90678

Basic benefit and medical policy

Respiratory syncytial virus vaccine (Abrysvo™)

32701, 77300, 77520, 77522, 77523, 77525

Basic benefit and medical policy

Proton beam therapy

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

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

Inclusionary and exclusionary criteria have been updated, effective March 1, 2024.

Payment policy:
 
Proton beam therapy requires prior authorization for most groups. Please reference member benefits before service.

Inclusions:
  
Charged-particle irradiation with proton or helium ion beams is established for the curative treatment of any of the following conditions when metastatic disease is not present:

• For treatment of small, localized tumors associated with genetic syndromes in which minimizing the total volume of radiated tissue is minimized, for example, in individuals with cancer syndromes such as Neurofibromatosis type 1 (NF-1), Li-Fraumeni, Ataxia Telangiectasia (with deleterious ATM mutations), Hereditary Retinoblastoma, Lynch syndrome, or hereditary breast or ovarian cancer (with BRCA1/2 mutations)
• 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
• Re-irradiation with curative intent where cumulative critical structure dose will exceed tolerance dose
• Primary malignant or benign bone tumors
• Primary ocular tumors including intraocular/uveal melanomas
• Base of skull primary tumors (e.g., Chordomas, Chondrosarcomas)
• Primary CNS tumors excluding IDH wild-type glioblastoma multiforme
• Primary spine or spinal cord tumors where organs at risk tolerance will be exceeded with photon treatments
• Nonmetastatic primary tumors requiring craniospinal irradiation (e,g, medulloblastoma)
• Nasopharynx, nasal cavity, paranasal sinuses or other accessory sinuses cancer
• Unresected T3, T4, or node positive head and neck cancers
• Esophageal cancer
• Thymoma or thymic carcinoma
• Mediastinal lymphomas
• Thoracic sarcomas
• Primary malignant pleural mesothelioma
• Hepatocellular cancer or intrahepatic cholangiocarcinoma
• Retroperitoneal sarcomas
• Individuals with a single kidney or transplanted pelvic kidney with treatment of an adjacent target volume
• Benign or malignant tumors or hematologic malignancies in children aged 21 years and younger treated with curative intent
• In the curative treatment of nonmetastatic primary non-small cell lung cancer

Note: Use of proton beam therapy may require prior authorization to verify that Blue Cross Blue Shield of Michigan or Blue Care Network criteria are met and, where appropriate, to explore the appropriateness of using alternative therapeutic modalities such as IMRT, 3-dimensional conformal radiation therapy.

Exclusions:

• Head and neck cancers not included in Group 1 (e.g., T1/T2 tumors, node negative tumors, postoperative tumors with negative margins, periorbital tumors)
• Cutaneous tumors with cranial nerve invasion to the base of skull, cavernous sinus or brainstem
• Head and neck cancers requiring ipsilateral radiation treatment (e.g., oral cavity, salivary gland)
• Mucosal melanoma
• Glioblastoma, IDH wild-type
• Breast cancer, including, but not limited to, when a photon-based plan can’t meet tolerances for organs at risk
• Pancreatic cancer
• Gastric cancer
• Extrahepatic cholangiocarcinoma
• Kidney cancer
• Adrenal cancers
• Liver metastases being treated with curative intent (i.e., oligometastases) in which a photon-based plan can’t meet tolerances for organs at risk
• Prostate cancer, including, but not limited to, when a photon-based plan can’t meet tolerances for organs at risk
• Colon cancer
• Rectal cancer
• Anal cancer
• Bladder cancer
• Cervical cancer
• Endometrial cancer
• Ovarian cancer
• Hodgkin lymphoma
• Non-Hodgkin lymphoma
• Skin cancer
• Palliative treatment
• Metastatic tumors
• Leptomeningeal disease
• Multiple myeloma
• Pelvic or proximal thigh where use of protons results in significant dose reduction to genitalia

33285, 33286, 93228, 93229, 93241,
93242, 93243, 93244, 93245, 93246,
93247, 93248, 93268, 93270, 93271,
93272  

Experimental:
93799,** 0650T

**Not otherwise classified procedure

Basic benefit and medical policy

Ambulatory cardiac monitors

The safety and efficacy of ambulatory cardiac monitors have been established. They may be considered a useful diagnostic option when specified criteria are met.

Inclusionary criteria have been updated, effective March 1, 2024.

Inclusions:
 
Patient-activated or auto-activated external ambulatory event monitors, or AEMs, or continuous ambulatory monitors that record and store information for periods longer than 48 hours up to 21 days (e.g., Zio Patch^®) used as a diagnostic alternative to Holter monitoring when one of the following are met:

• Symptoms are suggestive of cardiac arrhythmias (i.e., palpitations, dizziness, presyncope or syncope).
• Atrial fibrillation has been treated with catheter ablation and the discontinuation of systemic anticoagulation is being considered.
• Diagnosis of cryptogenic stroke.

Implantable ambulatory event monitors (patient-activated or auto-activated) when one of the following have been met:

• Recurrent symptoms are so infrequent that a prior trial using an external ambulatory event monitor (e.g., Holter or other monitor) has been unsuccessful.
• Long-term monitoring for atrial fibrillation is required.

Mobile Cardiac Outpatient Telemetry, or MCOT, when both of the following are met:

• One of the following conditions are present:
• Symptoms suggestive of cardiac arrhythmias that occur less than once every 48 hours.
• Unconfirmed suspicion of paroxysmal atrial fib following cryptogenic stroke when the monitoring is intended to guide medical management with anticoagulants.
• A non-diagnostic external ambulatory cardiac event monitoring trial of not less than 14 continuous days has been completed

Exclusions:
           
Other uses of ambulatory event monitors, including, but not limited to:

• Monitoring asymptomatic individuals with risk factors for arrhythmia
• Detection of myocardial ischemia by detecting ST segment changes (intracardiac ischemia monitoring systems)
• Monitoring effectiveness of antiarrhythmic medications in the absence of other inclusionary criteria

48550, 48551, 48552, 48554, S2065

Basic benefit and medical policy

Pancreas transplant

The safety and effectiveness of pancreas transplant have been established. It may be considered a useful therapeutic option for patients meeting selection criteria.

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

Inclusions:

Indications for a pancreas transplant include but are not limited to:

• A combined pancreas-kidney transplant, or SPK, for insulin-dependent diabetic individuals with uremia.
• Pancreas transplant after a prior kidney transplant, or PAK, for individuals with insulin-dependent diabetes.
• Pancreas transplant alone, or PTA, may be for individuals with severely disabling and potentially life-threatening complications due to hypoglycemia unawareness and labile insulin dependent diabetes that persists in spite of optimal medical management.
• Pancreas retransplant after a failed primary pancreas transplant in individuals who meet criteria for pancreas transplantation.

The consideration for risk-reducing procedure (e.g., CABG) performed at the same time as the organ transplant is a consideration based on the medical consultation review.

Exclusions:

• Poor cardiac function: Ejection fraction should be greater than 45% with no overt symptoms of congestive heart failure.
• Poor pulmonary function: Pulmonary function tests must be greater than or equal to 50% of predicted value.
• Poor renal function: Renal creatinine clearance should be greater than 40 ml/min or creatinine must be less than or equal to 2mg/dl (unless an SPK is being done).
• Poor liver function: There should be no history of severe chronic liver disease.
• Patients with ongoing alcohol or drug abuse. (Evidence for abstinence may vary among   programs, but generally, a minimum of three months is required or enrollment in a sanctioned program.)

Potential contraindications for transplant and retransplant:

Note: Final patient eligibility for transplant is subject to the judgment and discretion of the requesting transplant center.

• Potential contraindications represent situations where proceeding with transplant isn’t advisable in the context of limited organ availability. Contraindications may evolve over time as transplant experience grows in the medical community. Clinical documentation supplied to the health plan should demonstrate that attending staff at the transplant center have considered all contraindications as part of their overall evaluation of potential organ transplant recipients and have decided to proceed.
• Known current malignancy or history of recent malignancy
• Untreated systemic infection making immunosuppression unsafe, including chronic infection
• Other irreversible end-stage disease not attributed to kidney disease
• Systemic disease that could be exacerbated by immunosuppression
• Psychosocial conditions or chemical dependency affecting ability to adhere to therapy as defined by the transplant program

Pancreas specific guidelines:
 
Candidates for pancreas transplant alone should additionally meet one of the following severity of illness criteria:

• Documentation of severe hypoglycemia unawareness as evidenced by chart notes or emergency department visits.
• Documentation of potentially life-threatening labile diabetes as evidenced by chart notes, emergency department visits or hospitalization for diabetic ketoacidosis.

In addition, the vast majority of pancreas transplant patients will have Type 1 diabetes mellitus. Those transplant candidates with Type 2 diabetes mellitus, in addition to being insulin-dependent, should also not be obese (body mass index should be 32 kg/m2 or less).  According to International Pancreas Transplant Registry data, in 2018, 14.8% of pancreas transplant recipients had Type 2 diabetes.  

Multiple transplants:

Although there are no standard guidelines regarding multiple pancreas transplants, the following information may aid in case review:

• If there is early graft loss resulting from technical factors (e.g., venous thrombosis), a retransplant may generally be performed without substantial additional risk.
• Long-term graft losses may result from chronic rejection, which is associated with increased risk of infection following long-term immunosuppression, and sensitization, which increases the difficulty of finding a negative cross-match. Some transplant centers may wait to allow reconstitution of the immune system before initiating retransplant with an augmented immunosuppression protocol.

All transplants must be prior authorized through the Human Organ Transplant Program.

70544, 70545, 70546, 70547, 70548, 70549, 71555, 72198, 73725, 74185, 72159, 73225

Basic benefit and medical policy

Magnetic resonance angiography and venography

The safety and effectiveness of magnetic resonance angiography, or MRA, and magnetic resonance venography, or MRV, specified conditions of the head, chest, abdomen, pelvis, spinal canal, upper and lower extremities, and allergy have been established. They may be considered useful diagnostic options in patients with documented allergy to iodinated contrast material and in patients who have accelerating hypertension or accelerating renal insufficiency.

Inclusionary and exclusionary criteria have been updated, effective March 1, 2024.

Payment policy:

Services may be subject to preauthorization through the PPO Radiology Management Program, if applicable.

Inclusionary and exclusionary guidelines:

MRA and MRV inclusions:

MRA or MRV for head, neck, chest, abdomen, pelvis or extremities:

• In the diagnosis and management of congenital or developmental vascular anomalies, not otherwise specified in one of the condition-based indications within these inclusionary guidelines.
• For the diagnosis and management of traumatic vascular injuries or vasculitis.
• Vascular anatomic delineation before surgical and interventional procedures, not otherwise specified in one of the condition-based indications within these inclusionary guidelines. Except for stenting or angioplasty of the dural venous sinus, which is excluded.
• MRA is used for vascular evaluation before transcatheter aortic valve implantation or replacement. MRA of the neck requires duplex arterial ultrasound first.
• Evaluation for suspected vascular complications following a procedure.

Head and neck:

MRA or MRV for the diagnosis and management of:

• Stenosis or occlusion of vertebral or basilar arteries
1. Diagnosis of suspected stenosis or occlusion:
• Evaluation of syncope following exclusion of valvular heart disease and rhythm disturbance as the etiology
• Subclavian steal syndrome
2. Management of known stenosis or occlusion with worsening neurologic symptoms or signs attributable to the posterior circulation
• Extracranial (carotid or vertebral) aneurysms
• Arteriovenous malformation, or AVM, or fistula, or AVF
• Dissection-intracranial or extracranial
• Fibromuscular dysplasia
• For the diagnosis and management of intracranial hemorrhage in all pediatric patients and in adults with either intracerebral hemorrhage with clinical or imaging features atypical for hypertensive hemorrhage or subarachnoid hemorrhage suggested by lumbar puncture or by imaging
• For the diagnosis and management of extracranial venous thrombosis or compression following nondiagnostic venous ultrasound 
• Intracranial venous thrombosis or compression (includes dural venous sinus thrombosis, venous sinus thrombosis and cerebral vein thrombosis) for any of the following:
1. Exclusion of venous sinus thrombosis in the initial evaluation of idiopathic intracranial hypertension, or IIH, also known as pseudotumor cerebri
2. Patients with risk factors for venous thrombosis, elevated D-dimer, or following suspicious or nondiagnostic CT or MRI, associated with any of the following signs or symptoms:
• Unexplained headache
• Seizure
• Focal neurologic abnormality
• Altered mental status
3. History of intracranial venous sinus thrombosis, with current signs or symptoms of recurrent thrombosis
4. Follow-up of known venous sinus thrombosis
5. To exclude venous compression by an adjacent intracranial mass

MRA or MRV for the evaluation of a suspected vascular lesion in any of the following:

• Horner’s syndrome
• Pulsatile tinnitus
• Trigeminal neuralgia

MRA or MRV for the following:

• Intracranial stenosis or occlusion
1. Diagnosis of suspected intracranial stenosis
• People with predisposing congenital or genetic disease
• To exclude a tandem stenosis or occlusion before carotid revascularization
• Before cranial stenting
2. Management of know intracranial stenosis with new or progressive symptoms
3. Surveillance in patients with established Moyamoya disease who are being considered for revascularization

MRA or MRV for screening for intracranial aneurysm may be used for screening in any of the following high-risk groups:

• Two or more first-degree relatives with intracranial aneurysm or subarachnoid hemorrhage
• Heritable condition that is associated with intracranial aneurysm (examples include autosomal dominant polycystic kidney disease and Ehlers-Danlos syndrome type IV)
• Known fibromuscular dysplasia

MRA or MRV may be used for the diagnosis of clinically suspected intracranial aneurysm when:

• CT or MRI findings suspicious for aneurysm
• Neurologic signs or symptoms (including headache) suggestive of intracranial aneurysm with any of the following:
1. At least one first-degree relative with intracranial aneurysm or subarachnoid hemorrhage
2. Presence of a heritable condition associated with intracranial aneurysm (such as autosomal dominant polycystic kidney disease, Ehlers-Danlos syndrome type IV)
3. Known fibromuscular dysplasia
• Cranial nerve deficits
• Focal nerve deficits unexplained by CT or MRI
• Headache with any of the following features:
1. Sudden onset of the worst headache of life (“thunderclap”)
2. Brought on by and occurring in association with exertion or Valsalva
3. Persistent headache that remains undifferentiated or unexplained by MRI in any of the following scenarios:
1. Positional or orthostatic headache
2. New onset of headache over age 50
3. Change in headache pattern
4. Abnormal neurological exam
5. Unexplained and unexpected increase in frequency or severity of headaches
6. Comorbid conditions that increase the likelihood of an intracranial lesion, including malignancy, immunosuppression, sarcoidosis, neurocutaneous disorders (phakomatoses) or pregnancy
7. Initial evaluation of trigeminal autonomic cephalgia, or TAC, including cluster, paroxysmal hemicrania or hemicrania continua, and short-lasting unilateral neuralgiform headache

Management of known intracranial aneurysm:

• Evaluation for aneurysm progression or recurrence based on new or worsening neurologic symptoms
• Preoperative evaluation
• Initial postoperative evaluation

Surveillance: Initial evaluation at six to 12 months following diagnosis, then annually

Evaluation of extracranial carotid artery stenosis or occlusion in patients who are candidates for carotid revascularization (carotid endarterectomy or carotid artery stenting) when either duplex arterial ultrasound can’t be performed, is nondiagnostic or when duplex arterial ultrasound shows moderate to severe stenosis or occlusion with any of the following:

• Screening
1. Starting five years post-neck irradiation and every three years thereafter
2. Evaluation before cardiac surgery when needed to determine surgical strategy
• Diagnosis of suspected carotid stenosis
1. Hollenhorst plaques (cholesterol emboli) or retinal neovascularity on retinal examination
• Management of known carotid stenosis
1. Worsening neurologic symptoms or signs attributable to the anterior circulation
2. Initial baseline evaluation, and one additional evaluation during the first year following carotid revascularization
• Surveillance of established carotid disease
1. Stenosis or occlusion in asymptomatic people with no prior revascularization
1. Moderate (50% to 69%) stenosis: Every 12 months
2. Severe (70% or greater) stenosis: Every six months
2. Post-revascularization after the first year: Every 12 months

Intracranial or extracranial evaluation of acute stroke or transient ischemic attack, or TIA

• Intracranial evaluation for any of the following:
1. Acute (seven days or less) stroke/TIA in any of the following scenarios:
1. Acute stroke in an interventional candidate
2. Evidence of acute ischemia or infarct on brain imaging
3. Evaluation following acute TIA
2. Subacute (within 30 days) stroke/TIA in either of the following scenarios:
1. Signs or symptoms attributable to the anterior circulation, when the presence of intracranial stenosis will lead to use of dual antiplatelet therapy
2. Signs or symptoms other than syncope attributable to the posterior circulation
• Extracranial evaluation for any of the following:
1. Acute (seven days or less) stroke/TIA in any of the following scenarios:
1. Acute stroke in an interventional candidate
2. Evidence of acute ischemia or infarct on brain imaging
3. Evaluation following acute TIA
2. Subacute (within 30 days) stroke/TIA in either of the following scenarios:
1. Signs or symptoms attributable to the anterior (carotid) circulation, in patients who are candidates for carotid revascularization
2. Signs or symptoms other than syncope attributable to the posterior circulation
3. Chronic (30 days or more) stroke/TIA when no carotid evaluation since the stroke/TIA event in either of the following scenarios:
1. Signs or symptoms attributable to the anterior (carotid) circulation, in patients who are candidates for carotid revascularization when duplex arterial ultrasound cannot be performed is or nondiagnostic
2. Signs or symptoms other than syncope attributable to the posterior circulation

MRA and contrast angiography, or CA, aren’t expected to be performed on the same patient for the diagnostic purpose prior to the application of anticipated therapy.

Spinal canal:

MRA or MRV is useful in the following circumstances:

1. Preoperative or postoperative imaging
2. Follow up of prior imaging findings suggestive of a vascular lesion

Peripheral arteries of lower extremities:

• MRA or MRV for the diagnosis and management of venous thrombosis or occlusion when venous ultrasound can’t be performed or is nondiagnostic.
• Diagnosis, management and annual surveillance of peripheral arterial disease:
  • Diagnosis of suspected PAD:
  • Any sign or symptom with inconclusive physiologic testing, including exercise testing
  • Management of known PAD in any of the following scenarios:
  • Prior diagnosis of PAD with any of the following new or worsening signs or symptoms:
  1. Resting ischemic pain, non-healing wounds and gangrene
  2. Ischemic or discolored toes and livedo reticularis
  3. ISudden onset of pain associated with pulselessness, pallor, loss of motor or sensory function
  • Persistent claudication following a trial of three months of conservative therapy, including a supervised exercise therapy program in patients being evaluated for initial revascularization
  • Post revascularization with any new or worsening lower extremity non-joint pain not addressed above, following nondiagnostic physiologic testing (physiologic testing not required if venous graft was used)
  • Post revascularization when surveillance physiological testing is inconclusive (ABI > 1.40), borderline (ABI 0.91–0.99), or abnormal (ABI ≤ 0.90)
  • Baseline evaluation after surgical revascularization using a venous graft or after endovascular revascularization (angioplasty, stent or atherectomy)
  • Surveillance:
  1. After surgical revascularization using a venous graft: At three-month intervals within the first two years, and annually thereafter
  2. After endovascular revascularization (angioplasty, stent, or atherectomy): At four-month intervals within the first year, and annually thereafter
• When imaging results are essential in establishing a diagnosis or direct management of any of the following conditions:
• Arterial entrapment syndrome
• Aneurysm/dilation
• Arteriovenous malformation or arteriovenous fistula
• Dissection or intramural hematoma

Peripheral arteries of upper extremities:

For the diagnosis, management and surveillance of PAD

• Diagnosis of suspected PAD: Any sign or symptom with inconclusive physiologic testing (including exercise testing)
• Management of know PAD in any of the following scenarios:
• Resting ischemic pain or signs of atheroembolic disease of the upper extremities (such as ischemic or discolored fingers, livedo reticularis etc.)
• Atypical symptoms with inconclusive physiological testing
• Persistent claudication despite a trial of conservative therapy in initial revascularization candidates
• Baseline study following percutaneous or surgical revascularization
• Post-revascularization, with any new or worsening upper extremity signs or symptoms
• Post revascularization when surveillance physiological testing is inconclusive
• Surveillance: At six months, then annually following surgical revascularization
• Vascular access procedures when ultrasound can’t be performed or is nondiagnostic in any of the following scenarios:
• Evaluation of native arteries before AVF for dialysis access
• Planned harvest of the radial artery (e.g., for CABG)
• Complications of a vascular access procedure suggested by any of the following:
• Pulsatile mass, bruit or thrill at the access site
• Significant (more than expected post procedure) hematoma at the access site
• Severe (more than expected post procedure) pain at the access site
• Signs of ischemia or embolism in the involved extremity (such as ischemic or discolored fingers, livedo reticularis)
• For the diagnosis and management of venous thrombosis or occlusion when ultrasound can’t be performed or is nondiagnostic
• When the results of imaging are essential to establish a diagnosis or direct management of any of the following conditions:
• Aneurysm
• Arterial entrapment syndrome
• AVM or AVF
• Dissection or intramural hematoma

Abdomen or pelvis:

Imaging in acute aortic syndrome (includes aortic dissection, rupture, intramural hematoma, penetrating ulcer, and pseudoaneurysm) for any of the following scenarios:

1. Initial diagnosis of suspected aortic disease
2. Management of known aortic disease
3. Annual surveillance of clinically stable aortic disease

Aneurysm of the abdominal aorta or iliac arteries for management, surveillance with surgical repair, or when duplex arterial ultrasound can’t be performed or is non-diagnostic in any of the following scenarios:

1. Screening (one-time evaluation)
1. Males between 60 and 75 years who have ever smoked or have a first-degree relative with an abdominal aortic aneurysm, or AAA
2. Females between 60 and 75 years who have ever smoked and have a first-degree relative with AAA
3. Previously diagnosed aneurysm of the thoracic aorta, iliac, femoral or popliteal arteries

2. Diagnosis (in patients with suspected aortic or iliac aneurysm presenting with any of the following)
1. Pulsatile abdominal mass or bruit
2. Other imaging that is suggestive but not diagnostic
3. Decreased or absent femoral pulses or bruit
4. Lower extremity claudication
5. Suggestive physiologic testing
6. Signs or symptoms of atheroembolic disease in the lower extremities (e.g., ischemic or discolored toes, livedo reticularis)

3. Management
1. New or worsening symptoms or signs of aortic disease or enlargement by imaging
2. Pre-procedure planning
3. Baseline and initial 12-month evaluation following endograft repair
4. Every six months for endografts that are increasing in size or endoleaks

4. Surveillance
1. Stable aortic aneurysm without prior repair
1. 4.5 cm or greater: Every six months
2. 3.5 to 4.4 cm: Six months and 12 months following diagnosis, then annually
3. 3 to 3.4 cm: At one year following diagnosis, then every three years
2. Stable iliac aneurysm without prior repair
1. 3 cm or greater: Every six months
2. Less than 3 cm: Annually

• Stable aneurysms treated with open surgical repair: Every five years
• Diagnosis and management of arteriovenous malformation or fistula.
• Diagnosis and management of hematoma or hemorrhage within the abdomen
• Diagnosis and management of mesenteric ischemia or portal hypertension
• In patients suspected of having renal artery stenosis, or RAS, renovascular hypertension
• Stenosis or occlusion of the abdominal aorta or branch vessels, not otherwise specified (in any of the following scenarios):
1. Diagnosis of suspected aortoiliac stenosis or occlusion based on any of the following signs or symptoms:
1. Abdominal or femoral bruit
2. Decreased or absent femoral pulse
3. Atypical lower extremity claudication (including buttocks or thighs)
4. Leriche’s syndrome (buttock and thigh claudication, absent or decreased femoral pulses, erectile dysfunction)
5. Evidence of atheroembolic disease of the lower extremities such as ischemic or discolored toes or livedo reticularis
6. Physiological testing suggesting aorto-iliac disease
7. Established femoral or popliteal artery aneurysm
2. Management of known stenosis, presurgical evaluation or aortoiliac stenosis or occlusion when endovascular or surgical intervention is being considered
3. Surveillance (annual) of surgical bypass grafts
• Diagnosis and management of venous thrombosis or occlusion of major abdominal vessels in either of the following scenarios:
1. Evaluation of the hepatic or portal veins when duplex venous ultrasound can’t be performed or is nondiagnostic
2. Evaluation of all other abdominal venous structures
• Diagnosis, management and surveillance of visceral artery aneurysm involving any of the following arteries: renal, celiac, splenic, hepatic, or superior or inferior mesenteric arteries and their branches
• MRA or MRV is used for vascular evaluation before  transcatheter aortic valve implantation or replacement

Chest:

MRA/MRV of the chest is appropriate for any of the following conditions:

• For acute aortic syndrome (aortic dissection, rupture, intramural hematoma, penetrating ulcer and pseudoaneurysm) in any of the following scenarios: 
1. Initial diagnosis of suspected aortic disease
2. Management of known aortic disease
3. Annual surveillance of clinically stable aortic disease
• For screening, diagnosis, management and surveillance for aortic aneurysm in any of the following scenarios:
• Screening: Annual evaluation of patients with connective tissue disease or genetic mutations that predispose to aortic aneurysms as an alternative to screening with echocardiography or when echocardiography is nondiagnostic
• Diagnosis of suspected thoracic aneurysm based on signs, symptoms or other imaging studies suggesting the diagnosis.
• Management:
1. Evaluation for disease progression based on new or progressive signs, symptoms or enlargement by imaging.
2. Six-month follow up of newly diagnosed aneurysms to establish stability
3. Endoleak evaluation
4. Pre-procedure (surgical or endovascular repair) planning
• Surveillance:
1. Annual surveillance for aneurysms ≤ 4.4 cm
2. Every six months for aneurysms larger than 4.4 cm
• Atheromatous disease in adults only, to evaluate the thoracic aorta as a distal emboli source when a cardiac source hasn’t been identified on echocardiography and CTA is non-diagnostic or can’t be performed
• MRA or MRV for the diagnosis and management of any of the following conditions:
• Hematoma
• Pulmonary ateriovenous malformation
• Pulmonary sequestration
• Subclavian steal syndrome
• Superior vena cava syndrome
• Systemic venous thrombosis or occlusion
• Thoracic outlet syndrome
• MRA or MRV is used for vascular evaluation before transcatheter aortic valve implantation or replacement

Allergy and contraindications:

The use of MRA is appropriate in patients with documented allergy to iodinated contrast material and in patients who have accelerating hypertension, or accelerating renal insufficiency or when the patient is at significant risk for contrast-induced renal failure.

MRA and MRV exclusions:
 
For any other indications not meeting inclusionary criteria.

78608, 78609, 78811-78816, 78999,** G0235,** A9593-A9595, A9800

Experimental
G0219, G0252

Basic benefit and medical policy

Positron emission tomography for oncologic conditions

The safety and effectiveness of PET scanning for selected oncologic applications have been established. It’s a useful diagnostic option for individuals meeting patient selection criteria.

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

Payment policy:

Services may be subject to prior authorization through the PPO Radiology Management Program, if applicable.

Inclusionary and exclusionary guidelines:

General statements:

All inclusionary and exclusionary statements apply to both PET scans and PET/ CT scans, i.e., PET scans with or without PET/CT fusion.

A PET or PET/CT may be appropriate for a patient with known diagnosis of a malignancy to determine the optimal anatomic site for a biopsy or other invasive diagnostic procedure if standard imaging is equivocal. It also may replace conventional imaging when conventional imaging would be inadequate for accurate staging, and when clinical management will depend upon the stage of disease. In general, for most solid tumors, a tissue diagnosis is made before the PET scan. PET scans following a tissue diagnosis are performed for staging, not diagnosis. If the results of the PET scan won’t influence treatment decisions, these situations would be considered not medically necessary.

PET scans may be considered appropriate for the following oncologic conditions:

Anal cancer

Inclusions:

• For the diagnosis when standard imaging can’t be performed or is nondiagnostic for metastatic disease.
• Indicated in either of the following:
• Radiation planning for definitive treatment only
• Standard imaging cannot be performed or is nondiagnostic for recurrent or progressive disease
• For locally progressive or recurrent cancer with evidence of progression found on digital rectal exam.

Exclusions:

Conditions not listed above.

Bladder cancer

Inclusions:

• Diagnostic workup:
• Evaluation of stage II or stage III bladder cancer before definitive treatment when standard imaging can’t be performed or is nondiagnostic for metastatic disease.
• When bone metastasis is suspected based on signs and symptoms and standard imaging can’t be performed or is nondiagnostic.
• Management:
• Standard imaging can’t be performed or is nondiagnostic for recurrent or progressive disease.

Exclusions:

Conditions not listed above.

Bone cancer/sarcoma

Inclusions:

• Diagnostic workup indicated in any of the following scenarios (all tumor types):
• Initial work up of Ewing sarcoma and osteosarcoma if curative treatment planned
• Standard imaging can’t be performed or is nondiagnostic for metastatic disease
• Standard imaging suggests a resectable solitary metastasis
• Baseline study before neoadjuvant chemotherapy
• Management:
• Indicated following completion of neoadjuvant chemotherapy
• Standard imaging can’t be performed or is nondiagnostic for recurrent or progressive disease

Exclusions:

Conditions not listed above.

Brain cancer

Inclusions:

• Diagnostic workup:
• Evaluation of possible systemic disease in proven CNS lymphoma.
• For staging, where lesions metastatic from the brain are identified.
• For restaging, to distinguish recurrent tumor from radiation necrosis.

Exclusions:

Conditions not listed above.

Breast cancer

Inclusions:

• Staging and restaging of breast cancer
• Detecting locoregional or distant recurrence or metastasis (except axillary lymph nodes) when suspicion of disease is high and other imaging is inconclusive.

Exclusions:

• For the differential diagnosis in individuals with suspicious breast lesions or an indeterminate/low suspicion finding on mammography.
• Staging axillary lymph nodes.
• For predicting pathologic response to neoadjuvant therapy for locally advanced disease.

Cancer of unknown primary

Inclusions:

• Individuals with an unknown primary who meet all the following criteria:
• In individuals with a single site of disease suspicious for cervical nodal metastases of unknown origin.
• In individuals with a single site of metastatic disease if therapy with a curative intent is planned.
• Individual has received a negative workup for an occult primary tumor.
• The PET scan will be used to rule out or detect additional sites of disease that would eliminate the rationale for local or regional treatment.

Exclusions:

• For individuals with an unknown primary, including, but not limited to, the following:
• As part of the initial workup of an unknown primary
• As part of the workup of individuals with multiple sites of disease

Cervical cancer

Inclusions:

• For the initial staging of individuals with locally advanced cervical cancer.
• For the evaluation of known or suspected recurrence.

Exclusions:

For the initial diagnosis of cervical cancer in all other situations.

Colorectal cancer

Inclusions:

• Diagnostic workup:
• Indicated when standing imaging (CT chest, abdomen and pelvis) can’t be performed or isn’t diagnostic for surgically curable metastatic disease.
• Management indicated in any of the following scenarios:
• CT is equivocal for metastatic disease and lesion or lesions are greater than 1 cm in diameter.
• CT demonstrates recurrence that is potentially curable with surgery.
• CT doesn’t demonstrate a focus of recurrence but carcinoembryonic antigen, or CEA, level is rising.
• Signs or symptoms are suggestive of recurrence and CT is contraindicated.

Exclusions:

• When used as a technique to assess the presence of scarring versus local bowel recurrence in individuals with previously resected colorectal cancer.
• When used as a technique contributing to radiotherapy treatment planning.

Endometrial cancer

Inclusions:

• Detection of lymph node metastases
• Assessment of endometrial cancer recurrence

Exclusions:

Conditions not listed above.

Esophageal cancer

Inclusions:

• Staging and restaging of esophageal cancer. 
• Determining response to preoperative induction therapy.

Exclusions:

Detection of primary esophageal cancer.

Gastric (stomach) cancer

Inclusions:

• Diagnosis, staging and restaging of gastric carcinoma if other imaging is inconclusive.
• Determining response to preoperative induction therapy.

Exclusions:

Conditions not listed above.

Head and neck cancer

Inclusions:

• For the evaluation of the head and neck in the initial diagnosis of suspected head and neck cancer.
• For the initial staging of the disease.
• For restaging of residual or recurrent disease during follow up.
• Treatment response evaluation.

Exclusions:

Conditions not listed above.

Hepatobiliary cancer

Inclusions:

• When standard imaging studies are equivocal or nondiagnostic regarding extent of disease.
• When standard imaging before planned curative surgery has been performed and hasn’t demonstrated metastatic disease.

Exclusions:

Conditions not listed above.

Lung cancer

Inclusions:

• Individuals with a solitary pulmonary nodule as a single-scan technique (not dual-time) to distinguish between benign and malignant disease when prior CT scan and chest X-ray findings are inconclusive or discordant,
• To determine resectability for individuals with a presumed solitary metastatic lesion from lung cancer.
• As a staging or restaging technique in those with known non-small-cell lung cancer.
• PET scanning may be considered established in staging of small-cell lung cancer if limited stage is suspected based on standard imaging.

Exclusions:

• PET scanning in staging of small-cell lung cancer if extensive stage is established and in all other aspects of managing small-cell lung cancer.
• Conditions not listed above.

Lymphoma, including Hodgkin’s disease

Inclusions:

PET scanning as a technique for staging lymphoma either during initial staging or for restaging at follow-up.

Exclusions:

Conditions not listed above.

Melanoma

Inclusions:

Assessing extranodal spread of malignant melanoma at initial staging or at restaging during follow-up treatment for advanced disease.

Exclusions:

• In managing stage 0, I or II melanoma.
• When used as a technique to detect regional lymph node metastases in individuals with clinically localized melanoma who are candidates to undergo sentinel node biopsy.

Multiple myeloma

Inclusions:

For the initial and subsequent treatment strategy of multiple myeloma.

Exclusions:

Not applicable

Merkel cell carcinoma

Inclusions:

As clinically indicated.

Neuroendocrine tumors

Inclusions:

For the diagnosis, staging, restaging and monitoring of neuroendocrine tumors.

Exclusions:

Conditions not listed above.

Ovarian cancer

Inclusions:

• Initial staging of ovarian cancer
• For the evaluation of individuals with signs or symptoms of suspected ovarian cancer recurrence (restaging) when standard imaging, including CT scan, is inconclusive.

Exclusions:

For the initial evaluation (not staging) of known or suspected ovarian cancer in all other situations

Pancreatic cancer

Inclusions:

For the initial diagnosis and staging of pancreatic cancer when other imaging and biopsy are inconclusive.

Exclusions:

Evaluating other aspects of pancreatic cancer

Penile cancer

Inclusions:

• Diagnostic workup indicated in either of the following scenarios:
• Standard imaging can’t be performed or is nondiagnostic for metastatic disease.
• Staging of penile cancer when pelvic lymph nodes are enlarged on CT or MRI and needle biopsy isn’t technically feasible.
• Management indicated in any of the following scenarios:
• Radiation planning for preoperative or definitive treatment only.
• Standard imaging can’t be performed or is nondiagnostic for recurrent or progressive disease.
• Restaging of local recurrence when pelvic exenteration surgery is planned.

Exclusions:

All other indications

Pleural, thymus, heart and mediastinum cancer

Inclusions:

• For surgical resection being considered and metastatic disease hasn’t been detected by CT or MRI.
• For surgical evaluation of malignant pleural mesothelioma (clinical stage I-IIIA and epithelioid histology), after CT chest and abdomen.
• For restaging after induction chemotherapy if the patient is a surgical candidate.
• For radiation planning for definitive treatment.

Exclusions:

All other indications

Prostate cancer

Inclusions:

• PET scanning with carbon 11 choline and fluorine18 fluciclovine for evaluating suspected or biochemically recurrent prostate cancer.
• PSMA PET scanning with Gallium Ga-68 prostate-specific membrane antigen (PSMA)-11 and Piflufolastat fluorine-18 in individuals diagnosed with NCCN unfavorable intermediate-, high- or very-high risk prostate cancer for the following indications: 
1. As an alternative to standard imaging of bone and soft tissue for initial staging,
2. For the detection of biochemically (elevated PSA) recurrent disease,
3. As workup for progression with bone scan plus CT or MRI for the evaluation of bone, pelvis and abdomen.
• Individuals with metastatic prostate cancer for whom lutetium Lu-177 vipivotide tetraxetan PSMA-directed therapy is indicated.

Exclusions:

PET scanning for all other indications.

Renal cell carcinoma

Inclusions:

Not applicable

Exclusions:

PET scanning is considered experimental in all aspects of managing renal cancer.

Soft tissue sarcoma

Inclusions:

• Diagnostic workup indicated in any of the following scenarios (excluding desmoid tumors):
• Standard imaging can’t be performed or is nondiagnostic for metastatic disease
• Standard imaging suggests a resectable solitary metastasis
• Baseline study before neoadjuvant chemotherapy
• Initial staging for rhabdomyosarcoma
• Determination of response to therapy, gastrointestinal stromal tumor, or GIST, for initial staging and re-staging when there is documented recurrence
• Management:
• Indicated following completion of neoadjuvant chemotherapy.
• Standard imaging can’t be performed or is nondiagnostic for recurrent or progressive disease.

Exclusions:

• When used in evaluation of soft tissue sarcoma, including, but not limited to, the following applications:
• Distinguishing between low grade and high grade soft tissue sarcoma
• Detecting locoregional recurrence
• Detecting distant metastasis

Testicular cancer

Inclusions:

• Diagnostic workup:
• Indicated when standard imaging can’t be performed or is nondiagnostic for metastatic disease.
• Management:
• Standard imaging cannot be performed or is nondiagnostic for recurrent or progressive disease.
• Residual mass greater than 3 cm and normal tumor markers after completion of chemotherapy.

Exclusions:

All other indications.

Thyroid cancer

Inclusions:

• For the initial treatment strategy of thyroid cancer types known not to concentrate radioactive iodine, or RAI.
• For subsequent treatment strategy for differentiated thyroid cancer of follicular cell origin that is known to concentrate RAI in all the following situations:
• When done following prior treatment with thyroidectomy and radioiodine ablation.
• With a current serum thyroglobulin > 10 ng/ml (except in the setting of documented anti-thyroglobulin antibodies).
• With a negative whole body RAI scan in the past.

Exclusions:

For the evaluation of known or suspected differentiated or poorly differentiated thyroid cancer in all other situations.

Vaginal/vulvar cancers

Inclusions:

• Diagnostic workup indicated in the following scenario:
• Standard imaging can’t be performed or is nondiagnostic for metastatic disease.
• Management indicated in any of the following scenarios:
• Radiation planning for preoperative or definitive treatment only.
• Standard imaging can’t be performed or is nondiagnostic for recurrent or progressive disease.
• Restaging of local recurrence when pelvic exenteration surgery is planned.

Exclusions:

All other indications

Cancer surveillance

Inclusions:

Not applicable

Exclusions:

When used as a surveillance tool for individuals with cancer or with a history of cancer. A scan is considered surveillance if performed more than six months after completion of cancer therapy (12 months for lymphoma) in individuals without objective signs or symptoms suggestive of cancer recurrence.

81162, 81163, 81164, 81165, 81166,
81167, 81212, 81215, 81216, 81217, 81301, 81307, 81308, 81408,** 81432,
81479,*** 0037U, 0172U, 0239U

**Ataxia-telangiectasia mutated, or ATM
***Policy criteria must be met. This code is subject to individual review.

Experimental:
0129U

Basic benefit and medical policy

Germline/somatic biomarker testing for treatment of prostate cancer

Germline BRCA1/2 variant analysis for individuals with metastatic castrate-resistant prostate cancer, or mCRPC, to select treatment with FDA-approved targeted therapies may be considered medically necessary.

All other uses of germline BRCA1/2 variant analysis to guide prostate cancer targeted therapy haven’t been demonstrated and considered experimental.

Somatic testing using tissue biopsy or circulating tumor DNA testing (liquid biopsy) for homologous recombination repair, or HRR, gene alterations (BRCA1, BRCA2, ATM, BARD1, BRIP1, CDK12, CHEK1, CHEK2, FANCL, PALB2, RAD51B, RAD51C, RAD51D, and RAD54L) to select treatment for mCRPC with FDA-approved targeted therapies may be considered medically necessary.

All other uses of somatic testing using tissue biopsy or circulating tumor DNA (liquid biopsy) for HRR gene alterations to guide prostate cancer targeted therapy are considered experimental.

Somatic testing using circulating tumor DNA testing (liquid biopsy) for BRCA1, BRCA2, and ATM alterations to select treatment for mCRPC with FDA-approved targeted therapies may be considered medically necessary.

All other uses of somatic testing using circulating tumor DNA testing (liquid biopsy) to guide prostate cancer targeted therapy are considered experimental.

Simultaneous testing using liquid and tumor biopsies (outside of paired or concurrent somatic-germline testing) to guide treatment in individuals with prostate cancer is considered experimental.

This policy is effective March 1, 2024. 

Inclusions:

The clinical utility of germline and somatic biomarker testing (including liquid biopsy) for targeted treatment in prostate cancer (BRCA1/2, homologous recombination repair gene alterations) has been established when any of the following criteria are met:

• Somatic testing using tissue biopsy or circulating tumor DNA testing (liquid biopsy) for homologous recombination repair (HRR) gene alterations (BRCA1, BRCA2, ATM, BARD1, BRIP1, CDK12, CHEK1, CHEK2, FANCL, PALB2, RAD51B, RAD51C, RAD51D, and RAD54L) to select treatment for metastatic castrate-resistant prostate cancer, or mCRPC, with FDA-approved targeted therapies.
• Somatic testing using circulating tumor DNA testing (liquid biopsy) for BRCA1, BRCA2, and ATM alterations to select treatment for mCRPC with FDA-approved targeted therapies.

Exclusions:

• All other uses of germline BRCA1/2 variant analysis to guide prostate cancer targeted therapy are considered experimental.
• All other uses of somatic testing using tissue biopsy for HRR gene alterations to guide prostate cancer targeted therapy are considered experimental.
• All other uses of somatic testing using circulating tumor DNA testing (liquid biopsy) to guide prostate cancer targeted therapy are considered experimental.
• Simultaneous testing using liquid and tumor biopsies (outside of paired or concurrent somatic-germline testing) to guide treatment in individuals with prostate cancer is considered experimental.

81210, 81301, 81455, 81462, 81463, 81464, 88341, 88342, 88360, 88361, 81479,** 0037U, 0239U, 0242U, 0326U, 0334U

Basic benefit and medical policy

GT- Somatic biomarker testing for immune checkpoint inhibitor therapy

The safety and effectiveness of somatic biomarker testing for immune checkpoint inhibitor therapy has been established. It may be considered a useful option when indicated, effective March 1, 2024.

Inclusions and exclusions:

BRAF V600 variant testing:

BRAF V600 variant testing of tumor tissue or circulating tumor DNA (liquid biopsy) to select individuals for immune checkpoint inhibitor therapy may be considered established in the following circumstances:

• Individuals with unresectable or metastatic melanoma, or
• Metastatic colorectal cancer

And

• The individual doesn’t have any FDA-labeled contraindications to the requested agent and the agent is intended to be used consistently with the FDA-approved label.

Analysis of tumor tissue for the somatic BRAF V600 variant to select individuals for immune checkpoint inhibitor therapy is considered experimental in all other situations.

Mismatch repair/microsatellite instability testing:

Mismatch repair/microsatellite instability, or MMR/MSI, testing of tumor tissue or circulating tumor DNA (liquid biopsy)** to select individuals for immune checkpoint inhibitor therapy may be considered established in the following circumstances:

• Individuals with advanced or metastatic colorectal cancer, or
• Individuals with advanced endometrial carcinoma who have disease progression following prior systemic therapy and aren’t candidates for curative surgery or radiation, or
• Individuals with unresectable or metastatic solid tumors who have progressed following prior treatment and who have no satisfactory alternative treatment options.

And

• The individual doesn’t have any FDA-labeled contraindications to the requested agent and the agent is intended to be used consistently with the FDA-approved label.

Mismatch repair/microsatellite instability testing to select individuals for immune checkpoint inhibitor therapy is considered experimental in all other situations.

Programmed cell death ligand-1 testing:

Programmed cell death ligand protein-1, or PD-L1,  testing of tumor tissue or circulating tumor DNA (liquid biopsy) to select individuals for immune checkpoint inhibitor therapy may be considered established in the following circumstances:

• Individuals with metastatic non-small cell lung cancer, known as NSCLC, or
• Individuals with metastatic or unresectable, recurrent head and neck squamous cell carcinomas, or
• Individuals with locally advanced or metastatic esophageal or gastroesophageal junction carcinoma that isn’t amenable to surgical resection or definitive chemoradiation after one or more prior lines of systemic therapy for patients with tumors of squamous cell histology, or
• Individuals with persistent, recurrent or metastatic cervical cancer, or
• Individuals with locally recurrent unresectable or metastatic hormone receptor-negative/HER2-negative (triple negative) breast cancer.

And

• The individual doesn’t have any FDA-labeled contraindications to the requested agent and the agent is intended to be used consistently with the FDA-approved label.

PD-L1 testing of tumor tissue to select individuals for immune checkpoint inhibitor therapy is considered experimental in all other situations.

Circulating tumor DNA (liquid biopsy):

Variant analysis using circulating tumor DNA (liquid biopsy) is considered established for individuals with unresectable or metastatic melanoma or metastatic colorectal cancer to select treatment with FDA-approved targeted therapies when tissue-based analysis isn’t clinically feasible.

Tumor mutational burden testing, or TMB:

81479,** 81599,** 81541, 81542, 81551, 0037U, 0047U

Basic benefit and medical policy

Gene expression profile analysis for prostate cancer

The safety and effectiveness of gene expression analysis to guide the management of prostate cancer have been established. It may be considered a useful option when indicated.

The inclusionary criteria have been updated, effective
March 1, 2024.

Inclusions:

Inclusions for Decipher (for either of the following):

• Post-biopsy for NCCN very-low-, low-risk, favorable intermediate- and unfavorable intermediate-risk prostate cancer in patients with at least 10 years of life expectancy who haven’t received treatment for prostate cancer and are candidates for active surveillance or definitive therapy.
• Post-radical prostatectomy for pT2 with positive margins, any pT3 disease and rising PSA (above nadir).

Inclusions for Oncotype DX Prostate, Prolaris, ProMark:

Men with NCCN very-low-risk, low-risk and favorable intermediate-risk prostate cancer who have a greater than 10 years of  life expectancy who haven’t received treatment for prostate cancer and are candidates for active surveillance or definitive therapy.

Inclusions for AR-V7 testing:

Testing can be considered to help guide selection of therapy in the post-abiraterone/enzalutamide metastatic castration-resistant prostate cancer, or CRPC, setting.

Proprietary Laboratory Analyses, or PLA, Testing:

A PLA test as an FDA-approved companion diagnostic to determine the appropriate therapeutic drug is considered established when both of the following criteria are met:

• Biomarker confirmation is required by an FDA-approved or FDA-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’s webpage List of Cleared or Approved Companion Diagnostic Devices (In Vitro and Imaging Tools) at 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.

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

90678

Basic benefit and medical policy

Abrysvo (respiratory syncytial virus vaccine)

The United States Food and Drug Administration has updated the indications for Abrysvo (respiratory syncytial virus vaccine), effective Aug. 22, 2023.

95801, 95782, 95783, 95800, 95805, 95806, 95807, 96808, 95810, 95811, G0398, G0399

Experimental
94762, E0445, G0400

Basic benefit and medical policy

Diagnosis of sleep disorders

The policy has been updated to cover procedure code *95801 when criteria are met, effective Jan. 1, 2024.

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 or 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, or PAT, with oximetry and actigraphy) in a home setting (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.

Inclusionary and exclusionary guidelines:

Initial unattended (unsupervised) home sleep apnea test, or HSAT
 
This should be performed with a minimum of three recording channels (using, at a minimum, the following sensors: nasal pressure, chest and abdominal respiratory inductance plethysmography, and oximetry; or using Peripheral Arterial Tone, or PAT, with oximetry and actigraphy).

1. Adult individuals ages 18 or older with high pretest probability for moderate to severe OSA and either a, b or c:
1. Observed apneas during sleep
2. 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 an individual taking three or more antihypertensive medications).
• Obesity, defined as a body mass index  > 30 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
3. History of stroke (more than 30 days previously), transient ischemic attack, coronary artery disease, or sustained supraventricular tachycardic or bradycardic arrhythmias in patients who meet one of the six criteria listed under “b” above.
2. No exclusions or contraindications to a home sleep apnea test

Exclusions and contraindications to HSAT:

• Younger than 18 years of age
• Class III obesity, formerly referred to as morbid obesity, defined as a BMI >40 kg/m2 or the individual is 100 pounds over the ideal body weight for their height
• Obesity hypoventilation syndrome
• Narcolepsy
• Idiopathic hypersomnia
• Periodic limb movement disorder, or PLMD, when one of the following are present: pregnancy, renal failure, iron deficiency anemia, peripheral neuropathy, use of antidepressant or antipsychotic medications, or continued hypersomnia and clinical symptoms of PLMD after sleep disordered breathing is ruled out by home sleep apnea testing
• Central sleep disorder
• Parasomnias
• Nocturnal seizures
• REM behavior disorder
• Moderate or severe congestive heart failure – New York Heart Association, or NYHA, class III or IV
• Congestive heart failure with a history of ventricular fibrillation or sustained ventricular tachycardia in an individual who doesn’t have an implanted defibrillator
• Moderate or severe chronic pulmonary disease – forced expiratory volume in 1 second/forced vital capacity, or 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)
• Severe insomnia or chronic opioid use
• Impairment that results in inability to apply the home sleep apnea testing equipment
• Oxygen dependence

Repeat unattended (unsupervised) follow-up home sleep apnea test 

This should be performed with a minimum of three recording channels using, at a minimum, the following sensors: nasal pressure, chest, and abdominal respiratory inductance plethysmography and oximetry; or using 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, e.g., if there is a significant change in weight or change in symptoms suggesting that CPAP should be retitrated or possibly discontinued.

Initial attended (supervised) sleep study performed in a sleep lab

Adults with suspected OSA:

Inclusions:

1. Adult individuals 18 years of age or older with a moderate to high pretest probability for OSA and either a, b or c
1. Observed apneas during sleep
2. 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 an individual taking three or more antihypertensive medications)
• Obesity, defined as a BMI >30 kg/m2 or neck circumference > 17 inches in men or >16 inches in women
• Craniofacial or upper airway soft tissue abnormalities
• Unexplained nocturia
3. History of stroke (more than 30 days previously), transient ischemic attack, coronary artery disease, or sustained tachycardic or bradycardic arrhythmias in patients who meet ONE of 6 criteria listed under “b” above.

Or

2. When unattended (unsupervised) home sleep apnea test is contraindicated (see exclusions and contraindications to unattended home sleep apnea test above), or
3. When the initial unattended (unsupervised) study was negative, inadequate, equivocal or non-diagnostic and clinical suspicion for OSA remains

Adults with suspected sleep disorders other than OSA:

An in-lab supervised sleep study may be considered when there is suspicion of any of the following:

• Central sleep apnea
• Narcolepsy
• Nocturnal seizures
• Parasomnia
• Idiopathic hypersomnia
• Periodic limb movement disorder, or PLMD, to support a suspicion of PLMD in this context, one of the following must be documented: pregnancy, renal failure, iron deficiency anemia, peripheral neuropathy, use of antidepressant or antipsychotic medications, or continued hypersomnia and clinical symptoms of PLMD after sleep disordered breathing is ruled out by home sleep apnea testing
• Nocturnal desaturation (due to severe COPD or certain restrictive thoracic disorders)
• Any of the following conditions (right heart failure, polycythemia, cardiac arrhythmias during sleep, or pulmonary hypertension) when the etiology is unclear

Children (younger than age 18)

Inclusions:

Pediatric individuals younger than 18 years old with a moderate to high probability of OSA and one of the following solid bullets.

• 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
• 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 individuals 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 an individual who has undergone adenotonsillectomy for suspected OSA more than eight weeks previously
• The 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.

Repeat attended (supervised) sleep study performed in a sleep lab

Adults (ages 18 or older):

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 individuals 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 an individual 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 reevaluate 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 upper airway) or oral appliances/devices

Children (younger than 18 years old)

Inclusions:

• Initial PSG is negative and a clinical suspicion of OSA remains.
• 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.
• A patient with established OSA continues to exhibit persistent snoring or other symptoms of sleep disordered breathing despite PAP adherence as defined by Centers for Medicare & Medicaid Services criteria (use of PAP for at least four hours per night on 70% of nights during a consecutive 30-day period).
• The patient has undergone adenotonsillectomy more than eight weeks previously for management of established OSA.
• To reevaluate the diagnosis of OSA and need for continued PAP if there is significant weight loss (defined as 10% of body weight) since the most recent sleep study.
• To initiate or titrate CPAP or BPAP in a patient whose diagnostic study confirms that the patient is a candidate for positive airway pressure therapy and split-night study hasn’t been performed or was inadequate:
• In pediatric individuals, an AHI greater than 1.5 is considered abnormal, and an AHI of 10 or more may be considered severe.
• The initial sleep study has led to a diagnosis other than OSA and the repeat study is requested because of a change in clinical status or to assess efficacy after a change in therapy.

Multiple sleep latency testing, or MSLT

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

Nonivasive pulse oximetry

G2025

Basic benefit and medical policy

Procedure code G2025

J1930

Basic benefit and medical policy

Somatuline (lanreotide)

Blue Cross Blue Shield of Michigan has approved payment for the off-label use of Somatuline (lanreotide) in the treatment of malignant neoplasm of the adrenal gland.

J3490
J3590

Basic benefit and medical policy

Eylea HD (aflibercept)

Effective Aug. 18, 2023, Eylea HD (aflibercept) is covered for the following FDA-approved indications:

Eylea HD (aflibercept) is a vascular endothelial growth factor, or VEGF, inhibitor indicated for the treatment of patients with:

• Neovascular (wet) age-related macular degeneration, or nAMD
• Diabetic macular edema, or DME
• Diabetic retinopathy, or DR

Dosage and administration:

• Neovascular (wet) age-related macular degeneration, or nAMD: The recommended dose for Eylea HD (aflibercept) is 8 mg (0.07 mL of 114.3 mg/mL solution) administered by intravitreal injection every four weeks (approximately every 28 days +/- seven days) for the first three doses, followed by 8 mg (0.07 mL of 114.3 mg/mL solution) via intravitreal injection once every eight to 16 weeks, +/- one week.
• Diabetic macular edema, or DME: The recommended dose for Eylea HD (aflibercept) is 8 mg (0.07 mL of 114.3 mg/mL solution) administered by intravitreal injection every four weeks (approximately every 28 days +/- seven days) for the first three doses, followed by 8 mg (0.07 mL of 114.3 mg/mL solution) via intravitreal injection once every eight to 16 weeks, +/- one week.
• Diabetic retinopathy, or DR: The recommended dose for Eylea HD (aflibercept) is 8 mg (0.07 mL of 114.3 mg/mL solution) administered by intravitreal injection every four weeks (approximately every 28 days +/- seven days) for the first three doses, followed by 8 mg (0.07 mL of 114.3 mg/mL solution) via intravitreal injection once every eight to 12 weeks, +/- one week.

Dosage forms and strengths:

Injection: 8 mg (0.07 mL of 114.3 mg/mL solution) in a single-dose vial.

J3490
J3590

Basic benefit and medical policy

Pombiliti (cipaglucosidase alfa-atga)

Pombiliti (cipaglucosidase alfa-atga) is considered established, effective Sept. 28, 2023. 

Pombiliti is a hydrolytic lysosomal glycogen-specific enzyme indicated, in combination with Opfolda, an enzyme stabilizer, for the treatment of adult patients with late-onset Pompe disease (lysosomal acid alpha-glucosidase [GAA] deficiency) weighing ≥40 kg and who aren’t improving on their current enzyme replacement therapy, or ERT. 

Dosage and administration:

• Verify pregnancy status in females of reproductive potential before initiating treatment. 
• Administer Pombiliti in combination with Opfolda. 
• Consider administering antihistamines, antipyretics or corticosteroids before Pombiliti administration.
• Recommended Pombiliti dosage is 20 mg/kg (of actual body weight) administered every other week as an intravenous infusion over approximately four hours.
• Start Pombiliti in combination with Opfolda two weeks after the last ERT dose.
• Initiate the Pombiliti infusion approximately one hour after oral administration of Opfolda. If the Pombiliti infusion can’t be started within three hours of oral administration of Opfolda, reschedule Pombiliti in combination with Opfolda at least 24 hours after Opfolda was last taken. If Pombiliti in combination with Opfolda are both missed, re-start treatment as soon as possible.
• Must be reconstituted and diluted before use.

Dosage forms and strengths:

For injection: 105 mg of cipaglucosidase alfa-atga as a lyophilized powder in a single-dose vial for reconstitution.

This drug isn’t a benefit for URMBT.

J9358

Basic benefit and medical policy

Enhertu (fam-trastuzumab deruxtecan-nxki)

Blue Cross Blue Shield of Michigan has approved payment for the off-label use of Enhertu (fam-trastuzumab deruxtecan-nxki) for the
treatment of malignant neoplasm of the parotid gland.

0243U, 0247U, 0390U

Basic benefit and medical policy

Serum biomarkers to predict adverse obstetric outcomes

The use of maternal serum biomarker tests with or without additional algorithmic analysis for prediction of preeclampsia is considered experimental. The evidence is insufficient to determine that the technology results in an improvement in the net health outcome.

The use of maternal serum biomarker tests with or without additional algorithmic analysis for prediction of spontaneous preterm birth is considered experimental. The evidence is insufficient to determine that the technology results in an improvement in the net health outcome. This policy is effective March 1, 2024. 

90589

Basic benefit and medical policy

Chikungunya virus vaccine

The Chikungunya virus vaccine is experimental. Although it has been approved by the U.S. Food and Drug Administration, the Centers for Disease Control and Prevention’s Advisory Committee on Immunization Practices hasn’t yet reviewed or published any recommendations regarding the vaccine. This is effective March 1, 2024.

Inclusions and exclusions: