Transthyretin-Mediated (ATTR) Amyloidosis — CPB 0939 | AETNA Coverage Update

TL;DR: Aetna modified CPB 0939 for transthyretin-mediated (ATTR) amyloidosis, effective November 11, 2025. Here's what billing teams need to do.

Aetna, a CVS Health company, updated its ATTR amyloidosis coverage policy under CPB 0939 to address five medications — patisiran (Onpattro), vutrisiran (Amvuttra), inotersen (Tegsedi), eplontersen (Wainua), and the tafamidis/acoramidis stabilizers — with detailed medical necessity criteria for each. The policy governs HCPCS J0222 (patisiran injection) and J0225 (vutrisiran injection), along with CPT codes for infusion administration (96365–96372), diagnostic imaging (78800–78832), and molecular pathology (81404). These are high-cost specialty drugs routed through Aetna's GCIT program, which means prior authorization requirements are strict and denials for incomplete documentation are common.

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Quick-Reference Table

Field	Detail Copy
Payer	Aetna, a CVS Health company
Policy	Transthyretin-Mediated (ATTR) Amyloidosis
Policy Code	CPB 0939
Change Type	Modified
Effective Date	November 11, 2025
Impact Level	High
Specialties Affected	Neurology, Cardiology, Genetics, Specialty Pharmacy, Infusion Centers
Key Action	Confirm that prior authorization requests include TTR gene confirmation, specialist prescriber attestation, and combination therapy exclusion documentation before submitting claims for J0222 or J0225

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Aetna ATTR Amyloidosis Coverage Criteria and Medical Necessity Requirements 2025

The Aetna ATTR amyloidosis coverage policy under CPB 0939 treats all five medications as GCIT products. That means dedicated review by a specialized team — not your standard PA queue. Build extra lead time into your prior authorization workflow before November 11, 2025.

Patisiran (Onpattro) — HCPCS J0222

Aetna covers patisiran intravenous infusion (billed with J0222 and infusion administration CPT codes 96365–96368) for hATTR polyneuropathy when all four criteria are met:

The combination exclusion is the one your team will miss. If a member is already on any stabilizer, patisiran is not covered. Flag this in your prior auth intake process now.

For reauthorization, the member must show a beneficial response. Aetna looks at specific outcome measures — the mNIS+7 composite score, Norfolk QoL-DN total score, PND score, FAP disease stage, or manual grip strength. Vague documentation of "clinical stability" won't cut it. Your prescribers need to document one of these specific scales in the chart before you submit a renewal.

Eplontersen (Wainua) — Subcutaneous

Eplontersen subcutaneous injection follows the same structural criteria as patisiran. Member must be 18+, have TTR gene confirmation, show clinical manifestations, and not be on a combination regimen. The prescriber must be a neurologist, geneticist, or a physician specializing in amyloidosis treatment — general internists can't carry this alone.

Vutrisiran (Amvuttra) — HCPCS J0225

Vutrisiran (J0225) follows the same framework. This one also triggers Aetna's site-of-care utilization management policy. Before you bill 96365–96368 for an outpatient infusion suite, check whether Aetna's site-of-care policy redirects this to a lower-cost setting. A claim denial here isn't about medical necessity — it's about where the infusion happened.

Precertification for vutrisiran and patisiran uses the same phone line: (866) 752-7021 or fax (888) 267-3277. Eplontersen uses a separate SMN form through Aetna's specialty pharmacy precertification portal.

Inotersen (Tegsedi) and Tafamidis/Acoramidis Stabilizers

Inotersen also requires precertification through (866) 752-7021. The stabilizers — tafamidis meglumine (Vyndaqel), tafamidis (Vyndamax), and acoramidis (Attruby) — are addressed in the policy primarily as combination therapy exclusions for the RNA-targeted agents. If a member transitions from a stabilizer to a gene-silencing agent, document the discontinuation date. Aetna will ask.

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Aetna ATTR Amyloidosis Exclusions and Non-Covered Indications

Aetna considers all indications outside the approved criteria experimental, investigational, or unproven. That applies to all five agents in this policy.

The biggest exposure areas for your billing team:

#	Excluded Procedure Copy
1	Wild-type ATTR (wtATTR) cardiomyopathy — the RNA-targeted agents in this policy (patisiran, vutrisiran, inotersen, eplontersen) are approved under CPB 0939 specifically for hATTR polyneuropathy. Wild-type cardiac indications are a separate question. Don't assume coverage transfers.
2	Combination therapy — any claim for J0222 or J0225 for a member actively on a tafamidis stabilizer will deny. The policy is explicit.
3	Pediatric use — all four RNA-targeting agents require age 18+. Claims for members under 18 are not covered under this policy.

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Coverage Indications at a Glance

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Aetna ATTR Amyloidosis Billing Guidelines and Action Items 2025

These are the steps your team should take before or immediately after the November 11, 2025 effective date.

Copy Action Items

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CPT, HCPCS, and ICD-10 Codes for ATTR Amyloidosis Under CPB 0939

Covered HCPCS Codes (When Selection Criteria Are Met)

Code	Type	Description Copy
J0222	HCPCS	Injection, patisiran, 0.1 mg
J0225	HCPCS	Injection, vutrisiran, 1 mg

Covered CPT Codes (When Selection Criteria Are Met)

Radiopharmaceutical HCPCS Codes (Technetium Tc-99m — Diagnostic)

Key ICD-10-CM Diagnosis Codes

The CPB 0939 policy document does not list specific ICD-10-CM codes in the applicable codes section. Work with your coding team to assign the correct hereditary transthyretin amyloidosis diagnosis codes based on your documentation. Your compliance officer can confirm the appropriate ICD-10-CM codes before the November 11, 2025 effective date.

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