National Coverage Analysis (NCA) Tracking Sheet

Dermal injections for the treatment of facial lipodystrophy syndrome (FLS)



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. There is fat wasting in some areas and increased deposits of fat in other areas. Lipoatrophy occurs when there is a loss of subcutaneous tissue.

Facial lipodystrophy syndrome (FLS) is often characterized by a loss of fat that results in a facial abnormality such as severely sunken cheeks. This fat loss can arise as a complication of HIV and/or HAART. Due to their appearance and stigma of the condition, patients with FLS may become depressed, socially isolated and in some cases may stop their HIV treatments in an attempt to halt or reverse the complication.

CMS received a request for national coverage of treatments for FLS for HIV infected beneficiaries. On July 16, 2009 the agency determined that dermal injections to the treatment of FLS in HIV infected patients falls under a Medicare benefit category. Only services that fall under a benefit category are payable under the Medicare program. Also on July 16, 2009, the agency opened this tracking sheet announcing that CMS will review the evidence to determine if the service is reasonable and necessary.

Currently, two injectable dermal fillers are approved by the Food and Drug Administration specifically for these patients. Sculptra received FDA approval on August 3, 2004. The FDA labeled indication states, “Sculptra is intended for restoration and/or correction of the signs of facial fat loss (lipoatrophy) in people with or receiving treatment for human immunodeficiency virus.” Radiesse received FDA approval on December 22, 2006. The indication states, “Radiesse is indicated for subdermal implantation for restoration and/or correction of the signs of facial fat loss (lipoatrophy) in people with human immunodeficiency virus.”

In this national coverage analysis, CMS will review the available evidence for treating FLS in HIV infected patients with dermal injections and determine whether this service is reasonable and necessary.

Benefit Category

Physicians' Services

Requestor Information

Requestor Name Requestor Letter
Dr. Bruce Wilder, Esq and the University of Pittsburgh School of Law, Health Law Clinic N/A

Important Dates

Formal Request Accepted and Review Initiated
Expected NCA Completion Date
Public Comment Period
07/16/2009 - 08/15/2009
Proposed Decision Memo Due Date
Proposed Decision Memo Released
Proposed Decision Memo Public Comment Period
12/23/2009 - 01/22/2010
Decision Memo Released
Comments for this NCA
View Public Comments


Lead Analysts
JoAnna Baldwin, MS
Lead Medical Officers
Madeline Ulrich, MD

Medicare Benefit Category Determination Date

Actions Taken

July 16, 2009

CMS opens a national coverage analysis for the use of dermal injections for the treatment of FLS in HIV infected patients.

Certain treatments of facial lipodystrophy syndrome in association with HIV or AIDs may  be included in one of several benefit categories .

October 7, 2009

Posted comments [PDF, 7MB] received.

December 23, 2009

CMS posts the Proposed Decision Memorandum. The 30-day public comment period on the proposed decision begins with this posting date, and ends after 30 calendar days. CMS considers all public comments, and is particularly interested in new evidence relevant to the technology under review.

Instructions on submitting comments can be found at:

To submit a comment, please use the orange "COMMENT" button at the top of the page.

March 23, 2010