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December 2016 Texas Medicaid Provider Procedures Manual

Medical and Nursing Specialists, Physicians, and Physician Assistants Handbook : 9 Physician : 9.2 Services, Benefits, Limitations, and Prior Authorization : 9.2.39 Clinician-Administered Drugs : 9.2.39.30 * Monoclonal Antibodies—Asthma and Chronic Idiopathic Urticaria

9.2.39.30
9.2.39.30.1
Omalizumab is an injectable drug that is FDA-approved for the treatment of clients who are 6 years of age and older with moderate to severe asthma (as defined by the National Heart, Lung, and Blood Institute’s Guidelines for the Diagnosis and management of Asthma). Omalizumab is also FDA-approved for the treatment of clients who are 12 years of age or older and have chronic idiopathic urticaria (CIU) who remain symptomatic despite H1 antihistamine treatment.
Omalizumab may be a benefit of Texas Medicaid when medically necessary with prior authorization. Clients who are younger than the FDA approved age will be considered on a case-by-case basis by the TMHP medical director.
Providers may not bill for an office visit if the only reason for the visit is an omalizumab injection.
9.2.39.30.2
Mepolizumab procedure code C9473 is a benefit when prior authorized and administered by a nurse practitioner, clinical nurse specialist, physician assistant, or physician in the office setting, or by hospital providers in the outpatient hospital setting.
Mepolizumab is an injectable drug that is approved by the FDA for the treatment of clients who are 12 years of age or older and have severe asthma (as defined by the National Heart, Lung, and Blood Institute’s Guidelines for the Diagnosis and Management of Asthma) with an eosinophilic phenotype. Clients who are younger than the FDA-approved age will be considered on a case-by-case basis by the TMHP medical director.
Treatment with mepolizumab may not occur concurrently with omalizumab or any other interleukin-5 antagonist. Procedure code C9473 will be denied when submitted on the same date of service as procedure code J2357, by any provider.
Providers may not bill for an office visit if the only reason for the visit is a mepolizumab injection.
9.2.39.30.3
When requesting prior authorization, the exact dosage must be included with the request using omalizumab (procedure code J2357) or mepolizumab (procedure code C9473). Prior authorization will be considered for clients who are 6 years of age or older with moderate to severe asthma and for clients who are 12 years of age or older with CIU. Prior authorization for mepolizumab will also be considered for clients who are 12 years of age or older with severe asthma.
Prior authorization approvals for omalizumab or mepolizumab are for intervals of six months at a time. Clients must be compliant with their omalizumab or mepolizumab regimen in order to qualify for additional authorizations. The provider must submit a statement documenting compliance with the requests for each renewal.
Mepolizumab may only be initiated after a six-month trial of omalizumab therapy that has resulted in inadequate response.
9.2.39.30.4
Prior authorization for omalizumab will be considered for clients who are 12 years of age or older with CIU. Documentation supporting medical necessity for treatment of CIU with omalizumab must be submitted with the request and include all of the following:
9.2.39.30.5
Requests for prior authorization must be submitted by the treating physician to the Special Medical Prior Authorization (SMPA) department by mail or approved electronic method using the SMPA request form.
Documentation supporting medical necessity for treatment of asthma with omalizumab or mepolizumab must be submitted with the request and must indicate the following:
12 months of high-dose inhaled corticosteroid (ICS) given in combination with a minimum of 3 months of controller medication (either a long-acting beta2-agonist [LABA], leukotriene receptor antagonist [LTRA], or theophylline), unless the individual is intolerant of, or has a medical contraindication to these agents; or
6 months of ICS with daily oral glucocorticoids given in combination with a minimum of 3 months of controller medication (a LABA, LTRA, or theophylline), unless the individual is intolerant of, or has a medical contraindication to these agents.
Note:
Exceptions to the criteria above will be considered on a case-by-case basis, which will require a letter from the prescribing provider stating the medical necessity for omalizumab or mepolizumab, the client’s asthma severity level, and the duration of current and past therapies and lack of asthma control. Consideration for these exceptions will be reviewed by the TMHP medical director.
Note:
Mepolizumab
The following additional documentation for treatment with mepolizumab must also be submitted:
One of the following blood eosinophil counts in the absence of other potential causes of eosinophilia, including hypereosinophilic syndromes, neoplastic disease, and known or suspected parasitic infection:
Note:
Prior authorization for an initial request for mepolizumab will be considered when the client has had an inadequate response after being compliant for 6 months of treatment with omalizumab and meets the criteria for mepolizumab. Failure to respond to omalizumab must be documented in a letter, signed and dated by the prescribing provider, and submitted with the request.
Note:
Exceptions may be considered for clients who meet the criteria for treatment with mepolizumab but do not meet the criteria for omalizumab. Supporting documentation, such as an IgE level that falls outside of the required range or a negative skin test/RAST to a perennial aeroallergen, must be submitted along with the documentation for treatment with mepolizumab, as described above.
Omalizumab
The following additional documentation for treatment with omalizumab also must be submitted:
9.2.39.30.6
For continuation of therapy with omalizumab or mepolizumab after 6 continuous months, the requesting provider must submit the following documentation of the client’s compliance and satisfactory clinical response to omalizumab or mepolizumab:
Member has not exhibited symptoms of hypersensitivity or anaphylaxis (bronchospasm, hypotension, syncope, urticaria, and/or angioedema) after administration of omalizumab or mepolizumab.
After lapses in treatment of 3 months or greater, prior authorization requests submitted with documentation will be reviewed by the TMHP medical director.
Requests for clients who do not meet the above criteria will be reviewed for medical necessity by the TMHP medical director.

Texas Medicaid & Healthcare Partnership
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