Plaintiff has a life-threatening autoimmune disease, lipodystrophy, in which the individual cannot retain lipids and for which he has been prescribed a growth hormone.  HHS Medicare refused coverage for this prescription based on three compendia, none of which are public for all pertinent years, unless the following condition is satisfied.  In order to cover the prescribed medication, the individual must have another, unrelated autoimmune disease (HIV).  This requirement is irrational because for the past 20 years, people with HIV who also have lipodystrophy can be cured of their lipodystrophy by changing their HIV anti-viral medications.  Therefore, it is the population with lipodystrophy, as opposed to people with HIV, who are in more need of this medication because individuals with lipodystrophy cannot change HIV anti-viral medications because they do not have HIV.  HHS has continuously misrepresented that lipodystrophy must be caused by HIV to qualify for the prescription drug coverage, in spite of the fact that it is based on a false premise.

For a medication to be covered by Medicare, the statute[¹] requires a medication to either be listed in one or more of HHS’s compendia or supported by a citation in one of these compendia.  The problem is HHS does not make these compendia public, except for an outdated one for the year 2016.  Therefore, it is not possible for a Medicare beneficiary who needs the medication to know whether a medication is listed or not because the compendia are not publicly available.  Nonpublic criteria were made illegal in Bowen v. New York, 476 U.S. 467 (1986).  Plaintiff has alleged HHS has acted in bad faith and committed intrinsic fraud in U.S. District Court.  Oral arguments on motions for summary judgment were heard in Oakland on December 5, 2019 at 2 p.m. before Hon. Hayward S. Gilliam, Jr.