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).