Aldurazyme® Billing & Reimbursement

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Aldurazyme is eligible for reimbursement by commercial payers and Medicare.

To bill for Aldurazyme therapy, you must use the appropriate codes. The billing procedures may vary according to the site of service or third-party payer guidelines. Please reference this site or call a Sanofi Case Manager for updated billing codes.

In addition to the reimbursement information that is accessible through Sanofi Case Managers, Sanofi also has a written guide to Aldurazyme billing and reimbursement.

Guide to Aldurazyme Billing and Reimbursement

Information related to coverage, coding, and reimbursement for Aldurazyme

Download the Guide

The codes on this page may be used to communicate services rendered when filing claims for Aldurazyme. These codes are being provided for informational purposes only and should be verified, as codes may change. The provision of billing codes does not constitute reimbursement or legal advice. Providers are solely responsible for ensuring the accuracy of billing submissions to any payer.

Aldurazyme Billing Codes

Qualified individuals with MPS I whose physicians have recommended treatment with Aldurazyme may be eligible for the Patient Assistance Program. If a patient is ineligible for our program, their CareConnect Case Manager will work with the patient and their healthcare providers to explore alternative coverage options.

ICD-9-CM	277.5	Mucopolysaccharidosis type I (MPS I)
ICD-10-CM*	E 76.01 E 76.02 E 76.03	Hurler Syndrome Hurler-Scheie Syndrome Scheie Syndrome
NDC	58468-0070-1	2.9 mg laronidise per 5 mL
HCPCS	J1931	Aldurazyme (larondise) - injection, laronidise, 0.1 mg
CPT-4	96365 96365	Intravenous infusion therapy, prophylaxis, or diagnosis (specify substance or drug); Each additional hour (List separately in addition to primary procedure code, 96365).
Revenue	260 261 258 636	General IV therapy service Infusion pump IV solutions Drugs and biologicals requiring a HCPCS Code

This billing codes information is provided for informational purposes only and does not constitute legal or reimbursement advice. It is not intended to substitute for the physician’s independent diagnosis or treatment of each patient. The information contained herein is gathered from various resources and is subject to change. Providers are solely responsible for the accuracy of all coding and claims submitted for reimbursement to any third-party payer.

The unique J-code assigned to Aldurazyme significantly streamlines the reimbursement process. Aldurazyme is eligible for reimbursement by commercial payers and Medicare. However, specific policies vary across insurers and from plan to plan.

Providers are responsible for the selection of appropriate codes. Information in the table above provides a general framework for understanding possible coding alternatives. It should not be used as a substitute for a healthcare professional's own judgment. Any specific information regarding claims submission offered by the payer supersedes the information here or provided elsewhere by Sanofi.

Since third-party payers evaluate treatment based on medical necessity, expected outcome, and cost, they generally require documentation of diagnosis and clinical symptoms of MPS I. Refer to the Statement of Medical Necessity sample. This information may need to be submitted with the claim; for specific requirements, check with the payer or contact your Sanofi Case Manager.

To help avoid potential problems obtaining reimbursement, the treating physician should request written confirmation of coverage from the third-party payer prior to the initiation of enzyme replacement therapy. Sanofi Case Managers can assist in obtaining written authorization for Aldurazyme treatment.

For more information, contact Sanofi Support Services at 1-800-745-4447, Option 3.

Support for patients and families

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Indication

ALDURAZYME^® (laronidase) is indicated for the treatment of adult and pediatric patients with Hurler and Hurler-Scheie forms of Mucopolysaccharidosis I (MPS I) and for patients with the Scheie form who have moderate to severe symptoms.

Limitations of Use:

The safety and effectiveness of treating mildly affected patients with the Scheie form have not been established.
The effect of ALDURAZYME on central nervous system manifestations of the disorder has not been determined.

Important Safety Information

WARNING: HYPERSENTIVITIY REACTIONS INCLUDING ANAPHYLAXIS, and ACUTE RESPIRATORY COMPLICATIONS ASSOCIATED WITH ADMINISTRATION

Hypersensitivity Reactions Including Anaphylaxis
Patients treated with ALDURAZYME have experienced life-threatening hypersensitivity reactions, including anaphylaxis. Appropriate medical monitoring and support measures, including cardiopulmonary resuscitation equipment, should be readily available during ALDURAZYME administration. If a severe hypersensitivity reaction (e.g., anaphylaxis) occurs, discontinue ALDURAZYME immediately and initiate appropriate medical treatment. In patients with severe hypersensitivity reactions, a desensitization procedure to ALDURAZYME may be considered.

Acute Respiratory Complications Associated with Administration
Patients with compromised respiratory function or acute respiratory disease may be at risk of serious acute exacerbation of their respiratory compromise due to infusion reactions and require additional monitoring.

Warnings and Precautions
Hypersensitivity Reactions Including Anaphylaxis: See Boxed WARNING.

Pre-existing upper airway obstruction may contribute to the severity of some reactions. Consider premedicating patients with antihistamines, with or without antipyretics. Because of the potential for recurrent reactions, some patients who experience initial severe reactions may require prolonged observation.
Consider risks and benefits of re-administering ALDURAZYME following severe hypersensitivity reactions. Patients may be rechallenged using slower infusion rates which may be increased if tolerated to reach the recommended rate. If a mild or moderate hypersensitivity reaction occurs, consider temporarily holding the infusion or slowing the infusion rate.

Acute Respiratory Complications Associated with Administration: See Boxed WARNING.

Patients with an acute febrile or respiratory illness may be at greater risk for infusion reactions. Consider the patient’s clinical status prior to administration of ALDURAZYME and consider delaying the infusion.
Evaluation of airway patency should be considered prior to initiating ALDURAZYME. Patients using supplemental oxygen or continuous positive airway pressure (CPAP) during sleep should have these treatments readily available during infusion in the event of an infusion reaction or extreme drowsiness/sleep induced by antihistamine use.

Acute Cardiorespiratory Failure:

Use caution when administering ALDURAZYME to patients susceptible to fluid overload, or with an acute underlying respiratory illness or compromised cardiac and/or respiratory function for whom fluid restriction is indicated. Consider a decreased total infusion volume and infusion rate when administering ALDURAZYME to these patients.

Infusion-Associated Reactions:

ALDURAZYME may cause infusion-associated reactions (IARs). Consider pre-medicating with antihistamines, with or without antipyretics, however IARs may still occur in patients after receiving pre-medication. Discontinue immediately or adjust the infusion rate based on the severity of the reaction.

Adverse Reactions
Patients 6 months of age and older

The most common adverse reactions reported in ≥10% of patients were infusion reactions, which included pyrexia, chills, blood pressure increased, tachycardia, and oxygen saturation decreased.

Patients 6 years of age and older

The most common adverse reactions reported in ≥10% of patients were rash, upper respiratory tract infection, injection site reaction, hyperreflexia, paresthesia, flushing, and poor venous access.

Please see Full Prescribing Information including Boxed WARNING for Aldurazyme.

Aldurazyme® (laronidase) Billing and Reimbursement

Aldurazyme is eligible for reimbursement by commercial payers and Medicare.

Guide to Aldurazyme Billing and Reimbursement

Aldurazyme Billing Codes

Additional Billing Code Information

For more information, contact Sanofi Support Services at 1-800-745-4447, Option 3.

Support for patients and families

Indication

Limitations of Use:

Important Safety Information

Indication

Important Safety Information

Aldurazyme^® (laronidase) Billing and Reimbursement