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Interspinous Fixation (Fusion) Devices

Interspinous fixation (fusion) devices are considered investigational for any indication, including but not limited to use:
in combination with interbody fusion, or

alone for decompression in patients with spinal stenosis.


Electrical Stimulation of the Spine as an Adjunct to Spinal Fusion Procedures

Either invasive or noninvasive methods of electrical bone growth stimulation may be considered medically necessary as an adjunct to lumbar spinal fusion surgery in patients at high risk for fusion failure, defined as any one of the following criteria:
one or more previous failed spinal fusion(s);

grade 3 or worse spondylolisthesis;

fusion to be performed at more than 1 level;

current tobacco use;

diabetes;

renal disease;

alcoholism; or

steroid use.

Noninvasive electrical bone growth stimulation may be considered medically necessary as a treatment for patients with failed lumbar spinal fusion surgery. Failed spinal fusion is defined as a spinal fusion that has not healed at a minimum of 6 months after the original surgery, as evidenced by serial radiographs over a course of 3 months.

Semi-invasive electrical bone growth stimulation is considered investigational as an adjunct to lumbar spinal fusion surgery and for failed lumbar fusion.

Invasive, semi-invasive, and noninvasive electrical bone growth stimulation are considered investigational as an adjunct to cervical fusion surgery and for failed cervical spine fusion


Microwave Tumor Ablation

Microwave ablation of primary or metastatic hepatic tumors may be considered medically necessary under the following conditions:
The tumor is unresectable due to location of lesion[s] and/or comorbid conditions

A single tumor of ≤5 cm or up to 3 nodules ≤3 cm each.

Microwave ablation of primary or metastatic lung tumors may be considered medically necessary under the following conditions:

The tumor is unresectable due to location of lesion and/or comorbid conditions

A single tumor of ≤3 cm.

Microwave ablation of more than a single primary or metastatic tumor in the lung is considered investigational.

Microwave ablation of primary or metastatic tumors other than liver or lung is considered investigational.


SEPTOPLASTY

Septoplasty
It is considered medically necessary when any of the following clinical conditions is present:

•    Asymptomatic deformity of the nasal septum which limits the intranasal access when such access is necessary to perform a medically necessary surgical procedure (for example, edmoidectomy); or
•    Recurrent sinusitis documented as secondary to deviated nasal septal when there is no clinical response to medications and/or antibiotic-therapy; or
•    Recurrent epistaxis related to deformity of the nasal septum; or
•    Septal deviation causing continuous nasal obstruction resulting in shortness of breath which does not respond to proper medical treatment; or
•    When it is performed with the repair of a cleft lip.

Triple-S Salud does not consider Septoplasty for payment for any other indication (e.g. allergic rhinitis) because its effectiveness in other situations not included previously have not proved to be effective.


 Lung Volume Reduction Surgery for Severe Emphysema

Lung volume reduction surgery as a treatment for emphysema may be considered medically necessary in patients who meet all of the following criteriaa:
Predominantly upper-lobe emphysema with hyperinflation and heterogeneity (ie, target areas for removal)

Forced expiratory volume in 1 second (FEV1):

For patients who are younger than 70 years of age, FEV1 must be no more than 45% of the predicted value.

For patients who are 70 years of age or older, FEV1 must be no more than 45% of the predicted value and 15% or more of the predicted value.

Marked restriction in activities of daily living, despite maximal medical therapy

Age younger than 75 years

Acceptable nutrition status (ie, 70% to 130% of ideal body weight)

Ability to participate in a vigorous pulmonary rehabilitation program

No coexisting major medical problems that would significantly increase operative risk

Willingness to undertake the risk of morbidity and mortality associated with lung volume reduction surgery

Abstinence from cigarette smoking for at least 4 months.

Lung volume reduction surgery is considered investigational in all other patients.

a Patient selection criteria are based on the National Emphysema Treatment Trial.


Transanal Endoscopic Microsurgery

Transanal endoscopic microsurgery may be considered medically necessary for treatment of rectal adenomas, including recurrent adenomas that cannot be removed using other means of local excision.
Transanal endoscopic microsurgery may be considered medically necessary for treatment of clinical stage T1 rectal adenocarcinomas that cannot be removed using other means of local excision and that meet all of the following criteria:

Located in the middle or upper part of the rectum,

Well- or moderately differentiated (G1 or G2) by biopsy,

Without lymphadenopathy, and

Less than one-third the circumference of the rectum.

Transanal endoscopic microsurgery is considered investigational for the treatment of rectal tumors that do not meet the criteria noted above.


Artificial Intervertebral Disc: Lumbar Spine

Artificial intervertebral discs of the lumbar spine are considered investigational.


Risk-Reducing Mastectomy

Risk-reducing mastectomy may be considered medically necessary in patients at high risk of breast cancer. (For definitions of risk levels, see Policy Guidelines section.)
Risk-reducing mastectomy is considered investigational for all other indications, including but not limited to contralateral risk-reducing mastectomy in women with breast cancer who do not meet high-risk criteria.


Nerve Graft With Radical Prostatectomy

Unilateral or bilateral nerve graft is considered investigational in patients who have had resection of one or both neurovascular bundles as part of a radical prostatectomy.


Isolated Limb Perfusion/Infision for Malignant Melanoma

Isolated Limb Perfusion (ILP)
When used as a therapeutic treatment of local recurrence of nonresectable melanoma (i.e., satellite lesions or “in transit” melanoma), isolated limb perfusion with melphalan may be considered medically necessary.

When used as an adjuvant treatment of surgically treated locally recurrent melanoma with no other evidence of disease, isolated limb perfusion with melphalan is considered investigational.

Isolated limb perfusion in conjunction with hyperthermia or isolated limb perfusion using melphalan in conjunction with tumor necrosis factor or interferon gamma is considered investigational.

When used as an adjuvant treatment of surgically treated primary malignant melanoma with no clinical evidence of disease, isolated limb perfusion with melphalan is considered not medically necessary.

Isolated Limb Infusion (ILI)

When used as a therapeutic treatment of local recurrence of nonresectable melanoma (i.e., satellite lesions or “in transit” melanoma), isolated limb infusion with melphalan may be considered medically necessary.

Isolated limb infusion in the treatment of melanoma is considered investigational for all other indications.


TONSILECTOMIA ASISTIDA POR LASER

Tonsilectomia asistida por láser realizada en una o más sesiones no procede para pago. Tonsilectomia parcial o subtotal (criptolisis) no procede para pago.Estudios no han demostrado que el uso de láser mejore los resultados al compararlo con procedimiento convencional.


Radiofrequency Ablation of Miscellaneous Solid Tumors Excluding Liver Tumors 

Osteolytic bone metastases
Radiofrequency ablation may be considered medically necessary to palliate pain in individuals with osteolytic bone metastases who have failed or are poor candidates for standard treatments such as radiation or opioids.

Osteoid osteomas

Radiofrequency ablation may be considered medically necessary to treat osteoid osteomas that cannot be managed successfully with medical treatment.

Renal cell carcinoma

Radiofrequency ablation may be considered medically necessary to treat localized renal cell carcinoma that is no more than 4 cm in size when criteria 1 and 2 are met:

When it is necessary to preserve kidney function in individuals with significantly impaired renal function (ie, the individual has 1 kidney or renal insufficiency defined by a glomerular filtration rate of <60 mL/min/m2); When the standard surgical approach (ie, resection of renal tissue) is likely to worsen existing kidney function substantially; OR When the individual is not considered a surgical candidate. Non-small-cell lung cancer Radiofrequency ablation may be considered medically necessary to treat an isolated peripheral non-small-cell lung cancer lesion that is no more than 3 cm in size when criteria 1 and 2 are met: When surgical resection or radiotherapy with curative intent is considered appropriate based on stage of disease, however, medical comorbidity renders the individual unfit for those interventions; When the tumor is located at least 1 cm from the trachea, main bronchi, esophagus, aorta, aortic arch branches, pulmonary artery, and the heart. Nonpulmonary tumor(s) metastatic to the lung Radiofrequency ablation may be considered medically necessary to treat malignant nonpulmonary tumor(s) metastatic to the lung that are no more than 3 cm in size when criteria 1 and 2 are met: When it is necessary to preserve lung function because surgical resection or radiotherapy is likely to worsen pulmonary status substantially; OR When the individual is not considered a surgical candidate; When there is no evidence of extrapulmonary metastases; AND the tumor is located at least 1 cm from the trachea, main bronchi, esophagus, aorta, aortic arch branches, pulmonary artery, and the heart. (See the Policy Guidelines section for additional criteria.) Radiofrequency ablation is considered investigational as a technique for ablation of: 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; painful bony metastases as initial treatment; and all other tumors outside the liver including, but not limited to, the head and neck, thyroid, pancreas, adrenal gland, ovary, and pelvic/abdominal metastases of unspecified origin.


Axial Lumbosacral Interbody Fusion

Axial lumbosacral interbody fusion is considered investigational.


Plugs for Anal Fistula Repair

Biosynthetic fistula plugs, including plugs made of porcine small intestine submucosa or of synthetic material, are considered investigational for the repair of anal fistulas.


Occipital Nerve Stimulation

Occipital nerve stimulation is considered investigational for all indications.


Saturation Biopsy for Diagnosis, Staging, and Management of Prostate Cancer

Saturation biopsy is considered investigational in the diagnosis, staging, and management of prostate cancer.


Extracranial Carotid Artery Stenting

Carotid angioplasty with associated stenting and embolic protection may be considered medically necessary in individuals with:
50% to 99% stenosis (North American Symptomatic Carotid Endarterectomy Trial [NASCET] measurement); AND

symptoms of focal cerebral ischemia (transient ischemic attack or monocular blindness) in the previous 120 days, symptom duration less than 24 hours, or nondisabling stroke; AND

anatomic contraindication for carotid endarterectomy (eg, prior radiotherapy or neck surgery, lesions surgically inaccessible, spinal immobility, or tracheostomy).

Carotid angioplasty with associated stenting and embolic protection is considered investigational for all other indications, including but not limited to, individuals with carotid stenosis who are suitable candidates for carotid endarterectomy and patients with carotid artery dissection.

Carotid angioplasty without associated stenting and embolic protection is considered investigational for all indications, including but not limited to, individuals with carotid stenosis who are suitable candidates for carotid endarterectomy and patients with carotid artery dissection.


Facet Joint Denervation

Nonpulsed radiofrequency denervation of cervical facet joints (C3-4 and below) and lumbar facet joints is considered medically necessary when ALL of the following criteria are met.
No prior spinal fusion surgery in the vertebral level being treated; AND

Disabling low back (lumbosacral) or neck (cervical) pain, suggestive of facet joint origin as evidenced by absence of nerve root compression as documented in the medical record on history, physical, and radiographic evaluations; and the pain is not radicular; AND

Pain has failed to respond to 3 months of conservative management, which may consist of therapies such as nonsteroidal anti-inflammatory medications, acetaminophen, manipulation, physical therapy, and a home exercise program; AND

There has been a successful trial of controlled medial branch blocks (see Policy Guidelines section); AND

If there has been a prior successful radiofrequency denervation, a minimum time of 6 months has elapsed since prior radiofrequency treatment (per side, per anatomic level of the spine).

Radiofrequency denervation is considered investigational for the treatment of chronic spinal or back pain for all uses that do not meet the criteria listed above, including but not limited to treatment of thoracic facet joint pain.

All other methods of denervation are considered investigational for the treatment of chronic spinal or back pain, including, but not limited to pulsed radiofrequency denervation, laser denervation, chemodenervation (eg, alcohol, phenol, or high concentration local anesthetics), and cryodenervation.

Therapeutic medial branch blocks are considered investigational.

If there has been a prior successful radiofrequency denervation, additional diagnostic medial branch blocks for the same level of the spine are investigational.


Interspinous and Interlaminar Stabilization/Distraction Devices (Spacers)

Interspinous or interlaminar distraction devices as a stand-alone procedure are considered investigational as a treatment of spinal stenosis.
Use of an interlaminar stabilization device following decompression surgery is considered investigational.


Percutaneous Nephrostolithotomy and Lithetripsy for Kidney Stones

Percutaneous nephrostolithotomy and lithotripsy are considered medically necessary for treating upper urinary tract kidney stones that are symptomatic and cannot be managed conservatively.


Implantable Cardioverter Defibrillators

Adults
The use of the automatic implantable cardioverter defibrillator (ICD) may be considered medically necessary in adults who meet the following criteria.

Primary Prevention

Ischemic cardiomyopathy with New York Heart Association (NYHA) functional class II or III symptoms, a history of myocardial infarction at least 40 days before ICD treatment, and left ventricular ejection fraction of 35% or less; or
Ischemic cardiomyopathy with NYHA functional class I symptoms, a history of myocardial infarction at least 40 days before ICD treatment, and left ventricular ejection fraction of 30% or less; or
Nonischemic dilated cardiomyopathy and left ventricular ejection fraction of 35% or less, after reversible causes have been excluded, and the response to optimal medical therapy has been adequately determined; or
Hypertrophic cardiomyopathy (HCM) with 1 or more major risk factors for sudden cardiac death (history of premature HCM-related sudden death in ≥1 first-degree relatives younger than 50 years; left ventricular hypertrophy >30 mm; ≥1 runs of nonsustained ventricular tachycardia at heart rates of ≥120 beats per minute on 24-hour Holter monitoring; prior unexplained syncope inconsistent with neurocardiogenic origin) and judged to be at high risk for sudden cardiac death by a physician experienced in the care of patients with HCM.
Diagnosis of any one of the following cardiac ion channelopathies and considered to be at high risk for sudden cardiac death (see Policy Guidelines section):

congenital long QT syndrome; OR
Brugada syndrome; OR
short QT syndrome; OR
catecholaminergic polymorphic ventricular tachycardia.

Diagnosis of cardiac sarcoid and considered to be at high risk for sudden cardiac death (see Policy Guidelines section)

Secondary Prevention

Patients with a history of a life-threatening clinical event associated with ventricular arrhythmic events such as sustained ventricular tachyarrhythmia, after reversible causes (eg, acute ischemia) have been excluded.

The use of the ICD is considered investigational in primary prevention patients who:

have had an acute myocardial infarction (ie, <40 days before ICD treatment); have NYHA class IV congestive heart failure (unless patient is eligible to receive a combination cardiac resynchronization therapy ICD device); have had a cardiac revascularization procedure in past 3 months (coronary artery bypass graft or percutaneous transluminal coronary angioplasty) or are candidates for a cardiac revascularization procedure; or have noncardiac disease that would be associated with life expectancy less than 1 year. The use of the ICD for secondary prevention is considered investigational for patients who do not meet the criteria for secondary prevention. Pediatrics The use of the ICD may be considered medically necessary in children who meet any of the following criteria: survivors of cardiac arrest, after reversible causes have been excluded; symptomatic, sustained ventricular tachycardia in association with congenital heart disease in patients who have undergone hemodynamic and electrophysiologic evaluation; or congenital heart disease with recurrent syncope of undetermined origin in the presence of ventricular dysfunction or inducible ventricular arrhythmias. HCM with 1 or more major risk factors for sudden cardiac death (history of premature HCM-related sudden death in ≥1 first-degree relatives <50 years; massive left ventricular hypertrophy based on age-specific norms; prior unexplained syncope inconsistent with neurocardiogenic origin) and judged to be at high risk for sudden cardiac death by a physician experienced in the care of patients with HCM. diagnosis of any one of the following cardiac ion channelopathies and considered to be at high risk for sudden cardiac death (see Policy Guidelines): congenital long QT syndrome; OR Brugada syndrome; OR short QT syndrome; OR catecholaminergic polymorphic ventricular tachycardia. The use of the ICD is considered investigational for all other indications in pediatric patients. Subcutaneous Implantable Cardioverter Defibrillator (ICD) The use of a subcutaneous ICD may be considered medically necessary for adults or children who have an indication for ICD implantation for primary or secondary prevention for any of the above reasons and meet all of the following criteria: Have a contraindication to a transvenous ICD due to 1 or more of the following: (1) lack of adequate vascular access; (2) compelling reason to preserve existing vascular access (ie, need for chronic dialysis; younger patient with anticipated long-term need for ICD therapy); or (3) history of need for explantation of a transvenous ICD due to a complication, with ongoing need for ICD therapy. Have no indication forantibradycardia pacing; AND Do not have ventricular arrhythmias known or anticipated to respond to antitachycardia pacing. The use of a subcutaneous ICD is considered investigational for individuals who do not meet the criteria outlined above.


Balloon Ostial Dilation for Treatment of Chronic and Recurrent Acute Rhinosinusitis

Use of a catheter-based inflatable device (balloon ostial dilation) for the treatment of chronic rhinosinusitis in the sinus being considered for dilation may be medically necessary when the following criteria are present:
Patient is 18 years of age or older (see Policy Guidelines for younger ages).

AND

Chronic rhinosinusitis without nasal polyps that negatively impacts quality of life, characterized by at least two of the following, at least one of which is (a) or (b), present for at least 12 continuous weeks:

Mucopurulent nasal drainage (anterior, posterior, or both);

Nasal obstruction (congestion);

Facial pain-pressure-fullness;

Decreased sense of smell.

AND

Optimal medical therapy has been attempted and failed, as indicated by all of the following:

Allergy evaluation, education, and optimal treatment when indicated;

Two 10-day courses of antibiotics, or one prolonged course of at least 21 days duration;

Decongestants when indicated;

Topical and/or systemic corticosteroids for at least 8 weeks;

Saline nasal irrigation for at least 8 consecutive weeks;

Treatment of rhinitis medicamentosa (rebound nasal congestion due to extended use of topical decongestants), when present;

Education on environmental irritants including tobacco smoke.

AND

Clinical and radiographic documentation of persistent inflammation following optimal medical therapy (see Policy Guidelines).

The use of balloon ostial dilation for the treatment of chronic rhinosinusitis is considered investigational when the above criteria are not met.

The use of balloon ostial dilation for the treatment of recurrent acute rhinosinusitis is considered investigational.


Percutaneous and Subcutaneous Tibial Nerve Stimulation

Percutaneous tibial nerve stimulation for an initial 12-week course is considered medically necessary for individuals with non-neurogenic urinary dysfunction including overactive bladder who have both:
failed behavioral therapy following an appropriate duration of 8 to 12 weeks without meeting treatment goals; and

failed pharmacologic therapy following 4 to 8 weeks of treatment without meeting treatment goals.

Maintenance therapy using monthly percutaneous tibial nerve stimulation is considered medically necessary for individuals following a 12-week initial course of percutaneous tibial nerve stimulation that resulted in improved urinary dysfunction meeting treatment goals.

Percutaneous tibial nerve stimulation is considered investigational for all other indications, including but not limited to the following:

Neurogenic bladder dysfunction;

Fecal incontinence.

Subcutaneous tibial nerve stimulation delivered by an implantable peripheral neurostimulator system (e.g., eCoin®) is considered investigational for all indications, including individuals with non-neurogenic urinary dysfunction including overactive bladder.


Auditory Brainstem Implant

Unilateral use of an auditory brainstem implant (using surface electrodes on the cochlear nuclei) may be considered medically necessary in patients with neurofibromatosis type 2, who are 12 years of age or older, and who are rendered deaf due to bilateral resection of neurofibromas of the auditory nerve.
An auditory brainstem implant is considered investigational for all other conditions including non-neurofibromatosis type 2 indications.

Bilateral use of an auditory brainstem implant is considered investigational.

Penetrating electrode auditory brainstem implant is considered investigational.


Periureteral Bulking Agents as a Treatment of Vesicoureteral Reflux 

Periureteral bulking agents may be considered medically necessary as a treatment of vesicoureteral reflux grades II, III, or IV when medical therapy has failed and surgical intervention is otherwise indicated.
The use of bulking agents as a treatment of vesicoureteral reflux in other clinical situations is considered investigational.


Thermal Capsulorrhaphy as a Treatment of Joint Instability

Thermal capsulorrhaphy is considered not medically necessary as a treatment of joint instability, including, but not limited to the shoulder, knee, and elbow.


Wireless Pressure Sensors in Endovascular Aneurysm Repair

Use of wireless pressure sensors is considered investigational for the management (intraoperative and/or postoperative) of patients having endovascular aneurysm repair.


Radiofrequency Ablation of Primary or Metastatic Liver Tumors

Radiofrequency ablation of primary, inoperable (eg, due to location of lesion[s] and/or comorbid conditions), hepatocellular carcinoma may be considered medically necessary under the following conditions:
as a primary treatment of hepatocellular carcinoma meeting the Milan criteria (a single tumor of ≤5 cm or up to 3 nodules <3 cm). as a bridge to transplant, where the intent is to prevent further tumor growth and to maintain an individual's candidacy for liver transplant. Radiofrequency ablation as a primary treatment of inoperable hepatic metastases may be considered medically necessary under the following conditions: metastases are of colorectal origin and meet the Milan criteria (a single tumor of ≤5 cm or up to 3 nodules <3 cm). metastases are of neuroendocrine origin and systemic therapy has failed to control symptoms. Radiofrequency ablation of primary, inoperable, hepatocellular carcinoma is considered investigational under the following conditions: when there are more than 3 nodules or when not all sites of tumor foci can be adequately treated. when used to downstage (downsize) hepatocellular carcinoma in individuals being considered for liver transplant. Radiofrequency ablation of primary, operable hepatocellular carcinoma is investigational. Radiofrequency ablation for hepatic metastasis is considered investigational for: hepatic metastases from colorectal cancer or neuroendocrine tumors that do not meet the criteria above; and for hepatic metastases from other types of cancer except colorectal cancer or neuroendocrine tumors.


REEMPLAZO DE TOBILLO

El reemplazo total del tobillo usando un dispositivo aprobado por FDA se considera para pago en pacientes maduros esqueletalmente con dolor moderado a severo en el tobillo (tibiotalar) y que limita las actividades diarias y que va acompañado con las siguientes condiciones:Artritis en coyunturas adyacentes

Subtalar o mediopie
Artritis severa del tobillo contralateral

Artrodesis del tobillo contralateral

Artritis inflamatoria reumatoide

Contraindicaciones absolutas para realizar una artroplastia del tobillo:
Necrosis avascular extensa en talus

Tejido adyacente incluyendo hueso,musculo y piel comprometida

Mala alineación de intensidad severa de más de 15 grados no corregible con cirugía.

Inflexión activa de la coyuntura del tobillo.

Enfermedad periferovascular

Neuroatropatia de CharCot

Contraindicaciones relativas:
Neuropatía periférica

Inestabilidad de los ligamentos

Subluxación del talus

Historial de infecciones en el tobillo

Presencia de deformidades severas por encima o por debajo del tobillo

Reemplazo total del tobillo no se considera para pago en cualquier otra situación.


Artificial Intervertebral Disc: Cervical Spine

Cervical disc arthroplasty may be considered medically necessary when ALL of the following criteria are met:
The device is approved by the U.S. Food and Drug Administration (FDA);

The individual is skeletally mature;

The individual has intractable cervical radicular pain or myelopathy

which has failed at least 6 weeks of conservative nonoperative treatment, including an active pain management program or protocol, under the direction of a physician, with pharmacotherapy that addresses neuropathic pain and other pain sources AND physical therapy; OR

if the individual has severe or rapidly progressive symptoms of nerve root or spinal cord compression requiring hospitalization or immediate surgical treatment;

Degeneration is documented by magnetic resonance imaging, computed tomography, or myelography;

Cervical degenerative disc disease is from C3 through C7; and

The individual is free from contraindications to cervical disc arthroplasty.

Simultaneous cervical disc arthroplasty at a second contiguous level may be considered medically necessary if the above criteria are met for each disc level, and the device is FDA-approved for 2 levels (eg, Mobi-C®, Prestige LP™).

Subsequent cervical disc arthroplasty at an adjacent level may be considered medically necessary when all of the following are met:

Criteria 1 to 6 above are met; and

The device is FDA-approved for 2 levels; and

The planned subsequent procedure is at a different cervical level than the initial cervical artificial disc replacement; and

Clinical documentation that the initial cervical artificial intervertebral disc implantation is fully healed.

Cervical disc arthroplasty is considered investigational for all other indications, including the following:

Disc implantation at more than 2 levels

Combined use of an artificial cervical disc and fusion

Prior surgery at the treated level

Previous fusion at another cervical level

Translational instability

Anatomic deformity (eg, ankylosing spondylitis)

Rheumatoid arthritis or other autoimmune disease

Presence of facet arthritis

Active infection

Metabolic bone disease (eg, osteoporosis, osteopenia, osteomalacia)

Malignancy.


Transmyocardial Revascularization

Transmyocardial laser revascularization may be considered medically necessary for individuals with class III or IV angina, who are not candidates for coronary artery bypass graft surgery or percutaneous transluminal coronary angioplasty surgery, who meet ALL of the following criteria:
Presence of class III or IV angina refractory to medical management

Documentation of reversible ischemia

Left ventricular ejection fraction greater than 30%

No evidence of recent myocardial infarction or unstable angina within the last 21 days

No severe comorbid illness such as chronic obstructive pulmonary disease.

Transmyocardial laser revascularization may be considered medically necessary as an adjunct to coronary artery bypass graft in those individuals with documented areas of ischemic myocardium that are not amenable to surgical revascularization.

Transmyocardial laser revascularization is considered investigational for all other indications not meeting the above criteria.

Percutaneous transmyocardial laser revascularization is considered investigational.


Extracorporeal Shock Wave Lithotripsy (ESWL)

Extracorporeal Shock Wave Lithotripsy (ESWL) is considered for payment at the treatment of kidney stones.The following situations must be met:
· Calculi greater than 3mm in diameter.
· No more than three calculi present.
· The stone must be symptomatic and the chances of it passing spontaneously
they should be low.
· Urinary infections must be under control.
· There should be no obstructions to the urinary tract.
· The patient’s anatomy should facilitate the procedure.
· The treated kidney must be functional.
· There should be no renal artery calcifications or renal artery aneurysms.


OTOPLASTY

Reconstructive surgery of the ear is considered for payment if it meets the following criteria:
• When the deformity or absence of the ear is the result of trauma or illness.

• If because of this condition there is significant loss of hearing. This must be documented.

It is not considered for payment if:

• This is for correcting large or prominent ears or injury resulting from piercing or from normal aging.

• The deformity is not for the reasons stated above.


Phototherapeutic  Keratectomy

Phototherapeutic keratectomy is considered for payment when used as an alternative to lamellar keratoplasty in the treatment of visual or irritative problems related to to corneal scars, opacities or dystrophies that extend beyond the layer epithelial.Phototherapeutic keratectomy is not considered for payment under the following conditions:

Description
Tuberculosis of the eye
Keratoconjunctivitis due to Herpes zoster
Herpes simplex conjunctivitis
Measles keratoconjunctivitis
Keratoconjunctivitis epidemic
syphilitic interstitial keratitis
Keratitis or keratoconjunctivitis in exanthema


Policy Name:  Deep Brain Stimulation

Unilateral deep brain stimulation of the thalamus may be considered medically necessary in individuals with disabling, medically unresponsive tremor due to essential tremor or Parkinson disease.
Bilateral deep brain stimulation of the thalamus may be considered medically necessary in individuals with disabling, medically unresponsive tremor in both upper limbs due to essential tremor or Parkinson disease.

Unilateral or bilateral deep brain stimulation of the globus pallidus or subthalamic nucleus may be considered medically necessary in the following individuals:

·         Those with Parkinson disease and ALL of the following:

o    a good response to levodopa; AND

o    motor complications not controlled by pharmacologic therapy; AND

o    one of the following:

§  a minimum score of 30 points on the motor portion of the Unified Parkinson Disease Rating Scale when the patient has been without medication for approximately 12 hours OR

§  Parkinson disease for at least 4 years

·         Individuals older than 7 years with chronic, intractable (drug-refractory) primary dystonia, including generalized and/or segmental dystonia, hemidystonia, and cervical dystonia (torticollis).

Deep brain stimulation for other movement disorders, including but not limited to tardive dyskinesia and post-traumatic dyskinesia, is considered investigational.

Deep brain stimulation for the treatment of chronic cluster headaches is considered investigational.

Deep brain stimulation for the treatment of other psychiatric or neurologic disorders, including but not limited to epilepsy, Tourette syndrome, depression, obsessive-compulsive disorder, anorexia nervosa, alcohol addiction, Alzheimer disease, multiple sclerosis tremor, and chronic pain, is considered investigational.


Vagus Nerve Stimulation

Vagus nerve stimulation may be considered medically necessary as a treatment of medically refractory seizures.
Vagus nerve stimulation is considered investigational as a treatment of other conditions, including but not limited to depression, heart failure, upper-limb impairment due to stroke, essential tremor, headaches, fibromyalgia, tinnitus, and traumatic brain injury.

Transcutaneous (nonimplantable) vagus nerve stimulation devices are considered investigational for all indications.


Spinal Cord and Dorsal Root Ganglion Stimulation

Spinal cord stimulation with standard or high-frequency stimulation may be considered medically necessary for the treatment of severe and chronic pain of the trunk or limbs that is refractory to all other pain therapies when performed according to policy guidelines.
Dorsal root ganglion neurostimulation is considered medically necessary for the treatment of severe and chronic pain of the trunk or limbs that is refractory to all other pain therapies when performed according to policy guidelines.

Spinal cord stimulation is considered investigational in all other situations including, but not limited to, treatment of critical limb ischemia to forestall amputation and treatment of refractory angina pectoris, heart failure, and cancer-related pain.


Bone Morphogenetic Protein

Use of recombinant human bone morphogenetic protein-2 (Infuse™) may be considered medically necessary in skeletally mature individuals :
For anterior lumbar interbody fusion procedures when the use of autograft is not feasible;

For instrumented posterolateral intertransverse spinal fusion procedures when the use of autograft is not feasible;

For the treatment of acute, open fracture of the tibial shaft, when the use of autograft is not feasible.

Use of recombinant human bone morphogenetic protein-2 is considered investigationalfor all other indications, including but not limited to spinal fusion when the use of autograft is feasible and craniomaxillofacial surgery.


Automated Percutaneous and Percutaneous Endoscopic Discectomy

Automated percutaneous discectomy is considered investigational as a technique of intervertebral disc decompression in patients with back pain and/or radiculopathy related to disc herniation in the lumbar, thoracic, or cervical spine.
Percutaneous endoscopic discectomy is considered investigational as a technique of intervertebral disc decompression in patients with back pain and/or radiculopathy related to disc herniation in the lumbar, thoracic, or cervical spine.


Meniscal Allografts and Other Meniscal Implants

Meniscal allograft transplantation may be considered medically necessary in patients who have had a prior meniscectomy and have symptoms related to the affected side when all of the following criteria are met:
Adult patients should be too young to be considered an appropriate candidate for total knee arthroplasty or other reconstructive knee surgery (eg, <55 years) Disabling knee pain with activity that is refractory to conservative treatment Absence or near absence (>50%) of the meniscus, established by imaging or prior surgery
Documented minimal to absent diffuse degenerative changes in the surrounding articular cartilage (eg, Outerbridge grade II or less, <50% joint space narrowing) Normal knee biomechanics or alignment and stability achieved concurrently with meniscal transplantation. Meniscal allograft transplantation may be considered medically necessary when performed in combination, either concurrently or sequentially, with treatment of focal articular cartilage lesions using any of the following procedures: autologous chondrocyte implantation, or osteochondral allografting, or osteochondral autografting. Use of other meniscal implants incorporating materials such as collagen are considered investigational.


Post-Surgery Reconstructive Surgery Bariatric

Reconstructive procedures on the breasts, abdomen, back and lower back when you meet the following criteria established by SSS:· Intractable skin infection documented by dermatologist.
· One year must have elapsed after bariatric surgery or loss of weight by another method.
· Weight must have been stable for at least 4 months before reconstructive surgery
· The tension and elasticity of the skin varies greatly, at least a loss of 70% of the total expected loss.

This should be calculated:
o Starting weight minus achieved weight, divided by starting weight minus weight ideal = > 70%
o The ideal weight is the one that corresponds to a BMI of 24 kg/m2 for that patient in particular.
· It is expected that in a tummy tuck they will remove four to six and a half pounds and in a breast reconstruction up to four and a half pounds.
· Hernia repair and abdominal diastasis recti repair are included in the price of abdominoplasties. If the plastic surgeon requests the intervention of another surgeon for the repair, the first will be responsible for the payment of this procedure to the other surgeon.

· All cases require prior authorization.
· The collection of deductibles or co-payments to the insured will not proceed.
· Surgical assistance will not be paid, nor can it be charged to the insured.


Implantable Bone-Conduction and Bone-Anchored Hearing Aids

Unilateral or bilateral fully or partially implantable bone-conduction (bone-anchored) hearing aid(s) may be considered medically necessary as an alternative to an air-conduction hearing aid in individuals 5 years of age and older with conductive or mixed hearing loss who also meet at least one of the following medical criteria:
Congenital or surgically induced malformations (eg, atresia) of the external ear canal or middle ear; or

Chronic external otitis or otitis media; or

Tumors of the external canal and/or tympanic cavity; or

Dermatitis of the external canal;

and meet the following audiologic criteria:

A pure-tone average bone-conduction threshold measured at 0.5, 1, 2, and 3 kHz of better than or equal to 45 dB (OBC and BP100 devices), 55 dB (Intenso device), or 65 dB (Cordele II device).

For bilateral implantation, individuals should meet the above audiologic criteria and have symmetrically conductive or mixed hearing loss as defined by a difference between left- and right-side bone-conduction threshold of less than 10 dB on average measured at 0.5, 1, 2, and 3 kHz (4 kHz for OBC and Ponto Pro), or less than 15 dB at individual frequencies.

An implantable bone-conduction (bone-anchored) hearing aid may be considered medically necessary as an alternative to an air-conduction contralateral routing of signal hearing aid in individuals5 years of age and older with single-sided sensorineural deafness and normal hearing in the other ear. The pure-tone average air-conduction threshold of the normal ear should be better than 20 dB measured at 0.5, 1, 2, and 3 kHz.

Other uses of implantable bone-conduction (bone-anchored) hearing aids, including use in individuals with bilateral sensorineural hearing loss, are considered investigational.


Policy Name:    

Surgical ventricular restoration is considered investigational for the treatment of ischemic dilated cardiomyopathy.


CIRUGIA ROBOTICA (Prostatectomía Radical Laparoscópica)

La prostatectomía radical por laparoscopía asistida por robot se considera para pago.


Intraoperative Neurophysiologic Monitoring

Intraoperative neurophysiologic monitoring, which includes somatosensory-evoked potentials, motor-evoked potentials using transcranial electrical stimulation, brainstem auditory-evoked potentials, electromyography of cranial nerves, electroencephalography, and electrocorticography, may be considered medically necessary during spinal, intracranial, or vascular procedures.
Intraoperative neurophysiologic monitoring of the recurrent laryngeal nerve may be considered medically necessary in patients undergoing:

high-risk thyroid or parathyroid surgery, including:

total thyroidectomy

repeat thyroid or parathyroid surgery

surgery for cancer

thyrotoxicosis

retrosternal or giant goiter

thyroiditis.

anterior cervical spine surgery associated with any of the following increased risk situations:

prior anterior cervical surgery, particularly revision anterior cervical discectomy and fusion, revision surgery through a scarred surgical field, reoperation for pseudarthrosis, or revision for failed fusion

multilevel anterior cervical discectomy and fusion

preexisting recurrent laryngeal nerve pathology, when there is residual function of the recurrent laryngeal nerve.

Intraoperative neurophysiologic monitoring of the recurrent laryngeal nerve during anterior cervical spine surgery not meeting the criteria above or during esophageal surgeries is considered investigational.

Intraoperative monitoring of visual-evoked potentials is considered investigational.

Due to the lack of monitors approved by the U.S. Food and Drug Administration, intraoperative monitoring of motor-evoked potentials using transcranial magnetic stimulation is considered investigational.

Intraoperative electromyography and nerve conduction velocity monitoring during surgery on the peripheral nerves is considered investigational.

Note: These policy statements refer only to use of these techniques as part of intraoperative monitoring. Other clinical applications of these techniques, such as visual-evoked potentials and electromyography, are not considered in this policy.


Autografts and Allografts in the Treatment of Focal Articular Cartilage Lesions

Fresh osteochondral allografting may be considered medically necessary as a technique to repair:
Full-thickness chondral defects of the knee caused by acute or repetitive trauma when other cartilage repair techniques (eg, microfracture, osteochondral autografting or autologous chondrocyte implantation) would be inadequate due to lesion size, location, or depth.

Large (area >1.5 cm2) or cystic (volume >3.0 cm3) osteochondral lesions of the talus when autografting would be inadequate due to lesion size, depth, or location.

Revision surgery after failed prior marrow stimulation for large (area >1.5 cm2) or cystic (volume >3.0 cm3) osteochondral lesions of the talus when autografting would be inadequate due to lesion size, depth or location.

Osteochondral allografting for all other joints is considered investigational.

Osteochondral autografting, using 1 or more cores of osteochondral tissue, may be considered medically necessary:

For the treatment of symptomatic full-thickness cartilage defects of the knee caused by acute or repetitive trauma in patients who have had an inadequate response to a prior surgical procedure, when all of the following have been met:

Adolescent patients should be skeletally mature with documented closure of growth plates (eg, ≥15 years). Adult patients should be too young to be considered an appropriate candidate for total knee arthroplasty or other reconstructive knee surgery (eg, ≤55 years)

Focal, full-thickness (grade III or IV) unipolar lesions on the weight-bearing surface of the femoral condyles, trochlea, or patella that are between 1 and 2.5 cm2 in size

Documented minimal to absent degenerative changes in the surrounding articular cartilage (Outerbridge grade II or less), and normal-appearing hyaline cartilage surrounding the border of the defect

Normal knee biomechanics or alignment and stability achieved concurrently with osteochondral grafting.

Large (area >1.5 cm2) or cystic (volume >3.0 cm3) osteochondral lesions of the talus.

Revision surgery after failed marrow stimulation for osteochondral lesion of the talus.

Osteochondral autografting for all other joints and any indications other than those listed above is considered investigational.

Treatment of focal articular cartilage lesions with autologous minced or particulated cartilage is considered investigational.

Treatment of focal articular cartilage lesions with allogeneic minced or particulated cartilage is considered investigational.

Treatment of focal articular cartilage lesions with decellularized osteochondral allograft plugs (eg, Chondrofix) is considered investigational.

Treatment of focal articular cartilage lesions with reduced osteochondral allograft discs (eg, ProChondrix, Cartiform) is considered investigational.


Percutaneous Intradiscal Electrothermal Annuloplasty, Radiofrequency Annuloplasty, Biacuplasty and Intraosseous Basivertebral Nerve Ablation

Percutaneous annuloplasty (eg, intradiscal electrothermal annuloplasty, intradiscal radiofrequency annuloplasty, or intradiscal biacuplasty) for the treatment of chronic discogenic back pain is considered investigational.
Intraosseous radiofrequency ablation of the basivertebral nerve (e.g., Intracept® system) for the treatment of vertebrogenic back pain is considered investigational.


07.001.041

Bilateral or unilateral cochlear implantation of a U.S. Food and Drug Administration (FDA)‒approved cochlear implant may be considered medically necessary in patients ages 12 months and older with bilateral severe-to-profound pre- or postlingual (sensorineural) hearing loss, defined as a hearing threshold pure-tone average of 70 dB hearing loss or greater at 500, 1000, and 2000 Hz, who have shown limited or no benefit from hearing aids.
Cochlear implantation as a treatment for patients with unilateral hearing loss with or without tinnitus is considered investigational.

Upgrades of an existing, functioning external system to achieve aesthetic improvement, such as smaller profile components or a switch from a body-worn, external sound processor to a behind-the-ear model, are considered investigational.

Replacement of internal and/or external components solely for the purpose of upgrading to a system with advanced technology or to a next-generation device is considered investigational.

Replacement of internal and/or external components is considered medically necessary only in a small subset of members who have inadequate response to existing component(s) to the point of interfering with the individual’s activities of daily living, or the component(s) is/are no longer functional and cannot be repaired. Copies of original medical records must be submitted either hard copy or electronically to support medical necessity.

Cochlear implantation with a hybrid cochlear implant/hearing aid device that includes the hearing aid integrated into the external sound processor of the cochlear implant (eg, the Nucleus® Hybrid™ L24 Cochlear Implant System) may be considered medically necessary for patients ages 18 years and older who meet all of the following criteria:

·         Bilateral severe-to-profound high-frequency sensorineural hearing loss with residual low-frequency hearing sensitivity; AND

·         Receive limited benefit from appropriately fit bilateral hearing aids; AND

·         Have the following hearing thresholds:

o    Low-frequency hearing thresholds no poorer than 60 dB hearing level up to and including 500 Hz (averaged over 125, 250, and 500 Hz) in the ear selected for  implantation; AND

o    Severe-to-profound mid- to high-frequency hearing loss (threshold average of 2000, 3000, and 4000 Hz ≥75 dB hearing level) in the ear to be implanted; AND

o    Moderately severe to profound mid- to high-frequency hearing loss (threshold average of 2000, 3000, and 4000 Hz ≥60 dB hearing level) in the contralateral ear; AND

o    Aided consonant-nucleus-consonant word recognition score from 10% to 60% in the ear to be implanted in the preoperative aided condition and in the contralateral  ear will be equal to or better than                      that of the ear to be implanted but not more than 80% correct.


Computer-Assisted Navigation for Orthopedic Procedures

Computer-assisted surgical navigation for orthopedic procedures is considered investigational.


ARTROPLASTIA DE CADERA POR METODO MINIMAMENTE INVASIVO

La artroplastia minimamente invasiva para reemplazo de cadera o reemplazo de rodilla se considera para pago cuando se realiza en pacientes adecuadamente seleccionados por cirujanos adecuadamente entrenados y experimentados en las técnicas utilizadas y la institución donde se realiza esta debidamente acreditada con un programa abarcador de rehabilitación postoperatoria.Se consideran pacientes selectos aquellos que cumplan con los criterios para reemplazo de cadera o rodilla y no son obesos y están motivados a participar en un programa acelerado de rehabilitación.


Transurethral Water Vapor Thermal Therapy and Transurethral Water Jet Ablation (Aquablation) for Benign Prostatic Hypertrophy

Transurethral water vapor thermal therapy is considered investigational as a treatment of benign prostatic hyperplasia.
Transurethral waterjet ablation (aquablation) is considered investigational as a treatment of benign prostatic hyperplasia.


Whole Gland Cryoablation of Prostate Cancer

Whole gland cryoablation of the prostate may be considered medically necessary as treatment of clinically localized (organ-confined) prostate cancer when performed
as initial treatment or

as salvage treatment of disease that recurs following radiotherapy.


Treatment of Varicose Veins/Venous Insufficiency

Saphenous Veins
Great or Small Saphenous Veins

Treatment of the great or small saphenous veins by surgery (ligation and stripping), endovenous thermal ablation (radiofrequency or laser), microfoam sclerotherapy or cyanoacrylate adhesive may be considered medically necessary for symptomatic varicose veins/venous insufficiency when the following criteria have been met:

There is demonstrated saphenous reflux and CEAP [Clinical, Etiology, Anatomy, Pathophysiology] class C2 or greater; AND

There is documentation of 1 or more of the following indications:

Ulceration secondary to venous stasis; OR

Recurrent superficial thrombophlebitis; OR

Hemorrhage or recurrent bleeding episodes from a ruptured superficial varicosity; OR

Persistent pain, swelling, itching, burning, or other symptoms are associated with saphenous reflux, AND the symptoms significantly interfere with activities of daily living, AND conservative management including compression therapy for at least 3 months has not improved the symptoms.

Treatment of great or small saphenous veins by surgery, endovenous radiofrequency or laser ablation, microfoam sclerotherapy or cyanoacrylate adhesive that does not meet the criteria described above is considered cosmetic and is considered investigational.

Accessory Saphenous Veins

Treatment of accessory saphenous veins by surgery (ligation and stripping), endovenous radiofrequency or laser ablation, microfoam sclerotherapy or cyanoacrylate adhesive may be considered medically necessary for symptomatic varicose veins/venous insufficiency when the following criteria have been met:

Incompetence of the accessory saphenous vein is isolated, AND

There is demonstrated accessory saphenous reflux; AND

There is documentation of 1 or more of the following indications:

Ulceration secondary to venous stasis; OR

Recurrent superficial thrombophlebitis; OR

Hemorrhage or recurrent bleeding episodes from a ruptured superficial varicosity; OR

Persistent pain, swelling, itching, burning, or other symptoms are associated with saphenous reflux, AND the symptoms significantly interfere with activities of daily living, AND conservative management including compression therapy for at least 3 months has not improved the symptoms.

Concurrent treatment of the accessory saphenous veins along with the great or small saphenous veins may be considered medically necessary when criteria is met for each vein and there is documentation of anatomy showing that the accessory saphenous vein discharged directly into the common femoral vein.

Treatment of accessory saphenous veins by surgery, endovenous radiofrequency or laser ablation, or microfoam sclerotherapy or cyanoacrylate adhesive that does not meet the criteria described above is considered cosmetic and investigational.

Symptomatic Varicose Tributaries

The following treatments are considered medically necessary as a component of the treatment of symptomatic varicose tributaries when performed either at the same time or following prior treatment (surgical, radiofrequency, or laser) of the saphenous veins (none of these techniques has been shown to be superior to another):

Stab avulsion

Hook phlebectomy

Sclerotherapy

Transilluminated powered phlebectomy.

Treatment of symptomatic varicose tributaries, when performed either at the same time or following prior treatment of saphenous veins using any other techniques than those noted above, is considered investigational.

Perforator Veins

Surgical ligation (including subfascial endoscopic perforator surgery) or endovenous radiofrequency or laser ablation of incompetent perforator veins may be considered medically necessary as a treatment of leg ulcers associated with chronic venous insufficiency when the following conditions have been met:

There is demonstrated perforator reflux; AND

The superficial saphenous veins (great, small, or accessory saphenous and symptomatic varicose tributaries) have been previously eliminated; AND

Ulcers have not resolved following combined superficial vein treatment and compression therapy for at least 3 months; AND

The venous insufficiency is not secondary to deep venous thromboembolism.

Ligation or ablation of incompetent perforator veins performed concurrently with superficial venous surgery is investigational.

Telangiectasia

Treatment of telangiectasia such as spider veins, angiomata, and hemangiomata is considered cosmetic and investigational.

Other Veins

Techniques for conditions not specifically listed above are investigational, including, but not limited to:

Sclerotherapy techniques, other than microfoam sclerotherapy, of great, small, or accessory saphenous veins

Sclerotherapy of perforator veins

Sclerotherapy of isolated tributary veins without prior or concurrent treatment of saphenous veins

Stab avulsion, hook phlebectomy, or transilluminated powered phlebectomy of perforator, great or small saphenous, or accessory saphenous veins

Endovenous radiofrequency or laser ablation of tributary veins

Mechanochemical ablation of any vein

Endovenous cryoablation of any vein.


Reduction Mammaplasty for Breast-Related Symptoms

Reduction mammaplasty may be considered medically necessary for the treatment of macromastia when well-documented clinical symptoms are present, including but not limited to:
· Documentation of a minimum 6-week history of shoulder, neck, or back pain related to macromastia not responsive to conservative therapy, such as an appropriate support bra, exercises, heat/cold treatment, and appropriate nonsteroidal anti-inflammatory agents or muscle relaxants; OR

· Recurrent or chronic intertrigo between the pendulous breast and the chest wall.

Reduction mammaplasty is considered investigational for all other indications not meeting the above criteria.


Reconstructive Breast Surgery/Management of Breast Implants after Mastectomy

Coverage eligibility of breast implants for the purposes of augmentation may depend on contract language. After reconstructive breast surgery on one side, insertion of an implant on the contralateral, normal side is rarely necessary to achieve symmetry.
Reconstructive breast surgery may be considered medically necessary after a medically necessary mastectomy, accidental injury, or trauma. Medically necessary mastectomies are most typically done as treatment for cancer. Reconstruction may be performed by an implant-based approach or through the use of autologous tissue.

Explantation of a silicone gel-filled breast implant may be considered medically necessary in all cases for a documented implant rupture, infection, extrusion, Baker class IV contracture, or surgical treatment of breast cancer.

Explantation of a ruptured saline-filled breast implant may be considered medically necessary only in those individuals who had originally undergone breast implantation for reconstructive purposes. Otherwise, indications for the explantation of a saline-filled implant are similar to those of a silicone-filled implant.

Explantation of a breast implant associated with a Baker class III contracture may be considered medically necessary only in those individuals who had originally undergone breast implantation for reconstructive purposes.

Reconstructive breast surgery after explantation of an implant is considered medically necessary only in those individuals who had originally undergone breast implantation for reconstructive purposes.

The following indications for explantation of implants are considered investigational:

Systemic symptoms, attributed to connective tissue diseases, autoimmune diseases;

Anxiety;

Baker class III contractures in individuals with implants for cosmetic purposes;

Rupture of a saline implant in individuals with implants for cosmetic purposes;

Pain not related to contractures;

Preventive explantation in asymptomatic individuals to reduce remote risk of anaplastic large cell lymphoma;

Preventive explantation in asymptomatic individuals to reduce remote risk of B cell lymphoma.


STEREOTACTIC, ULTRASOUND & MRI GUIDED BREAST BIOPSY (MIBB)

Triple-S will consider for payment Stereotactic-guided non-palpable breast lesions that are seen only on mammography (not well visualized on Ultrasound).
Triple-S will consider for payment MRI- guided non-palpable breast lesions that are seen only on MRI  (not well visualized on Ultrasound or mammography).

Triple-S will consider for payment Ultrasound-guided of palpable or non-palpable high-risk breast lesion(s) or masse(s).

Triple-S considers MIBB  is an invasive procedure, which will limit the payment coverage to those surgeons and radiologists who submit evidence of training and experience as established by the «Board of Regents of the American College of Surgeons «and by the» Board of Chancellors of the American College of  Radiology «in the following document: Physician Qualifications for stereotactic breast biopsy: a revised statement. Bulletin of the American College of Surgeons. Vol. 83, No.5, January 2014, and ACR Practice Guideline for the performance of Stereotactic guided Breast interventional procedure of 1996, revised in 2009.

Indications:

a.    Indications – the main use of this technology is obtaining tissue for diagnosis of non-palpable breast lesions. Within this framework, the main indications are the following:

• non-palpable lesions that are highly suggestive of malignancy
• Indeterminate lesions
• Benign lesions associated with multiple risk factors in the patient
• Lesions with well-defined solid mass characteristics, solid lesions with indistinct or spiculated  margins and micro-calcifications

b.    Limitations – Triple-S will consider for payment the stereotactic breast biopsy when the services are rendered in the following places:

• Hospital (inpatient)
• Hospital (outpatient)
• Ambulatory surgery center
• Office


Ilizarov Bone-Lengthening Procedure

These services are considered for payment in the treatment of the following conditions:
• Treatment of post-traumatic osteomyelitis.
• Correction of bone defects with deformities.
• Bone lengthening necessary to match a discrepancy greater than 6 cm.
• Correction of post traumatic deformities or deformities that include limb rotation.
• To lengthen a stump after the amputation to facilitate the process of using the prosthesis.
• For correction of defective union of bone accompanied by bone loss or post-infection.

• In those cases in which the correction of the bone defect is not accompanied by deformity, we recommend evaluation by advisor.
• The use of the upper limb procedure is not considered for payment.
• The use of the technique for the sole purpose of increasing height is not considered for payment.


Electrical Bone Growth Stimulation of the Appendicular Skeleton

Noninvasive electrical bone growth stimulation may be considered medically necessary for the treatment of fracture nonunions or congenital pseudarthrosis in the appendicular skeleton (the appendicular skeleton includes the bones of the shoulder girdle, upper extremities, pelvis, and lower extremities). The diagnosis of fracture nonunion must meet ALL of the following criteria:
at least 3 months have passed since the date of fracture;

serial radiographs have confirmed that no progressive signs of healing have occurred;

the fracture gap is 1 cm or less;

the individual can be adequately immobilized; and

the individual is of an age likely to comply with nonweight bearing for fractures of the pelvis and lower extremities.

Investigational applications of electrical bone growth stimulation include, but are not limited to, delayed union, fresh fracture, stress fractures, immediate postsurgical treatment after appendicular skeletal surgery, arthrodesis, or failed arthrodesis.

Implantable and semi-invasive electrical bone growth stimulators are considered investigational.


CIRUGÍA DE PUENTES CORORIOS (CABG)

Al ocurrir una obstrucción de alguna(s) de la(s) arteria(s) principales del corazón, y si no ha ocurrido muerte de una cantidad significativa del músculo cardíaco, se puede revascularizar mediante la cirugía de puentes coronarios.
Hay varios tipos de estos puentes usando injertos venosos o arteriales. Estos son obtenidos principalmente de la vena safena. Se puede realizar también un puente coronario mediante el uso de la arteria mamaria interna, implantando esta distal a la obstrucción de la coronaria.


Bariatric Surgery

Bariatric Surgery in Adults With Class III Obesity
The following bariatric surgery procedures may be considered medically necessary for the treatment of class III obesity (see Policy Guidelines section for bariatric surgery selection criteria) in adults who have failed weight loss by conservative measures:

·         Open gastric bypass using a Roux-en-Y,

·         Laparoscopic gastric bypass using a Roux-en-Y,

·         Laparoscopic adjustable gastric banding,

·         Sleeve gastrectomy (SG), and

·         Open or laparoscopic biliopancreatic bypass (ie, Scopinaro procedure) with duodenal switch (DS).

Bariatric surgery should be performed in appropriately selected individuals , by surgeons who are adequately trained and experienced in the specific techniques used, and in institutions that support a comprehensive bariatric surgery program, including long-term monitoring and follow-up postsurgery.

The following bariatric surgery procedures are considered investigational for the treatment of class III obesity in adults who have failed weight loss by conservative measures:

·         Vertical-banded gastroplasty,

·         Gastric bypass using a Billroth II type of (mini-gastric bypass),

·         Biliopancreatic diversion (BPD) without DS,

·         Long-limb gastric bypass procedure (ie, >150 cm),

·         Two-stage bariatric surgery procedures (eg, SG as initial procedure followed by BPD at a later time),

·         Laparoscopic gastric plication, and

·         Single anastomosis duodeno-ileal bypass with SG.

The following endoscopic procedures are investigational as a primary bariatric procedure or as a revision procedure (ie, to treat weight gain after bariatric surgery to remedy large gastric stoma or large gastric pouches):

·         Insertion of the StomaphyX™ device,

·         Endoscopic gastroplasty,

·         Use of an endoscopically placed duodenojejunal sleeve,

·         Intragastric balloons, and

·         Aspiration therapy device.

Bariatric Surgery in Individuals With Diabetes and With a BMI > 30 kg/m2

For individuals with diabetes and with a BMI > 30 kg/m2, the following bariatric surgery procedures may be considered medically necessary in adults who have failed weight loss by conservative measures:

·         Biliopancreatic diversion,

·         Laparoscopic adjustable gastric banding,

·         Roux-en-Y gastric bypass, and

·         Sleeve gastrectomy.

Bariatric Surgery in Individuals With a Body Mass Index Less Than 35 kg/m2

Bariatric surgery is considered investigational for individuals with a body mass index less than 35 kg/m2 who do not have diabetes and for all individuals with a BMI < 30 kg/m2. Revision Bariatric Surgery Revision surgery to address perioperative or late complications of a bariatric procedure is considered medically necessary. These include but are not limited to, staple line failure, obstruction, stricture, nonabsorption resulting in hypoglycemia or malnutrition, weight loss of 20% or more below ideal body weight, and band slippage that cannot be corrected with manipulation or adjustment (see Policy Guidelines section). Revision of a primary bariatric procedure that has failed due to dilation of the gastric pouch or dilation proximal to an adjustable gastric band (documented by upper gastrointestinal examination or endoscopy) is considered medically necessary if the initial procedure was successful in inducing weight loss prior to pouch dilation, and the individual has been compliant with a prescribed nutrition and exercise program. Bariatric Surgery in Adolescents Bariatric surgery in adolescents may be considered medically necessary according to similar weight-based criteria used for adults, but greater consideration should be given to psychosocial and informed consent issues (see Policy Guidelines section). In addition, any devices used for bariatric surgery must be used in accordance with the U.S. Food and Drug Administration approved indications. Bariatric Surgery in Preadolescent Children Bariatric surgery is considered investigational for the treatment of class III obesity in preadolescent children. Concomitant Hiatal Hernia Repair With Bariatric Surgery Repair of a hiatal hernia at the time of bariatric surgery may be considered medically necessary for individuals who have a preoperatively diagnosed hiatal hernia with indications for surgical repair (see Policy Guidelines section). Repair of a hiatal hernia that is diagnosed at the time of bariatric surgery, or repair of a preoperatively diagnosed hiatal hernia in individuals who do not have indications for surgical repair is considered investigational.


Transurethral Radiofrequency Needle Ablation of the Prostate

Transurethral radiofrequency needle ablation of the prostate (TUNA) may be considered medically necessary as a treatment of benign prostatic hypertrophy.
Candidates for this procedure are men over 45 years of age with a Prostate with an estimated weight of 80 grams or less, volume of 90 ml or less, with a flow maximum urinal of less than 12cc per second and the urine volume is less than 300cc. Hyperplasia should be predominantly in the lateral lobes and that

demonstrate the symptoms described above for more than three months.

Those patients in whom TURP is contraindicated are included as candidates, tales like anticoagulated patients, hemophiliacs, patients with serious problems cardiovascular or respiratory and very old patients.

Radiofrequency ablation of the prostate is considered for payment as expressed in this policy.


Sacral Nerve Neuromodulation/Stimulation

Urinary Incontinence and Nonobstructive Retention
Criteria A

A trial period of sacral nerve neuromodulation with either percutaneous nerve stimulation or a temporarily implanted lead may be considered medically necessary in individuals who meet all of the following criteria:

1. There is a diagnosis of at least 1 of the following:

a. Urge incontinence

b. Urgency-frequency syndrome

c. Nonobstructive urinary retention

d. Overactive bladder

2. There is documented failure or intolerance to at least 2 conventional conservative therapies (eg, behavioral training such as bladder training, prompted voiding, or pelvic muscle exercise training, pharmacologic treatment for at least a sufficient duration to fully assess its efficacy, and/or surgical corrective therapy).

a. The individual is an appropriate surgical candidate.

b. Incontinence is not related to a neurologic condition.

Criteria B

Permanent implantation of a sacral nerve neuromodulation device may be considered medically necessary in individuals who meet all of the following criteria:

1. All of criteria A.1 and 2 above are met.

2. A trial stimulation period demonstrates at least 50% improvement in symptoms over a period of at least 48 hours.

Other urinary/voiding applications of sacral nerve neuromodulation are considered investigational, including but not limited to the treatment of stress incontinence or urge incontinence due to a neurologic condition (eg, detrusor hyperreflexia, multiple sclerosis, spinal cord injury, other types of chronic voiding dysfunction).

Fecal Incontinence

Criteria A

A trial period of sacral nerve neuromodulation with either percutaneous nerve stimulation or a temporarily implanted lead may be considered medically necessary in individuals who meet all of the following criteria:

1. There is a diagnosis of chronic fecal incontinence of more than 2 incontinent episodes on average per week for more than 6 months or for more than 12 months after vaginal childbirth.

2. There is documented failure or intolerance to conventional conservative therapy (eg, dietary modification, the addition of bulking and pharmacologic treatment) for at least a sufficient duration to fully assess its efficacy.

3. The individual is an appropriate surgical candidate.

4. The condition is not related to an anorectal malformation (eg, congenital anorectal malformation; defects of the external anal sphincter over 60°; visible sequelae of pelvic radiation; active anal abscesses and fistulae) or chronic inflammatory bowel disease.

5. Incontinence is not related to a neurologic condition.

6. The individual has not had rectal surgery in the previous 12 months or, in the case of cancer, the individual has not had rectal surgery in the past 24 months.

Criteria B

Permanent implantation of a sacral nerve neuromodulation device may be considered medically necessary in individuals who meet all of the following criteria:

1. All of criteria A.1 through 6 above are met.

2. A trial stimulation period demonstrates at least 50% improvement in symptoms over a period of at least 48 hours.

Sacral nerve neuromodulation is investigational in the treatment of chronic constipation or chronic pelvic pain.


Bronchial Thermoplasty

Bronchial thermoplasty for the treatment of asthma is considered investigational.


Transurethral destruction Of Prostate Tissue Using Microwave Thermotherapy

Transurethral destruction of prostate tissue as a treatment for benign prostatic hyperplasia by microwave therapy is considered for payment in those patients who, based on the severity of their symptoms, would be candidates for a transurethral resection of the prostate.


Injectable Bulking Agents for the Treatment of Urinary and Fecal Incontinence

The use of carbon-coated spheres, calcium hydroxylapatite, polyacrylamide hydrogel, or polydimethylsiloxane may be considered medically necessary to treat stress urinary incontinence in men and women who have failed appropriate conservative therapy.
The use of autologous cellular therapy (eg, myoblasts, fibroblasts, muscle-derived stem cells, adipose-derived stem cells), autologous fat, and autologous ear chondrocytes to treat stress urinary incontinence is considered investigational.

The use of any other periurethral bulking agent, including, but not limited to Teflon, to treat stress urinary incontinence is considered investigational.

The use of periurethral bulking agents to treat urge urinary incontinence is considered investigational.

The use of perianal bulking agents to treat fecal incontinence is considered investigational.


Surgical Treatment of Snoring and Obstructive Sleep Apnea Syndrome

Palatopharyngoplasty (eg, uvulopalatopharyngoplasty, uvulopharyngoplasty, uvulopalatal flap, expansion sphincter pharyngoplasty, lateral pharyngoplasty, palatal advancement pharyngoplasty, relocation pharyngoplasty) may be considered medically necessary for the treatment of clinically significant obstructive sleep apnea (OSA) syndrome in appropriately select adults who have failed an adequate trial of continuous positive airway pressure (CPAP) or failed an adequate trial of an oral appliance. Clinically significant OSA is defined as those individuals who have:
Apnea/Hypopnea Index (AHI) or Respiratory Disturbance Index (RDI) of 15 or more events per hour, or

AHI or RDI of at least 5 events per hour with 1 or more signs or symptoms associated with OSA (eg, excessive daytime sleepiness, hypertension, cardiovascular heart disease, or stroke).

Hyoid suspension, surgical modification of the tongue, and/or maxillofacial surgery, including mandibular-maxillary advancement (MMA), may be considered medically necessary in appropriately selected adults with clinically significant OSA and objective documentation of hypopharyngeal obstruction who have failed an adequate trial of CPAP or failed an adequate trial of an oral appliance. Clinically significant OSA is defined as those individuals who have:

AHI or RDI of 15 or more events per hour, or

AHI or RDI of at least 5 events per hour with 1 or more signs or symptoms associated with OSA (eg, excessive daytime sleepiness, hypertension, cardiovascular heart disease, or stroke).

Adenotonsillectomy may be considered medically necessary in pediatric individuals with clinically significant OSA and hypertrophic tonsils. Clinically significant OSA is defined as those pediatric individuals who have:

AHI or RDI of at least 5 per hour, or

AHI or RDI of at least 1.5 per hour in anindividual with excessive daytime sleepiness, behavioral problems, or hyperactivity.

Hypoglossal nerve stimulation may be considered medically necessary in adults with OSA under the following conditions:

Age ≥ 22 years; AND

AHI ≥ 15 with less than 25% central apneas; AND

CPAP failure (residual AHI ≥ 15 or failure to use CPAP ≥ 4 hr per night for ≥ 5 nights per week) or inability to tolerate CPAP; AND

Body mass index ≤ 32 kg/m2; AND

Non-concentric retropalatal obstruction on drug-induced sleep endoscopy (see Policy Guidelines).

Hypoglossal nerve stimulation may be considered medically necessary in adolescents or young adults with Down syndrome and OSA under the following conditions:

Age 10 to 21 years; AND

AHI >10 and <50 with less than 25% central apneas after prior adenotonsillectomy; AND Have either tracheotomy or be ineffectively treated with CPAP due to noncompliance, discomfort, undesirable side effects, persistent symptoms despite compliance use, or refusal to use the device; AND Body mass index ≤ 95th percentile for age; AND Non-concentric retropalatal obstruction on drug-induced sleep endoscopy (See Policy Guidelines). Surgical treatment of OSA that does not meet the criteria above would be considered not medically necessary. The following minimally invasive surgical procedures are considered investigational for the sole or adjunctive treatment of OSA or upper airway resistance syndrome: Laser-assisted palatoplasty or radiofrequency volumetric tissue reduction of the palatal tissues Radiofrequency volumetric tissue reduction of the tongue, with or without radiofrequency reduction of the palatal tissues Palatal stiffening procedures including, but not limited to, cautery-assisted palatal stiffening operation, injection of a sclerosing agent, and the implantation of palatal implants Tongue base suspension All other minimally invasive surgical procedures not described above. Implantable hypoglossal nerve stimulators are considered investigational for all indications other than listed above. All interventions, including laser-assisted palatoplasty, radiofrequency volumetric tissue reduction of the palate, or palatal stiffening procedures, are considered investigational for the treatment of snoring in the absence of documented OSA; snoring alone is not considered a medical condition.


Endovascular Stent Grafts for Abdominal Aortic Aneurysms

The use of endoprostheses approved by the U.S. Food and Drug Administration (FDA) as a treatment of abdominal aortic aneurysms (AAAs) may be considered medically necessary in any of the following clinical situations:
an aneurysmal diameter greater than 5.0 cm

an aneurysmal diameter of 4 to 5.0 cm that has increased in size by 0.5 cm in the last 6 months

an aneurysmal diameter that measures twice the size of the normal infrarenal aorta

a ruptured AAA (see Policy Guidelines section).

The use of endoprostheses approved by the FDA as a treatment of AAAs is considered investigational when the above criteria are not met, including but not limited to the following clinical situations:

Treatment of smaller aneurysms that do not meet the current recommended threshold for surgery

Treatment of aneurysms that do meet the recommended threshold for surgery in patients who are ineligible for open repair due to physical limitations or other factors.


Whole Body Dual X-Ray Absorptiometry to Determine Body Composition 

Dual-energy x-ray absorptiometry body composition studies are considered investigational.


Magnetic Resonance Imaging to Monitor the Integrity of Silicone Gel-Filled Breast Implants      

Magnetic resonance imaging may be considered medically necessary to confirm the clinical diagnosis of rupture of silicone breast implants.
Magnetic resonance imaging is considered investigational to monitor the integrity of silicone gel-filled breast implants when there are no signs or symptoms of rupture.


Radioimmunoscintigraphy (Monoclonal Antibody Imaging) With Indium 111 Capromab Pendetide for Prostate Cancer

Radioimmunoscintigraphy using indium 111 capromab pendetide (ProstaScint®) is considered investigational for the evaluation and management of individuals with prostate cancer.


Radioembolization for Primary and Metastatic Tumors of the Liver

Radioembolization may be considered medically necessary to treat primary hepatocellular carcinoma that is unresectable and limited to the liver (see Policy Guidelines section).
Radioembolization may be considered medically necessary in primary hepatocellular carcinoma as a bridge to liver transplantation.

Radioembolization may be considered medically necessary to treat primary intrahepatic cholangiocarcinoma in individuals with unresectable tumors.

Radioembolization may be considered medically necessary to treat hepatic metastases from neuroendocrine tumors (carcinoid and noncarcinoid) with diffuse and symptomatic disease when systemic therapy has failed to control symptoms.

Radioembolization may be considered medically necessary to treat unresectable hepatic metastases from colorectal carcinoma, melanoma (ocular or cutaneous), or breast cancer that are both progressive and diffuse, in individuals with liver-dominant disease who are refractory to chemotherapy or are not candidates for chemotherapy or other systemic therapies.

Radioembolization is considered investigational for all other hepatic metastases except as noted above.

Radioembolization is considered investigational for all other indications not described above.


Adjunctive Techniques for Screening and Surveillance of Barrett Esophagus and Esophageal Dysplasia

Wide-area transepithelial sampling with three-dimensional computer-assisted analysis (WATS3D) is considered investigational for all indications, including but not limited to the screening and surveillance of Barrett esophagus and esophageal dysplasia.


Insulin Pump

The use of the insulin pump is considered for payment for adults and pediatric population with diabetes under the following conditions:
• The need for improvement in glycemic control in individuals despite properly follow your diet and insulin dose, they cannot maintain Hgb A1c levels at normal levels.

• Hypoglycemia – the insulin pump has been of benefit in reducing hypoglycemic events, especially in people prone to them and persons with a range of erratic glucose levels.

• Pregnancy – hyperglycemia and / or ketoacidosis. Due to increased risk of  having children with congenital anomalies.

• Sensitivity to insulin – individuals with daily doses <20 Units or <0.4 units / kg. • Hypoglycemia at dawn. • Diabetic complications such as nephropathy, retinopathy stable, early neuropathy. • Lifestyles - Itineraries that preclude follow a strict pattern of power due to external factors


Implantable Infusion Pump for Pain and Spasticity

Implantable infusion pumps are considered medically necessary when used to deliver drugs having U. Food and Drug Administration approval for this route of access and for the related indication for the treatment of:
·   Severe, chronic, intractable pain (intravenous, intrathecal, and epidural injection of opioids), after a successful temporary trial of opioid or nonopioid analgesics by the same route of administration as the planned treatment. A successful trial is defined as greater than 50% reduction in pain after implementation of treatment; and

·    Severe spasticity of cerebral or spinal cord origin in patients who are unresponsive to or who cannot tolerate oral baclofen therapy (intrathecal injection of baclofen).

Implantable infusion pumps are considered investigational for all other uses related to pain and spasticity.


Breast Duct Endoscopy

Breast duct endoscopy is a technique that provides for direct visual examination of the breast ducts through nipple orifice cannulation and exploration. The technique has been investigated in the following clinical situations:
Diagnostic technique in women with spontaneous nipple discharge, where endoscopy might function as an alternative to surgical excision
Technique to obtain cellular material to stratify women for risk of breast cancer
As a follow-up test for women with atypical cytology as detected by ductal lavage (see policy No. 2.01.45)
Delineation of intraductal disease to define margins of surgical resection
The direct delivery of therapeutic agents, including photodynamic therapy, laser ablation, topical biological agents, etc.
Of related interest, three-dimensional reconstruction techniques of computed tomography scans are now being studied in another approach referred to as virtual ductoscopy.


Endovascular Stent Grafts for Disorders of the Thoracic Aorta

Endovascular stent grafts using devices approved by U.S. Food and Drug Administration (FDA) may be considered medically necessary for the following conditions:
Descending thoracic aortic aneurysms used according to FDA-approved specifications (see Policy Guidelines section).

Acute, complicated (organ or limb ischemia or rupture) type B thoracic aortic dissection.

Traumatic descending aortic tears or rupture.

Endovascular stent grafts are considered investigational for the treatment of descending aortic disorders that do not meet the above criteria, including but not limited to uncomplicated aortic dissection.

Endovascular stent grafts are considered investigational for the treatment of ascending aortic disorders, including but not limited to thoracic aortic arch aneurysms.


Gastric Electrical Stimulation

Gastric electrical stimulation is considered investigational for the treatment of gastroparesis of diabetic, idiopathic, or postsurgical etiology.
Gastric electrical stimulation is considered investigational for the treatment of obesity.


Cryoablation of Tumors Located in the Kidney, Lung, Breast, Pancreas, or Bone

Cryosurgical ablation may be considered medically necessary to treat localized renal cell carcinoma that is no more than 4 cm in size when either of the following criteria is met:
Preservation of kidney function is necessary (ie, the patient has 1 kidney or renal insufficiency defined by a glomerular filtration rate of <60 mL/min/m2), and standard surgical approach (ie, resection of renal tissue) is likely to worsen kidney function substantially; or The patient is not considered a surgical candidate. Cryosurgical ablation may be considered medically necessary to treat lung cancer when either of the following criteria is met: The patient has early-stage non-small-cell lung cancer and is a poor surgical candidate; or The patient requires palliation for a central airway obstructing lesion. Cryosurgical ablation is considered investigational as a treatment for benign or malignant tumors of the breast, lung (other than defined above), pancreas, or bone and to treat renal cell carcinomas in patients who are surgical candidates.


Decompression of the Intervertebral Disc Using Laser Energy (Laser Discectomy) or Radiofrequency Coblation (Nucleoplasty)

Laser discectomy and radiofrequency coblation (disc nucleoplasty) are considered investigational as techniques of disc decompression and treatment of associated pain.


Percutaneous Balloon Valvuloplasty

Pulmonic Balloon Valvotomy for Pulmonary Stenosis Percutaneous balloon valvuloplasty may be considered medically necessary in symptomatic patients or in patients with right ventricular to pulmonary artery peak gradient of 40 mm Hg or greater Aortic Balloon Valvotomy for Aortic Stenosis in Adolescents and Young Adults (in early 20s)
Percutaneous aortic balloon valvuloplasty may be considered medically necessary for adolescent patients and young adults in their early 20s with aortic stenosis who meet any one of the following criteria:

 Symptoms of angina, syncope and dyspnea on exertion, with catheterization peak gradient >= 50 mm Hg

 Catheterization peak gradient >60 mm Hg

 New-onset ischemic or repolarization changes on EKG at rest or with exercise (ST depression, Twave inversion over left precordium) with a gradient >50 mm Hg.

 Catheterization peak gradient >50 mm Hg if patient wants to play competitive sports or desires to become pregnant. Aortic Balloon Valvotomy for Aortic Stenosis in Adults Percutaneous aortic balloon valvuloplasty may be considered medically necessary for adult patients with aortic stenosis who the following criteria:

 As a bridge to surgery in hemodynamically unstable patients who are at high risk for aortic valve replacement.

Mitral Balloon Valvotomy for Mitral Valve Stenosis Percutaneous balloon valvuloplasty may be considered medically necessary for patients with mitral valve stenosis who meet any of the following criteria:

 Symptomatic patients (NYHA functional Class II, III or IV), moderate or severe mitral stenosis and valve morphology favorable for percutaneous balloon valvotomy in the absence of left atrial thrombus or moderate to severe mitral regurgitation.

 Asymptomatic patients with moderate or severe mitral stenosis* and valve morphology favorable for perctaneous balloon valvotomy who have pulmonary hypertension (pulmonary artery systolic pressure >50 mm Hg at rest or 60 mm Hg with exercise) in the absence of left atrial thrombus or moderate to severe mitral regurgitation.

 Patients with NYHA functional Class III-IV symptoms, moderate or severe mitral stenosis* and a nonpliable calcified valve who are at high risk for surgery in the absence of left atrial thrombus or moderate to severe mitral stenosis. * Moderate or severe mitral stenosis is defined as mitral valve area <= 1.5 cm2 . Policy Guidelines Class I: Conditions for which there is evidence and/or general agreement that given procedure is useful or effective. Class II: Conditions for which there is conflicting evidence and a divergent opinion about the usefulness/efficacy of a procedure or treatment. IIa. Weight of evidence/opinion is in favor of usefulness/efficacy IIb. Usefulness/efficacy is less well established by evidence/opinion. Class III. Conditions for which there is evidence and/or general agreement that the procedure/treatment is not useful and in some cases may be harmful. For the purposes of this policy, all indications categorized as Class I or Class IIa are considered to be medically necessary indications. Benefit Application BlueCard/National Account Issues Benefits are determined by the group contract, member benefit booklet, and/or individual subscriber certificate in effect at the time services were rendered.  Benefit products or negotiated coverages may have all or some of the services discussed in this medical policy excluded from their coverage. Background The technique of balloon valvuloplasty (also called valvotomy or commissurotomy) involves the percutaneous transcatheter insertion of 1 or more large balloons into the aortic and/or mitral valve.  The balloons are then inflated across the stenotic valve in order to decrease the degree of obstruction within the valve. Balloon mitral commissurotomy (BMC) has become the procedure of choice for the treatment of adult patients with rheumatic mitral stenosis.  Recent studies have shown that the long-term results of BMC are superior to open surgical commissurotomy in patients who have favorable mitral valve anatomy as determined by echocardiographic examination.  Criteria have been developed to identify which patients with symptomatic mitral stenosis are most likely to benefit from balloon valvuloplasty.  The valve is assessed on the basis of 4 characteristics, each of which is graded on a scale from 0 to 4 (favorable to unfavorable): leaflet mobility; valvular thickening; subvalvular thickening; and valvular calcification. leaflet mobility; valvular thickening; subvalvular thickening; and valvular calcification. Good procedural results have been obtained with echocardiographic scores of 8 or less, that is the valve characteristics include a pliable, non-calcified valve with mild subvalvular disease and no or mild mitral regurgitation. Aortic balloon valvuloplasty in adults with calcific aortic stenosis has been fraught with short-lived hemodynamic benefit and high rates of re-stenosis.  Despite disappointing intermediate-term (6 to 12 months) results, the procedure does have its role in the management of critical aortic stenosis in patients who are not surgical candidates. Balloon valvuloplasty has been used in children with congenital critical aortic stenosis, until the child is old enough to have valve replacement (NICE, 2004).  A comparative study involving 110 neonates with critical aortic stenosis found the mean reduction in systolic gradient to be 65 % for neonates treated with balloon valvuloplasty, compared to 41 % for neonates treated with open surgery (McCrindle et al, 2001).  Aortic regurgitation rates were 18 % (15/82) in the balloon valvuloplasty group compared with 3 % (1/28) in the open surgery group.  Immediate major complications were reported in 4 % (3/82) of the balloon valvuloplasty group and 0 % (0/28) of the open surgery group. Pulmonary valve stenosis is a congenital heart defect in which blood flow from the heart to the pulmonary artery is blocked.  Symptoms include cyanosis, fainting, fatigue, chest pains, shortness of breath, poor weight gain or failure to strive in infants, and, in some instances, sudden death.  If the stenosis is severe, the pulmonary valve must be opened to increase blood flow to the lungs.  Based upon limited evidence from published case series, the National Institute for Health and Clinical Excellence (NICE) concluded that percutaneous balloon valvuloplasty is an established alternative to open surgical valvotomy for pulmonary valve stenosis (NICE, 2004). Trans-esophageal echocardiogram (TEE) measurement alone of the aortic annulus may not be adequate to select a transcatheter heart valve (THV) size.  Balloon aortic valvuloplasty (BAV) can more accurately size the aortic annulus.  Babaliaros et al (2010) described the use of BAV to select proper THV size in patients undergoing THV implantation.  A total of 27 patients underwent sizing of the aortic annulus by BAV and TEE.  These researchers implanted the minimal THV size that was greater than the annulus measured by BAV.  The annulus measured by TEE was 21.3 +/- 1.6 mm and by BAV was 22.6 +/- 1.8 mm (p < 0.001).  The number of balloon inflations was 2.7 +/- 0.7 (range of 2 to 4), and the balloon sizes used were 22.0 +/- 1.8 mm (range of 20 to 25 mm).  Fourteen patients (52 %) required up-sizing of the initial balloon suggested by TEE; rapid pacing duration was 8 +/- 1.3 s (range of 6 to 11 s).  No change in aortic insufficiency or hemodynamic instability occurred with BAV.  Fifteen patients (56 %) received a 23-mm THV; 12 patients a 26-mm THV.  No coronary occlusion, annular damage, or THV embolization occurred.  Para-valvular leak was grade less than or equal to 1 in all patients.  In 7 patients (26 %), balloon sizing resulted in selection of a specific THV size that could not be done by TEE alone.  The authors concluded that BAV sizing of the aortic annulus is safe and is an important adjunct to TEE when selecting THV size.  Implanting the minimal THV greater than the BAV annulus size resulted in no adverse events.  These findings suggested that use of BAV for THV selection may improve the safety and effectiveness of THV implantation.  These preliminary findings need to be validated by well-designed studies. Singh et al (2015) stated that the use of percutaneous aortic balloon valvotomy (PABV) in high surgical risk patients has resurged because of development of less invasive endovascular therapies.  These investigators compared outcomes of concomitant PABV and percutaneous coronary intervention (PCI) with PABV alone during same hospitalization using nation's largest hospitalization database.  They identified patients and determined time trends using the International Classification of Diseases, Ninth Revision, Clinical Modification, procedure code for valvulotomy from Nationwide Inpatient Sample database 1998 to 2010.  Only patients greater than 60 years with aortic stenosis were included.  Primary outcome included in-hospital mortality, and secondary outcomes included procedural complications, length of stay (LOS), and cost of hospitalization.  A total 2,127 PABV procedures were identified, with 247 in PABV + PCI group and 1,880 in the PABV group.  Utilization rate of concomitant PABV + PCI during same hospitalization increased by 225 % from 5.1 % in 1998 to 1999 to 16.6 % in 2009 to 2010 (p < 0.001).  Overall in-hospital mortality rate and complication rates in PABV + PCI group were similar to that of PABV group (10.3 % versus 10.5 % and 23.4 % versus 24.7 %, respectively).  PABV + PCI group had similar LOS but higher hospitalization cost (median [interquartile range] $30,089 [$21,925 to $48,267] versus $18,421 [$11,482 to $32,215], p < 0.001) in comparison with the PABV group.  Unstable condition, occurrence of any complication, and weekend admission were the main predictors of increased LOS and cost of hospital admission.  The authors concluded that concomitant PCI and PABV during the same hospitalization are not associated with change in in-hospital mortality, complications rate, or LOS compared with PABV alone; however, it increases the cost of hospitalization.


Duplex Sanning

The Duplex scanning in the evaluation of the arterial / venous flow of abdominal, pelvic organs and of the scrotum, proceed for payment when they are performed for one or more of the following indications.
· Evaluation of a patient with symptoms and findings such as epigastric or periumbilical pain after meals which persists for one to three hours associated with weight loss and that is the result of decreased intake that may suggest a chronic intestinal ischemia.

· The evaluation of patients that have received trauma to the abdomen, pelvis or retroperitoneal area and that possibly involves damage to the arterial / venous flow of the abdominal, pelvic or retroperitoneal organs.

· The evaluation of a possible aneurysm of renal artery or another visceral artery

· The evaluation of a patient that not has responded to antihypertensive therapy as a form to eliminate the presence of renovascular disease such as stenosis of the renal artery, fistula, renal arteriovenous or a renal aneurysm as the cause of the uncontrolled hypertension.

· The evaluation of portal hypertension

· In the evaluation of suspicion of embolism, thrombosis, hemorrhage or infarction of the portal vein, the renal vein or renal artery.

· The evaluation of pain or swelling of the content of the scrotum that suggests obstruction in the arterial venous flow of the testicles or related structures.

The Duplex scanning for the evaluation of the flow of the aorta, lower cava vein, iliac or bridges (bypass graft) of these structures proceed for payment when they are performed for one or more of the following indications:
· Confirm the suspicions of an abdominal or iliac aneurysm.
· Monitor the progress of an aortic aneurysm. Usually the monitoring is done every six months.
· Evaluate the patient with symptoms and findings of a thoracic aneurysm. The usual symptoms of this condition are sub external chest pain, back pain and symptoms due to pressure on the trachea, esophagus, laryngeal nerve or superior vein cava.
· Evaluation of patient that presents findings and symptoms of abdominal aneurysm.
· Evaluation of the patient presenting symptoms and findings that suggest an aortic dissection
· Evaluation of the patient with symptoms and findings of intermittent claudication.
· Evaluation of patient with the suspicion of embolism or abdominal or chest thrombosis.
· Evaluation of patients presenting pain on palpation over the iliac vein region that suggests phlebitis or thrombophlebitis of the iliac vein or inferior vena cava.
· Assessment in patient that has received trauma to the anterior thoracic wall and/or abdomen that possibly brings trauma to the aorta, inferior vena cava and/or iliac veins.
· Evaluate the continuity of both venous and prosthetic bridges (bypass graft) after their realization. Usually this evaluation is performed after six weeks, three months and then every six months.
· Monitor areas of several percutaneous interventions including, but not limited to angioplasties, Thrombolysis, atherectomies and/or placement of mesh (stent). Usually this evaluation is performed after six weeks, three months and then every six months.


NON INVASIVE VASCULAR STUDIES UPPER AND LOWER EXTREMITIES

To perform a duplex scanning sweep is needed in real time, therefore the billing of a duplex scanning and ultrasound (Doppler) of the same body part represents «unbundling» and not appropriate as ageneral practice or standing protocol ,and therefore would not be expected.
The complete physiological study of an extremity includes measures pressure and other physiological studies (eg. Doppler). Duplex scanning and physiological studies are considered for payment  during the same visit only under the following conditions:

·        If abnormal physiological studies.

·        In the evaluation of vascular trauma.

·        The evaluation of thromboembolic events.

·        The evaluation of aneurysmal disease

Noninvasive physiological studies of the extremities are considered for payment:

cases of deep vein thrombophlebitis or if symptoms suggest where the possibility of it, such as pain in the limb without explanation or swelling and / or edema.

·        patient with symptoms and findings of pulmonary embolism.

·        assessment of symptomatic varicose veins such as pain, swelling and leg ulcers, edema that interferes with daily activities that has not responded to conservative therapy after three months of therapy.

·        The documentation of venous valvular incompetence prior to a therapeutic intervention.

·        The evaluation and selection of a vein to create a fistula or before revascularization.

Given the fact that the symptoms and findings of arterial occlusive disease and venous disease are so divergent that performing arterial and venous studies in the same match is not appropriate for payment.

Extracranial arterial performing studies (CPT 93880 or 93881) and non-invasive evaluation of extremity veins (CPT 93965, 93970 or 93971) during the same encounter is not like widespread protocol therefore do not come for payment.


NON INVASIVE EVALUATION OF EXTRACRANIAL ARTERIES

Non-invasive studies are recognized for payment if the results impact the clinical course of the patient, for example, they are considered unnecessary when the patient requires
other diagnostic tests or treatments regardless of the outcome of the non-invasive studies.

Performing non-invasive extracranial studies (CPT 93880 or 93881) and evaluation Non-invasive limb veins (CPT 93965, 93970 or 93971) in it encounter is not appropriate as a

general practice or accepted protocol and consequently they should not be billed.

Non-invasive physiological studies of extracranial arteries are considered for payment in the evaluation of the following conditions:

• Carotid puffs

• Monitoring of the patient with known carotid stenosis

• Stroke evaluation

• Evaluation of a transient cerebral ischemic attack

• Evaluation of a patient with syncope and symptoms suggestive of arterial disease
vertebrobasilar

• In the preoperative evaluation of a carotid endarterectomy

• In the evaluation of pulsatile masses in the neck

• In the evaluation of amaurosis fugax

• In the evaluation of a patient with vasculitis involving the carotid arteries
extracranial


NON-INVASIVE ARTERIAL VASCULAR STUDIES OF UPPER AND LOWER EXTREMITIES

To perform a Duplex scanning it is necessary to perform a real time scan, therefore the billing of a Duplex scanning and an ultrasound scan (Doppler) of the same part of the body represents «unbundling» and does not proceed for payment.
The complete physiological study of an extremity includes the measures of pressure and another of the physiological studies (e.g. Doppler).

Duplex scanning and physiological studies will be paid only during the same date encounter under the following conditions:

If the physiological studies are abnormal
In the evaluation of vascular trauma
In the evaluation of thromboembolic events
In the evaluation of aneurismal disease

The ankle / brachial index, even though it is required, is not a procedure that proceeds for payment by itself.


Optical Coherence Tomography of the Anterior Eye Segment

Scanning computerized ophthalmic (eg, optical coherence tomography) imaging of the anterior eye segment is considered investigational.


Digital Breast Tomosynthesis

Digital breast tomosynthesis (DBT) uses modified digital mammography (DM) equipment to obtain additional radiographic data that are used to reconstruct cross-sectional «slices» of breast tissue. Tomosynthesis may improve the accuracy of DM by reducing distortions caused by overlapping tissue. Tomosynthesis typically involves additional imaging time and radiation exposure, although recent improvements may change this.
For individuals who are asymptomatic and at average risk of breast cancer who receive 3-dimensional (3D) DBT as an adjunct to 2-dimensional (2D) mammography for screening, the evidence includes results from randomized controlled trials (RCTs), prospective observational studies, and retrospective observational studies. The relevant outcomes are overall survival, disease-specific survival, and test validity. There is a lack of direct evidence on the clinical utility of DBT from trials comparing health outcomes in patients screened using DBT and mammography. The available studies have provided limited data on interval cancers and follow-up of negative findings; however, available evidence would suggest that adding breast tomosynthesis to mammography may increase sensitivity and specificity of screening, potentially reducing the number of women who are recalled unnecessarily. Many studies had methodologic limitations, including inadequate follow-up of women with negative screening results, use of historical controls, and were based on screening practices in Europe that differ from those in the U.S. Preliminary results from the RETomo RCT would suggest an almost 90% increase in detection rate for mammography plus DBT compared with mammography alone with more instances of ductal carcinoma in situ with mammography plus DBT (+1 per 1000), benign lesions (+1 per 1000), and invasive cancers (+3 per 1000). The evidence is insufficient to determine the effects of the technology on health outcomes.


Positional Magnetic Resonance Imaging

Positional (nonrecumbent) magnetic resonance imaging is considered investigational, including its use in the evaluation of individuals with cervical, thoracic, or lumbosacral back pain.


Selected Positron Emission Tomography Technologies for Evaluation of Alzheimer Disease

Amyloid beta imaging with positron emission tomography (PET) to predict conversion to Alzheimer disease is considered investigational.
Amyloid beta imaging with PET as an adjunct to clinical diagnosis in individuals with dementia is considered investigational.

Amyloid beta imaging with PET to select individuals with mild cognitive impairment or mild dementia due to Alzheimer disease for amyloid beta targeting plaque-therapy is considered investigational.

Amyloid beta imaging with PET to evaluate individuals with mild cognitive impairment or mild dementia due to Alzheimer disease for continuation of amyloid beta plaque-targeting therapy is considered investigational.

PET Imaging with fluorine 18 fluorodeoxyglucose (FDG-PET) as an adjunct to clinical diagnosis in individuals with dementia is considered investigational.

All other uses of amyloid beta imaging with PET are considered investigational.


INTENSITY MODULATED RADIATION THERAPY (IMRT)

IMRT is considered reasonable and medically necessary in instances where sparing the surrounding normal tissue is of added clinical benefit to the patient. Common clinical indications that frequently support the use of IMRT include:
Primary, metastatic or benign tumors of the central nervous system.
Primary, metastatic tumors of the spine where spinal cord tolerance may be exceeded by conventional treatment.
Selected extracranial primary, metastatic or benign lesions.
Reirradiation that meets the requirements for medical necessity.

IMRT offers advantages as well as added complexity over conventional or three-dimensional conformal radiation therapy. Before applying IMRT techniques, a comprehensive understanding of the benefits and consequences is required. In addition to satisfying at least one of the four selection criteria noted above, the radiation oncologist’s decision to employ IMRT requires an informed assessment of benefits and risks including:

Determination of patient suitability for IMRT allowing for reproducible treatment delivery.
Adequate definition of the target volumes and organs at risk.
Equipment capability, including ability to account for organ motion when a relevant factor.
Physician and staff training.
Adequate quality assurance procedures.

On the basis of the above conditions demonstrating medical necessity, disease sites that may support the use of IMRT include the following:

• Primary, metastatic or benign tumors of the central nervous system including the brain, brain stem and spinal cord.

• Primary or metastatic tumors of the spine where the spinal cord tolerance may be exceeded with

• conventional treatment or where the spinal cord has previously been irradiated.

• Primary, metastatic, benign or recurrent head and neck malignancies including, but not limited to those involving:

• Orbits,

• Sinuses,

• Skull base,

• Aero-digestive tract, and

• Salivary glands.

• Thoracic malignancies.

• Abdominal malignancies when dose constraints to small bowel or other normal tissue are exceeded and prevent administration of a therapeutic dose.

• Pelvic malignancies, including prostatic, gynecologic and anal carcinomas.

• Other pelvic or retroperitoneal malignancies.

Clinical scenarios that would not typically support the use of IMRT include:

Where IMRT does not offer an advantage over conventional or three-dimensional conformal radiation therapy techniques that deliver good clinical outcomes and low toxicity.
Clinical urgency, such as spinal cord compression, superior vena cava syndrome or airway obstruction.
Palliative treatment of metastatic disease where the prescribed dose does not approach normal tissue tolerances.
Inability to accommodate for organ motion, such as for a mobile lung tumor.
Inability of the patient to cooperate and tolerate immobilization to permit accurate and reproducible dose delivery.


Dopamine Transporter Single-Photon Emission Computed Tomography

Dopamine transporter imaging with single-photon emission computed tomography may be considered medically necessary when used for individuals with:
clinically uncertain Parkinson disease; or

clinically uncertain dementia with Lewy bodies.

Use of dopamine transporter imaging with single-photon emission computed tomography is considered investigational for all other indications not included above.


Endobronchial Ultrasound for Diagnosis and Staging of Lung Cancer

Endobronchial ultrasound-guided transbronchial needle aspiration (EBUS-TBNA) may be considered medically necessary for the evaluation of peripheral pulmonary lesions in patients with suspected lung cancer when the following criteria are met:
Tissue biopsy of the peripheral pulmonary lesion is required for diagnosis (see Policy Guidelines section);

The peripheral pulmonary lesion is not accessible using standard bronchoscopic techniques.

EBUS-TBNA is considered medically necessary for mediastinal staging in patients with diagnosed lung cancer when the following criteria are met:

The patient is suitable and willing to undergo specific treatment for lung cancer, with either curative or palliative intent (see Policy Guidelines section);

Tissue biopsy of abnormal mediastinal lymph nodes seen on imaging is required for staging and specific treatment planning (see Policy Guidelines section);

Abnormal lymph nodes seen on imaging are accessible by EBUS-TBNA.

Endobronchial ultrasound is considered not medically necessary for diagnosis and staging of lung cancer when the above criteria are not met.

Endobronchial ultrasound is considered investigational for all other indications.


Diagnosis and Treatment of Sacroiliac Joint Pain

Arthrography of the sacroiliac joint (SIJ) is considered investigational.
Injection of anesthetic for diagnosing SIJ pain may be considered medically necessary when the following criteria have been met:

Pain has failed to respond to 3 months of conservative management, which may consist of therapies such as nonsteroidal anti-inflammatory medications, acetaminophen, manipulation, physical therapy, and a home exercise program; and

Dual (controlled) diagnostic blocks with 2 anesthetic agents with differing duration of action are used; and

The injections are performed under imaging guidance.

Injection of corticosteroid may be considered medically necessary for the treatment of SIJ pain when the following criteria have been met:

Pain has failed to respond to 3 months of conservative management, which may consist of therapies such as nonsteroidal anti-inflammatory medications, acetaminophen, manipulation, physical therapy, and a home exercise program; and

The injection is performed under imaging guidance; and

No more than 3 injections are given in 1 year.

Minimally invasive fixation/fusion of the SIJ using transiliac placement of a titanium triangular implant (eg, iFuse) may be considered medically necessary when ALL of the following criteria have been met:

Pain is at least 5 on a 0 to 10 rating scale that impacts quality of life or limits activities of daily living; and

There is an absence of generalized pain behavior (eg, somatoform disorder) or generalized pain disorders (eg, fibromyalgia); and

Individuals have undergone and failed a minimum 6 months of intensive nonoperative treatment that must include medication optimization, activity modification, bracing, and active therapeutic exercise targeted at the lumbar spine, pelvis, SIJ, and hip, including a home exercise program; and

Pain is caudal to the lumbar spine (L5 vertebra), localized over the posterior SIJ, and consistent with SIJ pain; and

A thorough physical examination demonstrates localized tenderness with palpation over the sacral sulcus (Fortin’s point) in the absence of tenderness of similar severity elsewhere; and

There is a positive response to a cluster of 3 provocative tests (eg, thigh thrust test, compression test, Gaenslen sign, distraction test, Patrick test, posterior provocation test); and

Diagnostic imaging studies include ALL of the following:

Imaging (plain radiographs and computed tomography or magnetic resonance imaging) of the SIJ excludes the presence of destructive lesions (eg, tumor, infection) or inflammatory arthropathy of the SIJ; and

Imaging of the pelvis (anteroposterior plain radiograph) rules out concomitant hip pathology; and

Imaging of the lumbar spine (computed tomography or magnetic resonance imaging) is performed to rule out neural compression or other degenerative conditions that can be causing low back or buttock pain; and

Imaging of the SIJ indicates evidence of injury and/or degeneration; and

There is at least a 75% reduction in pain for the expected duration of the anesthetic used following an image-guided, contrast-enhanced intra-articular SIJ injection on 2 separate occasions; and

A trial of a therapeutic SIJ injection (ie, corticosteroid injection) has been performed at least once.

Fixation/fusion of the SIJ for the treatment of back pain presumed to originate from the SIJ is considered investigational under all other conditions and with any other devices not listed above.

Radiofrequency denervation of the SIJ is considered investigational.


Coronary Computed Tomography Angiography With Selective Noninvasive Fractional Flow Reserve

The use of noninvasive fractional flow reserve following a positive coronary computed tomography angiography may be considered medically necessary to guide decisions about the use of invasive coronary angiography in individuals with stable chest pain at intermediate risk of coronary artery disease (ie, suspected or presumed stable ischemic heart disease).
The use of noninvasive fractional flow reserve not meeting the criteria outlined above is considered investigational.


Therapeutic Radiopharmaceuticals in Oncology

Lutetium 177
Initial Treatment

Lutetium 177 (Lu 177) dotatate treatment is considered medically necessary when conditions 1 through 8 are met:

Individual is an adult (≥18 years of age).

Individual has documented low or intermediate grade (Ki-67 index ≤20%), locally advanced or metastatic, gastroenteropancreatic (including foregut, midgut, and hindgut) or metastatic bronchopulmonary or thymus neuroendocrine tumor.

Individual has documented somatostatin receptor expression of a neuroendocrine tumor as detected by somatostatin receptor-based imaging (see Policy Guidelines).

Individual has documented disease progression while on octreotide long-acting release or lanreotide therapy.

Individual is not receiving long-acting somatostatin analogues (e.g., octreotide long-acting release or lanreotide) for at least 4 weeks prior to initiating Lu 177 dotatate and has discontinued use of short-acting octreotide for at least 24 hours prior to initiating Lu 177 dotatate.

Individual does not have severe renal impairment (creatinine clearance <30 mL/min). Individual has adequate bone marrow and hepatic function as determined by the treating physician. Individual has documented Karnofsky Performance Status score of 60 or greater. Continuation of Treatment Continuation of Lu 177 dotatate is considered medically necessary when conditions 1 through 5 are met: No recurrent grade 2, 3, or 4 thrombocytopenia (see Table PG1). No recurrent grade 3 or 4 anemia and neutropenia (see Table PG1). No recurrent hepatotoxicity (see definition of hepatotoxicity in the Policy Guidelines section). No recurrent grade 3 or 4 nonhematologic toxicity (see Table PG1). No renal toxicity requiring a treatment delay of 16 weeks or longer (see definition of renal toxicity in the Policy Guidelines section). Lu 177 dotatate treatment is considered investigational in all other situations in which the above criteria are not met. Lu 177 dotatate treatment greater than a total of 4 doses as per the U.S. Food and Drug Administration (FDA)-approved regimen is considered investigational. Lu 177 dotatate treatment is considered investigational for all other indications including pheochromocytoma and paraganglioma. Iobenguane I 131 Iobenguane I 131 is considered medically necessary when conditions 1 through 5 are met: Individual has documented iobenguane scan positive, locally advanced or metastatic pheochromocytoma and paraganglioma. Individual is 12 years or older. Individual has progressed on prior therapy for pheochromocytoma or paraganglioma OR is not a candidate for chemotherapy. Individual does not have severe renal impairment (creatinine clearance <30 mL/min). Individual has platelet count greater than 80,000/mcL OR absolute neutrophil count greater than 1,200/mcL. Iobenguane I 131 treatment is considered investigational for all other indications including neuroblastoma and gastroenteropancreatic neuroendocrine tumors. Use of iobenguane I 131 not in accordance with FDA approved dosing (first dosimetric dose followed by 2 therapeutic doses administered 90 days apart) is considered investigational. See Policy Guidelines below.


Thermography

The use of all forms of thermography is considered investigational.


Myocardial Sympathetic Innervation Imaging in Patients With Heart Failure

Myocardial sympathetic innervation imaging with iodine 123 meta-iodobenzylguanidine is considered investigational for patients with heart failure.


Magnetic Resonance Angiography of Vessels of the Head, Neck,Abdomen, Pelvis, and Lower Extremity

MRA of the head may be considered medically necessary for the assessment of: patients suspected of having steno-occlusive disease of the mid or large size intracranial arteries;
 patients suspected of having cerebral aneurysm;
 patients suspected of having intracranial vascular malformation;
 patients suspected of having cerebral venous sinus compression or thrombosis;
 patients with pulsatile tinnitus;

MRA of the neck may be considered medically necessary for the assessment of:
 patients suspected of having carotid stenosis or occlusion;
 patients suspected of having cervicocranial arterial dissection.

MRA of the abdomen/pelvis may be considered medically necessary for the assessment of patients with the following clinical indications in whom angiography would otherwise be indicated and in whom a negative MRA would obviate the need for angiography:
 patients suspected of having atherosclerotic renal artery stenosis;
 patients with suspected chronic mesenteric ischemia;
 patients with abdominal aortic aneurysm who are to undergo elective repair of the aneurysm;
 patients requiring evaluation of the portal and/or hepatic venous system; patients requiring evaluation of the systemic venous system.

MRA of the pelvis/lower extremities may be considered medically necessary for the assessment of patients with the following clinical indications:
 patients with suspected atherosclerotic disease of the lower extremity in whom angiography would otherwise be indicated and in whom MRA would obviate the need for angiography;
 patients with known atherosclerotic disease of the lower extremity who are being evaluated for bypass surgery and in whom angiography fails to identify runoff vessels suitable for bypass.

MRA may be considered medically necessary in the evaluation of potential renal donors for the presence of accessory renal arteries.


Magnetic Resonance Cholangiopancreatography

Magnetic resonance cholangiopancreatography (MRCP) may be considered medically necessary for diagnostic evaluation of the pancreaticobiliary system when:
· there is a low likelihood of needing therapeutic intervention or tissue sampling with ERCP or PTC,

· ERCP has been technically unsuccessful, or

· ERCP is considered unsafe or very unlikely to be successful (e.g., pediatric patient, major medical comorbidities, or complex pancreaticobiliary anatomy such as post biliary-enteric bypass).


TOMOGRAFIA COMPUTADORIZADA DEL CUERPO ENTERO COMO METODO DE CERNIMIENTO

Tomografía computadorizada de cuerpo entero cómo un método de cernimiento no se considera para pago. El Colegio Americano de Cardiología, la Asociación Americana del Corazón, la Asociación de Físicos en Medicina y el Colegio Americano de Radiología no recomienda la tomografía computadorizada del cuerpo entero como método de cernimiento.


Contrast-Enhanced Computed Tomographic Angiography for Coronary Artery Evaluation

Contrast-enhanced coronary computed tomography angiography (CCTA) for evaluation of individuals with acute chest pain and without known coronary artery disease in the emergency department setting is considered medically necessary.
Contrast-enhanced CCTA for evaluation of individuals with stable chest pain and meeting guideline criteria for a noninvasive test in the outpatient setting (see Policy Guidelines) is considered medically necessary.

Contrast-enhanced CCTA for evaluation of individuals with suspected anomalous (native) coronary arteries is considered medically necessary.

Contrast-enhanced CCTA for coronary artery evaluation is considered investigational for all other indications.


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