Form preview

Get the free STATEMENT OF MEDICAL NECESSITY (SMN) FOR XOLAIR (OMALIZUMAB) FOR SUBCUTANEOUS USE

Get Form
This document is used to request medical necessity authorization for XOLAIR (Omalizumab) treatment for patients, including insurance information and prescription details.
We are not affiliated with any brand or entity on this form

Get, Create, Make and Sign statement of medical necessity

Edit
Edit your statement of medical necessity form online
Type text, complete fillable fields, insert images, highlight or blackout data for discretion, add comments, and more.
Add
Add your legally-binding signature
Draw or type your signature, upload a signature image, or capture it with your digital camera.
Share
Share your form instantly
Email, fax, or share your statement of medical necessity form via URL. You can also download, print, or export forms to your preferred cloud storage service.

How to edit statement of medical necessity online

9.5
Ease of Setup
pdfFiller User Ratings on G2
9.0
Ease of Use
pdfFiller User Ratings on G2
To use the professional PDF editor, follow these steps below:
1
Register the account. Begin by clicking Start Free Trial and create a profile if you are a new user.
2
Prepare a file. Use the Add New button. Then upload your file to the system from your device, importing it from internal mail, the cloud, or by adding its URL.
3
Edit statement of medical necessity. Rearrange and rotate pages, insert new and alter existing texts, add new objects, and take advantage of other helpful tools. Click Done to apply changes and return to your Dashboard. Go to the Documents tab to access merging, splitting, locking, or unlocking functions.
4
Save your file. Select it from your records list. Then, click the right toolbar and select one of the various exporting options: save in numerous formats, download as PDF, email, or cloud.
pdfFiller makes dealing with documents a breeze. Create an account to find out!

Uncompromising security for your PDF editing and eSignature needs

Your private information is safe with pdfFiller. We employ end-to-end encryption, secure cloud storage, and advanced access control to protect your documents and maintain regulatory compliance.
GDPR
AICPA SOC 2
PCI
HIPAA
CCPA
FDA

How to fill out statement of medical necessity

Illustration

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.
Fill form : Try Risk Free
Users Most Likely To Recommend - Summer 2025
Grid Leader in Small-Business - Summer 2025
High Performer - Summer 2025
Regional Leader - Summer 2025
Easiest To Do Business With - Summer 2025
Best Meets Requirements- Summer 2025
Rate the form
4.7
Satisfied
49 Votes

People Also Ask about

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.
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.
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.
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.
HCPCS code J2357 for Injection, omalizumab, 5 mg as maintained by CMS falls under Drugs, Administered by Injection .
XOLAIR is the first FDA-approved biologic treatment for chronic hives with no known trigger.
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).

For pdfFiller’s FAQs

Below is a list of the most common customer questions. If you can’t find an answer to your question, please don’t hesitate to reach out to us.

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.
The healthcare provider, typically a physician or specialist, who is prescribing XOLAIR (Omalizumab) is required to file the Statement of Medical Necessity.
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.
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.
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.
Fill out your statement of medical necessity online with pdfFiller!

pdfFiller is an end-to-end solution for managing, creating, and editing documents and forms in the cloud. Save time and hassle by preparing your tax forms online.

Get started now
Form preview
If you believe that this page should be taken down, please follow our DMCA take down process here .
This form may include fields for payment information. Data entered in these fields is not covered by PCI DSS compliance.