Billing chart: Blues highlight medical, benefit policy changes

Established
Q4187

Experimental

Basic benefit and medical policy

Amniotic membrane and amniotic fluid

The listed new procedures have been added to the Amniotic Membrane and Amniotic Fluid policy. Procedure code Q4187 has been added as a payable service.

The policy is effective Jan. 1, 2021.

Inclusions:

Treatment of nonhealing** diabetic lower extremity/venous stasis ulcers using the following human amniotic membrane products:

• AmnioBand^® Membrane
• Biovance^®
• Epicord^®
• Epifix^®
• Grafix™

**Nonhealing is defined as less than a 20% decrease in wound area with standard wound care for at least two weeks.

Human amniotic membrane grafts with or without suture (Prokera, AmbioDisk™) for the treatment of any of the following ophthalmic indications:

• Neurotrophic keratitis with ocular surface damage and inflammation that doesn’t respond to conservativetherapy^a
• Corneal ulcers and melts that don’t respond to initial conservative therapy^a
• Corneal perforation when there is active inflammation after corneal transplant requiring adjunctive treatment
• Bullous keratopathy as a palliative measure in patients who aren’t candidates for curative treatment (e.g., endothelial or penetrating keratoplasty)
• Partial limbal stem cell deficiency with extensive diseased tissue where selective removal alone isn’t sufficient
• Moderate or severe Stevens‑Johnson syndrome
• Persistent epithelial defects that don’t respond within two days to conservative therapy^a
• Severe dry eye (DEWS 3 or 4)^b with ocular surface damage and inflammation that remains symptomatic after conservative therapy^a
• Moderate or severe acute ocular chemical burn

Human amniotic membrane grafts with suture or glue for the treatment of any of the following ophthalmic indications:

• Corneal perforation when corneal tissue isn’t immediately available
• Pterygium repair when there is insufficient healthy tissue to create a conjunctival autograft

^aConservative treatment is defined as use of topical lubricants or topical antibiotics or therapeutic contact lens or patching.

^b

• Dry eye severity level DEWS 3 to 4
• Discomfort, severity and frequency — Severe frequent or constant
• Visual symptoms — Chronic and/or constant, limiting to disabling
• Conjunctival Injection — +/- or +/+
• Conjunctive Staining — Moderate to marked
• Corneal Staining — Marked central or severe punctate erosions
• Corneal/tear signs — Filamentary keratitis, mucus clumping, increase in tear debris
• Lid/meibomian glands — Frequent
• Tear film breakup time — < 5
• Schirmer score (mm/5 min) — < 5

Exclusions:

All other human amniotic membrane products and indications not outlined under inclusions, including but not limited to:

• Grafts with or without suture for ophthalmic indications
• Injection of micronized or particulated human amniotic membrane for all indications, including but not limited to treatment of:
• Osteoarthritis and plantar fasciitis
• Injection of human amniotic fluid for all indications
• Treatment of lower-extremity ulcers due to venous insufficiency

J9999

Basic benefit and medical policy

Blenrep (belantamab mafodotin‑blmf)

Blenrep (belantamab mafodotin‑blmf) is payable when billed for the FDA‑approved indications, effective Aug. 5, 2020. Blenrep (belantamab mafodotin‑blmf) should be reported with procedure code J9999 and the appropriate national drug code until a permanent code is established.

URMBT groups are excluded from coverage of this drug. 

Blenrep (belantamab mafodotin‑blmf) is a B‑cell maturation antigen-directed antibody and microtubule inhibitor conjugate indicated for the treatment of adult patients with relapsed or refractory multiple myeloma who have received at least four prior therapies including an anti‑CD38 monoclonal antibody, a proteasome inhibitor and an immunomodulatory agent.

Dosage and administration:

The recommended dosage is 2.5 mg/kg as an intravenous infusion over approximately 30 minutes once every three weeks.

Dosage forms and strengths:

32701, 77300, 77520, 77522, 77523, 77525

Basic benefit and medical policy

Charged‑particle (proton or helium ion) radiotherapy for neoplastic conditions

Charged‑particle irradiation with proton or helium ion beams may be considered established for specific patient populations. It’s a useful therapeutic option when indicated.

If safe and effective, charged‑particle irradiation with proton or helium ion beams may be an option for individual consideration in the treatment of cancer based on the analysis of dosimetric data, including comparative models if necessary.

Other applications of charged‑particle irradiation with proton beams are considered experimental.

Note: There is insufficient evidence to show that PBRT provides an incremental benefit in the treatment of localized prostate cancer when compared to lower cost alternative procedures.

Inclusionary criteria have been updated, effective March 1, 2021.

Payment policy:

Use of proton beam therapy may require prior authorization to verify that Blue Cross Blue Shield of Michigan and Blue Care Network criteria are met and, where appropriate, to explore the appropriateness of using alternative therapeutic modalities such as IMRT and three‑dimensional conformal radiation therapy.

Inclusions:

Charged‑particle irradiation with proton or helium ion beams is established for the following indications:

• In the treatment of intracranial arteriovenous malformation not amenable to surgical excision or other conventional forms of treatment or adjacent to critical structures such as the optic nerve, brain stem or spinal cord
• Primary or metastatic central nervous system malignancies, such as gliomas, when adjacent to critical structures such as the optic nerve, brain stem, or spinal cord and when other standard radiation techniques such as IMRT or standard stereotactic modalities wouldn’t reduce the risk of radiation damage to the critical structure
• Post‑operative therapy (with or without conventional high‑energy X-rays) in patients who have undergone biopsy or partial resection of chordoma or low‑grade (I or II), chondrosarcoma of the basisphenoid region (skull‑base chordoma or chondrosarcoma), cervical spine, or sacral/lower spine. Patients eligible for this treatment have residual localized tumor without evidence of metastasis.
• Tumor that involves the base of skull and proton therapy is needed to spare the orbit, optic nerve, optic chiasm or brainstem (sinonasal cancer).
• Primary therapy for melanoma of the uveal tract (iris, choroid or ciliary body), with no evidence of metastasis or extrascleral extension and with tumors up to 24 mm in largest diameter and 14 mm in height, and particularly when plaque brachytherapy isn’t a feasible option.
• In the treatment of all pediatric tumor types (through 21 years of age).
• Repeat irradiation of previously treated fields where the dose tolerance of surrounding normal structures would be exceeded with 3D conformal radiation or IMRT

Exclusions:

• All other applications of charged‑particle irradiation, including but not limited to clinically localized prostate cancer, non‑small cell lung cancer at any stage or for recurrence, breast cancer, pancreatic cancer and hepatocellular carcinoma are experimental. 
• Proton beam therapy for the treatment of macular degeneration or choroidal neovascularization and hemangiomas.

76999,** 0398T, C9734    

**May be used to report unclassified service

Experimental:

Basic benefit and medical policy

Magnetic resonance‑guided focused ultrasound

The safety and effectiveness of magnetic resonance-guided high‑intensity ultrasound ablation have been established. It may be a considered a useful therapeutic option in specified situations.
 
Exclusionary criteria have been updated, effective March 1, 2021.

Inclusions:

• Pain palliation in adult patients with metastatic bone cancer who fail or aren’t candidates for radiotherapy
• Treatment of medicine-refractory essential tremors (e.g., a failure, intolerance or contraindication to at least two trials of medication therapy)

Exclusions:

All other situations, including but not limited to:

• Treatment of uterine fibroids
• Treatment of other tumors (e.g., brain cancer, breast cancer, desmoid)

81235, 81275, 81404, 81405, 81406, 81445, 81479

Basic benefit and medical policy

Molecular analysis for targeted therapy or immunotherapy of non‑small cell lung cancer

New genes and indications have been approved, effective March 1, 2021

EGFR testing 

• The safety and effectiveness of analysis of somatic variants in exons 18 (such as G719X), 19 (such as L858R, T790M), 20 (such as S678I) or 21 (such as L861Q) within the EGFR gene have been established to predict treatment response to an EGFR tyrosine kinase inhibitor (TKI) therapy (e.g., erlotinib [Tarceva^®], gefitinib [Iressa^®], or afatinib [Gilotrif^®]), or osimertinib (Tagrisso) in patients with advanced lung adenocarcinoma, large cell carcinoma, advanced squamous cell NSCLC, and NSCLC not otherwise specified
• The analysis for other EGFR mutations within exons 22‑24, or other applications related to NSCLC, is considered experimental. The peer reviewed medical literature has not yet demonstrated the clinical utility of this testing for this indication.

ALK testing

• The safety and effectiveness of analysis of somatic rearrangement mutations of the ALK gene have been established. It’s an effective diagnostic option for predicting treatment response to crizotinib (Xalkori^®), ceritinib (Zykadia™, alectinib [Alecensa], or brigatinib [Alunbrig]) in patients with advanced lung adenocarcinoma and large cell carcinoma or for patients in whom an adenocarcinoma component cannot be excluded,
• Analysis of somatic rearrangement mutations of the ALK gene is considered experimental in all other situations.

BRAF V600E testing

• Analysis of the BRAF V600E variant is established to predict treatment response to BRAF or MEK inhibitor therapy (e.g., dabrafenib [Tafinlar] and trametinib [Mekinist^®]), in patients with advanced lung adenocarcinoma or in whom an adenocarcinoma component can’t be excluded.

ROS1 testing

• Analysis of somatic rearrangement variants of the ROS1 gene is established to predict treatment response to ALK inhibitor therapy (crizotinib [Xalkori]) in patients with advanced lung adenocarcinoma or in whom an adenocarcinoma component can’t be excluded.

KRAS testing

• Analysis of somatic mutations of the KRAS gene is established as a technique to predict treatment nonresponse to anti‑EGFR therapy with tyrosine kinase inhibitors and for the use of the anti‑EGFR monoclonal antibody cetuximab in NSCLC. The peer reviewed medical literature has demonstrated the clinical utility of this testing for this indication.

HER2 testing

• Analysis of genetic alterations in the HER2 gene for targeted therapy in patients with NSCLC is considered experimental. The peer‑reviewed literature hasn’t yet demonstrated the clinical utility of this testing for this indication.

NTRK gene fusion testing

• Analysis of gene fusions is established to predict treatment response to larotrectinib in patients with advanced lung adenocarcinoma or in whom an adenocarcinoma component can’t be excluded.

RET rearrangement testing

• Analysis of genetic alteration in the RET gene may be considered established to predict treatment response to pralsetinib or selpercatinib in patients with metastatic NSCLC.

MET exon 14 skipping alteration

• Analysis of genetic alteration that leads to MET exon 14 skipping may be considered established to predict treatment response to capmatinib in patients with metastatic NSCLC.
• Analysis of genetic alterations of the MET gene is considered experimental in all other situations.

PD‑L1 testing

• PD‑L1 testing may be considered established to predict treatment response to atezolizumab or to the combination of nivolumab plus ipilimumab in patients with metastatic NSCLC.

Tumor mutational burden testing  

May be established for the treatment of adult and pediatric patients with unresectable or metastatic tumor mutational burden‑high (TMB‑H) [≥10 mutations/megabase (mut/Mb)] solid tumors, as determined by an FDA‑approved test, that have progressed following prior treatment and who have no satisfactory alternative treatment options (example. Keytruda).

81415, 81416, 81417    

Experimental:

Basic benefit and medical policy

Whole exome/whole genome sequencing for diagnosis of genetic disorders

Updates made to the medical policy statement are effective March 1, 2021.

Whole exome sequencing, or WES, may be considered established for the evaluation of unexplained congenital or neurodevelopmental disorders in children when all the following criteria are met:

1. The patient has been evaluated by a specialist with specific expertise in clinical genetics and counseled about the potential risks of genetic testing.
2. There is a potential for a change in management and clinical outcome for the individual being tested.
3. A genetic etiology is the most likely explanation for the phenotype despite previous genetic testing, such as chromosomal microarray and/or targeted single gene testing or when previous genetic testing has failed to yield a diagnosis and the affected individual is faced with invasive procedures/testing as the next diagnostic step, such as muscle biopsy.

Rapid whole exome sequencing or rapid whole genome sequencing, with trio testing when possible, may be considered established for the evaluation of critically ill infants and children in neonatal or pediatric intensive care with a suspected genetic disorder of unknown etiology when at least one of the following criteria is met:

1. Multiple congenital anomalies
2. An abnormal laboratory test or clinical features suggests a genetic disease or complex metabolic phenotype
3. An abnormal response to standard therapy for a major underlying condition
4. WES is considered experimental for the diagnosis of genetic disorders in all other situations.

Whole genome sequencing, or WGS, is considered experimental for the diagnosis of genetic disorders.

WES and WGS are considered experimental for screening for genetic disorders.

Exclusions:

Rapid whole exome sequencing or rapid whole genome sequencing, with trio testing when possible, isn’t established for the evaluation of critically ill infants and children in neonatal or pediatric intensive care with a suspected genetic disorder of unknown etiology in cases where:

• An infection with normal response to therapy
• Isolated prematurity
• Isolated unconjugated hyperbilirubinemia
• Hypoxic ischemic encephalopathy
• Confirmed genetic diagnosis explains illness
• Isolated transient neonatal tachypnea
• Nonviable neonates

95782, 95783, 95800, 95805, 95806, 95807, 95808, 95810, 95811, E0486, G0398, G0399 

Not covered:

Basic benefit and medical policy

Diagnosis and medical management of sleep disorders

The inclusionary and exclusionary criteria regarding oral appliances for obstructive sleep apnea have been updated, effective March 1, 2021.

Medical policy statement:

Diagnosis

Polysomnography, or PSG, is an attended (supervised) sleep study (sleep apnea test) performed in a hospital or freestanding sleep laboratory. The safety and effectiveness of PSG, including a split-night PSG, have been established. It may be considered a useful diagnostic option when indicated.

The safety and effectiveness of an unattended sleep study/sleep apnea test with a minimum of three recording channels (using, at a minimum, the following sensors: nasal pressure with chest and abdominal respiratory inductance plethysmography and oximetry; or using Peripheral Arterial Tone, known as PAT, with oximetry and actigraphy) in a home setting (home sleep study/home sleep apnea test) have been established. It may be considered a useful diagnostic option when indicated.

The safety and effectiveness of multiple sleep latency testing, or MSLT, have been established. It may be a useful tool in diagnosing narcolepsy.

Noninvasive pulse oximetry as a sole test (as an alternative to polysomnography or as a cardiorespiratory study for diagnosing sleep related breathing disorders) is considered experimental. Its effectiveness hasn’t been established.

Medical management

The safety and effectiveness of oral appliances to reduce upper airway collapsibility in the treatment of OSA have been established. An oral appliance may be considered a useful therapeutic option when indicated.

Palate and mandible expansion devices are considered experimental for the treatment of OSA. There is insufficient evidence in the current medical literature to support their efficacy and use in clinical practice.

Nasal Expiratory Positive Airway Pressure (nasal EPAP) for the treatment of OSA is considered experimental. There is insufficient evidence in the current medical literature to support its efficacy and use in clinical practice.

Oral pressure therapy for the treatment of OSA is considered experimental. There is insufficient medical literature found to support its efficacy.

Positional therapy devices, such as the NightBalance Lunoa SPT system, are considered experimental. They haven’t been proven to be more effective than standard care.

Inclusions:

Note: Due to the length of the complete policy guidelines, only the updates are included here. Below are the changes that were made to the medical management section regarding oral appliances for obstructive sleep apnea:

Oral appliances for OSA (e.g., tongue‑retaining devices or mandibular orthopedic positioning devices) may be considered established in adult patients with clinically significant OSA. (Verify coverage of intraoral appliances under the DME benefit.)

Definition of an oral appliance for OSA

• A custom‑fabricated appliance, using digital or physical impressions and models of an individual patient’s oral structures and physical needs
• Not a prefabricated item that is modified. Prefabricated components may be included in the final appliance.
• Includes all appliances, including titration appliances
• Made of biocompatible materials
• Engages the maxillary and mandibular arches
• Includes a mechanism that advances the mandible in increments of 1 mm or less with a protrusive adjustment range of at least 5 mm. This mechanism may or may not include fixed mechanical hinges or metallic materials.
• Reversal of the advancement is possible
• The protrusive setting must be verifiable

An appropriate oral appliance will allow for optimal protrusion of the mandible (e.g., less than 5 mm) to produce the desired relative opening of the airway, without contributing to an increased risk of temporal mandibular joint dysfunction.

Inclusions (includes all the following):

• OSA, as defined by (includes one of the following):
• An AHI, RDI or REI of at least 15 events per hour
• An AHI, RDI or REI of at least five events per hour in a patient with excessive daytime sleepiness, impaired cognition, mood disorders, insomnia, hypertension, ischemic heart disease or history of stroke
• A trial of CPAP has failed, isn’t tolerated by the patient or is contraindicated
• The device is prescribed by the treating physician
• The device is custom fitted by a dentist (preferably a dentist with certification/additional training in dental sleep medicine)
• There is a dental evaluation that documents:
• Absence of both temporomandibular dysfunction and periodontal disease
• Impressions, models, fabrication, materials, insertion/fitting, training, subsequent adjustments/modifications of the appliance, repairs and ancillary appliances are included with the OSA appliance and aren’t separately billable for the first 90 days after provision of the oral appliance.

Replacement of an oral appliance may be considered at the end of the five-year reasonable useful lifetime or prior if there’s a change in the patient’s condition.

Exclusions:

• Prefabricated (not custom‑fit) devices (e.g., sport mouth guards, mouth guards that can be purchased in a retail store or pharmacy)
• Screening tests (e.g., questionnaire, pulse oximetry, rhinometry, laryngometry, etc.) performed by a dentist

Palate and mandible expansion devices are considered experimental.

Nasal expiratory positive airway pressure is considered experimental.

Oral pressure therapy is considered experimental.

Positional therapy devices, such as the NightBalance Lunoa SPT system, are considered experimental. They haven’t been proven to be more effective than standard care.

Reference the medical policy for complete coverage guidelines on other services related to the diagnosis and management of obstructive sleep apnea.

J0588

Basic benefit and medical policy

Xeomin (incobotulinumtoxinA)  

Effective Dec. 18, 2020, Xeomin (incobotulinumtoxinA) is payable for the following updated FDA‑approved indications:

• Chronic sialorrhea in patients ages 2 years and older.

 Dosage and administration:

• Chronic sialorrhea in adults: The recommended total dose is 100 units per treatment session consisting of 30 units per parotid gland and 20 units per submandibular gland, no sooner than every 16 weeks.
• Chronic sialorrhea in pediatric patients: The recommended dose is based on body weight administered in a 3:2 dose ratio into the parotid and submandibular glands, respectively, no sooner than every 16 weeks; ultrasound guidance recommended.

J9203

Basic benefit and medical policy

Mylotarg (gemtuzumab ozogamicin)

Mylotarg (gemtuzumab ozogamicin) is approved for the following updated FDA indication:

22899,** C9752, C9753

**Used to report unclassified procedure

Basic benefit and medical policy

RF ablation of basivertebral nerve for low back pain (e.g., Intracept^®)