Health plan contracts typically have exclusions for treatments that an
insurance company considers “investigational” or “experimental.”
Health plans 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 plan conract. 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
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 handled 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. In
Escalante v. Blue Shield of California, Gianelli & Morris won class certification of a class of individuals
whose had these claims denied.
Escalante v. California Physicians Service dba Blue Shield of California, 309 F.R.D. 612 (C.D. Cal., 2015). That case was later resolved successfully
with Blue Shield retracting its “investigational” denial basis
and agreeing to cover the surgery.
Gianelli & Morris also won class certification in a case against UntiedHealth
Care based upon its refusal to cover artificial disc surgery as “investigational.”
Hill v. UnitedHealthcare Insurance Company, United States District Court for the Central District of California,
Case No. SA CV 15-0526-DOC.
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.
If your health plan has denied your claim on the basis it is “investigational”
or “experimental,” you should seek an opinion regarding the
covered nature of the claim. Health plans often deny such claims without
thoroughly vetting the science behind the treatment.