1.0 Description
The Department of Defense (DoD) Cancer Prevention
and Treatment Clinical Trials Demonstration was conducted from 1996
through March 2008 to improve access to promising new cancer therapies,
assist in meeting the National Cancer Institute’s (NCI’s) clinical
trial goals, and to assist in the formulation of conclusions regarding
the safety and efficacy of emerging therapies in the prevention
and treatment of cancer. This Demonstration included Phase II and
Phase III protocols sponsored by the NCI for the prevention, screening,
early detection, and treatment of all types of cancer. The Demonstration
ended on March 31, 2008 and applicable coverage guidance has been incorporated
into this policy. A new Interagency Agreement between DoD and the
NCI has been entered into which is effective April 1, 2008. Participation
in Phase I studies may be approved on a case-by-case basis when
the requirements listed below are met, effective February 14, 2011.
2.0 POLICY
2.1 Cancer
clinical trial participation is authorized for those TRICARE-eligible
patients selected to participate in NCI-sponsored Phase I, Phase
II, and Phase III studies for the prevention, screening, early detection,
and treatment of cancer. TRICARE will cost-share all medical care
and testing required to determine eligibility for an NCI-sponsored
trial, including the evaluation for eligibility at the institution conducting
the NCI-sponsored study. TRICARE will cost-share all medical care
required as a result of participation in NCI sponsored studies.
This includes purchasing and administering all approved chemotherapy
agents (except for NCI-funded investigational drugs), all inpatient
and outpatient care, including diagnostic and laboratory services
not otherwise reimbursed under an NCI grant program if the following
conditions are met:
2.1.1 The provider seeking treatment for a TRICARE-eligible
beneficiary in an NCI approved protocol has obtained preauthorization
for the proposed treatment before initial evaluation; and
2.1.2 Such treatments
are NCI sponsored Phase I, Phase II, or Phase III protocols; and
2.1.3 The patient
continues to meet entry criteria for said protocol; and
2.1.4 The institutional
and individual providers are TRICARE-authorized providers.
2.2 In addition
to the above requirements, all of the following conditions must
be met for participation in Phase I cancer clinical trials:
2.2.1 Standard
treatment has been or would be ineffective, does not exist, or there
is no superior non-investigational treatment alternative. Attending
physician, Primary Care Manager (PCM), or oncologist referral to
the trial, and the patient’s subsequent acceptance to the trial
fulfill this requirement; 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.
Attending physician, PCM, or oncologist referral to the trial, and
the patient’s subsequent acceptance to the trial fulfill this requirement;
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. NCI sponsored
trials meet this criteria; and
2.2.4 The enrollee’s participation
in such a trial would be appropriate based upon the satisfaction of
the above criteria. Attending physician, PCM, or oncologist referral
to the trial, and the patient’s subsequent acceptance to the trial
fulfill this requirement.
3.0 POLICY
CONSIDERATIONS
3.1 Referral
by Attending Physician
The attending physician,
PCM, or oncologist shall determine the eligible patient’s needs
and consult with the TRICARE contractor’s cancer clinical trials
case manager/NCI to determine which, if any, Phase I, Phase II,
or Phase III, NCI-sponsored studies are appropriate for the patient.
3.2 Identification
of Eligible NCI-Sponsored Clinical Trials
3.2.1 NCI sponsorship of clinical
trials occurs through the Cancer Therapy Evaluation Program (CTEP),
Cooperative Group Studies, NCI Grants or Cancer Center Studies.
Evidence of NCI sponsorship in one of these categories will be that
it is identified in the NCI comprehensive database, Physician’s
Data Query (PDQ), or NCI supplements to that database; formal notification
of approval from The Clinical Protocol Review and Monitoring Committee;
or verification from the NCI project officer; or through protocols
co-sponsored by the NCI and other Federal Agencies.
3.2.2 Unlike
the NCI-sponsored protocols for CTEP, Cooperative Group Studies,
or NCI Grants, protocols for Cancer Center Studies are not individually
reviewed by the NCI. Instead, the NCI designates specific institutions
as meeting NCI criteria for clinical and comprehensive cancer centers. Cancer
center protocols receive approval through an NCI approved institutional
peer review and quality control system at the institution. Protocols
which have been through this process receive formal notification
of approval from The Clinical Protocol Review and Monitoring Committee
and, therefore, are considered NCI sponsored, but may not appear
in the PDQ. A provider who is seeking to enter a patient into a
Cancer Center Study must provide evidence of NCI sponsorship by
forwarding the formal notification of approval from this specific
committee. Formal notification of approval by the Clinical Protocol
Review and Monitoring Committee will be required for approval of
treatment in Cancer Center Studies which are not otherwise sponsored
through the CTEP program, NCI cooperative groups, or NCI grants.
3.2.3 Certain
protocols listed in the PDQ may not be clearly identified in terms
of NCI sponsorship. Clinical trials conducted as part of an NCI
grant, or those identified with a “V” number, must be verified for
NCI sponsorship with the NCI project officer. Physicians who are
holders of the grant at the institution must provide written clarification
that the proposed treatment is a protocol under their NCI grant.
The grant title and number must be specified.
3.2.4 Requests
for treatment in clinical trials overseas must be verified as to
NCI sponsorship with the NCI project officer.
3.2.5 Protocols
that are co-sponsored by the NCI and other Federal Agencies must
be verified by the NCI project officer.
3.2.6 Some NCI-sponsored clinical
trials are designated as multiple-phased trials (e.g., Phase I/II). Multi-phase
NCI-sponsored clinical trials are eligible for TRICARE coverage
as long as the beneficiary is a participant in a trial phase that
would normally be covered in a single-phase trial.
3.3 The DoD
has no authority regarding the NCI 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 Retroactive
authorizations can be authorized in accordance with the provisions
outlined in
32 CFR 199.4(g)(19).
3.5 Claims will be paid from the
applicable underwritten Contract Line Item Number (CLIN) and submitted
through normal TRICARE Encounter Data (TED) system processing as
required in the TRICARE Systems Manual (TSM) with the applicable
coding for cancer clinical trials with enrollment in Phase II and
Phase III cancer clinical trials effective on or after April 1,
2008, and enrollment in Phase I cancer clinical trials effective
on or after February 14, 2011.
3.6 Normal TRICARE eligibility,
reimbursement, co-payments, cost-shares, deductibles, TRICARE for Life
(TFL), and double coverage rules apply.
3.7 The contractor shall:
3.7.1 Provide
a registered nurse to serve as case manager for inquiries and actions
pertinent to the cancer clinical trials benefit.
3.7.2 Ensure
the provider has submitted a letter on the facility’s letterhead:
3.7.2.1 Provide
the patient’s name and the last four digits of the sponsor’s Social
Security Number (SSN); and
3.7.2.2 Certify
the protocol is an NCI-sponsored study and providing the title and
phase of the protocol and the NCI number of the protocol and/or
other appropriate evidence of NCI sponsorship; and
3.7.2.3 Certify
the patient meets all entry criteria for said protocol; and
3.7.2.4 Certify
notification will be provided to the contractor’s cancer clinical
trials benefit case manager of the patient’s registration date when
treatment actually begins; and
3.7.2.5 Certify
notification will be provided to the contractor’s cancer clinical
trials benefit case manager if the patient becomes ineligible for
the study prior to the treatment.
3.7.3 Utilize
the NCI’s Comprehensive Cancer Database known as the PDQ, to assist
in determining whether a particular study meets the requirements
of the cancer clinical trials benefit and whether the patient is
eligible for a particular protocol. For those studies that are not
listed on the PDQ, the contractor will work with NCI staff to verify
NCI sponsorship and phase of the study.
3.8 The contractor
may at its discretion establish a dedicated toll-free telephone
number to receive inquiries from both patients and providers regarding
the cancer clinical trials benefit. If a dedicated toll-free telephone
number is established, the phone shall be staffed seven hours a
day during normal business hours in the contractor’s time zone where
the inquiries are received. In the absence of a dedicated toll-free
number for cancer clinical trials benefit inquiries, contractors
shall use their primary toll-free telephone inquiry system (see
the TOM,
Chapter 11, Section 6 and
Chapter 20, Section 4).
• The contractor may
at its discretion establish a dedicated mailing address where cancer clinical
trials benefit inquiries and claims shall be sent for expedited
response and/or claims adjudication. In the absence of a dedicated
mailing address for cancer clinical trials benefit inquiries and
claims, contractors shall use their primary address(es) for written correspondence
and claims (see the TOM,
Chapter 11, Section 4 and
5, and
Chapter 20, Section 4).