Does J3399 require prior authorization?

No, J3399 does not require prior authorization (high confidence). Code is covered without prior authorization.

What is the Medicare reimbursement rate for J3399?

Medicare facility rate: N/A. Non-facility rate: N/A. Work RVU: 0.00.

HCPCS/CPT

No Prior Auth Required

Code is covered without prior authorization (high confidence)

Work RVU

0.00

Facility

N/A

Non-Facility

N/A

Submission of medical records (chart notes, laboratory values) confirming the SMN1 gene mutation/deletion (homozygous deletion/mutation or compound heterozygous mutation) causing SMA.
For newborn-screen detected SMA: submission of medical records confirming SMN2 copy number of 4 or less.
Documentation of diagnosis: either chart notes documenting diagnosis of symptomatic SMA by a neurologist with expertise in SMA, or newborn screening results with SMN2 copy number documentation as above.
Documentation that a premature neonate has reached full-term gestational age before infusion (if applicable).

One treatment per lifetime for the treatment of spinal muscular atrophy (SMA) in patients who meet ALL of the following criteria:
Genetic confirmation of SMA caused by mutation or deletion of genes in chromosome 5q resulting in either: homozygous gene deletion or mutation of the survival motor neuron 1 (SMN1) gene (e.g., homozygous deletion of exon 7 at locus 5q13); or compound heterozygous mutation of SMN1 (e.g., deletion of SMN1 exon 7 on one allele and mutation of SMN1 on the other allele). (Submission of medical records e.g., chart notes, laboratory values, required.)
Either: (a) Diagnosis of symptomatic SMA by a neurologist with expertise in the diagnosis of SMA; OR (b) Diagnosis of SMA based on the results of newborn screening AND submission of medical records confirming the patient has 4 copies or less of the SMN2 gene.
If the patient is a neonatal patient born prematurely, Zolgensma may be given only after the full-term gestational age has been reached.
Patient is less than 2 years of age at time of treatment.
Patient is NOT dependent on invasive ventilation or tracheostomy.

ANTHEM-MED.00129 — MED.00129 Gene Therapy for Spinal Muscular Atrophy

UHC-POL-zolgensma — Zolgensma (Onasemnogene Abeparvovec-Xioi)

UMR-POL-UMR-zolgensma — Zolgensma (Onasemnogene Abeparvovec-Xioi)

SUREST-POL-SUREST-zolgensma — Zolgensma (Onasemnogene Abeparvovec-Xioi)

Ask Verity about documentation requirements, denial risks, or coverage in your state.