J3401 — Beremagene geperpavec-svdt for topical administration, containing nominal 5 x 10^9 pfu/ml vector genomes, per 0.1 ml
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
- Submission of medical records documenting that outpatient hospital facility-based administration is medically necessary and that the member meets at least one of the enumerated criteria.
- For the 'medically unstable' criterion: documentation of the specific instability and the anticipated need for hospital-only equipment or services during administration (examples listed: endotracheal tube, chest tube insertion equipment, cricothyroidotomy set, mechanical ventilator).
- For cardiopulmonary risk: clinical history and records documenting cardiopulmonary conditions that increase risk of severe adverse reactions during or immediately following infusion.
- For inability to tolerate fluid volume load (IV infusions): documentation of attempts to use the minimum fluid required and clinical evidence of unstable renal function or other inability to tolerate fluid load.
Key Coverage Criteria
- Authorization of hospital outpatient facility infusion services (place of service codes 19 and 22) for specialty medications and IVIG/SCIG when outpatient hospital facility-based administration is medically necessary and the member meets at least one of the criteria below.
- Patient is medically unstable and is at risk of requiring medical services and equipment available only in an outpatient hospital setting (e.g., endotracheal tube, chest tube insertion equipment, cricothyroidotomy set, mechanical ventilator) during administration of the requested drug.
- History of cardiopulmonary conditions that cause an increased risk of severe adverse reactions during or immediately following infusion.
- Inability to tolerate fluid volume load (for intravenous infusions only) despite using the minimum amount of fluid required for infusion (example: unstable renal function).
- Treatment at an alternative Site of Care presents a health risk due to a clinically significant physical or cognitive impairment.
- Severe patent vascular access issues (for intravenous infusions only) that require specialized equipment only available in an outpatient hospital setting (example: ultrasound guidance) and the member is not a viable candidate for long-term vascular access devices such as PICC line or port-a-cath.
10 Active Policies
UHC-POL-vyjuvek — Vyjuvek (Beramagene Geperpavec-Svdt)
UHC-POL-provider-administered-drugs-soc — Provider Administered Drugs – Site of Care
UMR-POL-UMR-provider-administered-drugs-soc — Provider Administered Drugs – Site of Care
UMR-POL-UMR-vyjuvek — Vyjuvek (Beramagene Geperpavec-Svdt)
SUREST-POL-SUREST-vyjuvek — Vyjuvek (Beramagene Geperpavec-Svdt)
Related Codes
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