Does J0597 require prior authorization?

Yes, J0597 requires prior authorization (high confidence). At least one active policy explicitly requires prior authorization.

What is the Medicare reimbursement rate for J0597?

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

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`J0597`, Injection, c-1 esterase inhibitor (human), berinert, 10 units

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

Laboratory documentation of HAE diagnosis: either C1-INH antigenic level below the laboratory lower limit of normal OR C1-INH functional level below the laboratory lower limit of normal (for Type I/II HAE).

If C1-INH levels are normal: genetic testing results confirming presence of variant(s) in one of the specified genes (factor XII, angiopoietin-1, plasminogen-1, kininogen-1, myoferlin, heparan sulfate-glucosamine 3-O-sulfotransferase 6).

If applicable, documentation that angioedema attacks are recurring and refractory to high-dose antihistamines, with either (a) confirmed family history of angioedema or (b) unknown de-novo mutation(s) (HAE-unknown).

Documentation that the medication will not be used in combination with other approved acute HAE treatments (or, if relevant, not in combination with other prophylactic agents for Cinryze).

Key Coverage Criteria

Treatment of an acute hereditary angioedema (HAE) attack with Berinert (C1 esterase inhibitor, human), Ruconest (C1 esterase inhibitor, recombinant), or Kalbitor (ecallantide) when: (a) used for treatment of an acute HAE attack; and (b) not used in combination with other approved treatments for acute HAE attacks (e.g., Berinert, Firazyr, Kalbitor, or Ruconest).
Initial therapy medical necessity criteria for Berinert, Ruconest, and Kalbitor when all of the following are met: diagnosis of hereditary angioedema (HAE) confirmed by either (a) C1 inhibitor (C1-INH) deficiency or dysfunction (Type I or II HAE) documented by C1-INH antigenic level below the lower limit of normal OR C1-INH functional level below the lower limit of normal; OR (b) normal C1 inhibitor levels and either a confirmed pathogenic variant in one of the listed genes (factor XII, angiopoi [...]
Berinert is FDA-labeled for treatment of acute abdominal, facial, or laryngeal HAE attacks in adult and pediatric patients (as noted in FDA section).
Ruconest is FDA-labeled for treatment of acute attacks in adult and adolescent patients with HAE (effectiveness not established in HAE patients with laryngeal attacks).
Kalbitor (ecallantide) is FDA-labeled for treatment of acute HAE attacks in patients 12 years of age and older.
Cinryze (C1 esterase inhibitor, human) is indicated for routine prophylaxis against angioedema attacks in adults, adolescents, and pediatric patients 6 years of age and older (note: policy distinguishes coverage between Medical Necessity Plans and Non‑Medical Necessity Plans).

8 Active Policies

BCBSLA-00276-390C137804, 00276 C1 Esterase Inhibitor (Berinert)

BCBSNJ-DRUGS-063-5CE01BD5D5, Drug Therapy for Hereditary Angioedema [Cinryze, Berinert, Haegarda (Human C1 Inhibitor), Kalbitor (Ecallantide), Firazyr (Icatibant), Ruconest (C1 Esterase Inhibitor [Recombinant]), Takhzyro (lanadelumab-flyo)]

MODA-BERINERT-60CBE0818D, Berinert (C1 Esterase Inhibitor, Human)

HEALTHNET_OR-HNOR-C1-ESTERASE-INHIBITORS-BERINERT-CINRYZE-HAEGARDA-RUCONES-B71BA98422, C1 Esterase Inhibitors (Berinert, Cinryze, Haegarda, Ruconest); CP.PHAR.202

UMR-POL-UMR-hereditary-angioedema-treatment-prophylaxis, Hereditary Angioedema (HAE), Treatment and Prophylaxis

EVICORE-MEDICAL_DRUG-5A3192422BCD, Berinert (C1 esterase inhibitor [human])

UHC-POL-hereditary-angioedema-treatment-prophylaxis, Hereditary Angioedema (HAE), Treatment and Prophylaxis

SUREST-POL-SUREST-hereditary-angioedema-treatment-prophylaxis, Hereditary Angioedema (HAE), Treatment and Prophylaxis

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J0597, Injection, c-1 esterase inhibitor (human), berinert, 10 units