If an individual has Lipodystrophy, a life-threatening autoimmune condition, he can be denied coverage for a medication used to treat its symptomatology – cachexia/wasting syndrome – because he does not have another unrelated auto-immune disease, HIV.

Appellant’s position is there is no rational basis for denial of coverage. The prescribed treatment is for wasting syndrome aka cachexia and not for any HIV treatment. The substantial evidence of record shows that Lipodystrophy can be cured in the HIV population simply by changing the antiviral drugs (ART[¹]) used to treat the HIV.[²]

Throughout the administrative proceedings, which include three ALJ hearings, three Appeal Council opinions and the U.S. District Court, HHS has never once revealed any rational basis for this distinction. They simply say they have a written list which states the medication is only available for people who also have HIV. In other words, it is prescribed for the population with HIV; it is for people who have cachexia, otherwise known as wasting syndrome, which is a symptom of Lipodystrophy and not related to HIV. Lipodystrophy is an auto-immune disease where one’s body cannot retain lipids. Lipids are adipose tissue (fats) under the skin and internally in and around organs. Lipids produce a hormone called Leptin, which is synthetically available to people with Lipodystrophy, but has severe side effects such as Lymphoma, cancer of the lymphatic system. The name of this synthetic hormone is Myalept.

PWDF has appealed this case under the Medicare Act, Part D (prescription drugs), Constitutional Due Process (substantive due process), and Section 504 of the Rehabilitation Act of 1973.

What is particularly striking is that the District Court stated the Court does not have the competence to decide this question as to what is the legally correct statute’s Compendia requirement. Normally in these cases, a remand back to the Agency (HHS) under Section 405 of the Social Security Act is used to obtain an expert; i.e., a biochemist doctor, to find out if there indeed is any rational basis for depriving the population with Lipodystrophy, but without HIV, of this medication. Since there is no law in any U.S. Court of Appeals, this is an issue of first instance and we hope it will lead to a well-reasoned decision.

Appellant asked the case be expedited based on facts; that it is a life-threatening condition that can result in death. We do not expect a three-judge panel to be assigned until this summer, after which time oral arguments will be scheduled.

A public Appellant opening brief is attached:

doe v. Azar.opening.brief.redacted.3.30