Lumizyme Billing Codes

The following table lists the most commonly used codes when filing claims for reimbursement for Lumizyme® (alglucosidase alfa) treatment:

ICD-10-CM

E74.02 – Pompe Disease

NDC

NDC 58468-0160-1 (Carton of one single-use vial)

NDC

NDC 58468-0160-2 (Carton of ten single-use vials)

HCPCS

J0221 – Injection, alglucosidase alfa (Lumizyme), 10 MG

CPT-4

96365 – Intravenous infusion therapy, prophylaxis,
             or diagnosis (specify substance or drug); initial, up to 1 hour
96366 – Each additional hour (list separately in addition to primary code, 96365)

Revenue

260 – General IV therapy service
261 – Infusion pump
258 – IV solutions
636 – Drugs and biologicals requiring an HCPCS code


The codes here are provided for informational purposes only and is not intended to substitute for the physician’s independent diagnosis or treatment of each patient. Providers are responsible for the accuracy and validity of any claims, invoices, and related documentation submitted to payers. Physicians should contact the payer if they have any specific questions about coverage or payment. Any specific guidance or direction on the submission of claims offered by the payer supersede the codes listed below. Use of the following codes does not guarantee reimbursement.

Assistance with Billing & Reimbursement

If you would like to confirm the most recent billing codes, have questions about which codes to use, or need assistance submitting claims or other supporting documentation, contact a Sanofi Genzyme Case Manager: 800-745-4447, option 3

Coding Glossary

Following are definitions of the different types of coding systems used to classify and identify medical conditions and prescription medications.

  • ICD-10-CM (International Classification of Diseases, 10th Edition) – ICD-10-CM codes represent the patient’s medical condition or reason for treatment (diagnosis code). These codes are used by hospitals and physicians, and are recognized by all insurers.
  • NDC (National Drug Code) – NDCs are codes that identify FDA-approved drugs. The NDC identifies the manufacturer, product, and package size. NDCs are used primarily by retail pharmacies.
  • HCPCS (Healthcare Common Procedure Coding System) – HCPCS codes are assigned by CMS (Center for Medicare and Medicaid Services) and are used by Medicare and most private payers to describe products administered in the physician office or hospital setting.
  • CPT-4 (Current Procedural Terminology) – CPT-4 Codes are used by physicians and hospitals to designate the procedures performed.
  • Revenue Codes – Revenue Codes are used by hospitals to classify services by category, and typically are required by payers when billing infusions in the hospital setting.

INDICATION

LUMIZYME® (alglucosidase alfa) is a hydrolytic lysosomal glycogen-specific enzyme indicated for patients with Pompe disease (GAA deficiency).

IMPORTANT SAFETY INFORMATION

WARNING: RISK OF ANAPHYLAXIS, HYPERSENSITIVITY AND IMMUNE-MEDIATED REACTIONS, and RISK OF CARDIORESPIRATORY FAILURE
  • Life-threatening anaphylactic reactions and severe hypersensitivity reactions, presenting as respiratory distress, hypoxia, apnea, dyspnea, bradycardia, tachycardia, bronchospasm, throat tightness, hypotension, angioedema (including tongue or lip swelling, periorbital edema, and face edema), and urticaria, have occurred in some patients during and after alglucosidase alfa infusions. Immune-mediated reactions presenting as proteinuria, nephrotic syndrome, and necrotizing skin lesions have occurred in some patients following alglucosidase alfa treatment. Closely observe patients during and after alglucosidase alfa administration and be prepared to manage anaphylaxis and hypersensitivity reactions. Inform patients of the signs and symptoms of anaphylaxis, hypersensitivity reactions, and immune-mediated-reactions and have them seek immediate medical care should signs and symptoms occur.
  • Infantile-onset Pompe disease patients with compromised cardiac or respiratory function may be at risk of serious acute exacerbation of their cardiac or respiratory compromise due to fluid overload, and require additional monitoring.

WARNINGS AND PRECAUTIONS

Anaphylaxis and Hypersensitivity Reactions: Life-threatening anaphylaxis and hypersensitivity reactions have been observed in some patients during and after treatment with alglucosidase alfa. If anaphylaxis or severe hypersensitivity reactions occur, immediately discontinue infusion and institute appropriate medical treatment. Appropriate medical support and monitoring measures should be available during infusion.

Immune-Mediated Reactions: Monitor patients for the development of systemic immunemediated reactions involving skin and other organs.

Risk of Acute Cardiorespiratory Failure: Patients with acute underlying respiratory illness and compromised cardiac and/or respiratory function may be at risk of acute cardiorespiratory failure. Caution should be exercised when administering alglucosidase alfa to patients susceptible to fluid volume overload. Appropriate medical support and monitoring measures should be available during infusion and some patients may require longer observation times.

Risk of Cardiac Arrhythmia and Sudden Cardiac Death during General Anesthesia for Central Venous Catheter Placement: Caution should be used when administering general anesthesia for the placement of a central venous catheter intended for alglucosidase alfa infusion.

Risk of Antibody Development: As with all therapeutic proteins, there is potential for immunogenicity. There is some evidence to suggest that some patients who develop high and sustained IgG antibody titers may experience reduced clinical efficacy. Patients should be monitored for IgG antibody formation every 3 months for 2 years and then annually thereafter.

ADVERSE REACTIONS

The most frequently reported adverse reactions (≥ 5%) in clinical trials were hypersensitivity reactions and included: anaphylaxis, rash, pyrexia, flushing/feeling hot, urticaria, headache, hyperhidrosis, nausea, cough, decreased oxygen saturation, tachycardia, tachypnea, chest discomfort, dizziness, muscle twitching, agitation, cyanosis, erythema, hypertension/increased blood pressure, pallor, rigors, tremor, vomiting, fatigue, and myalgia.

USE IN SPECIFIC POPULATIONS

Pregnancy: Based on animal data, alglucosidase alfa may cause fetal harm.

Please see the Full Prescribing Information, for complete details, including boxed WARNING

Contact Us

Sanofi Genzyme
50 Binney Street
Cambridge, MA 02142

Tel : 617-768-9000
Fax : 617 252 7600
Toll free : 800-745-4447