Lipodystrophy Syndrome – HIV associated Form

1

Lipodystrophy Syndrome – HIV associated - Medical Policy
Updated Revision Effective: 10/1/2025 Policy Number:

UM389POL

Approval Date:

Line(s) of Business:

Commercial
Medicare Advantage
Medicaid (BeHealthy)

Description

Human immunodeficiency virus (HIV)–associated lipodystrophy is a syndrome that occurs in HIV-infected patients who are being treated with antiretroviral medications. Antiretroviral therapy (ART) has successfully improved HIV-associated complications and mortality by reducing opportunistic infections. However, metabolic complications and lipodystrophy stemming from long-term ART are concerning and may lead to discontinuation of therapy or regimen substitution. HIV lipodystrophy does not lead to uniform morphologic changes. It may result in abnormal central fat accumulation (lipohypertrophy) and localized loss of fat tissue (lipoatrophy). Some patients have only lipohypertrophy, while some have only lipoatrophy, and, less commonly, a subset of patients exhibits a mixed clinical presentation.

Lipohypertrophy syndrome is characterized by the presence of an enlarged dorsocervical fat pad, circumferential expansion of the neck, breast enlargement, and abdominal visceral fat accumulation.

Lipoatrophy syndrome is exemplified by peripheral fat wasting with loss of subcutaneous tissue in the face, arms, legs, and buttocks.

Facial lipoatrophy consists of a progressive loss of facial fat and can be disfiguring cosmetically. Involvement of the face is most common and carries a social stigma and is associated with decreased self-esteem, depression, sexual dysfunction, social isolation, and decreased quality of life; it may also pose a barrier to treatment and reduce medical adherence. Decreased malar fat and temporal fat results in deep skin furrows, and lines of expression become more prominent. This can result in an aged or wasting appearance. This emaciated look creates a stigma of HIV infection and the fear of an unintentional disclosure of HIV status.

Etiology of lipodystrophy is still unknown, both ART and HIV cause changes in lipid distribution. Metabolic abnormalities associated with ART include insulin resistance, hyperlipidemia, and endothelial dysfunction, which can increase the risk of cardiovascular disease. The incidence of diabetes mellitus or atherosclerotic cardiovascular disease is increased secondary to hyperglycemia (from insulin resistance) or hyperlipidemia, respectively. Dietary consideration should be provided to optimize treatment-associated complications. Preventive screening for cardiovascular diseases caused by metabolic alterations should be

2

routinely performed. Lipodystrophy has been shown to be associated with anxiety and poor body image, for which mental health services are needed. Alternative treatments for HIV are emerging, which may address the adverse effects caused by ART.

Prevention of HIV-associated lipoatrophy consists mainly of avoidance of antiretroviral agents (mainly thymidine analogues, and in particular, stavudine) that have been associated with its development. Neither stavudine nor zidovudine is a first-line nucleoside reverse transcriptase inhibitor (NRTI) for treatment-naïve patients with HIV initiating antiretroviral therapy (ART), and stavudine is very rarely used. However, some patients who initiated treatment years ago may still be on regimens that contain these agents.

Treating HIV-associated lipodystrophy beyond pure cosmesis comes with several potential benefits. Changes in body morphology can be associated with psychological distress that affects self-esteem and/or adherence to antiretroviral therapy (ART). Additionally, certain therapeutic interventions for HIV-associated lipodystrophy have the potential to favorably affect associated metabolic derangements, such as dyslipidemia and abnormal glucose metabolism.

Management of HIV-associated lipoatrophy include modification of the antiretroviral regimen, surgical correction, and pioglitazone. Surgical options include injectable temporary fillers for patients who desire cosmetic remodeling for severe facial lipoatrophy.

Management of HIV-associated fat accumulation (lipodeposition) include diet and exercise, metformin, the growth hormone-releasing factor analogue tesamorelin, and surgical interventions. For patients with fat accumulation in delimited areas, certain surgical interventions, such as dorsocervical fat pad liposuction or reduction mammoplasty, may be effective, although recurrent fat accumulation in these sites can occur.

 Line of Business

Commercial:
Refer to criteria under the Policy section in this medical policy.

Medicaid – BeHealthy:
Refer to criteria under the Policy section in this medical policy. There are no MassHealth guidelines for treatment of HIV associated Lipodystrophy Syndrome.

Medicare:
Health New England follows National Coverage Determination (NCD) 250.5 (Dermal Injections for the Treatment of Facial Lipodystrophy Syndrome [LDS]) for the Medicare line of business. https://www.cms.gov/medicare- coverage-database/search.aspx

Policy

Commonwealth of Massachusetts Mandate: Pursuant to chapter 233 of Acts of 2016 (An Act Relative to HIV Associated Lipodystrophy Treatment), all fully-insured health plans must include coverage for medical or drug treatments to correct or repair disturbances of body composition caused by HIV associated lipodystrophy syndrome including, but not limited to, reconstructive surgery, such as suction assisted lipectomy, other restorative procedures and dermal injections or fillers for reversal of facial lipoatrophy syndrome.

3

A. FDA approved fillers for HIV-associated lipoatrophy of the face, suction assisted lipectomy or other restorative procedures are considered MEDICALLY NECESSARY in HIV associated lipodystrophy syndrome caused by antiretroviral HIV treatment when following criteria are met.

1. Member documented to have Lipodystrophy related to highly active antiretroviral therapy for the treatment of HIV infections resulting in lipoatrophy and physical abnormalities such as abnormal fat distribution in the body; AND

2. Conservative treatment (modification of the antiretroviral regimen, diet and exercise) and pharmacotherapy (pioglitazone or metformin or tesamorelin) have failed to treat the condition or are not appropriate treatments for member’s condition.

   B. Fillers for lipoatrophy of face, suction assisted lipectomy or other restorative procedures are considered NOT MEDICALLY NECESSARY for non-HIV related lipodystrophy syndrome.

   C. Dermal fillers that are not approved by the FDA for the treatment of lipodystrophy syndrome are considered EXPERIMENTAL and INVESTIGATIONAL.

   Policy Guidelines and Definitions

   Policy Guidelines:

   Required Documentation:

   • Submission of a prior authorization request from a treating provider with attached clinical information indicating treatment is medically necessary for correcting, repairing or ameliorating the effects of HIV- associated lipodystrophy syndrome.

   Coding Guidance

   Code
   Description
   PA Required HCPC Codes

   Yes G0429 Dermal filler injection(s) for the treatment of facial lipodystrophy syndrome (LDS) (e.g., as a result of highly active antiretroviral therapy) Yes CPT Codes:

   Yes 11950 Subcutaneous injection of filling material (eg, collagen); 1 cc or less
   Yes 11951 Subcutaneous injection of filling material (eg, collagen); 1.1 to 5.0 cc Yes 11952 Subcutaneous injection of filling material (eg, collagen); 5.1 to 10.0 cc Yes 11954 Subcutaneous injection of filling material (eg, collagen); over 10.0 cc Yes 15876 Suction lipectomy of head and neck Yes 15877 Suction lipectomy of trunk Yes

4

Code
Description
PA Required 15878 Suction assisted lipectomy; upper extremity Yes 15879 Suction assisted lipectomy; lower extremity Yes *Not covered for Medicare

CPT® Copyright 2025 American Medical Association. All rights reserved. CPT is a registered trademark of the American Medical Association.

Note: CPT/HCPCS codes are included for informational purposes and may not be all-inclusive. Inclusion or exclusion of a CPT/HCPCS code(s) does not signify or imply that the service described by the code is a covered or non-covered health service. Benefit coverage for health services is determined by the member’s specific benefit plan document and applicable laws that may require coverage for a specific service. The inclusion of a code does not imply any right to reimbursement or guarantee of payment. Other policies and coverage determination guidelines may apply.

References

Chapter 233 of Acts of 2016, “An Act Relative to HIV Associated Lipodystrophy Treatment”. https://www.mass.gov/doc/bulletin-2016-14-hiv-associated-lipodystrophy-syndrome-medical-benefit- requirements- issued/download#:~:text=Pursuant%20to%20Chapter%20233%2C%20all,suction%20assisted%20lipectomy%2C %20other%20restorative

NCD 250.5: Dermal Injections for the Treatment of Facial Lipodystrophy Syndrome (LDS). https://www.cms.gov/medicare-coverage- database/view/ncd.aspx?NCDId=338&ncdver=1&DocID=250.5&SearchType=Advanced&bc=IAAAAAgAAAAAAA% 3d%3d

Medscape: Lipodystrophy in HIV Treatment & Management. https://emedicine.medscape.com/article/1082199-treatment#d3

UpToDate: Treatment of HIV-associated lipodystrophy. https://www.uptodate.com/contents/treatment-of-hiv-associated-lipodystrophy

Policy Implementation

Approved by the Medical and Pharmacy Policy Committee

Kate McIntosh MD MBA

Chief Medical Officer

Saad Usmani MD MBA

Medical Director

Date Update 10/2023 Massachusetts State Mandate specified, definitions updated and criteria clarified with no significant change.
Added CPT codes 11951, 11952, 11953, 11954, 15878, 15879 1/2024 Line of Business section added

5

Date Update 10/2024 Annual review with no changes. 7/2024 Annual review with no changes.
7/2025 Annual review with no changes

Medical Criteria Disclaimer

Property of Health New England. All rights reserved. The treating physician or primary care provider must submit to Health New England the clinical evidence that the patient meets the criteria for the treatment, testing or surgical procedure. Without this documentation and information, Health New England will not be able to properly review the request for prior authorization. The clinical review criteria reflect how Health New England determines whether certain services or supplies are medically necessary. Health New England established the clinical review criteria based upon a review of currently available clinical information (including clinical outcome studies in the peer-reviewed published medical literature, regulatory status of the technology, evidence-based guidelines of public health and health research agencies, evidence-based guidelines and positions of leading national health professional organizations, views of physicians practicing in relevant clinical areas, and other relevant factors).
Health New England expressly reserves the right to revise these conclusions as clinical information changes, and welcomes further relevant information. Each benefit program defines which services are covered. The conclusion that a particular service or supply is medically necessary does not constitute a representation or warranty that this service or supply is covered and/or paid for by Health New England, as some programs exclude coverage for services or supplies that Health New England considers medically necessary. If there is a discrepancy between this guideline and a member's benefits program, the benefits program will govern. In addition, coverage may be mandated by applicable legal requirements of a state, the Federal Government or the Centers for Medicare & Medicaid Services (CMS) for Medicare and Medicaid members. All coding and web site links are accurate at time of publication. Health New England has adopted the herein policy in providing management, administrative and other services to its Health Plan.