Information on Coding, Billing and Reimbursement to assist with patient access to ANDEXXA.
|Carton NDC Number||69853-0102-1*|
4 single-use vials in a carton
Each vial contains 200 mg
Vial Cap Color
Red flip-off cap
*Medicaid and some commercial payers may require conversion of 10-digit NDCs to 11-digit NDCs for claims submission. Providers are responsible for verifying formatting requirements related to entry of NDCs on claims with payers.
ANDEXXA is available exclusively through these approved distributors:
Medicare Inpatient Coding and Payment (Part A) This information details our general understanding of the application of certain codes to ANDEXXA. It is the provider's sole responsibility to determine the appropriate codes for any action taken in billing. This information is not intended to be definitive or exhaustive, and Alexion makes no warranties or guarantees as to the accuracy or appropriateness of this information. Before filing any claim, providers should verify these requirements with specific payers.
Introduction of Andexanet Alfa, Factor Xa Inhibitor Reversal Agent into Peripheral Vein, Percutaneous Approach, New Technology Group 2
Introduction of Andexanet Alfa, Factor Xa Inhibitor Reversal Agent into Central Vein, Percutaneous Approach, New Technology Group 2
ANDEXXA (coagulation factor Xa (recombinant), inactivated-zhzo) is also referred to by the US adopted name (USAN) of andexanet alfa.
Medicare New Technology Add-on Payment (NTAP)
Medicare coverage is available for ANDEXXA. Centers for Medicare & Medicaid Services (CMS) increased New Technology Add-on Payments (NTAPs) in fiscal year 2020 to promote patient access and reimbursement confidence for “new” and “transformative technologies.” An NTAP provides additional payment to hospitals above the standard Medicare Severity Diagnosis-Related Group (MS-DRG) payment amount.2†
†NTAP reimbursement for this product has been renewed until September 30, 2021.3
Commercial health plan reimbursement may vary. Many plans follow Medicare reimbursement guidance.4‡
‡Payers may vary on timing.
Eligibility to receive add-on payments may vary. Hospitals not reimbursed under the IPPS are not eligible to receive add-on payments
Standardized code for ANDEXXA insurance claims across Medicare, Medicare Advantage, Medicaid and commercial plans
Effective July 1, 2020, the Centers for Medicare and Medicaid Services (CMS) has granted ANDEXXA its permanent J-code, facilitating reimbursement in all hospital outpatient departments and freestanding emergency facilities in the United States.5
Hospitals and physicians are responsible for compliance with Medicare and other payer rules and requirements and for the information
submitted with all claims and appeals. Before any claims or appeals are submitted, hospitals and physicians should review official payer
instructions and requirements, should confirm the accuracy of their coding or billing practices with these payers, and should use independent
judgment when selecting codes that most appropriately describe the services or supplies provided to a patient.
|HCPCS Code||Brand Name||HCPCS Description|
Injection, coagulation Factor Xa (recombinant), inactivated-zhzo (ANDEXXA), 10 mg
For services on or after July 1, 2020§
§For ANDEXXA claims for dates of service before July 1, 2020, hospitals must bill for ANDEXXA using its unique HCPCS C-code, C9041, to be eligible for pass-through payment. For payers who do not accept C-code claims before July 1, 2020, institutions may bill the miscellaneous J-code, J3590, for ANDEXXA.6
Because coding and billing requirements may vary, providers should check with payers directly to verify the information needed for claims submission.
1. Andexxa (prescribing information). Boston, MA: Alexion Pharmaceuticals, Inc.; 2021. 2. Centers for Medicare & Medicaid Services (CMS) Medicare program; hospital inpatient prospective payment systems for acute care hospitals and the long-term care hospital prospective payment system and policy changes and fiscal year 2020 rates; quality reporting requirements for specific providers: Medicare & Medicaid promoting interoperability programs requirements for eligible hospitals and critical access hospitals. Fed Regist. 2019;84(159):42044-42701. 3. CMS HHS Medicare Program Federal Register 2020 ONLINE. 4. Data on file. Alexion Pharmaceuticals, Inc. 5. Centers for Medicare & Medicaid Services (CMS). CMS Healthcare Common Procedure Coding System (HCPCS) Application Summaries and Coding Decisions: First Quarter, 2020 Coding Cycle for Drug and Biological Products. https://www.cms.gov/files/document/2020-hcpcs-application-summary-quarter-1-2020-drugs-and-biologicals.pdf. Published Q1 2020. Accessed April 8, 2020. 6. Centers for Medicare & Medicaid Services (CMS). April 2019 update of the Hospital Outpatient Prospective Payment System (OPPS). https://www.cms.gov/Regulations-and-Guidance/Guidance/Transmittals/2019Downloads/R4256CP.pdf. Accessed January 13, 2019.
WARNING: THROMBOEMBOLIC RISKS, ISCHEMIC RISKS, CARDIAC ARREST, AND SUDDEN DEATHS
See full prescribing information for complete boxed warning
Treatment with ANDEXXA has been associated with serious and life-threatening adverse events, including:
Arterial and venous thromboembolic events
Ischemic events, including myocardial infarction and ischemic stroke
Monitor for thromboembolic events and initiate anticoagulation when medically appropriate. Monitor for symptoms and signs that precede cardiac arrest and provide treatment as needed.
ANDEXXA (coagulation factor Xa (recombinant), inactivated-zhzo) is a recombinant modified human factor Xa (FXa) protein indicated for patients treated with rivaroxaban or apixaban, when reversal of anticoagulation is needed due to life-threatening or uncontrolled bleeding.
This indication is approved under accelerated approval based on the change from baseline in anti-FXa activity in healthy volunteers. An improvement in hemostasis has not been established. Continued approval for this indication may be contingent upon the results of studies that demonstrate an improvement in hemostasis in patients.
Limitations of Use
ANDEXXA has not been shown to be effective for, and is not indicated for, the treatment of bleeding related to any FXa inhibitors other than apixaban or rivaroxaban.
Thromboembolic and Ischemic Risks
The thromboembolic and ischemic risks were assessed in 352 bleeding subjects who received ANDEXXA. Of the 63 subjects who experienced a thrombotic event, the median time to first event was 7 days, and 21 subjects experienced the event within the first three days. A total of 63 (18%) experienced 88 thromboembolic or ischemic events. Of the 352 subjects who received ANDEXXA, 223 received at least one anticoagulation dose within 30 days after treatment. Of these 223, 18 subjects (8%) had a thrombotic event and/or ischemic event after resumption.
Monitor patients treated with ANDEXXA for signs and symptoms of arterial and venous thromboembolic events, ischemic events, and cardiac arrest. To reduce thromboembolic risk, resume anticoagulant therapy as soon as medically appropriate following treatment with ANDEXXA.
The safety of ANDEXXA has not been evaluated in patients who experienced thromboembolic events or disseminated intravascular coagulation within two weeks prior to the life-threatening bleeding event requiring treatment with ANDEXXA. Safety of ANDEXXA also has not been evaluated in patients who received prothrombin complex concentrates, recombinant factor VIIa, or whole blood products within seven days prior to the bleeding event.
Re-elevation or Incomplete Reversal of Anti-FXa Activity
The time course of anti-FXa activity following ANDEXXA administration was consistent among the healthy volunteer studies and the ANNEXA-4 study in bleeding patients. Compared to baseline, there was a rapid and substantial decrease in anti-FXa activity corresponding to the ANDEXXA bolus. This decrease was sustained through the end of the ANDEXXA continuous infusion. The anti-FXa activity returned to the placebo levels approximately two hours after completion of a bolus or continuous infusion. Subsequently, the anti-FXa activity decreased at a rate similar to the clearance of the FXa inhibitors.
Seventy-one subjects were anticoagulated with apixaban and had baseline levels of anti-FXa activity > 150 ng/mL. Nineteen subjects who were anticoagulated with rivaroxaban had elevated baseline anti-FXa activity levels >300 ng/mL. Forty-eight of the 71 apixaban-treated subjects (68%) experienced a > 90% decrease from baseline anti-FXa activity after administration of ANDEXXA. Ten of the 19 rivaroxaban subjects (53%) experienced a > 90% decrease from baseline anti-FXa activity after administration of ANDEXXA.
Use of Heparin Following Administration of ANDEXXA
ANDEXXA may interfere with the anticoagulant effect of heparin. Use of ANDEXXA as an antidote for heparin has not been established. Avoid use of ANDEXXA for the reversal of direct FXa inhibitors (apixaban and rivaroxaban) prior to heparinization as ANDEXXA may cause unresponsiveness to heparin. If anticoagulation is needed, use an alternative anticoagulant to heparin.
The most common adverse reactions (≥ 5%) in bleeding patients receiving ANDEXXA were urinary tract infections and pneumonia.
The most common adverse reactions (≥ 3%) in healthy subjects treated with ANDEXXA were infusion-related reactions.
As with all therapeutic proteins, there is the potential for immunogenicity. Using an electrochemiluminescence (ECL)-based assay, 145 ANDEXXA-treated healthy subjects were tested for antibodies to ANDEXXA as well as antibodies cross-reacting with Factor X (FX) and FXa. Low titers of anti-ANDEXXA antibodies were observed in 26/145 healthy subjects (17%); 6% (9/145) were first observed at Day 30 with 20 subjects (14%) still having titers at the last time point (Days 44 to 48). To date, the pattern of antibody response in patients in the ongoing ANNEXA-4 study has been similar to that observed in healthy volunteers. Of the 236 subjects with available samples, 6.8% (16/236) had antibodies against ANDEXXA. None of these anti-ANDEXXA antibodies were neutralizing. No neutralizing antibodies cross-reacting with FX or FXa were detected in healthy subjects (0/145) or in bleeding patients (0/209) to date.
Please see full Prescribing Information including Boxed Warning on thromboembolic risks, ischemic risks, cardiac arrest, and sudden death.