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).