Title: 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)
Actions Taken
January 16, 2009
CMS opens BCD NCD process. 30-day public comment period begins.
July 16, 2009
CMS closes the benefit coverage determination process. Certain treatments of facial lipodystrophy syndrome in association with HIV or AIDs may be included in one of several benefit categories.
DEPARTMENT OF HEALTH & HUMAN SERVICES
Centers for Medicare & Medicaid Services
7500 Security Boulevard, Mail Stop C5-15-12
Baltimore, Maryland 21244-1850
Center for Medicare Management
Date: July 16, 2009
Benefit Category Determination for Reconstructive Treatments for
Facial Lipodystrophy Syndrome
Lipodystrophy is characterized by abnormal fat distribution in the body. In association with the human immunodeficiency virus (HIV) or the acquired immunodeficiency syndrome (AIDS), there is fat wasting in some areas and increased deposition of fat in other areas. Lipohypertrophy is occurs when there is increased fat deposition in the back, neck, breast, and internal abdominal areas. Lipoatrophy occurs when there is a loss of subcutaneous tissue in the face, arms, legs, and buttocks. When this abnormal fat distribution occurs in the face, it is commonly described as Facial Lipodystrophy Syndrome. Treatment for facial lipodystrophy syndrome may include various approaches to facial contour resolution, such as dermal-fat grafts, fat injections, submalar silicone implants, liquid injectable silicone, polylactic acid injections, collagen, hyaluronic acid fillers, and a biocompatible implant filler consisting of calcium hydroxylapatite.
We have examined whether treatment of FLS in association with the human immunodeficiency virus (HIV) or the acquired immunodeficiency syndrome (AIDS) with the approaches described above would be excluded from Medicare coverage under section 1862(a)(10) of the Social Security Act (the Act). We have determined that with respect to treatment occurring through an injection of fat or other substances into the patient's face, this statutory bar does not apply.
With respect to treatment of FLS in association with the human immunodeficiency virus (HIV) or the acquired immunodeficiency syndrome (AIDS) through an injection of fat or other substances into the patient's face, we believe this procedure or service may be included under the benefit categories set forth at section 1861(s)(1) of the Act when performed by a physician, section 1861(s)(2)(A) of the Act when performed incident to a physician's professional service in a physician's office, and section 1861(s)(2)(B) of the Act as a hospital service incident to physicians' services when rendered to hospital outpatients. This may not be an exhaustive list of all applicable Medicare benefit categories for this item or service.
