J7178, Injection, human fibrinogen concentrate, not otherwise specified, 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
- Diagnosis documentation: clinical diagnosis of the relevant bleeding disorder (e.g., hemophilia A, hemophilia B, congenital factor deficiencies, von Willebrand disease, acquired hemophilia, Glanzmann thrombasthenia) For inhibitor-related indications: 'Documentation of inhibitors (e.g., Bethesda inhibitor assay)' (policy repeatedly cites Bethesda assay as required documentation for inhibitor presence) For Xyntha: 'Submission of documentation showing failure to meet clinical goals (e.g., continuation of spontaneous bleeds, inability to achieve appropriate trough level) after a trial of three of the following recombinant factor products: Advate, Kogenate FS, Kovaltry, NovoEight, Nuwiq, Recombinate' OR 'Submission of documentation showing history of hypersensitivity to three of the following recombinant factor products' OR 'Prescriber attestation that patient would preferentially benefit' with specified examples For continuation of non-factor therapies (Alhemo, Hemlibra, Hympavzi, Qfitlia): 'Documentation of positive clinical response to [product] therapy' and evidence patient has previously been treated with the product when continuation requested Access/benefit route criteria for self-injectables: documentation that patient 'cannot self-inject and does not have a caretaker who can be trained to administer [product]' OR documentation that 'patient is receiving [product] from a contracted hemophilia treatment center' is required for medical-benefit (versus pharmacy benefit) coverage Age documentation: evidence of patient age to confirm age-based eligibility (e.g., patient is 12 years of age or older for Alhemo/Hympavzi/Qfitlia initial therapy; Jivi requires age >=7) For VWD products that require desmopressin trial: documentation of 'history of failure, contraindication, or intolerance to treatment with desmopressin' when applicable (e.g., Humate-P, Alphanate) General clinical documentation supportive of medical necessity: records of bleeding episodes, peri-operative bleeding management needs, prior treatment history (including prophylaxis vs on-demand), and clinical assessments (e.g., failure to meet clinical goals, trough levels) as described in product-specific criteria Where applicable, laboratory or pharmacokinetic testing results used to guide dosing or indicate inadequate response (e.g., VWF:RCo activity, FVIII trough levels, aPTT changes for FIX products) should be included in the medical record per examples cited in clinical-evidence sections Initial diagnosis documentation: documentation of diagnosis of hemophilia A and/or hemophilia B as applicable. Age documentation: patient's age must meet product-specific minimums (e.g., Hympavzi initial therapy age ≥ 12 years; Jivi initial therapy age ≥ 7 years). Inhibitor testing documentation: documentation of inhibitor status (Bethesda units) when required — e.g., documentation that the patient has not developed high-titer factor VIII and/or factor IX inhibitors (defined in policy as greater than or equal to 5 Bethesda units (BU)). For Hympavzi medical-benefit coverage: documentation that patient cannot self-inject and does not have a caretaker who can be trained to administer Hympavzi OR documentation that patient is receiving Hympavzi from a contracted hemophilia treatment center. Continuation requirements: documentation of positive clinical response to therapy (explicitly required for continuation of Hympavzi). For Fitusiran (Qfitlia) when used instead of Hympavzi: documentation of the provider's clinical assessment and reason that the patient is not an appropriate candidate for Hympavzi (the policy states: "Based on clinical patient assessment, the provider has determined that the patient is not an appropriate candidate for Hympavzi (document reason)"). General medical records submission where applicable: chart notes and laboratory values documenting prior treatment history and clinical course (examples in policy include documenting failure to meet clinical goals such as continuation of spontaneous bleeds, inability to achieve appropriate trough level, previous history of inhibitors) — note: some of these prior requirements were removed for specific products as described in the policy changes.
Key Coverage Criteria
- Congenital Factor XIII Deficiency: Factor XIII (plasma-derived) (Corifact) is proven when both of the following criteria are met: - Diagnosis of congenital factor XIII deficiency; and - One of the following: Routine prophylactic treatment; or Peri-operative management of surgical bleeding; or Treatment of bleeding episodes Congenital Factor XIII A-subunit Deficiency: Coagulation Factor XIII A-subunit (recombinant) (Tretten) is proven when both of the following criteria are met: - Diagnosis of co [...]
- Diagnose congenital factor XIII deficiency and one of: routine prophylaxis OR peri-operative management of surgical bleeding OR treatment of bleeding episodes (Corifact)
- Diagnose congenital factor XIII A-subunit deficiency and one of: routine prophylaxis OR peri-operative management of surgical bleeding OR treatment of bleeding episodes (Tretten)
- Factor XIII (plasma-derived) (Corifact) is proven when both of the following criteria are met: Diagnosis of congenital factor XIII deficiency; and One of the following: o Routine prophylactic treatment; or o Peri-operative management of surgical bleeding; or o Treatment of bleeding episodes
- Factor VIII (plasma-derived)/von Willebrand Factor Complex (plasma-derived) (Alphanate) is proven when both of the following criteria are met: Diagnosis of mild or moderate von Willebrand disease; and Peri-operative management of surgical bleeding; and History of failure, contraindication, or intolerance to treatment with desmopressin
- Hemophilia A (i.e., Factor VIII Deficiency, Classical Hemophilia) Factor VIII (plasma-derived)/von Willebrand Factor Complex (plasma-derived) (Alphanate or Humate-P), Factor VIII (plasma-derived) (Hemofil M or Koāte-DVI), and Factor VIII (recombinant) (Advate, Kogenate FS, Kovaltry, NovoEight, Nuwiq, or Recombinate) are proven when both of the following criteria are met: Diagnosis of hemophilia A; and One of the following: o Routine prophylactic treatment; or o Peri-operative management of surgi [...]
3 Active Policies
UHC-POL-clotting-factors-coagulant-blood-products, Clotting Factors, Coagulant Blood Products, & Other Hemostatics
UMR-POL-UMR-clotting-factors-coagulant-blood-products, Clotting Factors, Coagulant Blood Products, & Other Hemostatics
SUREST-POL-SUREST-clotting-factors-coagulant-blood-products, Clotting Factors, Coagulant Blood Products, & Other Hemostatics
Related Codes
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