CMS Dermal Injections for the Treatment of Facial Lipodystrophy Syndrome (LDS) Form

A. General

Treatment of persons infected with the human immunodeficiency virus (HIV) or persons who have Acquired Immune Deficiency Syndrome (AIDS) may include highly active antiretroviral therapy (HAART). Drug reactions commonly associated with long-term use of HAART include metabolic complications such as, lipid abnormalities, e.g., hyperlipidemia, hyperglycemia, diabetes, lipodystrophy, and heart disease. Lipodystrophy is characterized by abnormal fat distribution in the body.

The LDS is often characterized by a loss of fat that results in a facial abnormality such as severely sunken cheeks. The patient’s physical appearance may contribute to psychological conditions (e.g., depression) or adversely impact a patient’s adherence to antiretroviral regimens (therefore jeopardizing their health) and both of these are important health-related outcomes of interest in this population. Therefore, improving a patient’s physical appearance through the use of dermal injections could improve these health-related outcomes.

B. Nationally Covered Indications

Effective for claims with dates of service on and after March 23, 2010, dermal injections for LDS are only reasonable and necessary using dermal fillers approved by the Food and Drug Administration (FDA) for this purpose, and then only in HIV-infected beneficiaries when LDS caused by antiretroviral HIV treatment is a significant contributor to their depression.

C. Nationally Non-Covered Indications

1. Dermal fillers that are not approved by the FDA for the treatment of LDS.
2. Dermal fillers that are used for any indication other than LDS in HIV-infected individuals who manifest depression as a result of their antiretroviral HIV treatments.

D. Other

N/A

(This NCD last reviewed March 2010.)