Billing chart: Blue Cross highlights medical, benefit policy changes

95012

Experimental:
83987

Basic benefit and medical policy

Exhaled nitric oxide/exhaled breath condensate

Measurement of fractional exhaled nitric oxide is considered established in the diagnosis of mild, moderate or severe asthma and the management of asthma when criteria are met.

Measurement of fractional exhaled nitric oxide in the diagnosis and management of other respiratory disorders such as asthma variants (for example, eosinophilic asthma, cough variant asthma and asthma-COPD overlap syndrome) is considered established when criteria are met.

Measurement of exhaled breath condensate in the diagnosis and management of other respiratory disorders including, but not limited to, chronic obstructive pulmonary disease and chronic cough is considered experimental.

The clinical utility of exhaled breath condensate in the diagnosis and management of respiratory disorders, including asthma, hasn’t been demonstrated. In addition, there is insufficient evidence that the use of this test improves health outcomes. 

This policy change is effective March 1, 2023.

Payment policy:

Modifiers 26 and TC don’t apply to this procedure.

Inclusions:

Diagnosis of asthma:

Measurement of fractional exhaled nitric oxide, or FeNO, is considered medically necessary. It’s covered when used as an adjunctive test to aid in the diagnosis of asthma using spirometry for individuals with suspected mild, moderate, severe asthma or asthma variants. 

Management of asthma:

Measurement of fractional exhaled nitric oxide, or FeNO, in individuals with an established diagnosis of mild, moderate, severe asthma or asthma variants is considered medically necessary and is established when used for any of the following purposes:

• Evaluation of response to anti-inflammatory treatment
• Monitoring compliance with anti-inflammatory treatment
• Aid with identification of underlying inflammatory phenotype or identification of inflammatory phenotypes to guide with the appropriate therapy

Exclusions:

Measurement of fractional exhaled nitric oxide, or FeNO, for the diagnosis and management of other respiratory disorders including, but not limited to, chronic obstructive pulmonary disease, or COPD, and chronic cough, is considered experimental. The safety and efficacy of these procedures haven’t been shown to improve clinical health outcomes.

Measurement of exhaled breath condensate in the diagnosis and management of asthma and other respiratory disorders including, but not limited to, chronic obstructive pulmonary disease and chronic cough is considered experimental. The safety and efficacy of these procedures haven’t been shown to improve clinical health outcomes.

11920, 11921, 11922, 17380, 17999,** 19303, 19318, 19325, 19350, 21120, 21121, 21122, 21123, 21125, 21127, 21137, 21138, 21139, 21209, 30400, 30410, 30420, 31599,** 31899,** 54520, 55970, 55980, 56805, 57291, 57292, 57335, 58150, 58152, 58180, 58260, 58262, 58275, 58291, 58541, 58542, 58543, 58544, 58550, 58552, 58553, 58554

Experimental
11950, 11951, 11952, 11954, 15769, 15771, 15772, 15773, 15774, 15820, 15821, 15822, 15823, 15824, 15825, 15826, 15828, 15830, 15832, 15833, 15834, 15835, 15836, 15837, 15838, 15839, 15876, 15877, 15878, 15879, 19316, 21208, 30430, 30435, 30450, 69300, Q2026, Q2028

Basic benefit and medical policy

Gender-affirming services

The safety and effectiveness of select medical and surgical treatments for gender dysphoria have been established. The established treatments for gender dysphoria include:

• Puberty suppression in adolescents
• Hormone therapy (for masculinization/feminization) for adolescents who meet criteria, and adults
• Medically necessary gender-affirming surgery:**
• Genitalia reconstruction
• Mastectomy for a transgender man (a person who has a gender identity as a man and who was assigned female at birth) 
• Augmentation mammoplasty (implants) for transgender women (a person who has a gender identity as a woman and who was assigned male at birth)
• Thyroid reduction chondroplasty (tracheal shave)
• Facial feminization
• Facial masculinization

**Gender-affirming surgery may require prior authorization.

Gender-specific services may be medically necessary for transgender and gender-diverse people appropriate to their anatomy. Examples include:

• Breast cancer screening in transgender and gender-diverse people with breasts from natal puberty who haven’t undergone gender-affirming chest surgery and for transgender and gender-diverse people who have received estrogens, taking into account the length of time of hormone use, dosing, current age and age at which the hormones were initiated
• Prostate cancer screening for transgender and gender-diverse people who have retained their prostate
• Cervical screening for transgender and gender-diverse people who currently have or previously had a cervix following local guidelines for cisgender women
• Obstetric services for transgender and gender-diverse people when they are pregnant
• To guide preventive medical care, any anatomical structure present that warrants screening should be screened, regardless of gender identity.

Exclusionary criteria have been updated, effective May 1, 2023.

Inclusions:

While the following procedures are considered established for this policy, the specific coverage for each member is based on the benefit, which is defined by the group or employer.

Assessment, diagnosis and treatment should be provided through a multidisciplinary gender services clinic or program affiliated with a major medical center. If this level of service is unavailable, there should be documentation that reflects a coordinated approach to care by specialists involved (mental health specialists, physicians, surgeons, etc.).

Puberty suppression**

Health care professionals taking care of transgender and gender-diverse adolescents should involve relevant disciplines, including mental health and medical professionals, to reach a decision about whether puberty suppression, hormone initiation or gender-related surgery for these adolescents is appropriate and remain involved throughout the course of treatment until the transition is made to adult care. Puberty suppression hormones for adolescents may be indicated for members who meet all the following inclusionary criteria:

• Meets diagnostic criteria for gender dysphoria.
• Gender dysphoria is marked and sustained.
• Demonstrates emotional and cognitive maturity required to provide informed consent for the treatment; and, particularly when the adolescent hasn’t reached the age of medical consent, the parents, guardians or other legally authorized caretakers have consented to the treatment and are involved in supporting the adolescent throughout the treatment process.
• Mental health concerns (if any) that may interfere with diagnostic clarity, capacity to consent and gender-affirming medical treatments have been addressed; sufficiently so that gender-affirming medical treatment can be provided optimally.
• Onset of puberty to at least Tanner stage 2 has been reached.
• The absence of contraindications to therapy in the judgment of the managing physician.

**Medications for puberty suppression may be managed under the member’s pharmacy benefit.

Hormone therapy**

Hormone therapy may be indicated for members that meet all the following inclusionary criteria.

Inclusions for adolescents, defined as from the start of puberty until the legal age of majority (18 years of age):

• Meets diagnostic criteria for gender dysphoria.
• Gender dysphoria is marked and sustained.
• Demonstrates emotional and cognitive maturity required to provide informed consent for the treatment; and, particularly when the adolescent hasn’t reached the age of medical consent, the parents, guardians or other legally authorized caretakers have consented to the treatment and are involved in supporting the adolescent throughout the treatment process.
• Mental health concerns (if any) that may interfere with diagnostic clarity, capacity to consent, and gender-affirming medical treatments have been addressed; sufficiently so that gender-affirming medical treatment can be provided optimally.
• Onset of puberty to at least Tanner stage 2 has been reached.
• The absence of contraindications to therapy in the judgment of the managing physician. 
• One letter of assessment as indicated below***
• Medications will be prescribed by or in consultation with a pediatric endocrinologist that has collaborated care with a mental health care provider for members less than 18 years of age.

Inclusions for adults:

• Age 18 or older (age of majority).
• Meets diagnostic criteria for gender dysphoria.
• Gender dysphoria is marked and sustained.
• Other possible causes of apparent gender incongruence have been identified and excluded.
• Demonstrates capacity to make a fully informed decision and to consent for gender-affirming hormone treatment.
• The absence of contraindications to therapy in the judgment of the managing physician.  
• Mental health and physical conditions that could negatively affect the outcome of gender-affirming medical treatments have been assessed, with the risks and benefits discussed, before a decision is made regarding treatment.

**Medications for hormone therapy may be managed under the member’s pharmacy benefit.

Hair removal

• If gender-affirming surgery is approved for a transgender or gender-diverse person, hair removal (e.g., electrolysis, laser hair removal) may be considered established following medical review:  
• Hair removal is considered established only when the scrotal and surrounding tissues are used in the surgical construction of the vagina.
• Hair removal is considered established only when free flap, or other donor tissues, are used for phalloplasty performed in conjunction with vaginectomy and full-length urethroplasty.

Gender affirming surgery

Inclusions:

Gender-affirming surgery may be indicated for members that meet all the following inclusionary criteria:

1. Chest surgery**
1. Mastectomy is considered reconstructive when all the following criteria have been met:
• The individual is at least 18 years of age.
• The individual has been diagnosed with gender dysphoria (see Description/Background section for diagnostic criteria).
• Gender dysphoria is marked and sustained.
• The individual has capacity to make fully informed decisions and consent for treatment.
• One letter of assessment as indicated below***
• Other possible causes of apparent gender incongruence have been identified and excluded.
• Mental health and physical conditions that could negatively affect the outcome of gender-affirming medical treatments have been assessed, with the risks and benefits discussed, before a decision is made regarding treatment.
• Hormone therapy prior to mastectomy isn’t required, as the aim of hormone therapy before facial surgery or gonadectomy is primarily to introduce a period of reversible testosterone or estrogen suppression before the individual undergoes irreversible surgical intervention.
• Living in a gender role congruent with gender identity for 12 continuous months isn’t required prior to a mastectomy.
• Pre-operative and post-operative care that addresses both surgical results and possible behavioral health results is highly recommended.

Nipple reconstruction, including tattooing, following a gender affirming mastectomy that meets the reconstructive criteria above is considered reconstructive.

2. Breast augmentation is considered reconstructive when all the following criteria have been met:
• The individual is at least 18 years of age.
• The individual has been diagnosed with gender dysphoria (see Description/Background section for diagnostic criteria).
• Gender dysphoria is marked and sustained.
• The individual has capacity to make fully informed decisions and consent for treatment.
• One letter of assessment as indicated below***
• Other possible causes of apparent gender incongruence have been identified and excluded.
• Mental health and physical conditions that could negatively affect the outcome of gender-affirming medical treatments have been assessed, with the risks and benefits discussed, before a decision is made regarding treatment.
• The individual is stable on their gender-affirming hormonal treatment regimen for at least 12 months, unless a rationale is provided by the HCP that indicates that hormone treatment is either contraindicated or not necessary for the individual’s clinical situation.
• Living in a gender role congruent with gender identity for 12 continuous months isn’t required prior to breast augmentation.
• Existing chest appearance demonstrates significant variation from normal appearance for the experienced gender.
• Pre-operative and post-operative care that addresses both surgical results and possible behavioral health results is highly recommended.

Note: ***The procedures needed to reconstruct a feminine/masculine appearance can only be performed once per lifetime.

2. Facial surgery^† is considered reconstructive when all the following criteria have been met: 
• The individual is at least 18 years of age.
• The individual has been diagnosed with gender dysphoria (see Description/Background section for diagnostic criteria).
• Gender dysphoria is marked and sustained.
• The individual has capacity to make fully informed decisions and consent for treatment.
• Other possible causes of apparent gender incongruence have been identified and excluded.
• One letter of assessment as indicated below***
• Mental health and physical conditions that could negatively affect the outcome of gender-affirming medical treatments have been assessed, with the risks and benefits discussed, before a decision is made regarding treatment.
• The individual is stable on their gender-affirming hormonal treatment regimen for at least 12 months, unless a rationale is provided by the HCP that indicates that hormone treatment is either contraindicated or not necessary for the individual’s clinical situation.
• The new gender identity should be present for at least 12 months.
• The member has a consistent stable gender identity that is well documented by their treating providers and, when possible, lives as their affirmed gender in places where it is safe to do so.
• Existing facial appearance demonstrates significant variation from normal appearance for the experienced gender.
• The procedure directly addresses variation from normal appearance for the experienced gender (Note: Each procedure requested should be considered separately as some procedures may be cosmetic and others may be reconstructive).
• Pre-operative and post-operative care that addresses both surgical results and possible behavioral health results is highly recommended.

Note: ***The procedures needed to reconstruct a feminine/masculine appearance can only be performed once per lifetime.

^†List of procedures included in this group is thyroid reduction chondroplasty (tracheal shave), genioplasty (repositioning or reshaping of the chin), mandible augmentation (jawline contouring/reconstruction), facial bone reduction, forehead reduction/contouring, rhinoplasty (reshaping/contouring of the nose).

3. Genital surgery is considered medically necessary when all the following criteria have been met: 
• The individual is at least 18 years of age.
• The individual has been diagnosed with gender dysphoria (see Description/Background section for diagnostic criteria).
• Gender dysphoria is marked and sustained.
• The individual has capacity to make fully informed decisions and consent for treatment.
• Other possible causes of apparent gender incongruence have been identified and excluded.
• One letter of assessment as indicated below****
• Mental health and physical conditions that could negatively affect the outcome of gender-affirming medical treatments have been assessed, with the risks and benefits discussed, before a decision is made regarding treatment.
• The individual is stable on their gender affirming hormonal treatment regimen for at least 12 months, unless a rationale is provided by the HCP that indicates that hormone treatment is either contraindicated or not necessary for the individual’s clinical situation.
• The new gender identity should be present for at least 12 months.
• The member has a consistent stable gender identity that is well documented by their treating providers and, when possible, lives as their affirmed gender in places where it is safe to do so.
• Pre-operative and post-operative care that addresses both surgical results and possible behavioral health results is highly recommended.

These criteria don’t apply to patients who are having these surgical procedures for medical indications other than gender dysphoria.

***Letter requirements:

1. Required for hormone therapy for adolescents
2. Required for facial, pelvic, gonadal and/or genital surgery for adults

Adolescents

One letter of assessment from the multidisciplinary team (or in situations where a multidisciplinary team is not available, a professional from one of the multiple disciplines who are experts in transgender health and in the management of the care required for transgender and gender-diverse adolescents who is taking care of the individual) is required for adolescents receiving gender-affirming medical treatment. This letter needs to reflect the assessment and opinion of the team, which involves both medical HCPs and mental health professionals, supports that the individual meets the criteria for gender dysphoria. The detailed assessment must have been performed within 12 months of the requested submission. 

The HCP assessing and working with the adolescent should meet all the following criteria:

1. Are licensed by their professional body and hold a postgraduate degree or its equivalent in a clinical field related to transgender health granted by a nationally accredited institution.
2. Receive theoretical and evidenced-based training and develop expertise in general child, adolescent, and family mental health across the developmental spectrum.
3. Receive training and have expertise in gender identity development, gender diversity in children and adolescents, have the ability to assess capacity to assent/consent and possess general knowledge of gender diversity across the life span.
4. Continue engaging in professional development in all areas relevant to gender-diverse children, adolescents, and families.

Adults

One letter of assessment from an HCP who has competencies in the assessment of transgender and gender-diverse people documenting that the individual meets the criteria for gender dysphoria is required for transgender and gender-diverse adults who meet the below criteria for gender-affirming medical and surgical treatments. The detailed assessment must have been performed within 12 months of the requested submission. 

The HCP should meet all the following criteria:

1. Are licensed by their professional body and hold, at a minimum, a master’s degree or equivalent training in a clinical field related to transgender health or equivalent further clinical training in this area and granted by a nationally accredited institution.
2. Should be competent using the latest edition of the Diagnostic and Statistical Manual of Mental Disorders, or DSM-5, for diagnosis.
3. Are able to identify co-existing mental health or other psychosocial concerns and distinguish these from gender dysphoria, incongruence and diversity.
4. Are able to assess capacity to consent for treatment.
5. Have experience or be qualified to assess clinical aspects of gender dysphoria, incongruence and diversity.
6. Undergo continuing education in health care relating to gender dysphoria, incongruence and diversity.

Exclusions:

• Gender-affirming services aren’t covered if contract or certificate language contains specific exclusion of these services.
• Reversal of physical or functional outcomes due to gender-affirming services.
• Reversal of surgical procedures performed for gender-affirming services. 
• All procedures that are primarily cosmetic and not reconstructive or not medically necessary including, but not limited to:
• Abdominoplasty
• Blepharoplasty
• Brow lift
• Calf implants
• Cheek/malar implants
• Chin/nose implants
• Collagen injections
• Drugs for hair loss or growth
• Forehead lift
• Hair removal (for exception: see Inclusions, Electrolysis)
• Hair transplantation
• Injectable dermal fillers (for example, Sculptra, Radiesse)
• Lip reduction
• Liposuction
• Mastopexy
• Neck tightening
• Otoplasty
• Pectoral implants
• Removal of redundant skin
• Rhytidectomy
• Speech-language therapy
• Non-covered services

20982, 32994, 32998, 50542, 50592, 58674

Experimental

Basic benefit and medical policy

Radiofrequency ablation of miscellaneous solid tumors

The safety and effectiveness of radiofrequency ablation to palliate pain in patients with osteolytic bone metastases have been established. It may be considered a useful therapeutic option when indicated.

The safety and effectiveness of radiofrequency ablation of osteoid osteomas have been established. It may be considered a useful therapeutic option when indicated.

The safety and effectiveness of radiofrequency ablation of renal tumors have been established. It may be considered a useful therapeutic option when indicated.

Radiofrequency ablation is an established treatment option in selected patients with primary, non-small cell lung cancer and metastatic pulmonary tumors who aren’t candidates for surgical intervention.

Exclusionary criteria have been updated, effective May 1, 2023.

Inclusions:

Radiofrequency ablation is appropriate to palliate pain in patients with osteolytic bone metastases for those who have failed or are poor candidates for standard treatments such as radiation or opioids.

Radiofrequency ablation is appropriate for osteoid osteomas for those who can’t be managed successfully with medical treatment.

Radiofrequency ablation is appropriate to treat localized renal cell carcinoma that is no more than 4 cm in size when any of the following criteria are met:

• It’s necessary to preserve kidney function in patients with significantly impaired renal function (i.e., the patient has one kidney or renal insufficiency defined by a glomerular filtration rate [GFR] of less than 60 mL/min/m2).
• The standard surgical approach (i.e., resection of renal tissue) is likely to substantially worsen existing kidney function.
• The patient isn’t considered a surgical candidate.

Radiofrequency ablation is appropriate to treat an isolated peripheral non-small cell lung cancer lesion that is no more than 3 cm in size when all the following criteria are met:

• Surgical resection or radiation treatment with curative intent is considered appropriate based on stage of disease, however, medical co-morbidity renders the individual unfit for those interventions.
• The tumor is located at least 1 cm from the trachea, main bronchi, esophagus, aorta, aortic arch branches, pulmonary artery and the heart.

Radiofrequency ablation is appropriate to treat malignant non-pulmonary tumors metastatic to the lung that are no more than 3 cm in size when all the following criteria are met:

• It’s necessary to preserve lung function when surgical resection or radiation treatment is likely to substantially worsen pulmonary status.   
• The patient isn’t considered a surgical candidate.
• There’s no evidence of extrapulmonary metastases.
• The tumor is located at least 1 cm from the trachea, main bronchi, esophagus, aorta, aortic arch branches, pulmonary artery and the heart.

Additional criteria that have been developed by clinical judgment/consensus and existing guidelines for the use of radiofrequency ablation in metastatic tumors to the lung are as follows:
• No more than three tumors per lung should be ablated.
• Tumors should be amenable to complete ablation.
• Twelve months should elapse before a repeat ablation is considered.

Radiofrequency ablation may be appropriate to treat uterine fibroids (Refer to “Myolysis of Uterine Fibroids using Laparoscopic, Percutaneous, or Transcervical Techniques” for criteria)

Exclusions:

• Breast tumors
• Lung cancer not meeting the criteria above
• Renal cell cancer not meeting the criteria above
• Osteoid osteomas that can be managed with medical treatment
• Initial treatment of painful bony metastases
• Benign thyroid nodule
• All indications and tumor types not specifically noted in the Inclusion section of this policy

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

Basic benefit and medical policy

Magnetic resonance angiography and venography

The magnetic resonance angiography and venography
policy has been updated to cover procedure *73225 when criteria are met, effective March 1, 2023.

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/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.

MRA inclusions:

Head and neck:

• MRA is used to evaluate the carotid arteries, the Circle of Willis, the anterior, middle or posterior cerebral arteries, the vertebral or basilar arteries or the venous sinuses for diagnosis of suspected stenosis of occlusion or management of known stenosis or occlusion with worsening neurologic symptoms or signs.
• MRA for the diagnosis and management of:
• Tumor
• Extracranial (carotid or vertebral) aneurysms
• Arteriovenous malformation, or AVM, or fistula, or AVF
• Dissection-intracranial or extracranial
• Fibromuscular dysplasia
• 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
• Intracranial vascular occlusions or thrombosis  
• Extracranial vascular occlusions or thrombosis following nondiagnostic venous ultrasound 
• Intracranial or extracranial vascular occlusions or thrombosis
• MRA for the evaluation of a suspected vascular lesion:
• Horner’s syndrome
• Pulsatile tinnitus
• Trigeminal neuralgia
• MRA for the following:
• Intracranial stenosis or occlusion:
1. Diagnosis of suspected intracranial stenosis
2. Management of known intracranial stenosis
3. Surveillance in patients with established Moyamoya disease who are being considered for revascularization
• Vascular malformations

• MRA 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’s associated with intracranial aneurysm (examples include autosomal dominant polycystic kidney disease and Ehlers-Danlos syndrome type IV)
• Known fibromuscular dysplasia

• MRA is used for the diagnosis and management of traumatic vascular injuries and vasculitis.
• MRA may be used for the diagnosis of clinically suspected 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:
• Sudden onset worst headache of life (“thunderclap”)
• Brought on by and occurring in association with exertion or valsalva
• Persistent headache that meets Brain Imaging Guidelines for headache and that remains undifferentiated/unexplained by MRI

• Management of known intracranial aneurysm:
• Evaluation for aneurysm progression or recurrence based on new or worsening neurologic symptoms
• Preoperative evaluation
• Initial postoperative evaluation

• Diagnosis, management and surveillance for extracranial carotid artery stenosis or occlusion in patients who are candidates for carotid revascularization when duplex arterial ultrasound can’t be performed, is nondiagnostic or shows moderate to severe stenosis or occlusion
• Intracranial or extracranial evaluation of acute- stoke or transient ischemic attack, or TIA
• Surveillance of intracranial aneurysm, initial evaluation at 6 to 12 months following diagnosis, then annually
• MRA is used for vascular evaluation prior to transcatheter aortic valve implantation/replacement. MRA of neck requires duplex arterial ultrasound first.
• 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 is useful in the following circumstances:

• Preoperative or postoperative imaging
• Follow-up of prior imaging findings suggestive of a vascular lesion

Peripheral arteries of lower extremities:
 
Studies have proven that MRA of peripheral arteries is useful in determining the presence and extent of peripheral vascular disease in lower extremities. MRA is useful in:

• Evaluation of common femoral, superficial femoral and calf veins for suspected venous thromboembolic disease. MRA for the diagnosis and management of venous thrombosis or occlusion when venous ultrasound can’t be performed or is nondiagnostic.
• Evaluation of the lower arterial vasculature for disease when the patient is at significant risk for contrast-induced renal failure, allergic reaction to contrast material and complications associated with arterial cannulation (e.g., bleeding, poor vascular access).
• Non-invasive follow-up for prior revascularization procedure (e.g., angioplasty or surgical revascularization).
• Diagnosis, management and annual surveillance of peripheral arterial disease after venous graft has been used for surgical revascularization
• When imaging results are essential in establishing a diagnosis and/or direct management of the following conditions:
• Arterial entrapment syndrome
• Aneurysm/dilation
• Arteriovenous malformation or arteriovenous fistula
• Dissection or intramural hematoma

Peripheral arteries of upper extremities:

Studies have proven that MRA of peripheral arteries is useful for the diagnosis, management and surveillance of the following:

• Peripheral arterial disease of the upper extremities
• Vascular access procedures when ultrasound cannot be performed or is nondiagnostic
• Venous thrombosis or occlusion
• Aneurysm
• Arterial entrapment syndrome
• AVM or AVF
• Dissection or intramural hematoma

Abdomen or pelvis:

• Abdominal aortic or iliac aneurysm with elective repair of the aneurysm. MRA abdomen or pelvis for management, surveillance with endografts or surgical repair or when duplex arterial ultrasound can’t be performed or is nondiagnostic and has criteria for management and surveillance.
• Evaluation of the portal and/or hepatic venous system.
• Evaluation of the renal or aortoiliac arteries when a contrast agent is contraindicated (e.g., allergy or potential contrast-induced nephrotoxicity).
• Diagnosis, management and annual surveillance of acute aortic syndrome (including aortic dissection, rupture, intramural hematoma, penetrating ulcer and pseudoaneurysm)
• Diagnosis and management of arteriovenous malformation or fistula.
• Diagnosis and management of hematoma/hemorrhage within the abdomen
• Diagnosis and management of mesenteric ischemia or portal hypertension
• In patients suspected of having renal artery stenosis, or RAS, or renovascular hypertension
• Diagnosis of suspected aortoiliac stenosis or occlusion. Presurgical evaluation and management of known stenosis and annual surveillance of bypass grafts.
• Diagnosis and management of venous thrombosis or occlusion of major abdominal vessels, except for initial evaluation of hepatic or portal veins unless ultrasound can’t be performed or is nondiagnostic.
• Diagnosis, management and surveillance of visceral artery aneurysm involving any of the following arteries: renal, celiac, splenic, hepatic or superior/inferior mesenteric arteries and their branches
• MRA is used for vascular evaluation prior to transcatheter aortic valve implantation/replacement

Chest:

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

• For initial diagnosis, management and annual surveillance for acute aortic syndrome (aortic dissection, rupture, intramural hematoma, penetrating ulcer and pseudoaneurysm) when CTA can’t be performed or is nondiagnostic
• For screening, diagnosis, management and surveillance for aortic aneurysm
• For diagnosis, treatment planning and postoperative follow-up for conditions of the thoracic aorta such as aneurysm (true or pseudoaneurysm), dissection or stenotic/occlusive vascular disease:
• Surveillance for aneurysms <4.4 cm, annual
• Surveillance for aneurysms larger than 4.4 cm, every six months

• Atheromatous disease, 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
• For diagnosis, treatment planning and postoperative surgical shunt evaluation in patients with congenital heart disease, or CHD, or developmental anomalies of the thoracic vasculature (e.g., coarctation of the aorta, right-sided aortic arch, double aortic arch, truncus arteriosus, persistent left superior vena cava, interrupted inferior vena cava, total anomalous pulmonary venous connection, partial anomalous venous connection, atresia or hypoplasia of the pulmonary arteries)
• For diagnosing a suspected pulmonary embolism when the use of intravascular iodinated contrast material is contraindicated, or as a substitute for pulmonary angiography when a VQ scan does not provide sufficient information to make treatment decisions
• MRA may be considered an option for the diagnosis and management 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 is used for vascular evaluation prior to transcatheter aortic valve implantation/replacement

Allergy:

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.

MRA exclusions:

Medical literature doesn’t support the use of magnetic resonance angiography for the following conditions:

• Screening of the general population for intracranial aneurysms
• Ruling out intracranial aneurysms in patients who have vague CNS symptoms (e.g., non-specific sensory loss, dizziness, vertigo or headache)
• Evaluating patients with symptoms suggestive of dural, sagittal or cavernous sinus thrombosis/occlusion
• Screening for reno-vascular hypertension
• For the evaluation of accessory renal arteries in prospective renal donors, including potential living kidney donors

MRV inclusions:

MRV is appropriate for any of the following conditions:

• For evaluation of thrombosis or compression by tumor of the cerebral venous sinus in patients who are at risk (e.g., otitis media, meningitis, sinusitis, oral contraceptive use, underlying malignant process, hypercoagulable disorders) or have signs or symptoms (e.g., papilledema, focal motor or sensory deficits, seizures, or drowsiness and confusion accompanying a headache).
• For evaluation of venous thrombosis or occlusion in the large systemic veins (e.g., superior vena cava, subclavian, or other deep veins in the chest).
• For evaluation of venous thrombosis or occlusion in the portal and/or hepatic venous system (e.g., Budd-Chiari syndrome).

Established

Basic benefit and medical policy

Genetic testing: Analysis of MGMT in malignant gliomas

The safety and effectiveness of the analysis of MGMT promoter methylation and IDH1/IDH2 mutation testing in malignant gliomas are established. It may be considered a useful option when indicated.

The medical policy statement, as well as inclusionary and exclusionary criteria, have been updated, effective May 1, 2023.

Inclusions:

Methylation analysis of the O6-methylguanine DNA methyltransferase, or MGMT, gene promoter from glioma tumor tissue is established for individuals who meet all the following criteria:

• They have a tumor type consistent with high-grade malignant glioma (e.g., glioblastoma multiforme, anaplastic astrocytoma).
• Candidate for temozolomide therapy or radiation therapy.
• Methylation results will be used to direct their therapy choices.

IDH1/IDH2

IDH mutation testing is required in the workup of all gliomas.

Exclusions:

MGMT promoter methylation analysis and IDH1/IDH2 testing are experimental in situations that don’t meet the above criteria.

81450, 81455, 0017U, 81219, 81270,

Basic benefit and medical policy

JAK2, MPL and CALR genetic testing for myeloproliferative neoplasms

The safety and effectiveness of JAK2 testing have been established. It may be considered a useful diagnostic option for patients presenting with clinical, laboratory or pathologic findings suggesting polycythemia vera, essential thrombocythemia or primary myelofibrosis.

The safety and effectiveness of MPL and CALR testing have been established. They may be considered useful diagnostic options for patients presenting with clinical, laboratory or pathologic findings suggesting essential thrombocythemia or primary myelofibrosis.

The use of a genomic panel for hematolymphoid neoplasms may be considered appropriate for the diagnosis and for selecting the therapy of a myeloproliferative disorder or myelodysplastic syndrome.

The peer-reviewed medical literature hasn’t yet demonstrated the clinical utility for JAK2, MPL and CALR testing in other circumstances. Therefore, these services are considered experimental.

Inclusionary and exclusionary criteria have been updated, resulting in updated payable diagnoses for procedures *81450 and *81455. The change is effective March 1, 2023.

*81450: Payable for C92.10, C92.11, C92.12, C93.90-
C93.92, C94.6, C96.20- C96.22, C96.29, D45, D46.9,
D47.1, D47.3, D47.4, D75.81

*81455: Added D45, D46.9, D47.1, D47.3, D47.4, D75.81

Inclusions:

JAK2 testing as a diagnostic option for patients presenting with clinical, laboratory or pathologic findings suggesting polycythemia vera, essential thrombocythemia or primary myelofibrosis.

MPL and CALR testing as diagnostic options for patients presenting with clinical, laboratory or pathologic findings suggesting essential thrombocythemia or primary myelofibrosis.

The use of a genomic panel for hematolymphoid neoplasms may be considered appropriate for the diagnosis and for selecting the therapy of a myeloproliferative disorder or myelodysplastic syndrome.

Exclusions:

JAK2, MPL and CALR testing in other circumstances including, but not limited to, the following:

• Diagnosis of nonclassic forms of myeloproliferative neoplasms, or MPNs
• Molecular phenotyping of patients with MPNs

90867, 90868, 90869

Basic benefit and medical policy

Transcranial magnetic stimulation

Transcranial magnetic stimulation of the brain has been established. It may be a useful treatment option in certain specified situations.

Inclusionary criteria have been updated, effective May 1, 2023.

Inclusions:

Transcranial magnetic stimulation therapy should be ordered by a board-certified psychiatrist upon completion of a comprehensive evaluation.

Major depressive disorder

Transcranial magnetic stimulation must be administered by an approved U.S. Food and Drug Administration-cleared device for the treatment of major depressive disorder, or MDD, and modalities may include conventional TMS, deep TMS and theta burst stimulation. Specified stimulation parameters as follows: five days a week for six weeks (total of 30 sessions), however, the treatment plan can be individualized depending on the type of device used, safety and side effect considerations and response to treatment.

Must meet all:

1. The member is 18 to 70 years of age.
2. A drug screen is obtained if indicated by history, current clinical evaluation or a high degree of clinical suspicion.
3. A confirmed diagnosis of severe major depressive disorder (single or recurrent episode) measured by evidence-based scales such as Beck Depression Inventory (score 30-63), Zung Self-Rating Depression Scale (>70), PHQ-9 (>20), Hamilton Depression Rating Scale (>20), or Montgomery-Asberg Depression Rating Scale (MADRS) (score >34).
4. At least one of the following:
• The individual has tried and had an inadequate response to two antidepressant agents from two different antidepressant classes (e.g., selective serotonin reuptake inhibitors, serotonin and norepinephrine reuptake inhibitors, tricyclic antidepressants, bupropion or mirtazapine). An adequate trial of an antidepressant is defined by both of the following:
• The trial length was at least six weeks at generally accepted doses or of sufficient duration as determined by the treating physician at the generally accepted doses.
• Individual was ≥ 80% adherent to the agent during the trial.
• The individual is unable to tolerate a therapeutic dose of medications. Intolerance is defined as severe somatic or psychological symptoms that can’t be modulated by any means including, but not limited to, additional medications to ameliorate side effects. Examples of somatic side effects: persistent electrolyte imbalance, pancytopenia, severe weight loss, poorly controlled metabolic syndrome or diabetes. Examples of psychological side effects: suicidal-homicidal thinking/attempts, impulse dyscontrol.
  Note: A trial of less than one week of a medication isn’t considered a qualifying trial to establish intolerance.
• The individual has a history of response to TMS in a previous depressive episode (and it has been at least three months since the prior episode)
• The individual is a candidate for electroconvulsive therapy; further, electroconvulsive therapy wouldn’t be clinically superior to transcranial magnetic stimulation. For example, in cases with psychosis, acute suicidal risk, catatonia or life-threatening inanition, TMS should not be utilized).
5. The individual failed a trial of an evidence-based psychotherapy known to be effective in the treatment of MDD of an adequate frequency and duration without significant improvement in depressive symptoms as documented by standardized rating scales that reliably measure depressive symptoms (e.g., Becks Depression Inventory, Zung Self-Rating Depression Scale, PHQ-9, Hamilton Depression Rating Scale or MADRS).

Obsessive-compulsive disorder

Individual consideration may be extended to patients based on review of applicable medical records for refractory OCD defined as two therapeutic trials of medications and psychotherapy with one augmentation episode that has failed.

Conditions that must be met during the entire TMS treatment:

• The treatment must be administered by a board-certified psychiatrist trained in TMS therapy or a trained technician, under the supervision of a board-certified psychiatrist trained in TMS therapy.
• An attendant trained in BCLS, the management of complications (such as seizures), and the use of appropriate equipment, must be present.
• Adequate resuscitation equipment must be available (e.g., suction and oxygen).
• The facility must maintain awareness of response times of emergency services (either fire/ambulance or “code team”), which should be available within five minutes. These relationships are reviewed at least once per year and include mock drills.

Exclusions:

• All other behavioral health, neuropsychiatric or medical conditions (e.g., anxiety disorders, mood disorders, schizophrenia, Alzheimer’s, dysphagia, seizures, migraine headaches, etc.)
• Pregnancy
• Maintenance treatment
• Presence of psychosis in the current episode
• Seizure disorder or any history of seizure, except those induced by ECT or isolated febrile seizures in infancy without subsequent treatment or recurrence
• Presence of an implanted magnetic-sensitive medical device located less than or equal to 30 centimeters from the TMS magnetic coil or other implanted metal items including, but not limited to, a cochlear implant, implanted cardioverter defibrillator, pacemaker, vagus nerve stimulator, or metal aneurysm clips or coils, staples, or stents

Note: Dental amalgam fillings aren’t affected by the magnetic field and are acceptable for use with TMS.

• If the patient (or, when indicated, the legal guardian) is unable to understand the risk and benefits of TMS and provide informed consent
• Presence of a medical or co-morbid psychiatric contraindication to TMS
• Patient lacks a suitable environmental, or social or professional support system for post-treatment recovery
• There isn’t a reasonable expectation that the patient will be able to adhere to post-procedure recommendations
  Note: Caution should be exercised in any situation where the patient’s seizure threshold may be decreased. Examples include:

• Presence in the bloodstream of a variety of agents including, but not limited to, tricyclic antidepressants, clozapine, antivirals, theophylline, amphetamines, PCP, MDMA, alcohol and cocaine as these present a significant risk
• Presence of the following agents including, but not limited to, SSRIs, SNRIs, bupropion, some antipsychotics, chloroquine, some antibiotics and some chemotherapeutic agents as they present a relative risk and should be considered when making risk-benefit assessments
• Withdrawal from alcohol, benzodiazepines, barbiturates and chloral hydrate also present a strong relative hazard

E1399**

Basic benefit and medical policy

Digital health therapies: Diagnostic

Prescription digital health technologies for diagnostic application that have received clearance for marketing by the U.S. Food and Drug Administration as a diagnostic aid for autism spectrum disorder (Canvas Dx) are considered experimental, effective May 1, 2023.

Inclusionary and exclusionary guidelines:

Not applicable

J3490

Basic benefit and medical policy

Altuviiio (antihemophilic factor [recombinant], Fc-VWF-XTEN fusion protein-ehtl)

Altuviiio (antihemophilic factor [recombinant], Fc-VWF-XTEN fusion protein-ehtl) is considered established, effective Feb. 23, 2023.  

Altuviiio (antihemophilic factor [recombinant], Fc-VWF-XTEN fusion protein-ehtl) is a recombinant DNA-derived, Factor VIII concentrate indicated for use in adults and children with hemophilia A (congenital factor VIII deficiency) for:

• Routine prophylaxis to reduce the frequency of bleeding episodes
• On-demand treatment and control of bleeding episodes
• Perioperative management of bleeding

Limitation of use:
 
Altuviiio isn’t indicated for the treatment of von Willebrand disease.

Dosage forms and strengths:

For intravenous use only.

• Each Altuviiio vial label states Factor VIII activity in international units (IU or unit)
• For routine prophylaxis: 50 IU/kg once weekly.
• For on-demand treatment and control of bleeding episodes and perioperative management: 50 IU/kg
  Estimated Increment of Factor VIII (IU/dL or % of normal) = 50 IU/kg x 2 (IU/dL per IU/kg.)

To achieve a specific target Factor VIII activity level, use the following formula: Dosage (IU) = Body Weight (kg) x Desired Factor VIII Increase (IU/dL or % normal) x 0.5 (IU/kg per IU/dL).

Dosage forms and strengths:

For injection: Nominally 250, 500, 750, 1000, 2000, 3000 or 4000 IU, lyophilized powder in single-dose vials for reconstitution.

This drug isn’t a benefit for URMBT.

J3490

Basic benefit and medical policy

Skysona (elivaldogene autotemcel)

Effective Sept. 16, 2022, Skysona (elivaldogene autotemcel) is covered for the following FDA-approved indications:

Skysona (elivaldogene autotemcel) is indicated to slow the progression of neurologic dysfunction in boys ages 4 to 17 with early, active cerebral adrenoleukodystrophy, or CALD. Early, active CALD refers to asymptomatic or mildly symptomatic (neurologic function score, NFS ≤ 1) boys who have gadolinium enhancement on brain magnetic resonance imaging and Loes scores of 0.5-9.

This indication is approved under accelerated approval based on 24-month Major Functional Disability-free survival. Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trials.

Limitations of use:

• Skysona (elivaldogene autotemcel) doesn’t treat or prevent adrenal insufficiency.
• An immune response to Skysona (elivaldogene autotemcel) may cause rapid loss of efficacy of Skysona (elivaldogene autotemcel) in patients with full deletions of the human adenosine triphosphate binding cassette, sub family D, member 1 (ABCD1) gene.
• Skysona (elivaldogene autotemcel) hasn’t been studied in CALD secondary to head trauma.
• Given the risk of hematologic malignancy with Skysona (elivaldogene autotemcel), and unclear long-term durability of Skysona (elivaldogene autotemcel) and human adrenoleukodystrophy protein, or ALDP, expression, careful consideration should be given to the timing of treatment for each boy and treatment of boys with isolated pyramidal tract disease as clinical manifestations don’t usually occur until adulthood.

Dosage and administration:

For autologous use only. For intravenous use only.

• Patients must undergo hematopoietic stem cell, or HSC, mobilization and apheresis to obtain CD34+ cells for Skysona manufacturing.
• Dosing of Skysona is based on the number of CD34+ cells in the infusion bags per kg of body weight.
• The minimum recommended dose is 5.0 × 106 CD34+ cells/kg. 
• Full myeloablative and lymphodepleting conditioning must be administered before infusion of Skysona.
• Verify the patient’s identity matches the unique patient identification information on the Skysona infusion bags prior to infusion.
• Don’t sample, alter or irradiate Skysona.
• Don’t use an in-line blood filter or an infusion pump.

Dosage forms and strengths:

Skysona is a cell suspension for intravenous infusion.

• A single dose of Skysona contains a minimum of 5.0 × 106 CD34+ cells/kg of body weight, suspended in a solution containing 5% dimethyl sulfoxide, or DMSO. 

Skysona (elivaldogene autotemcel) isn’t a benefit for URMBT.

J9173

Basic benefit and medical policy

Imfinzi (durvalumab)

The FDA has updated the payable indications for Imfinzi (durvalumab), effective Nov. 10, 2022. The payable indications include the following:

• In combination with tremelimumab-actl, for the treatment of adult patients with unresectable hepatocellular carcinoma, or uHCC
• In combination with tremelimumab-actl and platinum-based chemotherapy, for the treatment of adult patients with metastatic non-small cell lung cancer, or NSCLC, with no sensitizing epidermal growth factor receptor, or EGFR, mutations or anaplastic lymphoma kinase, or ALK, genomic tumor aberrations

S2202, 36465, 36466, 36470, 36471,

Basic benefit and medical policy

Echosclerotherapy for varicose veins

The safety and effectiveness of echosclerotherapy for the treatment of the saphenous vein varicosities are established. It may be considered a useful therapeutic option in individuals for whom traditional sclerotherapy of saphenous vein varicosities would be indicated.

The policy inclusions were updated, effective May 1, 2023.

Inclusions:

Ultrasound guidance to the saphenous vein in individuals having sclerotherapy would be considered established.

Ultrasound guidance to symptomatic varicose tributaries in individuals having sclerotherapy would be considered established.