Metreleptin (Myalept) — CPB 0882 | AETNA Coverage Update

Aetna modified CPB 0882 for metreleptin (Myalept), effective September 26, 2025. Here's what billing teams need to know before submitting claims.

Aetna, a CVS Health company, updated CPB 0882 — its coverage policy for metreleptin (Myalept) — with a September 26, 2025 effective date. This policy governs prior authorization and medical necessity criteria for Myalept claims, including administration billed under CPT 96372. If your practice treats lipodystrophy patients and bills Aetna, this update sets the exact criteria your precertification requests must hit to avoid a claim denial.

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Quick-Reference Table

Field	Detail Copy
Payer	Aetna, a CVS Health company
Policy	Metreleptin (Myalept) — CPB 0882
Policy Code	CPB 0882
Change Type	Modified
Effective Date	September 26, 2025
Impact Level	High
Specialties Affected	Endocrinology, Internal Medicine, Metabolic Disease, Rare Disease
Key Action	Confirm all three initial approval criteria are documented before submitting precertification for new Myalept starts

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Aetna Metreleptin Coverage Criteria and Medical Necessity Requirements 2025

The Aetna metreleptin coverage policy has a three-part gate for initial approval. All three criteria must be met. If any one is missing from the documentation, expect a denial.

Criterion 1 — Diagnosis. The member must have congenital generalized lipodystrophy (Berardinelli-Seip syndrome), acquired generalized lipodystrophy (Lawrence syndrome), or partial lipodystrophy. ICD-10 code E88.1 (Lipodystrophy) is the primary diagnosis code. Diabetes mellitus codes E08.00–E13.9 may appear as comorbidities, but they don't substitute for the lipodystrophy diagnosis itself.

Criterion 2 — Leptin deficiency confirmed by lab. The member's leptin level must be below 12 ng/mL on lab testing. This isn't a clinical judgment call — Aetna wants the number in the chart. Build this into your precertification checklist now. No lab result, no approval.

Criterion 3 — At least one metabolic complication. The member must have diabetes mellitus, hypertriglyceridemia, or increased fasting insulin (E16.1 — hyperinsulinemia) as a documented complication of lipodystrophy. E78.1 (pure hyperglyceridemia) also qualifies when tied to generalized or acquired generalized leptin deficiency.

For continuation of therapy, medical necessity requires documented improvement from baseline in metabolic control. Think improved glycemic control, decreased triglycerides, or normalized hepatic enzyme levels. If your practice manages ongoing Myalept patients, you need to show progress — not just stability — at each recertification.

Prior authorization is mandatory. Precertification of metreleptin (Myalept) is required for all Aetna participating providers and members in applicable plan designs. Call (866) 752-7021 or fax (888) 267-3277. You can also access the Statement of Medical Necessity form through Aetna's Specialty Pharmacy Precertification portal.

The real issue here is documentation specificity. Aetna isn't asking for a general lipodystrophy diagnosis — it wants a specific subtype, a specific lab value, and a specific complication. Generic chart notes won't hold up at precertification. Make sure your ordering physicians know exactly what the chart needs to say before the prior auth request goes in.

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Aetna Metreleptin Exclusions and Non-Covered Indications

Aetna draws two hard exclusions. Neither will get approved regardless of documentation.

HIV-related lipodystrophy — Aetna won't cover Myalept for HIV-associated lipodystrophy (HALS). This includes anti-retroviral therapy-associated acquired lipodystrophy. ICD-10 B20 (HIV disease) appearing as a primary or contributing diagnosis flags this exclusion. The clinical rationale is that the safety and efficacy data for HALS don't support approval.

Generalized obesity not associated with generalized lipodystrophy — ICD-10 codes E66.1 through E66.9 appear in this policy for a reason: they're listed to define what's not covered. Obesity alone — even severe obesity — doesn't qualify for Myalept. The distinction matters because metabolic complications of obesity and lipodystrophy can look similar on a problem list. If the primary driver is obesity, not lipodystrophy, Aetna will deny it.

Beyond those two hard exclusions, Aetna considers metreleptin experimental, investigational, or unproven for a long list of other indications. These include anorexia nervosa (F50.0–F50.9), Celia's encephalopathy (G93.49), and conditions like nonalcoholic steatohepatitis and hypothalamic amenorrhea. The anorexia nervosa codes appear extensively in the ICD-10 list precisely because this is a known off-label use — and Aetna is explicitly calling it unproven.

If your practice sees crossover patients — eating disorder programs, HIV clinics, or bariatric programs — flag this coverage policy with your clinical team. An off-label Myalept prescription that hits one of these excluded diagnoses won't survive precertification review.

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Coverage Indications at a Glance

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Aetna Metreleptin Billing Guidelines and Action Items 2025

These are direct steps for your billing and RCM team before and after the September 26, 2025 effective date.

Copy Action Items

If your practice has a high volume of lipodystrophy patients or mixed-diagnosis rare disease cases, loop in your compliance officer before the September 26, 2025 effective date. The three-part criteria structure is clear on paper, but documentation gaps are where these claims fall apart.

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CPT, HCPCS, and ICD-10 Codes for Metreleptin (Myalept) Under CPB 0882

Covered CPT Codes (When Selection Criteria Are Met)

Code	Type	Description Copy
96372	CPT	Therapeutic, prophylactic, or diagnostic injection (specify substance or drug); subcutaneous or intramuscular

Key ICD-10-CM Diagnosis Codes

Covered (Primary and Comorbidity Diagnosis Codes)

Hard Exclusions (Claims with These as Primary Diagnoses Will Deny)

Experimental / Unproven Indications

Liver / Hepatic Codes (Continuation Criteria Only — Not Standalone Coverage)

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