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Arguments To Use Against An Insurer's Denial Of A Health Claim

A Claim Denied On The Basis That The Procedure Is Experimental

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With new procedures, treatments or off-label uses of drugs (uses other than those for which the drug was approved by the FDA), an insurer may say the situation is "experimental" and therefore not covered. The insurer's primary argument is that until more is known, there is no reasonable way to tell whether the procedure, treatment or use will work, and in fact that it may be harmful. Of course, money may be a factor as well.

It becomes your burden to prove that a procedure is not experimental (even if it is performed in a research hospital). The goal becomes finding objective evidence which shows that the therapy is potentially effective for the group which includes you (the patient), that it is medically necessary, that it is a last resort that is reasonable and necessary for you, and/or that it has succeeded in prolonging life or improving quality of life. 

Insurers have been known to approve coverage for "experimental treatments" on a case-by-case basis. The decision should be made on a medical basis. According to the Health Insuirance Answer Book, 6th Edition, twelve major insurers polled by the Government Accounting Office said that nonmedical factors such as the fear of costly litigation and adverse public relations were also factors in the decision.

In order to build your case: 

Step 1. Check the wording in your insurance policy about "experimental." Definitions vary from company to company, and possibly from policy to policy within the same company.


Step 2. Speak with the doctor who recommended the procedure, treatment or off-label use. He or she is likely to be the best source of the information you will need. Your doctor can let you know if the procedure, treatment or use is indeed approved by the FDA for your diagnosis -- and can supply verification if that is the case.

Step 3. If the procedure is not FDA approved for your particular diagnosis, build your case that the procedure, treatment or use is not experimental before filing your appeal. If you can't complete your research before the deadline for filing an appeal, file the appeal and submit additional information as you learn it.  Find out:

    • If other specialists or health professionals in the area are using the procedure or treatment.  Many times procedures will be state of the art before they are FDA approved for your diagnosis.
    • If the procedure is being used in other regions of the country.  "Standard" medical procedures can vary by region. (Don't be surprised if it is difficult to find out how widely any given treatment is used.)
    • Whether your national or local disease specific non-profit organization has information on the use of this procedure, treatment or use with your diagnosis, including how often it is used and by whom.
    • If the procedure, treatment or use has been covered in any peer reviewed medical journals. [A peer reviewed journal is one in which articles are reviewed by experts (peers) before publication. One of the best known peer reviewed journals is JAMA -- the Journal of the American Medical Association]. Peer reviewed journals can be obtained from your local library, a nearby medical school library or on the internet. You can also find abstracts of many articles free on the library of the National Institutes of Heal's web site: www.pubmed.gov offsite link
    • If other insurers in your area cover the treatment in question.  Many large insurers list their policies concerning treatments on their Web sites. If the procedure, treatment or use is not listed,  your doctor may have knowledge of what other insurers do.
    • If this procedure, treatment or use is being used for people with your diagnosis in other medically advanced countries such as Canada, those in Europe, or Israel.  Many treatments, procedures and uses have been accepted in other medically advanced countries before being approved for use in the United States.
    • If members of your support group (if you have one) know about using this procedure, treatment or use.  Those with a particular medical condition are often better informed about treatments and results than doctors.

Step 4.When you write your appeal letter, ask that your claim be reviewed by the insurer's medical director or staff doctor. Even though paid by the insurer, a doctor is more likely to back good patient care. 

Following is a list of sites that may provide some of the information you need.

For treatments, services or procedures

  • PubMed (from the National Institutes of Health): www.ncbi.nim.nih.gov/sites/entrez offsite link. Abstracts (summaries of the articles) are free. The full articles may be expensive. If you need them, ask your doctor's office for help or check with a local medical school library for a free copy.
  • Annals of Internal Medicine (from the American College of Surgeons): www.annals.org offsite link
  • Journal Of The American Medical Association: http://jama.ama-assn.org/ offsite link
  • National Guideline Clearinghouse (US Department of Health and Human Services): www.guideline.gov offsite link (a public resource for evidence-based clinical practice guidelines. Check the date of guidelines before using to be sure they are current).
  • National Institutes of Health: http://www.nih.gov/ offsite link
  • The New England Journal of Medcine: http://content.nejm.org/ offsite link
  • Public Library of Science (PLoS) Journals: http://www.plos.org/journals/index.php offsite link

For drugs

If a drug is involved,  the manufacturer may be an excellent source for evidence that a drug or use of the drug is not experimental. Also see:


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