J1304 — Injection, tofersen, 1 mg
HCPCS/CPT
Prior Authorization
No Prior Auth Required
Code is covered without prior authorization (high confidence)
Medicare Pricing
Work RVU
0.00
Facility
N/A
Non-Facility
N/A
Documentation Required
- Submission of medical records to support the diagnosis of ALS (examples listed: chart notes, previous medical history, diagnostic testing including imaging, nerve conduction studies, laboratory values).
- Submission of medical records confirming mutation in the superoxide dismutase 1 (SOD1) gene.
- Provider attestation that the patient's baseline functional ability has been documented prior to initiating treatment (examples: speech, walking, climbing stairs, etc.).
- For continuation of therapy, provider attestation that the patient has slowed disease progression from baseline.
Key Coverage Criteria
- Treatment of amyotrophic lateral sclerosis (ALS) in patients who meet all specified criteria
- Initial therapy indication: ALS with supporting medical records (chart notes, prior medical history, diagnostic testing) AND documented mutation in the superoxide dismutase 1 (SOD1) gene AND baseline functional ability documented prior to initiating treatment AND patient is not dependent on invasive ventilation AND Qalsody is prescribed by, or in consultation with, a neurologist with expertise in the diagnosis of ALS AND Qalsody dosing for ALS is in accordance with FDA approved labeling (initial [...]
- Continuation of therapy indication: Diagnosis of ALS AND patient is currently receiving Qalsody therapy AND provider attestation that the patient has slowed disease progression from baseline AND patient is not dependent on invasive ventilation AND Qalsody is prescribed by, or in consultation with, a neurologist with expertise in the diagnosis of ALS AND Qalsody dosing for ALS is in accordance with FDA approved labeling (authorization for no more than 12 months).
- Coverage intended to follow FDA indication: Qalsody is indicated for the treatment of ALS in adults who have a mutation in the SOD1 gene (FDA accelerated approval).
3 Active Policies
UHC-POL-qalsody — Qalsody (Tofersen)
UMR-POL-UMR-qalsody — Qalsody (Tofersen)
SUREST-POL-SUREST-qalsody — Qalsody (Tofersen)
Related Codes
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