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).