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) record editing 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. The contractor shall work with
NCI staff to verify NCI sponsorship and phase of the study, for those
studies that are not listed on the PDQ.
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, the contractor shall use their primary
toll-free telephone inquiry system (see the TOM,
Chapter 11, Section 6 and
Chapter 20, Section 4).
3.9 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, the contractor shall use their primary address(es)
for written correspondence and claims (see the TOM,
Chapter 11, Sections 4 and
5, and
Chapter 20, Section 4).