QALSODY J Code: J1304

Drug & Product Overview

HCPCS Descriptor Injection, tofersen, 1 mg

HCPCS Added Date January 1, 2024

Manufacturer Biogen

Route of Administration Intrathecal

Generic Status Single-Source; Branded

Dosage Type Single-Dose

Dosage Form Injection

About QALSODY

Qalsody is a medication aligned to the HCPCS J Code: J1304 for billing, pricing, and reimbursement purposes in the United States. Classified under Neurology, it is administered via the intrathecal route and manufactured by Biogen.

According to CMS Drug Use Information: Tofersen is used to treat a certain type of nerve disease called amyotrophic lateral sclerosis (ALS, also commonly called Lou Gehrig's disease).

Disclaimer: This is a summary and does not contain all possible information about this product. For complete information about this product or your specific health needs, ask your healthcare professional.

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
64406-0109-01	Qalsody	Biogen Inc.	100	100 MG / 15 ML

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QALSODY Pricing & Reimbursement

J1304 Private Payer Reimbursement

$160.01 / 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 Q4 2026

QALSODY CPT Administration Codes

CPT Code	Description
96450	Chemotherapy administration, into CNS (eg, intrathecal), requiring and including spinal puncture
62272	Spinal puncture, therapeutic, for drainage of cerebrospinal fluid (by needle or catheter).
62329 Login for More	Injection(s), including indwelling catheter placement, continuous infusion or intermittent bolus, of diagnostic or therapeutic substance(s) (e.g., anesthetic, antispasmodic, opioid, steroid, other solution), not including neurolytic substances, including needle or catheter placement, interlaminar epidural or subarachnoid, lumbar or sacral (caudal); with imaging guidance (i.e., fluoroscopy or CT) Login for More

Not on the CMS JW / JZ list

This product is new and does not yet appear on the CMS list of HCPCS pertaining to single-dose containers. Wastage billing guide →

QALSODY Medically Unlikely Edits (MUE)

The most billing units of J1304 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 →

QALSODY 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.

Amyotrophic Lateral Sclerosis (ALS) with SOD1 mutation

Drug Class

Antisense Oligonucleotide [EPC]OligonucleotidesAntisense [CS]

Frequently Asked Questions

Is there an available Qalsody billing and coding guide?

Billing and coding information for QALSODY can be found through Biogen. Visit Here →

Are there any available Qalsody patient assistance programs?

QALSODY patient assistance information can be found through BIOGEN MA INC.. Visit Here →

Where can I find Qalsody prescribing information?

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

Where can I find Qalsody side effect information?

Information regarding QALSODY's side effects can be found at MedlinePlus Visit Here →

Does billing QALSODY require JZ/JW wastage modifiers?

CMS does not include QALSODY (J1304) on its list of HCPCS pertaining to single-dose containers. Per CMS guidelines, the JZ/JW wastage modifiers may not apply when billing J1304. For more information, visit the link below.

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