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HCPCS Unassigned

PASATRU

garetosmab-grts · Regeneron Pharmaceuticals

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Miscellaneous Code ?
J3590
bill now · NOC code
Permanent Code ?
None yet
not published by CMS
WAC ?
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AWP ?
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NDCs Listed
1
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Drug & Product Overview

Proposed Billing Descriptor Available at HCPCS code assignment
Miscellaneous Billing Code J3590
FDA Approval Date August 19, 2026
Manufacturer Regeneron Pharmaceuticals
Active Ingredient garetosmab-grts
Route of Administration Intravenous
Dosage Form Injection, Solution, Concentrate

How to Bill PASATRU Now

Until CMS assigns PASATRU its own code, bill it with J3590, the code for unclassified biologics, and identify the product by its NDC. Once a permanent code takes effect, J3590 claims for PASATRU will be denied.

Setting Claim Form Billing Code Notes
Physician office / Part B CMS-1500 / 837P J3590 Enter the drug name, dose and NDC in Item 19 (or the 837P equivalent). The MAC prices the claim manually.
Hospital outpatient (OPPS) UB-04 / 837I C9399 Unclassified drug or biological. Separately payable and priced manually by the MAC.
Required Claim Documentation
Drug name and dosage administered National Drug Code (NDC) of the product given Total quantity administered, in the applicable unit of measure Date the drug was administered

About PASATRU

PASATRU (garetosmab-grts) is an intravenous infusion from Regeneron Pharmaceuticals used to reduce formation of new heterotopic ossification (HO) lesions and clinician-assessed flare-ups in adults with fibrodysplasia ossificans progressiva (FOP). It was approved by the FDA on August 19, 2026.

PASATRU Pricing & NDCs

Package WAC and AWP for each NDC, updated monthly. There's no ASP payment limit until a permanent code takes effect.

NDC Code Package WAC AWP

1 NDC on file. Subscribe to see its package, WAC and AWP, with monthly history.

HCPCS Code Status

As of Nov 5, 2026
Billed under today
J3590
Unclassified biologics
Permanent code
Not published yet

CMS publishes new drug codes each quarter. This page shows the code and its effective date once it does.

A miscellaneous code is valid only until a drug’s own code takes effect. Confirm coding with your payer before billing.

PASATRU Clinical Information

Treated Diseases & Conditions
Reduce formation of new heterotopic ossification (HO) lesions and clinician-assessed flare-ups in adults with fibrodysplasia ossificans progressiva (FOP)

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Frequently Asked Questions

What HCPCS code is used for PASATRU?

J3590 (unclassified biologics) in the physician office, and C9399 in the hospital outpatient setting, until CMS assigns a permanent code.

What NDC goes on a PASATRU claim?

The NDC of the package you administered. Subscribers can see PASATRU’s NDCs with package, WAC and AWP.

When will PASATRU get a permanent J-code?

CMS has not published one yet. CMS publishes permanent codes in its quarterly coding decisions; this page will show the code and effective date once they are out.

Where can I find the full prescribing information?