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.