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.