DESCRIPTION
An injectable form of poly-L-lactic acid, a biodegradable and biocompatible synthetic polymer from the alpha-hydroxy-acid family, is now available for use as a facial implant device. It is being used for a condition known as lipoatrophy (facial wasting or loss of facial fat). Lipoatrophy is a common condition among individuals with human immunodeficiency virus (HIV). A sinking of the cheeks, eyes and temples can occur due to the loss of fat tissue under the skin. This device will not correct the underlying cause of the facial fat loss, but will help improve the appearance by increasing skin thickness in the treated area.
A doctor injects the poly-L-lactic acid implant into areas of facial fat loss. It works by temporarily adding volume to facial tissue and restoring a smoother, fuller appearance to the face. The initial treatment series may consist of four to five injection sessions conducted at approximately two-week intervals. Repeat treatments are needed to maintain the effect. The effect lasts from several months to a year or more. The number of injection sessions and the quantity of injected product depends upon the severity of the lipoatrophy.
Examples of poly-L-lactic acid injectable implant devices include Sculptra™ and New-Fill®.
POLICY
Poly-L-lactic acid injectable implant devices for the restoration and/or correction of the signs of lipoatrophy are considered cosmetic.
Poly-L-lactic acid injectable implant devices for the treatment of all other diseases/conditions are considered investigational.
IMPORTANT REMINDER
We develop Medical Policies to provide guidance to Members and Providers. This Medical Policy relates only to the services or supplies described in it. The existence of a Medical Policy is not an authorization, certification, explanation of benefits or a contract for the service (or supply) that is referenced in the Medical Policy. For a determination of the benefits that a Member is entitled to receive under his or her health plan, the Member's health plan must be reviewed. If there is a conflict between the Medical Policy and a health plan, the express terms of the health plan will govern.
ADDITIONAL INFORMATION
Well-designed studies regarding the use of poly-L-lactic acid injectable implant devices for the treatment other diseases/conditions (e.g., facial wrinkles and folds due to ageing) are lacking. The device does not improve the underlying cause of facial fat loss or improve net health outcomes.
SOURCES
Carey, D. L., Baker, D., Rogers, G. D., Petoumenos, K., Chuah, J., Easey, N., et al. (2007). A randomized, multicenter, open-label study of poly-L-lactic acid for HIV-1 facial lipoatrophy. Journal of Acquired Immune Deficiency Syndromes, 46 (5), 581-589. (Level 1 - Industry sponsored)
Hirsch, R., & Stier, M. (2009). Complications and their management in cosmetic dermatology. Dermatologic Clinics, 27 (4), 507-520.
Mest, D., & Humble, G. (2009). Retreatment with injectable Poly-L-Lactic Acid for HIV-associated facial lipoatrophy: 24 month extension of the Blue Pacific study. Dermatology Surgery, 35 (S-1), 350-359. (Level 4 Evidence - Industry supported)
Narins, R. S., Baumann, L., Brandt, F. S., Fagien, S., Glazer, S., Lowe, N. J., et al. (2010). A randomized study of the efficacy and safety of injectable poly-L-lactic acid versus human-based collagen implant in the treatment of nasolabial fold wrinkles. Journal of the American Academy of Dermatology, 62 (3), 448-462. (Level 2 - Industry sponsored)
National Institute for Health and Clinical Excellence. Deep dermal injection of non-absorbable gel polymer for HIV-related facial lipoatrophy. Retrieved November 16, 2011 from http://www.nice.org.uk/nicemedia/live/11293/43642/43642.PDF.
Sadove, R. (2009). Injectable poly-L-lactic acid: A novel sculpting agent for the treatment of dermal fat atrophy after severe acne. Aesthetic Plastic Surgery, 33 (1), 113-116. (Level 4 - Industry sponsored)
U. S. Food and Drug Administration. (2009, July). Center for Devices and Radiological Health. Sculptra - P030050. Retrieved March 19, 2010 from http://www.accessdata.fda.gov/cdrh_docs/pdf3/P030050b.pdf.
ORIGINAL EFFECTIVE DATE: 4/14/2005
MOST RECENT REVIEW DATE: 1/12/2012
ID_BT
Policies included in the Medical Policy Manual are not intended to certify coverage availability. They are medical determinations about a particular technology, service, drug, etc. While a policy or technology may be medically necessary, it could be excluded in a member's benefit plan. Please check with the appropriate claims department to determine if the service in question is a covered service under a particular benefit plan. Use of the Medical Policy Manual is not intended to replace independent medical judgment for treatment of individuals. The content on this Web site is not intended to be a substitute for professional medical advice in any way. Always seek the advice of your physician or other qualified health care provider if you have questions regarding a medical condition or treatment.
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