Does J3391 require prior authorization?

No, J3391 does not require prior authorization (high confidence). Covered without prior authorization.

What is the Medicare reimbursement rate for J3391?

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

HCPCS/CPT

No Prior Auth Required

Covered without prior authorization (high confidence)

Work RVU

0.00

Facility

N/A

Non-Facility

N/A

A one-time infusion of atidarsagene autotemcel is consideredmedically necessaryin individuals who meetallof the following criteria:
Diagnosis of metachromatic leukodystrophy (MLD); and
Documentation of an arylsulfatase A (ARSA) genotype (biallelic ARSA pathogenic variant);and
One of the following forms of MLD:Pre-symptomatic1late infantile MLD (children with expected disease onset at or before 30 months of age);orPre-symptomatic1early juvenile MLD (children with expected disease onset at more than 30 months and less than 7 years of age);orEarly symptomatic2early juvenile MLD (children with disease onset at more than 30 months of age and less than 7 years of age);and
Pre-symptomatic1late infantile MLD (children with expected disease onset at or before 30 months of age);or
Pre-symptomatic1early juvenile MLD (children with expected disease onset at more than 30 months and less than 7 years of age);or