Does J1307 require prior authorization?

Yes, J1307 requires prior authorization (high confidence). Code explicitly requires prior authorization.

What is the Medicare reimbursement rate for J1307?

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

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`J1307`, Injection, crovalimab-akkz, 10 mg

HCPCS/CPT

Prior Authorization

Prior Auth Required

Code explicitly requires prior authorization (high confidence)

Medicare Pricing

Work RVU

0.00

Facility

N/A

Non-Facility

N/A

Documentation Required

Peripheral blood flow cytometry results showing the absence or deficiency of glycosylphosphatidylinositol (GPI)-anchored proteins on at least two cell lineages to confirm diagnosis of PNH.
Documentation of patient age (≥13 years) and actual body weight (≥40 kg) used for dose selection.
Record of prescription and/or consultation from a hematologist authorizing PiaSky therapy.
For re-authorization: clinical documentation demonstrating ongoing benefit, for example: changes in hemoglobin levels (increase or stabilization), documentation of transfusion requirements or transfusion independence, measures of hemolysis, and/or improvement in Functional Assessment of Chronic Illness Therapy (FACIT)-Fatigue score.
Dosing records showing administration of the recommended loading regimen (IV Day 1; SUBQ Days 2, 8, 15, 22) and maintenance dosing (Day 29 and every 4 weeks) with weight-based dose amounts and administration dates.
Records supporting that dosing amounts were based on the patient's actual body weight and that maintenance therapy was initiated appropriately when applicable.

Key Coverage Criteria

Medically necessary for initial therapy of aHUS when: documentation ruling out STEC-HUS and TTP; diagnosis with signs of aHUS; treatment-naïve; FDA-labeled dosing for aHUS; prescribed by hematologist/nephrologist; initial authorization up to 12 months. Continuation requires positive clinical response and dosing per FDA labeling, with reauthorization up to 12 months.
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.
FDA-approved indication: treatment of adult and pediatric patients 13 years and older with paroxysmal nocturnal hemoglobinuria (PNH) and body weight of at least 40 kg.
Initial authorization: patient is ≥13 years of age, weighs ≥40 kg, diagnosis of PNH confirmed by peripheral blood flow cytometry showing the absence or deficiency of glycosylphosphatidylinositol (GPI)-anchored proteins on at least two cell lineages, and PiaSky is prescribed by or in consultation with a hematologist.
Re-authorization: patient is ≥13 years of age, weighs ≥40 kg, is continuing to derive benefit from PiaSky (e.g., increase in or stabilization of hemoglobin levels, decreased transfusion requirements or transfusion independence, reduction in hemolysis, improvement in FACIT-Fatigue score), and PiaSky is prescribed by or in consultation with a hematologist.
Maintenance therapy: dosing and continuation for patients who meet the above criteria and have initiated the recommended loading and maintenance regimen (weight-based dosing as specified).

20 Active Policies

ARKBLUE-CROVALIMAB-AKKZ-E-G-PIASKY-94230A5D8A, Crovalimab-akkz (e.g., PiaSky)

BCBSLA-00903-D633F24467, 00903 crovalimab-akkz (PiaSky)

BCBSM-2189404-B02B25A451, PIASKY (CROVALIMAB-AKKZ)

BCBSNE-X-131-5053ACE7BD, ULTOMIRIS, PIASKY, UPLIZNA, EMPAVELI, PIASKY,RYSTIGGO, IMAAVY

MODA-MODA-MPS-PIASKY-3BB4E184AB, Piasky (crovalimab-akkz)

HEALTHNET_OR-HNOR-CROVALIMAB-AKKZ-PIASKY-CP-PHAR-664-84CB18740A, Crovalimab-akkz (PiaSky); CP.PHAR.664

IBX-COMMERCIAL-08-02-31-229834A935, Crovalimab-akkz (Piasky)

IBX-MEDICARE-ADVANTAGE-MA08-178-3F3E839392, Crovalimab-akkz (PiaSky)

SUREST-POL-SUREST-complement-inhibitors, Complement C5 Inhibitors

AMERIHEALTH-COMMERCIAL-08-02-31-738891CA5E, Crovalimab-akkz (Piasky)

AMERIHEALTH-MEDICARE-ADVANTAGE-MA08-178-68E98A2C87, Crovalimab-akkz (PiaSky)

BCBSTN-b5e61fb4a6, Crovalimab-akkz (Piasky)

EVICORE-MEDICAL_DRUG-601AE08EC657, PiaSky (crovalimab-akkz)

UHC-POL-complement-inhibitors, Complement C5 Inhibitors

OSCAR-PIASKY-CROVALIMAB-AKKZ-PG262-VER-1-C09A3775E0, PiaSky (crovalimab-akkz) (PG262, Ver. 1)

UHC-POL-provider-administered-drugs-soc, Provider Administered Drugs – Site of Care

BCBSIL-RX501.176, Crovalimab-akkz

BCBSMT-RX501.176, Crovalimab-akkz

BCBSNM-RX501.176, Crovalimab-akkz

BCBSOK-RX501.176, Crovalimab-akkz

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J1307, Injection, crovalimab-akkz, 10 mg

HCPCS/CPT

Prior Authorization

Prior Auth Required

Code explicitly requires prior authorization (high confidence)

Medicare Pricing

Work RVU

0.00

Facility

N/A

Non-Facility

N/A

Documentation Required

Peripheral blood flow cytometry results showing the absence or deficiency of glycosylphosphatidylinositol (GPI)-anchored proteins on at least two cell lineages to confirm diagnosis of PNH.
Documentation of patient age (≥13 years) and actual body weight (≥40 kg) used for dose selection.
Record of prescription and/or consultation from a hematologist authorizing PiaSky therapy.
For re-authorization: clinical documentation demonstrating ongoing benefit, for example: changes in hemoglobin levels (increase or stabilization), documentation of transfusion requirements or transfusion independence, measures of hemolysis, and/or improvement in Functional Assessment of Chronic Illness Therapy (FACIT)-Fatigue score.
Dosing records showing administration of the recommended loading regimen (IV Day 1; SUBQ Days 2, 8, 15, 22) and maintenance dosing (Day 29 and every 4 weeks) with weight-based dose amounts and administration dates.
Records supporting that dosing amounts were based on the patient's actual body weight and that maintenance therapy was initiated appropriately when applicable.

Key Coverage Criteria

Medically necessary for initial therapy of aHUS when: documentation ruling out STEC-HUS and TTP; diagnosis with signs of aHUS; treatment-naïve; FDA-labeled dosing for aHUS; prescribed by hematologist/nephrologist; initial authorization up to 12 months. Continuation requires positive clinical response and dosing per FDA labeling, with reauthorization up to 12 months.
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.
FDA-approved indication: treatment of adult and pediatric patients 13 years and older with paroxysmal nocturnal hemoglobinuria (PNH) and body weight of at least 40 kg.
Initial authorization: patient is ≥13 years of age, weighs ≥40 kg, diagnosis of PNH confirmed by peripheral blood flow cytometry showing the absence or deficiency of glycosylphosphatidylinositol (GPI)-anchored proteins on at least two cell lineages, and PiaSky is prescribed by or in consultation with a hematologist.
Re-authorization: patient is ≥13 years of age, weighs ≥40 kg, is continuing to derive benefit from PiaSky (e.g., increase in or stabilization of hemoglobin levels, decreased transfusion requirements or transfusion independence, reduction in hemolysis, improvement in FACIT-Fatigue score), and PiaSky is prescribed by or in consultation with a hematologist.
Maintenance therapy: dosing and continuation for patients who meet the above criteria and have initiated the recommended loading and maintenance regimen (weight-based dosing as specified).

20 Active Policies

ARKBLUE-CROVALIMAB-AKKZ-E-G-PIASKY-94230A5D8A, Crovalimab-akkz (e.g., PiaSky)

BCBSLA-00903-D633F24467, 00903 crovalimab-akkz (PiaSky)

BCBSM-2189404-B02B25A451, PIASKY (CROVALIMAB-AKKZ)

BCBSNE-X-131-5053ACE7BD, ULTOMIRIS, PIASKY, UPLIZNA, EMPAVELI, PIASKY,RYSTIGGO, IMAAVY

MODA-MODA-MPS-PIASKY-3BB4E184AB, Piasky (crovalimab-akkz)

HEALTHNET_OR-HNOR-CROVALIMAB-AKKZ-PIASKY-CP-PHAR-664-84CB18740A, Crovalimab-akkz (PiaSky); CP.PHAR.664

IBX-COMMERCIAL-08-02-31-229834A935, Crovalimab-akkz (Piasky)

IBX-MEDICARE-ADVANTAGE-MA08-178-3F3E839392, Crovalimab-akkz (PiaSky)

SUREST-POL-SUREST-complement-inhibitors, Complement C5 Inhibitors

AMERIHEALTH-COMMERCIAL-08-02-31-738891CA5E, Crovalimab-akkz (Piasky)

AMERIHEALTH-MEDICARE-ADVANTAGE-MA08-178-68E98A2C87, Crovalimab-akkz (PiaSky)

BCBSTN-b5e61fb4a6, Crovalimab-akkz (Piasky)

EVICORE-MEDICAL_DRUG-601AE08EC657, PiaSky (crovalimab-akkz)

UHC-POL-complement-inhibitors, Complement C5 Inhibitors

OSCAR-PIASKY-CROVALIMAB-AKKZ-PG262-VER-1-C09A3775E0, PiaSky (crovalimab-akkz) (PG262, Ver. 1)

UHC-POL-provider-administered-drugs-soc, Provider Administered Drugs – Site of Care

BCBSIL-RX501.176, Crovalimab-akkz

BCBSMT-RX501.176, Crovalimab-akkz

BCBSNM-RX501.176, Crovalimab-akkz

BCBSOK-RX501.176, Crovalimab-akkz

Have a follow-up question?

Ask Backwork about documentation requirements, denial risks, or coverage in your state.

Ask Backwork about J1307 Sign up free

`J1307`, Injection, crovalimab-akkz, 10 mg

Prior Authorization

Medicare Pricing

Documentation Required

Key Coverage Criteria

20 Active Policies

Related Codes

Have a follow-up question?

`J1307`, Injection, crovalimab-akkz, 10 mg

Prior Authorization

Medicare Pricing

Documentation Required

Key Coverage Criteria

20 Active Policies

Related Codes

Have a follow-up question?

J1307, Injection, crovalimab-akkz, 10 mg

Prior Authorization

Medicare Pricing

Documentation Required

Key Coverage Criteria

20 Active Policies

Related Codes

Have a follow-up question?

J1307, Injection, crovalimab-akkz, 10 mg

Prior Authorization

Medicare Pricing

Documentation Required

Key Coverage Criteria

20 Active Policies

Related Codes

Have a follow-up question?

`J1307`, Injection, crovalimab-akkz, 10 mg

`J1307`, Injection, crovalimab-akkz, 10 mg