Billing & Reimbursement

Treatment with Lumizyme® (alglucosidase alfa) is eligible for reimbursement under most major commercial insurance plans as well as the Medicare and Medicaid programs. In this section you'll find a list of current Lumizyme billing codes, claim forms and sample letters, plus other information to help you successfully bill and obtain reimbursement from different payers.

Guidelines for Successful Reimbursement

In many cases, physicians must obtain prior authorization for Lumizyme treatment, and insurers often require physicians to document the patient's medical necessity before approving coverage. You may also need to obtain written confirmation of coverage from the insurer before beginning treatment.

Billing for reimbursement for Lumizyme therapy requires using the appropriate codes. The Center for Medicare and Medicaid Services has not yet assigned a permanent HCPCS code (commonly used by many payers) to Lumizyme, although temporary biologic J-codes are available, and their use may streamline the reimbursement process.

However, billing procedures vary from plan to plan, so you are advised to carefully review each patient's coverage, and when necessary check with the payer about its billing requirements, before initiating treatment. Keep in mind that you may need different claim forms depending on whether the patient receives treatment in a physician's office or outpatient setting.

This page is 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.


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


  • 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.


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.


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.


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

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

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