Lumasiran (Oxlumo) — CPB 0983 | AETNA Coverage Update

Aetna modified CPB 0983 for lumasiran (Oxlumo), effective February 19, 2026. Here's what billing teams need to do.

Aetna, a CVS Health company, updated its lumasiran Oxlumo coverage policy under CPB 0983 in the Aetna system. This policy governs reimbursement for J0224 (lumasiran injection, 0.5 mg per unit) and CPT 96372 (subcutaneous injection administration) for members with primary hyperoxaluria type 1 (PH1). If your team bills for rare kidney or metabolic disorders, this policy directly affects your prior authorization workflow and claim submission process.

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Quick-Reference Table

Field	Detail Copy
Payer	Aetna
Policy	Lumasiran (Oxlumo) — CPB 0983
Policy Code	CPB 0983
Change Type	Modified
Effective Date	2026-02-19
Impact Level	High
Specialties Affected	Genetics, Nephrology, Urology
Key Action	Verify precertification through Aetna's GCIT team before submitting claims for J0224 or CPT 96372

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Aetna Lumasiran (Oxlumo) Coverage Criteria and Medical Necessity Requirements 2026

Aetna's lumasiran Oxlumo coverage policy is narrow by design. PH1 is a rare genetic disorder, and Aetna built a tight set of criteria that your team needs to match exactly before submitting for prior authorization.

To meet medical necessity under CPB 0983 in the Aetna system, the member must satisfy all four of the following criteria:

1. Confirmed PH1 diagnosis. The member needs diagnostic proof via one of two methods:

#	Covered Indication Copy
1	Molecular genetic testing showing a pathogenic variant in the AGXT gene, or
2	Liver enzyme analysis showing absent or significantly reduced alanine:glyoxylate aminotransferase (AGT) activity.

No AGXT result or enzyme analysis on file means no coverage. Make sure the ordering provider documents which pathway was used before you submit.

2. Elevated oxalate levels. The member must have elevated urinary oxalate, urinary oxalate:creatinine ratio, or plasma oxalate levels prior to starting therapy. These values need to fall outside normal range per the performing laboratory's reference standards. This is what CPT 83945 (oxalate measurement) and CPT 82570 (creatinine, urine) are in the chart for — they're the lab codes that support medical necessity documentation.

3. No prior liver transplant. Members with liver transplant status (ICD-10 Z94.4) do not qualify. This is a hard stop. If Z94.4 appears in the member's problem list, lumasiran billing will result in a claim denial. Check the member's transplant history before initiating the prior authorization request.

4. No combination with nedosiran (Rivfloza). Aetna will not cover lumasiran when prescribed alongside nedosiran. If both drugs appear on the patient's medication list, you need clarification from the prescriber before submitting. A claim for J0224 while the member is also on nedosiran will not pass medical necessity review.

Prescriber Requirements

The prescribing provider must be a geneticist, nephrologist, or urologist — or the prescription must document a formal consultation with one of those specialists. If your practice is outside those specialties and you're billing J0224, you need a consultation note in the record. This is a documentation gap that causes denials at precertification, not at claim submission, so catch it early.

Precertification Is Mandatory

Aetna designated lumasiran as a GCIT (Gene-based, Cellular & Other Innovative Therapies) product. That means it gets dedicated review by a specialized team, not a standard utilization management reviewer. Call (866) 752-7021 or fax (888) 267-3277 to initiate precertification. Statement of Medical Necessity forms are available on Aetna's specialty pharmacy precertification page.

The site of care also requires separate utilization management review. Don't assume that getting the drug approved means the site is approved. Aetna's Site of Care policy for specialty drug infusions applies here. Check both.

Continuation of Therapy

Aetna's coverage policy for continuation is straightforward but requires documented evidence of response. The member must still meet all initial criteria, and the record must show a positive therapeutic response. Acceptable markers include a decrease or normalization of urinary or plasma oxalate levels, or measurable improvement in kidney function. Vague notes saying the patient "is tolerating the medication well" will not be enough. Make sure your clinical team documents specific lab-based outcomes at every renewal cycle.

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Aetna Lumasiran (Oxlumo) Exclusions and Non-Covered Indications

Aetna is explicit: all uses of lumasiran outside of PH1 are considered experimental, investigational, or unproven. There is no off-label coverage path under this policy.

The two most relevant exclusion scenarios your billing team will encounter are:

#	Excluded Procedure Copy
1	Members with prior liver transplant (Z94.4): Excluded regardless of PH1 diagnosis confirmation.
2	Combination therapy with nedosiran: Not covered when both drugs are prescribed concurrently.

ICD-10 E72.538 covers other primary hyperoxaluria types (type 2 and type 3). That code is in the policy document, but the medical necessity criteria only address PH1 (E72.530). If you're billing for PH2 or PH3, Aetna's current coverage policy does not support that. Claims with E72.538 as the primary diagnosis will likely be denied as experimental. Talk to your compliance officer if you have members with PH2 or PH3 who are on lumasiran — don't submit without a coverage determination in hand.

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Coverage Indications at a Glance

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Aetna Lumasiran (Oxlumo) Billing Guidelines and Action Items 2026

The effective date of February 19, 2026 means this policy is live now. Here is exactly what your team should do.

Copy Action Items

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CPT, HCPCS, and ICD-10 Codes for Lumasiran (Oxlumo) Under CPB 0983

HCPCS Codes Covered When Selection Criteria Are Met

Code	Type	Description Copy
J0224	HCPCS	Injection, lumasiran, 0.5 mg

CPT Codes Related to CPB 0983

CPT 83945 and 82570 are the workhorse lab codes here. They document the elevated oxalate and oxalate:creatinine ratio that medical necessity requires. Bill them consistently and make sure results are in the record before you submit the prior authorization request for J0224.

CPT 96372 is the administration code for the subcutaneous injection. It's straightforward, but remember that the site where you bill it must clear Aetna's separate site of care review. Reimbursement for the administration is contingent on that approval.

Key ICD-10-CM Diagnosis Codes

Code	Description Copy
E72.530	Primary hyperoxaluria, type 1
E72.538	Other specified primary hyperoxaluria (type 2; type 3)
Z94.4	Liver transplant status

E72.530 is your primary billing diagnosis for covered claims. E72.538 and Z94.4 both appear in the policy as markers that affect coverage — E72.538 maps to non-covered indications, and Z94.4 is a hard exclusion. Train your coding team to treat either of those codes as a stop sign in the lumasiran billing workflow.

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