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Frequently Asked Questions About ANDEXXA Access and Reimbursement

The specifics of coverage may vary by payer and can be specific to the patient’s unique plan. Please reference the individual patient’s plan to determine any applicable coverage requirements.

The codes identified below may be applicable to ANDEXXA. Each provider is responsible for ensuring all coding is accurate and documented in the medical record based on the condition of the patient. The use of the following codes does not guarantee reimbursement.

Our emergency department (ED) mixed all drug but only administered the intravenous (IV) bolus before transferring the patient on the same day to our main hospital. Does the ED bill for ANDEXXA?

  • An ED that is wholly owned and/or operated by the admitting inpatient prospective payment system (IPPS) hospital may not separately bill for ANDEXXA. ANDEXXA should be billed under the inpatient stay
  • An ED that is not wholly owned and/or operated by the admitting IPPS hospital may separately bill for ANDEXXA when administered in the outpatient setting

Does NTAP apply to all Medicare inpatient claims?

  • NTAP only applies to Medicare fee-for-service inpatient claims from hospitals paid through the IPPS
  • NTAP does not apply to Medicare Advantage inpatient claims

Can NTAP be paid on claims already processed by Medicare?

  • Claims within the timely filing limit of 1 year from the date of service may be corrected and resubmitted with the appropriate ICD-10-PCS code

When does NTAP expire?

  • NTAP will expire after September 30, 2022

Which ICD-10 procedure codes describe the administration of ANDEXXA?

  • The 2 ICD-10 procedure (ICD-10-PCS) codes that describe the administration of ANDEXXA are:
    • XW03372 Introduction of Inactivated Coagulation Factor Xa into Peripheral Vein, Percutaneous Approach, New Technology Group 2
    • XW04372 Introduction of Inactivated Coagulation Factor Xa into Central Vein, Percutaneous Approach, New Technology Group 2
  • In order to qualify for an NTAP, hospitals must report use of ANDEXXA in the patient’s medical record and include an ICD-10-PCS code on the claim, indicating that ANDEXXA was administered during the inpatient stay

What is the NTAP amount for ANDEXXA?

  • The additional payment for ANDEXXA will be determined on a case-by-case basis. The reimbursement amount shall be limited to the lesser of:
    • 65% of the amount by which the total covered costs of the case exceed the Medicare Severity Diagnosis Related Group (MS-DRG) payment, or
    • 65% of the costs of ANDEXXA
  • This add-on payment will be incremental to the MS-DRG reimbursement for qualifying Medicare inpatient cases

What is the correct outpatient revenue code for ANDEXXA J7169?

  • The appropriate outpatient revenue code is 0636 (Drugs requiring detailed coding)

When does pass-through expire?

  • ANDEXXA outpatient temporary pass-through payment expired December 31, 2022

Can unused or expired drug be billed to the insurance?

  • Drug that was completely unused (previously mixed but not administered) or expired is not billed or reimbursed by the payer
  • Drug wastage (drug left over after proper dosage administration) is billed and reimbursed by payers. Modifier JW is attached to J7169 to report the amount of unused drug

INDICATION

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.

IMPORTANT SAFETY INFORMATION FOR ANDEXXA® (coagulation factor Xa [recombinant], inactivated-zhzo)

WARNING: THROMBOEMBOLIC RISKS, ISCHEMIC RISKS, CARDIAC ARREST, AND SUDDEN DEATHS

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
  • Cardiac arrest
  • Sudden deaths

Monitor for thromboembolic events and initiate anticoagulation when medically appropriate. Monitor for symptoms and signs that precede cardiac arrest and provide treatment as needed.

WARNINGS AND PRECAUTIONS

  • Arterial and venous thromboembolic events, ischemic events, and cardiac events, including sudden death, have occurred during treatment with ANDEXXA. 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 subjects 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 subjects 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 anticoagulant activity can occur.
  • ANDEXXA may interfere with the anticoagulant effect of heparin. If anticoagulation is needed, use an alternative anticoagulant to heparin.

ADVERSE REACTIONS

The most common adverse reactions (≥ 5%) in bleeding subjects receiving ANDEXXA were urinary tract infections and pneumonia. The most common adverse reactions (≥ 3%) in healthy volunteers treated with ANDEXXA were infusion-related reactions.

Please see full Prescribing Information, including Boxed WARNING.

INDICATION

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.

IMPORTANT SAFETY INFORMATION FOR ANDEXXA® (coagulation factor Xa [recombinant], inactivated-zhzo)

WARNING: THROMBOEMBOLIC RISKS, ISCHEMIC RISKS, CARDIAC ARREST, AND SUDDEN DEATHS

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
  • Cardiac arrest
  • Sudden deaths

Monitor for thromboembolic events and initiate anticoagulation when medically appropriate. Monitor for symptoms and signs that precede cardiac arrest and provide treatment as needed.

 

WARNINGS AND PRECAUTIONS

  • Arterial and venous thromboembolic events, ischemic events, and cardiac events, including sudden death, have occurred during treatment with ANDEXXA. 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 subjects 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 subjects 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 anticoagulant activity can occur.
  • ANDEXXA may interfere with the anticoagulant effect of heparin. If anticoagulation is needed, use an alternative anticoagulant to heparin.

ADVERSE REACTIONS

The most common adverse reactions (≥ 5%) in bleeding subjects receiving ANDEXXA were urinary tract infections and pneumonia. The most common adverse reactions (≥ 3%) in healthy volunteers treated with ANDEXXA were infusion-related reactions.

Please see full Prescribing Information, including Boxed WARNING.