Billing chart: Blue Cross highlights medical, benefit policy changes

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Experimental
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Basic benefit and medical policy

Balloon dilation of the eustachian tube
The safety and effectiveness of U.S. Food and Drug Administration-approved balloon dilation devices have been established. They may be considered a useful therapeutic option in the treatment of chronic obstructive eustachian tube dysfunction when criteria are met.

The medical policy statement, and inclusionary and exclusionary criteria have been updated, effective March 1, 2024.

Inclusionary and exclusionary guidelines

Inclusions:
Balloon dilation of the eustachian tube for treatment of chronic obstructive eustachian tube dysfunction may be considered established under all the following conditions:

• Adults (age 18 years and older) with symptoms of obstructive eustachian tube dysfunction (aural fullness, aural pressure, otalgia or hearing loss) for three months or longer in one or both ears that significantly affects quality of life or functional health status. Aural fullness and pressure must be present.
• The individual has undergone a comprehensive diagnostic assessment, including patient-reported questionnaires, history and physical exam, tympanometry if the tympanic membrane is intact, nasal endoscopy and comprehensive audiometry, with the following findings:
• Abnormal tympanogram (Type B or C)
• Abnormal tympanic membrane (retracted membrane, effusion, perforation or any other abnormality identified on exam)
• Failure to respond to appropriate medical management of potential co-occurring conditions, if any, such as allergic rhinitis, rhinosinusitis and laryngopharyngeal reflux, including four to six weeks of a nasal steroid spray, if indicated.
• Other causes of aural fullness such as temporomandibular joint disorders, extrinsic obstruction of the eustachian tube, superior semicircular canal dehiscence and endolymphatic hydrops have been ruled out.
• If the individual had a history of tympanostomy tube placement, symptoms of obstructive eustachian tube dysfunction should have improved while tubes were patent.
• The individual doesn’t have patulous eustachian tube dysfunction or another contraindication to the procedure. (See Policy Guidelines.)
• The individual’s eustachian tube dysfunction has been shown to be reversible. (See Policy Guidelines.)
• Symptoms are continuous rather than episodic (e.g., symptoms occur only in response to barochallenge, such as pressure changes while flying).
• The individual hasn’t had a previous BDET procedure.
• In certain situations, consideration may be given to individuals younger than 18 years of age.  The most likely scenario is older children or adolescents who have failed standard treatment with grommet (ventilation or tympanostomy tube insertion), adenoidectomy or both.

Reversibility of eustachian tube dysfunction:
Reversibility of eustachian tube dysfunction can be demonstrated by several means, including any of the following:

• The individual states that they are able to relieve the pressure by performing a Valsalva maneuver to “pop” their ears.
• Performing a Valsalva maneuver produces temporary improvement of the individual’s tympanogram to Type A tympanogram.
• Performing a Valsalva maneuver causes the member’s middle ear to aerate, which is indicated by the provider visualizing lateral movement of the tympanic membrane on otoscopy.

Balloon dilation of the eustachian tube used in combination with other procedures:

• Individuals undergoing BDET concurrent with sinus ostial dilation should meet the same diagnostic criteria for BDET as those undergoing BDET alone.
• Individuals with a middle ear effusion at the time of BDET may benefit from concurrent myringotomy with or without tympanostomy tube placement.

Exclusions:
Balloon dilation of the eustachian tube is considered experimental if the above criteria aren’t met.

Symptoms of obstructive eustachian tube dysfunction may include aural fullness, aural pressure, otalgia and hearing loss. Nearly all individuals will have aural fullness and aural pressure. Many individuals will have otalgia, but hearing loss may not be present in all individuals (e.g., patients with Type C tympanograms).

Contraindications:
The following individuals should not be considered for balloon dilation of the eustachian tube:

• Individuals with patulous eustachian tube dysfunction
• A diagnosis of patulous ETD is suggested by symptoms of autophony of voice, audible respirations, pulsatile tinnitus or aural fullness.
• Individuals with extrinsic reversible or irreversible causes of eustachian tube dysfunction, including, but not limited to:
• Craniofacial syndromes, including cleft palate spectrum
• Neoplasms causing extrinsic obstruction of the eustachian tube
• History of radiation therapy to the nasopharynx
• Enlarged adenoid pads
• Nasopharyngeal mass
• Neuromuscular disorders that lead to hypotonia or ineffective eustachian tube dynamic opening
• Systemic mucosal or autoimmune inflammatory disease affecting the mucosa of the nasopharynx and eustachian tube (e.g. Samter’s triad, Wegener’s disease, mucosal pemphigus) that is ongoing or active (i.e., not in remission)
• Individuals with aural fullness but normal exam and tympanogram
• Individuals with chronic and severe atelectatic ears

81191, 81192, 81193, 81194, 81210, 81301, 81445, 81449, 81450, 81451, 81455, 81456, 81479,** 0022U, 0244U, 0250U, 0334U, 0379U, 0037U, 0172U

Basic benefit and medical policy

GT – NGS of multiple genes (panel)
The policy has been updated to cover procedure codes *81449, *81451, *81456, *0244U, *0250U, *0334U and *0379U when criteria are met, effective Jan. 1, 2024.

Next-generation sequence testing of clinically actionable genes, through a multiple-gene panel, may be considered established for solid cancers or hematolymphoid cancers for diagnostic and prognostic purposes, and in guiding the selection of appropriate therapeutic options, when criteria are met.

Next-generation sequencing, or NGS, of clinically actionable genes, through a multiple-gene panel may be considered established for metastatic or advanced cancers when criteria are met.

Inclusionary and exclusionary guidelines

Inclusions:
If there is a medical policy specific to the cancer (type or treatment) and to the appropriate genetic testing, that policy direction supersedes this policy.

Hematolymphoid cancer:
Next-generation sequencing, with a multiple-gene panel test (e.g., CPT codes *81450, *81451, *81455 or *81456), may be considered established when used for diagnostic and prognostic purposes or for guidance in the selection of appropriate targeted FDA therapeutic options for the following conditions.

• Suspected hematolymphoid neoplasms supported by clinical records that reflect an inconclusive diagnosis despite the clinical history, physical examination findings, blood work (e.g., CBC with peripheral smear, chromosome analysis)
• Acute lymphoblastic leukemia
• Acute myelogenous leukemia
• Basophilia
• B-acute lymphocytic leukemia
• B-cell non-Hodgkin lymphoma
• Chronic lymphocytic leukemia
• Chronic myeloid leukemia
• Chronic myeloid proliferative disease
• Essential thrombocythemia or thrombocytosis
• Myelodysplastic syndrome
• Pancytopenia
• Plasma cell dyscrasia
• Pediatric hematologic malignancies
• Polycythemia vera
• Primary myelofibrosis, or PMF, Pre-PMF, or suspicion for PMF
• T-acute lymphocytic leukemia
• T-cell lymphoma, peripheral

Solid cancers:
Next-generation sequencing, or NGS, with a multiple-gene panel test (e.g., CPT codes *81445, *81449, *81455 and *81456), may be considered established when used for diagnostic and prognostic purposes or for guidance in the selection of appropriate targeted FDA-therapeutic options for any of the following conditions:

• Metastatic cancers
• Inoperable locally advanced cancers
• Refractory cancers
• Recurrent cancers
• When diagnosis can’t be made by histopathologic means alone (e.g., sarcomas, neurologic neoplasms, etc.)
• NGS testing for adjuvant therapy in non-advanced cancers may be considered, if consistent with FDA-approved indications

Tumor agnostic therapy:
Next-generation sequencing, or NGS, with a multiple-gene panel test may be considered established when the following criteria are met:

Adult and pediatric individuals for whom there are no satisfactory options in the treatment of metastatic or unresectable solid tumors, or disease progression following prior treatment.

Note: Tumor agnostic therapy is established for the following genetic variants:

• BRAF V600E or V600K variants
• Mismatch repair deficient, or dMMR, or microsatellite instability-high, or MSI-H
• Tumor mutational burden-high, or TMB-H, (≥10 mutations/mega base [mut/Mb])
• Neurotrophic tyrosine receptor kinase, or NTRK 1/2/3, gene fusion
• Programmed cell death ligand 1, or PD-L1

Proprietary laboratory analyses, or PLA, testing:
A PLA test is considered established when both the following criteria are met:

• Biomarker confirmation is required by an FDA-approved or cleared test before initiating treatment (as described in the FDA prescribing label of the therapeutic in the section “Indications and Usage”).
• The test is an FDA-approved companion diagnostic.

Information regarding FDA-approved companion diagnostic tests should be obtained from the FDA “List of Cleared or Approved Companion Diagnostic Devices (In Vitro and Imaging Tools)” website: fda.gov/medical-devices/in-vitro-diagnostics/list-cleared-or-approved-companion-diagnostic-devices-in-vitro-and-imaging-tools**

For accuracy, access the information directly from the FDA site because the website is updated frequently.

Exclusions:

• Next-generation sequencing, with multiple-gene panel testing (five to 50 genes; or 51 or more genes) when the above criteria aren’t met
• Concurrent ordering of more than one multiple-gene panel test

**Blue Cross Blue Shield of Michigan doesn’t own or control this website.

C9399, J3490, J3590, J9999

Basic benefit and medical policy

Avzivi (bevacizumab-tnjn)
Avzivi (bevacizumab-tnjn) is considered established, effective Dec. 6, 2023. 

Avzivi is a vascular endothelial growth factor inhibitor indicated for the treatment of:

• Metastatic colorectal cancer, in combination with intravenous fluorouracil-based chemotherapy for first- or second-line treatment.
• Metastatic colorectal cancer, in combination with fluoropyrimidine-irinotecan- or fluoropyrimidine-oxaliplatin-based chemotherapy for second-line treatment in patients who have progressed on a first-line bevacizumab product-containing regimen. 

Limitations of use

• Avzivi isn’t indicated for adjuvant treatment of colon cancer.
• Unresectable, locally advanced, recurrent or metastatic non-squamous non-small cell lung cancer, in combination with carboplatin and paclitaxel for first-line treatment. 
• Recurrent glioblastoma in adults. 
• Metastatic renal cell carcinoma in combination with interferon alfa. 
• Persistent, recurrent or metastatic cervical cancer, in combination with paclitaxel and cisplatin, or paclitaxel and topotecan.
• Epithelial ovarian, fallopian tube or primary peritoneal cancer in combination with paclitaxel, pegylated liposomal doxorubicin, or topotecan for platinum-resistant recurrent disease who received no more than two prior chemotherapy regimens. 

Dosage and administration
Withhold for at least 28 days before elective surgery. Don’t administer Avzivi for 28 days following major surgery and until adequate wound healing.

Metastatic colorectal cancer:

• 5 mg/kg every two weeks with bolus-IFL
• 10 mg/kg every two weeks with Folfox4
• 5 mg/ kg every two weeks or 7.5 mg/kg every three weeks with fluoropyrimidine-irinotecan- or fluoropyrimidine-oxaliplatin-based chemotherapy after progression on a first-line bevacizumab product containing regimen

First-line non-squamous non-small cell lung cancer: 
15 mg/kg every three weeks with carboplatin and paclitaxel 

Recurrent glioblastoma:
10 mg/kg every two weeks

Metastatic renal cell carcinoma:
10 mg/kg every two weeks with interferon alfa

Persistent, recurrent or metastatic cervical cancer:
 15 mg/kg every three weeks with paclitaxel and cisplatin, or paclitaxel and topotecan

Platinum-resistant recurrent epithelial ovarian, fallopian tube or primary peritoneal cancer: 

• 10 mg/kg every two weeks with paclitaxel, pegylated liposomal doxorubicin or topotecan given every week
• 15 mg/kg every three weeks with topotecan given every three weeks

Administer as an intravenous infusion after dilution.
 
Dosage forms and strengths
Injection: 100 mg/4 mL (25 mg/mL) or 400 mg/16 mL (25 mg/mL) in a single-dose vial.

This drug isn’t a benefit for URMBT.

C9399, J3490, J3590, J9999

Basic benefit and medical policy

Lyfgenia (lovotibeglogene autotemcel)
Effective Dec. 8, 2023, Lyfgenia (lovotibeglogene autotemcel) is covered for its FDA-approved indications.

Coverage of Lyfgenia (lovotibeglogene autotemcel) is provided when all the following are met:

• FDA-approved indication
• FDA-approved age
• Prescribing by or in consultation with a hematologist
• Genetic test confirming a diagnosis of sickle cell disease
• Must not be diagnosed with sickle β-thalassemia
• Must have experienced at least four severe vaso-occlusive crises in the past 24 months
• Trial and failure, contraindication or intolerance to hydroxyurea
• Must not have any of the following:
• Positive presence of HIV-1 or HIV-2, hepatitis B or hepatitis C
• Inadequate bone marrow function, as defined by an absolute neutrophil count of less than 1000/μL or less than 500/μL for patient taking hydroxyurea or a platelet count less than 120,000/μL without hypersplenism
• Advanced liver disease defined as AST, ALT or total bilirubin greater than three times the upper limit of normal
• Prior treatment with an allogenic stem cell transplant
• Prior or current malignancy or immunodeficiency disorder
• Must not have received prior treatment with any gene therapy for sickle cell disease or are being considered for treatment with any other gene therapy for sickle cell disease
• Trial and failure, intolerance or a contraindication to the preferred products as specified in the Blue Cross Blue Shield of Michigan or Blue Care Network medical utilization management drug list

Quantity limitations, authorization period and renewal criteria:

• Quantity limits: Align with FDA-recommended dosing
• Initial authorization period: Three months
• Renewal criteria: No renewal allowed, one infusion per lifetime

J3490, J3590

Basic benefit and medical policy

Omvoh (mirikizumab-mrkz)
Effective Oct. 26, 2023, Omvoh (mirikizumab-mrkz) is covered for its FDA-approved indications.

Coverage of Omvoh (mirikizumab-mrkz) is provided when all the following are met:

• FDA-approved indication
• FDA-approved age
• Treatment with an adequate course of conventional therapy (such as steroids for seven days, immunomodulators such as azathioprine for at least two months) has been ineffective or is contraindicated or not tolerated.
• Not to be used in combination with biologic therapies or targeted disease-modifying anti-rheumatic drugs, known as DMARDs.
• Trial and failure, contraindication or intolerance to the preferred drugs as listed in Blue Cross’ or BCN’s utilization management medical drug list

Quantity limitations, authorization period and renewal criteria:

• Quantity limits: Align with FDA-recommended dosing
• Initial authorization period: One year at a time
• Renewal criteria: Clinical documentation must be provided to confirm that current criteria are met and that the medication is providing clinical benefit.

This drug isn’t a benefit for URMBT.

J3490, J3590

Basic benefit and medical policy

Tofidence (tocilizumab-bavi)
Effective Sept. 29, 2023, Tofidence (tocilizumab-bavi) is covered for its FDA-approved indications.

Coverage of Tofidence (tocilizumab-bavi) is provided when all the following are met:

• FDA-approved indication
• FDA-approved age
• Diagnosis of rheumatoid arthritis: Trial and failure of at least three months of one disease-modifying anti-rheumatic agent, or DMARD, unless contraindicated or not tolerated. Examples include methotrexate, hydroxychloroquine, leflunomide and sulfasalazine.
• Diagnosis of polyarticular juvenile idiopathic arthritis, or pJIA: Trial and failure of at least three months of one DMARD unless contraindicated or not tolerated. Examples include methotrexate and leflunomide.
• Diagnosis of Still’s disease, including systemic juvenile idiopathic arthritis, or sJIA, and adult-onset Still’s disease, or AOSD: Trial and treatment failure with one of the following: glucocorticoids or NSAIDs.
• Diagnosis of cytokine release syndrome, or CRS: Prescribed by or in consultation with an oncologist. Severe or life-threatening CRS associated with chimeric antigen receptor, or CAR-T cell therapy.
• Diagnosis of giant cell arteritis, or GCA.
• Diagnosis of systemic sclerosis-associated interstitial lung disease, or SSc-ILD: Inadequate response to (as evidenced by disease progression, e.g., worsening of pulmonary function) or not a candidate for either mycophenolate mofetil or cyclophosphamide.
• Not to be used in combination with other biologics or other targeted DMARDs.
• Coverage will be provided for biosimilar products for FDA-labeled indications of the innovator product when criteria are met.
• Trial and failure of the preferred products as specified in the Blue Cross Blue Shield of Michigan and Blue Care Network utilization management medical drug list or the Blue Cross and BCN prior authorization and step therapy documents.

Quantity limitations, authorization period and renewal criteria

Quantity limits:
Align with FDA-recommended dosing

Initial authorization period:
RA, pJIA, sJIA, GCA, AOSD, SSc-ILD: One year at a time
CRS: 60 days

Renewal criteria:
RA, pJIA, sJIA, GCA, AOSD, SSc-ILD: Clinical documentation must be provided to confirm that current criteria are met and that the medication is providing clinical benefit.
CRS: Not applicable as no further authorization will be provided.

This drug isn’t a benefit for URMBT.