
clinical trials reimbursement landscape and the comments the DoD
received in response to the COVID-19 Clinical Trials IFR.
I. Background
A. Statement of Need for This Rule
In 2020, the DoD published three IFRs with request for comments to
respond to the COVID-19 pandemic, which included two provisions
addressed in this final rule: temporary coverage of investigational
drugs authorized for treatment use under FDA EA programs and temporary
coverage of services and supplies provided in conjunction with NIAID-
sponsored clinical trials for the treatment or prevention of COVID-19;
both provisions were originally effective for the duration of the
President's declared national emergency. All other provisions of those
IFRs, including the first COVID-19 IFR published by the DoD on May 12,
2020 (85 FR 27921-27927), titled ``TRICARE Coverage and Payment for
Certain Services in Response to the COVID-19 Pandemic,'' were finalized
in a final rule, titled ``TRICARE Coverage and Reimbursement of Certain
Services Resulting From Temporary Program Changes in Response to the
COVID-19 Pandemic,'' published on June 1, 2022 (87 FR 33001-33015). The
DoD published a fourth IFR titled ``Expanding TRICARE Access to Care in
Response to the COVID-19 Pandemic'' on January 12, 2023 (88 FR 1992-
2002); its provisions have not yet been finalized in a final rule.
In addition to rulemaking, before the COVID-19 clinical trial
provisions could be published, Title 10, United States Code (U.S.C.),
Section 1079(a)(12) also required the DoD to first enter into an inter-
agency agreement with the Secretary of the Department of Health and
Human Services (HHS). Instead of entering into an agreement with NIAID
only, the Department foresaw the possibility of expanding the TRICARE
clinical trial benefit as authorized under 10 U.S.C. 1079(a)(12) to
cover studies sponsored or approved by other NIH Centers and
Institutes. The DoD therefore entered into an agreement with NIH to
cover certain routine costs associated with clinical trials; this
inter-agency agreement is not limited to NIAID or clinical trials
related to COVID-19, although the IFR published by the DoD on October
30, 2020 (85 FR 68753-68758), titled ``TRICARE Coverage of National
Institute of Allergy and Infectious Disease Coronavirus Disease 2019
Clinical Trials,'' only authorized coverage of services and supplies
provided in conjunction with certain NIAID-sponsored clinical trials
for the treatment or prevention of COVID-19. The inter-agency agreement
includes clinical trials sponsored or approved by NIH, is effective
from September 19, 2020, through September 18, 2029, and provides for
both parties to review the agreement every three years.
This final rule promulgates three major changes to the provisions
enacted in the IFRs in response to public comments, the COVID-19
pandemic, and the DoD's comprehensive review of the clinical trials
reimbursement landscape:
Consideration of Permanent TRICARE Coverage of Investigational Drugs
Authorized for Treatment Use Under FDA EA Programs
First, this final rule considered permanent TRICARE coverage of
investigational drugs authorized for treatment use under FDA EA
programs for the treatment of COVID-19. This temporary coverage was
authorized in the IFR published September 3, 2020, but that
authorization expired when the President's national emergency for
COVID-19 ended April 10, 2023. In the IFR, the ASD(HA) stated that the
DoD would consider if any permanent coverage was appropriate and
publish a final rule detailing the Department's analysis and decision.
While the DoD recognizes the value of access to emerging therapies, as
demonstrated by its coverage of investigational drugs during the early
part of the COVID-19 pandemic, there is insufficient statutory
authority to permit permanent coverage. This final rule discusses the
DoD's decision and adds clarifying language regarding coverage of care
associated with such drugs for any disease.
The IFR authorizing temporary coverage of these drugs permitted
that temporary coverage in response to the COVID-19 pandemic and stated
that the DoD would consider permanent coverage after thoroughly
examining the
[[Page 35424]]
FDA-authorized EA program and determining what coverage, if any, was
appropriate given TRICARE's statutory requirement to only cover
medically necessary care under 10 U.S.C. 1079(a)(12).
To determine what coverage was appropriate, the DoD examined its
own regulatory history for coverage of FDA-approved drugs, as well as
changes to FDA EA programs since the DoD's regulatory provisions were
enacted. The DoD, under the Civilian Health and Medical Programs of the
Uniformed Services (CHAMPUS) Program (now TRICARE), first established
an ``absolute requirement for approval by the [FDA] of all prescription
drugs and medicines'' as a criterion for coverage on November 26, 1991
(56 FR 59870). The 1991 final rule established that care associated
with certain Group ``C'' cancer drugs and treatment INDs could be
covered, while the treatment IND itself could not. The 1991 rule placed
these provisions in Sec. 199.2, under the definitions for
``experimental'' and ``prescription drugs and medicines,'' with the
prescription drugs and medicines provision repeated in Sec. 199.4.
That rule concluded that any use of a drug that had not been approved
for general use by the FDA was necessarily experimental and could not
be covered. In a final rule published January 6, 1997 (62 FR 625), the
DoD issued clarifying language regarding the exclusion of unproven
drugs, devices, and medical treatments and procedures. The requirement
for FDA approval of drugs remained, though the definition of
experimental was removed from Sec. 199.2, and the language in Sec.
199.4 was substantially revised. However, none of those changes had a
substantive impact on coverage criteria. FDA approval remained a key
requirement for coverage of drugs, and treatment INDs could not be
covered although care associated with them could be covered. Since that
time, no significant changes have been made to TRICARE regulations that
would impact the FDA-approval requirement for drugs, or the exclusion
of cost-sharing treatment INDs. Importantly, no changes have been made
to the DoD's statutory authority for coverage of care under TRICARE,
which mandates that such care be medically necessary in order to be
eligible for TRICARE coverage. The statutory provision concerning
medical necessity (10 U.S.C. 1079(a)(12)) specifically exempts care
provided in certain NIH clinical trials (in which investigational drugs
are often administered). Because Congress specifically carved out
circumstances under which drugs and other treatments not otherwise
coverable were permitted to be cost-shared, the Department has
historically read the statute to mean that the carve-out represents the
only exemption Congress intended to make for TRICARE coverage in
investigational settings. Based on this interpretation, the DoD finds
that Congress did not intend for the DoD to include unproven care in
its coverage of medically necessary care.
In evaluating whether it would be appropriate for TRICARE to cost
share investigational drugs authorized for treatment use under EA
programs, the DoD next evaluated changes to FDA's regulation of its EA
programs to determine if those changes were such that this care could
be considered medically necessary under TRICARE. The FDA first
formalized the treatment use of investigation drugs on May 22, 1987 (52
FR 19466), in a final rule that included the establishment of treatment
INDs. The DoD's 1991 rule published after that rule, and the DoD found
that treatment INDs were unproven and, thus, could not be covered under
its statutory authority. The FDA revised its regulations authorizing
the treatment use of investigational drugs in a final rule establishing
its EA programs, which published on August 13, 2009 (74 FR 40900).
FDA's rule was published under new authority granted by Congress in the
FDA Modernization Act of 1997 (Pub. L. 105-115), which contained
provisions specific to expanding access to treatment use of
investigational drugs. In the final rule implementing its EA programs,
the FDA established three categories of treatment uses of
investigational drugs: single patients, including for emergency use;
intermediate-size patient populations; and treatment INDs or treatment
protocols. Each category of EA established criteria for authorization,
with single patient access requiring the lowest level of evidence and
treatment INDs and treatment protocols requiring the highest levels of
evidence. The evidence for treatment INDs was not substantially
different than it was in the earlier 1987 rule.
According to 21 CFR 312.320, established by the 2009 final rule, in
order for the FDA to authorize a treatment IND or protocol for the
treatment of a serious disease or condition, there must be ``sufficient
clinical evidence of safety and effectiveness to support the [EA]
use.'' The FDA states this would ordinarily be data from a Phase III
trial, though compelling data from completed Phase II trials may be
used. Section 312.320 further states that when the treatment IND or
protocol is for a life-threatening disease or condition, ``the
available scientific evidence, taken as a whole, provides a reasonable
basis to conclude that the investigational drug may be effective and
would not expose patients to an unreasonable and significant risk of
illness or injury.'' The FDA expects this level of evidence would
typically come from Phase III or Phase II trials but could be based on
more preliminary clinical evidence. Additionally, in its preamble to
the 2009 final rule, the FDA acknowledges ``that drugs made available
under expanded access programs are typically investigational'' (74 FR
40907) and that ``it is likely that some drugs made available for
treatment use will ultimately be shown to have no benefit, and in fact
cause harm'' (74 FR 40911). Further, all EA drugs require an
Institutional Review Board (IRB) review, similar to such reviews for
clinical trials, underlining the unproven nature of these drugs.
Although the DoD appreciates the value of early access to drugs for
patients with serious or life-threatening diseases, the DoD does not
have the statutory authority that would allow it to permanently cover
investigational therapies, even for severe illnesses. The level of
evidence required by the FDA for widespread treatment use of INDs, the
most stringent evidence requirement of the three EA drug categories, is
insufficient to meet the DoD's statutory requirement for medically
necessary care, as implemented through the regulation excluding
unproven care at 32 CFR 199.4(g)(15) from TRICARE coverage as
determined by a review of the available literature that falls under the
categories of the hierarchy of reliable evidence in Sec. 199.2. The
DoD lacks statutory authority to treat serious or life-threatening
diseases differently than other diseases when determining medical
necessity. In fact, the rule that formalized the criteria for a
treatment to be considered ``proven'' was prompted by a treatment for
life-threatening breast cancer. The therapy in question, high dose
chemotherapy with stem cell rescue, was seen by some in the medical
community at the time as the best and only treatment available to
patients with certain types of breast cancer resistant to other
treatments. However, the DoD excluded coverage due to lack of evidence
of efficacy and the presence of evidence that the therapy may actually
cause harm. Over 25 years later, the therapy remains unproven and is
excluded from coverage under TRICARE. The DoD noted in the 1997 rule
that the purpose of its process for determining whether care should be
covered is ``to prevent CHAMPUS
[[Page 35425]]
beneficiaries from being exposed to less than fully developed and
tested medical procedures and to avoid the associated risk of
unnecessary and unproven treatment'' (62 FR 628). Based on the above
analysis, investigational drugs authorized for treatment use by the FDA
must continue to be excluded under the TRICARE Program.
While the DoD cannot permanently cover investigational drugs
authorized by the FDA for treatment use, care associated with these
therapies may continue to be covered when long-standing program
requirements are met: (1) that the patient's medical condition warrants
the treatment, and (2) the care is provided in accordance with the
generally accepted standards of medical practice. The DoD is updating
the regulation to clarify that this care may be covered for any
investigational drug authorized for treatment use by the FDA under its
EA programs, not just treatment INDs (i.e., this coverage applies also
to single-patient use, including emergency access, and intermediate
access). This clarification is not a change in coverage, as the DoD has
long interpreted the regulation regarding care associated with
treatment INDs to include the other categories of EA treatment uses.
Establishing a TRICARE Clinical Trial Benefit for Infectious Disease
Health Emergencies
Second, this final rule authorizes coverage of services and
supplies provided in conjunction with Phase I, II, III, and IV clinical
trials sponsored or approved by any NIH Center or Institute other than
the NIH Clinical Center for the treatment or prevention of an
infectious disease that results in a Government-recognized infectious
disease health emergency, rather than only covering NIAID-sponsored
studies for the treatment or prevention of COVID-19. In this context, a
Government-recognized infectious disease health emergency means that
the President of the United States has declared a national emergency,
or the HHS Secretary has declared a PHE for a pandemic or epidemic that
occurs as a result of an infectious disease. For care rendered overseas
(defined as locations outside of the 50 United States and the District
of Columbia) to TRICARE beneficiaries, this definition also includes
epidemics and pandemics recognized by foreign governments and by the
World Health Organization, although only NIH-approved clinical trials
in the region experiencing the Government-recognized epidemic or
pandemic qualify for TRICARE coverage. An NIH-approved clinical trial
means a clinical trial for which NIH, including an NIH Center or
Institute, serves as a collaborator, as the term ``collaborator'' is
defined by NIH.\1\ At the time this rule's publication, NIH defines a
collaborator as ``An organization other than the sponsor that provides
support for a clinical study. This support may include activities
related to funding, design, implementation, data analysis, or
reporting.'' As 10 U.S.C. 1079(a)(12) requires clinical trials covered
under the TRICARE program to be either NIH-sponsored or NIH-approved,
but does not define the term ``NIH-approved,'' the DoD finds it
appropriate to use the current NIH definition of ``collaborator'' as
meaning ``NIH-approved'' when an NIH Center or Institute is listed as a
collaborator for a clinical trial that is otherwise eligible for
TRICARE coverage. Should NIH update this definition or cease listing
collaborators, the DoD would determine if a change in TRICARE
regulation would be beneficial to TRICARE's beneficiary population and,
if so, make appropriate changes through rulemaking. The National
Library of Medicine's registry of clinical trials, available from
<a href="https://www.ClinicalTrials.gov">https://www.ClinicalTrials.gov</a> at the time of this final rule's
publication, lists information about trials, including sponsors and
collaborators. These changes will ensure that TRICARE beneficiaries
receive access to all clinical trials sponsored or approved by NIH
Centers or Institutes for the treatment or prevention of infectious
diseases associated with Government-recognized infectious disease
health emergencies, including COVID-19, not only NIAID-sponsored
clinical trials studying the treatment or prevention of COVID-19. In
the absence of this change, beneficiaries may opt not to participate in
COVID-19 clinical trials sponsored or approved by other NIH Centers and
Institutes due to the potential for large out-of-pocket costs when they
would have participated had TRICARE covered these costs. Many of these
NIH Centers and Institutes study specific organ systems or areas of
research (e.g., diabetes and aging), and COVID-19 clinical trials
sponsored or approved by these Centers and Institutes tend to study the
short-term and long-term impact of COVID-19 in these specific areas of
research, including specific short-term and long-term health problems
caused by COVID-19, whereas NIAID COVID-19 clinical trials tend to
study the virus and disease as a whole.
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\1\ <a href="https://clinicaltrials.gov/study-basics/glossary">https://clinicaltrials.gov/study-basics/glossary</a>.
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COVID-19 patients experience increased risk of complications such
as severe fatigue and muscle weakness, anosmia and ageusia (i.e., loss
of taste and smell), dyspnea (i.e., difficulty breathing), cognitive
impairment, encephalitis, pneumonia, acute respiratory distress
syndrome, acute liver injury, acute myocardial injury, cytokine storms,
and stroke during or shortly after infection and recovery. Long-term or
chronic health consequences (i.e., sequelae) of COVID-19 are often
referred to as ``long COVID'' and include myocarditis, multisystem
inflammatory syndrome, autoimmune disorders, venous thromboembolism,
diabetes mellitus, Guillain-Barre syndrome, kidney damage, lung damage,
and psychiatric disorders. These short-term and long-term complications
impact both individual and population health. For example, health
systems, providers, and public health officials must prepare to treat
and mitigate higher rates of pulmonary, cardiovascular, and kidney
disease and to prevent, diagnose, and treat these conditions in
populations not previously thought to be higher risk.
In addition, this change will not expire upon the termination of
the President's declared national emergency for COVID-19, as is stated
in the IFR published by the DoD on October 30, 2020 (85 FR 68753-
68758). Continuing to cover services and supplies provided in
conjunction with NIH-sponsored or approved Phase I, II, III, and IV
clinical trials for the treatment or prevention of COVID-19 will ensure
that TRICARE beneficiaries have the ability to participate in COVID-19
clinical trials after the termination of the national emergency without
fear of significant out-of-pocket costs. Due to the novel nature of
COVID-19 and the large number of COVID-19 cases since the advent of the
pandemic, it is crucial that researchers continue to study treatments
(including preventive treatments) for the disease and short-term and
long-term health impacts of the disease and its treatments in order to
improve treatment for individuals with complications from COVID-19; to
better support population health efforts (e.g., chronic disease
management and identification of high-risk patients); and to better
prepare public health experts and clinicians to mitigate future
diseases and pandemics. Likewise, TRICARE coverage of clinical trials
investigating treatments for and prevention of future infectious
diseases that are associated with Government-recognized health
emergencies will allow TRICARE to quickly and efficiently maximize
beneficiary access to emerging treatments in the event of
[[Page 35426]]
future epidemics and pandemics, as well as support the societal need
for research into emerging treatments and preventive medicine,
including vaccinations.
These changes will greatly expand beneficiaries' access to clinical
trials beyond the termination of the President's national emergency and
will further DoD support of research studying COVID-19 and other
infectious diseases that may cause a pandemic or an epidemic, including
investigating treatments to improve the long-term prognosis or symptoms
in sufferers of the disease.
Establishing a TRICARE Clinical Trial Benefit for Severely Debilitating
Conditions, Life-Threatening Conditions, and Rare Diseases
Lastly, this final rule authorizes coverage of services and
supplies provided in conjunction with Phase I, II, III, and IV clinical
trials sponsored or approved by any NIH Center or Institute (except the
NIH Clinical Center, which already provides all care free of charge to
participating patients) for which the clinical trial studies a new
treatment or cure for a specific condition or the treatment of a
currently uncontrolled symptom or aspect of that condition, provided
that the condition is severely debilitating, life-threatening, or a
rare disease. This provision modernizes the TRICARE benefit by
expanding existing coverage of clinical trials and will result in
increased access to emerging therapies for beneficiaries with serious
conditions and ineffective or no viable treatment options. This change
will also add coverage of Phase IV NCI-sponsored and approved clinical
trials and remove existing requirements specific to Phase I NCI
clinical trials to maintain parity between the clinical trial benefits.
TRICARE's Phase I-specific requirements are no longer necessary, as
requirements in this final rule and changes to how Phase I clinical
trial protocols are approved result in the existing Phase I
requirements being duplicative, which may also duplicate administrative
costs and increase patient, provider, and Government burden without any
improvement to patient safety or access to eligible clinical trials.
Phase IV trials are critical in continuing to assess a treatment's
safety and efficacy, especially safety and efficacy within specific
sub-populations and in conjunction with certain drugs, even after the
treatment is FDA-approved.
As used in this provision, ``uncontrolled'' refers to a symptom or
aspect of a specific condition that cannot be effectively managed or
cured with existing medications, durable medical equipment, surgery, or
other therapies. This can mean, for example, that an existing treatment
has a high likelihood of harmful side effects experienced by a
significant proportion of patients, including chemical dependence,
elevated risk of mortality, or teratogenic effects. It can also mean
that the existing treatment has a relatively miniscule probability of
successfully treating a specific condition or is only palliative in
nature. It does not mean that harmful side effects have the potential
to occur with a specific treatment or that a specific treatment has a
possibility of failure.
A ``rare disease'' refers to any disease or condition that has a
prevalence of fewer than 200,000 persons in the United States; TRICARE
already uses this definition for regulatory and policy requirements
specific to rare diseases. ``Severely debilitating'' is defined as
``diseases or conditions that cause major irreversible morbidity'' and
``life-threatening'' is defined as ``diseases or conditions where the
likelihood of death is high unless the course of the disease is
interrupted; and diseases or conditions with potentially fatal
outcomes, where the end point of clinical trial analysis is survival.''
The FDA uses both definitions in 21 CFR 312.81 for classifying
treatments, developing clinical trials and emergency use requirements,
and creating drug development guidelines. As the FDA is directly
involved in the regulation and approval of new drugs and devices, the
DoD finds it appropriate to use the FDA's definitions to determine
which clinical trials are most appropriate to cover in writing this
rule and to determine which clinical trials will be eligible for
coverage under this rule. While the DoD is mirroring the FDA's
definitions in implementing these provisions, the DoD's determination
that these categories of diseases and corresponding definitions should
be included under the TRICARE clinical trial benefit is based on the
Department's evaluation of the needs of the TRICARE beneficiary
population. Should the FDA update either definition, the DoD would
evaluate the changes to determine if a similar change in TRICARE
regulation would be beneficial to TRICARE's beneficiary population and,
if so, make appropriate changes through rulemaking.
Severely debilitating conditions may have existing treatments that
manage certain aspects of the condition but have no curative treatments
for aspects of the disease that severely decrease the patient's health
and quality of life. New clinical trials generally seek to improve upon
existing treatments by improving patient outcomes, reducing side
effects, or improving cost efficiency. Examples of severely
debilitating conditions include Canavan Disease and Cystic Fibrosis.
Like severely debilitating conditions, many life-threatening diseases
have existing treatments, but these treatments may increase expected
life expectancy for patients with the disease while resulting in
serious side effects or not curing the disease (e.g., open surgery to
treat cardiovascular diseases, thrombolytics or anticoagulants to treat
blood clots, insulin injections for diabetes); provide a chance of
remission or disease reversal but not restore life expectancy in all
patients (e.g., chemotherapy); or manage symptoms associated with the
disease but not increase life expectancy (e.g., treatments for
Alzheimer's Disease). Examples of life-threatening diseases include
Hepatic Encephalopathy and Amyotrophic Lateral Sclerosis. Researchers
conducting clinical trials on treatments for rare diseases experience
difficulty in recruiting sufficient patient sample sizes, so it is
especially important that TRICARE facilitate beneficiary participation
in rare disease trials. Examples of rare diseases include Acquired
Hemophilia and Guillain-Barr[eacute] Syndrome. Many diseases may fall
into multiple categories; for example, many rare diseases such as
Duchenne Muscular Dystrophy and Creutzfeldt Jakob Disease are also
severely debilitating and life-threatening. These examples are used in
the context of the time of this rule's publication with the
understanding that treatments for these conditions may advance over
time. Additionally, these clinical trials may involve participation by
vulnerable populations, such as children and pregnant individuals. As
this benefit is not intended to influence beneficiaries into
participating or not participating in a clinical trial, only to remove
financial barriers to participation for certain clinical trials, the
Department emphasizes that IRB approval and full informed consent for
patients continues to be required for these clinical trials. When
appropriate, the Director, DHA, may issue additional requirements for
these populations in TRICARE's implementing instructions.
Requirements for TRICARE coverage of these clinical trials are
similar to existing requirements for the COVID-19 and cancer clinical
trial benefits, namely that TRICARE will cost-share all routine medical
care and testing required for participation in the clinical trial; that
participants meet entry criteria for said protocol; that providers
[[Page 35427]]
rendering care as part of the clinical trial be TRICARE-authorized
providers; that TRICARE will not cover care rendered in the NIH
Clinical Center or costs associated with non-treatment research
activities; and that cost-shares and deductibles apply to TRICARE
coverage of clinical trials. Like the COVID-19 and cancer clinical
trial benefits, this provision also does not permit coverage of any
services or supplies that are already covered under the investigational
protocol, including the treatment being studied through the clinical
trial. For example, TRICARE will not reimburse costs for a biologic
used in clinical trials testing the efficacy of that biologic. Only
routine care, meaning those supplies and services that TRICARE
otherwise would have covered during the normal course of treatment
(including costs for screening tests to determine clinical trial
eligibility), will be eligible for coverage. Routine care includes
services such as examinations, imaging, and blood tests to monitor or
assess patient health during the clinical trial and supplies such as
drugs that TRICARE would cover in the absence of the clinical trial
that are medically necessary to treat side effects associated with the
treatment under study in the clinical trial. Routine care may differ in
frequency and magnitude than care would have otherwise in the absence
of the investigational treatment. For example, a patient with lung
cancer might receive monthly blood tests as part of a standard
treatment but require weekly tests while undergoing an investigational
treatment that is part of an eligible clinical trial to monitor adverse
events. To further distinguish between coverage of routine services and
supplies and other services and supplies provided as part of a clinical
trial, this final rule amends Sec. 199.4(g)(14) to clarify that the
exclusion of ``services and supplies provided as a part of or under a
scientific or medical study, grant, or research program'' does not
apply to routine services and supplies provided in conjunction with
clinical trials as authorized in Sec. 199.4(e)(26). The exclusion
still applies to non-routine services and supplies provided under
clinical trials subject to Sec. 199.4(e)(26), e.g., the
investigational treatment being studied within the clinical trial.
However, TRICARE may cover treatments for complications (i.e.,
unfortunate sequelae) related to unproven care, including care received
as part of a clinical trial eligible under this benefit, as authorized
in Sec. 199.4(e)(9). Lastly, as with the COVID-19 and cancer clinical
trial benefits, this provision authorizes the Director, DHA, to issue
procedures and guidelines regarding the administrative process by which
individual patients may be eligible for this benefit. Additional
examples of requirements for the types of clinical trials, conditions,
and routine costs eligible for coverage under this change to the
TRICARE benefit will be detailed in the TRICARE implementing
instructions (i.e., the TRICARE manuals), which are available at
<a href="https://manuals.health.mil/">https://manuals.health.mil/</a> at the time of this final rule's
publication.
All provisions of this final rule support NIH research by expanding
the potential pool of patients who can participate in clinical trials
for emerging treatments and expand TRICARE beneficiary access to
emerging treatments and therapies for serious conditions. Participation
of patients in clinical trials is crucial to the development of new
treatments, particularly for conditions with few or no effective
existing treatments. Patients with severely debilitating, life-
threatening, or rare conditions may also seek early access to
investigational treatments by participating in clinical trials, which
may improve their symptoms, quality of life, and/or prognosis. While
participation in clinical trials must always be voluntary and
participants must be provided with full and informed consent, it is
likewise critical that beneficiaries with severely debilitating, rare,
or life-threatening conditions have access to and choice in available
potential treatments offered through clinical trials in order to
maximize their opportunity to receive available treatments, especially
when the standard treatment may not successfully treat or cure the
condition, or when no treatment exists. The provisions in this final
rule provide additional options for and access to emerging treatments
for these beneficiaries by decreasing some financial barriers to
clinical trials. The Department initially established a demonstration
to test the benefits and feasibility of the NCI cancer clinical trials
benefit, which subsequently became a permanent benefit through
rulemaking. Due to the success of that demonstration at expanding
access to emerging treatments and the similarities to the types of
conditions eligible under this final rule (i.e., like cancer, such
conditions are likewise severely debilitating, life-threatening, and/or
rare diseases), the Department finds that an initial demonstration for
this benefit is unnecessary and that promulgating a permanent benefit
for clinical trials studying emerging treatments for these conditions
under the requirements specified in this final rule will provide
beneficiaries with the most efficient access to emerging treatments in
the safest manner possible.
The DoD also acknowledges that clinical trial participation carries
risks as well as benefits and therefore this final rule includes
several components to protect patients while offering expanded coverage
for clinical trials. First, the Department is limiting the clinical
trial benefit to those trials studying new treatments or treatments for
an uncontrolled symptom or aspect of conditions that are severely
debilitating, life-threatening, and/or a rare disease. This will ensure
that the DoD is only covering care that beneficiaries could not receive
in the absence of the clinical trial and that may improve their
symptoms or prognosis. Second, clinical trials eligible for DoD
coverage must be sponsored or approved by an NIH Center or Institute.
This provision, which is also required in the statutory authority for
coverage of clinical trials at 10 U.S.C. 1079(a)(12), will ensure that
covered clinical trials meet conventional ethical, safety, quality, and
general Good Clinical Practice standards, such as IRB approval and
informed consent for all participants. Lastly, Phase 0 clinical trials
(exploratory IND studies that assess pharmacokinetics and
pharmacodynamics) will not be eligible for coverage. TRICARE coverage
of routine services associated with clinical trials that meet these
standards will be the safest way for beneficiaries to pursue emerging
treatments.
B. Legal Authority
This rule is issued under 10 U.S.C. 1073(a)(2) giving authority and
responsibility to the Secretary of Defense to administer the TRICARE
Program. The text of 10 U.S.C. chapter 55 can be found at <a href="https://manuals.health.mil/">https://manuals.health.mil/</a>.
C. Community Impact
Beneficiaries who enroll in NIAID-sponsored COVID-19 clinical
trials after the expiration of the COVID-19 national emergency will
benefit from TRICARE continuing to reimburse costs for services and
supplies provided in conjunction with eligible clinical trials, instead
of having to pay for these costs out-of-pocket. Likewise, under the new
provisions within this final rule, beneficiaries who enroll in future
COVID-19 clinical trials sponsored or approved by other NIH Centers and
Institutes will also be able to participate in such trials without
paying for costs related to the clinical trials out-of-
[[Page 35428]]
pocket. In the event of a future pandemic or epidemic, TRICARE
beneficiaries will benefit from being able to enroll in clinical trials
studying the treatment or prevention of the infectious disease causing
the Government-recognized infectious disease health emergency.
This final rule also expands clinical trial coverage to services
and supplies provided in conjunction with clinical trials that are
sponsored or approved by NIH Centers and Institutes and that involve a
new treatment or cure for a specific condition or the treatment of a
currently uncontrolled symptom or aspect of that condition for severely
debilitating, life-threatening, and rare diseases. TRICARE
beneficiaries with a severely debilitating or life-threatening
condition, or who have a rare disease, will benefit from the ability to
enroll in clinical trials studying investigational treatments for their
condition without worrying about paying for significant medical costs
related to the clinical trial out-of-pocket. This final rule will also
positively impact research institutions, including NIH Centers and
Institutes, by improving access for these beneficiaries to participate
in valuable research, which expands the participant pool for clinical
trials; this research will likewise benefit the public, who may be able
to access emerging treatments for a severely debilitating, life-
threatening, or rare disease depending on the results for each clinical
trial. The public may also benefit from improved treatment of these
conditions, which often result in higher rates of disability and lower
life expectancy. Lastly, this final rule will impact the TRICARE
managed care support contractors, who will be responsible for ensuring
the requirements set out in these provisions are met. DHA will
delineate the full extent of these responsibilities in contract
modifications.
D. Regulatory History
Each of the sections under which TRICARE is administered are
revised periodically to ensure requirements continue to align with the
evolving health care field. The DoD most recently updated 32 CFR 199.4
on June 1, 2022 (87 FR 33001) by permanently adopting coverage of
telephonic services. The coverage of care associated with treatment
INDs in the second paragraph of the note to Sec. 199.4(g)(15)(A)(i)
has not been permanently revised since the 1997 final rule (62 FR 625)
discussed earlier in this final rule, which clarified the coverage
criteria for proven therapies under TRICARE to include that treatment
INDs were not eligible for coverage but care associated with their
administration could be covered when certain criteria were met. The
clinical trials provision modified in this final rule last changed due
to the IFR establishing the COVID-19 clinical trial benefit (85 FR
68753-68758).
II. Regulatory Impact Analysis
A. Baseline
TRICARE covered investigational drugs for treatment use when
authorized by the FDA under its EA programs through a previous IFR;
this coverage was temporary, limited to treatments of COVID-19, and
expired upon the termination of the President's national emergency for
COVID-19 on April 10, 2023. The FDA granted emergency use authorization
for several COVID-19 therapies such as Remdesivir shortly after their
initial authorization under FDA EA programs, and therefore TRICARE
coverage of EA drugs has been very limited. Likewise, Government costs
due to coverage of EA treatments have been minimal. Due to a lack of
statutory authority to continue the benefit in perpetuity or to expand
it for treatments other than COVID-19, the DoD is not considering
continuing or expanding coverage of EA treatments in the potential
courses of action below.
TRICARE also currently covers routine costs associated with Phase
I, II, and III NCI-sponsored Cancer Clinical trials and Phase I, II,
III, and IV clinical trials sponsored by NIAID for the treatment or
prevention of COVID-19. TRICARE coverage of routine costs associated
with the current clinical trial benefit, which includes NCI-sponsored
Phase I, II, and III Cancer Clinical Trials, is estimated to cost
$18.0M in Fiscal Year 2022 (FY22), and we estimate that this baseline
cost will increase by 4.5% annually to $20.4M in FY24. These estimates
were calculated using historical expenditures, current NCI clinical
trials available from <a href="http://ClinicalTrials.gov">ClinicalTrials.gov</a>, and projections of increases
for medical costs and beneficiary demand.
TRICARE coverage of NIAID-sponsored COVID-19 clinical trials also
expired upon the termination of the President's national emergency for
COVID-19, although this final rule resumes coverage for NIAID-sponsored
COVID-19 clinical trials starting on the final rule's effective date.
Because this rule published after the termination of the national
emergency, all costs related to COVID-19 clinical trials will represent
incremental costs to the Government, but costs associated with NIAID-
sponsored COVID-19 clinical trials are included here as baseline costs
to distinguish them from the costs associated with other clinical
trials. Upon examining TRICARE Encounter Data (TED) Records through
July 2022, only two claims exist for TRICARE beneficiaries
participating in NIAID-sponsored COVID-19 clinical trials; both claims
totaled $28,683 over a 22-month period, equaling an average of $1,366
per month, or an expected average annual cost of $16,392 in FY22. Using
the expected value approach, we anticipate that the Government will
incur this monthly cost, on average, in the future. This low
utilization is likely because most COVID-19 clinical trials were fully
funded by sponsors and therefore no claims were filed for other TRICARE
beneficiaries participating in COVID-19 clinical trials; therefore, we
anticipate that $1,366 per month is likely over-estimating actual
baseline costs.
B. Coverage of Government-Recognized Health Emergency Clinical Trials
and Select NIH-Sponsored or Approved Clinical Trials
The DoD's final regulation expands TRICARE's clinical trial benefit
to (1) make the coverage of NIAID-sponsored COVID-19 clinical trials
permanent and cover all NIH-sponsored or approved COVID-19 trials; (2)
expand coverage of NCI Cancer clinical trials to include Phase IV
trials and NCI-approved Cancer clinical trials; (3) cover services and
supplies provided in conjunction with Phase I, II, III, and IV clinical
trials sponsored or approved by any NIH Center or Institute for the
treatment or prevention of an infectious disease that results in a
Government-recognized infectious disease health emergency, as defined
above in the Statement of Need for this Rule section; and (4) cover
services and supplies provided in conjunction with Phase I, II, III,
and IV clinical trials sponsored or approved by any NIH Center or
Institute in which the clinical trial studies a new treatment or cure
for a specific condition or the treatment of a currently uncontrolled
symptom or aspect of that condition, provided that the condition is
severely debilitating, life-threatening, or a rare disease, as these
terms are defined in this final rule. This expansion of clinical trial
benefits creates several requirements for coverage of each type of
trial.
Through this final rule, current coverage of COVID-19 clinical
trials becomes permanent and is further expanded with coverage of NIH-
sponsored and approved clinical trials for treatment or prevention of
COVID-19, rather than NIAID-sponsored clinical trials only. This final
rule also broadens the benefit in anticipation of
[[Page 35429]]
future infectious diseases that result in a pandemic or epidemic and
result in the declaration of a national emergency or PHE. Additionally,
this final rule expands coverage of NCI Cancer clinical trials to
include NCI-approved Cancer clinical trials and Phase IV clinical
trials, and adds coverage for clinical trials for severely
debilitating, life-threatening, and rare diseases. Coverage
requirements will reflect those currently in effect for NIAID-sponsored
COVID-19 clinical trials. For example, the clinical trial must study a
specific treatment (including preventive treatments) rather than the
infectious disease or population health in general, and TRICARE will
only cover routine costs associated with eligible clinical trials
(e.g., TRICARE will not reimburse the cost of an investigational drug
or new imaging method). These clinical trials may study treatments for
short or long-term health complications from the infectious disease, as
well as treatments that prevent the infection or transmission of a
contagion that causes the infectious disease.
This targeted approach greatly expands the clinical trial benefit
to NIH-sponsored or approved Phase I, II, III, and IV clinical trials
while specifying TRICARE's clinical trial benefit by imposing
requirements on the types of eligible treatments (i.e., the clinical
trial study of a new treatment or cure for a specific condition or the
treatment of a currently uncontrolled symptom or aspect of that
condition) and types of eligible diseases and conditions (i.e., those
that are severely debilitating, life-threatening, or a rare disease).
In this rule, a severely debilitating disease is defined as causing
major irreversible morbidity; a life-threatening disease is defined as
a disease or condition where the likelihood of death is high unless the
course of the disease is interrupted or a disease with potentially
fatal outcomes in which the end point of clinical trial analysis is
survival; and a rare disease is defined as having a prevalence of fewer
than 200,000 persons in the United States. Definitions for ``severely
debilitating conditions'' and ``life-threatening conditions'' will be
added to 32 CFR 199.2, as well as definitions for ``NIH-sponsored
clinical trial'' and ``NIH-approved clinical trial.'' Additional
discussion and examples of eligible treatments and diseases are
provided earlier in the Background section of this preamble.
In addition to these changes, the termination of coverage of EA
treatments for COVID-19 is also discussed in this rule. An in-depth
analysis of this decision is discussed in the Background section of
this preamble.
1. Analysis of Final Regulation
By (1) making the coverage of NIAID COVID-19 clinical trials
permanent and covering all NIH-sponsored or approved COVID-19 trials,
beneficiaries would be able to enroll in any NIH-sponsored or approved
COVID-19 clinical trial for the treatment or prevention of COVID-19
after the termination of the President's national emergency for COVID-
19 and be eligible for coverage of routine costs associated with such
trials. Clinical trials studying treatments for short- or long-term
health complications (i.e., sequelae) caused by COVID-19 would also be
eligible for coverage under this benefit (e.g., a clinical trial
studying a new oral steroid to treat Acute Respiratory Distress
Syndrome caused by COVID-19 pneumonia would be eligible for coverage).
Clinical trials that are solely observational or that are not studying
a specific drug, vaccine, device, or other treatment would continue to
be ineligible for coverage. Other coverage requirements would mirror
existing regulatory requirements for NIAID COVID-19 clinical trials.
For example, clinical trials conducted at the NIH Clinical Center would
be ineligible for TRICARE coverage of any costs. Requirements for (2)
Phase IV Cancer clinical trials will largely mirror existing regulatory
requirements for NCI Cancer clinical trials, including requiring pre-
authorization before the initial evaluation; requiring that providers
be TRICARE-authorized; requiring that care rendered in the NIH Clinical
Center be excluded from coverage; and applying normal cost-share
procedures.
Additionally, this final rule financially supports clinical trial
research sponsored or approved by any NIH Center or Institute for the
(3) prevention and treatment for future Government-recognized
infectious disease emergencies, as well as for (4) severely
debilitating, life-threatening, and rare diseases. It also improves
access to treatments for such diseases in the safest manner possible
for TRICARE beneficiaries with the greatest need for emerging
treatments, i.e., beneficiaries with severely debilitating, life-
threatening and rare conditions when the treatment has limited efficacy
or when no treatment exists. These treatments may significantly improve
beneficiary health outcomes (including symptoms, quality of life,
prognosis, and life expectancy), and support of this research may
assist with the full approval of emerging treatments, which would also
improve the health outcomes for the general public and may reduce
public and private spending due to death and disability that result
from these conditions. Through expanded coverage for routine costs,
clinical trials may receive higher application rates from TRICARE
beneficiaries. Additionally, many groups are underrepresented in
clinical trials research; this expansion in access may contribute to
increased diversity within the clinical trial sample population. As
discussed above, both factors are necessary to determine the actual
efficacy of a treatment, especially across sub-populations (e.g., is a
treatment less effective for men over the age of 75 or more effective
for female Indigenous Americans). For Phase IV trials studying a
treatment already covered by TRICARE, the Government may realize cost-
savings by paying for routine costs only, rather than also paying for
the treatment. Likewise, the Government may realize cost savings from
beneficiaries receiving an experimental treatment through a clinical
trial, which is paid for by the investigator, over potentially less
effective treatments covered by the TRICARE Program. This is especially
relevant for novel infectious diseases such as COVID-19, which have few
non-investigational treatments for short-term or long-term
complications from the disease. Continuing the COVID-19 clinical trial
benefit and expanding it to future infectious diseases that result in a
pandemic or epidemic to the extent that a national emergency or PHE is
declared will also support the development of treatment options for
individuals who experience these complications.
The Government-recognized infectious disease health emergency
clinical trial benefit, including continued coverage of COVID-19
clinical trials, will also support research efforts that may mitigate
future pandemics and epidemics, including the development of treatments
(as well as vaccines or other preventive treatments) for future novel
infectious diseases and their associated short-term and long-term
complications. While most of these benefits are intangible or otherwise
infeasible to quantify, this benefit is also expected to save
beneficiaries who were otherwise inclined to participate in a
particular clinical trial hundreds to thousands of dollars per trial,
although this amount is highly variable based on the specific type of
trial. This cost is transferred from TRICARE beneficiaries
participating in clinical trials to the Government and is further
discussed in the cost analysis below.
[[Page 35430]]
As participation in this benefit is optional for clinical trial
investigators, providers, and beneficiaries, this change imposes no
direct burden on the public, but the pre-authorization requirement for
clinical trials studying treatments for severely debilitating, life-
threatening, or rare diseases will impose a minor barrier to this
benefit. Pre-authorization provides some assurance that the beneficiary
will not be financially liable for routine care provided under the
trial. The Department finds that pre-authorization is necessary to
ensure that these clinical trials meet all requirements set forth in
this rule and does not anticipate pre-authorization imposing a
significant burden, as most clinical trials require months to years to
complete recruitment and enrollment, and a significant number of
clinical trials for these categories of diseases utilize rolling
enrollment. Additionally, TRICARE coverage of NCI Cancer Clinical
Trials currently requires pre-authorization, and many treatments for
severely debilitating, life-threatening, and rare diseases likewise
have existing pre-authorization requirements under public and private
health insurance plans. This requirement will also impose
administrative costs to the Government; these costs are discussed in
this analysis. TRICARE coverage of clinical trials studying treatments
for Government-recognized infectious disease health emergencies will
continue to not require pre-authorization due to the emergent, fast-
paced, and novel nature of infectious diseases that cause pandemics and
epidemics.
As discussed above, coverage of clinical trials carries risks to
beneficiaries, who may experience mild or severe adverse events due to
clinical trial participation or who may be randomly assigned to the
control group. However, this rule limits eligible clinical trials to
those studying a new treatment or cure for a specific condition or the
treatment of a currently uncontrolled symptom or aspect of that
condition, provided that the condition is severely debilitating, life-
threatening, or a rare disease. These requirements therefore restrict
the TRICARE clinical trial benefit to those beneficiaries in the
greatest need of emerging treatments. Additionally, pursuing emerging
treatments provided under an NIH-sponsored or approved clinical trial
generally carries less risk to patients than unproven treatments
pursued outside of clinical trial protocols due to the safety
parameters required by NIH-sponsored or approved clinical trial
protocols and requirements, such as IRB approval and informed consent
for all patients. The Background section of this preamble further
discusses patient protection.
As discussed in the baseline cost section, we estimate average
annual costs at $16,392 for FY22 for NIAID-sponsored COVID-19 clinical
trials. Due to low utilization and because COVID-19 clinical trials
sponsored or approved by non-NIAID NIH Centers and Institutes tend to
incur similar or lower costs than NIAID-sponsored COVID-19 clinical
trials, we assume that costs for all NIH-sponsored or approved COVID-19
clinical trials will not exceed those for NIAID-sponsored COVID-19
clinical trials. However, we estimate a potential increase in demand
and medical costs, so we projected a 4.5% increase in costs annually.
Therefore, we estimate costs to be $18,704 in FY24 and estimate 5-year
costs to be $102,323 from FY24-FY28. We estimate no incremental start-
up or incremental administrative costs, as any administrative
requirements (e.g., eligibility determinations and customer support)
are within the existing scope of the Managed Care Support contracts,
which have already been modified to include the COVID-19 clinical trial
benefit.
To approximate TRICARE costs for NCI Phase IV trials, we used a
cost ratio approach to calculate the relative costs of NCI Phase IV
trials compared to NCI Phase I-III clinical trials. Direct costs to the
Government were calculated by first analyzing historical TRICARE
expenditures for NCI-sponsored Cancer Phase I, II, and III clinical
trials from TED records, representing baseline costs for this rule
($18.0M in FY22). We chose this approach because NCI Phase IV clinical
trial costs are an unknown variable, but we know TRICARE-specific costs
for NCI-sponsored Phase I-III trials and total enrollment in NCI-
sponsored clinical trials. To accomplish this, we first analyzed public
data on <a href="http://ClinicalTrials.gov">ClinicalTrials.gov</a> for active, non-recruiting NCI-sponsored or
approved Phase I-IV clinical trials and identified the number of
participants in each trial. Each trial was also classified into one of
11 categories representing various types of clinical trials and their
associated costs, including a category that represented no costs. The
historical TRICARE expenditures for the NCI Phase I-III trials were
then used to calculate an annual average TRICARE cost per trial
enrollee for each category; this average cost per enrollee for each
specific category was also used to estimate TRICARE costs for the NCI
Phase IV trials. This estimate, therefore, assumes that the average
cost per enrollee will be the same from NCI Phase I-III to NCI Phase IV
trials in a given category, as there is no other visibility into NCI
Phase IV clinical trial costs. For example, we assume that an NCI Phase
IV clinical trial studying a pharmaceutical drug would incur the same
costs, on average, as an NCI Phase I, II, or III clinical trial
studying a pharmaceutical drug.
The annual average TRICARE cost per trial enrollee for each
category was then multiplied by the total number of non-NCI, non-COVID-
19 clinical trial enrollees in each category (as reported on
<a href="http://ClinicalTrials.gov">ClinicalTrials.gov</a>) to estimate total costs for each category. Costs
were calculated separately for Phase I-III and for Phase IV trials, and
then Phase IV trial costs were divided by Phase I-III trial costs to
calculate an estimated cost ratio of 3.53%, meaning that NCI Phase IV
trial costs for all enrollees are 3.53% of the cost of non-NCI, non-
COVID-19 Phase I-III trials for all enrollees. Note that these costs
represent routine costs associated with clinical trials for all
patients, not TRICARE beneficiaries alone, using TRICARE cost data from
NCI clinical trials. This calculation is, therefore, not intended to
estimate total NCI clinical trial costs for all participants. Instead,
using this methodology provides an unbiased estimate of relative costs
for NCI Phase IV trials compared to NCI Phase I-III clinical trials. To
estimate incremental TRICARE costs for NCI Phase IV clinical trials, we
multiplied the 3.53% cost ratio by the TRICARE costs for NCI Phase I,
II, and III clinical trials, which equals $0.7M in projected FY24 costs
for NCI Phase IV trials.
To estimate costs for coverage of Government-recognized infectious
disease health emergencies, we first identified all national
emergencies and PHEs due to infectious diseases within the last ten
years. The Zika virus epidemic was declared a PHE on August 12, 2016,
and lasted ten months. The mpox (initially referred to as monkeypox)
outbreak was declared a PHE on August 2, 2022, and the PHE lasted
nearly six months. The COVID-19 pandemic was declared a PHE on January
31, 2020, and a national emergency on March 13, 2020; the national
emergency ended on April 10, 2023, and the PHE ended on May 11, 2023.
Using historical data, we assume that the COVID-19 pandemic is a 100-
year event, like the 1918 H1N1 flu pandemic. Additionally, using NIAID
COVID-19 claims data and the total duration of the three Government-
recognized infectious disease health emergencies in the United States
from 2012 to 2022, we assume that expenditures for clinical trials will
[[Page 35431]]
average approximately $735 per month ($8,820 annually in 2022 dollars).
Like other estimates discussed in this rule, we assume a 4.5% increase
in costs annually, based on projections made by the Centers for
Medicare and Medicaid Services (CMS) Office of the Actuary. As with
COVID-19 clinical trials, it is difficult to project the incidence and
duration of future national emergencies and PHEs caused by pandemics
and epidemics, as well as the number, duration, and type of clinical
trials constructed to study each infectious disease and the
participation in by TRICARE beneficiaries, so this estimate should be
interpreted as an expected value over time. Therefore, we expect
incremental Government costs of approximately $10,065 in FY24 and five-
year costs of $55,063 from FY24-FY28.
We also used the same overall cost ratio methodology as the
estimate for other NIH-sponsored or approved clinical trials to begin
our estimate of covering the subset of NIH clinical trials that study
severely debilitating, life-threatening, or rare diseases. After
calculating costs for each category of clinical trial, we estimated the
probability that each of the 556 clinical trials would meet eligibility
criteria, i.e., study a new treatment or cure for a specific condition
or the treatment of a currently uncontrolled symptom or aspect of that
condition, provided that the condition or the uncontrolled symptom of
the condition under study in the clinical trial is severely
debilitating, life-threatening, or a rare disease. The probabilities
for each trial were multiplied by the average cost for that trial's
category to estimate an expected value for the annual probability-
adjusted costs for all participants. As discussed above, these costs
represent Government costs for all participants if TRICARE had covered
all routine costs; this calculation is also not intended to estimate
total national costs for this subset of clinical trials. This
methodology is instead intended to provide an unbiased estimate of
relative costs to use in projecting TRICARE-specific costs for this
subset of NIH clinical trials. Dividing the costs for NCI Cancer Phase
I-IV clinical trials by the costs for this subset of NIH clinical
trials resulted in a cost-adjustment ratio of 8.6%. In other words, we
estimated that the costs of covering this subset of NIH clinical trials
would be 8.6% of the costs of covering NCI Cancer Phase I-IV clinical
trials. Multiplying this adjustment ratio by projected TRICARE costs
for NCI Cancer Phase I-IV clinical trials equals an estimated TRICARE
cost of $1.81M in FY24 to cover this subset of NIH clinical trials,
including NCI-approved Cancer Phase I-III clinical trials. Adding this
total to the costs of covering routine care associated with NCI Cancer
Phase IV clinical trials ($0.72M), NIAID COVID-19 clinical trials
($0.02M), and Government-recognized health emergency clinical trials
($0.01M) equals a total estimated cost of $2.56M in FY24 to the
Government for covering NIH-sponsored and approved clinical trials. We
assume that these costs will increase 4.5% annually and project $14.00M
in direct costs to the Government over five years from FY24-FY28.
Additionally, we anticipate administrative costs related to
coverage of NIH-sponsored or approved clinical trials for severely
debilitating, life-threatening, and rare diseases. Administrative costs
represent the value of labor incurred by Government employees
(including military and civilian DoD employees) and Government
contractors (including sub-contractors) who administer the TRICARE
benefit. One-time start-up costs and recurring administrative costs are
therefore estimated at $445,510 and $88,344, respectively, in FY24; we
also project a 4.5% increase in recurring administrative costs each
following year. Start-up costs refer to resources used before
implementing this final rule, including an impact assessment and
development of requirements, administrative components, and information
technology system changes. We project that approximately 1,810 full-
time equivalent (FTE) hours will be required to implement all changes
associated with this final rule, for an estimated one-time start-up
cost of $445,510. For recurring resources required to implement these
changes, we anticipate approximately one hour of labor per claim; this
recurring labor includes care management, referral and pre-
authorization requirements, eligibility reviews, and customer support.
We assume no administrative costs will be incurred due to coverage of
NIAID COVID-19 clinical trials or Government-recognized infectious
disease health emergency clinical trials.
2. Total Costs for Government & Non-Government
This final rule impacts four direct medical cost components: (1)
NIAID-sponsored and approved COVID-19 clinical trials, (2) NCI-
sponsored and approved Cancer Phase IV clinical trials, (3) Government-
recognized infectious disease health emergency clinical trials, and (4)
other NIH-sponsored and approved clinical trials, which includes NCI-
approved Cancer clinical trials. The subtotal for direct medical cost
is estimated at $2.56M in FY24 and the five-year direct cost subtotal
is estimated at $14.00M from FY24-FY28, assuming a 4.5% increase in
costs annually based on projections made by the CMS Office of the
Actuary. Costs for NCI-sponsored Cancer Phase I, II, and III trials are
existing baseline costs and are therefore excluded. Start-up and
recurring administrative costs for FY24 are estimated at $445,510 and
$88,344, respectively, for a FY24 administrative cost total of $0.53M.
Start-up costs are one-time costs occurring before the implementation
of these provisions, while recurring administrative costs are projected
to increase by 4.5% annually.
Table 1 summarizes the direct medical and administrative costs
discussed above. These costs do not include any potential cost-savings,
intangible benefits, or intangible costs to either the Government or
non-Government entities. Additionally, healthcare providers and the
general public are expected to incur zero costs, while costs to
patients and Government contractors are transferred to the Government
as direct medical costs or administrative costs, respectively.
Table 1--Government Costs
[All costs in millions]
--------------------------------------------------------------------------------------------------------------------------------------------------------
FY24 FY25 FY26 FY27 FY28 FY24-FY28
--------------------------------------------------------------------------------------------------------------------------------------------------------
NIAID COVID-19 Clinical Trials.......................... $0.02 $0.02 $0.02 $0.02 $0.02 $0.10
NCI Cancer Phase IV Clinical Trials..................... 0.72 0.75 0.79 0.82 0.86 3.94
Government-recognized Health Emergency Clinical Trials.. 0.01 0.01 0.01 0.01 0.01 0.05
Subset of NIH Sponsored and Approved Clinical Trials.... 1.81 1.89 1.98 2.06 2.16 9.90
[[Page 35432]]
Administrative Costs.................................... 0.53 0.08 0.09 0.09 0.09 0.88
-----------------------------------------------------------------------------------------------
Totals.............................................. 3.09 2.75 2.89 3.00 3.14 14.87
--------------------------------------------------------------------------------------------------------------------------------------------------------
3. Benefits
Compared to the TRICARE baseline, this final rule provides greater
assistance to federally funded or approved clinical studies. It also
allows a greater number of beneficiaries to benefit from emerging
treatments, and, based on public comments, the COVID-19 pandemic, and
the clinical trials reimbursement landscape, the Department finds it
appropriate to expand TRICARE's clinical trial benefit. Making the
coverage of NIAID-sponsored COVID-19 clinical trials permanent and
covering all NIH-sponsored or approved COVID-19 trials will further
support scientific efforts into studying COVID-19, provide
beneficiaries with access to emerging treatments for COVID-19
treatments that are not yet proven, and would remove some financial
barriers for TRICARE beneficiaries who wish to participate in a
clinical trial for an emerging treatment. Removing these financial
barriers may encourage participation in NIH-sponsored or approved
COVID-19 clinical trials over riskier, unproven treatments outside the
safety parameters required by clinical trial protocols. Additionally,
our targeted approach to expanded clinical trial coverage better
protects patients by selecting certain diseases and conditions, as
discussed above; patient safety is a key reason TRICARE generally only
covers treatments proven safe and effective. As a Government-funded
health program, TRICARE must also strive to use Government dollars in a
cost-effective manner. The Department believes access to emerging,
unproven treatments should be provided to beneficiaries who may
substantially benefit from emerging treatments, namely beneficiaries
with severely debilitating, life-threatening, or rare conditions for
which treatments are limited, as well as conditions that result in
epidemics or pandemics. Treatments for these conditions also tend to
have limited reliable evidence and the Department's coverage of routine
costs will further research into treatments for these conditions by
improving beneficiary access to these clinical trials.
Additionally, the Patient Protection and Affordable Care Act
(PPACA) requires health plans subject to PPACA requirements to cover
routine patient costs for items and services furnished in connection
with participation in the trials only if the clinical trial is
federally approved or funded; studies the prevention, detection, or
treatment of cancer or another life-threatening disease or condition;
and either has an investigational new drug application or is exempt
from investigational new drug application requirements. This rule,
therefore, more closely aligns TRICARE's clinical trial benefit with
clinical trial coverage offered by many private health plans.
Ultimately, the DoD included these provisions to achieve a balance
between assisting more beneficiaries--as well as the general public--at
a lower cost to the Government while also protecting patient safety and
ensuring that coverage of clinical trials is provided only to
individuals who have a need for emerging treatments because they have a
debilitating or life-threatening disease or condition or a rare
disease.
III. Regulatory Compliance Analysis
A. Executive Order 12866, ``Regulatory Planning and Review,'' and
Executive Order 13563, ``Improving Regulation and Regulatory Review''
Executive Order 12866 and Executive Order 13563 direct agencies to
assess all costs, benefits, and available regulatory alternatives and,
if regulation is necessary, to select regulatory approaches that
maximize net benefits (including potential economic, environmental,
public health, safety effects, distributive impacts, and equity). These
Executive Orders emphasize the importance of quantifying both costs and
benefits, of reducing costs, of harmonizing rules, and of promoting
flexibility. This rule has been designated not significant, under
section 3(f) of Executive Order 12866.
B. Executive Order 14192, ``Unleashing Prosperity Through
Deregulation''
This rule is not an Executive Order 14192 regulatory action because
this rule is not significant under Executive Order 12866.
C. Congressional Review Act (5 U.S.C. 801 et seq.)
Pursuant to the Congressional Review Act, this rule has not been
designated a major rule, as defined by 5 U.S.C. 804(2).
D. Public Law 96-354, ``Regulatory Flexibility Act'' (5 U.S.C. 601)
The ASD(HA) certified that this rule is not subject to the
Regulatory Flexibility Act (5 U.S.C. 601) because it would not, if
promulgated, have a significant economic impact on a substantial number
of small entities. Therefore, the Regulatory Flexibility Act, as
amended, does not require us to prepare a regulatory flexibility
analysis.
E. Sec. 202, Public Law 104-4, ``Unfunded Mandates Reform Act''
Section 202 of the Unfunded Mandates Reform Act of 1995 (2 U.S.C.
1532) requires agencies to assess anticipated costs and benefits before
issuing any rule whose mandates require spending in any 1 year of $100
million in 1995 dollars, updated annually for inflation. This rule will
not mandate any requirements for state, local, or tribal governments,
and will not affect private sector costs.
F. Public Law 96-511, ``Paperwork Reduction Act'' (44 U.S.C. Chapter
35)
It has been determined that this rule does not impose reporting or
recordkeeping requirements under the Paperwork Reduction Act of 1995.
G. Executive Order 13132, ``Federalism''
Executive Order 13132 establishes certain requirements that an
agency must meet when it promulgates a final rule that imposes
substantial direct requirement costs on state and local governments,
preempts state law, or otherwise has federalism implications. This rule
will not have a substantial effect on State and local governments.
H. Executive Order 13175, ``Consultation and Coordination With Indian
Tribal Governments''
Executive Order 13175 establishes certain requirements that an
agency
[[Page 35433]]
must meet when it promulgates a final rule that imposes substantial
direct compliance costs on one or more Indian tribes, preempts tribal
law, or effects the distribution of power and responsibilities between
the Federal Government and Indian tribes. This rule will not have a
substantial effect on Indian tribal governments.
List of Subjects in 32 CFR Part 199
Administrative practice and procedure, Claims, Dental, Fraud,
Health care, Health insurance, Individuals with disabilities, Mental
health programs, and Military personnel.
For the reasons stated in the preamble, the DoD adopts the interim
final rules amending 32 CFR part 199, which were published at 85 FR
54914-54924 on September 3, 2020 and 85 FR 68753-68758 on October 30,
2020 as final with the following changes:
PART 199--CIVILIAN HEALTH AND MEDICAL PROGRAM OF THE UNIFORMED
SERVICES (CHAMPUS)
0
1. The authority citation for part 199 continues to read as follows:
Authority: 5 U.S.C. 301; 10 U.S.C. chapter 55.
0
2. Amend Sec. 199.2(b) by adding definitions for ``Life threatening
conditions'', ``National Institutes of Health (NIH)-approved clinical
trial'', ``NIH-sponsored clinical trial'', and ``Severely debilitating
conditions'' in alphabetical order to read as follows:
Sec. 199.2 Definitions.
* * * * *
Life threatening conditions. Diseases or conditions where the
likelihood of death is high unless the course of the disease is
interrupted and diseases or conditions with potentially fatal outcomes,
where the end point of clinical trial analysis is survival.
* * * * *
National Institutes of Health (NIH)-approved clinical trial. An
NIH-defined clinical trial, i.e., a research study in which one or more
human subjects are prospectively assigned to one or more interventions
(which may include placebo or other control) to evaluate the effects of
those interventions on health-related biomedical or behavioral
outcomes, in which the NIH collaborates with the study sponsor to
provide resources or other support towards the development of the
clinical trial and/or analysis of its results. This support may include
funding, design, implementation, data analysis, or reporting.
* * * * *
NIH-sponsored clinical trial. An NIH-defined clinical trial, i.e.,
a research study in which one or more human subjects are prospectively
assigned to one or more interventions (which may include placebo or
other control) to evaluate the effects of those interventions on
health-related biomedical or behavioral outcomes, in which the NIH
initiates, funds, manages, and otherwise oversees the clinical trial.
* * * * *
Severely debilitating conditions. Diseases or conditions that cause
major irreversible morbidity.
* * * * *
0
3. Amend Sec. 199.4 by:
0
a. Revising paragraph (e)(26)(ii) and (iii);
0
b. Revising paragraph (g)(14); and
0
c. Revising the second paragraph of the note to paragraph
(g)(15)(i)(A).
The revisions read as follows:
Sec. 199.4 Basic program benefits.
* * * * *
(e) * * *
(26) * * *
(ii) Continuous waiver--(A) General. As a result of a demonstration
project or rulemaking under which a waiver has been granted in
connection with a National Institutes of Health (NIH)-sponsored or
approved clinical trial, a determination may be made that it is in the
best interest of the government and eligible beneficiaries to provide a
waiver for CHAMPUS cost-sharing of routine services and supplies
associated with the eligible clinical trial. Only those specified
clinical trials identified under this paragraph (e)(26)(ii) and
paragraph (e)(26)(iii) of this section have been authorized a
continuous waiver under CHAMPUS. Continuous waivers specific to public
health emergencies are described in paragraph (e)(26)(iii) of this
section.
(B) National Cancer Institute (NCI) sponsored or approved cancer
prevention, screening, and early detection clinical trials. A
continuous waiver under paragraph (e)(26) of this section has been
granted for CHAMPUS cost-sharing for those eligible beneficiaries
selected to participate in NCI-sponsored or approved Phase I, Phase II,
Phase III, and Phase IV studies for the prevention and treatment of
cancer.
(1) CHAMPUS will cost-share all medical care and testing required
to determine eligibility for an NCI-sponsored or approved trial,
including the evaluation for eligibility at the institution conducting
the NCI-sponsored or approved study. CHAMPUS will cost-share all
medical care required as a result of participation in NCI-sponsored or
approved studies. This includes purchasing and administering all
approved chemotherapy agents (except for NCI-funded investigational
drugs provided as part of the clinical trial) and all inpatient and
outpatient care, including diagnostic and laboratory services not
otherwise reimbursed under an NCI grant program if the following
conditions are met:
(i) The provider seeking treatment for an eligible beneficiary in
an NCI approved protocol has obtained pre-authorization for the
proposed treatment before initial evaluation;
(ii) Such treatments are NCI-sponsored or approved Phase I, Phase
II, Phase III, or Phase IV protocols;
(iii) The beneficiary continues to meet entry criteria for said
protocol; and
(iv) The institutional and individual providers are CHAMPUS
authorized providers.
(2) CHAMPUS will not provide reimbursement for care rendered in the
National Institutes of Health Clinical Center or costs associated with
non-treatment research activities associated with the clinical trials.
(3) Cost-shares and deductibles applicable to CHAMPUS will also
apply under the NCI-sponsored or approved clinical trials.
(4) The Director shall issue procedures and guidelines establishing
NCI-sponsorship and approval of clinical trials and the administrative
process by which individual patients apply for and receive cost-sharing
under NCI-sponsored or approved cancer clinical trials.
(C) NIH-sponsored and approved clinical trials for severely
debilitating diseases, life-threatening diseases, and rare diseases.
The Secretary has approved a continuous waiver under paragraph (e)(26)
of this section for CHAMPUS cost-sharing for those eligible
beneficiaries selected to participate in NIH-sponsored or approved
Phase I, Phase II, Phase III, and Phase IV clinical trials in which the
clinical trial studies a new treatment or cure for a specific condition
or the treatment of a currently uncontrolled symptom or aspect of that
condition, provided that the condition is severely debilitating, life-
threatening, or a rare disease.
(1) CHAMPUS will cost-share all medical care and testing required
to determine eligibility for an NIH-sponsored or approved trial,
including
[[Page 35434]]
the evaluation for eligibility at the institution conducting the NIH-
sponsored or approved study. CHAMPUS will cost-share all medical care
(including associated health complications) required as a result of
participation in NIH-sponsored or approved studies. This includes
purchasing and administering all approved pharmaceutical agents (except
for sponsor-funded investigational drugs provided as part of the
clinical trial) and all inpatient and outpatient care, including
diagnostic, laboratory, rehabilitation, and home health services not
otherwise reimbursed under an NIH grant program if the following
conditions are met:
(i) The provider seeking treatment for an eligible beneficiary in
an NIH approved protocol has obtained pre-authorization for the
proposed treatment before initial evaluation;
(ii) Such treatments are NIH-sponsored or approved Phase I, Phase
II, Phase III, or Phase IV protocols;
(iii) The beneficiary continues to meet entry criteria for said
protocol; and,
(iv) The institutional and individual providers are CHAMPUS
authorized providers,
(2) CHAMPUS will not provide reimbursement for care rendered in the
NIH Clinical Center or costs associated with non-treatment research
activities associated with the clinical trials.
(3) Cost-shares and deductibles applicable to CHAMPUS will also
apply under the NIH-sponsored or approved clinical trials.
(4) The Director shall issue procedures and guidelines establishing
NIH-sponsorship and approval of clinical trials and the administrative
process by which individual patients apply for and receive cost-sharing
under eligible NIH-sponsored or approved clinical trials.
(iii) Public health emergency or national emergency waiver--(A)
General. A waiver has been granted for CHAMPUS cost-sharing for
eligible beneficiaries who participate in Phase I, II, III, or IV
trials that are sponsored or approved by the NIH or an NIH Center or
Institute for the purposes of treatment or prevention of a Government-
recognized epidemic or pandemic that results in a national emergency or
public health emergency.
(B) Infectious disease health emergencies. CHAMPUS will cover cost-
sharing for those eligible beneficiaries selected to participate in
NIH-sponsored or approved Phase I, II, III, and IV studies examining
the treatment or prevention of an infectious disease (and any
associated sequelae) that causes a pandemic or epidemic, when part of a
national emergency declared by the President of the United States or a
public health emergency declared by the Secretary of Health and Human
Services. For eligible beneficiaries receiving covered services
overseas, this coverage also includes pandemics and epidemics
recognized by foreign governments and pandemics and epidemics
recognized by the World Health Organization, although only NIH-approved
clinical trials in the region experiencing the Government-recognized
pandemic or epidemic qualify for coverage under this provision.
(1) CHAMPUS will cost-share all medical care and testing required
to determine eligibility for an NIH-sponsored or approved trial,
including the evaluation for eligibility at the institution conducting
the NIH-sponsored or approved study. CHAMPUS will cost-share all
medical care (including associated health complications) required as a
result of participation in NIH-sponsored or approved studies. This
includes purchasing and administering all approved pharmaceutical
agents (except for NIH-funded investigational drugs provided as part of
the clinical trial) and all inpatient and outpatient care, including
diagnostic, laboratory, rehabilitation, and home health services not
otherwise reimbursed under an NIH grant program if the following
conditions are met:
(i) Such treatments are NIH-sponsored or approved Phase I, Phase
II, Phase III, or Phase IV protocols;
(ii) The beneficiary continues to meet entry criteria for said
protocol; and
(iii) The institutional and individual providers are CHAMPUS
authorized providers.
(2) CHAMPUS will not provide reimbursement for care rendered in the
NIH Clinical Center or costs associated with non-treatment research
activities associated with the clinical trials.
(3) Cost-shares and deductibles applicable to CHAMPUS will also
apply under the NIH-sponsored or approved clinical trials.
(4) Coverage of cost-sharing for those eligible beneficiaries
selected to participate in a clinical trial that meets criteria under
paragraph (e)(26)(iii)(B) of this section is effective the date the
national or public health emergency is declared and does not terminate
at the end of the emergency period.
(5) The Director shall issue procedures and guidelines establishing
NIH-sponsorship and approval of clinical trials and the administrative
process by which individual patients apply for and receive cost-sharing
under eligible NIH-sponsored or approved clinical trials.
Note: A waiver has been authorized for CHAMPUS cost-sharing for
those eligible beneficiaries selected to participate in NIH-
sponsored or approved Phase I, II, III, and IV studies examining the
treatment or prevention of Coronavirus Disease 2019 and its
associated sequelae.
* * * * *
(g) * * *
(14) Study, grant, or research programs. Services and supplies
provided as a part of or under a scientific or medical study, grant, or
research program, except as authorized under paragraph (e)(26) of this
section.
(15) * * *
(i) * * *
(A) * * *
Note to paragraph (g)(15)(i)(A): * * *
Certain cancer drugs, designated as Group C drugs (approved and
distributed by the National Cancer Institute), and investigational
drugs authorized by the FDA for treatment use under expanded access
programs are not covered under TRICARE because they are not approved
for marketing by the FDA. However, medical care related to the use of
Group C drugs and investigational drugs authorized for treatment use
under FDA expanded access programs can be cost-shared under TRICARE
when the patient's medical condition warrants their administration, and
the care is provided in accordance with generally accepted standards of
medical practice.* * *
* * * * *
Dated: July 24, 2025.
Aaron T. Siegel,
Alternate OSD Federal Register Liaison Officer, Department of Defense.
[FR Doc. 2025-14206 Filed 7-25-25; 8:45 am]
BILLING CODE 6001-FR-P
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