J0223, Injection, givosiran, 0.5 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 demonstrating the therapy is proven effective for the relevant diagnosis.
- For drug therapy, documentation of proposed dose, frequency, and duration that matches recommendations from at least one authoritative source.
- Supporting references such as FDA-approved labeling, DrugDex (IIa+), MCG care guidelines, or NCCN guidelines/compendia should be provided when applicable.
- Citation or documentation demonstrating the indication is listed in one or more HHS‑adopted standard medical reference compendia.
Key Coverage Criteria
- Initial therapy with Givlaari is medically necessary for adults with acute hepatic porphyria (AHP) when: diagnosis of AHP is established; and the patient has active disease defined by at least 2 porphyria attacks in the past 6 months, OR patient is on prophylactic hemin with documented baseline hemin requirements and attack history; and patient has not had a liver transplant; and patient will not receive concomitant prophylactic hemin while on Givlaari; and treatment is prescribed by or in consu [...]
- Covered when hospital outpatient facility infusion services for specialty medications and IVIG/SCIG therapy are considered medically necessary and the member meets the specific clinical criteria described in the policy.
- Coverage of services, exclusions, and any dollar caps or limitations are determined by the member's benefit plan, summary plan description, or contract.
- Providers and members must consult the member's benefit plan/contract to determine whether a service or supply is covered or excluded.
- Coverage of any FDA‑approved drug when prescribed for a use recognized as safe and effective in one or more standard medical reference compendia adopted by the U.S. Department of Health and Human Services.
- Coverage of FDA‑approved drugs for off‑label indications supported by medical literature when safety and efficacy are confirmed in at least two articles from major peer‑reviewed professional medical journals.
14 Active Policies
UHC-POL-givlaari-givosiran, Givlaari (Givosiran)
UHC-POL-provider-administered-drugs-soc, Provider Administered Drugs – Site of Care
RX501.125, Givosiran for Acute Hepatic Porphyria
BCBSIL-RX501.125, Givosiran for Acute Hepatic Porphyria
BCBSIL-ADM1001.034, Specialty Medication Administration Site of Care
Related Codes
Have a follow-up question?
Ask Verity about documentation requirements, denial risks, or coverage in your state.