NAGLAZYME J Code: J1458

Drug & Product Overview

HCPCS Descriptor Injection, galsulfase, 1 mg

HCPCS Added Date January 1, 2007

Manufacturer Biomarin Pharmaceuticals

Route of Administration Intravenous

Generic Status Single-Source; Branded

Dosage Form Solution

About NAGLAZYME

Naglazyme is a medication aligned to the HCPCS J Code: J1458 for billing, pricing, and reimbursement purposes in the United States. This Enzyme Replacement Therapy medication is administered via the intravenous route and manufactured by Biomarin Pharmaceuticals.

Manufacturers, reach out to us to add more information.

NDC Code Information

Based on publicly available CMS files. The list of NDCs below is not exhaustive.

NDC Code	Drug	Manufacturer	Billing Units / Pkg	Package Size
68135-0020-01	Naglazyme	BioMarin Pharmaceutical Inc.	5	5 MG / 5 ML

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NAGLAZYME Pricing & Reimbursement

J1458 Private Payer Reimbursement

$513.65 / HCPCS unit as of Jan 2026

National median reimbursement across major commercial payers.

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Historical Graphing and Billing Calculator

per HCPCS unit

As of Q3 2026

NAGLAZYME CPT Administration Codes

CPT Code	Description
96365	Intravenous infusion, for therapy, prophylaxis, or diagnosis (specify substance or drug); initial, up to 1 hour
96366	Intravenous infusion, for therapy, prophylaxis, or diagnosis (specify substance or drug); each additional hour (List separately in addition to code for primary procedure)

Not on the CMS JW / JZ list

CMS does not include Naglazyme (J1458) on its list of HCPCS pertaining to single-dose containers. Per CMS guidelines, the JZ/JW wastage modifiers may not apply when billing J1458. Wastage billing guide →

NAGLAZYME Medically Unlikely Edits (MUE)

The most billing units of J1458 Medicare will pay for one patient in one day, as published by CMS. 1 unit = 1 mg.

Practitioner Office & Hospital Outpatient

100 units / day

= 100 mg per day

MAI 3 · Date of Service Edit: Clinical. Per-day limit based on clinical expectations; excess units are denied but may be appealed with documentation of medical necessity. See all MUE limits →

NAGLAZYME Clinical Information

Indications and drug classification.

Treated Diseases & Conditions

This list of indications is not exhaustive and may be subject to errors. The information on BuyandBill.com is intended for informational purposes only and should not be used for medical advice.

Mucopolysaccharidosis VI (MPS VI, Maroteaux-Lamy syndrome)

Drug Class

Hydrolytic Lysosomal Glycosaminoglycan-specific Enzyme [EPC]alpha-Glucosidases [CS]

Frequently Asked Questions

Is there an available Naglazyme billing and coding guide?

Billing and coding information for NAGLAZYME can be found through Biomarin Pharmaceuticals. Visit Here →

Are there any available Naglazyme patient assistance programs?

NAGLAZYME patient assistance information can be found through Biomarin Pharma. Visit Here →

Where can I find Naglazyme prescribing information?

NAGLAZYME prescribing information can be found at the link below: Visit Here →

Where can I find Naglazyme side effect information?

Our team has not yet identified a source of side effects information for NAGLAZYME. Please check back in a few weeks.

Does billing NAGLAZYME require JZ/JW wastage modifiers?

CMS does not include NAGLAZYME (J1458) on its list of HCPCS pertaining to single-dose containers. Per CMS guidelines, the JZ/JW wastage modifiers may not apply when billing J1458. For more information, visit the link below.

About BuyandBill.com:

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