Clinical Trials for Non-cancer Indications

Medical Policy: 10.01.01 
Original Effective Date: September 1998 
Reviewed: February 2012 
Revised: July 2010 

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: 

Clinical trials are research studies designed to answer scientific questions and achieve specific outcomes in the evaluation of new or emerging drugs, biologics, devices, medical, behavioral, or radiological treatments or procedures, or surgical procedures. New uses of existing therapies are also studied in clinical trials.

Generally, there are four phases of clinical trials.

Phase I trials usually are the first time a new drug, device, or treatment is used in human subjects, typically involve small populations (20 to 100 participants) and are short-term (3-12 months). The goal is to evaluate safety, determine safe treatment ranges, and identify side effects.  The data obtained are used to design phase II trials.

Phase II trials involve larger numbers of subjects (50 – 500 participants) who have the disease or condition under study to determine treatment effectiveness, further evaluate safety, and further refine optimal use of the drug, biologic or device, or technique of the medical or surgical procedure. Phase II trials can be randomized and may or may not be blinded, placebo- or standard therapy-controlled. These trials may require up to several years to complete.

Phase III trials are conducted with large groups of subjects (hundreds to thousands of participants) to confirm the effectiveness of a treatment, compare it to commonly used treatments and collect additional information on safety and side effects. These trials often occur across multiple institutions and may require several years to complete.

Phase IV trials are also known as post-marketing studies and are typically conducted after a governing agency, typically the Food and Drug Administration (FDA),  has given approval for a drug, biologic, or device to be marketed. Often these trials may be required as a condition for approval. They are designed to evaluate effectiveness in a broader population of patients and to gain additional information about suspected or known adverse reactions. Phase IV trials may be conducted by a drug or device manufacturer to compare their product with a competitor’s in order to determine if one offers clinical advantage over another.

Note: This policy addresses coverage of medical costs in clinical trials for non-cancer indications related to medical procedures or treatments and is not intended to address coverage of clinical trials of investigational devices or investigational uses of medications, which are considered the responsibility of the device or drug manufacturer.

For information concerning cancer clinical trials see the following policy:

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Prior Approval: 

Not applicable

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Policy: 

Wellmark Blue Cross Blue Shield provides coverage for routine patient care costs incurred for treatment in an approved clinical trial to the same extent coverage is provided if the patient were receiving standard treatment.

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 clinical trial
• Care costs that are consistent with the usual standards of care whenever a patient receives medical care associated with an approved clinical trial

Routine patient care costs do not include:

• Any treatments, procedures, drugs, devices, services, or items that are the subject of the approved 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 clinical trial
• Costs associated with managing the research that is associated with the approved 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 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 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 clinical trial
• Costs associated with approved 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 clinical trial
• Costs attributed to any damages to a patient who participates in an approved clinical trial arising out of participation in the approved clinical trial

Eligibility for coverage is contingent upon meeting ALL of the following:

• The member must be enrolled in a phase II or phase III clinical trial
• The trial must be approved by one of the following:
  • National Institutes of Health (NIH)
  • U. S. Food and Drug Administration (FDA)
  • U. S. Food and Drug Administration (FDA)
  • U.S. Department of Veterans Affairs (VA)
• The clinical trial is conducted under a written research protocol with applicable Institutional Review Board (IRB) approval
• The technology being studied is a treatment for a condition that is either life-threatening or severely and chronically disabling and that has a poor prognosis with the most effective treatment available
  • The technology must be therapeutic, used to directly improve health outcomes, and not for diagnosis
  • The condition is considered to be life-threatening if it has a substantial probability of causing premature death
  • A condition is considered severely and chronically disabling if the individual is unable to perform the functions that are required for daily life and if the severe disability is not expected to improve with the most effective available treatment

The approved clinical trial must be a scientific study of a new therapy for the treatment of a non-cancerous condition in human beings and consist 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

Wellmark does not cover medical costs directly associated with clinical trials that fail to meet the criteria detailed above. However, Wellmark does cover the costs of medically necessary procedures and treatments that would otherwise be provided under a standard, non-investigational treatment plan for the condition being treated. In these circumstances, a service may be considered for coverage if it is medically necessary because of the member’s condition or because of other medically necessary treatment that the member is receiving.

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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 diagnostic codes.

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Selected References: 

• Medical Director's, Wellmark Blue Cross Blue Shield.

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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.