Cancer Clinical Trials
Medical Policy: 10.01.16
Original Effective Date: July 2010
Reviewed: February 2012
Revised:
Benefit Application
Benefit determinations are based on the applicable contract language in effect at the time the
services were rendered. Exclusions, limitations or exceptions may apply. Benefits may vary
based on contract, and individual member benefits must be verified. Wellmark determines medical
necessity only if the benefit exists and no contract exclusions are applicable. This medical
policy may not apply to FEP. Benefits are determined by the Federal Employee Program.
This Medical Policy document describes the status of medical technology at the time the document
was developed. Since that time, new technology may have emerged or new medical literature may
have been published. This Medical Policy will be reviewed regularly and be updated as scientific
and medical literature becomes available.
Description:
Wellmark Blue Cross Blue Shield provides coverage for medically necessary routine patient care costs incurred for cancer treatment in an approved cancer clinical trial to the same extent coverage is provided if the patient were receiving standard cancer treatment.
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Prior Approval:
Not applicable
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Policy:
Routine patient care costs include the following items and services:
- Otherwise covered physician fees, laboratory expenses, and expenses associated with a hospitalization
- Evaluation and treatment of the patient associated with the underlying disease
- Care that would be covered if such items and services were provided other than in connection with an approved cancer clinical trial
- Care costs that are consistent with the usual standards of care whenever a patient receives medical care associated with an approved cancer clinical trial
Routine patient care costs do not include:
- Any treatments, procedures, drugs, devices, services, or items that are the subject of the approved cancer clinical trial or any other investigational treatments, procedures, drugs, devices, services, or items
- Non-health care services that the patient is required to receive as a result of participation in the approved cancer clinical trial
- Costs associated with managing the research that is associated with the approved cancer clinical trial
- Costs that would not be covered if non-investigational treatments were provided
- Costs of any services, procedures, or tests provided solely to satisfy data collection and analysis needs that are not used in the direct clinical management of the patient
- Costs paid for, or not charged for, by the approved cancer clinical trial providers
- Costs for transportation, lodging, food, or other expenses for the patient, a family member, or a companion of the patient that are associated with travel to or from a facility where an approved cancer clinical trial is conducted
- Costs for services, items, or drugs that are eligible for reimbursement from a source other than a patients’ Wellmark policy, including the sponsor of the approved cancer clinical trial
- Costs associated with approved cancer clinical trials designed exclusively to test toxicity or disease pathophysiology
- Costs of extra treatments, services, procedures, tests, or drugs that would not be performed or administered except for participation in the cancer clinical trial
An approved cancer clinical trial is a scientific study of a new therapy for the treatment of cancer in human beings and consists of a scientific plan of treatment that includes ALL of the following:
- Specified goals
- A rationale and background for the plan
- Criteria for patient selection
- Specific directions for administering therapy and monitoring patients
- A definition of quantitative measures for determining treatment response
- Methods for documenting and treating adverse reactions
The approved cancer clinical trial must be provided with therapeutic intent to improve a patient’s health outcome relative to ONE of the following:
The available clinical or pre-clinical data indicate that the treatment or intervention provided pursuant to the approved cancer clinical trial will be at least as effective as standard therapy, if such therapy exists, and is anticipated to constitute an improvement in effectiveness for treatment, prevention, or palliation of cancer
The patient must be referred for the approved cancer clinical trial by at least one physician who specializes in oncology.
The approved cancer clinical trial must be one that has been approved or authorized by one of the following:
- The National Institutes of Health (NIH)
- The U.S. Food and Drug Administration (FDA)
- The U.S. Department of Defense (DOD)
- The U.S. Department of Veterans Affairs (VA)
The proposed cancer treatment must have been reviewed and approved by the applicable Qualified Institutional Review Board.
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Procedure Codes and Billing Guidelines:
- To report provider services, use appropriate CPT* codes, Alpha Numeric (HCPCS level 2) codes, Revenue codes, and/or ICD-9-CM diagnostic codes.
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Selected References:
- Cancer Clinical Trials Insurance Coverage of Routine Patient Care, HF 2075; 83rd General Assembly, State of Iowa (2010).
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Policy History:
Date Reason Action
March 2011 Annual review Policy renewed
February 2012 Annual review Policy renewed
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Wellmark medical policies address the complex issue
of technology assessment of new and emerging treatments, devices,
drugs, etc. They are developed to
assist in administering plan benefits and constitute neither offers of
coverage nor medical advice. Wellmark medical policies contain only a
partial, general description of plan or program benefits and do not
constitute a contract. Wellmark does not provide health care services
and, therefore, cannot guarantee any results or outcomes.
Participating providers are independent contractors in private
practice and are neither employees nor agents of Wellmark or its
affiliates. Treating providers are solely responsible for medical
advice and treatment of members. Our medical policies may be updated
and therefore are subject to change without notice.
*Current Procedural Terminology © 2012 American Medical Association. All Rights Reserved.
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