TRICARE Coverage of National Institute of Allergy and Infectious Disease Coronavirus Disease 2019 Clinical Trials, 68753-68758 [2020-24114]
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Federal Register / Vol. 85, No. 211 / Friday, October 30, 2020 / Rules and Regulations
Executive Order 13175, Consultation
and Coordination With Indian Tribal
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This rule does not have tribal
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68753
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List of Subjects
21 CFR Part 1308
Administrative practice and
procedure, Drug traffic control,
Reporting and recordkeeping
requirements.
For the reasons set out above, DEA
amends 21 CFR part 1308 as follows:
PART 1308—SCHEDULES OF
CONTROLLED SUBSTANCES
1. The authority citation for 21 CFR
part 1308 continues to read as follows:
■
Authority: 21 U.S.C. 811, 812, 871(b),
956(b), unless otherwise noted.
2. Amend § 1308.12 by:
a. Redesignating paragraph (c)(18)
through (c)(29) as (c)(19) through (c)(30);
■ b. Adding new paragraph (c)(18).
The addition to read as follows:
■
■
§ 1308.12
*
Schedule II.
*
*
(c) * * *
*
*
(18) Oliceridine (N-[(3-methoxythiophen-2-yl)methyl] ({2-[(9R)-9-(pyridin-2-yl)-6-oxaspiro [4.5]decan-9-yl]ethyl})amine fumarate) ...........
*
*
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Timothy J. Shea,
Acting Administrator.
[FR Doc. 2020–22762 Filed 10–29–20; 8:45 am]
BILLING CODE 4410–09–P
DEPARTMENT OF DEFENSE
Office of the Secretary
32 CFR Part 199
[Docket ID: DOD–2020–HA–0050]
RIN 0720–AB83
TRICARE Coverage of National
Institute of Allergy and Infectious
Disease Coronavirus Disease 2019
Clinical Trials
Office of the Secretary,
Department of Defense (DoD).
ACTION: Interim final rule with request
for comments.
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AGENCY:
The Assistant Secretary of
Defense for Health Affairs (ASD(HA))
issues this interim final rule (IFR) with
request for comments to temporarily
modify the TRICARE regulation by
adding coverage for National Institute of
SUMMARY:
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Allergy and Infectious Disease (NIAID)sponsored clinical trials for the
treatment or prevention of coronavirus
disease 2019 (COVID–19).
DATES: Effective date: This interim final
rule is effective on October 30, 2020
through the end of the President’s
national emergency regarding COVID–
19 (Proclamation 9994, 85 FR 15337
(Mar. 18, 2020)). The ASD(HA) will
publish a document announcing the
expiration date.
Comment date: Comments are invited
and must be submitted on or before
November 30, 2020.
ADDRESSES: You may submit comments,
identified by docket number and/or
Regulation Identification Number (RIN)
number and title, by any of the
following methods:
• Federal Rulemaking Portal: https://
www.regulations.gov. Follow the
instructions for submitting comments.
• Mail: The DoD cannot receive
written comments at this time due to the
COVID–19 pandemic. Comments should
be sent electronically to the docket
listed above.
Instructions: All submissions received
must include the agency name and
docket number or RIN for this Federal
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9245
Register document. The general policy
for comments and other submissions
from members of the public is to make
these submissions available for public
viewing on the internet at https://
www.regulations.gov as they are
received without change, including any
personal identifiers or contact
information.
FOR FURTHER INFORMATION CONTACT:
Erica Ferron, Medical Benefits and
Reimbursement Section, 303–676–3626,
erica.c.ferron.civ@mail.mil.
Expiration
Date: Unless extended after
consideration of submitted comments,
this IFR will cease to be in effect upon
termination of the President’s declared
national emergency regarding COVID–
19, in accordance with applicable law
(50 U.S.C.1622(a)).
If the ASD(HA) determines it would
be appropriate to make these changes
permanent, the ASD(HA) will follow-up
with final rulemaking. The ASD(HA)
will publish a document in the Federal
Register announcing the expiration
date.
SUPPLEMENTARY INFORMATION:
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Federal Register / Vol. 85, No. 211 / Friday, October 30, 2020 / Rules and Regulations
I. Executive Summary
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A. Purpose of the Rule
A novel coronavirus (SARS-CoV–2),
which causes COVID–19, was first
detected in December 2019 and has
spread rapidly throughout the world.
On March 13, 2020, the President
declared a national emergency due to
the COVID–19 outbreak, retroactive to
March 1, 2020 (Proclamation 9994, 85
FR 15337). According to data from the
Centers for Disease Control and
Prevention (CDC), on August 24, 2020,
there were 5,682,491 confirmed COVID–
19 cases in the United States (176,223
confirmed deaths), with the number of
cases rapidly expanding each day.1
Medical experts from NIAID anticipated
more cases in the United States and
overseas beginning in February 2020.2
While stay-at-home orders and
recommendations for social distancing
have slowed the spread of COVID–19,
there is currently no cure for COVID–19,
nor are there vaccines capable of
preventing transmission of the virus.
Many potential COVID–19 treatments
and vaccines are being tested in clinical
trial settings designed to evaluate their
safety and effectiveness. As of June 23,
2020, there were 27 clinical trials
underway sponsored by NIAID.
A TRICARE COVID–19-related IFR
published on May 12, 2020 (85 FR
27921), provided a temporary exception
to the regulatory exclusion prohibiting
audio-only telehealth services,
temporarily eliminated copayments and
cost-shares for TRICARE Prime and
Select beneficiaries utilizing authorized
telehealth services provided by network
providers as a necessary incentive to
prevent further spread of COVID–19,
and temporarily authorized
reimbursement of interstate practice by
providers (both in-person and remotely)
for care provided to TRICARE
beneficiaries when such practice is
permitted by federal or state law, even
if the provider is not licensed in the
state where practicing. That IFR was
focused on temporary changes to the
TRICARE program to aid in slowing
community transmission of COVID–19.
A second IFR, published on September
3, 2020 (85 FR 54914–54924), continued
efforts by the ASD(HA) to implement
temporary regulation changes in
response to COVID–19 by focusing on
temporary benefit and reimbursement
changes that would support treatment of
1 COVID–19 case information updated daily on
the CDC website at https://www.cdc.gov/
coronavirus/2019-ncov/cases-updates/cases-inus.html.
2 https://www.niaid.nih.gov/news-events/covid19-reminder-challenge-emerging-infectiousdiseases.
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TRICARE beneficiaries. It also
implemented two permanent regulation
changes consistent with the statutory
requirement that TRICARE reimburse
like Medicare, to the extent practicable.
This third COVID–19-related IFR builds
on the efforts of the second IFR to
provide beneficiaries access to emerging
treatments (including vaccines) for
COVID–19 by adding coverage for
NIAID-sponsored COVID–19 clinical
trials. This regulation implements an
agreement entered into by the DoD with
the National Institutes of Health (NIH)
to cover such clinical trials, in
accordance with statutory requirements.
Pursuant to the President’s national
emergency declaration regarding
COVID–19 and as a result of the
worldwide COVID–19 pandemic, the
ASD(HA) hereby temporarily modifies
the regulation to permit coverage of
NIAID-sponsored COVID–19 phase I, II,
III, and IV clinical trials. Details as
follows:
a. 32 CFR 199.4(e)(26): Title 10, U.S.C.
1079(a)(12) authorizes, pursuant to an
agreement with the Secretary of Health
and Human Services (HHS) and under
such regulations as the Secretary of
Defense may prescribe, a waiver of the
requirement that covered care be
medically or psychologically necessary
in connection with clinical trials
sponsored by the NIH, provided the
Secretary of Defense determines that
such a waiver will promote access by
covered beneficiaries to promising new
treatments and contribute to the
development of such treatments. On
September 19, 2020, the DoD entered
into an agreement with NIH to permit
coverage of such trials.
Based on an agreement with the
National Cancer Institute (NCI) and 32
CFR 199.4(e)(26), TRICARE currently
covers NCI sponsored clinical trials
related to cancer prevention, screening,
and early detection. The intent of these
statutory and regulatory provisions is to
expand TRICARE beneficiary access to
new treatments and to contribute to the
development of such treatments.
This IFR will, pursuant to the
agreement with the NIH, temporarily
amend the regulation to authorize
coverage of cost-sharing for medical care
and testing of TRICARE-eligible patients
who participate in Phase I, II, III, or IV
clinical trials examining the treatment
or prevention of COVID–19 that are
sponsored by NIAID, enforcing the
provisions within the agreement
between DoD and NIH. Additionally,
this change establishes requirements for
TRICARE cost-sharing care related to
NIAID-sponsored COVID–19 clinical
trials; these new requirements mirror
the existing requirements set forth in 32
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CFR 199.4(e)(26)(ii)(B) for coverage of
cancer clinical trials. This change
supports statutory intent by encouraging
participation of TRICARE beneficiaries
in clinical trials studying the prevention
or treatment of COVID–19 and
contributing to the development of
treatments, including vaccines, for
COVID–19. This temporary modification
will be effective for the duration of the
President’s national emergency
regarding COVID–19; however, a patient
who has been enrolled in an NIAIDsponsored clinical trial during the
national emergency will continue to
have his or her care cost-shared for the
duration of that clinical trial, even if the
national emergency has ended.
Although this temporary provision is
only effective for clinical trials for the
treatment or prevention of COVID–19,
and only for the duration of the national
emergency, the DoD may consider
expanding coverage to include other
NIH clinical trials for the treatment of
other diseases after evaluation of
associated costs, benefits, risks, and
other considerations; any such change
would occur through future rulemaking.
We invite comment on all benefit
changes in this provision of the IFR,
including comments on potential
expansion of TRICARE’s clinical trial
benefit beyond cancer clinical trials and
COVID–19 clinical trials.
b. Dates. This modification will
become effective on October 30, 2020,
and will cease to be in effect upon
termination of the President’s declared
national emergency regarding COVID–
19.
If the DoD determines it would be
appropriate to continue coverage of
COVID–19 clinical trials sponsored by
NIAID or otherwise expand the clinical
trial benefit beyond the duration of the
national emergency, the DoD will issue
a final rule to make permanent changes.
B. Interim Final Rule Justification
Agency rulemaking is governed by the
Administrative Procedure Act (APA), 5
U.S.C. 551 et seq. Section 553 of title 5,
U.S.C., requires that, unless the rule
falls within one of the enumerated
exemptions, the DoD must publish a
notice of proposed rulemaking in the
Federal Register that provides
interested persons an opportunity to
submit written data, views, or
arguments, prior to finalization of
regulatory requirements. Section
553(b)(B) authorizes a department or
agency to dispense with the prior notice
and opportunity for public comment
requirement when the agency, for ‘‘good
cause,’’ finds that notice and public
comment thereon are impracticable,
unnecessary, or contrary to the public
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interest. Section 553(d)(3) requires that
an agency must include an explanation
of such good cause with the publication
of the new rule.
As noted in this preamble, the United
States, as well as numerous other
countries, has taken unprecedented
measures to try to contain or slow the
spread of COVID–19. Although studies
of potential treatments of COVID–19 are
in progress, these studies are expected
to take time. Unfortunately, TRICARE
beneficiaries who have contracted
COVID–19 may not have time to wait for
these treatments, given the rapidity with
which the disease overtakes individuals
who develop the most severe responses
to the illness.
Given the national emergency caused
by COVID–19, it would be impracticable
and contrary to the public health—and,
by extension, the public interest—to
delay these implementing regulations
until a full public notice-and-comment
process is completed.
Therefore, pursuant to 5 U.S.C.
553(b)(B), and for the reasons stated in
this preamble, the ASD(HA) concludes
that there is good cause to dispense with
prior public notice and the opportunity
to comment on this rule before
finalizing this rule. For the same
reasons, the ASD(HA) has determined,
consistent with section 5 U.S.C. 553(d),
that there is good cause to make this IFR
effective immediately upon publication
in the Federal Register, with
applicability of its provisions to
coincide with the duration of the
President’s national emergency
regarding the COVID–19 outbreak.
C. Summary of Major Provisions
This provision, 32 CFR 199.4(e)(26),
temporarily waives the medical
necessity requirements under 10 U.S.C.
1079(a)(12), as authorized by that
statute, and establishes a clinical trial
benefit for patients participating in
NIAID-sponsored clinical trials for the
prevention or treatment of COVID–19
during the President’s national
emergency regarding the COVID–19
outbreak. This provision also removes
the reference to the NCI from the 32 CFR
199.4(e)(26) introductory text and
authorizes coverage of clinical trials
sponsored by any NIH Institute or
Center, provided that the statutory
requirements are also met (i.e., the
creation of an agreement with the
Secretary of HHS and the creation of
regulatory requirements implementing
the agreement). This allows TRICARE
coverage of clinical trials sponsored by
the NIAID, one of the NIH Institutes and
Centers responsible for sponsoring and
approving clinical trials related to the
treatment and prevention of COVID–19,
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among other diseases. In other words,
this change temporarily removes the
restriction that clinical trials under this
paragraph be limited to NCI clinical
trials.
The current regulatory language only
includes waivers for NCI trials related to
past or existing demonstrations, and it
would be infeasible to create and
implement a new COVID–19
demonstration due to the rapid spread
of the pandemic, so this provision adds
a third category of waiver for public
health emergencies and specifically
authorizes TRICARE coverage of
beneficiary costs related to participation
in NIAID-sponsored clinical trials for
the treatment or prevention of COVID–
19. This third category of waiver for
public health emergencies is also a
temporary provision; it merely provides
an additional waiver type under which
the NIAID clinical trials fall and criteria
for that waiver type. This provision also
establishes regulatory requirements for
the coverage of NIAID-sponsored
COVID–19 clinical trials to implement
the agreement between DHA and NIH,
as required by statute.
The DoD and NCI established a
partnership in 1994 that allowed
TRICARE beneficiaries to participate in
cancer clinical trials for certain breast
cancer treatments under a
demonstration. The demonstration
project expanded in 1996 to include all
cancers and NCI-sponsored phase II and
III cancer treatment clinical trials. The
demonstration project partnership was
ended by 71 FR 35390, which instead
provided a continuous waiver of the
medical necessity provision under 10
U.S.C. 1079(a)(12) when care was
provided under NIH sponsored trials.
That rule established the existing
regulations under § 199.4(e)(26) for
phase II and III cancer clinical trials.
The DoD noted in the preamble for that
rule that the demonstration had
improved beneficiary access and
resulted in contributions to the
development of such treatments,
justifying the formalization of the
clinical trial benefit under TRICARE
regulation. The regulation was modified
again in 2011, with the addition of
coverage for phase I cancer clinical
trials (76 FR 2253).
Based on the success of the cancer
clinical trial benefit and the urgent need
for patients to have access to new
treatments during the COVID–19 global
pandemic, the ASD(HA) is temporarily
waiving the medical necessity provision
at 10 U.S.C. 1079(a)(12) for NIAIDsponsored clinical trials for the
prevention or treatment of COVID–19
under a public health emergency
waiver, as established in this regulation
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change, which implements the
provisions of the agreement between
DHA and NIH. TRICARE will cover
cost-sharing for medical care and testing
required for determining eligibility and
participating in Phase I, Phase II, Phase
III, and Phase IV clinical trials that meet
the requirements set forth in this
change. These requirements will
implement the agreement between DHA
and NIH and will be similar to the
existing requirements for coverage of
NCI cancer clinical trials, with the
following differences: References to NCI
and cancer will be changed to NIAID
and COVID–19, respectively; Phase IV
clinical trials will also be covered under
the benefit; and there will be no prior
authorization requirement for COVID–
19 clinical trials, as the rapid
progression of the disease necessitates a
more rapid enrollment of beneficiaries
and prior authorization would inhibit
this enrollment. TRICARE will continue
to deny coverage for care rendered in
the NIH or costs associated with nontreatment research activities associated
with the clinical trials, as well as for any
items or services that are already
covered under the investigational
protocol, such as the drug and device
being studied. For example, if the
clinical trial were testing the efficacy of
a COVID–19 vaccine, that vaccine
would already be covered under the
protocol (i.e., neither TRICARE nor the
patient would be liable for cost-sharing).
Only 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 costsharing. This is consistent with the
coverage policy which has been used for
the cancer clinical trial benefit.
Coverage will last for the duration of the
President’s national emergency
regarding the COVID–19 outbreak, or,
provided that the clinical trial begins
and the beneficiary enrolls in the
clinical trial before the termination of
the national emergency, until the
completion of the clinical trial,
whichever occurs later. As required by
10 U.S.C. 1079(a)(12), DHA has entered
into an agreement with NIH in order to
cost-share eligible clinical trials; these
regulatory provisions enforce this
agreement.
Covering these trials will encourage
participation by TRICARE beneficiaries
in eligible clinical trials, contribute to
the development of treatments and
vaccines for COVID–19, and ensure that
covered clinical trials meet similar
requirements as those for NCI clinical
trials for treatment of cancer. Due to the
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rapid progression of the COVID–19
pandemic, the severity of the disease in
many individuals, and the absence of
any existing treatments or vaccines,
participation in clinical trials may also
be the safest and most successful
method of providing TRICARE
beneficiaries with early access to care
for prevention or treatment of COVID–
19. There are already multiple ongoing
NIAID-sponsored COVID–19 trials for
treatments and vaccines, and we expect
many more to be developed. The
requirements in this provision, as well
as NIAID protocols and institutional
review board requirements, will protect
participant safety.
Any NIAID-sponsored Phase I, II, III,
or IV trial with the purpose of: (1)
Preventing infection with COVID–19; (2)
diagnosing infection (current or past
infection); (3) treating the infection; (4)
treating the symptoms of infection (to
include associated symptoms such as
neurological impairment, cardiovascular
illness, or other symptoms as they arise,
both acute and long-term); or (5)
alleviating pain or other conditions
associated with the infection; may be
covered under this regulatory provision.
Trials that are solely for the purpose of
public health research and which do not
affect the medical management of the
individual patient, such as randomized
serological testing to determine
prevalence or lasting immunity, may be
covered only to the extent that the
health plans of other, non-DoD
participants are also billed for such care,
consistent with TRICARE’s regulation at
32 CFR 199.9 regarding appropriate
billing practices. Further, care
reimbursed under this regulatory
provision applies to NIH extramural
care, such as NIAID-sponsored trials
occurring at partner universities. Care
provided at NIH facilities (termed
‘‘intramural’’ care) is excluded.
This temporary provision, including
the creation of a public health
emergency waiver category, is only
effective for the period beginning the
date this rule publishes in the Federal
Register through the end of President’s
national emergency regarding the
COVID–19 outbreak. However, we may
consider creating additional waivers to
cover NIH-sponsored clinical trials in
the future, including establishing
permanent coverage of NIAID trials, if
appropriate, after a review of the costs,
benefits, risks, and other considerations.
Such waivers would fall under the
agreement between DHA and NIH that
is being implemented in this provision
and would require further rulemaking.
We invite public comment on the NIAID
COVID–19 clinical trial benefit as
implemented in this IFR, as well as the
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potential expansion of the clinical trial
benefit as part of a final rule to cover
other NIH Institutes or Centers trials or
clinical trials for other diseases.
D. Legal Authority for This Program
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.
II. Regulatory History
Title 32 CFR 199.4 is revised every
few years to ensure requirements
continue to align with the evolving
health care field. It was most recently
permanently updated on September 29,
2017, with an IFR (82 FR 45438) that
implemented the Congressionallymandated TRICARE Select benefit plan.
This revision to 32 CFR 199.4 included
the addition of medically necessary
foods as a benefit under the TRICARE
Basic Program. Paragraph 199.4(e)(26)
was last revised on January 13, 2011 (76
FR 2253), with the addition of coverage
for NCI sponsored phase I clinical trials.
III. Regulatory Analysis
A. Regulatory Planning and Review
a. Executive Orders
Executive Order 12866, ‘‘Regulatory
Planning and Review’’ and Executive
Order 13563, ‘‘Improving Regulation
and Regulatory Review’’
Executive Orders 12866 and 13563
direct agencies to assess all costs and
benefits of available regulatory
alternatives and, if regulation is
necessary, to select regulatory
approaches that maximize net benefits
(including potential economic,
environmental, public health and safety
effects, distributive impacts, and
equity). Executive Order 13563
emphasizes the importance of
quantifying both costs and benefits, of
reducing costs, of harmonizing rules,
and of promoting flexibility.
Accordingly, the rule has been reviewed
by the Office of Management and
Budget (OMB) under the requirements
of these Executive Orders. This rule has
been designated a ‘‘significant
regulatory action,’’ although not
determined to be economically
significant, under section 3(f) of
Executive Order 12866. This rule is not
expected to have a significant impact on
the economy.
Executive Order 13771, ‘‘Reducing
Regulation and Controlling Regulatory
Costs’’
Executive Order 13771 requires that
for every significant regulation
promulgated, an agency must identify
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two for elimination and offset its costs.
Executive Order 13771 seeks to control
costs associated with the government
imposition of private expenditures
required to comply with Federal
regulations and to reduce regulations
that impose such costs. Consistent with
the analysis of transfer payments under
OMB Circular A–4, this interim final
rule does not involve regulatory costs
subject to Executive Order 13771.
b. Summary
The modifications to paragraph
199.4(e)(26) in this IFR will temporarily
permit TRICARE coverage of costsharing for NIAID-sponsored clinical
trials for the treatment or prevention of
COVID–19 for the duration of the
President’s national emergency for the
COVID–19 outbreak. The modifications
will also implement the agreement
between NIH and DHA by establishing
requirements for coverage of Phase I, II,
III, and IV clinical trials. TRICARE will
cover cost-sharing for medical care and
testing required for determining
eligibility and participating in clinical
trials that meet these requirements.
c. Affected Population
This change affects all TRICARE
beneficiaries who wish to participate in
NIAID-sponsored clinical trials for the
treatment or prevention of COVID–19.
TRICARE-authorized providers will be
affected by being able to treat TRICARE
beneficiaries in NIAID clinical trials.
The participation of TRICARE
beneficiaries in NIAID-sponsored trials
positively affects the general public
through the development of treatments
and vaccines, although it may
negatively affect some individuals who
desire to participate in such trials but
are unable to do so because they were
displaced from participation by
TRICARE beneficiaries. TRICARE’s
health care contractors will be affected
by being required to implement the
provisions of this regulatory change.
State, local, and tribal governments will
not be affected.
d. Costs
We estimate the total cost for
TRICARE participation in NIAIDsponsored COVID–19 clinical trials will
be $3.2M for the duration of the national
emergency, with an additional $4.0M
for continued care for beneficiaries
enrolled in clinical trials prior to
termination of the national emergency.
There were several assumptions we
made in developing this estimate. The
duration of the COVID–19 national
emergency is uncertain; however, for
the purposes of this estimate, we
assumed the national emergency would
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expire on September 30, 2021 the end
of fiscal year (FY) 2021, for ease of
calculations. As of the drafting of this
IFR, there were 27 NIAID-sponsored
COVID–19 clinical trials begun since the
start of the national emergency. We
assumed 6.5 new trials every 30 days,
for a total of 126 trials by September
2021, and that trials would last 17
months, on average, which is the
average of the 27 NIAID-sponsored
COVID–19 trials used in calculating this
estimate. We assumed, based on average
trial enrollment (1,770 participants per
trial, on average) and that TRICARE
beneficiaries would participate in trials
at the same rate as the general
population, that 4,549 TRICARE
beneficiaries would participate through
September 2021. Additionally, we
assumed that costs for NIAID-sponsored
trials will be similar to costs for NCIsponsored trials, excluding
chemotherapy, radiation, and surgery
costs; the average government cost for
NCI-sponsored trials less the excluded
items was $93.00 per participant, per
month in FY 2018 and FY 2019. Each
of the assumptions in this estimate is
highly uncertain, and our estimate
could be higher or lower depending on
real world events (more or fewer trials,
a longer or shorter national emergency,
and/or higher or lower participation in
clinical trials by TRICARE
beneficiaries).
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e. Benefits
This change expands the therapies
available to TRICARE beneficiaries in
settings that ensure informed consent of
the beneficiary, and where the benefits
of treatment outweigh the potential
risks. Participation in clinical trials may
provide beneficiaries with benefits such
as reduced hospitalizations and/or use
of a mechanical ventilator. Although we
cannot estimate the value of this
avoidance quantitatively, the potential
long-term consequences of serious
COVID–19 illness, including permanent
cardiac or lung damage, are not
insignificant. Beneficiary access to
emerging therapies that reduce these
long-term consequences or even death
can be considered to be high-value for
those able to participate.
Providers will be positively affected
by being able to provide their patients
with a broader range of treatment
options. The general public will benefit
from an increased pool of available
participants for the development of
treatments and vaccines for COVID–19,
as well as the evidence (favorable or
otherwise) that results from this
participation.
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16:11 Oct 29, 2020
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68757
f. Alternatives
F. Executive Order 13132, ‘‘Federalism’’
The DoD considered several
alternatives to this IFR. The first
alternative involved taking no action.
Although this alternative would be the
most cost neutral for DHA, it was
rejected as not addressing the urgent
medical needs of the beneficiary
population in response to the COVID–19
pandemic.
The second alternative the DoD
considered was implementing a more
limited benefit change for COVID–19
patients by not covering phase I clinical
trials. While this would have the benefit
of reimbursing only care that has more
established evidence in its favor, this
alternative is not preferred because early
access to treatments is critical for
TRICARE beneficiaries given the rapid
progression of the disease and the lack
of available approved treatments.
Executive Order 13132 establishes
certain requirements that an agency
must meet when it promulgates an IFR
(and subsequent final rule) that imposes
substantial direct requirement costs on
State and local governments, preempts
State law, or otherwise has Federalism
implications. This IFR will not have a
substantial effect on State and local
governments.
B. Public Law 96–354, ‘‘Regulatory
Flexibility Act’’ (5 U.S.C. 601 et seq.)
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.
Accordingly, 32 CFR part 199 is
amended to read as follows:
PART 199—CIVILIAN HEALTH AND
MEDICAL PROGRAM OF THE
UNIFORMED SERVICES (CHAMPUS)
1. The authority citation for part 199
continues to read as follows:
The Secretary certifies that this IFR is
not subject to the Regulatory Flexibility
Act (5 U.S.C. 601 et seq.) 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.
■
C. Congressional Review Act
§ 199.4
Pursuant to the Congressional Review
Act (5 U.S.C. 801 et seq.), the Office of
Information and Regulatory Affairs
designated this rule as not a major rule,
as defined by 5 U.S.C. 804(2).
*
D. Sec. 202, Public Law 104–4,
‘‘Unfunded Mandates Reform Act of
1995’’
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 by State, local, and
tribal governments, in the aggregate, or
by the private sector, in any one year of
$100 million in 1995 dollars, updated
annually for inflation. This IFR will not
impose any Federal mandate for State,
local, or tribal governments, nor will it
affect private sector costs.
E. Public Law 96–511, ‘‘Paperwork
Reduction Act of 1995’’ (44 U.S.C.
Chapter 35)
32 CFR part 199 does not impose
reporting or recordkeeping requirements
under the Paperwork Reduction Act of
1995.
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Frm 00041
Fmt 4700
Sfmt 4700
Authority: 5 U.S.C. 301; 10 U.S.C. chapter
55.
2. Amend § 199.4 by:
a. Revising the second sentence in
paragraph (e)(26).
■ b. Adding new paragraph (e)(26)(iii).
The additions read as follows:
■
■
Basic program benefits.
*
*
*
*
(e) * * *
(26) * * * By law, and pursuant to an
agreement between the Department of
Defense and the Department of Health
and Human Services, the general
prohibition against CHAMPUS costsharing of unproven drugs, devices, and
medical treatments or procedures may
be waived by the Secretary of Defense
in connection with clinical trials
sponsored or approved by the National
Institutes of Health (NIH) or an NIH
Institute or Center if it is determined
that such a waiver will promote access
by covered beneficiaries to promising
new treatments and contribute to the
development of such treatments. * * *
(iii) Public Health Emergency Waiver.
(A) General. During public health
emergencies (e.g., a national state of
emergency declared by the President),
TRICARE may cover cost-sharing for
TRICARE-eligible patients who
participate in Phase I, II, III, or IV trials
that are sponsored by the NIH or an NIH
Institute for the purposes of treatment or
prevention of the pandemic or public
health emergency.
(B) National Institute of Allergy and
Infectious Diseases (NIAID)-sponsored
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Federal Register / Vol. 85, No. 211 / Friday, October 30, 2020 / Rules and Regulations
clinical trials for COVID–19. For the
duration of the President’s national
emergency regarding the COVID–19
outbreak, TRICARE will cover costsharing for those TRICARE-eligible
patients selected to participate in
NIAID-sponsored Phase I, II, III, and IV
studies examining the treatment or
prevention of COVID–19 and its
associated sequelae (e.g., cardiac and
pulmonary issues). TRICARE will
continue to cover cost-sharing for any
eligible beneficiary enrolled in such a
study until the conclusion of that study,
even if the national emergency ends
before the conclusion of the study.
(1) TRICARE will cost-share all
medical care (including associated
health complications) and testing
required to determine eligibility for an
NIAID-sponsored trial, including the
evaluation for eligibility at the
institution conducting the NIAIDsponsored study. TRICARE will costshare all medical care required as a
result of participation in NIAIDsponsored studies. This includes
purchasing and administering all
approved pharmaceutical agents (except
for NIAID-funded investigational drugs),
all inpatient and outpatient care,
including diagnostic, laboratory,
rehabilitation, and home health services
not otherwise reimbursed under an
NIAID grant program if the following
conditions are met:
(i) Such treatments are NIAIDsponsored Phase I, Phase II, Phase III, or
Phase IV protocols;
(ii) The patient continues to meet
entry criteria for said protocol;
(iii) The institutional and individual
providers are TRICARE-authorized
providers; and
(iv) The requirements for Phase I
protocols in paragraph (e)(26)(iii)(B)(2)
of this section are met.
(2) Requirements for Phase I protocols
are:
(i) Standard treatment has been or
would be ineffective, does not exist, or
there is no superior non-investigational
treatment alternative;
(ii) The available clinical or
preclinical data provide a reasonable
expectation that the treatment will be at
least as effective as the noninvestigational alternative;
(iii) The facility and personnel
providing the treatment are capable of
doing so by virtue of their experience,
training, and volume of patients treated
to maintain expertise; and
(iv) The referring physician has
concluded that the enrollee’s
participation in such a trial would be
appropriate based upon the satisfaction
of paragraphs (e)(26)(iii)(B)(2)(i) through
(iii) of this section.
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16:11 Oct 29, 2020
Jkt 253001
(3) TRICARE 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.
(4) Cost-shares and deductibles
applicable to TRICARE will also apply
under the NIAID-sponsored clinical
trials.
(5) The Director, Defense Health
Agency (or designee), shall issue
procedures and guidelines establishing
NIAID-sponsorship of clinical trials and
the administrative process by which
individual patients apply for and
receive cost-sharing under NIAIDsponsored COVID–19 clinical trials.
*
*
*
*
*
Dated: October 27, 2020.
Aaron T. Siegel,
Alternate OSD Federal Register Liaison
Officer, Department of Defense.
[FR Doc. 2020–24114 Filed 10–28–20; 11:15 am]
BILLING CODE 5001–06–P
ENVIRONMENTAL PROTECTION
AGENCY
40 CFR Part 52
[EPA–R05–OAR–2019–0302, EPA–R05–
OAR–2019–0676; FRL–10015–49–Region 5]
Air Plan Approval; Ohio; Volatile
Organic Compounds
Environmental Protection
Agency (EPA).
ACTION: Final rule.
AGENCY:
The Environmental Protection
Agency (EPA) is approving under the
Clean Air Act, a State Implementation
Plan (SIP) submittal from the Ohio
Environmental Protection Agency
(OEPA). This SIP revision request,
submitted on April 5, 2019, and
supplemented on November 21, 2019,
consists of amendments and additions
to the volatile organic compound (VOC)
rules in the Ohio Administrative Code
(OAC). These changes provide clarity to
facilities that are subject to multiple
VOC requirements in the SIP, or whose
applicable requirements have been
moved to other sections within the OAC
as a result of a previous revision. The
changes also correct errors and provide
general administrative cleanup. An
alternative monitoring, recordkeeping,
and reporting program was added to the
requirements for the BP-Husky Refining
LLC, Toledo Refinery. In addition, the
SIP submittal adds a mechanism for
Ohio to approve alternate limitations for
site-specific miscellaneous industrial
adhesive and sealant facilities and
includes alternate site-specific
SUMMARY:
PO 00000
Frm 00042
Fmt 4700
Sfmt 4700
limitations for certain process lines at
the Accel Group, Incorporated (Accel)
facility in Wadsworth, Ohio. EPA
proposed to approve this action on July
22, 2020, and received no adverse
comments.
DATES: This final rule is effective on
November 30, 2020.
ADDRESSES: EPA has established dockets
for this action under Docket ID Nos.
EPA–R05–OAR–2019–0302 (pertaining
to amendments to OAC Chapter 3745–
21) and EPA–R05–OAR–2019–0676
(pertaining to site-specific alternate
VOC SIP limits for the Accel facility).
All documents in the dockets are listed
on the www.regulations.gov website.
Although listed in the index, some
information is not publicly available,
i.e., Confidential Business Information
(CBI) or other information whose
disclosure is restricted by statute.
Certain other material, such as
copyrighted material, is not placed on
the internet and will be publicly
available only in hard copy form.
Publicly available docket materials are
available either through
www.regulations.gov or at the
Environmental Protection Agency,
Region 5, Air and Radiation Division, 77
West Jackson Boulevard, Chicago,
Illinois 60604. This facility is open from
8:30 a.m. to 4:30 p.m., Monday through
Friday, excluding Federal holidays and
facility closures due to COVID–19. We
recommend that you telephone Anthony
Maietta, Environmental Protection
Specialist, at (312) 353–8777 before
visiting the Region 5 office.
FOR FURTHER INFORMATION CONTACT:
Anthony Maietta, Environmental
Protection Specialist, Control Strategies
Section, Air Programs Branch (AR–18J),
Environmental Protection Agency,
Region 5, 77 West Jackson Boulevard,
Chicago, Illinois 60604, (312) 353–8777,
maietta.anthony@epa.gov.
SUPPLEMENTARY INFORMATION:
Throughout this document whenever
‘‘we,’’ ‘‘us,’’ or ‘‘our’’ is used, we mean
EPA.
I. Background Information
On July 22, 2020, EPA proposed to
approve amendments and additions to
the VOC rules located at OAC Chapter
3745–21, including an alternative
monitoring, recordkeeping, and
reporting program for the BP-Husky
Refining LLC, Toledo Refinery at OAC
3745–21–09(T)(4), and alternate sitespecific limitations for the Accel facility
contained in its September 19, 2019,
operating permit (85 FR 44255). An
explanation of the applicable Clean Air
Act requirements, a detailed analysis of
the revisions, and EPA’s reasons for
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]]>Agencies
[Federal Register Volume 85, Number 211 (Friday, October 30, 2020)]
[Rules and Regulations]
[Pages 68753-68758]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2020-24114]
=======================================================================
-----------------------------------------------------------------------
DEPARTMENT OF DEFENSE
Office of the Secretary
32 CFR Part 199
[Docket ID: DOD-2020-HA-0050]
RIN 0720-AB83
TRICARE Coverage of National Institute of Allergy and Infectious
Disease Coronavirus Disease 2019 Clinical Trials
AGENCY: Office of the Secretary, Department of Defense (DoD).
ACTION: Interim final rule with request for comments.
-----------------------------------------------------------------------
SUMMARY: The Assistant Secretary of Defense for Health Affairs
(ASD(HA)) issues this interim final rule (IFR) with request for
comments to temporarily modify the TRICARE regulation by adding
coverage for National Institute of Allergy and Infectious Disease
(NIAID)-sponsored clinical trials for the treatment or prevention of
coronavirus disease 2019 (COVID-19).
DATES: Effective date: This interim final rule is effective on October
30, 2020 through the end of the President's national emergency
regarding COVID-19 (Proclamation 9994, 85 FR 15337 (Mar. 18, 2020)).
The ASD(HA) will publish a document announcing the expiration date.
Comment date: Comments are invited and must be submitted on or
before November 30, 2020.
ADDRESSES: You may submit comments, identified by docket number and/or
Regulation Identification Number (RIN) number and title, by any of the
following methods:
Federal Rulemaking Portal: https://www.regulations.gov.
Follow the instructions for submitting comments.
Mail: The DoD cannot receive written comments at this time
due to the COVID-19 pandemic. Comments should be sent electronically to
the docket listed above.
Instructions: All submissions received must include the agency name
and docket number or RIN for this Federal Register document. The
general policy for comments and other submissions from members of the
public is to make these submissions available for public viewing on the
internet at https://www.regulations.gov as they are received without
change, including any personal identifiers or contact information.
FOR FURTHER INFORMATION CONTACT: Erica Ferron, Medical Benefits and
Reimbursement Section, 303-676-3626, [email protected].
SUPPLEMENTARY INFORMATION: Expiration Date: Unless extended after
consideration of submitted comments, this IFR will cease to be in
effect upon termination of the President's declared national emergency
regarding COVID-19, in accordance with applicable law (50
U.S.C.1622(a)).
If the ASD(HA) determines it would be appropriate to make these
changes permanent, the ASD(HA) will follow-up with final rulemaking.
The ASD(HA) will publish a document in the Federal Register announcing
the expiration date.
[[Page 68754]]
I. Executive Summary
A. Purpose of the Rule
A novel coronavirus (SARS-CoV-2), which causes COVID-19, was first
detected in December 2019 and has spread rapidly throughout the world.
On March 13, 2020, the President declared a national emergency due to
the COVID-19 outbreak, retroactive to March 1, 2020 (Proclamation 9994,
85 FR 15337). According to data from the Centers for Disease Control
and Prevention (CDC), on August 24, 2020, there were 5,682,491
confirmed COVID-19 cases in the United States (176,223 confirmed
deaths), with the number of cases rapidly expanding each day.\1\
Medical experts from NIAID anticipated more cases in the United States
and overseas beginning in February 2020.\2\
---------------------------------------------------------------------------
\1\ COVID-19 case information updated daily on the CDC website
at https://www.cdc.gov/coronavirus/2019-ncov/cases-updates/cases-in-us.html.
\2\ https://www.niaid.nih.gov/news-events/covid-19-reminder-challenge-emerging-infectious-diseases.
---------------------------------------------------------------------------
While stay-at-home orders and recommendations for social distancing
have slowed the spread of COVID-19, there is currently no cure for
COVID-19, nor are there vaccines capable of preventing transmission of
the virus. Many potential COVID-19 treatments and vaccines are being
tested in clinical trial settings designed to evaluate their safety and
effectiveness. As of June 23, 2020, there were 27 clinical trials
underway sponsored by NIAID.
A TRICARE COVID-19-related IFR published on May 12, 2020 (85 FR
27921), provided a temporary exception to the regulatory exclusion
prohibiting audio-only telehealth services, temporarily eliminated
copayments and cost-shares for TRICARE Prime and Select beneficiaries
utilizing authorized telehealth services provided by network providers
as a necessary incentive to prevent further spread of COVID-19, and
temporarily authorized reimbursement of interstate practice by
providers (both in-person and remotely) for care provided to TRICARE
beneficiaries when such practice is permitted by federal or state law,
even if the provider is not licensed in the state where practicing.
That IFR was focused on temporary changes to the TRICARE program to aid
in slowing community transmission of COVID-19. A second IFR, published
on September 3, 2020 (85 FR 54914-54924), continued efforts by the
ASD(HA) to implement temporary regulation changes in response to COVID-
19 by focusing on temporary benefit and reimbursement changes that
would support treatment of TRICARE beneficiaries. It also implemented
two permanent regulation changes consistent with the statutory
requirement that TRICARE reimburse like Medicare, to the extent
practicable. This third COVID-19-related IFR builds on the efforts of
the second IFR to provide beneficiaries access to emerging treatments
(including vaccines) for COVID-19 by adding coverage for NIAID-
sponsored COVID-19 clinical trials. This regulation implements an
agreement entered into by the DoD with the National Institutes of
Health (NIH) to cover such clinical trials, in accordance with
statutory requirements.
Pursuant to the President's national emergency declaration
regarding COVID-19 and as a result of the worldwide COVID-19 pandemic,
the ASD(HA) hereby temporarily modifies the regulation to permit
coverage of NIAID-sponsored COVID-19 phase I, II, III, and IV clinical
trials. Details as follows:
a. 32 CFR 199.4(e)(26): Title 10, U.S.C. 1079(a)(12) authorizes,
pursuant to an agreement with the Secretary of Health and Human
Services (HHS) and under such regulations as the Secretary of Defense
may prescribe, a waiver of the requirement that covered care be
medically or psychologically necessary in connection with clinical
trials sponsored by the NIH, provided the Secretary of Defense
determines that such a waiver will promote access by covered
beneficiaries to promising new treatments and contribute to the
development of such treatments. On September 19, 2020, the DoD entered
into an agreement with NIH to permit coverage of such trials.
Based on an agreement with the National Cancer Institute (NCI) and
32 CFR 199.4(e)(26), TRICARE currently covers NCI sponsored clinical
trials related to cancer prevention, screening, and early detection.
The intent of these statutory and regulatory provisions is to expand
TRICARE beneficiary access to new treatments and to contribute to the
development of such treatments.
This IFR will, pursuant to the agreement with the NIH, temporarily
amend the regulation to authorize coverage of cost-sharing for medical
care and testing of TRICARE-eligible patients who participate in Phase
I, II, III, or IV clinical trials examining the treatment or prevention
of COVID-19 that are sponsored by NIAID, enforcing the provisions
within the agreement between DoD and NIH. Additionally, this change
establishes requirements for TRICARE cost-sharing care related to
NIAID-sponsored COVID-19 clinical trials; these new requirements mirror
the existing requirements set forth in 32 CFR 199.4(e)(26)(ii)(B) for
coverage of cancer clinical trials. This change supports statutory
intent by encouraging participation of TRICARE beneficiaries in
clinical trials studying the prevention or treatment of COVID-19 and
contributing to the development of treatments, including vaccines, for
COVID-19. This temporary modification will be effective for the
duration of the President's national emergency regarding COVID-19;
however, a patient who has been enrolled in an NIAID-sponsored clinical
trial during the national emergency will continue to have his or her
care cost-shared for the duration of that clinical trial, even if the
national emergency has ended. Although this temporary provision is only
effective for clinical trials for the treatment or prevention of COVID-
19, and only for the duration of the national emergency, the DoD may
consider expanding coverage to include other NIH clinical trials for
the treatment of other diseases after evaluation of associated costs,
benefits, risks, and other considerations; any such change would occur
through future rulemaking. We invite comment on all benefit changes in
this provision of the IFR, including comments on potential expansion of
TRICARE's clinical trial benefit beyond cancer clinical trials and
COVID-19 clinical trials.
b. Dates. This modification will become effective on October 30,
2020, and will cease to be in effect upon termination of the
President's declared national emergency regarding COVID-19.
If the DoD determines it would be appropriate to continue coverage
of COVID-19 clinical trials sponsored by NIAID or otherwise expand the
clinical trial benefit beyond the duration of the national emergency,
the DoD will issue a final rule to make permanent changes.
B. Interim Final Rule Justification
Agency rulemaking is governed by the Administrative Procedure Act
(APA), 5 U.S.C. 551 et seq. Section 553 of title 5, U.S.C., requires
that, unless the rule falls within one of the enumerated exemptions,
the DoD must publish a notice of proposed rulemaking in the Federal
Register that provides interested persons an opportunity to submit
written data, views, or arguments, prior to finalization of regulatory
requirements. Section 553(b)(B) authorizes a department or agency to
dispense with the prior notice and opportunity for public comment
requirement when the agency, for ``good cause,'' finds that notice and
public comment thereon are impracticable, unnecessary, or contrary to
the public
[[Page 68755]]
interest. Section 553(d)(3) requires that an agency must include an
explanation of such good cause with the publication of the new rule.
As noted in this preamble, the United States, as well as numerous
other countries, has taken unprecedented measures to try to contain or
slow the spread of COVID-19. Although studies of potential treatments
of COVID-19 are in progress, these studies are expected to take time.
Unfortunately, TRICARE beneficiaries who have contracted COVID-19 may
not have time to wait for these treatments, given the rapidity with
which the disease overtakes individuals who develop the most severe
responses to the illness.
Given the national emergency caused by COVID-19, it would be
impracticable and contrary to the public health--and, by extension, the
public interest--to delay these implementing regulations until a full
public notice-and-comment process is completed.
Therefore, pursuant to 5 U.S.C. 553(b)(B), and for the reasons
stated in this preamble, the ASD(HA) concludes that there is good cause
to dispense with prior public notice and the opportunity to comment on
this rule before finalizing this rule. For the same reasons, the
ASD(HA) has determined, consistent with section 5 U.S.C. 553(d), that
there is good cause to make this IFR effective immediately upon
publication in the Federal Register, with applicability of its
provisions to coincide with the duration of the President's national
emergency regarding the COVID-19 outbreak.
C. Summary of Major Provisions
This provision, 32 CFR 199.4(e)(26), temporarily waives the medical
necessity requirements under 10 U.S.C. 1079(a)(12), as authorized by
that statute, and establishes a clinical trial benefit for patients
participating in NIAID-sponsored clinical trials for the prevention or
treatment of COVID-19 during the President's national emergency
regarding the COVID-19 outbreak. This provision also removes the
reference to the NCI from the 32 CFR 199.4(e)(26) introductory text and
authorizes coverage of clinical trials sponsored by any NIH Institute
or Center, provided that the statutory requirements are also met (i.e.,
the creation of an agreement with the Secretary of HHS and the creation
of regulatory requirements implementing the agreement). This allows
TRICARE coverage of clinical trials sponsored by the NIAID, one of the
NIH Institutes and Centers responsible for sponsoring and approving
clinical trials related to the treatment and prevention of COVID-19,
among other diseases. In other words, this change temporarily removes
the restriction that clinical trials under this paragraph be limited to
NCI clinical trials.
The current regulatory language only includes waivers for NCI
trials related to past or existing demonstrations, and it would be
infeasible to create and implement a new COVID-19 demonstration due to
the rapid spread of the pandemic, so this provision adds a third
category of waiver for public health emergencies and specifically
authorizes TRICARE coverage of beneficiary costs related to
participation in NIAID-sponsored clinical trials for the treatment or
prevention of COVID-19. This third category of waiver for public health
emergencies is also a temporary provision; it merely provides an
additional waiver type under which the NIAID clinical trials fall and
criteria for that waiver type. This provision also establishes
regulatory requirements for the coverage of NIAID-sponsored COVID-19
clinical trials to implement the agreement between DHA and NIH, as
required by statute.
The DoD and NCI established a partnership in 1994 that allowed
TRICARE beneficiaries to participate in cancer clinical trials for
certain breast cancer treatments under a demonstration. The
demonstration project expanded in 1996 to include all cancers and NCI-
sponsored phase II and III cancer treatment clinical trials. The
demonstration project partnership was ended by 71 FR 35390, which
instead provided a continuous waiver of the medical necessity provision
under 10 U.S.C. 1079(a)(12) when care was provided under NIH sponsored
trials. That rule established the existing regulations under Sec.
199.4(e)(26) for phase II and III cancer clinical trials. The DoD noted
in the preamble for that rule that the demonstration had improved
beneficiary access and resulted in contributions to the development of
such treatments, justifying the formalization of the clinical trial
benefit under TRICARE regulation. The regulation was modified again in
2011, with the addition of coverage for phase I cancer clinical trials
(76 FR 2253).
Based on the success of the cancer clinical trial benefit and the
urgent need for patients to have access to new treatments during the
COVID-19 global pandemic, the ASD(HA) is temporarily waiving the
medical necessity provision at 10 U.S.C. 1079(a)(12) for NIAID-
sponsored clinical trials for the prevention or treatment of COVID-19
under a public health emergency waiver, as established in this
regulation change, which implements the provisions of the agreement
between DHA and NIH. TRICARE will cover cost-sharing for medical care
and testing required for determining eligibility and participating in
Phase I, Phase II, Phase III, and Phase IV clinical trials that meet
the requirements set forth in this change. These requirements will
implement the agreement between DHA and NIH and will be similar to the
existing requirements for coverage of NCI cancer clinical trials, with
the following differences: References to NCI and cancer will be changed
to NIAID and COVID-19, respectively; Phase IV clinical trials will also
be covered under the benefit; and there will be no prior authorization
requirement for COVID-19 clinical trials, as the rapid progression of
the disease necessitates a more rapid enrollment of beneficiaries and
prior authorization would inhibit this enrollment. TRICARE will
continue to deny coverage for care rendered in the NIH or costs
associated with non-treatment research activities associated with the
clinical trials, as well as for any items or services that are already
covered under the investigational protocol, such as the drug and device
being studied. For example, if the clinical trial were testing the
efficacy of a COVID-19 vaccine, that vaccine would already be covered
under the protocol (i.e., neither TRICARE nor the patient would be
liable for cost-sharing). Only 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 cost-sharing. This is consistent with
the coverage policy which has been used for the cancer clinical trial
benefit. Coverage will last for the duration of the President's
national emergency regarding the COVID-19 outbreak, or, provided that
the clinical trial begins and the beneficiary enrolls in the clinical
trial before the termination of the national emergency, until the
completion of the clinical trial, whichever occurs later. As required
by 10 U.S.C. 1079(a)(12), DHA has entered into an agreement with NIH in
order to cost-share eligible clinical trials; these regulatory
provisions enforce this agreement.
Covering these trials will encourage participation by TRICARE
beneficiaries in eligible clinical trials, contribute to the
development of treatments and vaccines for COVID-19, and ensure that
covered clinical trials meet similar requirements as those for NCI
clinical trials for treatment of cancer. Due to the
[[Page 68756]]
rapid progression of the COVID-19 pandemic, the severity of the disease
in many individuals, and the absence of any existing treatments or
vaccines, participation in clinical trials may also be the safest and
most successful method of providing TRICARE beneficiaries with early
access to care for prevention or treatment of COVID-19. There are
already multiple ongoing NIAID-sponsored COVID-19 trials for treatments
and vaccines, and we expect many more to be developed. The requirements
in this provision, as well as NIAID protocols and institutional review
board requirements, will protect participant safety.
Any NIAID-sponsored Phase I, II, III, or IV trial with the purpose
of: (1) Preventing infection with COVID-19; (2) diagnosing infection
(current or past infection); (3) treating the infection; (4) treating
the symptoms of infection (to include associated symptoms such as
neurological impairment, cardiovascular illness, or other symptoms as
they arise, both acute and long-term); or (5) alleviating pain or other
conditions associated with the infection; may be covered under this
regulatory provision. Trials that are solely for the purpose of public
health research and which do not affect the medical management of the
individual patient, such as randomized serological testing to determine
prevalence or lasting immunity, may be covered only to the extent that
the health plans of other, non-DoD participants are also billed for
such care, consistent with TRICARE's regulation at 32 CFR 199.9
regarding appropriate billing practices. Further, care reimbursed under
this regulatory provision applies to NIH extramural care, such as
NIAID-sponsored trials occurring at partner universities. Care provided
at NIH facilities (termed ``intramural'' care) is excluded.
This temporary provision, including the creation of a public health
emergency waiver category, is only effective for the period beginning
the date this rule publishes in the Federal Register through the end of
President's national emergency regarding the COVID-19 outbreak.
However, we may consider creating additional waivers to cover NIH-
sponsored clinical trials in the future, including establishing
permanent coverage of NIAID trials, if appropriate, after a review of
the costs, benefits, risks, and other considerations. Such waivers
would fall under the agreement between DHA and NIH that is being
implemented in this provision and would require further rulemaking. We
invite public comment on the NIAID COVID-19 clinical trial benefit as
implemented in this IFR, as well as the potential expansion of the
clinical trial benefit as part of a final rule to cover other NIH
Institutes or Centers trials or clinical trials for other diseases.
D. Legal Authority for This Program
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.
II. Regulatory History
Title 32 CFR 199.4 is revised every few years to ensure
requirements continue to align with the evolving health care field. It
was most recently permanently updated on September 29, 2017, with an
IFR (82 FR 45438) that implemented the Congressionally-mandated TRICARE
Select benefit plan. This revision to 32 CFR 199.4 included the
addition of medically necessary foods as a benefit under the TRICARE
Basic Program. Paragraph 199.4(e)(26) was last revised on January 13,
2011 (76 FR 2253), with the addition of coverage for NCI sponsored
phase I clinical trials.
III. Regulatory Analysis
A. Regulatory Planning and Review
a. Executive Orders
Executive Order 12866, ``Regulatory Planning and Review'' and Executive
Order 13563, ``Improving Regulation and Regulatory Review''
Executive Orders 12866 and 13563 direct agencies to assess all
costs and benefits of available regulatory alternatives and, if
regulation is necessary, to select regulatory approaches that maximize
net benefits (including potential economic, environmental, public
health and safety effects, distributive impacts, and equity). Executive
Order 13563 emphasizes the importance of quantifying both costs and
benefits, of reducing costs, of harmonizing rules, and of promoting
flexibility. Accordingly, the rule has been reviewed by the Office of
Management and Budget (OMB) under the requirements of these Executive
Orders. This rule has been designated a ``significant regulatory
action,'' although not determined to be economically significant, under
section 3(f) of Executive Order 12866. This rule is not expected to
have a significant impact on the economy.
Executive Order 13771, ``Reducing Regulation and Controlling Regulatory
Costs''
Executive Order 13771 requires that for every significant
regulation promulgated, an agency must identify two for elimination and
offset its costs. Executive Order 13771 seeks to control costs
associated with the government imposition of private expenditures
required to comply with Federal regulations and to reduce regulations
that impose such costs. Consistent with the analysis of transfer
payments under OMB Circular A-4, this interim final rule does not
involve regulatory costs subject to Executive Order 13771.
b. Summary
The modifications to paragraph 199.4(e)(26) in this IFR will
temporarily permit TRICARE coverage of cost-sharing for NIAID-sponsored
clinical trials for the treatment or prevention of COVID-19 for the
duration of the President's national emergency for the COVID-19
outbreak. The modifications will also implement the agreement between
NIH and DHA by establishing requirements for coverage of Phase I, II,
III, and IV clinical trials. TRICARE will cover cost-sharing for
medical care and testing required for determining eligibility and
participating in clinical trials that meet these requirements.
c. Affected Population
This change affects all TRICARE beneficiaries who wish to
participate in NIAID-sponsored clinical trials for the treatment or
prevention of COVID-19. TRICARE-authorized providers will be affected
by being able to treat TRICARE beneficiaries in NIAID clinical trials.
The participation of TRICARE beneficiaries in NIAID-sponsored trials
positively affects the general public through the development of
treatments and vaccines, although it may negatively affect some
individuals who desire to participate in such trials but are unable to
do so because they were displaced from participation by TRICARE
beneficiaries. TRICARE's health care contractors will be affected by
being required to implement the provisions of this regulatory change.
State, local, and tribal governments will not be affected.
d. Costs
We estimate the total cost for TRICARE participation in NIAID-
sponsored COVID-19 clinical trials will be $3.2M for the duration of
the national emergency, with an additional $4.0M for continued care for
beneficiaries enrolled in clinical trials prior to termination of the
national emergency. There were several assumptions we made in
developing this estimate. The duration of the COVID-19 national
emergency is uncertain; however, for the purposes of this estimate, we
assumed the national emergency would
[[Page 68757]]
expire on September 30, 2021 the end of fiscal year (FY) 2021, for ease
of calculations. As of the drafting of this IFR, there were 27 NIAID-
sponsored COVID-19 clinical trials begun since the start of the
national emergency. We assumed 6.5 new trials every 30 days, for a
total of 126 trials by September 2021, and that trials would last 17
months, on average, which is the average of the 27 NIAID-sponsored
COVID-19 trials used in calculating this estimate. We assumed, based on
average trial enrollment (1,770 participants per trial, on average) and
that TRICARE beneficiaries would participate in trials at the same rate
as the general population, that 4,549 TRICARE beneficiaries would
participate through September 2021. Additionally, we assumed that costs
for NIAID-sponsored trials will be similar to costs for NCI-sponsored
trials, excluding chemotherapy, radiation, and surgery costs; the
average government cost for NCI-sponsored trials less the excluded
items was $93.00 per participant, per month in FY 2018 and FY 2019.
Each of the assumptions in this estimate is highly uncertain, and our
estimate could be higher or lower depending on real world events (more
or fewer trials, a longer or shorter national emergency, and/or higher
or lower participation in clinical trials by TRICARE beneficiaries).
e. Benefits
This change expands the therapies available to TRICARE
beneficiaries in settings that ensure informed consent of the
beneficiary, and where the benefits of treatment outweigh the potential
risks. Participation in clinical trials may provide beneficiaries with
benefits such as reduced hospitalizations and/or use of a mechanical
ventilator. Although we cannot estimate the value of this avoidance
quantitatively, the potential long-term consequences of serious COVID-
19 illness, including permanent cardiac or lung damage, are not
insignificant. Beneficiary access to emerging therapies that reduce
these long-term consequences or even death can be considered to be
high-value for those able to participate.
Providers will be positively affected by being able to provide
their patients with a broader range of treatment options. The general
public will benefit from an increased pool of available participants
for the development of treatments and vaccines for COVID-19, as well as
the evidence (favorable or otherwise) that results from this
participation.
f. Alternatives
The DoD considered several alternatives to this IFR. The first
alternative involved taking no action. Although this alternative would
be the most cost neutral for DHA, it was rejected as not addressing the
urgent medical needs of the beneficiary population in response to the
COVID-19 pandemic.
The second alternative the DoD considered was implementing a more
limited benefit change for COVID-19 patients by not covering phase I
clinical trials. While this would have the benefit of reimbursing only
care that has more established evidence in its favor, this alternative
is not preferred because early access to treatments is critical for
TRICARE beneficiaries given the rapid progression of the disease and
the lack of available approved treatments.
B. Public Law 96-354, ``Regulatory Flexibility Act'' (5 U.S.C. 601 et
seq.)
The Secretary certifies that this IFR is not subject to the
Regulatory Flexibility Act (5 U.S.C. 601 et seq.) 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.
C. Congressional Review Act
Pursuant to the Congressional Review Act (5 U.S.C. 801 et seq.),
the Office of Information and Regulatory Affairs designated this rule
as not a major rule, as defined by 5 U.S.C. 804(2).
D. Sec. 202, Public Law 104-4, ``Unfunded Mandates Reform Act of 1995''
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 by State, local, and
tribal governments, in the aggregate, or by the private sector, in any
one year of $100 million in 1995 dollars, updated annually for
inflation. This IFR will not impose any Federal mandate for State,
local, or tribal governments, nor will it affect private sector costs.
E. Public Law 96-511, ``Paperwork Reduction Act of 1995'' (44 U.S.C.
Chapter 35)
32 CFR part 199 does not impose reporting or recordkeeping
requirements under the Paperwork Reduction Act of 1995.
F. Executive Order 13132, ``Federalism''
Executive Order 13132 establishes certain requirements that an
agency must meet when it promulgates an IFR (and subsequent final rule)
that imposes substantial direct requirement costs on State and local
governments, preempts State law, or otherwise has Federalism
implications. This IFR will not have a substantial effect on State and
local 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.
Accordingly, 32 CFR part 199 is amended to read as follows:
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. 199.4 by:
0
a. Revising the second sentence in paragraph (e)(26).
0
b. Adding new paragraph (e)(26)(iii).
The additions read as follows:
Sec. 199.4 Basic program benefits.
* * * * *
(e) * * *
(26) * * * By law, and pursuant to an agreement between the
Department of Defense and the Department of Health and Human Services,
the general prohibition against CHAMPUS cost-sharing of unproven drugs,
devices, and medical treatments or procedures may be waived by the
Secretary of Defense in connection with clinical trials sponsored or
approved by the National Institutes of Health (NIH) or an NIH Institute
or Center if it is determined that such a waiver will promote access by
covered beneficiaries to promising new treatments and contribute to the
development of such treatments. * * *
(iii) Public Health Emergency Waiver.
(A) General. During public health emergencies (e.g., a national
state of emergency declared by the President), TRICARE may cover cost-
sharing for TRICARE-eligible patients who participate in Phase I, II,
III, or IV trials that are sponsored by the NIH or an NIH Institute for
the purposes of treatment or prevention of the pandemic or public
health emergency.
(B) National Institute of Allergy and Infectious Diseases (NIAID)-
sponsored
[[Page 68758]]
clinical trials for COVID-19. For the duration of the President's
national emergency regarding the COVID-19 outbreak, TRICARE will cover
cost-sharing for those TRICARE-eligible patients selected to
participate in NIAID-sponsored Phase I, II, III, and IV studies
examining the treatment or prevention of COVID-19 and its associated
sequelae (e.g., cardiac and pulmonary issues). TRICARE will continue to
cover cost-sharing for any eligible beneficiary enrolled in such a
study until the conclusion of that study, even if the national
emergency ends before the conclusion of the study.
(1) TRICARE will cost-share all medical care (including associated
health complications) and testing required to determine eligibility for
an NIAID-sponsored trial, including the evaluation for eligibility at
the institution conducting the NIAID-sponsored study. TRICARE will
cost-share all medical care required as a result of participation in
NIAID-sponsored studies. This includes purchasing and administering all
approved pharmaceutical agents (except for NIAID-funded investigational
drugs), all inpatient and outpatient care, including diagnostic,
laboratory, rehabilitation, and home health services not otherwise
reimbursed under an NIAID grant program if the following conditions are
met:
(i) Such treatments are NIAID-sponsored Phase I, Phase II, Phase
III, or Phase IV protocols;
(ii) The patient continues to meet entry criteria for said
protocol;
(iii) The institutional and individual providers are TRICARE-
authorized providers; and
(iv) The requirements for Phase I protocols in paragraph
(e)(26)(iii)(B)(2) of this section are met.
(2) Requirements for Phase I protocols are:
(i) Standard treatment has been or would be ineffective, does not
exist, or there is no superior non-investigational treatment
alternative;
(ii) The available clinical or preclinical data provide a
reasonable expectation that the treatment will be at least as effective
as the non-investigational alternative;
(iii) The facility and personnel providing the treatment are
capable of doing so by virtue of their experience, training, and volume
of patients treated to maintain expertise; and
(iv) The referring physician has concluded that the enrollee's
participation in such a trial would be appropriate based upon the
satisfaction of paragraphs (e)(26)(iii)(B)(2)(i) through (iii) of this
section.
(3) TRICARE 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.
(4) Cost-shares and deductibles applicable to TRICARE will also
apply under the NIAID-sponsored clinical trials.
(5) The Director, Defense Health Agency (or designee), shall issue
procedures and guidelines establishing NIAID-sponsorship of clinical
trials and the administrative process by which individual patients
apply for and receive cost-sharing under NIAID-sponsored COVID-19
clinical trials.
* * * * *
Dated: October 27, 2020.
Aaron T. Siegel,
Alternate OSD Federal Register Liaison Officer, Department of Defense.
[FR Doc. 2020-24114 Filed 10-28-20; 11:15 am]
BILLING CODE 5001-06-P
