J2326 — Injection, nusinersen, 0.1 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
- The claim must include the appropriate primary ICD-10-CM diagnosis code (G12.0 or G12.1) that identifies the SMA type after full evaluation and diagnosis.
- Claims must report HCPCS J2326 with appropriate billable units and indicate intrathecal administration; CPT 96450 must be billed the same date to reflect spinal puncture administration.
- If the facility bills separately from the provider, documentation must reflect the facility billing CPT 96450 as a no-pay service and the drug as the presumed covered service.
- For any dosing, frequency, or diagnosis deviations from FDA labeling, submit supporting medical necessity documentation for claim-by-claim review.
Key Coverage Criteria
- Nusinersen (SPINRAZA®, HCPCS J2326) is covered when administered intrathecally for patients fully evaluated and diagnosed with spinal muscular atrophy (SMA) identified by primary ICD-10-CM code G12.0 or G12.1.
- Covered SMA subtypes include infantile spinal muscular atrophy type I (Werdnig-Hoffman), other inherited SMA (adult form, childhood form/type II, distal SMA, juvenile form/type III, progressive bulbar palsy of childhood, scapuloperoneal SMA) when billed with the appropriate primary ICD-10-CM code.
- Treatment of spinal muscular atrophy (SMA) in patients who meet ALL of the following criteria: diagnosis of SMA by, or in consultation with, a neurologist with expertise in the diagnosis of SMA; AND submission of medical records confirming mutation or deletion of genes in chromosome 5q resulting in one of the following: homozygous gene deletion or mutation (e.g., homozygous deletion of exon 7 at locus 5q13); OR compound heterozygous mutation (e.g., deletion of SMN1 exon 7 (allele 1) and mutation [...]
- Initial therapy: same as above (diagnosis by/with neurologist experienced in SMA; documented 5q SMN1 mutation/deletion), patient is NOT dependent on invasive ventilation OR on non-invasive ventilation beyond use for naps and nighttime sleep, submission of baseline motor exam (HINE-2, HFMSE, RULM, or CHOP INTEND) except baseline assessments for patients < 2 months of age are not necessary, Spinraza prescribed by/with a neurologist experienced in SMA, patient either has not previously received gen [...]
- Continuation therapy: diagnosis by, or in consultation with, a neurologist with expertise in the diagnosis of SMA; patient has previously received Spinraza therapy; patient is NOT dependent on invasive ventilation OR on non-invasive ventilation beyond use for naps and nighttime sleep; patient is NOT receiving concomitant chronic SMN modifying therapy (e.g., risdiplam/Evrysdi); submission of medical records with most recent results documenting a positive clinical response from pretreatment baseli [...]
- Spinraza is to be administered intrathecally by, or under the direction of, healthcare professionals experienced in performing lumbar punctures, and dosing must be in accordance with FDA-approved labeling.
4 Active Policies
UHC-POL-spinraza-nusinersen — Spinraza (Nusinersen)
A58578 — Billing and Coding: Spinraza (nusinersen)
UMR-POL-UMR-spinraza-nusinersen — Spinraza (Nusinersen)
SUREST-POL-SUREST-spinraza-nusinersen — Spinraza (Nusinersen)
Related Codes
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