J0567, Injection, cerliponase alfa, 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
- Documentation of diagnosis: record showing Diagnosis of Late Infantile Neuronal Ceroid Lipofuscinosis type 2 (CLN2) by a neurologist with expertise in CLN2 OR documentation of diagnosis by a physician and consultation notes with a neurologist with expertise in CLN2.
- CLN2 Clinical Scoring System results: for initial therapy document combined motor + language score (3 to 6) and individual motor and language domain scores (each ≥1); for continuation document motor domain score (≥1).
- Documentation identifying the prescribing clinician’s specialty and evidence of expertise in CLN2 or documentation of consultation with a CLN2-expert neurologist.
- Documentation that Brineura will be/were administered intraventricularly via an intracerebroventricular catheter and that the administering clinicians are experienced in performing intraventricular infusions (procedure notes, facility/provider credentials, catheter/device documentation).
Key Coverage Criteria
- Slowing the loss of ambulation in pediatric patients with late infantile neuronal ceroid lipofuscinosis (LINCL) type 2 (CLN2), also known as tripeptidyl peptidase 1 (TPP1) deficiency, when all of the following criteria are met.
- Initial therapy — all of the following: Diagnosis of Late Infantile Neuronal Ceroid Lipofuscinosis type 2 (CLN2) by a neurologist with expertise in the diagnosis of CLN2 OR diagnosis of CLN2 by a physician in consultation with a neurologist with expertise in the diagnosis of CLN2; combined score of 3 to 6 in the motor and language domains of the Clinical Scoring System for LINCL; score of at least 1 in the motor domain; score of at least 1 in the language domain; Brineura prescribed by a neurolo [...]
- Continuation of therapy — all of the following: Diagnosis of CLN2 by a neurologist with expertise in the diagnosis of CLN2 OR diagnosis by a physician in consultation with such a neurologist; patient has a score of 1 or higher in the motor domain of the Clinical Scoring System for LINCL; prescribed by a neurologist with expertise in the treatment of CLN2 OR prescribed by a physician in consultation with such a neurologist; to be administered intraventricularly by, or under the direction of, heal [...]
- FDA indication (informational): "to slow the loss of ambulation in pediatric patients with neuronal ceroid lipofuscinosis type 2 (CLN2), also known as tripeptidyl peptidase 1 (TPP1) deficiency."
- Applicable billing/diagnosis reference: HCPCS J0567 (Injection, cerliponase alfa, 1 mg) and diagnosis code E75.4 (Neuronal ceroid lipofuscinosis).
- Therapy is covered when proven effective for the relevant diagnosis or procedure per generally accepted standards of practice.
8 Active Policies
UHC-POL-brineura-cerliponase-alfa, Brineura (Cerliponase Alfa)
RX501.092, Cerliponase alfa
BCBSIL-RX501.092, Cerliponase alfa
BCBSMT-RX501.092, Cerliponase alfa
BCBSNM-RX501.092, Cerliponase alfa
Related Codes
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