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This document is used to request medical necessity authorization for XOLAIR (Omalizumab) treatment for patients, including insurance information and prescription details.
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How to fill out statement of medical necessity

How to fill out STATEMENT OF MEDICAL NECESSITY (SMN) FOR XOLAIR (OMALIZUMAB) FOR SUBCUTANEOUS USE
01
Obtain a copy of the STATEMENT OF MEDICAL NECESSITY (SMN) form for XOLAIR.
02
Fill out patient information: Include the patient's full name, date of birth, and medical record number.
03
Provide diagnosis: Clearly state the medical condition for which XOLAIR is being prescribed, such as moderate to severe asthma or chronic idiopathic urticaria.
04
Document the treatment history: List previous treatments tried and their outcomes, including dosage and duration.
05
Justify the medical necessity: Explain why XOLAIR is needed for the patient, including any applicable clinical guidelines.
06
Include prescribing physician details: Provide the physician's name, contact information, and signature.
07
Submit the completed form: Send to the insurance provider or relevant payer as part of the prior authorization process.
Who needs STATEMENT OF MEDICAL NECESSITY (SMN) FOR XOLAIR (OMALIZUMAB) FOR SUBCUTANEOUS USE?
01
Patients with moderate to severe asthma who are not adequately controlled on standard therapies.
02
Individuals with chronic idiopathic urticaria who have not responded to antihistamines.
03
Patients with other conditions approved for treatment with XOLAIR, as determined by their physician.
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People Also Ask about
Will insurance cover XOLAIR?
For patients with commercial insurance, about 55% of patients paid $0 out-of-pocket costs per month for XOLAIR. For those patients who did have out-of-pocket costs, 90% paid between $5 to $1,475 per month, after satisfying their deductible. The amount you pay for XOLAIR will depend on your insurance plan.
What are the eligibility criteria for Xolair?
Moderate-to-Severe Persistent Asthma • Prescriber is an allergist or pulmonologist • Patient is at least 6 years of age • Patient has a diagnosis of asthma • Patient has a positive skin or RAST test to a perennial aeroallergen. Patient has a documented baseline serum IgE of at least 30 IU/mL.
What is Xolair omalizumab for subcutaneous use?
XOLAIR® (omalizumab) for subcutaneous use is an injectable prescription medicine used to treat: moderate to severe persistent asthma in people 6 years of age and older whose asthma symptoms are not well controlled with asthma medicines called inhaled corticosteroids.
How do you qualify for XOLAIR?
Moderate-to-Severe Persistent Asthma • Prescriber is an allergist or pulmonologist • Patient is at least 6 years of age • Patient has a diagnosis of asthma • Patient has a positive skin or RAST test to a perennial aeroallergen. Patient has a documented baseline serum IgE of at least 30 IU/mL.
What is diagnosis code J2357?
HCPCS code J2357 for Injection, omalizumab, 5 mg as maintained by CMS falls under Drugs, Administered by Injection .
Is XOLAIR FDA approved for urticaria?
XOLAIR is the first FDA-approved biologic treatment for chronic hives with no known trigger.
What is the approved diagnosis for Xolair?
The FDA-approved indication for omalizumab is moderate-to-severe persistent asthma of an allergic nature, not controlled with the use of inhaled corticosteroids. In addition, the patient should have an IgE level between 30 IU and 700 IU and not weigh more than 150 kg (330 lbs).
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What is STATEMENT OF MEDICAL NECESSITY (SMN) FOR XOLAIR (OMALIZUMAB) FOR SUBCUTANEOUS USE?
The Statement of Medical Necessity (SMN) for XOLAIR (Omalizumab) for subcutaneous use is a formal document that healthcare providers submit to justify the medical necessity of prescribing Omalizumab for a patient's treatment, particularly for conditions like allergic asthma or chronic idiopathic urticaria.
Who is required to file STATEMENT OF MEDICAL NECESSITY (SMN) FOR XOLAIR (OMALIZUMAB) FOR SUBCUTANEOUS USE?
The healthcare provider, typically a physician or specialist, who is prescribing XOLAIR (Omalizumab) is required to file the Statement of Medical Necessity.
How to fill out STATEMENT OF MEDICAL NECESSITY (SMN) FOR XOLAIR (OMALIZUMAB) FOR SUBCUTANEOUS USE?
To fill out the Statement of Medical Necessity, the healthcare provider must provide patient information, diagnosis, treatment history, and the rationale for using Omalizumab, ensuring all required fields are accurately completed according to payer guidelines.
What is the purpose of STATEMENT OF MEDICAL NECESSITY (SMN) FOR XOLAIR (OMALIZUMAB) FOR SUBCUTANEOUS USE?
The purpose of the Statement of Medical Necessity is to validate the need for Omalizumab in treating the patient's condition and to facilitate insurance coverage by demonstrating that the therapy is appropriate and necessary.
What information must be reported on STATEMENT OF MEDICAL NECESSITY (SMN) FOR XOLAIR (OMALIZUMAB) FOR SUBCUTANEOUS USE?
The information that must be reported on the SMN includes the patient's name, age, diagnosis, prior treatment history, specific reasons for the medication's necessity, and any relevant clinical findings that support the treatment plan.
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