1.0 Description
On
October 30, 2020, the Department of Defense (DoD) published an Interim
Final Rule (85 FR 68753) that authorizes Defense Health Agency (DHA)
coverage of drugs, devices, and medical treatments or procedures
provided in clinical trials sponsored by National Institute of Allergy
and Infectious Diseases (NIAID) for the prevention or treatment
of COVID-19. These regulatory provisions enforce an agreement between
DoD and the National Institutes of Health (NIH), executed September 19,
2020, both of which authorize DoD cost-sharing of care provided
in connection with NIH sponsored or approved clinical trials and
establishes requirements and responsibilities for both parties.
2.0 POLICY
2.1 COVID-19 clinical trial participation
is authorized for those TRICARE-eligible patients selected to participate
in NIAID-sponsored Phase I, II, III, and IV studies for the prevention,
screening, early detection, and treatment of COVID-19 and its associated
sequelae (e.g., cardiac and pulmonary complications). TRICARE will
cost-share all medical care and testing required to determine eligibility
for an NIAID-sponsored trial, including the evaluation for eligibility
at the institution conducting the NIAID-sponsored trial. TRICARE
will cost-share all medical care required as a result of participation
in NIAID-sponsored studies, including necessary follow-up care and
testing that takes place after the period of active treatment on
protocol is completed. This includes purchasing and administering
all approved pharmaceutical drugs (except for the NIAID-funded investigational
agents) and 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:
2.1.1 Such treatments
are NIAID-sponsored Phase I, Phase II, Phase III, or Phase IV protocols
(see
paragraph 3.1);
2.1.2 The patient continues to meet entry criteria
for said protocol;
2.1.3 The
institutional and individual providers are TRICARE-authorized providers.
2.2 In addition to the above requirements,
the following conditions must be met for participation in Phase
I COVID-19 clinical trials. Attending physician, Primary Care Manager
(PCM), or specialist referral to the trial, and the beneficiary’s
subsequent acceptance to the trial fulfill these requirements.
2.2.1 Standard treatment has been or would be
ineffective, does not exist, or there is no superior non-investigational
treatment alternative; and
2.2.2 The available clinical or preclinical
data provide a reasonable expectation that the treatment will be
at least as effective as the non-investigational alternative; and
2.2.3 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
2.2.4 The beneficiary’s
participation in such a trial would be appropriate based upon the satisfaction
of the above criteria.
3.0 POLICY CONSIDERATIONS
3.1 Identification
of Eligible Clinical Trials
3.1.1 There is no central repository for
COVID-19 clinical trials eligible under this benefit. However, most
clinical trials conducted in the United States are listed in the
US National Library of Medicine Database at
https://clinicaltrials.gov/.
Trials listed in this database will indicate the topic of study
(e.g., evaluating the efficacy of a COVID-19 vaccine) and the study
sponsor and collaborators (e.g., NIAID). A trial is considered to
meet the requirement for NIAID-sponsorship or approval if NIAID
is listed as either the trial sponsor or a trial collaborator.
3.1.3 Clinical trials must meet the criteria
in this section to be eligible under this benefit.
3.1.4 If there is any uncertainty about the eligibility
of a clinical trial, then providers, contractors, and beneficiaries
may contact NIH or NIAID directly.
3.1.5 Requests for treatment in COVID-19 clinical
trials overseas must be verified as to NIAID sponsorship using the
procedures described in
paragraph 3.2.1.
3.2 Contractor Responsibilities
3.2.1 The contractors
shall verify that the COVID-19 clinical trial is sponsored by NIAID
and otherwise meets all requirements of this section. If the contractor
is unable to ascertain the NIAID-sponsorship status of a clinical
trial at either clinicaltrials.gov or the NIAID website, the contractor
shall obtain the trial sponsorship status via other means including
contacting NIAID, NIH, the trial investigators, and the provider
submitting the claim. The contractor shall not deny coverage of
a beneficiary claim for participation in a COVID-19 clinical trial
based solely on information obtained from clinicaltrials.gov or
the NIAID website.
3.2.2 The contractors shall verify that
all services and supplies that are submitted for cost-sharing meet
the requirements of this section.
3.2.3 The contractors may at their discretion
establish a dedicated toll-free telephone number to receive inquiries
from both patients and providers regarding the COVID-19 clinical
trials benefit, or may use the dedicated cancer clinical trial toll-free
telephone number, if available. If a dedicated toll-free telephone
number is established, the phone shall be staffed seven hours a
day during normal business hours in the contractors’ time zones
where the inquiries are received. In the absence of a dedicated
toll-free number for COVID-19 clinical trials or cancer and COVID-19
clinical trials benefit inquiries, contractors shall use their primary
toll-free telephone inquiry system (see the TRICARE Operations Manual
(TOM),
Chapter 11, Section 6 and
Chapter 20, Section 4).
3.3 The DoD has no authority regarding the
NIAID protocol eligibility for the sponsored study. Therefore, if
a patient does not meet the protocol eligibility criteria for enrollment,
appeal rights do not apply.
3.4 Claims will be submitted and paid
through normal TRICARE Encounter Data (TED) system processing as
required in the TRICARE Systems Manual (TSM) with the applicable
coding for COVID-19 clinical trials with enrollment in Phase I,
II, III, and IV COVID-19 clinical trials.
3.5 Normal TRICARE eligibility, reimbursement,
co-payments, cost-shares, deductibles, TRICARE for Life (TFL), and
double coverage rules apply.
4.0 EXCLUSIONS
4.1 Care rendered in the NIH Clinical Center.
4.2 Costs associated with non-treatment
research activities associated with the clinical trials. These include,
but are not limited to: data collection activities, management and
analysis of the data, salaries of the research nurses, and the cost
of the investigational agents (if used in the protocol). These research
costs will also not be the responsibility of the beneficiaries participating
in the clinical trials.
4.3 Trials
not meeting the requirements of this section are excluded, for example,
industry-sponsored trials where NIAID is not a sponsor or collaborator.
5.0 EFFECTIVE DATE
Effective October
30, 2020.
5.1 Coverage for COVID-19 clinical trials
will last through the end of the President’s national emergency.
5.2 Beneficiaries who have been enrolled
in an eligible COVID-19 clinical trial during the national emergency
will continue to have their care covered for the duration of that
clinical trial, even if the national emergency has ended, so long
as the requirements of this section are met.