J3394 — Injection, lovotibeglogene autotemcel, per treatment
HCPCS/CPT
Prior Authorization
Prior Auth Required
Conditional coverage; review criteria to confirm PA need (medium confidence)
Medicare Pricing
Work RVU
0.00
Facility
N/A
Non-Facility
N/A
Documentation Required
- No documentation requirements are specified in this excerpt.
- Please refer to CMS Medicare Coverage Database for the most current applicable CMS National Coverage Determination (NCD)/Local Coverage Determination (LCD)/Local Coverage Article (LCA).
- Refer to CMS website for the most current applicable CMS Online Manual System (IOMs) and Transmittals.
- None stated in this document chunk.
Key Coverage Criteria
- Inferred: Treatment of sickle cell disease (SCD) associated with abnormal hemoglobin S (HbS) — intended to address the underlying HbS pathology, reduce vaso-occlusive crises (VOCs), and prevent organ damage.
- The mainstays of treatment for SCD have been supportive care to manage complications and preventive measures to reduce the incidence of VOCs.
- Currently, the only potential cure is hematopoietic stem cell transplantation (HSCT) using cells from a healthy donor.
- Allogeneic (donor) HSCT is the most successful potentially curative treatment for SCD.
- Gene therapy is rising to the forefront of the discussion as a potentially curative or highly disease-modifying option for abating the complications of the disease.
- Gene therapy is a technique that introduces a normal gene or alters the expression of a disease-causing gene.
3 Active Policies
HUMANA-GENE-THERAPY-TREATMENTS-FOR-SICKLE-CELL-DISEASE-MA — Gene Therapy Treatments for Sickle Cell Disease - Medicare Advantage
HUMANA-GENE-THERAPY-TREATMENTS-FOR-SICKLE-CELL-DISEASE-SC-MEDICAID — Gene Therapy Treatments for Sickle Cell Disease - MEDICAID - SOUTH CAROLINA
ANTHEM-MED.00146 — MED.00146 Gene Therapy for Sickle Cell Disease
Related Codes
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