BALFAXAR Reimbursement
BALFAXAR Reimbursement and Coding
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Reimbursement for a hospital inpatient setting
Under the Medicare hospital Inpatient Prospective Payment System (IPPS), each inpatient stay is assigned to a single Medicare Severity Diagnosis Related Group (MS-DRG) depending on1:
  • Patient’s diagnosis
  • Procedures performed
  • Complicating conditions
  • Age
  • Sex
  • Discharge status
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Use the following specific ICD-10-PCS code when administering BALFAXAR
30283B1
Transfusion of nonautologous 4-factor prothrombin complex concentrate into vein, percutaneous approach
Reimbursement for hospital outpatient pass-through
Effective April 1, 2024, the Centers for Medicare and Medicaid Services (CMS) have established a product-specific HCPCS code for BALFAXAR.
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Use the following HCPCS J-code when administering BALFAXAR
J7165
Injection, prothrombin complex concentrate (human), BALFAXAR, per i.u. of factor IX activity
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Summary of Coding for BALFAXARa
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aThe treating physician is solely responsible for the determination of the appropriate ICD-10-CM diagnosis codes that describe the patient’s condition and are supported by the medical record. All codes provided are for informational purposes and do not constitute an exhaustive list. The provided CPT®, HCPCS, ICD-10-CM, and ICD-10-PCS codes are based on AMA or CMS guidelines. The billing party is solely responsible for the coding of services. Please verify current coding requirements directly with the payer being billed as government and other third-party payer coding requirements may change.

bInfusion of 4F-PCC.

Reference: 1. CMS.gov. Inpatient Prospective Payment System (IPPS). Updated October 19, 2023. Accessed October 31, 2023. https://www.cms.gov/cms-guide-medical-technology-companies-and-other-interested-parties/payment/ipps

Important Safety InformationView More +

WARNING: ARTERIAL AND VENOUS THROMBOEMBOLIC COMPLICATIONS

Patients being treated with Vitamin K antagonists (VKA) therapy have underlying disease states that predispose them to thromboembolic events. Potential benefits of reversing VKA should be weighed against the potential risks of thromboembolic events, especially in patients with the history of a thromboembolic

Important Safety InformationView Less —

WARNING: ARTERIAL AND VENOUS THROMBOEMBOLIC COMPLICATIONS

Patients being treated with Vitamin K antagonists (VKA) therapy have underlying disease states that predispose them to thromboembolic events. Potential benefits of reversing VKA should be weighed against the potential risks of thromboembolic events, especially in patients with the history of a thromboembolic event. Resumption of anticoagulation should be carefully considered as soon as the risk of thromboembolic events outweighs the risk of acute bleeding. Both fatal and non-fatal arterial and venous thromboembolic complications have been reported with BALFAXAR in clinical trials and post marketing surveillance. Monitor patients receiving BALFAXAR for signs and symptoms of thromboembolic events. BALFAXAR may not be suitable in patients with thromboembolic events in the prior 3 months.

BALFAXAR is contraindicated in patients with known anaphylactic or severe systemic reactions to BALFAXAR or any of its components. BALFAXAR is also contraindicated in patients with a known allergy to heparin, a history of heparin-induced thrombocytopenia (HIT), and IgA deficient patients with known antibodies against IgA.

In clinical trials, the most frequent (≥3%) adverse reactions observed in subjects receiving BALFAXAR were procedural pain, wound complications, asthenia, anemia, dysuria, procedural vomiting, and catheter-site-related reaction.

BALFAXAR is derived from human plasma. The risk of transmission of infectious agents, including viruses and, theoretically, the Creutzfeldt-Jakob disease (CJD) agent and its variant (vCJD), cannot be completely eliminated.

Indications

BALFAXAR (prothrombin complex concentrate, human-lans) is a blood coagulation factor replacement product indicated for the urgent reversal of acquired coagulation factor deficiency induced by Vitamin K antagonist (VKA, e.g., warfarin) therapy in adult patients with need for an urgent surgery/invasive procedure.

Please click here for Full Prescribing Information, including BOXED WARNING.

To report suspected adverse reactions, contact Octapharma USA Inc. at 1-866-766-4860 or the FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.