The lawsuit arises out of the administrative decision of HHS’s Medicare Appeals Council to deny coverage of a life-saving medication under Medicare Part D, allegedly because the medication, Serostim, is only approved to treat wasting syndrome/lipodystrophy of people who also have HIV.  Even though according to National Institutes of Health studies it is at best unclear that HIV, vs. the anti-viral medications used to treat HIV, causes wasting syndrome, HHS and the insurance companies are denying coverage. According to HHS, any other use, including treating wasting syndrome/lipodystrophy of people without HIV, is considered “off-label” and not approved by the FDA, nor is it listed in the Medicare drug compendia as an approved use of this medication. Plaintiff challenges this overly-restrictive interpretation, in that limiting it to people who have HIV is discriminatory and without rational basis.

The lawsuit names the two insurance companies, Envision and Blue Shield, who initially denied coverage of this medication to Plaintiff based on a formulary (a list of medicines that may be prescribed), alleging discrimination based on disability.

This issue is very important because some medications are so expensive, e.g., out of pocket costs of $1,000 or even $12,500 each month, as they are in this case, that denying insurance coverage effectively prevents the patient from obtaining the prescribed medication at all.  PWDF hopes that this litigation will result in a positive impact on Medicare and Medicaid decisions in allowing drug coverage to more individuals whose medically-necessary medications are not covered.  PWDF also hopes this litigation will have greater impact by making policy revisions on what can be considered a “medically-accepted indication” for drugs that can be used to treat multiple conditions, without the “off label” excuse being (mis)used when there is no real basis in fact for denying coverage, except the insurance companies’ profits.