Amvuttra (J0225): Medicare coverage & FDA-indicated diagnoses

Amvuttra (vutrisiran) · Medicare Part B (physician-administered) · 7 FDA-indicated ICD-10 codes

Medicare pays for Amvuttra (J0225) under Part B per medical necessity. There is no drug-specific Medicare LCD, so the 7 ICD-10 codes below are the FDA-approved indications — the labeled uses Medicare generally pays for — grouped by condition. Coverage is judged by your MAC. Page reviewed Aug 23, 2026.

Page reviewed Aug 23, 2026 · from FDA-approved labeling (Drugs@FDA) — no drug-specific Medicare LCD

Quick answer

Medicare benefit
Part B (physician-administered)
FDA-indicated diagnoses
7 ICD-10 codes
Governing policy
FDA indications (no LCD)
Contractor (MAC)
Per medical necessity
Source
FDA labeling
Page reviewed
Aug 23, 2026
HCPCS codes covered:
J0225
No drug-specific Medicare coverage article exists for Amvuttra. Coverage is decided per medical necessity by your MAC. The FDA-approved indications below are the labeled uses Medicare generally pays for; an off-label use may be covered if supported by an approved compendium. Find your MAC by state →

What Medicare pays for Amvuttra (2026 Q4)

2026 Q4 payment limit per billing unit for Amvuttra’s HCPCS code (how ASP + 6% works):

HCPCSDescriptionPer unitAllowed (ASP + 6%)
J0225Inj, vutrisiran, 1 mg1 mg$5008.939

CMS ASP Drug Pricing File, 2026 Q4. Amvuttra patient out-of-pocket estimate →

Worked billing example for Amvuttra

A concrete, paste-checkable example using J0225’s own billing-unit basis and vial sizes — not a hypothetical.

Scenario25 mg fixed SC dose, every 3 months
Dose administered25 mg
Billing unit basis1 unit = 1 mg
Billing units (dose ÷ unit basis, rounded up)25 units of J0225
Vial combination drawn (min-waste plan)1 × 25 mg vial
Discarded (waste)None
Wastage modifier (JW / JZ)Bill all 25 units on a single line with JZ (attests zero drug discarded). JW vs JZ, with examples →
Medicare allowable (ASP + 6%, 2026 Q4)25 units × $5008.939/unit = $125223.48

Allowable, not paid: sequestration and the covered diagnosis still apply.

Dose source: drugs/amvuttra.html — "Standard dose: 25 mg SC q3mo ... fixed dose, NOT weight-based". Different dose or drug? Compute your own dose → or estimate the full cost & patient out-of-pocket →.

Amvuttra (HCPCS J0225) is paid under Part B only when the claim’s ICD-10 code is one the MAC accepts; otherwise expect a CO-50 denial. How Part B drug coverage is decided →

Covered ICD-10 diagnoses for Amvuttra

The 7 FDA-approved indications for J0225, grouped by condition — filter to find a code.

hATTR Amyloidosis — 5 diagnoses (applies to J0225)

Endocrine, nutritional & metabolic diseases (4)

ICD-10Covered diagnosis
E85.1Neuropathic heredofamilial amyloidosis
E85.2Heredofamilial amyloidosis, unspecified
E85.4Organ-limited amyloidosis
E85.89Other amyloidosis

Diseases of the nervous system (1)

ICD-10Covered diagnosis
G63Polyneuropathy in diseases classified elsewhere

Amyloidosis — 2 diagnoses (applies to J0225)

Endocrine, nutritional & metabolic diseases (2)

ICD-10Covered diagnosis
E85.81Light chain (AL) amyloidosis
E85.82Wild-type transthyretin-related (ATTR) amyloidosis

What commercial payers require for Amvuttra

Medicare Part B is only half the answer — most Amvuttra claims are adjudicated by a commercial plan with its own medical policy. Below is what 27 commercial payers publish for Amvuttra, read from each payer's own policy document. 18 of 18 that state a position require prior authorization (9 do not say clearly, so confirm those on the call), and 9 run a site-of-care program that can push the infusion out of the hospital outpatient setting. 1 name a preferred product you must try or fail first.

PayerPrior authPreferred product firstSite of careIndications namedPolicy date
Aetna policy ↗Required—Site-of-care program applies22026-03-13
Anthem / Elevance policy ↗Required——12024-09-23
Arkansas BCBS policy ↗Required——22022-11-09
BCBS Federal Employee Program policy ↗Required——22026-04-01
BCBS Kansas policy ↗Required——22025-05-05
BCBS Louisiana policy ↗Unclear — confirm on the call——22026-08-01
BCBS Massachusetts policy ↗Required——22026-03-15
BCBS Michigan policy ↗Required——22026-07-27
BCBS Minnesota policy ↗Required——22025-05-05
BCBS South Carolina policy ↗Unclear — confirm on the call——2—
BCBS Tennessee policy ↗Required——22026-01-30
Blue Shield of California policy ↗Required—Site-of-care program applies22026-07-01
Capital BlueCross policy ↗Required——22025-05-05
CareFirst BCBS policy ↗RequiredJ0225Site-of-care program applies2—
Centene / Ambetter policy ↗Unclear — confirm on the call——12022-06-13
Cigna policy ↗Required——22026-04-15
Excellus BCBS policy ↗Unclear — confirm on the call—Site-of-care program applies22026-07-01
Florida Blue policy ↗Unclear — confirm on the call——22026-07-01
HCSC (IL/TX/OK/NM/MT) policy ↗Required—Site-of-care program applies12024-07-15
Highmark BCBS policy ↗Unclear — confirm on the call—Site-of-care program applies22026-02-23
HMSA (BCBS Hawaii) policy ↗Required——22026-04-01
Horizon BCBS NJ policy ↗Required——22025-05-05
Independence Blue Cross policy ↗Not stated — confirm on the call——22025-08-18
Premera Blue Cross policy ↗Unclear — confirm on the call—Site-of-care program applies2—
Regence BCBS policy ↗Required—Site-of-care program applies22026-06-01
UnitedHealthcare policy ↗Not stated — confirm on the call—Amvuttra is on UnitedHealthcare's Provider Administered Drugs – Site of Care list (updated 10/01/2026). An infusion in a hospital outpatient department (place of service 19 or 22) has to meet that policy's criteria; a physician office, home infusion or ambulatory infusion suite is an accepted alternative.22026-06-01
Wellmark BCBS policy ↗Required——22026-03-06

What Amvuttra payers put in writing

Quoted from the medical policies linked above — 24 distinct requirements across 27 payers. These are the sentences an appeal has to answer.

Clinical prerequisites — what must be true before they pay

Prior authorization

Quantity and frequency limits

Dosing rules

Read from each payer's published medical policy between 2026-08-03 and 2026-08-13. Every requirement above is quoted from the policy it links to. Commercial policy changes without notice — confirm before you bill.

How to bill Amvuttra

Put a medically necessary, FDA-indicated diagnosis from the list above on the claim line with J0225. Matching codes, units and JZ/JW wastage →

Which policy governs Amvuttra

No drug-specific LCD or Article — see the note at the top of this page. Find your MAC → What an LCD, an Article and an NCD each govern →

If a claim for Amvuttra is denied

With no drug-specific Article, the usual cause is a diagnosis the MAC does not accept as medically necessary for J0225, or an off-label use with no compendium support. The five denial patterns and how to fix each →

Frequently asked questions

Is Amvuttra covered by Medicare?
Yes. Amvuttra (J0225) is covered under Medicare Part B as a physician-administered drug when billed for a medically necessary indication. There is no drug-specific Local Coverage Determination (LCD) for it, so coverage is determined per medical necessity by your MAC; the FDA-approved indications below are the starting point. None of the 8 Medicare Administrative Contractors lists J0225 as self-administered.
What diagnoses are covered for Amvuttra (J0225)?
Medicare publishes no drug-specific covered-diagnosis list for J0225. The 7 ICD-10 codes here are the FDA-approved indications; an off-label use needs approved-compendium support (DrugDex, NCCN) to be payable.
Which Medicare policy covers Amvuttra?
No drug-specific LCD or Billing & Coding Article exists for Amvuttra. It's covered under the general Medicare Part B drug benefit per medical necessity, as judged by your Medicare Administrative Contractor (MAC).
Why was my Amvuttra claim denied as not medically necessary?
The most common cause is a diagnosis the MAC doesn't consider medically necessary for J0225. Bill a covered/FDA-approved indication from the list below, document medical necessity, and confirm any local guidance with your MAC.

Related references

Covered is only half the answer.

You know the diagnosis is payable. Now quote the patient before the visit and catch underpayments: get Amvuttra's exact Medicare allowed amount, your payer's rate vs. ASP+6%, and the patient's out-of-pocket — in about 30 seconds, free.

Estimate Amvuttra cost & patient owe →

Source & verification

Source
FDA-approved indications (Drugs@FDA labeling) mapped to ICD-10-CM. No drug-specific Medicare LCD/Article exists for Amvuttra — Part B coverage is determined per medical necessity by your MAC.
Primary sources
DailyMed — Amvuttra prescribing information · CMS Part B Drug ASP Pricing File — the quarterly payment limit quoted above · CMS Medicare Coverage Database — searched for “Amvuttra”; no drug-specific NCD, LCD or Billing & Coding Article exists, which is why the FDA-indicated codes above are the working list
Page last reviewed by CareCost
Aug 23, 2026 (coverage data retrieved 2026-09-21; we re-verify against CMS quarterly).
Notes
ICD-10-CM is public domain; CPT® (AMA) is intentionally not listed. Reference, not billing advice — built from the CMS Coverage API per our methodology; corrections to editorial@carecostestimate.com.