Reconstructive Treatments for Facial Lipodystrophy Syndrome

Issue: Reconstructive treatments for Facial Lipodystrophy Syndrome generally involve injecting various substances to supplement or fill out certain contours of the face. Lipodystrophy Syndrome (LDS) is characterized by abnormal redistribution of fat. Facial LDS refers to a wasting of the fat stores in the face in some individuals with the Human Immunodeficiency Virus (HIV) taking anti-retroviral medication.

A requestor has asked CMS to open a national coverage determination (NCD) to determine that reconstructive treatments for Facial LDS are covered under Medicare.

The first inquiry after a request for an NCD is made it to determine whether the requested item or service is statutorily excluded and whether there is a benefit category. Therefore, we will first determine whether or not the reconstructive treatments as requested are statutorily excluded as cosmetic surgery under section 1862(a)(10) of the Social Security Act. See also 42 CFR 411.15(h). If we were to determine that these treatments are not statutorily excluded by 1862(a)(10), we would then need determine whether this service falls within one or more statutory benefit categories under part A or part B. If so, we would also need to determine whether the treatment is reasonable and necessary to treat "illness or injury or to improve the functioning of a malformed body member" under section 1862(a)(1)(A) of the Social Security Act in order to be covered under the Medicare program.

Benefit Category: To be determined.

Requestor Name(s):

• Dr. Bruce Wilder, Esq., Wilder & Mahood, PC

• Stella L. Smetanka, Esq. and Amber L. Trischler, Certified Legal Intern, University of Pittsburgh School of Law Health Law Clinic

Expected Completion Date: October 14, 2009.

PDM Due Date: July 16, 2009.

Lead Medical Officer(s): E. L. Hambrick, M.D.
410.786.5340
ReconstructionNCD@cms.hhs.gov

Actions Taken: CMS opens BCD NCD process. 30-day public comment period begins.

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