Does J1299 require prior authorization?

Yes, J1299 requires prior authorization (high confidence). At least one active policy explicitly requires prior authorization.

What is the Medicare reimbursement rate for J1299?

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

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`J1299`, Injection, eculizumab, 2 mg

HCPCS/CPT

Prior Authorization

Prior Auth Required

At least one active policy explicitly requires prior authorization (high confidence)

Medicare Pricing

Work RVU

0.00

Facility

N/A

Non-Facility

N/A

Documentation Required

Document meningococcal immunization at least 2 weeks prior to the first eculizumab dose or a clinical justification that delaying eculizumab posed greater risk than meningococcal infection.
For PNH initiation, document flow cytometry confirming PNH and either evidence of clinically significant hemolysis or a documented history of a major adverse vascular event (MAVE) from thromboembolism.
For aHUS initial trial, document absence of signs of STEC-HUS and that TTP was ruled out (e.g., normal ADAMTS13 activity and no inhibitor), or document a plasma exchange trial that failed to produce clinical improvement.
If continuing eculizumab after the aHUS initial trial, document clinical improvement such as increased platelet count or laboratory evidence of reduced hemolysis.
For dense deposit disease, document biopsy-proven diagnosis and elevated serum sC5b-9 (sMAC) levels.
Document that prescribed dose and frequency conform to the FDA label for eculizumab (Soliris) or to recognized compendia (e.g., Clinical Pharmacology, Lexi-Drugs, Micromedex, NCCN) when used off-label.

Key Coverage Criteria

Eculizumab is covered for treatment of paroxysmal nocturnal hemoglobinuria (PNH) when flow cytometry confirms PNH and there is either evidence of clinically significant hemolysis or a documented history of a major adverse vascular event (MAVE) from thromboembolism.
Eculizumab is covered for treatment of atypical hemolytic uremic syndrome (aHUS) as an initial trial (generally 6–12 weeks) when the individual has no signs of STEC-HUS and thrombotic thrombocytopenic purpura (TTP) has been ruled out or a trial of plasma exchange did not produce clinical improvement.
Eculizumab is covered for biopsy-proven dense deposit disease when elevated serum sC5b-9 (sMAC) levels are documented.
Eculizumab may be covered for other label and off-label indications supported by recognized compendia or the FDA label when dose and frequency conform to FDA labeling or recognized compendia guidance.
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.

20 Active Policies

ARKBLUE-ECULIZUMAB-E-G-SOLIRIS-AND-BIOSIMILARS-A3F45D5B00, Eculizumab (e.g., Soliris) and Biosimilars

NGS-J6-L33394, Drugs and Biologicals, Coverage of, for Label and Off-Label Uses

A54548, Billing and Coding: Eculizumab, and Biosimilars: EPYSQLI-eculizumab-aagh, and BKEMV-eculizumab-aeeb

NGS-JK-L33394, Drugs and Biologicals, Coverage of, for Label and Off-Label Uses

BCBSMA-093-BE97FF0851, Soliris, Ultomiris, Complement 3 Glomerulopathy (C3G), Myasthenia Gravis, Paroxysmal nocturnal hemoglobinuria (PNH), and Neuromyelitis Optica Policy

BCBSND-ECULIZUMAB-SOLIRIS-73F6415889, Eculizumab Soliris

BCBSNE-X-95-1C0E8DBFA0, ECULIZUMAB/SOLIRIS (PREAUTHORIZATION REQUIRED)

BCBSNJ-DRUGS-061-2EAD318F66, Eculizumab (Soliris) and Ravulizumab-cwvz (Ultomiris)

HEALTHNET_OR-HNOR-ECULIZUMAB-SOLIRIS-ECULIZUMAB-AEEB-BKEMV-ECULIZUMAB-AAGH-FDBA3BF476, Eculizumab (Soliris), Eculizumab-aeeb (Bkemv), Eculizumab-aagh (Epysqli); CP.PHAR.97

MODA-SOLIRIS-ECULIZUMAB-AC7ACFD6DD, Eculizumab: Soliris; Bkemv; Epysqli

IBX-COMMERCIAL-08-00-84M-20FD6F6CEC, Eculizumab (Soliris) and Related Biosimilars, Ravulizumab-cwvz (Ultomiris) for intravenous administration

IBX-MEDICARE-ADVANTAGE-MA08-044L-DB6102C6B3, Eculizumab (Soliris) and Related Biosimilars, Ravulizumab-cwvz (Ultomiris) for intravenous  administration

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

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

AMERIHEALTH-COMMERCIAL-08-00-84M-1360D6ACC1, Eculizumab (Soliris) and Related Biosimilars, Ravulizumab-cwvz (Ultomiris) for intravenous administration

AMERIHEALTH-MEDICARE-ADVANTAGE-MA08-044L-63881A4CDB, Eculizumab (Soliris) and Related Biosimilars, Ravulizumab-cwvz (Ultomiris) for intravenous  administration

EVICORE-MEDICAL_DRUG-42D804718709, Eculizumab Products (Soliris, Bkemv, Epysqli)

OSCAR-SOLIRIS-ECULIZUMAB-AND-BIOSIMILARS-PG188-VER-75B9A6152A, Soliris (eculizumab) and Biosimilars (PG188, Ver. 4)

UHC-POL-complement-inhibitors, Complement C5 Inhibitors

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

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J1299, Injection, eculizumab, 2 mg