Billing chart: Blue Cross highlights medical, benefit policy changes

76390

Experimental
0609T, 0610T, 0611T, 0612T

Basic benefit and medical policy

Magnetic resonance spectroscopy

The safety and effectiveness of magnetic resonance spectroscopy have been established for patients meeting specific patient selection criteria.

Exclusionary criteria have been updated, effective July 1, 2022.

Inclusions:

Magnetic resonance spectroscopy, or MRS, is an appropriate clinical tool for diagnosing:

• Disorders of creatine metabolism
• Presence of mitochondrial disease
• MRS may be used to assist in distinguishing tissue necrosis from persistent or recurrent brain tumor as an alternative to invasive brain biopsy

Exclusions:

• MRS for discogenic pain (cervical, thoracic or lumbar)
• MRS for any condition other than those listed in the Inclusions section

78608, 78609, 788112, 78812, 78813, 78814, 78815, 78816, A9552

Experimental
Q9982, Q9983

Basic benefit and medical policy

Positron emission tomography for miscellaneous applications

The safety and effectiveness of positron emission tomography, or PET, scanning have been established. It’s a useful diagnostic option for patients meeting patient selection criteria.

Inclusionary and exclusionary criteria have been updated, effective July 1, 2022.

Inclusions:

PET using 2-[fluorine-18]-fluoro-2-deoxy-D-glucose, or FDG, may be considered established when one of the following are met:

• The assessment of select patients with epileptic seizures who are candidates for surgery
• The diagnosis of chronic osteomyelitis
• One-time evaluation to differentiate between frontotemporal dementia and Alzheimer’s disease when substantial diagnostic uncertainty remains after all the following have been completed:
• Neuropsychological testing
• Evaluation by a physician experienced in neurodegenerative disease
• Structural imaging (CT or MRI)

Exclusions:

The use of FDG-PET is experimental for all other miscellaneous indications not listed in inclusion criteria above including, but not limited to:

CNS diseases

• Autoimmune disorders with CNS manifestations, including:
• Behçet syndrome
• Lupus erythematosus

• Cerebrovascular diseases, including:
• Arterial occlusive disease (arteriosclerosis, atherosclerosis)
• Carotid artery disease
• Cerebral aneurysm
• Cerebrovascular malformations (AVM and Moya-Moya disease)
• Hemorrhage
• Infarct
• Ischemia

• Degenerative motor neuron diseases, including:
• Amyotrophic lateral sclerosis
• Friedreich ataxia
• Olivopontocerebellar atrophy
• Parkinson's disease
• Progressive Supranuclear Palsy
• Shy-Drager syndrome
• Spinocerebellar degeneration
• Steele-Richardson-Olszewski disease
• Tourette syndrome

• Dementias, including:
• Alzheimer disease
• Multi-infarct dementia
• Pick disease
• Dementia with Lewy-Bodies
• Presenile dementia

• Demyelinating diseases, such as multiple sclerosis
• Developmental, congenital, or inherited disorders, including:
• Adrenoleukodystrophy
• Down syndrome
• Huntington chorea
• Kinky-hair disease (Menkes’ syndrome)
• Sturge-Weber syndrome (encephalofacial angiomatosis) and the phakomatoses

• Miscellaneous:
• Chronic fatigue syndrome
• Sick building syndrome
• Post-traumatic stress disorder

• Nutritional or metabolic diseases and disorders, including:
• Acanthocytosis
• Hepatic encephalopathy
• Hepatolenticular degeneration
• Metachromatic leukodystrophy
• Mitochondrial disease
• Subacute necrotizing encephalomyelopathy

• Psychiatric diseases and disorders, including:
• Affective disorders
• Depression
• Obsessive-compulsive disorder
• Psychomotor disorders
• Schizophrenia

• Pyogenic infections, including:
• Aspergillosis
• Encephalitis

• Substance abuse, including the CNS effects of alcohol, cocaine and heroin
• Trauma, including brain injury and carbon monoxide poisoning
• Viral infections, including:
• HIV/AIDS
• AIDS dementia complex
• Creutzfeldt-Jakob syndrome
• Progressive multifocal leukoencephalopathy
• Progressive rubella encephalopathy
• Subacute sclerosing panencephalitis

• Mycobacterium infection
• Migraine
• Anorexia nervosa
• Assessment of cerebral blood flow in newborns:
• Vegetative versus "locked-in" state

Pulmonary diseases

• Adult respiratory distress syndrome
• Diffuse panbronchiolitis
• Emphysema
• Obstructive lung disease
• Pneumonia

Musculoskeletal diseases

• Spondylodiscitis
• Joint replacement follow-up

Other

• Fever of unknown origin
• Giant cell arteritis
• Inflammation of unknown origin
• Inflammatory bowel disease
• Sarcoidosis
• Vascular prosthetic graft infection
• Vasculitis

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

Experimental
95801, A7047, E0485, E1399, G0400, K1028, K1029

Basic benefit and medical policy

Sleep disorders

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, known as 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.

Exclusionary criteria have been updated, effective July 1, 2022.

Inclusionary and exclusionary guidelines:

Diagnosis

Unattended (unsupervised) home sleep study, 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)

Inclusions:

• Adult patients ages 18 or older with high pretest probability for moderate to severe OSA:
• Observed apneas during sleep, or
• A combination of at least two of the following:
• Excessive daytime sleepiness evidenced by an Epworth sleepiness >10, inappropriate daytime napping (e.g., during driving, conversation or eating), or sleepiness that interferes with daily activities and isn’t explained by other conditions
• Habitual snoring or gasping/choking episodes associated with awakenings
• Treatment-resistant hypertension (persistent hypertension in a patient taking three or more antihypertensive medications)
• Obesity, defined as a body mass index > 35 kg/m2 or neck circumference defined as >17 inches in men or >16 inches in women
• Craniofacial or upper airway soft tissue abnormalities
• Unexplained nocturia
• No exclusions/contraindications to a home sleep study

Exclusions/contraindications:

• Younger than 18 years of age
• Morbid obesity, defined as a body mass index >40 kg/m2 or the patient is 100 pounds over the ideal body weight for their height
• Obesity hypoventilation syndrome
• Narcolepsy
• Periodic limb disorder during sleep
• Central sleep disorder
• Parasomnias
• Nocturnal seizures
• REM behavior disorder
• Moderate or severe congestive heart failure – New York Heart Association class III or IV
• Congestive heart failure with a history of ventricular fibrillation or sustained ventricular tachycardia in a patient who doesn’t have an implanted defibrillator
• Moderate or severe chronic pulmonary disease – forced expiratory volume in 1 second/forced vital capacity (FEV1/FVC) less than or equal to 0.7 and FEV1 less than 80% of predicted
• Documented neuromuscular disease (e.g., Parkinson’s, myotonic dystrophy, ALS)
• History of stroke, severe insomnia or chronic opioid use
• Impairment that results in inability to apply the home sleep testing equipment
• Oxygen dependence
• History of seizures with use of anticonvulsants
• Cardiac conditions
• Restless leg syndrome

Repeat unattended (unsupervised) home sleep study, 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)

Inclusions (one of the following):

• To assess efficacy of surgery or oral appliances or devices
• To re-evaluate the diagnosis of OSA and need for continued continuous positive airway pressure, or CPAP, e.g., if there is a significant change in weight or change in symptoms suggesting that CPAP should be retitrated or possibly discontinued.

Attended (supervised) sleep study performed in a sleep lab
Note: Check our prior authorization program for in-lab sleep testing. All procedures/codes may not be covered by all contracts or certificates.

Adults (ages 18 or older):

Inclusions:

• Adult patients age 18 or older with a moderate to high pretest probability for OSA
• Observed apneas during sleep, or
• A combination of at least two of the following:
• Excessive daytime sleepiness evidenced by an Epworth sleepiness >10, inappropriate daytime napping (e.g., during driving, conversation or eating), or sleepiness that interferes with daily activities and is not explained by other conditions
• Habitual snoring or gasping/choking episodes associated with awakenings
• Treatment-resistant hypertension (persistent hypertension in a patient taking three or more antihypertensive medications)
• Obesity, defined as a body mass index (BMI) >35 kg/m2 or neck circumference > 17 inches in men or >16 inches in women
• Craniofacial or upper airway soft tissue abnormalities
• Unexplained nocturia
• When unattended (unsupervised) home sleep study is contraindicated (see exclusions/contraindications to unattended home sleep study above)
• When the initial unattended (unsupervised) study was negative, inadequate, equivocal or non-diagnostic and clinical suspicion for OSA remains

Children (younger than age 18)

Inclusions:

• Pediatric patients younger than age 18 with a moderate to high probability of OSA and one of the following:
• Habitual snoring in association with one or more of criteria below:
• Restless or disturbed sleep
• Behavioral disturbance or learning disorders including deterioration in academic performance, attention deficit disorder, hyperactivity
• Frequent awakenings
• Enuresis (bedwetting)
• Growth retardation or failure to thrive; OR
• Excessive daytime somnolence or altered mental status not explained by other conditions
• Polycythemia not explained by other conditions
• Cor pulmonale not explained by other conditions
• Witnessed apnea with duration greater than two respiratory cycles
• Labored breathing during sleep
• Hypertrophy of the tonsils or adenoids in patients at significant surgical risk such that the exclusion of OSA would allow avoidance of surgery
• Suspected congenital central alveolar hypoventilation syndrome or sleep-related hypoventilation due to neuromuscular disease or chest wall deformities
• Clinical evidence of a sleep-related breathing disorder in infants who have experienced an apparent life-threatening event
• For exclusion of OSA in a patient who’s undergone adenotonsillectomy for suspected OSA more than eight weeks previously

Repeated (attended) sleep study performed in a sleep lab:

Inclusions:

• Equipment failure or less than six hours of recording
• Initial PSG is negative and a clinical suspicion of OSA remains
• To initiate and titrate CPAP in adult patients who have one of the following:
• An AHI or RDI of at least 15 events per hour
• An AHI or RDI of at least five events per hour in a patient with excessive daytime sleepiness or unexplained hypertension.
  
  Note: A split-night study, in which moderate to severe OSA is documented during the first portion of the study using PSG, followed by CPAP during the second portion of the study, can eliminate the need for a second study to titrate CPAP.

• To initiate and titrate CPAP in children:
• In pediatric patients, an AHI greater than 1.5 is considered abnormal, and an AHI of 10 or more may be considered severe.
• To re-evaluate the diagnosis of OSA and need for continued CPAP (e.g., if there is a significant change in weight or change in symptoms suggesting that CPAP should be retitrated or possibly discontinued).
  Note: This statement doesn’t imply that supervised studies are needed routinely following unattended studies. This statement means a re-evaluation based on a substantial change in symptoms or in the clinical situation.

• To assess efficacy of surgery (including adenotonsillectomy) or oral appliances/devices
• For patients younger than age 18 and initial study was inadequate, equivocal or non-diagnostic and the child’s parents or caregiver report that the breathing patterns observed at home were different from those during testing.

Mutliple sleep latency testing, or MSLT

MSLT is considered experimental to diagnose obstructive sleep apnea except to exclude or confirm narcolepsy in the diagnostic workup of OSA syndrome.

Nonivasive pulse oximetry

The effectiveness of 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

Pap therapies, i.e., continuous positive airway pressure, known as CPAP; automatic positive airway pressure, or APAP; bilevel positive airway pressure, or BiPAP; and variable positive airway pressure, or VPAP, may be considered medically necessary for the management of OSA, central sleep apnea or mixed apnea. These devices for treatment are addressed in policy titled “Positive Pressure Airway Devices.”

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 (all of the following):

• OSA, as defined by 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 the 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 RUL, 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, and laryngometry, etc.) performed by a dentist

The use of an abbreviated daytime sleep session for acclimation to CPAP (PAP-NAP) is considered experimental.

The use of daytime electrical stimulation of the tongue is considered experimental for the treatment of OSA.

Palate and mandible expansion devices are considered experimental.

Nasal expiratory positive airway pressure and oral pressure therapy devices are 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.

Policy guidelines:

Polysomnography or home sleep apnea testing is ordered by a physician or qualified health care provider who has evaluated the patient and is managing the medical care of the patient, i.e., either a primary care physician or a specialist. Following the review of the sleep study results, recommendations for the most appropriate medical treatment may be made by the treating physician or qualified health care provider, or may be a collaborative effort between the treating physician or qualified health care provider and the board-certified sleep medicine physician who interprets the results of the testing.

Facility/provider requirements:

If an attended sleep study is performed in a non-hospital-based sleep laboratory, the laboratory must be accredited by the American Academy of Sleep Medicine.

An attended sleep study in a hospital-based sleep testing center must be accredited by AASM or an accreditation organization accepted under the Participating Hospital Agreement.

To perform and receive reimbursement for in-center and out-of-center sleep testing, a physician must be board-certified in sleep medicine by the American Board of Medical Specialties or the American Board of Sleep Medicine. Any M.D. or D.O. may order a sleep test; however, it must be performed and interpreted by a physician who is board-certified in sleep medicine.

The technician performing the sleep testing must have one of the following certifications:

• American Board of Sleep Medicine, Registered Sleep Technologist
• Board of Registered Polysomnographic Technologists, Registered Polysomnographic Technologist
• National Board for Respiratory Care (any of the following):
• Certified pulmonary function technologist
• Registered pulmonary function technologist
• Certified respiratory therapist
• Registered respiratory therapist

Treatment of patients diagnosed with OSA should be initiated and monitored by a physician who is board-certified in sleep medicine. It’s important to monitor symptoms and adherence to positive airway pressure, or PAP, treatment (e.g., review of symptoms and device utilization at 90 days with a minimum of four hours per night for at least five nights per week).

Risk factors for OSA:

Although not an exclusive list, patients with all four of the following symptoms are considered to be at high risk for obstructive sleep apnea:

• Habitual snoring
• Observed apneas
• Excessive daytime sleepiness
• A body mass index greater than 35 kg/m2

If no bed partner is available to report snoring or observed apneas, other signs and symptoms suggestive of OSA (e.g., age of the patient, male gender, thick neck, craniofacial or upper airway soft tissue abnormalities or unexplained hypertension) may be considered. Objective clinical prediction rules are being developed; however, at present, risk assessment is based primarily on clinical judgment.

The STOP-BANG questionnaire is a method developed for non-sleep specialists to assess the signs and symptoms of OSA (Snore, Tired, Observed apnea, blood Pressure, BMI, Age, Neck, Gender) and has been shown to have 97% sensitivity and 96% negative predictive value (specificity, 33%) for the identification of patients with severe OSA (Apnea/Hypopnea Index score >30 events per hour). Overnight oximetry has been used by some sleep specialists as a component of the risk assessment but isn’t adequate for the diagnosis of OSA. Therefore, a follow-up polysomnography, or PSG, or home sleep study/home sleep apnea test would still be required to confirm or exclude a diagnosis of OSA.

OSA in children:

The presentation of OSA in children may differ from that of adults. Children frequently exhibit behavioral problems or hyperactivity rather than daytime sleepiness. Obesity is defined as a body mass index greater than the 90th percentile for the weight/height ratio. Although the definition of severe OSA in children isn’t well established, an AHI or RDI greater than 1.5 events per hour is considered abnormal (an AHI or RDI of >10 events per hour may be considered severe). In addition, the first-line treatment in children is usually adenotonsillectomy. Continuous positive airway pressure is an option for children who aren’t candidates for surgery or who have an inadequate response to surgery.

Bariatric surgery patients:

Screening for OSA should be performed routinely in patients scheduled for bariatric surgery, due to the high prevalence of OSA in this population. The optimal screening approach isn’t certain. An in-laboratory PSG or home sleep study/home sleep apnea test is the most accurate screening method. Some experts recommend a symptom-based screening instrument, followed by PSG in patients who exceed a certain threshold, as an alternative to performing PSG in all patients. It should be noted that there is a high prevalence of obesity hypoventilation syndrome in patients who are candidates for bariatric surgery. Therefore, obesity hypoventilation syndrome should be ruled out prior to home sleep testing in this population.

Significant weight change:

There’s no established threshold for significant change in weight. Studies have reported improvements in OSA with an average weight loss of 20 kg or 20% of body weight.

Multiple sleep latency test:

The multiple sleep latency test, or MSLT, is an objective measure of the tendency to fall asleep in the absence of alerting factors, while the maintenance of wakefulness test, or MWT, is an objective measure of the ability to stay awake under soporific conditions (used to assess occupational safety). The MSLT and MWT aren’t routinely indicated in the evaluation and diagnosis of OSA or in assessment of change following treatment with CPAP. The MSLT may be indicated as part of the evaluation of patients with suspected narcolepsy to confirm the diagnosis (often characterized by cataplexy, sleep paralysis, and hypnagogic/hypnopompic hallucinations) or to differentiate between suspected idiopathic hypersomnia and narcolepsy. Narcolepsy and OSA can co-occur. Because it’s not possible to differentiate the excessive sleepiness caused by OSA and narcolepsy, OSA should be treated before confirming a diagnosis of narcolepsy with the MSLT.

Split-night studies:

American Academy of Sleep Medicine practice parameters indicate that a split-night study (initial diagnostic PSG followed by CPAP titration during PSG on the same night) is an alternative to one full night of diagnostic PSG followed by a second night of titration if the following four criteria are met:

1. An AHI of at least 40 is documented during a minimum of two hours of diagnostic PSG. Split-night studies may sometimes be considered at an AHI of 20 to 40 events per hour, based on clinical judgment (e.g., if there are also repetitive long obstructions and major desaturations). However, at AHI values below 40, determination of CPAP-level requirements, based on split-night studies, may be less accurate than in full-night calibrations.
2. CPAP titration is carried out for more than three hours (because respiratory events can worsen as the night progresses).
3. PSG documents that CPAP eliminates or nearly eliminates the respiratory events during rapid eye movement and non-REM sleep, including REM sleep with the patient in the supine position.
4. A second full night of PSG for CPAP titration is performed if the diagnosis of a sleep-related breathing disorder, or SRBD, is confirmed, but criteria b and c aren’t met.

99281, 99282, 99283, 99284, 99285

Basic benefit and medical policy

Emergency medical services

The provision of emergency medical services as defined by the Emergency Medical Treatment and Labor Act and American College of Emergency Physicians are considered established. This policy is effective July 1, 2022.

Inclusions:

Visits for a medical condition with acute symptoms of sufficient severity (including severe pain) that could cause a prudent layperson with average knowledge of health and medicine to reasonably expect that the absence of immediate medical attention would result in one of the following:

1. Health of the patient (or with respect to a pregnant woman, the health of the woman or her unborn child) to be in serious jeopardy
2. Serious impairment to bodily function
3. Serious dysfunction of any bodily organ or part
4. Visits for a psychiatric (behavioral health) condition of sufficient severity where the patient is at immediate risk of self-harm or immediate risk of harm to another person. 

Exclusions:

• Routine follow-up of previous emergency room visit.
• Visits where signs and symptoms haven’t worsened to a level that emergent care is required.
• Visit for evaluation of signs, symptoms where appropriate care could have been provided in a setting of lower acuity than an emergency room (e.g., primary care provider’s office or urgent care center).

C9399, J3490, J3590, J9999

Basic benefit and medical policy

Opdualag (nivolumab and relatlimab-rmbw)

Opdualag (nivolumab and relatlimab-rmbw) is payable for the FDA-approved indications, effective March 18, 2022.

Opdualag is a combination of nivolumab, a programmed death receptor-1 (PD-1) blocking antibody, and relatlimab, a lymphocyte activation gene-3 (LAG-3) blocking antibody, indicated for the treatment of adult and pediatric patients ages 12 or older with unresectable or metastatic melanoma.

Dosage and administration:

• Adult patients and pediatric patients 12 years of age or older who weigh at least 40 kg: 480 mg nivolumab and 160 mg relatlimab intravenously every four weeks.
• Administer Opdualag as an intravenous infusion over 30 minutes.

Dosage forms and strengths:

• Injection: 240 mg of nivolumab and 80 mg of relatlimab per 20 mL (12 mg and 4 mg per mL) in a single-dose vial.

Opdualag (nivolumab and relatlimab-rmbw) isn’t a benefit for URMBT.

J1599

Basic benefit and medical policy

Cutaquig (immune globulin subcutaneous [human]-hipp)

Effective Nov. 1, 2021, Cutaquig (immune globulin subcutaneous [human]-hipp) is covered for the following FDA-approved indications:

Cutaquig (immune globulin subcutaneous [human]-hipp) is a 16.5% immune globulin solution for subcutaneous infusion indicated for treatment of primary humoral immunodeficiency in adults and pediatric patients ages 2 and older.

Dosage information:
 
For subcutaneous use only.

Before switching to Cutaquig, obtain the patient’s serum IgG trough level to guide subsequent dose adjustments.

Dose:

• Switching from immune globulin intravenous, or IGIV, to Cutaquig: Calculate the dosing by using a dose conversion factor (1.30).
• Switching from other immune globulin subcutaneous, or IGSC: Dosing should be the same as for previous IGSC.
• Weekly: Start Cutaquig one week after last IGIV infusion

Initial weekly dose = Previous IGIV dose (in grams) x 1.30
                                 Number of weeks between IGIV doses

• Every other week: Start Cutaquig one or two weeks after the last IGIV dosing or one week after the last IGSC administration. Infuse twice the calculated weekly dose.
• More frequent than weekly (two to seven times a week): Start Cutaquig one week after last IGIV or IGSC administration. Divide the calculated weekly dose by the desired number of infusions per week.
• Adjust dosing according to patient’s pharmacokinetics and clinical response

Administration:

Administer at regular interval from daily up to every other week. Infusion rate and infusion volume per site may gradually be increased every two to four weeks as tolerated by patients.

Infusion parameters:*

Volume (mL/site):  

• For ages 7-17 – Initial two infusions are ≤ 15. Subsequent infusions gradually increase by approximately 5-10 mL/site every two to four weeks up to a maximum of 29
• For ages 2-6 years – Initial two infusions are ≤ 10. Subsequent infusions gradually increase by approximately 5-10 mL/site every two to four eeks up to a maximum of 15.5

Rate (mL/hr/site):

• For children ages 2-17 – Initial two infusions are ≤ 15. Subsequent infusions gradually increase by approximately 10 mL/hr/site every two to four weeks up to a maximum of 25

*As tolerated

Infusion sites: Up to six infusion sites simultaneously, with at least two inches between sites. Rotate sites for each administration.

J3490

Basic benefit and medical policy

Dapzura RT (daptomycin)

Effective Jan. 25, 2022, Dapzura RT (daptomycin) is covered for the following FDA-approved indications:

Dapzura RT is a lipopeptide antibacterial indicated for the treatment of:

• Complicated skin and skin structure infections (cSSSI) in adult and pediatric patients (ages 1 to 17)
• Staphylococcus aureus bloodstream infections (bacteremia), in adult patients including those with right-sided infective endocarditis
• Staphylococcus aureus bloodstream infections (bacteremia) in pediatric patients (ages 1 to 17 years)

Limitations of use:

• Dapzura RT isn’t indicated for the treatment of pneumonia.
• Dapzura RT isn’t indicated for the treatment of left-sided infective endocarditis due to S. aureus.
• Dapzura RT isn’t recommended in pediatric patients younger than age 1 due to the risk of potential effects on muscular, neuromuscular, and/or nervous systems (either peripheral and/or central) observed in neonatal dogs.

To reduce the development of drug-resistant bacteria and maintain the effectiveness of Dapzura RT and other antibacterial drugs, Dapzura RT should be used to treat or prevent infections that are proven or strongly suspected to be caused by bacteria.

Dosage information:

Adult patients

• Administer to adult patients intravenously in 0.9% sodium chloride, either by injection over a 2-minute period or by infusion over a 30-minute period.
• Recommended dosage regimen for adult patients:

• Creatinine clearance, or CLCR: ≥30 mL/min
• Dosage regimen for cSSSI: For seven to 14 days, 4 mg/kg once every 24 hours
• Dosage regimen for S. aureus bacteremia: For two to six weeks, 6 mg/kg once every 24 hours
• Creatinine clearance, or CLCR: <30 mL/min, including hemodialysis and CAPD
• Dosage regimen: 4 mg/kg once every 48 hours**
• Dosage regimen for S. aureus bacteremia: For two to six weeks, 6 mg/kg once every 48 hours**

**Administered following hemodialysis on hemodialysis days.

Pediatric patients

• Unlike in adults, don’t administer by injection over a two minute period to pediatric patients.
• Administer to pediatric patients intravenously in 0.9% sodium chloride, by infusion over a 30- or 60-minute period, based on age.
• Recommended dosage regimen for pediatric patients (ages 1 to 17) with cSSSI, based on age:

• Age group 12 to 17 years: Dosage is 5 mg/kg once every 24 hours infused over 30 minutes.** Duration of therapy is up to 14 days.
• Age group 7 to 11 years: Dosage is 7 mg/kg once every 24 hours infused over 30 minutes.** Duration of therapy is up to 14 days.
• Age group 2 to 6 years: Dosage is 9 mg/kg once every 24 hours infused over 60 minutes.** Duration of therapy is up to 14 days.
• Age group 1 to less than 2 years: Dosage is 10 mg/kg once every 24 hours infused over 60 minutes.** Duration of therapy is up to 14 days.
  
  **Recommended dosage is for pediatric patients (ages 1 to 17) with normal renal function. Dosage adjustment for pediatric patients with renal impairment hasn’t been established.

• Recommended dosage regimen for pediatric patients (ages 1 to 17) with S. aureus bacteremia, based on age:

• Age group 12 to 17 years: Dosage is 7 mg/kg once every 24 hours infused over 30 minutes.** Duration of therapy is up to 42 days
• Age group 7 to 11 years: Dosage is 9 mg/kg once every 24 hours infused over 30 minutes.** Duration of therapy is up to 42 days
• Age group 1 to 6 years: Dosage is 12 mg/kg once every 24 hours infused over 60 minutes.** Duration of therapy is up to 42 days
  
  **Recommended dosage is for pediatric patients (1 to 17 years of age) with normal renal function. Dosage adjustment for pediatric patients with renal impairment hasn’t been established.

• There are other formulations of daptomycin that have differences concerning storage and reconstitution.
• Don’t use in conjunction with ReadyMED^® elastomeric infusion pumps in adult and pediatric patients.

Dosage forms and strengths:

For injection: 500 mg lyophilized powder for reconstitution in a single-dose vial

Dapzura RT (daptomycin) isn’t a benefit for URMBT.

J3490, J3590

Basic benefit and medical policy

Leqvio (inclisiran)

Effective Dec. 22, 2021, Leqvio (inclisiran) is covered for the following FDA-approved indications:

Leqvio is a small interfering RNA, or siRNA, directed to PCSK9, known as proprotein convertase subtilisin kexin type 9, mRNA indicated as an adjunct to diet and maximally tolerated statin therapy for the treatment of adults with heterozygous familial hypercholesterolemia, or HeFH, or clinical atherosclerotic cardiovascular disease, or ASCVD, who require additional lowering of low-density lipoprotein cholesterol, or LDL-C.
 
Limitations of use:

The effect of Leqvio on cardiovascular morbidity and mortality hasn’t been determined.
 
Dosage and administration:

• The recommended dosage of Leqvio, in combination with maximally tolerated statin therapy, is 284 mg administered as a single subcutaneous injection initially, again at three months and then every six months. 
• Leqvio should be administered by a health care professional. 
• Inject Leqvio subcutaneously into the abdomen, upper arm or thigh.

Dosage forms and strengths:

Injection: 284 mg/1.5 mL (189 mg/mL) in a single-dose prefilled syringe

This drug is not a benefit for URMBT.

J3490, J3590

Basic benefit and medical policy

Tezspire (tezepelumab-ekko)

Effective Dec. 17, 2021, Tezspire (tezepelumab-ekko) is covered for the following FDA-approved indications:

Tezspire is a thymic stromal lymphopoietin, or TSLP, blocker, human monoclonal antibody (IgG2λ), indicated for the add-on maintenance treatment of adult and pediatric patients ages 12 years and older with severe asthma.

Limitations of use:

Not for relief of acute bronchospasm or status asthmaticus.

Dosage information:

• Administer by subcutaneous injection.
• Recommended dosage is 210 mg administered once every four weeks.

Dosage forms and strengths:

• 210 mg/1.91 mL (110 mg/mL) solution in a single-dose glass vial
• 210 mg/1.91 mL (110 mg/mL) solution in a single-dose pre-filled syringe

Tezspire (tezepelumab-ekko) isn’t a benefit for URMBT.

J9144

Basic benefit and medical policy

Darzalex Faspro (daratumumab and hyaluronidase-fihj)

Effective Nov. 30, 2021, Darzalex Faspro (daratumumab and hyaluronidase-fihj) is covered for the following FDA-approved indications:

Darzalex Faspro is a combination of daratumumab, a CD38-directed cytolytic antibody, and hyaluronidase, an endoglycosidase, indicated for the treatment of adult patients with:

• Multiple myeloma in combination with carfilzomib and dexamethasone in patients with relapsed or refractory multiple myeloma who have received one to three prior lines of therapy

Dosage information:

For subcutaneous use only.

• Pre-medicate with a corticosteroid, acetaminophen and a histamine-1 receptor antagonist
• The recommended dosage of Darzalex Faspro is (1,800 mg daratumumab and 30,000 units hyaluronidase) administered subcutaneously into the abdomen over approximately three to five minutes according to recommended schedule.
• Administer post-medications as recommended.

J9271

Basic benefit and medical policy

Keytruda (pembrolizumab)

Effective Dec. 3, 2021, Keytruda (pembrolizumab) is covered for the following updated FDA-approved indications:

Keytruda (pembrolizumab) is a programmed death receptor-1 (PD-1)-blocking antibody indicated for:

Urothelial carcinoma

• For the treatment of patients with locally advanced or metastatic urothelial carcinoma who meet one of the following:
• Aren’t eligible for any platinum-containing chemotherapy
• Who have disease progression during or following platinum-containing chemotherapy or within 12 months of neoadjuvant or adjuvant treatment with platinum-containing chemotherapy
• Or the treatment of patients with Bacillus Calmette-Guerin, or BCG, unresponsive, high-risk, non-muscle invasive bladder cancer, or NMIBC, with carcinoma in situ, or CIS, with or without papillary tumors who are ineligible for or have elected not to undergo cystectomy

Cervical cancer

• In combination with chemotherapy, with or without bevacizumab, for the treatment of patients with persistent, recurrent, or metastatic cervical cancer whose tumors express PD-L1 (CPS ≥1) as determined by an FDA-approved test
• As a single agent for the treatment of patients with recurrent or metastatic cervical cancer with disease progression on or after chemotherapy whose tumors express PD-L1 (CPS ≥1) as determined by an FDA-approved test. (Clarified indication underlined.)

Renal cell carcinoma, or RCC

• In combination with axitinib, for the first-line treatment of patients with advanced RCC
• In combination with lenvatinib, for the first-line treatment of adult patients with advanced RCC
• For the adjuvant treatment of patients with RCC at intermediate-high or high risk of recurrence following nephrectomy, or following nephrectomy and resection of metastatic lesions

Melanoma

• For the treatment of patients with unresectable or metastatic melanoma
• For the adjuvant treatment of adult and pediatric (12 years and older) patients with Stage IIB, IIC, or III melanoma following complete resection

Dosage and administration:

• Urothelial carcinoma: 200 mg every three weeks or 400 mg every six weeks
• Cervical cancer: 200 mg every three weeks or 400 mg every six weeks
• Renal cell carcinoma: 200 mg every three weeks or 400 mg every six weeks as a single agent in the adjuvant setting, or in the advanced setting with one of the following:
• Axitinib 5 mg orally twice daily
• Lenvatinib 20 mg orally once daily
• Melanoma: 200 mg every three weeks or 400 mg every six weeks.

J9312, Q5115, Q5119, Q5123

Basic benefit and medical policy

Rituxan (rituximab), Truxima (rituximab-abbs), Ruxience (rituximab-pvvr) and Riabni (rituximab-arrx)

Effective Dec. 2, 2021, Rituxan (rituximab), Truxima (rituximab-abbs), Ruxience (rituximab-pvvr) and Riabni (rituximab-arrx) are payable for the following updated FDA-approved indications:

• Pediatric patients ages 6 months and older with mature B-cell NHL and mature B-cell acute leukemia (B-AL):
• Previously untreated, advanced stage, CD20-positive, diffuse large B-cell lymphoma, Burkitt lymphoma, Burkitt-like lymphoma or mature B-cell acute leukemia in combination with chemotherapy.

Ford Motor Company hourly employees

Retroactive to Jan. 1, 2022, allergy serum is covered under the medical plan for Ford Motor Company hourly employees, group numbers 87950 and 87951.

Group numbers: 87950 and 87951
Alpha prefix: FGP and FBP
Platform: NASCO