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Fighting a Health Plan’s “Investigational” Denial of a Medical Claim

Health insurance policies typically have exclusions for treatments that an insurance company considers “investigational” or “experimental.” Insurance companies say there is insufficient proof demonstrating that certain treatments are safe and effective for their intended use, making them investigational or experimental and not a covered medical benefit.

Whether a particular treatment is investigational or experimental will depend on how it is defined in the health insurance policy. One example of such an exclusion is Anthem Blue Cross’s policy provision excluding experimental and investigational treatments. Anthem Blue Cross defines those terms as:

Experimental or Investigational — any treatment, therapy, procedure, Drug or Drug usage for non-FDA approved indications, facility or facility usage, equipment or equipment usage, device or device usage, or supplies which are not recognized in accordance with generally accepted professional medical standards as being safe and effective for use in the treatment of an illness, injury, or condition at issue.

Under this language, treatments that are FDA approved and generally accepted in the medical profession as safe and effective should not be denied as investigational or experimental.Boldon v. Humana Ins. Co., 466 F.Supp.2d 1199, 1212 (D. Ariz. 2006) (health plan’s classification of cancer treatment as “investigational” was an abuse of discretion based in part on evidence of treatment’s widespread use in cancer treatment centers across the United States). Potter v. Blue Cross Blue Shield of Michigan, No. 10-cv-14981, 2013 WL 4413310 (Mar. 30, 2013 E.D. Mich.) (medical literature established “long term” efficacy of treatment).

United HealthCare Insurance Company uses an exclusion in its medical policies for treatments it considers “Experimental or Investigational or Unproven.” The investigational definition merely requires that the treatment have approval from an appropriate regulatory body such as the FDA. The Unproven definition, however, excludes treatments:

that are determined not to be effective for treatment of the medical condition and/or not to have a beneficial effect on net health outcomes due to insufficient and inadequate clinical evidence from well-conducted randomized controlled trials or cohort studies in the prevailing published peer-reviewed medical literature.

Companies like Anthem Blue Cross, Kaiser, Aetna, Cigna, Health Net and United HealthCare Insurance Company often deny medical claims using these types of denial reasons. For instance, Anthem Blue Cross, Aetna and United HealthCare Insurance Company have refused to cover lumbar artificial disc surgery despite the fact that the surgery has been FDA approved since 2004 and is frequently performed by renowned surgeons at leading medical centers.

Gianelli & Morris successfully resolved a class action lawsuit against Blue Shield of California over that company’s refusal to cover lumbar artificial disc surgery on the basis it was investigational. Escalante v. Blue Shield of California, United States District Court for the Central District of California Case No. 2:14-CV-3021 DDP-PJWx As a result of this lawsuit, Blue Shield has changed its position and now covers the surgery.

Many companies, including United HealthCare Insurance Company and Blue Shield, also deny medical claims for proton beam therapy for the treatment of prostate cancer on the basis it is investigational. But Proton beam therapy is an established form of treatment that is widely accepted by physicians, government agencies and many insurers, including Medicare and Medicaid (which do not cover investigational or experimental treatments). Proton beam therapy to treat prostate cancer is performed at leading medical centers such as Loma Linda University Medical Center and Scripps Health in San Diego.

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