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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.
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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.
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