Insurance Issues Related to Clinical Trials
Many times participation in a clinical trial requires learning more about your insurance policy. Many policies do not provide coverage for clinical trials that are considered Experimental and/or Investigational. This means the insurance company does not recognize the proposed treatment as a standard of care and will not pay for it. Some policies may cover trials in certain stages – for example, coverage for Phase 3 or Phase 4 trials. This information will be explained in your insurance policy language. Health plans may specify specific criteria a trial must meet to be covered. The trial might have to be sponsored by a specified organization, be judged "medically necessary" by the health plan, not be significantly more expensive than treatments the health plan considers standard, or focus on types of cancer for which no standard treatments are available. In addition, the facility and medical staff might have to meet the plan’s qualifications for conducting certain procedures, such as bone marrow transplants.
How do I know if I have coverage?
Read your policy language to see what it says about Clinical Trials. You will want to review the Covered Benefits, Non-Covered Benefits and Exclusions of the plan language. In addition, you will want to read how the policy defines Experimental and/or Investigational in the definitions section of the policy. Your policy should provide coverage for current Standard of Care treatment.
Medicare reimburses patient care costs for its beneficiaries who participate in clinical trials designed to diagnose or treat cancer.5 Information about Medicare coverage of clinical trials is available at http://www.medicare.gov, or by calling Medicare's toll-free number for beneficiaries at 1–800–633–4227 (1–800–MEDICARE). The toll-free number for the hearing impaired is 1–877–486–2048. In addition, the National Cancer Institute (NCI) fact sheet More Choices in Cancer Care: Information for Beneficiaries on Medicare Coverage of Cancer Clinical Trials is available at: http://seer.cancer.gov/statfacts/.
After reviewing your plan language, you should have a better understanding of what is and is not covered. More information about insurance coverage can be found on the internet at NCI's Cancer Clinical Trials at the NIH Clinical Center Web page at: http://www.cancer.gov/cancertopics/factsheet/NCI/clinical-center.
Many states have passed laws or developed policies requiring health plans to cover the costs of certain clinical trials. For more information, visit the NCI's Web site at: http://www.cancer.gov/clinicaltrials/developments/laws-about-clinical-trial-costs.
If your insurance company denies coverage of the trial, do not be discouraged. You need to submit an appeal to your insurance company, requesting that they reconsider the denial and provide coverage for the requested treatment. Your appeal should be based on the medical necessity of the clinical trial and why your physician feels that a clinical trial is the best treatment option for you. If there is enough information to show that the approach is safe and effective, your health plan may consider the approach "established" and cover some or all of the costs. If you find yourself in a situation where you need to appeal you may find "Your Guide to the Appeals Process" helpful. You can read or download the publication from our website, www.patientadvocate.org. You can contact Patient Advocate Foundation at 1-800-532-5274 and one of our Patient Service representatives is available to assist you. You can speak with the sponsor of the trial or one of the trial representatives. There may be funds available through the trial sponsor to assist you. In addition, there are fund raising organizations that may be of assistance.
What if your policy does not provide coverage?
The informed consent will outline costs that are covered under the trial and costs that are not. It will also outline what charges will be submitted to your insurance company for consideration. Speaking with your insurance company prior to your participation can help to prevent unforeseen financial costs to you. Again, be sure to speak with the Research Nurse or Principal Investigator to get an idea of the out of pocket costs to you, if any, for participation.
The biggest challenge in participating in a clinical trial if your insurance denies coverage, is obtaining coverage for those charges that would otherwise be covered if you were receiving standard treatment. Your insurance company may deny charges for blood work (complete blood count) or x-rays (e.g. CT scan) if the tests are ordered more often than they deem necessary. The insurance company will deny the tests as "Experimental/Investigational" feeling they are being done to monitor the trial. You will want to stay in close contact with your treating physicians' office for assistance in appealing medical necessity claims of this nature. They will be able to help establish what is standard of care and what is related to the trial.
Financial assistance often is available via the hospital or treating facility. Remember, there are income guidelines that always must be considered.
Federal programs that help pay the costs of care in a clinical trial include those listed below:
- Beneficiaries of TRICARE, the Department of Defense’s health program, can be reimbursed for the medical costs of participation in NCI-sponsored Phase 2 and Phase 3 cancer prevention (including screening and early detection) and treatment trials. Additional information is available in the NCI fact sheet TRICARE Beneficiaries Can Enter Clinical Trials for Cancer |Prevention and Treatment Through a Department of Defense and National Cancer Institute Agreement.
- The Department of Veterans Affairs (VA) allows eligible veterans to participate in NCI-sponsored prevention, diagnosis, and treatment studies nationwide. All Phases and types of NCI-sponsored trials are included. The NCI fact sheet The NCI/VA Agreement on Clinical Trials: Questions and Answers has more information. It is available at: http://www.cancer.gov/images/Documents/ec037d3c-d6c3-45f6-9cc1-263602a4a034/fs1_17.pdf.
5 National Cancer Institute Fact Sheet. Retrieved 2/28/09 from http://www.cancer.gov/cancertopics/factsheet/support/medicare