Does J2561 require prior authorization?

No, J2561 does not require prior authorization (high confidence). Covered without prior authorization.

What is the Medicare reimbursement rate for J2561?

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

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`J2561`, Injection, phenobarbital sodium (sezaby), 1 mg

HCPCS/CPT

Prior Authorization

No Prior Auth Required

Covered without prior authorization (high confidence)

Medicare Pricing

Work RVU

0.00

Facility

N/A

Non-Facility

N/A

Documentation Required

Record of transcutaneous bilirubin (TcB) result when used for screening, with notation if infant is/was undergoing phototherapy (note: TcB is not reliable during phototherapy).
Documentation of infant's age in hours, neurotoxicity risk factors, and indications used to initiate phototherapy or exchange transfusion (per AAP-derived thresholds).

Clinical notes documenting response to phototherapy (improvement or poor response) to justify further testing (e.g., G6PD measurement) or escalation of care.

Family history and ethnic/geographic origin documentation when assessing likelihood of G6PD deficiency (to support measurement of G6PD level).

G6PD level test result when measured for a jaundiced infant receiving phototherapy with suggestive history or poor response.

If performing exchange transfusion: documentation of indication (TSB level, failure of phototherapy, or acute bilirubin encephalopathy), informed consent, performance in NICU, and details of procedure.

Key Coverage Criteria

Exchange transfusion for infants with bilirubin levels ≥ 25 mg/dL, those not responding to phototherapy, and infants with evidence of acute bilirubin encephalopathy (initiation based on infant's age in hours and neurotoxicity risk factors).
Home-based phototherapy as an alternative to hospital-based phototherapy for treatment of neonatal hyperbilirubinemia (when appropriate and per device/clinical criteria; appears effective in reviewed studies).
Intermittent phototherapy as an alternative to continuous phototherapy for treatment of neonatal hyperbilirubinemia (appears similarly effective and possibly safer in available studies).
Use of transcutaneous bilirubin (TcB) devices for screening/evaluation of hyperbilirubinemia in term and near-term infants not undergoing phototherapy (screening modalities such as early TSB, TcB, and risk scores can predict hyperbilirubinemia, though impacts on long-term outcomes are uncertain).
Measurement of G6PD level in a jaundiced infant who is receiving phototherapy when family history or ethnic/geographic origin suggests likely G6PD deficiency or when response to phototherapy is poor (per AAP guidance).
Inpatient treatment for healthy full-term infants who present with a TSB greater than or equal to 20 mg/dL in the first post-natal week.

1 Active Policy

AETNA-CPB-0332, Neonatal Hyperbilirubinemia

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J2561, Injection, phenobarbital sodium (sezaby), 1 mg