Clinical trials are scientific investigations of treatment alternatives designed to help compare the safety and efficacy of new, untested or non-standard treatments to standard currently accepted treatments. Clinical trials are intended to improve clinicians’ knowledge about a treatment and to improve clinical outcomes for future patients. Improvement of health outcomes for patients enrolled in clinical trials is a desirable but secondary consideration.

Clinical trials generally proceed through four phases:

Phase I - The study drug or treatment is given to, or a medical procedure is performed on, a small group of people for the first time to evaluate its safety, determine a safe dosage range and to identify side effects;

Phase II - The experimental drug or treatment is given to, or a procedure is performed on, a larger group of people to further measure its effectiveness and safety.

Phase III - Further research is conducted to confirm the effectiveness of the drug, treatment or procedure, to monitor the side effects, to compare commonly used treatments and to collect information on safe use.

Phase IV – After the drug, treatment or medical procedure is marketed, investigators continue testing to determine the effects on various populations and to determine whether there are side effects associated with long-term use.

Consistent with W. Va. Code §33-25F-1 et seq., the Plan will consider medically necessary and provide coverage for patient cost to a member in a clinical trial as a result of:

1. Treatment of a life-threatening medical conditions; or
2. Prevention of, early detection of or treatment studies on cancer.

To be covered, a clinical trial must also meet the following additional requirements:

• The treatment is being provided or the studies are being conducted in a Phase II, Phase III or Phase IV clinical trial for cancer and has therapeutic intent; or
• The treatment is being provided in Phase II, Phase III or IV clinical trial for any other life-threatening condition and has therapeutic intent.

The treatment is being provided in a clinical trial approved by:

1. One of the National Institutes of Health; or
2. An NIH Cooperative Group or an NIH center; or
3. The U.S. Food and Drug Administration (FDA) in the form of an investigational new drug application or investigational device exemption; or
4. The U.S. Department of Veterans Affairs; or
5. An institutional review board of an institution in the State of West Virginia which has a Multiple Project Assurance Contract approved by the Office of Protection From Research Risks of the NIH.

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.

There is no clearly superior, non-investigational treatment alternative.

The available clinical or pre-clinical data provide a reasonable expectation that the treatment will be more effective than the non-investigational treatment alternative.

Covered Patient Costs will 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 costs that are consistent with the usual standards of care whenever a patient receives medical care associated with an approved clinical trial; and
• Care that would be covered if such items and services were provided other than in connection with an approved clinical trial.

Covered Patient Costs for clinical trials do not include:

• The cost of the investigational drug or device;
• The cost of non-health care services (e.g. transportation, hotel, meals and other travel expenses) that a patient may be required to receive as a result of the treatment being provided to the member for purposes of the clinical trial;
• Services customarily provided by the research sponsor free of charge for any participant in the trial;
• Costs associated with managing the research associated with the clinical trial including, but not limited to, services furnished to satisfy data collection and analysis needs that are not used in the direct clinical management of the participant; or
• Costs that would not be covered under the participant’s policy, plan, or contract for non-investigational treatments;
• Adverse events during treatment are divided into those that reflect the natural history of the disease, or its progression, and those that are unique in the experimental treatment. Costs for the former will be covered by the Plan, and costs for the latter shall be the responsibility of the clinical trial sponsor and are not covered. The sponsor shall hold harmless the Plan for any losses and injuries sustained by any member as a result of his or her participation in the clinical trials.

Coverage for Patient Costs shall not be provided if:

• The purpose of the clinical trial is designed to extend the patent of any existing drug, or to gain approval or coverage relating to additional clinical indication for an existing drug; or
• The purpose of the clinical trial is designed to keep a generic version of a drug from becoming available on the market; or
• The purpose of the clinical trial is to gain approval of or coverage for a reformulated or repackaged version of an existing drug;
• The trial is a Phase I clinical trial.

Reimbursement:

• Is subject to all applicable coinsurance, co-payment, and deductibles and is otherwise subject to all terms, conditions, restrictions and limitations of the Plan;
• Reimbursement for treatment by an out-of-network or non-contracting provider shall be at a rate which is no greater than that which would be paid to an in-network or contracting provider. Coverage shall not be provided if the out-of-network or non-contracting provider will not accept this level of reimbursement.
• Billing by a provider for services or products provided to a patient in a clinical trial shall be accompanied by written notice that specifically identifies the services as part of a clinical trial.
• Hospitals, facilities, physicians and members requesting coverage and reimbursement for services provided in connection with a clinical trial must be able to provide satisfactory documentation that the conditions set forth in this policy are met. The Plan may request medical records to determine medical necessity.
• All clinical trials shall require authorizations for inpatient and outpatient services.

DEFINITIONS

Clinical Trial: A study that determines whether new drugs, treatments or medical procedures are safe and effective on humans. Such studies are typically conducted in four phases.

Cooperative Group: A formal network of facilities that collaborate on research projects and have an established National Institutes of Health (NIH)- approved peer review program operating within the group. Cooperative Group includes: the National Cancer Institute (NCI) Clinical Cooperative Group; the NCI Community Clinical Oncology Program; the AIDS Clinical Trial Group; and the Community Programs for Clinical Research in AIDS.

Life-Threatening Condition: Means that a member has a terminal condition or illness that according to current diagnosis has a high probability of death within two years, even with treatment with an existing generally accepted treatment protocol.

Member: A person covered by the Plan.

Multiple Project Assurance Contract: A contract between an institution and the U.S. Department of Health and Human Services (DHHS) that defines the relationship of the institution to DHHS and sets out the responsibilities of the institution and the procedures that will be used by the institution to protect human subjects.

Patient Cost: The routine costs of a medically necessary health care service that is incurred by a member as a result of the treatment being provided pursuant of the protocols of a clinical trial. Routine costs of a clinical trial include all items or services that are otherwise generally available to members or beneficiaries of the Plan. Patient Cost does not include those items expressly excluded in Section III of this policy.

Plan: Means Mountain State Blue Cross Blue Shield and the health benefit plans it insures and/or administers.

The Federal Employee Program allows for benefits for certain blood or marrow stem cell transplants and related services or supplies when performed as part of an approved clinical trial.  These procedures are to be conducted at a Cancer Research Facility.  Requirements for approval are applicable:

• Prior approval must be obtained by the Plan from the Transplant Clinical Trials Information Unit.
• The clinical trial must be reviewed and approved by the Institutional Review Board of the Cancer Research Facility where the procedure is to be delivered.
• The patient must be properly  and lawfully registered in the clinical trial, meeting all the eligibility requirements of the trial.

1. W. Va. Code §33-25F-1 et seq.

2. Blue Cross and Blue Shield of North Carolina, ADM 9027

3. Highmark Medical Policy Bulletin, Number G-27

4. CareFirst BlueCross BlueShield 10.01.01A