[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]
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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 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.
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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: http://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 http://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.
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\
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\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.
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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