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Access 360 can help answer your questions about ordering, coding, and reimbursement for ANDEXXA

ANDEXXA Coding Resource

This resource provides specific codes related to diagnosis and billing for ANDEXXA.

ANDEXXA Coding Information

The codes identified on this page 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.

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How is ANDEXXA supplied?

Packaging information and NDC1

Carton 10-digit NDC number 0310-3200-04*
Carton 11-digit NDC number 00310-3200-04*
Carton configuration 4 single-use vials per carton; each vial contains 200 mg
Vial cap color Red flip-off cap
Carton 10-digit NDC number 0310-3200-04*
Carton 11-digit NDC number 00310-3200-04*
Carton configuration 5 single-use vials per carton; each vial contains 200 mg
Vial cap color Red flip-off cap

NDC=National Drug Code.

*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.

How can I order ANDEXXA?

ANDEXXA is available exclusively through the following approved distributors:

Distributor Phone Fax Website
ASD Healthcare 1-800-746-6273 1-800-547-9413 www.asdhealthcare.com
BioCareSD 1-800-304-3064 N/A www.biocaresd.com
Cardinal Health 1-866-300-3838 N/A www.cardinalhealth.com
FFF Enterprises 1-800-843-7477 1-800-418-4333 www.fffenterprises.com
McKesson 1-877-625-2566 1-888-752-7626 www.mckesson.com

N/A=not available.

Billing and coding

Hospital Inpatient Setting

Medicare Inpatient Coding and Payment (Part A)

This information details a 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 AstraZeneca 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.

  • ANDEXXA® (coagulation factor Xa (recombinant), inactivated-zhzo) is also referred to by the United States adopted name (USAN) of andexanet alfa
  • Medicare assigns only 1 Severity-Diagnosis Related Group (MS-DRG) to a particular hospital admission, which is determined by ICD-10-CM diagnosis and ICD-10-PCS procedure codes

There are 2 unique ICD-10-PCS procedure codes that may be applicable to the introduction of ANDEXXA:

ICD-10-PCS Code2 Description
XW03372 Introduction of Andexanet Alfa, Factor Xa Inhibitor Reversal Agent into Peripheral Vein, Percutaneous Approach, New Technology Group 2
XW04372 Introduction of Andexanet Alfa, Factor Xa Inhibitor Reversal Agent into Central Vein, Percutaneous Approach, New Technology Group 2
Commercial Reimbursement

Commercial health plan reimbursement may vary. Many plans follow Medicare reimbursement guidance.*

*Payers may vary on timing. Eligibility to receive add-on payments may also vary. Hospitals not reimbursed under the IPPS are not eligible to receive add-on payments.

Hospital Outpatient Setting

Permanent Healthcare Common Procedure Coding System (HCPCS) code for ANDEXXA insurance claims across all payers

ANDEXXA has a permanent HCPCS J-code that may facilitate reimbursement in all hospital outpatient departments and freestanding emergency facilities in the United States.

HCPCS Code3 Description
J7169 Injection, coagulation Factor Xa (recombinant), inactivated-zhzo (ANDEXXA), 10 mg

Modifier JW may be used to report unused and discarded drug. The discarded amount is typically reported as J7169-JW on the claim form with the appropriate number of units.

For Medicare and many private payer claims, modifier JW must be used to report unused and discarded drug. The discarded amount is typically reported as J7169-JW on the claim form with the appropriate number of units. For Medicare claims, the newly established JZ modifier should be used when there is no discarded amount from a single-use vial.

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, confirm the accuracy of their coding or billing practices with these payers, and use independent judgment when selecting codes that most appropriately describe the services or supplies provided to a patient.

Because coding and billing requirements may vary, providers should check with payers directly to verify the information needed for claims submission.

If you have questions regarding billing and coding for ANDEXXA, please contact Access 360 at 1-844-ASK-A360 (1-844-275-2360).

References: 1. ANDEXXA® (coagulation factor Xa [recombinant], inactivated-zhzo) [prescribing information]. Boston, MA: Alexion Pharmaceuticals, Inc.; 2022. 2. Centers for Medicare & Medicaid Services. 2022 ICD-10-PCS Codes. Accessed May 6, 2022. https://www.cms.gov/medicare/icd-10/2022-icd-10-pcs 3. Centers for Medicare & Medicaid Services. HCPCS Quarterly Update. Accessed May 6, 2022. https://www.cms.gov/Medicare/Coding/HCPCSReleaseCodeSets/HCPCS-Quarterly-Update

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.