J7352, Afamelanotide implant, 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
- Submission of medical records (e.g., chart notes, laboratory values, etc.) to support the diagnosis of erythropoietic protoporphyria (EPP).
- Laboratory evidence supporting diagnosis: increased total erythrocyte protoporphyrin (usually 300 to 8000 mcg/dL; normal <80 mcg/dL) and increased percentage of erythrocyte metal-free protoporphyrin rather than zinc protoporphyrin (generally greater than 85% of total porphyrins), OR
- Molecular/genetic testing confirming Ferrochelatase (FECH) gene mutation OR Delta-aminolevulinate synthase-2 (ALAS2) gain-of-function gene mutation.
- Documentation of patient age (>= 18 years).
Key Coverage Criteria
- Scenesse (afamelanotide) is proven and medically necessary for the treatment of erythropoietic protoporphyria (EPP) when all the following criteria are met:
- Diagnosis of erythropoietic protoporphyria (EPP) confirmed by submission of medical records (e.g., chart notes, laboratory values, etc.) showing one of the following:
- Both of the following laboratory findings: Increased total erythrocyte protoporphyrin (usually 300 to 8000 mcg/dL; normal <80 mcg/dL) AND Increased percentage of erythrocyte metal-free protoporphyrin rather than zinc protoporphyrin (generally greater than 85% of total porphyrins).
- OR molecular/genetic testing confirming one of the following genetic abnormalities: Ferrochelatase (FECH) gene mutation OR Delta-aminolevulinate synthase-2 (ALAS2) gain-of-function gene mutation.
- Patient is 18 years of age or older.
- Patient has a history of phototoxic reactions due to EPP.
3 Active Policies
UHC-POL-scenesse, Scenesse (Afamelanotide)
UMR-POL-UMR-scenesse, Scenesse (Afamelanotide)
SUREST-POL-SUREST-scenesse, Scenesse (Afamelanotide)
Related Codes
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