Highmark provides coverage for medically indicated and otherwise covered patient care costs associated with qualifying/approved cancer clinical trials as defined below.

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

• the costs of the investigational drugs or devices themselves,
• the costs of any non-health service that might be required for a person to receive the treatment or intervention (e.g., transportation, hotel, meals, and other travel expenses),
• the costs of managing the research, or
• the costs which would not be covered under the member's contractual benefits for non-investigational treatments.
  

1. The treatment or intervention is provided pursuant to an approved cancer clinical trial that has been funded, authorized or approved by one of the following:
   
   • The National Institutes of Health (NIH) including the National Cancer Institute (NCI);
   • The United States Food and Drug Administration (FDA) in the form of an investigational new drug (IND) exemption;
   • The United States Department of Defense (DOD);
   • The United States Department of Veterans Affairs (VA);
   • Centers for Disease Control and Prevention (CDC);
   • Agency for Healthcare Research and Quality (AHRQ);or
   • Health Care Financing Administration (HCFA).
     
2. The proposed therapy has been reviewed and approved by the applicable qualified Institutional Review Board.
3. 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.
4. The facility and personnel providing the treatment are capable of doing so by virtue of their experience and training.
5. The trial consists of a scientific plan of treatment that includes specific goals, a rationale and background for the plan, criteria for patient selection, specific directions for administering therapy and monitoring patients, a definition of the quantitative measures for determining treatment response, and methods for documenting and treating adverse reactions. All such trials must have undergone a review for scientific content and validity, as evidenced by approval from one of the federal entities identified above.
   

• Evaluate a service which falls within covered benefits;
• Have a therapeutic intent (i.e., not designed exclusively to test toxicity or disease pathophysiology); and
• Enroll diagnosed members.
  

The Federal Employee Program allows for the bone marrow transplant procedures and related services and supplies which are covered only through clinical trials. The following criteria are applicable:

• Prior approval by the Plan is required. The Plan will direct inquiries and prior approval requests to the Clinical Trials Information Unit of the Blue Cross Blue Shield Association.
  
• 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 registered in the clinical trial, meeting all of its eligibility requirements.
  

Comprehensive and Wraparound

This policy on cancer clinical trials is applicable only to members enrolled through Highmark Blue Cross Blue Shield in Western Pennsylvania.

PRN References

06/2001, Coverage for Cancer Clinical Trials