CMS NCD 338: Dermal Injections for Facial Lipodystrophy Syndrome — What Billing Teams Need to Know in 2026

The Centers for Medicare & Medicaid Services (CMS) has issued a modification to National Coverage Determination (NCD) 338, governing Medicare coverage of dermal injections for the treatment of facial lipodystrophy syndrome (LDS). This policy is narrowly scoped — it applies exclusively to HIV-infected Medicare beneficiaries whose LDS was caused by antiretroviral therapy and who manifest clinically significant depression as a result. If you bill dermal filler procedures for this population, understanding the exact coverage criteria is essential to avoiding denials.

CMS NCD 338: Understanding the Coverage Framework for Facial LDS

NCD 338 covers a very specific clinical intersection — patients living with HIV or AIDS who are on highly active antiretroviral therapy (HAART) and have developed lipodystrophy syndrome as a metabolic side effect. HAART is associated with a range of metabolic complications, including hyperlipidemia, hyperglycemia, diabetes, and lipodystrophy. Lipodystrophy refers to abnormal fat distribution — and in the facial presentation, it typically manifests as severely sunken cheeks, which can profoundly affect a patient's appearance and psychological well-being.

CMS's coverage rationale here is worth understanding because it directly informs medical necessity documentation. The agency recognizes two pathways through which facial LDS creates a clinically meaningful problem: first, it can contribute to depression; second, it can reduce a patient's willingness to adhere to their antiretroviral regimen — which directly jeopardizes their health outcomes. CMS has determined that correcting the physical abnormality through dermal injection can improve both of those outcomes, which is the basis for coverage.

This is not a cosmetic coverage determination. It is a functional and psychological one. That distinction matters enormously when building a claim.

CMS Medicare Coverage Criteria: What Makes a Dermal Injection for LDS Covered

Per NCD 338, dermal injections for LDS are covered when all three of the following conditions are met:

Additionally, only dermal fillers that have received FDA approval specifically for the treatment of LDS are covered. The policy does not name specific products in the NCD text itself, but the FDA approval designation for LDS treatment is what drives compliance here. At the time NCD 338 was last substantively reviewed (March 2010), FDA-approved options for this indication were limited — confirm current FDA approval status before billing.

What CMS Does NOT Cover Under NCD 338

The non-covered indications are equally specific and just as important to flag in your documentation review process.

CMS will not cover dermal filler procedures under this NCD in the following scenarios:

• Dermal fillers without FDA approval for LDS treatment — regardless of the patient's HIV status or clinical presentation, using a filler not FDA-approved for LDS disqualifies the claim.
• Any use of dermal fillers beyond LDS in HIV-infected patients with antiretroviral-associated depression — the policy scope is deliberately narrow. Dermal filler procedures for facial rejuvenation, aging, scarring, or any other LDS presentation (without the depression link) are not covered under this NCD.

Billing these services when the criteria are not fully met exposes your practice to claim denial, post-payment audit risk, and potential Medicare fraud and abuse scrutiny given the cosmetic-vs.-clinical nature of the service.

Affected Codes

The policy document for NCD 338 does not list specific CPT or HCPCS codes. Billing teams should consult the associated CMS claims processing transmittals — Transmittal 1978 and Transmittal 2105 — for procedure code guidance applicable to dermal filler services under this NCD.

No covered or non-covered CPT/HCPCS codes are enumerated in the current policy text.

Related ICD-10 Diagnosis Codes to Consider (based on clinical criteria — confirm against current LCD and transmittal guidance):

Important: These ICD-10 codes are not enumerated in NCD 338 itself. They reflect the clinical conditions described in the policy criteria. Work with your coding team and verify against any applicable Local Coverage Determinations (LCDs) in your MAC jurisdiction before submitting claims.

Prior Authorization Requirements Under NCD 338

NCD 338 does not explicitly mandate prior authorization as a condition of coverage. However, given the narrow and clinically specific coverage criteria — HIV infection, antiretroviral-induced LDS, and depression as a significant contributor — pre-service documentation review is strongly recommended. Many Medicare Administrative Contractors (MACs) may apply additional local coverage policy on top of this NCD, and the clinical complexity of this case type makes a strong pre-claim documentation file essential.

Building a Defensible Medical Necessity File for NCD 338

Given the multi-condition nature of this coverage determination, a thin chart note won't hold up to audit scrutiny. Your documentation should include:

• Confirmed HIV diagnosis — supported by current lab work or treating physician records
• HAART/antiretroviral medication history — documenting the specific regimen and duration, establishing the causal link to LDS
• Clinical description of facial lipodystrophy — including severity, onset timeline relative to antiretroviral therapy, and physical findings
• Depression diagnosis — documented by a qualified provider, with explicit clinical notation that facial LDS is a significant contributing factor to the depression (not just a co-occurring condition)
• FDA approval verification — documentation confirming the specific dermal filler product used holds FDA approval for LDS treatment

The linkage between LDS and depression is the element most likely to be challenged. A referring physician's or psychiatrist's note that explicitly connects the two — rather than simply listing both diagnoses — is the strongest evidentiary support you can provide.

What Your Billing Team Should Do