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.

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.

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 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 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 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 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.

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.

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

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.

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.

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 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

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.

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

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

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.

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 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-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.

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.

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.

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.

The use of all forms of thermography is considered investigational.

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

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 (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).

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 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.

Screening for vertebral fractures using dual-energy x-ray absorptiometry is considered investigational.

The use of computed tomography to detect coronary artery calcification is considered investigational.

Endoscopic ultrasonography is considered for payment, as recommended by the American Society for Gastrointestinal Endoscopy (ASGE) and the American  Gastroenterological Association for the following indications:

Establish the stages of gastrointestinal tract tumors (including the esophagus,  pancreas and biliary ducts;
Evaluate anomalies on the gastrointestinal walls or adjacent structures.
Obtain tissue of organs adjacent to the gastrointestinal wall.
Evaluate anomalies in the pancreas, including masses, pseudocysts and chronic pancreatitis;
Evaluate anomalies of the biliary tract;
Provide endoscopic therapies under sonographic control;
Evaluation of adenopathies and mases in the mediastenium
Establish stages of lung cancer (Endoscopic Sonography with aspiration with a fine needle)
Evaluation of gastric subephitelial masses

Ultrasonographic endoscopy is not considered for payment to establish the stages of tumors which have been proved methastatic through other means.

Ultrasound in the evaluation of paranasal sinuses is considered investigational.

Functional magnetic resonance imaging may be considered medically necessary as a complementary test in the preoperative evaluation of patients with refractory epilepsy or brain tumors who are candidates for neurosurgery when: (1) the lesion is in close proximity to an eloquent area of the brain (eg, controlling verbal or motor function); and (2) testing is expected to have an important role in assessing the spatial relation between the lesion and eloquent brain area.

Functional magnetic resonance imaging is considered investigational for all other applications.

SPECT is considered for payment to demonstrate myocardial viability.

SPECT is not considered for payment in:

· Bone and joints – to differentiate between infectious, neo-plastic, avascular and traumatic processes

· Brain tumors-to differentiate between lymphomas from infections such as toxoplasmosis, particularly in the immunosuppressed patient

Hepatic hemangioma uses red cells marked to define lesions identified by other means

· Location of abscesses / infections / inflammation in soft tissues or in cases of fever of unknown origin

· Neuroendocrine tumors (eg adenomas, carcinoid, pheochromocytomas, tumors secreting intestinal vasoactive peptides (VIP), thyroid carcinoma, adrenal tumors.

· Location of parathyroid

SPECT is not considered for payment for any other indication, including but not limited to the following:

· Attention deficit hyperactivity disorder

· Chronic fatigue syndrome

· Colorectal carcinoma

· Sweep in the transport of dopamine- all indications

· Malignities except those listed above

· Neuropsychiatric disorders without evidence of cerebrovascular disease

· Pervasive developmental disorders

· Prostate carcinoma

· scintimamography for breast cancer

Cardiac positron emission tomography (PET) scanning may be considered medically necessary to assess myocardial perfusion and thus diagnose coronary artery disease in individuals with indeterminate single photon emission computed tomography (SPECT) scan; or in individuals for whom SPECT could be reasonably expected to be suboptimal in quality on the basis of body habitus.

Cardiac PET scanning may be considered medically necessary to assess myocardial viability in individuals with severe left ventricular dysfunction as a technique to determine candidacy for a revascularization procedure. (See the Background section regarding the relative effectiveness of PET and SPECT scanning.)

Cardiac PET scanning is investigational for quantification of myocardial blood flow for cardiac event risk stratification in individuals diagnosed with coronary artery disease.

Cardiac PET scanning may be considered medically necessary for diagnosing cardiac sarcoidosis in individuals who are unable to undergo magnetic resonance imaging. Examples of individuals who are unable to undergo magnetic resonance imaging include, but are not limited to, individuals with pacemakers, automatic implanted cardioverter defibrillators, or other metal implants.

The use of positron emission mammography is considered investigational for all indications.

The use of interim fluorine 18 fluorodeoxyglucose positron emission tomography scans to determine response to tyrosine kinase inhibitor treatment in individuals with gastrointestinal stromal tumors is considered medically necessary.

The use of positron emission tomography scans to determine early response to treatment (positron emission tomography scans done during a planned course of chemotherapy and/or radiotherapy) in individuals with gastrointestinal stromal tumors on palliative or adjuvant therapy, as well as all other cancers, is considered investigational.

Magnetoencephalography/magnetic source imaging as part of the preoperative evaluation of patients with drug-resistant epilepsy may be considered medically necessary when standard techniques, such as magnetic resonance imaging and electroencephalogram, do not provide satisfactory localization of epileptic lesion(s) (see Policy Guidelines).

Magnetoencephalography/magnetic source imaging for the purpose of determining the laterality of language function, as a substitute for the Wada test, in patients being prepared for surgery for epilepsy, brain tumors, and other indications requiring brain resection, may be considered medically necessary.

Magnetoencephalography/magnetic source imaging is considered investigational for all other indications.

The use of dynamic spinal visualization is considered investigational.

Vertebral motion analysis is considered investigational.

Computed tomography perfusion imaging may be considered medically necessary to select patients with anterior large-vessel stroke for mechanical embolectomy.

Computed tomography perfusion imaging of the brain is considered investigational for all other indications.

Scintigraphic imaging of acute venous thrombus in the lower extremities may be considered medically necessary in patients with signs and symptoms of acute thrombus.

Scintigraphic imaging of acute venous thrombus in the lower extremities is considered investigational in asymptomatic patients at risk of acute venous thrombus.

Low osmolality contrast medium is considered medically necessary in patients with high risk of severe reactions to conventional agents. The following are recognized as risk factors:

1. Kidney factors

a. Renal failure (serum creatinine greater than 1.5mg / dl)

2. Multiple myeloma

3. Cardiovascular factors

a. Under 1-year-old

b. Unstable angina.

c.Congestive heart failure (Class IV of the American Heart Association of New York)

d. Recurrent ventricular tachycardia and an ejection fraction below 0.30

e. Severe pulmonary hypertension (systolic over 70 mm / Hg)

f. Cardiogenic shock or other hemodynamic instability

g. Period within 6 months after myocardial infarction complicated with hypotension.

h. Stenosis of the main left coronary artery, greater than 50%

i. Symptomatic severe aortic stenosis

j. Septal ventricular defect

4. Allergy to conventional contrast:

a. Where no other imaging modality can be offered

The dose of contrast is not absolute. In large and complex areas, a large volume of dye is required for an accurate diagnosis.

Example: Computerized tomography

1. Use of a single dose head, ear, eye orbit, renal, pelvic (prostate, ovaries, etc.)

2. Use of two doses: neck (submandibular parathyroid glands), chest, abdominals (liver, pancreas).

El uso del material de contraste se considera para pago en presencia de una de las siguientes situaciones.

Cabeza

a.Tumores como:
*Neuromas Acústicos
*Meningiomas, etc.
b.Evaluación de:
*Infartos
*Fosa posterior
*Sella Túrcica
c.Inflamaciones
d.Abscesos
e.Meningitis
f.Malformaciones arteriovenosas
2.Cuello
a.Evaluación de:
*Masas
*Tumores
*Infecciones
3.Abdomen y Pélvico
a.Evaluación de diagnóstico de:
* Masas en órganos
4.Espina
a.Evaluación o diagnóstico
*Operaciones previas
*Sospecha de tumor
*Enfermedad Demielinizante
5.Músculo Esqueletal
a.Evaluar o diagnosticar
*Tumores
Favor ver protocolo sugerido referente al uso de gadolinio (se acompaña como anejo).
Contraindicaciones – No se utiliza en la evaluación inicial de: dolor de cabeza, Alheimer’s, hidrocefalia, disco herniado, cirugía previa o músculo esqueletal.

El material de contraste debe ser facturado junto a la Resonancia Magnética.

Estos servicios se evaluarán post pago, de acuerdo con los criterios del Departamento de Auditoría.

Magnetic resonance spectroscopy is considered investigational.

All policy statements below refer to performing magnetic resonance imaging (MRI) of the breast with contrast agents and a breast coil. An MRI of the breast without a breast coil, regardless of the clinical indication, is considered investigational. See additional comments in the Policy Guidelines section about the breast imaging team and the need for breast MRI centers to perform MRI-guided biopsy and localization.

Screening Uses

MRI of the breast may be considered medically necessary for individuals undergoing breast cancer screening with a high risk of breast cancer (for definitions on each of the risk levels, see the Policy Guidelines section).

MRI of the breast is considered investigational as a screening technique in average-risk individuals.

MRI of the breast is considered investigational as a screening technique for the detection of breast cancer when the sensitivity of mammography (ie, mammography using low-dose x-rays for imaging) is limited (ie, dense breasts, breast implants, scarring after breast cancer treatment).

Detection Uses

MRI of the breast may be considered medically necessary for detection of a suspected occult breast primary tumor in individuals with axillary nodal adenocarcinoma (ie, negative mammography and physical exam).

MRI of the breast may be considered medically necessary in individuals with a new diagnosis of breast cancer to evaluate the contralateral breast when clinical and mammographic findings are normal.

MRI of the breast is considered investigational for diagnosis of low-suspicion findings on conventional testing not indicated for immediate biopsy and referred for short-interval follow-up.

MRI of the breast is considered investigational for the diagnosis of a suspicious breast lesion in order to avoid biopsy.

Treatment-Related Uses

MRI of the breast may be considered medically necessary for preoperative tumor mapping of the involved (ipsilateral) breast to evaluate the presence of multicentric disease in individuals with clinically localized breast cancer who are candidates for breast conservation therapy (see the Policy Guidelines section).

MRI of the breast may be considered medically necessary for presurgical planning in individuals with locally advanced breast cancer (before and after completion of neoadjuvant chemotherapy) to permit tumor localization and characterization.

MRI of the breast may be considered medically necessary to determine the presence of pectoralis major muscle/chest wall invasion in individuals with posteriorly located tumors.

MRI of the breast may be considered medically necessary to evaluate a documented abnormality of the breast before obtaining an MRI-guided biopsy when there is documentation that other methods, such as palpation or ultrasound, are not able to localize the lesion for biopsy.

MRI of the breast is considered investigational to determine response during neoadjuvant chemotherapy in individuals with locally advanced breast cancer.

MRI of the breast is considered investigational for evaluation of residual tumor in individuals with positive margins after initial lumpectomy or breast conservation surgery.

Positron emission tomography (PET) using 2-[fluorine-18]-fluoro-2-deoxy-D-glucose (FDG) may be considered medically necessary in:

The assessment of select patients with epileptic seizures who are candidates for surgery (see Policy Guidelines section)

The diagnosis of chronic osteomyelitis.

The use of FDG-PET for all other miscellaneous indications is investigational, including, but not limited to:

Central Nervous System Diseases

Autoimmune disorders with central nervous system manifestations, including:

Behçet syndrome

lupus erythematosus

Cerebrovascular diseases, including:

arterial occlusive disease (arteriosclerosis, atherosclerosis)

carotid artery disease

cerebral aneurysm

cerebrovascular malformations (arteriovenous malformation and Moya-Moya disease)

hemorrhage

infarct

ischemia

Degenerative motor neuron diseases, including:

amyotrophic lateral sclerosis

Friedreich ataxia

olivopontocerebellar atrophy

Parkinson disease

progressive supranuclear palsy

Shy-Drager syndrome

spinocerebellar degeneration

Steele-Richardson-Olszewski syndrome

Tourette syndrome

Demyelinating diseases, such as multiple sclerosis

Developmental, congenital, or inherited disorders, including:

adrenoleukodystrophy

Down syndrome

Huntington chorea

kinky-hair disease (Menkes disease)

Sturge-Weber syndrome (encephalofacial angiomatosis) and the phakomatoses

Miscellaneous

chronic fatigue syndrome

sick building syndrome

posttraumatic stress disorder

Nutritional or metabolic diseases and disorders, including:

acanthocytosis

hepatic encephalopathy

hepatolenticular degeneration

metachromatic leukodystrophy

mitochondrial disease

subacute necrotizing encephalomyelopathy

Psychiatric diseases and disorders, including:

affective disorders

depression

obsessive-compulsive disorder

psychomotor disorders

schizophrenia

Pyogenic infections, including:

aspergillosis

encephalitis

Substance abuse, including the central nervous system effects of alcohol, cocaine, and heroin

Trauma, including brain injury and carbon monoxide poisoning

Viral infections, including:

HIV/AIDS

AIDS dementia complex

Creutzfeldt-Jakob disease

progressive multifocal leukoencephalopathy

progressive rubella encephalopathy

subacute sclerosing panencephalitis

Mycobacterium infection

Migraine

Anorexia nervosa

Assessment of cerebral blood flow in newborns

Vegetative vs locked-in syndrome

Pulmonary Diseases

Adult respiratory distress syndrome

Diffuse panbronchiolitis

Emphysema

Obstructive lung disease

Pneumonia

Musculoskeletal Diseases

Spondylodiscitis

Joint replacement follow-up

Other

Giant cell arteritis

Vasculitis

Vascular prosthetic graft infection

Inflammatory bowel disease

Sarcoidosis

Fever of unknown origin

Inflammation of unknown origin.

All policy statements apply to both positron emission tomography (PET) scans and PET plus computed tomography (CT) scans (ie, PET scans with or without PET/CT fusion).

For the clinical situations indicated that may be considered medically necessary, this assumes that the results of the PET scan will influence treatment decisions. If the results will not influence treatment decisions, these situations would be considered not medically necessary.

Bladder Cancer

PET scanning may be considered medically necessary in the staging or restaging of muscle-invasive bladder cancer when CT or magnetic resonance imaging are not indicated or remained inconclusive on distant metastasis.

PET scanning is considered investigational for bladder tumors that have not invaded the muscle (stage less than cT2).

Bone Sarcoma

PET scanning may be considered medically necessary in the staging or restaging of Ewing sarcoma and osteosarcoma.

PET scanning is considered investigational in the staging of chondrosarcoma.

Brain Cancer

PET scanning may be considered medically necessary in the staging or restaging of brain cancer.

Breast Cancer

PET scanning may be considered medically necessary in the staging or restaging of breast cancer for the following application:

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

PET scanning is considered investigational in the evaluation of breast cancer for all other applications, including but not limited to the following:

Differential diagnosis in individuals with suspicious breast lesions or an indeterminate or low suspicion finding on mammography

Staging axillary lymph nodes.

Predicting pathologic response to neoadjuvant therapy for locally advanced disease.

Cervical Cancer

PET scanning may be considered medically necessary in the initial staging of individuals with locally advanced cervical cancer.

PET scanning may be considered medically necessary in the evaluation of known or suspected recurrence.

Colorectal Cancer

PET scanning may be considered medically necessary as a technique for

Staging or restaging to detect and assess resectability of hepatic or extrahepatic metastases of colorectal cancer, and

To evaluate a rising and persistently elevated carcinoembryonic antigen levels when standard imaging, including CT scan, is negative.

PET scanning is considered investigational as:

A technique to assess the presence of scarring versus local bowel recurrence in individuals with previously resected colorectal cancer.

A technique contributing to radiotherapy treatment planning.

Endometrial Cancer

PET scanning is considered medically necessary in the:

Detection of lymph node metastases, and

Assessment of endometrial cancer recurrence.

Esophageal Cancer

PET scanning may be considered medically necessary in the

Staging of esophageal cancer, and

Determining response to preoperative induction therapy.

PET scanning is considered investigational in other aspects of the evaluation of esophageal cancer, including but not limited to the following applications:

Detection of primary esophageal cancer.

Gastric Cancer

PET scanning may be considered medically necessary in the:

Initial diagnosis and staging of gastric cancer, and

Evaluation for recurrent gastric cancer after surgical resection, when other imaging modalities are inconclusive.

Head and Neck Cancer

PET scanning may be considered medically necessary in the evaluation of head and neck cancer in the

Initial diagnosis of suspected cancer,

Initial staging of disease, and restaging of residual or recurrent disease during follow-up, and

Evaluation of response to treatment.

Lung Cancer

PET scanning may be considered medically necessary for any of the following applications:

Individuals with a solitary pulmonary nodule as a single scan technique (not dual-time) to distinguish between benign and malignant disease when prior CT scan and chest x-ray findings are inconclusive or discordant,

As staging or restaging technique in those with known non-small-cell lung cancer, and

To determine resectability for individuals with a presumed solitary metastatic lesion from lung cancer.

PET scanning may be considered medically necessary in staging of small-cell lung cancer if limited stage is suspected based on standard imaging.

PET scanning is considered investigational in staging of small-cell lung cancer if extensive stage is established and in all other aspects of managing small-cell lung cancer.

Lymphoma, Including Hodgkin Disease

PET scanning may be considered medically necessary as a technique for staging lymphoma either during initial staging or for restaging at follow-up.

Melanoma

PET scanning may be considered medically necessary as a technique for assessing extranodal spread of malignant melanoma at initial staging or at restaging during follow-up treatment for advanced disease (stage III or IV).

PET scanning is considered investigational in managing stage 0, I, or II melanoma.

PET scanning is considered investigational as a technique to detect regional lymph node metastases in individuals with clinically localized melanoma who are candidates to undergo sentinel node biopsy.

Multiple Myeloma

PET scanning may be considered medically necessary in the staging or restaging of multiple myeloma, particularly if the skeletal survey is negative.

Neuroendocrine Tumors

PET scanning with gallium 68 and copper 64 may be considered medically necessary as a technique for staging neuroendocrine tumors either during initial staging or for restaging at follow-up.

PET scanning with other radiotracers is considered investigational in all aspects of managing neuroendocrine tumors.

Ovarian Cancer

PET scanning may be considered medically necessary in the evaluation of individuals with signs and/or symptoms of suspected ovarian cancer recurrence (restaging) when standard imaging, including CT scan, is inconclusive.

PET scanning is considered investigational in the initial evaluation of known or suspected ovarian cancer in all situations.

Pancreatic Cancer

PET scanning may be considered medically necessary in the initial diagnosis and staging of pancreatic cancer when other imaging and biopsy are inconclusive.

PET scanning is considered investigational as a technique to evaluate other aspects of pancreatic cancer.

Penile Cancer

PET scanning may be considered medically necessary for staging and restaging in individuals with suspected inguinal lymph node positive disease.

PET scanning is considered investigational in all other aspects of managing penile cancer.

Prostate Cancer

PET scanning with carbon 11 choline and fluorine 18 fluciclovine may be consideredmedically necessary for evaluating suspected or biochemically recurrent prostate cancer after primary treatment to detect small volume disease in soft tissues.

PET scanning with gallium 68-prostate-specific membrane antigen and piflufolastat fluorine-18 may be considered medically necessary for any of the following applications:

Individuals with diagnosed prostate cancer in need of staging information and:

NCCN unfavorable intermediate-, high-, or very-high-risk prostate cancer (see Policy Guidelines); OR

NCCN unfavorable intermediate-, high-, or very-high-risk prostate cancer with equivocal results or oligometastatic disease on initial conventional imaging (see Policy Guidelines).

Individuals with suspected recurrence of prostate cancer based on serum PSA level who have received:

Radical prostatectomy with PSA level persistence or rise from undetectable level (see Policy Guidelines); OR

Definitive radiotherapy with PSA rise above nadir (see Policy Guidelines).

Individuals with treated prostate cancer (including active surveillance/observation) in need of imaging as part of a workup for progression (see Policy Guidelines).

Individuals with metastatic prostate cancer for whom lutetium Lu-177 vipivotide tetraxetan PSMA-directed therapy is indicated.

Use of gallium 68-prostate-specific membrane antigen and piflufolastat fluorine-18 in known or suspected prostate cancer is considered investigational for all other indications, including diagnosis, primary staging of very-low, low- or favorable intermediate-risk prostate cancer, and evaluation of response to therapy.

PET scanning for all other indications in known or suspected prostate cancer is considered investigational.

Renal Cell Carcinoma

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

Soft Tissue Sarcoma

PET scanning is considered investigational in evaluation of soft tissue sarcoma, including but not limited to the following applications:

Distinguishing between benign lesions and malignant soft tissue sarcoma,

Distinguishing between low-grade and high-grade soft tissue sarcoma,

Detecting locoregional recurrence, and

Detecting distant metastasis.

PET scanning is considered medically necessary for evaluating response to imatinib and other treatments for gastrointestinal stromal tumors.

Testicular Cancer

PET scanning may be considered medically necessary in evaluation of residual mass following chemotherapy of stage IIB and III seminomas (the scan should be completed no sooner than 6 weeks after chemotherapy).

Except as noted above for seminoma, PET scanning is considered investigational in evaluation of testicular cancer, including but not limited to the following applications:

Initial staging of testicular cancer,

Distinguishing between viable tumor and necrosis/fibrosis after treatment of testicular cancer, and

Detection of recurrent disease after treatment of testicular cancer.

Thyroid Cancer

PET scanning may be considered medically necessary in the restaging of individuals with differentiated thyroid cancer when thyroglobulin levels are elevated and whole-body iodine-131 imaging is negative.

PET scanning is considered investigational in the evaluation of known or suspected differentiated or poorly differentiated thyroid cancer in all other situations.

Cancer of Unknown Primary

PET scanning may be considered medically necessary in individuals with a cancer of unknown primary who meet ALL of the following criteria:

In individuals with a single site of disease outside the cervical lymph nodes, and

Individual is considering local or regional treatment for a single site of metastatic disease, and

After a negative workup for an occult primary tumor, and

PET scan will be used to rule out or detect additional sites of disease that would eliminate the rationale for local or regional treatment.

PET scanning is considered investigational for other indications in individuals with a cancer of unknown primary, including, but not limited to the following:

As part of the initial workup of a cancer of unknown primary, and

As part of the workup of individuals with multiple sites of disease.

Cancer Surveillance

PET scanning is considered investigational when used as a surveillance tool for individuals with cancer or with a history of cancer. A scan is considered surveillance if performed more than 6 months after completion of cancer therapy (12 months for lymphoma) in individuals without objective signs or symptoms suggestive of cancer recurrence (see Policy Guidelines section).

Stereotactic radiosurgery using a gamma-ray or linear accelerator unit may be considered medically necessary for the following indications:

arteriovenous malformations;

trigeminal neuralgia refractory to medical management;

mesial temporal lobe epilepsy refractory to medical management when standard alternative surgery is not an option;

acoustic neuromas;

pituitary adenomas;

nonresectable, residual, or recurrent meningiomas;

craniopharyngiomas;

glomus jugulare tumors;

malignant neoplastic intracranial lesion(s) (eg, gliomas, astrocytomas);

solitary or multiple brain metastases in individuals having good performance status and no active systemic disease (defined as extracranial disease that is stable or in remission) (see Policy Guidelines section);

uveal melanoma.

Stereotactic body radiotherapy may be considered medically necessary for the following indications:

primary or metastatic spinal or vertebral body tumors in individuals who have received prior spinal radiotherapy;

spinal or vertebral metastases that are radioresistant (eg, renal cell carcinoma, melanoma, sarcoma);

individuals with stage T1 or T2a non-small cell lung cancer (not >5 cm) showing no nodal or distant disease and who are not candidates for surgical resection;

primary or metastatic tumors of the liver as an alternative locoregional treatment for individuals with inoperable primary or metastatic lesions;

primary renal cell carcinoma in individuals who are not good surgical candidates or who have metastatic renal cell carcinoma;

oligometastases involving the lung, adrenal glands, and bone (other than spine or vertebral body).

When stereotactic radiosurgery or stereotactic body radiotherapy are performed using fractionation (defined in the Policy Guidelines section) for the medically necessary indications described above, it may be considered medically necessary.

Stereotactic radiosurgery is investigational for other applications including, but not limited to, the treatment of functional disorders (other than trigeminal neuralgia), including chronic pain and tremor.

Stereotactic body radiotherapy is investigational for prostate cancer, pancreatic adenocarcinoma, and other conditions except as outlined in the policy statements above.

Brachytherapy using permanent transperineal implantation of radioactive seeds may be considered medically necessary for the treatment of localized prostate cancer when used in conjunction with external-beam radiotherapy or as monotherapy (see Policy Guidelines section).

Focal prostate brachytherapy is considered investigational in the treatment of prostate cancer.

Percutaneous vertebroplasty may be considered medically necessary for the treatment of symptomatic osteoporotic vertebral fractures that have failed to respond to conservative treatment (eg, analgesics, physical therapy, rest) for at least 6 weeks.

Percutaneous vertebroplasty may be considered medically necessary for the treatment of symptomatic osteoporotic vertebral fractures that are less than 6 weeks in duration that have led to hospitalization or persist at a level that prevents ambulation.

Percutaneous vertebroplasty may be considered medically necessary for the treatment of severe pain due to osteolytic lesions of the spine related to multiple myeloma or metastatic malignancies.

Percutaneous vertebroplasty is considered investigational for all other indications, including use in acute vertebral fractures due to osteoporosis or trauma.

Percutaneous sacroplasty is considered investigational for all indications, including use in sacral insufficiency fractures due to osteoporosis and sacral lesions due to multiple myeloma or metastatic malignancies

Computed tomography colonography (CTC) may be considered medically necessary for the purposes of colon cancer screening.

Computed tomography colonography may be considered medically necessary in individuals for whom a conventional colonoscopy is indicated but who are unable to undergo conventional colonoscopy for medical reasons (see Policy Guidelines section); CTC may also be considered medically necessary for individuals with an incomplete conventional colonoscopy because of colonic stenosis or obstruction.

Except for the indications outlined in the policy statements above, CTC is considered investigational.

Computer-aided detection devices as an adjunct to single-reader interpretation of digitized screen-film mammograms may be considered medically necessary.

Computer-aided detection devices as an adjunct to single-reader interpretation of direct, full-field digital mammography is considered investigational.

The use of IVUS in transcatheter revascularization therapy of coronary artery disease may be considered medically necessary as a technique of guiding transcatheter revascularization.

Intracoronary ultrasonography is considered for payment, to determine the significance of an intermediate stenosis (40% to 70% obstruction) or to determine the lesion to be revascularized in case of multiple lesions. The great advantage of intracoronary ultrasound is that the clinical significance of stenosis intermedia can be assessed at the time of angiography and treatment not postponed (PTCA or CABG) until performing cardiac function tests.

The IVUS is considered for payment under the following conditions:
When through a pre-angiogram functional test (eg perfusion test cardiac) it is not possible to establish the diagnosis. The use of ultrasound will be required intravascular to determine the degree of obstruction.
When a pre-angiogram functional test is positive for a lesion significant, but that at the time of angiography lesions are found multiple. In this case, intravascular ultrasound would be used to determine which lesion or lesions would proceed to revascularize.
The routine use of intracoronary ultrasound and the concomitant use of Functional tests of the heart*, be they pre or post angiogram will not be considered for payment. *Cardiac perfusion test.

MRA of the chest may be considered medically necessary in patients with the following indications in whom angiography/venography would otherwise be indicated and in whom the result of MRA could obviate the need for angiography/venography:

Acquired disease of the thoracic aorta (i.e., aortic dissection, aneurysm occlusive disease, and aortitis);

· Developmental anomaly of the thoracic vasculature; or

· Systemic venous thrombosis or occlusion.

MRA of the chest may be considered medically necessary as an alternative to angiography for evaluation of pulmonary embolus in patients who have a contraindication to the use of IV iodinated contrast material (e.g., a history of severe contrast media allergy, such as anaphylactic shock or a cardiac arrest; or high risk of contrast-induced renal failure such as in diabetic patients with moderate renal insufficiency).

Investigational applications of MRA of the chest include, but are not limited to, the following:

· Evaluation of pulmonary emboli in patients without contraindications to the use of IV iodinated contrast agents.

Initial or repeat bone mineral density (BMD) measurement is not indicated unless the results will influence treatment decisions.

An initial measurement of central (hip/spine) BMD using dual x-ray absorptiometry (DXA) may be considered medically necessary to assess future fracture risk and the need for pharmacologic therapy in both women and men who are considered at risk for osteoporosis. BMD testing may be indicated under the following conditions:

Women age 65 and older, independent of other risk factors;

Men age 70 and older, independent of other risk factors;

Younger postmenopausal women with an elevated risk factor assessment; (See policy guidelines)

Men age 50 to 70 with an elevated risk factor assessment; (See policy guidelines)

Adults with a pathologic condition associated with low bone mass or increased bone loss;

Adults taking a medication associated with increased bone loss.

Repeat measurement of central (hip/spine) BMD using dual x-ray absorptiometry for individuals who previously tested normal may be considered medically necessary at an interval not more frequent than every 3 to 5 years; the interval depends on an updated patient fracture risk assessment.

Repeat measurement of central (hip/spine) BMD using dual x-ray absorptiometry may be considered medically necessary at an interval of not more frequent that every 1-2 years in individuals:

With a baseline evaluation of osteopenia (BMD T- score between -1.0 to -2.5)

Adults with a pathologic condition associated with low bone mass or increased bone loss;

Adults taking a medication associated with increased bone loss.

Repeat measurement of central (hip/spine) BMD using dual x-ray absorptiometry may be considered medically necessary at an interval not more frequent than every 1-3 years in individuals who are receiving pharmacologic treatment for osteoporosis when the information will affect treatment decisions (continuation, change in drug therapy, cessation or resumption of drug therapy).

Peripheral (lower arm, wrist, finger or heel) BMD testing may be considered medically necessary when conventional central (hip/spine) DXA screening is not feasible or in the management of hyperparathyroidism, where peripheral DXA at the forearm (ie, radius) is essential for evaluation.

BMD measurement using ultrasound densitometry is considered investigational.

Dual x-ray absorptiometry of peripheral sites is considered investigational except as noted above.

BMD measurement using quantitative computed tomography is considered investigational.

Screening Mammogram

A screening mammography is a radiologic procedure furnished to a woman without signs or symptoms of breast disease, for the purpose of early detection breast cancer,and includes a physician’s interpretation of the results of the procedure. A screening mammogram does not require a physician’s referral, however, detection of a radiographic abnormality, may prompt the interpreting radiologist to order additional views on the same day. When this is the case, the mammography is no longer considered to be a screening exam and should be reported as a diagnostic mammogram. Radiologists who order additional tests must refer back to the treating physician or qualified non-physician practitioner for his/her UPIN and report back to the treating physician the condition of the patient. No separate reimbursement will be made for additional views. The cost for additional views is included in the cost of the diagnostic mammography service. Screening mammogram(s) (digital and non-digital) for the following indications are allowed:

Asymptomatic women ages 50-74 are eligible for a screening mammography (digital and non-digital) performed after at least 11 months have passed following the month in which the last screening mammography was performed.

Diagnostic Mammography

A diagnostic mammography is a radiologic procedure furnished to a man or woman with signs and symptoms of breast disease, or a personal history of breast cancer, or a personal history of biopsy-proven benign breast disease, and includes a physician’s interpretation of the results of the procedure.

Diagnostic mammogram(s) are allowed for the following indications:

the patient is under the care of the referring/ordering physician or qualified non-physician practitioner;
there are signs and/or symptoms suggestive of malignancy (mass, some types of spontaneous nipple discharge or skin changes);
there are possible radiographic abnormalities detected on screening mammography;
there is short interval follow-up (less than one year) necessary for unresolved clinical/radiographic concerns; or
follow-up of established history of a malignancy is necessary

Diagnostic breast evaluation may be indicated in cases of a personal history of malignancy and in cases of benign biopsy-proven breast disease. These diagnoses should not, however, routinely warrant a diagnostic mammography.

A breast implant does not necessarily imply that a mammogram is diagnostic in nature. Although additional views may be needed, these additional views do not necessarily constitute a diagnostic mammogram, unless there are specific findings that require investigation.

A physician (or qualified non-physician practitioner) referral is required for diagnostic mammography. The patient must be under the care of the physician (or qualified non-physician practitioner) who orders the procedure. The order should specify the diagnosis prompting the referral for a diagnostic mammogram.

Diagnostic mammography should be performed under the direct, on-site supervision of an interpreting physician qualified in mammography. Diagnostic mammography may require that the performing radiologist review the history with the patient, review the prior mammograms, and perform an examination as part of the mammography. Also, the findings of the examination are typically discussed with the patient at the completion of the mammogram. Therefore, if telemammography is being used with digital diagnostic mammography, the radiologist need not be present for the mammography; however, he/she must be available to discuss the history with the patient, examine the patient, and discuss results of the findings of the examination with the patient within an acceptable period of time.

The use of aducanumab and lecanemab is considered investigational for all indications including treatment of Alzheimer disease.

The use of fibrin sealants is considered medically necessary  in situations where usual  and standard surgical hemostasis is not suficcient to control bleeding.

Initial Treatment

Givosiran may be considered medically necessary if all of the following conditions are met:

Individual is 18 years of age or older.

Individual has a diagnosis of acute hepatic porphyria (AHP) and confirmation of 1 of the following subtypes:

Acute intermittent porphyria (AIP)

Hereditary coproporphyria (HCP)

Variegate porphyria (VP)

Delta-aminolevulinic acid (ALA) dehydratase deficiency (ADP).

Documentation is provided that the individual has an elevated porphobilinogen (PBG)- or ALA in the urine or plasma within the past year.

Individual meets any 1 of the following criteria:

Individual has documented active symptomatic disease with at least 2 porphyria attacks within the last 6 months.

Individual is currently on prophylactic hemin treatment due to a history of severe or frequent porphyria attacks.

Individual will not be receiving prophylactic hemin treatment and givosiran concurrently.

Prescriber agrees to monitor liver function tests (LFTs).

Prescriber agrees to monitor renal function.

Initial authorization is for 12 months.

Continuation of Treatment

Incremental reauthorization for givosiran may be considered medically necessary if the following conditions are met:

Individual continues to meet the initial treatment criteria cited above.

Documentation is provided that the individual has experienced a clinical response to therapy (e.g., a reduction in rate of porphyria attacks or reduction in hemin requirements for acute attacks) since initiating therapy.

PBG or ALA concentration has not increased from baseline.

Individual does not have severe or clinically significant transaminase elevations, defined as alanine aminotransferase (ALT) greater than 5 times the upper limit of normal.

Reauthorization period is for 12 months.

Givosiran is considered investigational for all other indications.

Omidubicel

The product label of omidubicel recommends that patients be treated under the supervision of a physician experienced in the treatment of hematologic malignancies at centers with expertise in hematopoietic stem cell transplantation.

The product label contains several boxed warnings:

Infusion reactions: Fatal infusion reactions may occur. Individuals should be monitored during infusion and discontinue for severe reactions. The use of omidubicel is contraindicated for individuals with a known allergy to dimethyl sulfoxide, Dextran 40, gentamicin, human serum albumin, or bovine material.

Graft versus host disease (GVHD): Fatal GVHD may occur. The administration of immunosuppressive therapies may decrease the risk of GVHD.

Engraftment syndrome: Fatal engraftment syndrome may occur. Engraftment syndrome should be treated promptly with corticosteroids.

Graft failure: Fatal graft failure may occur. Patients should be monitored for hematopoietic recovery using laboratory evidence.

Idecabtagene vicleucel and ciltacabtagene autoleucel may be considered medically necessary for individuals with multiple myeloma if they meet criteria 1 through 6:

Are adults (age ≥18) at the time of infusion

Have a documented diagnosis of multiple myeloma

Have relapsed or refractory disease after 4 or more prior lines of therapy, including an immunomodulatory agent, a proteasome inhibitor, and an anti-CD38 monoclonal antibody (see Policy Guidelines)

Have adequate organ and bone marrow function as determined by the treating oncologist/hematologist

Does not have active infection(s) or inflammatory disorders

Have not received prior chimeric antigen receptor T therapy or any other gene therapy or are being considered for treatment with any other gene therapy.

Idecabtagene vicleucel and ciltacabtagene autoleucel are considered investigational when the above criteria are not met.

Idecabtagene vicleucel and ciltacabtagene autoleucel are considered investigational for all other indications.

El Doppler Transcraneal se considera para pago en:
Monitoreo del vasoespasmo en pacientes con hemorragia subaracnoidea.

Para la evaluación inicial de la circulación colateral y flujo de sangre durante una endarterectomía carotídea. De forma que se puede detectar a tiempo una isquemia severa, y establecer un puente para evitar el riesgo de un “stroke”.

El diagnóstico de estenosis y oclusión de arterias intracraneales en pacientes con accidentes cerebro vasculares (CVA) o ataques isquémicos transitorios (TIA).

Para la evaluación de pacientes con anemia trepanocítica (“sickle cell disease”) sin síntomas de TIA o CVA, para evaluar el riesgo de un accidente transitorio isquémico (TIA) o un accidente cardiovascular.

El Doppler Transcraneal no se considera para pago:
En la evaluación de los cambios hemodinámicos de aterosclerosis vascular extracraneal.

En el diagnóstico y evaluación de patrones circulatorios de malformaciones arteriovenosas.

La evaluación del flujo sanguíneo cerebral como resultado de trauma.

La evaluación de la circulación cerebral como una medida de muerte cerebral.

En la evaluación de migraña y dolor de cabeza por tensión.

En la evaluación del flujo sanguíneo cerebral y posibles eventos embólicos durante el uso de circulación extracorpórea.

En la evaluación de patrones de flujo sanguíneo-cerebral en infecciones del sistema nervioso central.

La evaluación de demencia.

La evaluación de hidrocefalia.

La evaluación de glaucoma.

Monitoreo de la terapia vasodilatora como tratamiento de desórdenes del comportamiento o del desarrollo incluyendo pero no limitándose a desorden de atención con hiperactividad, autismo, o síndrome de Touerette

La resonancia magnética requiere preautorización para evaluar la necesidad médica del servicio en las cubiertas que así lo establecen. Se recomienda utilizar la tabla de guía para evaluar las pruebas diagnósticas de primera línea relevantes a cada área anatómica.
El material de contraste no requiere preautorización, una vez pre-autorizada la Resonancia Magnética. El participante que realiza el estudio es el perito que decide su uso. Referirse al tema Contraste para Resonancia Magnética.

La biopsia de mama asistida por vacío y guiada con MRI se considera para pago bajo las siguientes circunstancias:
Lesión que se identifiquen en sólo una de las placas de una mamografía.

Lesión previamente identificada en un MRI y que no se identifique en mamografía o sonomamografía convencional y que requiera biopsia dirigida.

La biopsia a realizarse debe ser percutánea, asistida por vacío y con aguja de calibre grande (9G).

La necesidad debe documentarse con copias de los informes de mamografías y sonomamografías previamente obtenidas.

Inhaled cannabis or extracted cannabinoids are considered investigational for the treatment of the following:

Chronic non-cancer pain

Cancer pain

Acute post-operative pain

Spasticity associated with multiple sclerosis.

Inhaled cannabis or extracted cannabinoids are considered investigational for all other conditions that have not received approval from the U.S. Food and Drug Administration.

Individuals may be considered for a 1 time use of brexanolone per pregnancy if they meet all of the following criteria:

Individual is 15 years of age or older and ≤6 months postpartum at the time of infusion.

Individual meets the Diagnostic and Statistical Manual of Mental Disorders-5 (DSM-5) criteria for a major depressive episode (See Table 1) by a structured clinical interview for DSM-5 disorders.

Individual has a onset of depressive episode between 3rd trimester through 4 weeks postpartum.

Individual has a diagnosis of moderate to severe postpartum depression based on either of the following:

Hamilton Rating Scale for Depression (HAM-D) score ≥ 20 (see policy guidelines) OR

Edinburgh Postnatal Depression Scale (EPDS) score ≥ 13 (see policy guidelines)

Individual meets 1 of the following:

Has tried and had an inadequate response to 2 antidepressant agents from 2 different antidepressant classes (i.e. SSRIs, SNRIs, TCAs, bupropion, or mirtazapine). An adequate trial of an antidepressant is defined by BOTH of the following:

The trial length was at least 6 weeks at generally accepted doses or of sufficient duration as determined by the treating physician at the generally accepted doses; and

Individual was ≥80% adherent to the agent during the trial; OR

Has a documented intolerance or U.S. Food and Drug Administration (FDA) labeled contraindication, to major classes of antidepressant agents; OR

Shows a potential risk of immediate harm to self and/or others as determined by the treating physician and supported by documentation.

Individual does NOT have any FDA labeled contraindications to the requested agent and is intended to be used consistently with the FDA approved label (see policy guidelines).

The prescriber is a specialist in the area of the individual’s diagnosis (e.g. psychiatrist) or the prescriber has consulted with a specialist in the area of the individual’s diagnosis.

Brexanolone is considered investigational when the above criteria are not met.

Brexanolone is considered investigational for all other indications.

Larotrectinib and entrectinib are considered medically necessary when ALL of the following are met:

Individual has a confirmatory diagnosis of a solid tumor which is metastatic OR when surgical resection is likely to result in severe morbidity.

The tumor has an NTRK gene fusion without a known acquired resistance variant.

Individual has progressed following standard of care OR failed standard of care for the given solid tumor.

Must be prescribed by an oncologist/hematologist.

Individual does NOT have any U.S. Food and Drug Administration (FDA) labeled contraindications to the requested agent and is intended to be used consistently with the FDA approved label (see policy guidelines).

Larotrectinib and entrectinib are considered investigational in all other situations.

Buprenorphine subdermal implants may be considered medically necessary when all four of the following criteria have been met:

The individual has been diagnosed with opioid dependence; and

The individual has been treated with a stable transmucosal buprenorphine dose (≤8 mg/d of a sublingual Subutex or Suboxone tablet or its transmucosal buprenorphine product equivalent) for 3 months or more without any need for supplemental dosing or adjustments; and

The individual is currently on a maintenance dosea of 8 mg per day or less of a sublingual Subutex or Suboxone tablet or its transmucosal buprenorphine product equivalent to achieve sustained prolonged clinical stability on transmucosal buprenorphine; and

Buprenorphine implants are used as part of a comprehensive substance use disorder treatment program that includes counseling and psychosocial support.

a U.S. Food and Drug Administration indications specify that maintenance doses should not be tapered to a lower dose for the sole purpose of transitioning to buprenorphine implants (https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/204442s006lbl.pdf).

Buprenorphine implants are considered investigational for all other indications, including but not limited to:

When the medically necessary criteria above have not been met;

For new entrants to treatment;

For individuals who have not achieved and sustained prolonged clinical stability while being maintained on buprenorphine 8 mg or less per day of a Subutex or Suboxone sublingual tablet or generic equivalent;

For individuals not enrolled in a comprehensive substance use disorder treatment program;

Treatment for longer than 12 months.

Individuals can be transitioned back to transmucosal buprenorphine-containing medications for continued treatment after 12 months as needed. Retreatment with buprenorphine implant after a prior 12-month treatment period is considered investigational and not medically necessary under all circumstances.

The prescribing information also provides guidance on acceptable doses of transmucosal buprenorphine that demonstrating stable maintenance dosing (https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/204442s006lbl.pdf):

Buprenorphine (Subutex) sublingual tablet (generic equivalent) 8 mg or less per day;

Buprenorphine and naloxone (Suboxone) sublingual tablet (generic equivalent) 8 mg/2 mg or less per day;

Buprenorphine and naloxone (Bunavail) buccal film 4.2 mg/0.7 mg or less per day;

Buprenorphine and naloxone (Zubsolv) sublingual tablets 5.7 mg/1.4 mg or less per day.

Additionally, the prescribing information includes the following factors in determining clinical stability and suitability for Probuphine treatment (https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/204442s006lbl.pdf):

Period free from illicit opioid drug use;

Stability of living environment;

Participation in a structured activity/job;

Consistent participation in recommended behavioral therapy/peer support program;

Consistent compliance with clinic visit requirements;

Minimal to no desire or need to use illicit opioids;

Period without episodes of hospitalizations (addiction or mental health issues), emergency room visits, or crisis interventions;

Social support system.

The use of epoetin alfa, darbepoetin, or pegylated epoetin beta may be considered medically necessary for:

treatment of anemia associated with chronic kidney disease.a,b,c

The use of pegylated epoetin beta is investigational for all other indications.

The use of epoetin alfa or darbepoetin may be considered medically necessary for:

treatment of anemia in individuals with cancer with non-myeloid malignancies where anemia is due to the effect of concomitantly administered chemotherapy;a,b

treatment of anemia related to therapy with AZT (zidovudine) in HIV-infected individuals;a

reduction of allogeneic blood transfusion in surgery individuals;a

treatment of individuals after allogeneic bone marrow transplantation; and

treatment of individuals with myelodysplastic syndromes to reduce transfusion dependency.

The use of epoetin alfa or darbepoetin may be considered medically necessary for:

treatment of individuals with hepatitis C and anemia related to ribavirin treatment.

For medically necessary conditions noted above, the following criteria also apply:

The lowest dose of erythropoiesis-stimulating agents should be used to avoid red blood cell transfusions;

Erythropoiesis-stimulating agents should not be used to raise the hemoglobin level above 12 g/dL; and

Erythropoiesis-stimulating agent therapy should not be administered without adequate iron stores.

For medically necessary use in cancer patients, these additional U.S. Food and Drug Administration criteria apply:

Epoetin alfa or darbepoetin treatment should not be initiated at hemoglobin levels of 10 g/dL or higher; and

Epoetin alfa or darbepoetin treatment should be discontinued after completion of a myelosuppressive chemotherapy course.

The use of epoetin alfa or darbepoetin is investigational for:

treatment of individuals after high-dose chemotherapy with autologous stem cell support;

treatment of noniatrogenic chronic anemia of cancer; and

other cancer-associated anemia except as noted above.

a FDA-approved label for epoetin alfa (Epogen, Procrit).
b FDA-approved label for darbepoetin alfa (Aranesp).
c FDA-approved label for pegylated epoetin beta (Mircera).

Lyme Disease

Treatment of Lyme disease consists of oral antibiotics, except for the following indications.

Neuroborreliosis

A 2- to 4-week course of intravenous (IV) antibiotic therapy may be considered medically necessary in individuals with neuroborreliosis with objective neurologic complications of documented Lyme disease (see the following for methods of documentation).

Objective neurologic findings include:

Lymphocytic meningitis with documented cerebrospinal fluid (CSF) abnormalities

Cranial neuropathy, other than uncomplicated cranial nerve palsy, with documented CSF abnormalities

Encephalitis or encephalomyelitis with documented CSF abnormalities

Radiculopathy

Polyneuropathy.

Lyme disease may be documented by serologic testing or by clinical findings of erythema migrans in early infection. Documentation of CSF abnormalities is required for suspected central nervous system infection, as indicated above.

Serologic documentation of infection requires:

Positive or indeterminate enzyme-linked immunosorbent assay, AND

Positive immunoblot blot by Centers for Disease Control and Prevention criteria.

Documented CSF abnormalities include ALL of the following:

Pleocytosis;

Evidence of intrathecal production of Borrelia burgdorferi antibodies in CSF; and

Increased protein levels.

Polymerase chain reaction (PCR)-based direct detection of B. burgdorferi in CSF samples may be considered medically necessary and may replace serologic documentation of infection in individuals with a short duration of neurologic symptoms (<14 days) during the window between exposure and production of detectable antibodies. Lyme Carditis A single 2- to 4-week course of IV antibiotics may be considered medically necessary in individuals with Lyme carditis, as evidenced by positive serologic findings (defined above) and associated with high degree atrioventricular block or a PR interval more than 0.3 seconds. Documentation of Lyme carditis may include PCR-based direct detection of B. burgdorferi in the blood when results of serologic studies are equivocal. Lyme Arthritis A single 2- to 4-week course of IV antibiotic therapy may be considered medically necessary in the small subset of individuals with well-documented Lyme arthritis who have such severe arthritis that it requires the rapid response associated with IV antibiotics. Documentation of Lyme arthritis may include PCR-based direct detection of B. burgdorferi in the synovial tissue or fluid when results of serologic studies are equivocal. Antibiotic Therapy Intravenous antibiotic therapy is considered investigational in the following situations: Individuals with symptoms consistent with chronic fatigue syndrome or fibromyalgia, in the absence of objective clinical or laboratory evidence of Lyme disease; Individuals with seronegative Lyme disease in the absence of CSF antibodies; Initial therapy in individuals with Lyme arthritis without coexisting neurologic symptoms; Cranial nerve palsy (eg, Bell palsy) without clinical evidence of meningitis; Post-antibiotic Lyme arthritis (unresponsive to 2 courses of oral antibiotics or to 1 course of oral and 1 course of IV antibiotic therapy); Individuals with vague systemic symptoms without supporting serologic or CSF studies; Individuals with a positive enzyme-linked immunosorbent assay test, unconfirmed by an immunoblot or Western blot test (see definition above); Individuals with an isolated positive serologic test in the setting of multiple negative serologic studies; Individuals with chronic (≥6 months) subjective symptoms (“post-Lyme syndrome”) after receiving recommended treatment regimens for documented Lyme disease. Repeat or prolonged courses (eg, >4 weeks) of IV antibiotic therapy are considered investigational.

Diagnostic Testing

Repeat PCR-based direct detection of B. burgdorferi is considered investigational in the following situations:

as a justification for the continuation of IV antibiotics beyond 1 month in individuals with persistent symptoms

as a technique to follow therapeutic response.

PCR-based direct detection of B. burgdorferi in urine samples is considered investigational in all clinical situations.

Genotyping or phenotyping of B. burgdorferi is considered investigational.

Other diagnostic testing is considered investigational including but not limited to “stand-alone” C6 peptide enzyme-linked immunosorbent assay, determination of levels of the B-lymphocyte chemoattractant CXCL13, or Outer surface protein A (OspA) antigen testing for diagnosis or monitoring treatment.

Repository corticotropin injection may be considered medically necessary for the treatment of infantile spasms (West syndrome).

Use of repository corticotropin injection is considered investigational as a treatment of corticosteroid-responsive conditions (see Policy Guidelines section).

Except as noted above, use of repository corticotropin injection is considered investigational for conditions that are not responsive to corticosteroid therapy including, but not limited to, use in tobacco cessation, acute gout, and childhood epilepsy.

Repository corticotropin injection is considered investigational for use in diagnostic testing of adrenocortical function.

Injectable clostridial collagenase for the treatment of Dupuytren’s contracture in adults with a palpable cord may be considered medically necessary, for up to 3 injections at intervals of at least 30 days (see the Policy Guidelines section).

Injectable clostridial collagenase for the treatment of Peyronie’s disease in adults may be considered medically necessary for a maximum of 4 treatment cycles when the following criteria are met:

Individual has a diagnosis of Peyronie’s disease with a palpable plaque; AND individual has a curvature deformity of at least 30 degrees at the start of therapy; AND the injections will be used in combination with a penile modeling procedure (1 to 3 days after injection).

Injectable clostridial collagenase is considered investigational for all other indications including, but not limited to, adhesive capsulitis.

Treatment-Resistant Depression

Esketamine nasal spray may be considered medically necessary if all of the following conditions are met:

Initial Authorization for 28 Days

Individual is 18 years of age or older.

Individual meets the Diagnostic and Statistical Manual of Mental Disorders-5 (DSM-5) criteria for a major depressive episode (See Table 1) by a structured clinical interview for DSM-5 disorders.

Individual current depressive episode is moderate or severe based on either of the following:

Montgomery-Asberg Depression Rating Scale (MADRS) ≥ 28 (see policy guidelines) OR

Hamilton Rating Scale for Depression (HAM-D) score ≥ 17 (see policy guidelines).

Individual has tried and had an inadequate response to 2 antidepressant agents from 2 different antidepressant classes (i.e., selective serotonin reuptake inhibitors, serotonin and norepinephrine reuptake inhibitors, tricyclic antidepressants, bupropion, or mirtazapine). An adequate trial of an antidepressant is defined by BOTH of the following:

The trial length was at least 6 weeks at generally accepted doses or of sufficient duration as determined by the treating physician at the generally accepted doses; AND

Individual was ≥80% adherent to the agent during the trial.

Individual is to receive esketamine nasal spray in conjunction with an oral antidepressant.

Individual does not have a current substance use disorder unless in remission (complete abstinence for a month).

Individual does NOT have any U.S. Food and Drug Administration (FDA) labeled contraindications to the requested agent and esketamine nasal spray is intended to be used consistently with the FDA approved label (see policy guidelines) including meeting Spravato Risk Evaluation and Mitigation Strategy (REMS) program requirements (see policy guidelines).

The prescriber is a specialist in the area of the individual’s diagnosis (e.g. psychiatrist) or the prescriber has consulted with a specialist in the area of the individual’s diagnosis.

Reauthorization for UP TO 1 Year

Esketamine nasal spray may be reauthorized for up to 1 year if all of the following conditions are met:

Individual has had improvement in depression symptoms as evaluated with an appropriate depression rating scale (e.g. Patient Health Questionnaire‐9, Clinically Useful Depression Outcome Scale, Quick Inventory of Depressive Symptomatology‐Self Report 16 Item, MADRS, HAM‐D).

Individual is to receive esketamine nasal spray in conjunction with an oral antidepressant.

Individual does not have a current substance use disorder.

Individual does NOT develop any FDA-labeled contraindications to the requested agent and esketamine nasal spray is intended to be used consistently with the FDA-approved label (see policy guidelines) including meeting Spravato REMS program requirements (see policy guidelines).

Major Depressive Disorder with Acute Suicidal Ideation or Behavior

Esketamine nasal spray may be considered medically necessary for a treatment period of 28 days if all of the following conditions are met:

Individual is 18 years of age or older.

Individual meets the DSM-5 criteria for a major depressive episode (See Table 1) by a structured clinical interview for DSM-5 disorders.

Individual current depressive episode is moderate or severe based on either of the following scales:

MADRS ≥ 28 (see policy guidelines) OR

HAM-D score ≥ 17 (see policy guidelines).

Individual is currently hospitalized and is at imminent risk of suicide as documented by

Individual response to a structured assessment for suicidal ideation indicative of imminent risk of suicide (see policy guidelines) AND

Confirmation of imminent risk of suicide by clinical assessment by a mental health professional/psychiatrist (see policy guidelines).

Individual is to receive esketamine nasal spray in conjunction with standard-of-care treatment based on clinical judgment and practice guidelines that may be comprised of oral antidepressant(s), an atypical antipsychotic, or a mood stabilizer.

Individual does NOT have any FDA-labeled contraindications to the requested agent and esketamine nasal spray is intended to be used consistently with the FDA-approved label (see policy guidelines) including meeting Spravato REMS program requirements (see policy guidelines).

The prescriber is a specialist in the area of the individual’s diagnosis (e.g. psychiatrist) or the prescriber has consulted with a specialist in the area of the individual’s diagnosis.

Esketamine nasal spray is considered investigational in all other situations.

Trple S considers short-acting granulocyte colony stimulating factors (G-CSFs), medically necessary for prevention of neutropenia in persons with cancer receiving myelosuppressive chemotherapy when the following criteria are met:
I.    The short-acting G-CSF will not be used in combination with other colony stimulating factors within any chemotherapy cycle; and
II.    The member will not be receiving concurrent chemotherapy and radiation therapy; and
III.    One of the following criteria is met
A.    The short-acting G-CSF will be used for primary prophylaxis in individuals with a solid tumor or non-myeloid malignancies who have received, is currently receiving, or will be receiving myelosuppressive chemotherapy that is expected to result in:
1.    20% or higher incidence of febrile neutropenia (FN) (see Appendix); or
2.    10 – 19% risk of FN (see Appendix)
Note: In the absence of special circumstances, most commonly used regimens have risks of FN of less than 20 %.  When available, alternative regimens offering equivalent efficacy, but not requiring CSF support, should be utilized (Smith et al, 2006).
B.    The short-acting G-CSF will be used for secondary prophylaxis in members with solid tumors or non-myeloid malignancies who experienced a febrile neutropenic complication or a dose-limiting neutropenic event (a nadir or day of treatment count impacting the planned dose of chemotherapy) from a prior cycle of similar chemotherapy, with the same dose and schedule planned for the current cycle (for which primary prophylaxis was not received).
Note: Colony-stimulating factors should not be routinely used for afebrile neutropenia (Smith et al, 2006).

C.    The short-acting G-CSF will be used for treatment of febrile neutropenia (FN).
Tripe S considers short-acting G-CSF products medically necessary for the following indications:
I.    Acute Myeloid Leukemia
II.    Agranulocytosis (non-chemotherapy drug-induced)
III.    Aplastic anemia
IV.    CAR T-cell-related toxicities: Supportive care for neutropenic persons with CAR T-cell-related toxicities
V.    Chronic Myeloid Leukemia: Members with chronic myeloid leukemia (CML) for treatment of persistent neutropenia due to tyrosine kinase inhibitor therapy
VI.    Glycogen Storage Disease (GSD) Type 1: Individuals with GSD Type 1 for treatment of low neutrophil counts
VII.    Hairy Cell Leukemia: Members with hairy cell leukemia with neutropenic fever following chemotherapy
VIII.    Hematopoietic Syndrome of Acute Radiation Syndrome – Treatment for radiation-induced myelosuppression following a radiological/nuclear incident
IX.    Myelodysplastic syndrome (anemia or neutropenia)
X.    Neutropenia related to HIV/AIDS
XI.    Neutropenia related to renal transplantation
XII.    Severe chronic neutropenia (congenital, cyclic, or idiopathic)
XIII.    Stem cell transplantation-related indications.

Trple S considers long-acting granulocyte colony stimulating factors (G-CSFs), pegfilgrastim (Neulasta), pegfilgrastim-jmdb (Fulphila), Nyvepria (pegfilgrastim -apgf), pegfilgrastim-cbqv (Udenyca), and pegfilgrastim-bmez (Ziextenzo) medically necessary for prevention of neutropenia in persons with cancer receiving myelosuppressive chemotherapy when the following criteria are met:
I.    The long-acting G-CSF will not be used in combination with other colony stimulating factors within any chemotherapy cycle; and
II.    The member will not be receiving concurrent chemotherapy and radiation therapy; and
III.    The requested medication will not be administered with weekly chemotherapy regimens; and
IV.    One of the following criteria is met
A.    The long-acting G-CSF will be used for primary prophylaxis in individuals with a solid tumor or non-myeloid malignancies who have received, is currently receiving, or will be receiving myelosuppressive chemotherapy that is expected to result in:
1.    20% or higher incidence of febrile neutropenia (FN) (see Appendix); or
2.    10 – 19% risk of FN (see Appendix)
Note: In the absence of special circumstances, most commonly used regimens have risks of FN of less than 20 %.  When available, alternative regimens offering equivalent efficacy, but not requiring CSF support, should be utilized (Smith et al, 2006).
B.    The long-acting G-CSF will be used for secondary prophylaxis in members with solid tumors or non-myeloid malignancies who experienced a febrile neutropenic complication or a dose-limiting neutropenic event (a nadir or day of treatment count impacting the planned dose of chemotherapy) from a prior cycle of similar chemotherapy, with the same dose and schedule planned for the current cycle (for which primary prophylaxis was not received).
Note: Colony-stimulating factors should not be routinely used for afebrile neutropenia (Smith et al, 2006).
C.    The short-acting G-CSF will be used for treatment of febrile neutropenia (FN).
Triple S considers long-acting G-CSF products medically necessary for the following indications:
I.    Chronic Myeloid Leukemia – Members with chronic myeloid Leukemia (CML) for treatment of persistent neutropenia due to tyrosine kinase inhibitor therapy
II.    Hairy cell leukemia – Members with hairy cell leukemia with neutropenic fever following chemotherapy
III.    Hematopoietic Syndrome of Acute Radiation Syndrome – Treatment for radiation-induced myelosuppression following a radiological/nuclear incident
IV.    Stem cell transplantation-related indications.

Polatuzumab vedotin-piiq (Polivy) is considered medically necessary for the treatment of adult patients with diffuse large B-cell lymphoma (DLBCL) when the following criteria are met:

• The patient has relapsed or refractory disease; and

• Polatuzumab vedotin is administered in combination with bendamustine and a rituximab product; and

• The patient has received at least two prior systemic chemotherapies; and

• The patient is not a candidate for autologous hematopoietic stem cell transplantation (HSCT);

and

• The patient has not previously undergone allogeneic HSCT; and

• The patient does not have active central nervous system lymphoma or histologically transformed lymphoma.

Authorization: 12 months

Use of polatuzumab vedotin-piiq (Polivy) may be considered medically necessary for clinical indications not listed above when the drug is prescribed for the treatment of cancer either:

• In accordance with FDA label (when clinical benefit has been established, (see Policy

Guidelines); OR

• In accordance with specific strong endorsement or support by nationally recognized compendia, when such recommendation is based on strong/high levels of evidence, and/or uniform consensus of clinical appropriateness has been reached.

Initial Treatment

Lumasiran may be considered medically necessary if all of the following conditions are met:

Diagnosis of primary hyperoxaluria type 1 confirmed by identification of biallelic pathogenic variants in alanine:glyoxylate aminotransferase (AGT or AGXT) gene OR liver biopsy demonstrating AGT deficiency.

Presence of 1 of the following clinical signs or symptoms of primary hyperoxaluria type 1:

Elevated urine oxalate excretion (body surface area-normalized daily urine oxalate excretion output ≥0.7 mmol/1.73 m2)

Elevated plasma oxalate concentration >20 μmol/L or >1.76 mg/L

Urine oxalate excretion:creatinine ratio above age-specific upper limit of normal.

Individual has not received a liver transplant.

Prescribed by or in consultation with a nephrologist, urologist, geneticist, or any healthcare provider with expertise in treating primary hyperoxaluria type 1.

Initial authorization period is for 6 months.

Continuation of Treatment

Incremental reauthorization for lumasiran may be considered medically necessary if the following conditions are met:

Individual continues to meet the initial treatment criteria cited above.

Documented evidence to support clinically meaningful response to therapy from pre-treatment baseline (eg, decreased urinary oxalate concentrations, decreased urinary oxalate:creatinine ratio, decreased plasma oxalate concentrations, improvement, stabilization or slowed worsening of nephrocalcinosis, renal stone events, renal impairment or systemic calcinosis).

Does not exceed United States Food and Drug Administration approved maintenance dose.

Reauthorization period is for 12 months.

Lumasiran is considered investigational when the above criteria are not met.

Lumasiran is considered investigational for all other indications.

Pulmonary Arterial Hypertension (PAH)

Combination therapy for the treatment of PAH (World Health Organization [WHO] Group I) may be considered medically necessary when all of the following conditions are met (see Policy Guidelines section):

Individuals have failed to demonstrate an adequate response to a single medication;

Medications are from different therapeutic classes;

Each medication may be considered medically necessary for the treatment of PAH (see above statement).

Combination therapy with tadalafil and ambrisentan as first-line treatment may be considered medically necessary in the treatment of treatment naïve individuals with PAH who have WHO Functional Class Groups II and III disease.

Combination therapy with macitentan, tadalafil, and selexipag as first-line treatment is considered investigational in the treatment of treatment naïve individuals with PAH.

Use of other advanced therapies for the pharmacologic treatment of PAH (WHO group 1) that are not approved by the U.S. Food and Drug Administration for this indication, including but not limited to imatinib, simvastatin, and atorvastatin, is considered investigational.

Pulmonary Hypertension

The use of epoprostenol, treprostinil, iloprost, bosentan, ambrisentan, macitentan, sildenafil, tadalafil, or vardenafil is considered investigational for the treatment of pulmonary hypertension (PH; WHO Groups 2-5), including but not limited to:

PH associated with left heart diseases;

PH associated with lung diseases and/or hypoxemia (including chronic obstructive pulmonary disease);

PH due to chronic thrombotic and/or embolic disease;

Miscellaneous group (ie, sarcoidosis, histiocytosis X, lymphangiomatosis).

Chronic Thromboembolic Pulmonary Hypertension

The use of riociguat (Adempas) for the treatment of chronic thromboembolic pulmonary hypertension (CTEPH; WHO group 4) may be considered medically necessary in the following conditions:

Persistent PH after surgical thrombectomy, or

Inoperable CTEPH.

The use of riociguat or medications specific to PAH to reduce pulmonary vascular resistance before surgery in individuals with CTEPH who are considered candidates for pulmonary endarterectomy is considered investigational.

The use of riociguat is considered investigational for the treatment of PH (WHO groups 2, 3, and 5), including but not limited to:

PH associated with left heart diseases;

PH associated with lung diseases and/or hypoxemia (including chronic obstructive pulmonary disease);

Miscellaneous group (ie, sarcoidosis, histiocytosis X, lymphangiomatosis).

Intravenous Rituximab

Intravenous rituximab (Rituxan) may be considered medically necessary to treat patients with non-Hodgkin lymphoma (NHL) for the following U.S. Food and Drug Administration (FDA) labeled indications:

Follicular lymphoma (FL):

Previously untreated follicular, CD20-positive, B-cell NHL in combination with first line chemotherapy and, in patients achieving a complete or partial response to a rituximab product in combination with chemotherapy, as single-agent maintenance therapy

Non-progressing (including stable disease), low-grade, CD20-positive, B-cell NHL, as a single agent, after first-line CVP (cyclophosphamide, vincristine and prednisolone) chemotherapy

Relapsed or refractory, low-grade or follicular, CD20-positive, B-cell NHL as a single agent

Diffuse large B-cell lymphoma (DLBCL):

Previously untreated diffuse large B-cell, CD20-positive NHL in combination with CHOP (cyclophosphamide, doxorubicin, vincristine, prednisone) or other anthracycline-based chemotherapy regimens

Chronic lymphocytic leukemia (CLL):

Previously untreated and previously treated CD20-positive CLL in combination with FC (fludarabine and cyclophosphamide)

Intravenous rituximab (Rituxan) may be considered medically necessary to treat patients with NHL for the following off-label indications:

Mantle cell lymphoma:

First-line therapy in combination with one of guideline-based chemotherapy regimens.

Maintenance therapy until progression or intolerance.

Burkitt lymphoma:

First-line therapy

Posttransplant lymphoproliferative disorders:

For patients who have had an inadequate response to reduction of immunosuppression or are not candidates for reduction of immunosuppression

Subcutaneous Rituximab

Subcutaneous rituximab (Rituxan) may be considered medically necessary to treat patients with non-Hodgkin lymphoma (NHL) for the following FDA labeled indications:

Subcutaneous rituximab (rituximab and hyaluronidase human) [Rituxan Hycela]) may be considered medically necessary to treat patients with NHL who have received at least one full dose of intravenous rituximab for the following FDA labeled indications:

Follicular lymphoma (FL):

Previously untreated FL in combination with first-line chemotherapy and, in patients achieving a complete or partial response to rituximab in combination with chemotherapy, as single-agent maintenance therapy.

Non-progressing (including stable disease) FL as a single agent after first-line cyclophosphamide, vincristine, and prednisone (CVP) chemotherapy.

Relapsed or refractory FL as a single agent.

Diffuse large B-cell lymphoma (DLBCL):

Previously untreated diffuse large B-cell lymphoma in combination with cyclophosphamide, doxorubicin, vincristine, prednisone (CHOP) or other anthracycline based-chemotherapy regimens.

Chronic lymphocytic leukemia (CLL):

Previously untreated and previously treated CLL in combination with fludarabine and cyclophosphamide (FC).

Ofatumumab

Intravenous ofatumumab (Arzerra) may be considered medically necessary to treat patients with NHL for the following FDA labeled indications:

Chronic lymphocytic leukemia (CLL):

In combination with chlorambucil, for the treatment of previously untreated patients with CLL for whom fludarabine-based therapy is considered inappropriate

In combination with fludarabine and cyclophosphamide (FC) for the treatment of patients with relapsed CLL

For extended treatment of patients who are in complete or partial response after at least 2 lines of therapy for recurrent or progressive CLL

For the treatment of patients with CLL refractory to fludarabine and alemtuzumab

Ofatumumab (Arzerra) is considered investigational as maintenance therapy in patients with CLL.

Ofatumumab (Arzerra) is considered investigational for the treatment of malignancies other than CLL.

Obinutuzumab

Intravenous obinutuzumab (Gazyva) may be considered medically necessary to treat patients with NHL for the following FDA labeled indications:

Follicular lymphoma (FL):

In combination with chemotherapy followed by obinutuzumab monotherapy in patients achieving at least a partial remission, for the treatment of adult patients with previously untreated stage II bulky, III or IV FL.

In combination with bendamustine followed by obinutuzumab monotherapy, for the treatment of patients with FL who relapsed after, or are refractory to, a rituximab-containing regimen.

Chronic lymphocytic leukemia (CLL):

In combination with chlorambucil, for the treatment of patients with previously untreated CLL.

Obinutuzumab (Gazyva) is considered investigational for relapsed or refractory CLL.

The use of bevacizumab is considered medically necessary for the following conditions:

I. FDA-approved indications:

Cervical cancer – in combination with paclitaxel and cisplatin or topotecan for persistent, recurrent, or metastatic disease
Cervical cancer – in combination with pembrolizumab and chemotherapy for persistent, metastatic, or recurrent disease with PD-L1 combined positive score ≥ 1
CNS – Brain cancer (glioblastoma) – as a single agent or in combination with carmustine, temozolomide, or lomustine in patients with recurrent disease
Colon cancer – in combination with intravenous fluorouracil-based chemotherapy for first- or second-line treatment of metastatic disease
Colon cancer – in combination with fluoropyrimidine-, irinotecan-, or fluoropyrimidine-oxaliplatin-based chemotherapy for second-line treatment of metastatic disease in patients who have progressed on a first-line bevacizumab-containing regimen
Hepatocellular carcinoma – in combination with atezolizumab in patients with unresectable or metastatic disease who have not received prior systemic therapy
Non-small cell lung cancer – in combination with carboplatin and paclitaxel for first-line treatment of non-squamous, unresectable, locally advanced, recurrent, or metastatic disease
Ovarian cancer – for the treatment of recurrent epithelial disease in combination with paclitaxel, pegylated liposomal doxorubicin, or topotecan for platinum-resistant disease or in combination with carboplatin and paclitaxel or carboplatin and gemcitabine followed by single agent bevacizumab for platinum-sensitive disease
Ovarian cancer – in combination with carboplatin and paclitaxel followed by single agent bevacizumab for stage III-IV disease following initial surgical resection
Rectal cancer – in combination with intravenous 5-FU-based chemotherapy for first- or second-line treatment of metastatic disease
Rectal cancer – in combination with fluoropyrimidine-, irinotecan-, or fluoropyrimidine-oxaliplatin-based chemotherapy for second-line treatment in patients who have progressed on a first-line bevacizumab-containing regimen

II. Bevacizumab is recommended by the NCCN Drugs and Biologics Compendium® for off-label use for the following indications and considered medically necessary :

Ampullary adenocarcinoma – as first-line therapy for intestinal type disease in combination with FOLFOXIRI (fluorouracil, leucovorin, oxaliplatin, and irinotecan), FOLFOX (fluorouracil, leucovorin, and oxaliplatin), FOLFIRI (fluorouracil, leucovorin, and irinotecan), or CapeOx (capecitabine and oxaliplatin) for unresectable localized disease, stage IV resected disease, or metastatic disease at initial presentation in patients with performance status 0 – 1; and in combination with FOLFOX (fluorouracil, leucovorin, and oxaliplatin), FOLFIRI (fluorouracil, leucovorin, and irinotecan), CapeOx (capecitabine and oxaliplatin), capecitabine, or fluorouracil and leucovorin in patients with performance status 2
Ampullary adenocarcinoma – as subsequent therapy for disease progression for intestinal type disease in combination with FOLFIRI (fluorouracil, leucovorin, and irinotecan) for patients with performance status 0 – 1, and in combination with FOLFOX (fluorouracil, leucovorin, and oxaliplatin), FOLFIRI (fluorouracil, leucovorin, and irinotecan), CapeOx (capecitabine and oxaliplatin), capecitabine, or fluorouracil and leucovorin in patients with performance status 2
Appendiceal adenocarcinoma – as initial systemic therapy for advanced or metastatic disease in combination with FOLFOX (fluorouracil, leucovorin, and oxaliplatin), CapeOx (capecitabine and oxaliplatin), FOLFIRI (fluorouracil, leucovorin and irinotecan), FOLFIRINOX (fluorouracil, leucovorin, irinotecan, and oxaliplatin), 5-FU/LV (fluorouracil and leucovorin), or capecitabine
Appendiceal adenocarcinoma – as subsequent therapy for progression of advanced or metastatic disease in combination with irinotecan with or without oxaliplatin, FOLFIRI (fluorouracil, leucovorin and irinotecan), FOLFOX (fluorouracil, leucovorin, and oxaliplatin), CapeOx (capecitabine and oxaliplatin), or trifluridine and tipiracil
Cervical cancer – as first-line therapy in combination with paclitaxel and carboplatin for squamous cell carcinoma, adenosquamous, or adenocarcinoma with local/regional recurrence or stage IVB disease or disease with distant metastases
Cervical cancer – as second-line or subsequent therapy in combination with paclitaxel and carboplatin for squamous cell carcinoma, adenosquamous, or adenocarcinoma with local/regional recurrence or stage IVB disease or disease with distant metastases, if not used previously as first-line therapy
Cervical cancer – as single agent second-line or subsequent therapy for squamous cell carcinoma, adenosquamous, or adenocarcinoma with local/regional recurrence or stage IVB disease or disease with distant metastases
Cervical cancer – as single agent second-line or subsequent therapy for persistent, recurrent, or metastatic small cell neuroendocrine carcinoma of the cervix (NECC)
CNS – Brain cancer (astrocytoma or oligodendroglioma) – as a single agent or in combination with carmustine, temozolomide, or lomustine for recurrent disease; or as short course, single agent therapy for the management of symptoms driven by radiation therapy necrosis, poorly controlled vasogenic edema, or mass effect
CNS – Brain cancer (glioblastoma) – as short course, single agent therapy for the management of symptoms driven by radiation therapy necrosis, poorly controlled vasogenic edema, or mass effect
CNS – Brain cancer (glioma, medulloblastoma, or metastatic spine tumors) – as short course, single agent therapy for the management of symptoms driven by radiation therapy necrosis, poorly controlled vasogenic edema, or mass effect
CNS – Brain cancer (meningioma) – as short course, single agent therapy for the management of symptoms driven by radiation therapy necrosis, poorly controlled vasogenic edema, or mass effect, or as a single agent or in combination with everolimus for patients with surgically inaccessible recurrent or progressive disease when radiation therapy is not possible
CNS – Brain metastases (limited or extensive) – as short-course single agent therapy for the management of symptoms driven by radiation therapy necrosis, poorly controlled vasogenic edema, or mass effect
CNS – Intracranial and spinal ependymoma (excluding subependymoma) – as a single agent for progression or recurrent disease in patients who are refractory to surgery or radiation therapy, if received prior radiation therapy and had gross total or subtotal resection with negative cerebrospinal fluid (CSF) cytology, subtotal resection and evidence of metastases (brain, spine, or CSF), or unresectable disease
CNS – Intracranial and spinal ependymoma (excluding subependymoma) – as short-course, single agent therapy for the management of symptoms driven by radiation therapy necrosis, poorly controlled vasogenic edema, or mass effect
CNS – Primary CNS lymphoma – as short-course, single agent therapy for management of symptoms driven by radiation therapy necrosis, poorly controlled vasogenic edema, or mass effect
Colon cancer – as primary treatment in combination with FOLFOX (fluorouracil, leucovorin, and oxaliplatin), FOLFIRI (fluorouracil, leucovorin and irinotecan), CapeOx (capecitabine and oxaliplatin), FOLFIRINOX (fluorouracil, leucovorin, irinotecan, and oxaliplatin), 5-FU/LV (fluorouracil and leucovorin), or capecitabine for locally unresectable or medically inoperable disease
Colon cancer – as adjuvant treatment in combination with FOLFOX (fluorouracil, leucovorin, and oxaliplatin), FOLFIRI (fluorouracil, leucovorin, and irinotecan), CapeOx (capecitabine and oxaliplatin), FOLFIRINOX (fluorouracil, leucovorin, irinotecan, and oxaliplatin), 5-FU/LV (fluorouracil and leucovorin), or capecitabine following synchronized or staged resection and/or local therapy for synchronous liver and/or lung metastases that converted from unresectable to resectable disease after primary treatment, following resection and/or local therapy for resectable metachronous metastases in patients who have received previous chemotherapy, or for unresectable metachronous metastases that converted to resectable disease after primary treatment
Colon cancer – as adjuvant treatment in combination with irinotecan for unresectable metachronous metastases that converted to resectable disease after primary treatment
Colon cancer – as primary treatment in combination with CapeOx (capecitabine and oxaliplatin) or FOLFIRINOX (fluorouracil, leucovorin, irinotecan, and oxaliplatin) for unresectable synchronous liver and/or lung metastases
Colon cancer – as primary treatment in combination with CapeOx (capecitabine and oxaliplatin), FOLFIRINOX (fluorouracil, leucovorin, irinotecan, and oxaliplatin), or capecitabine for synchronous abdominal/peritoneal metastases, unresectable synchronous metastases of other sites, unresectable metachronous metastases that remain unresectable after primary treatment, or for unresectable metachronous metastases in patients who have not received adjuvant FOLFOX or CapeOx therapy within the past 12 months and have had previous 5-FU/LV (fluorouracil and leucovorin) or capecitabine therapy or who have not had previous chemotherapy
Colon cancer – as primary treatment in combination with irinotecan for unresectable metachronous metastases in patients who have had adjuvant FOLFOX or CapeOx therapy within the past 12 months
Colon cancer – as subsequent treatment for disease progression in combination with FOLFOX (fluorouracil, leucovorin, and oxaliplatin), FOLFIRI (fluorouracil, leucovorin, and irinotecan), FOLFIRINOX (fluorouracil, leucovorin, irinotecan, and oxaliplatin), CapeOx (capecitabine and oxaliplatin), irinotecan with or without oxaliplatin, or trifluridine and tipiracil
Diffuse high-grade glioma (Pediatric) – single agent, palliative treatment for recurrent or progressive disease in patients who do NOT have a diagnosis of oligodendroglioma, IDH-mutant and 1p/19q co-deleted or astrocytoma IDH-mutant
Endometrial cancer (serous carcinoma, clear cell carcinoma, undifferentiated/dedifferentiated carcinoma, and carcinosarcoma) – in combination with carboplatin and paclitaxel as first-line therapy for advanced and recurrent disease or as second-line and subsequent therapy for advanced and recurrent disease when bevacizumab or a bevacizumab biosimilar in combination with paclitaxel was not previously used
Endometrial cancer (serous carcinoma, clear cell carcinoma, undifferentiated/dedifferentiated carcinoma, and carcinosarcoma) – as a single agent, second-line or subsequent therapy for disease that progressed on prior cytotoxic chemotherapy
Hepatocellular carcinoma – first-line therapy in combination with atezolizumab for patients with Child-Pugh class A only unresectable disease who are not a transplant candidate; have liver-confined disease, disease that is inoperable by performance status, comorbidity, or with minimal or uncertain extrahepatic disease; or metastatic disease or with extensive liver tumor burden
Mesothelioma: Peritoneal – as first-line systemic therapy in combination with pemetrexed and cisplatin or, for non-candidates for cisplatin, pemetrexed and carboplatin for diffuse disease with unicavitary, epithelioid histology; for diffuse disease with biphasic/sarcomatoid histology or bicavitary disease; or for recurrence of benign multicystic or well-differentiated papillary disease after prior cytoreductive surgery with or without hyperthermic intraperitoneal chemotherapy
Mesothelioma: Peritoneal – as subsequent systemic therapy in combination with atezolizumab, pemetrexed and cisplatin, or (in non-candidates for cisplatin) pemetrexed and carboplatin
Mesothelioma: Pleural – as first-line systemic therapy or induction chemotherapy in combination with pemetrexed and cisplatin or pemetrexed and carboplatin (if not a candidate for cisplatin) for clinical stage I-IIIA disease with epithelioid histology or for clinical stage IIIB or IV disease, sarcomatoid or biphasic histology, or medically inoperable tumors
Mesothelioma: Pleural – as subsequent therapy in combination with pemetrexed and cisplatin or pemetrexed and carboplatin (if not a candidate for cisplatin) when immunotherapy was administered as first-line treatment or when given as a rechallenge if good response to front-line pemetrexed-based treatment
Non-small cell lung cancer (NSCLC) – as first-line therapy for the treatment of stage IV or recurrent disease in combination with carboplatin and pemetrexed; cisplatin and pemetrexed; or atezolizumab, carboplatin, and paclitaxel
Non-small cell lung cancer (NSCLC) – as a single agent or in combination with pemetrexed or atezolizumab as continuation maintenance therapy for non-squamous, stage IV metastatic or recurrent disease
Non-small cell lung cancer (NSCLC) – as subsequent therapy for the treatment of stage IV or recurrent disease in combination with carboplatin and paclitaxel; carboplatin and pemetrexed; cisplatin and pemetrexed; or atezolizumab, carboplatin, and paclitaxel
Non-small cell lung cancer – in combination with erlotinib as first-line or initial therapy for EGFR mutation positive Stage IV, recurrent or advanced disease
Non-small cell lung cancer – as single agent therapy or in combination with pemetrexed or atezolizumab for continuation maintenance therapy when negative for actionable molecular markers and PD-L1 expression ‹ 1%
Ovarian cancer (epithelial ovarian cancer/fallopian tube cancer/primary peritoneal cancer) – in combination with carboplatin and paclitaxel as neoadjuvant therapy; or in combination with carboplatin and paclitaxel or carboplatin and docetaxel as continued treatment for stable disease following neoadjuvant therapy in patients who are poor surgical candidates and have low likelihood of optimal cytoreduction
Ovarian cancer (malignant sex cord-stromal tumors) – as a single agent for persistent or recurrent disease in patients with clinical relapse and stage II-IV disease
Ovarian cancer (epithelial ovarian cancer/fallopian tube cancer/primary peritoneal cancer, mucinous carcinoma, grade 1 endometrioid carcinoma, low-grade serous carcinoma, carcinosarcoma, clear cell carcinoma) – as adjuvant therapy in combination with carboplatin and paclitaxel; carboplatin and docetaxel; fluorouracil, leucovorin, and oxaliplatin; or capecitabine and oxaliplatin in patients with pathologic stage II-IV disease
Ovarian cancer (epithelial ovarian cancer/fallopian tube cancer/primary peritoneal cancer, mucinous carcinoma, grade 1 endometrioid carcinoma, low-grade serous carcinoma, carcinosarcoma, clear cell carcinoma) – as a single agent or in combination with capecitabine and oxaliplatin; carboplatin and gemcitabine; carboplatin and liposomal doxorubicin; carboplatin and paclitaxel; fluorouracil, leucovorin, and oxaliplatin; ixabepilone; liposomal doxorubicin; mirvetuximab soravtansine-gynx; niraparib; oral cyclophosphamide; paclitaxel and carboplatin; topotecan; or weekly paclitaxel for persistent or recurrent disease
Ovarian cancer (epithelial ovarian cancer/fallopian tube cancer/primary peritoneal cancer, mucinous carcinoma, grade 1 endometrioid carcinoma, low-grade serous carcinoma, carcinosarcoma, clear cell carcinoma) – as single agent maintenance therapy in patients with partial or complete response following recurrence therapy with chemotherapy plus bevacizumab for platinum-sensitive disease; or as maintenance therapy in combination with olaparib in patients with stage II-IV disease with complete or partial response to primary therapy including bevacizumab or a bevacizumab biosimilar
Rectal cancer – as primary treatment in combination with FOLFOX (fluorouracil, leucovorin, and oxaliplatin), FOLFIRI (fluorouracil, leucovorin, and irinotecan), CapeOx (capecitabine and oxaliplatin), capecitabine, or 5FU-LV (fluorouracil and leucovorin) in patients with T3, N Any; T1-2, N1-2; T4, N Any disease; or locally unresectable or medically inoperable disease when resection is contraindicated following neoadjuvant therapy or total neoadjuvant therapy
Rectal cancer – as adjuvant treatment in combination with FOLFOX (fluorouracil, leucovorin, and oxaliplatin), FOLFIRI (fluorouracil, leucovorin, and irinotecan), FOLFIRINOX (fluorouracil, leucovorin, irinotecan, and oxaliplatin), CapeOx (capecitabine and oxaliplatin), 5FU-LV (fluorouracil and leucovorin), or capecitabine following resection and/or local therapy for resectable metachronous metastases
Rectal cancer – as adjuvant treatment in combination with FOLFOX (fluorouracil, leucovorin, and oxaliplatin), FOLFIRI (fluorouracil, leucovorin, and irinotecan), FOLFIRINOX (fluorouracil, leucovorin, irinotecan, and oxaliplatin), CapeOx (capecitabine and oxaliplatin), 5FU-LV (fluorouracil and leucovorin), capecitabine, or irinotecan for unresectable metachronous metastases that converted to resectable disease after primary treatment
Rectal cancer – as primary treatment in combination with CapeOx (capecitabine and oxaliplatin), FOLFIRINOX (fluorouracil, leucovorin, irinotecan, and oxaliplatin), or capecitabine for synchronous abdominal/peritoneal metastases, unresectable synchronous metastases of other sites, or unresectable isolated pelvic/anastomotic recurrence; or for unresectable metachronous metastases in patients who have not received adjuvant FOLFOX or CapeOx therapy within the past 12 months and have had previous 5FU-LV (fluorouracil and leucovorin) or capecitabine therapy or who have not had previous chemotherapy
Rectal cancer – as primary treatment in combination with CapeOx (capecitabine and oxaliplatin) or FOLFIRINOX (fluorouracil, leucovorin, irinotecan, and oxaliplatin) for synchronous liver only and/or lung only metastases that are unresectable or medically inoperable
Rectal cancer – as primary treatment in combination with irinotecan for unresectable metachronous metastases in patients who have had adjuvant FOLFOX or CapeOx therapy within the past 12 months
Rectal cancer – as subsequent treatment for disease progression in combination with FOLFOX (fluorouracil, leucovorin, and oxaliplatin), FOLFIRI (fluorouracil, leucovorin, and irinotecan), FOLFIRINOX (fluorouracil, leucovorin, irinotecan, and oxaliplatin), CapeOx (capecitabine and oxaliplatin), irinotecan with or without oxaliplatin, or trifluridine and tipiracil
Renal cell cancer – in combination with erlotinib for relapsed or stage IV, advanced papillary renal cell carcinoma (RCC), including hereditary leiomyomatosis and renal cell carcinoma (HLRCC)-associated RCC
Renal cell cancer – as subsequent, single agent therapy for relapsed or stage IV, clear cell disease
Renal cell cancer – as a single agent or in combination with everolimus for relapsed or stage IV, non-clear cell disease
Small bowel adenocarcinoma – for advanced metastatic disease in combination with FOLFOX (fluorouracil, leucovorin, and oxaliplatin), CapeOx (capecitabine and oxaliplatin), FOLFIRI (fluorouracil, leucovorin, and irinotecan), or FOLFIRINOX (fluorouracil, leucovorin, irinotecan, and oxaliplatin) when intensive therapy is recommended and in combination with capecitabine, 5-FU/leucovorin (fluorouracil and leucovorin), or FOLFIRI (fluorouracil, leucovorin, and irinotecan) when intensive therapy is not recommended
Soft tissue sarcoma – as a single agent for the treatment of angiosarcoma
Soft tissue sarcoma – in combination with temozolomide for the treatment of solitary fibrous tumor
Vulvar cancer – as first-line therapy in combination with cisplatin and paclitaxel or carboplatin and paclitaxel for locally advanced unresectable disease (larger T2, T3) or initially unresectable nodes regardless of T stage that is clinically positive for residual tumor at the primary site and/or nodes or for locally advanced disease (larger T2, T3) or initially unresectable nodes regardless of T stage with positive margins following resection
Vulvar cancer – as second-line or subsequent therapy in combination with cisplatin and paclitaxel or carboplatin and paclitaxel as additional treatment following primary therapy with concurrent chemoradiation; as primary treatment for metastatic disease beyond the pelvis (any T, any N, M1 beyond pelvis); for isolated inguinofemoral/pelvic lymph node recurrence if prior external beam radiation therapy (EBRT); or for clinical nodal or distant recurrence with multiple pelvic nodes, distant metastasis, or prior pelvic EBRT when bevacizumab or a bevacizumab biosimilar in combination with cisplatin and paclitaxel or carboplatin and paclitaxel was not used previously

If the drug use is not on the FDA label, does not appear  NCCN Drugs and Biologics Compendium or Triple-S has not published a  Medical Policy covering the off-label use, then the drug use is not approved and the use of the drug is considered investigational.

Abatacept is considered for payment in the following indications:

Adults with rheumatoid arthritis (RA) age 18 or older when the patient has had inadequate response after three months in treatment with any of the following:

a.    Inhibitors of the tumor necrosis factor (etanercept, infliximab, adalimumab, antagonists of the receiver of Interleukin-1)

b.    Non biological Disease modifying anti-rheumatic drugs (DMARDs) (methotrexate, sulfasalazine, hydroxychloroquine, leflunomide).

Moderate to severe Juvenile Idiopathic Arthritis (JIA) in children ≥ 2 years of age, as monotherapy or in combination with methotrexate
Arthropathic psoriasis

Active Psoriatic Arthritis (PsA)
Rheumatoid lung disease with rheumatoid arthritis
Rheumatoid arthritis with rheumatoid factor, unspecified

Juvenile dermatopolymyositis:  Juvenile dermatomyositis, a rare but often severe and chronic systemic autoimmune disease, includes a large number of patients who are treatment resistant, requiring long term immunosuppressive therapy. A small open-label study published in Arthritis and Rheumatology shows promise using a targeted biologic therapy called abatacept to treat such patients.
Other and acute Pericarditis and Acute Myocarditis unspecified

Orencia may be considered investigational for all other ages and indications.

A.  Vandetanib is considered medically indicated in the treatment of metastatic or unresectable locally advanced medullary thyroid cancer (symptomatic or progressive)..

B.    The decision to treat a patient with vandetanib must be based on the following criteria:

a.    Base Electrocardiogram

b.    Base electrolyte as: K, Ca and Mg

c.     Base TSH

C.    By Triple-S, it is considered for payment for the treatment with vendetanib in the following conditions, identified by their corresponding ICD-10 codes.

D.    Triple-S does not consider for payment the use of vandetanib under the following circumstances:

a.    When there is documentation of:

i.    Congenital syndrome with prolongation of the QT segment

ii.    <18 years of age Off label indication;  Non-Small Cell Lung Cancer ; Patient’s tumor is confirmed to have RET gene rearrangements

Nonvalvular Atrial Fibrillation

Rivaroxaban* (Xarelto®), dabigatran* (Pradaxa®), apixaban* (Eliquis®), and edoxaban* (Savaysa®) may be considered medically necessary in adult patients 18 years of age or older with documented paroxysmal, persistent, or permanent atrial fibrillation (AF) not complicated by valvular disease, as an alternative to warfarin therapy

DVT/PE Prophylaxis for Patients Undergoing THR/TKR

Rivaroxaban* (Xarelto®), dabigatran (Pradaxa®), and apixaban* (Eliquis®) may be considered medically necessary for prophylaxis of deep vein thrombosis (DVT) and pulmonary embolism in adult patients 18 years of age or older who are undergoing knee or hip replacement surgery.

Edoxaban (Savaysa®) is considered investigational for this indication.

Treatment and Secondary Prevention of Acute DVT/PE

Rivaroxaban* (Xarelto®), dabigatran* (Pradaxa®), apixaban* (Eliquis®), and edoxaban* (Savaysa®) may be considered medically necessary for treatment of acute DVT or PE, including long-term treatment and secondary prevention of thromboembolism.

Other Indications

The use of rivaroxaban, dabigatran, and apixaban, and edoxaban is considered investigational for all other indications, including but not limited to:

1. Prophylaxis of DVT and PE in hospitalized medically ill patients

2. Secondary prevention of cardiovascular events after an ACS

3. Periprocedural anticoagulation for catheter ablation of atrial fibrillation

4. Electrical or pharmaceutical cardioversion of atrial fibrillation

* FDA-approved indication.

The use of ado-trastuzumab emtansine may be considered medically necessary in individuals with:

Human epidermal growth factor receptor 2-positive (HER2), metastatic breast cancer who have received prior HER2-targeted therapy (e.g., trastuzumab or trastuzumab with a taxane) OR who developed disease recurrence during or within 6 months of completing adjuvant therapy.

Or

Human epidermal growth factor receptor 2-positive, early breast cancer who have residual invasive disease after neoadjuvant taxane and trastuzumab-based treatment.

The use of ado-trastuzumab emtansine is investigational in all other situations, including but not limited to previously untreated progressive or recurrent locally advanced breast cancer, earlier stages of breast cancer, combination treatment with different agents, and treatment of gastric cancer.

Rituximab may be considered medically necessary for the following off-label indications:

•         the following autoimmune hemolytic anemias (AIHA):

o    warm AIHA in glucocorticoid-refractory or glucocorticoid-dependent patients;

o    cold agglutination syndrome;

•         thrombotic thrombocytopenic purpura in patients with refractory disease or relapse (ie, lack of response to plasma exchange therapy and glucocorticoids);

•         Churg-Strauss syndrome (eosinophilic granulomatosis with polyangiitis):

o    first-line treatment in combination with glucocorticoids for patients with severe (organ-threatening) disease;

o    add-on therapy for treatment-refractory disease;

•         factor inhibitors in patients with hemophilia who are refractory to conventional first-line treatments (eg, immune tolerance induction, glucocorticoids with or without cyclophosphamide), preferably as add-on therapy

•         add-on therapy for patients with hepatitis C virus-associated cryoglobulinemic vasculitis who have:

o    active disease resistant to antiviral drugs; or

o    severe or life-threatening cryoglobulinemic vasculitis;

•         multicentric Castleman disease (first- or second-line therapy);

•         primary Sjögren syndrome that is refractory to glucocorticoids and other immunosuppressive agents;

•         add-on therapy for systemic lupus erythematosus refractory to standard first-line treatment;

•         add-on therapy for lupus nephritis refractory to standard first-line treatment regimens;

•         systemic sclerosis (scleroderma) in patients refractory to first-line treatment;

•         neuromyelitis optica for relapse prevention;

•         idiopathic membranous nephropathy;

•         glucocorticoid-refractory chronic graft-versus-host disease; and

•         desensitization of human leukocyte antigen-sensitized renal transplant candidates before transplantation.

•      Moderate to severe Pemphigus Vulgaris (PV) in adult patients

Rituximab is investigational for all other nononcologic uses, including but not limited to:

•         idiopathic thrombocytopenic purpura in patients who do not respond to first-line treatments;

•         paroxysmal cold hemoglobinuria;

•         mixed connective tissue disease;

•         multiple sclerosis;

•         treatment of myasthenia gravis;

•         treatment of minimal change disease;

•         prophylaxis for graft-versus-host disease;

•         induction immunosuppressive therapy for kidney transplantation;

•         induction immunosuppressive therapy for heart transplantation

•         treatment of antibody-mediated rejection in solid organ transplant recipients; and

•         treatment of antibody-mediated rejection after pancreatic islet transplantation.

Testosterone replacement therapy may be considered medically necessary under the following conditions:

An established diagnosis of hypogonadism with androgen deficiency (see Policy Guidelines section) that includes:

Persistently low testosterone levels, and

Multiple symptoms of hypogonadism including at least 1 «more specific» symptom (see Policy Guidelines section)

HIV-infected men (biological sex) with low testosterone levels and weight loss; or

Men (biological sex) on chronic steroid treatment with low testosterone levels (see Policy Guidelines section).

Testosterone replacement therapy is considered investigational in all other situations in which the above criteria are not met, including but not limited to older men (biological sex) with type 2 diabetes mellitus and androgen deficiency or low testosterone levels in the absence of clinical signs and symptoms of hypogonadism.

The use of antisense oligonucleotides (such as eteplirsen, golodirsen, viltolarsen,and casimersen) is considered investigational for all indications including treatment of Duchenne muscular dystrophy.

Nusinersen

Initial Treatment

Nusinersen may be considered medically necessary if all the following conditions are met:

Diagnosis of spinal muscular atrophy confirmed by genetic testing demonstrating bi-allelic mutations in the survival motor neuron 1 (SMN1) gene as stated below:

Deletion of both copies of the SMN1 gene OR

Compound heterozygous mutations of the SMN1 gene (defined below):

Pathogenic variant(s) in both copies of the SMN1 gene

Pathogenic variant in 1 copy and deletion of the second copy of the SMN1 gene.

If the individual is symptomatic, documentation of a genetic test confirms 2, 3, or 4 copies of the SMN2 gene; OR if the individual is asymptomatic, documentation of a genetic test confirms a minimum of 2 but less than 4 copies of the SMN2 gene.

The individual is not on permanent ventilator dependence.

Initial approval is for 1 year, limited to the U.S. Food and Drug Administration approved dosing of 12 mg (5 mL) administered intrathecally per treatment with 4 loading doses; the first 3 loading doses should be administered at 14-day intervals. The fourth loading dose should be administered 30 days after the third dose. A maintenance dose should be administered once every 4 months thereafter.

The individual is not concurrently enrolled in a clinical trial for any experimental therapy for spinal muscular atrophy.

Prescribed by a neurologist with expertise in treating spinal muscular atrophy.

Continuation of Treatment

Incremental reauthorization for nusinersen for 1 year may be considered medically necessary if the following conditions 1 and 2 are met:

The individual was previously approved for nusinersen based on the criteria cited above

Documented evidence to support clinically meaningful improvement in motor milestones during the previous treatment period. Obtain a baseline motor milestone score from a validated assessment such as Hammersmith Infant Neurologic Exam (HINE), Children’s Hospital of Philadelphia Infant Test of Neuromuscular Disorders (CHOP-INTEND) etc.

Nusinersen is considered investigational for all other indications.

Concurrent use of nusinersen with onasemnogene abeparvovec-xioi and/or risdiplam is considered investigational.

Use of nusinersen after administration of onasemnogene abeparvovec-xioi is considered investigational.

Onasemnogene Abeparvovec-Xioi

Onasemnogene abeparvovec-xioi may be considered medically necessary if all of the following conditions are met:

Diagnosis of spinal muscular atrophy confirmed by genetic testing demonstrating bi-allelic mutations in the survival motor neuron 1 (SMN1) gene as stated below:

Deletion of both copies of the SMN1 gene OR

Compound heterozygous mutations of the SMN1 gene (defined below):

Pathogenic variant(s) in both copies of the SMN1 gene OR

Pathogenic variant in 1 copy and deletion of the second copy of the SMN1 gene.

Documentation of a genetic test confirms no more than 3 copies of the SMN2 gene.

The individual is less than 2 years of age at the time of infusion of onasemnogene abeparvovec-xioi.

Documentation of baseline laboratory assessments such as AST, ALT, total bilirubin, and prothrombin time.

The individual does not have advanced spinal muscular atrophy (e.g., complete paralysis of limbs, permanent ventilator dependence).

Baseline anti-adeno-associated virus serotype 9 (AAV9) antibody titers < 1:50. Prescribed by a neurologist with expertise in treating spinal muscular atrophy. Repeat treatment or ante-partum use of onasemnogene abeparvovec-xioi is considered investigational. Onasemnogene abeparvovec-xioi is considered investigational for all other indications. Concurrent use of onasemnogene abeparvovec-xioi with nusinersen and/or risdiplam is considered investigational. Use of nusinersen and/or risdiplam after administration of onasemnogene abeparvovec-xioi is considered investigational. Risdiplam Initial Treatment Risdiplam may be considered medically necessary if all the following conditions are met: Diagnosis of spinal muscular atrophy confirmed by genetic testing demonstrating bi-allelic mutations in the survival motor neuron 1 (SMN1) gene as stated below: Deletion of both copies of the SMN1 gene OR Identification of pathogenic variant(s) in both copies of the SMN1 gene. If the individual is symptomatic, documentation of a genetic test confirms 2, 3, or 4 copies of the SMN2 gene; OR if the individual is asymptomatic, documentation of a genetic test confirms a minimum of 2 but less than 4 copies of the SMN2 gene. Individual age is 25 years or less. The individual is not on permanent ventilator dependence. Initial approval is for 1 year, limited to the U.S. Food and Drug Administration approved dosing. The individual is not concurrently enrolled in a clinical trial for any experimental therapy for spinal muscular atrophy. Prescribed by a neurologist with expertise in treating spinal muscular atrophy. Continuation of Treatment Incremental reauthorization for risdiplam for 1 year may be considered medically necessary if the following conditions 1 and 2 are met: The individual was previously approved for risdiplam based on the criteria cited above. Documented evidence to support clinically meaningful stabilization or improvement in motor milestones during the previous treatment period. Obtain a baseline motor milestone score from a validated assessment such as Hammersmith Infant Neurologic Exam (HINE), Children’s Hospital of Philadelphia Infant Test of Neuromuscular Disorders (CHOP-INTEND) etc. Risdiplam is considered investigational for all other indications. Concurrent use of risdiplam with onasemnogene abeparvovec-xioi and/or nusinersen is considered investigational. Use of risdiplam after administration of onasemnogene abeparvovec-xioi is considered investigational.

In patients who have human epidermal growth factor receptor 2 (HER2)-positive breast cancer, the use of pertuzumab may be considered medically necessary:

in combination with trastuzumab and a taxane (eg, docetaxel, paclitaxel) for treatment of locally recurrent or metastatic breast cancer if pertuzumab was not previously administered; or

for neoadjuvant treatment of locally advanced, inflammatory, or early-stage (either >2 cm in diameter or node-positive) breast cancer; or

the adjuvant treatment of patients with HER2-positive early breast cancer at high risk of recurrence.

The use of pertuzumab is considered investigational for all other indications, including but not limited to HER2-positive gastric, colorectal, non-small-cell lung, and ovarian cancers; HER2-positive cancers of the gastroesophageal junction; and HER2-negative cancers.

NCCN 2A positioning category for Off label indications:

Extensive Brain Metastases

Used in combination with high-dose trastuzumab as treatment for limited brain metastases in patients with HER2 positive breast cancer may be considered as initial treatment in select patients (eg, patients with small asymptomatic brain metastases) consider as treatment for recurrent brain metastases treatment of relapsed disease with either stable systemic disease or reasonable systemic treatment options

Biliary Tract Cancers: Gallbladder Cancer

Subsequent treatment in combination with trastuzumab for progression on or after systemic treatment for unresectable or metastatic disease that is HER2-positive (useful in certain circumstances)

Biliary Tract Cancers: Extrahepatic Cholangiocarcinoma

Subsequent treatment in combination with trastuzumab for progression on or after systemic treatment for unresectable or metastatic disease that is HER2-positive (useful in certain circumstances)

Salivary Gland Tumors

Useful in certain circumstances, in combination with trastuzumab, as systemic therapy for human epidermal growth factor receptor 2 (HER2)-positive recurrent disease with distant metastases in patients with a performance status (PS) of 0-3 unresectable locoregional recurrence or second primary with prior radiation therapy

Colon Cancer

Therapy in combination with trastuzumab (HER2-amplified and RAS and BRAF wildtype) if intensive therapy not recommended and no previous treatment with a HER2 inhibitor as primary treatment for locally unresectable or medically inoperable disease as primary treatment for synchronous abdominal/peritoneal metastases that are nonobstructing, or following local therapy for patients with existing or imminent obstruction for synchronous unresectable metastases of other sites as primary treatment for unresectable metachronous metastases in patients who have not received previous adjuvant FOLFOX or CapeOX within the past 12 months, who have received previous fluorouracil/leucovorin (5-FU/LV) or capecitabine therapy, or who have not received any previous chemotherapy

Therapy in combination with trastuzumab in patients (HER2-amplified and RAS and BRAF wild-type) if intensive therapy not recommended as adjuvant treatment following resection and/or local therapy for resectable metachronous metastases in patients who have received previous chemotherapy as adjuvant treatment for unresectable metachronous metastases that converted to resectable disease after primary treatment. Biologic therapy is only appropriate for continuation of favorable response from conversion therapy.

Subsequent therapy in combination with trastuzumab for progression of advanced or metastatic disease (HER2-amplified and RAS and BRAF wild-type) not previously treated with HER2 inhibitor, in patients previously treated with oxaliplatin-based therapy without irinotecan with irinotecan-based therapy without oxaliplatin with oxaliplatin and irinotecan without irinotecan or oxaliplatin without irinotecan or oxaliplatin followed by FOLFOX (fluorouracil, leucovorin, and oxaliplatin) or CapeOX (capecitabine and oxaliplatin) with or without bevacizumab

Initial systemic therapy for advanced or metastatic disease (HER2-amplified and RAS and BRAF wild-type) in combination with trastuzumab if intensive therapy not recommended and no previous treatment with a HER2 inhibito

Subsequent therapy in combination with trastuzumab for progression of advanced or metastatic disease (HER2-amplified and RAS and BRAF wild-type) not previously treated with HER2 inhibitor, in patients previously treated with oxaliplatin-based therapy without irinotecan with irinotecan-based therapy without oxaliplatin with oxaliplatin and irinotecan without irinotecan or oxaliplatin without irinotecan or oxaliplatin followed by FOLFOX (fluorouracil, leucovorin, and oxaliplatin) or CapeOX (capecitabine and oxaliplatin) with or without bevacizumab

Rectal Cancer

Therapy in combination with trastuzumab in patients (HER2-amplified and RAS and BRAF wild-type) if intensive therapy not recommended and no previous treatment with a HER2 inhibitor as primary treatment for T3, N Any; T1-2, N1-2; T4, N Any; or locally unresectable or medically inoperable disease if resection is contraindicated following neoadjuvant or total neoadjuvant therapy as primary treatment for synchronous abdominal/peritoneal metastases that are nonobstructing, or following local therapy for patients with existing or imminent obstruction as primary treatment for synchronous unresectable metastases of other sites as primary treatment for unresectable isolated pelvic/anastomotic recurrence as primary treatment for unresectable metachronous metastases in patients who have not received previous adjuvant FOLFOX or CapeOX within the past 12 months, who have received previous fluorouracil/leucovorin (5-FU/LV) or capecitabine therapy, or who have not received any previous chemotherapy

Therapy in combination with trastuzumab in patients (HER2-amplified and RAS and BRAF wild-type) if intensive therapy not recommended as adjuvant treatment (following resection and/or local therapy) for resectable metachronous metastases in patients who have received previous chemotherapy as adjuvant treatment for unresectable metachronous metastases that converted to resectable disease after primary treatment. Biologic therapy is only appropriate for continuation of favorable response from conversion therapy

Subsequent therapy in combination with trastuzumab for progression of advanced or metastatic disease (HER2-amplified and RAS and BRAF wild-type) not previously treated with HER2 inhibitor, in patients previously treated with oxaliplatin-based therapy without irinotecan with irinotecan-based therapy without oxaliplatin with oxaliplatin and irinotecan without irinotecan or oxaliplatin without irinotecan or oxaliplatin followed by FOLFOX (fluorouracil, leucovorin, and oxaliplatin) or CapeOX (capecitabine and oxaliplatin) with or without bevacizumab

Se considera para pago el uso de sevelamer en pacientes de enfermedad renal de último estadío ó diálisis cuando se cumplen todos los siguientes criterios:
Pacientes ya en diálisis (hemodiálisis o diálisis peritoneal).

Pacientes con diagnóstico de enfermedad crónica de los riñones.

Paciente que ha recibido tratamiento con acetato de calcio o carbonato de calcio por un mínimo de ocho (8) semanas y el resultado ha sido poco favorable.

Las recetas deben ser escritas por un nefrólogo y preautorizadas por el Departamento de Manejo Individual ó Farmacia.

Además, deben cumplirse uno ó más de los siguientes criterios:
Hiperfosfatemia mayor de 5.5 mg/dl aún con restricción en dieta de fosfato a menos de 1gm/día o hipercalcemia igual o mayor de 10.2 mg/dl (corregido por albúmina)a

El producto de calcio por fósforo (Ca X PO4) debe ser mayor de 55mg2/dl2 a pesar de restricciones dietarias de fosfato de <1 gm/d. Sevelamer requiere preautorizar la receta y que el nefrólogo cumpla con: Documentar en la receta el uso previo de acetato o carbonato de calcio. Presentar copia reciente de los resultados de laboratorio que evidencien los niveles de fosfato, calcio, creatinina y PTH.

The use of botulinum toxin may be considered medically necessary for the following:

• Cervical dystonia (spasmodic torticollis; applicable whether congenital, due to child birth injury, or traumatic injury). For this use, cervical dystonia must be associated with sustained head tilt or abnormal posturing with limited range of motion in the neck AND a history of recurrent involuntary contraction of one or more of the muscles of the neck, eg, sternocleidomastoid, splenius, trapezius, or posterior cervical muscles.a (See additional details in Policy Guidelines section.)

• Upper-limb spasticitya

• Dystonia/spasticity resulting in functional impairment (interference with joint function, mobility, communication, nutritional intake) and/or pain in patients with any of the following:

o Focal dystonias:

§ Focal upper-limb dystonia (eg, organic writer’s cramp)

§ Oromandibular dystonia (orofacial dyskinesia, Meige syndrome)

§ Laryngeal dystonia (adductor spasmodic dysphonia)

§ Idiopathic (primary or genetic) torsion dystonia

§ Symptomatic (acquired) torsion dystonia

o Spastic conditions

§ Cerebral palsy

§ Spasticity related to stroke

§ Acquired spinal cord or brain injury

§ Hereditary spastic paraparesis

§ Spastic hemiplegia

§ Neuromyelitis optica

§ Multiple sclerosis or Schilder disease

• Strabismusa

• Blepharospasm or facial nerve (VII) disorders (including hemifacial spasm)a

• Prevention (treatment) of chronic migraine headache in the following situationsa:

o Initial 6-month trial: Adults who:

§ meet International Classification of Headache Disorders diagnostic criteria for chronic migraine headache (see Policy Guidelines) and

§ have symptoms that persist despite adequate trials of at least 2 agents from different classes of medications used in the treatment of chronic migraine headaches (eg, antidepressants, antihypertensives, antiepileptics). Patients who have contraindications to preventive medications are not required to undergo a trial of these agents.

o Continuing treatment beyond 6 months:

§ Migraine headache frequency reduced by at least 7 days per month compared with pretreatment level, or

§ Migraine headache duration reduced at least 100 hours per month compared with pretreatment level.

• Esophageal achalasia in patients who have not responded to dilation therapy or who are considered poor surgical candidates

• Sialorrhea (drooling) associated with Parkinson disease

• Chronic anal fissure

• Urinary incontinence due to detrusor overactivity associated with neurogenic causes (eg, spinal cord injury, multiple sclerosis) in patients unresponsive to or intolerant of anticholinergicsa

• Overactive bladder in adults unresponsive to or intolerant of anticholinergics.a

a Food and Drug Administration-approved indication for at least one of the agents.

With the exception of cosmetic indications, the use of botulinum toxin is considered investigational for all other indications not specifically mentioned above, including, but not limited to:

• headaches, except as noted above for prevention (treatment) of chronic migraine headache

• sialorrhea (drooling) except that associated with Parkinson disease

• internal anal sphincter achalasia

• benign prostatic hyperplasia

• interstitial cystitis

• detrusor sphincteric dyssynergia (after spinal cord injury)

• chronic low back pain

• joint pain

• mechanical neck disorders

• neuropathic pain

• myofascial pain syndrome

• temporomandibular joint disorders

• trigeminal neuralgia

• pain after hemorrhoidectomy or lumpectomy

• tremors such as benign essential tremor (upper extremity)

• tinnitus

• chronic motor tic disorder and tics associated with Tourette syndrome (motor tics)

• lateral epicondylitis

• prevention of pain associated with breast reconstruction after mastectomy

• Hirschsprung disease

• gastroparesis

• facial wound healing

• depression.

The use of botulinum toxin may be considered investigational as a treatment of wrinkles or other cosmetic indications.

The use of assays to detect antibodies to botulinum toxin is considered investigational.

Recombinant human growth hormone (GH) therapy may be considered medically necessary for the following individuals (see specific patient selection criteria in the Policy Guidelines section):

Children with proven growth hormone deficiency

Children with growth failure due to Prader-Willi syndrome, who do not have the following contraindications: severe obesity or a history of upper airway obstruction, sleep apnea, or severe respiratory impairment

Children with a height below the third percentile for chronologic age with chronic renal insufficiency

Individuals with Turner syndrome

Individuals with short stature due to Noonan syndrome

Children with short stature due to SHOX (short stature homeobox-containing gene) deficiency

Promotion of wound healing in individuals with burns

Prevention of growth delay in children with severe burns

Individuals with AIDS wasting

Individuals with short bowel syndrome receiving specialized nutritional support in conjunction with optimal management of short bowel syndrome

Adults with proven growth hormone deficiency.

Recombinant human growth hormone is considered investigational for all other applications including, but not limited to the following:

Children born small for gestational age who fail to show catch-up growth by age 2 years

Children with height standard deviation score of -2.25 or below without documented growth hormone deficiency.

Treatment of altered body habitus (eg, buffalo hump) associated with antiviral therapy in HIV-infected individuals

Constitutional delay (lower than expected height percentiles compared with target height percentiles and delayed skeletal maturation when growth velocities and rates of bone age advancement are normal)

Treatment of children with “genetic potential” (ie, lower than expected height percentiles based on parents’ height)

In conjunction with gonadotropin-releasing hormone analogs as a treatment of precocious puberty

Growth hormone therapy in older adults without proven deficiency

Treatment of cystic fibrosis

Anabolic therapy (except for AIDS) provided to counteract acute or chronic catabolic illness (eg, surgery outcomes, trauma, cancer, chronic hemodialysis, chronic infectious disease) producing catabolic (protein wasting) changes in both adult and pediatric individuals

Anabolic therapy to enhance body mass or strength for professional, recreational, or social reasons

Glucocorticoid-induced growth failure

Short stature due to Down syndrome

Treatment of obesity

Treatment of idiopathic dilated cardiomyopathy

Treatment of juvenile idiopathic or juvenile chronic arthritis.

Triple-S cubrirá medicamentos para el tratamiento de infección crónica de Hepatitis-C a los asegurados que tengan cubierta de farmacia que incluya medicamentos de seguimiento.
Se autorizaran los medicamentos Peg-Intron y Rebetol siempre y cuando cumpla con cada uno de los siguientes requisitos:
Pacientes mayores de 18 años.

Receta tendrá que ser emitida por un gastroenterólogo ó infectólogo

Indicar diagnóstico utilizando código ICD-9 (070.54)

Está contraindicado en:
Mujeres embarazadas

Enfermedad hepática descompensada

El tratamiento de elección es peginterferon y ribavirina
La decisión de tratamiento se debe individualizar basado en la severidad de daño hepático, el potencial de efectos secundarios adversos, la posible respuesta al tratamiento y la presencia de comorbilidad.

Tratamiento de infecciones HCV – genotipo – 1
El tratamiento será con peginterferon más ribavirina por 48 semanas usando dosis de ribavirina de mil miligramos para aquellos pacientes de menos de 75 kg de peso y de 1200mg para aquellos de más de 75 kg de peso.

Se harán análisis cuantitativos de carga viral al comienzo del tratamiento y a las 12 semanas de terapia. El tratamiento puede ser descontinuado en pacientes que no logren un EVR a las 12 semanas, aunque este tratamiento debe ser individualizado de acuerdo a la tolerancia del tratamiento y la severidad de la enfermedad hepática.

En pacientes cuyo tratamiento continúe hasta las 48 semanas y cuya carga hepática sea negativa a ese tiempo, deben ser evaluados para presencia de virus 24 semanas más tarde para documentar la presencia de respuesta virológica sostenida (SVR).

Tratamiento de infecciones HCV – genotipo –2 y 3
El tratamiento de pacientes genotipos 2 y 3 será usando pegiinterferon mas ribavirina durante 24 semanas. La dosis de rivavirina es 800mg.

Personas que completen el tratamiento por las 24 semanas y que su carga viral sea negativa al final de ese periodo deben ser evaluados 24 semanas más tarde, para documentar una respuesta virologica sostenida (SVR).

Re-tratamiento a personas que no respondieron al tratamiento
Re-tratamiento con pegiinterferon mas ribavirina se debe considerar en aquellas personas que fueron tratados con interferon no-pegilado y que tienen cirrosis o un grado significativo de fibrosis hepática.

Re-tratamiento con pegiinterferon mas ribavirina con el propósito de erradicar HCV en pacientes que no respondieron a un tratamiento de pegiinterferon más ribavirina anterior, no está indicado. Esto es así aún cuando un tipo distinto de pegiinterferon fue el usado inicialmente.

Intravenous Immunoglobulin Therapy

Intravenous immunoglobulin (IVIG) therapy may be considered medically necessary for the following indications:

Immunodeficiency States

Individuals with primary immunodeficiencies, including congenital agammaglobulinemia, hypogammaglobulinemia, common variable immunodeficiency, severe combined immunodeficiency, Wiskott-Aldrich syndrome, X-linked agammaglobulinemia, X-linked hyperimmunoglobulinemia M syndrome, and ataxia telangiectasia.

Individuals with primary immunodeficiency syndromes should meet all the following criteria for treatment with immunoglobulin:

Laboratory evidence of immunoglobulin deficiency (see Policy Guidelines section)

Documented inability to mount an adequate immunologic response to inciting antigens (see Policy Guidelines section)

Persistent and severe infections, despite treatment with prophylactic antibiotics.

Individuals with chronic lymphocytic leukemia who have immunoglobulin G (IgG) levels less than 400 mg/dL and persistent bacterial infections.
Infections

Individuals (children) with HIV who have IgG levels less than 400 mg/dL to prevent opportunistic infections.
Individuals with severe anemia associated with human parvovirus B19.

Individuals with toxic shock syndrome.
Autoimmune and Inflammatory Conditions

Individuals with acute, severe idiopathic thrombocytopenic purpura (see Policy Guidelines section) or chronic idiopathic thrombocytopenic purpura with a disease duration of at least 6 months, presence of symptoms, and with persistent thrombocytopenia (platelet <20,000 per microliter [adult] or 30,000 per microliter [child])-despite treatment with corticosteroids and splenectomy. Adults with Guillain-Barré syndrome as an equivalent alternative to plasma exchange. Individuals with Kawasaki syndrome. Individuals with Wegener granulomatosis. Individuals with chronic inflammatory demyelinating polyneuropathy (CIDP) with progressive symptoms for at least 2 months. Individuals with multifocal motor neuropathy. Individuals with Eaton-Lambert myasthenic syndrome who have failed to respond to anticholinesterase medications and/or corticosteroids. Individuals with neuromyelitis optica as an alternative for those with contraindications or lack of response to first-line treatment, particularly in children. Individuals with severe refractory myasthenia gravis with chronic debilitating disease despite treatment with cholinesterase inhibitors, or complications from or failure of corticosteroids and/or azathioprine. Individuals with myasthenic exacerbation (ie, an acute episode of respiratory muscle weakness) in whom plasma exchange is contraindicated. Individuals with severe, progressive autoimmune mucocutaneous blistering diseases that include pemphigus, pemphigoid, pemphigus vulgaris, and pemphigus foliaceus who have failed treatment with conventional agents such as corticosteroids, azathioprine, and cyclophosphamide. Individuals with dermatomyositis or polymyositis that is refractory to treatment with corticosteroids; in combination with other immunosuppressive agents. Individuals with warm antibody hemolytic anemia who are refractory to prednisone and splenectomy. Individuals with catastrophic antiphospholipid syndrome. Alloimmune Processes Individuals with neonatal alloimmune thrombocytopenia. Individuals with hemolytic disease of the fetus and newborn (erythroblastosis fetalis). Miscellaneous Individuals with stiff-person syndrome not controlled by other therapies. Intravenous immunoglobulin (IVIG) therapy is considered investigational for the following indications: Immunodeficiency States Individuals who have received solid organ transplant for prophylaxis or treatment of acute antibody-mediated rejection. Individuals undergoing or who have undergone hematopoietic cell transplantation who have IgG levels less than 400 mg/dL. Prior to solid organ transplant, treatment for individuals at high risk of antibody-mediated rejection including highly sensitized individuals and those receiving an ABO-incompatible organ. Infections Individuals with neonatal sepsis (prophylaxis or treatment). Individuals (adults) with sepsis. Autoimmune and Inflammatory Conditions Individuals with toxic epidermal necrolysis and Stevens-Johnson syndrome. Individuals with inclusion body myositis. Individuals with systemic lupus erythematosus. Individuals with immune optic neuritis. Individuals with Crohn disease. Individuals with hemophagocytic lymphohistiocytosis. Alloimmune Processes Individuals with recurrent spontaneous abortion. Miscellaneous Individuals with pediatric autoimmune neuropsychiatric disorders associated with Streptococcal infections. Individuals with autism spectrum disorder. Individuals with complex regional pain syndrome. Individuals with Alzheimer disease. Individuals with paraproteinemic neuropathy. Individuals with chronic fatigue syndrome. Individuals with acute myocarditis. Individuals with refractory recurrent pericarditis. Individuals with noninfectious uveitis. Individuals with postpolio syndrome. Individuals with necrotizing fasciitis. Individuals with thrombotic thrombocytopenic purpura, hemolytic uremic syndrome, paraneoplastic syndromes, epilepsy, chronic sinusitis, asthma, aplastic anemia, Diamond-Blackfan anemia, red cell aplasia, acquired factor VIII inhibitors, acute lymphoblastic leukemia, multiple myeloma, immune-mediated neutropenia, nonimmune thrombocytopenia, cystic fibrosis, recurrent otitis media, diabetes mellitus, Behçet syndrome, adrenoleukodystrophy, organ transplant rejection, Fisher syndrome, IgG subclass deficiency, opsoclonus-myoclonus, birdshot retinopathy, epidermolysis bullosa acquisita, polyradiculoneuropathy (other than CIDP), refractory rheumatoid arthritis, other vasculitides besides Kawasaki disease, including polyarteritis nodosa, Goodpasture syndrome, and vasculitis associated with other connective tissue diseases. Intravenous immunoglobulin (IVIG) is considered Investigational for: Individuals with relapsing-remitting multiple sclerosis. Subcutaneous Immunoglobulin Therapy Subcutaneous immunoglobulin therapy (SCIG) may be considered medically necessary for the following indications: Individuals with primary immunodeficiencies, including congenital agammaglobulinemia, hypogammaglobulinemia, common variable immunodeficiency, severe combined immunodeficiency, Wiskott-Aldrich syndrome, and X-linked agammaglobulinemia. Other applications of SCIG therapy are considered investigational, including but not limited to CIDP.

Infliximab is a tumor necrosis factor (TNF) blocker that may be used and Medically Necessary for treatment of::

Crohn’s Disease:

reducing signs and symptoms and inducing and maintaining clinical remission in adult patients with moderately to severely active disease who have had an inadequate response to conventional therapy.
reducing the number of draining enterocutaneous and rectovaginal fistulas and maintaining fistula closure in adult patients with fistulizing disease.

Pediatric Crohn’s Disease: reducing signs and symptoms and inducing and maintaining clinical remission in pediatric patients with moderately to severely active disease who have had an inadequate response to conventional therapy.

Ulcerative Colitis: reducing signs and symptoms, inducing and maintaining clinical remission and mucosal healing, and eliminating corticosteroid use in adult patients with moderately to severely active disease who have had an inadequate response to conventional therapy.

Pediatric Ulcerative Colitis: reducing signs and symptoms and inducing and maintaining clinical remission in pediatric patients with moderately to severely active disease who have had an inadequate response to conventional therapy.

Rheumatoid Arthritis in combination with methotrexate: reducing signs and symptoms, inhibiting the progression of structural damage, and improving physical function in patients with moderately to severely active disease.

Ankylosing Spondylitis: reducing signs and symptoms in patients with active disease.

Psoriatic Arthritis: reducing signs and symptoms of active arthritis, inhibiting the progression of structural damage, and improving physical function.

Plaque Psoriasis: treatment of adult patients with chronic severe (i.e., extensive and/or disabling) plaque psoriasis who are candidates for systemic therapy and when other systemic therapies are medically less appropriate.

The use of infliximab may be considered medically necessary for the treatment of Behçet syndrome and Behçet syndrome uveitis when:

patient is 18 years of age or older AND
has had an inadequate response with conventional therapy (i.e., systemic corticosteroids or immunosuppressive agents) OR
has an intolerance or contraindication with conventional therapy OR
if with uveitis has previously received a biologic indicated for uveitis.

Infliximab is recommended for off-label use for the following indications:

Fistulizing CD in children aged 6 years or older
JIA with sacroiliitis, enthesitis, or uveitis
Noninfectious uveitis
Polyarticular and oligoarticular JIA
RA without methotrexate
Sarcoidosis
Systemic JIA

The use of infliximab is considered investigational for the following conditions:

systemic juvenile idiopathic arthritis;
rheumatic and autoimmune conditions potentially treatable with tumor necrosis factor a inhibitors:

sarcoidosis;
systemic sclerosis;
Sjögren syndrome;
Kawasaki disease;
Primary sclerosing cholangitis;

vasculitides potentially treatable with tumor necrosis factor α inhibitors:

giant cell arteritis/polymyalgia rheumatic;
granulomatosis with polyangiitis (Wegener granulomatosis);
polyarteritis nodosa;

nonrheumatic musculoskeletal conditions:

arthritis (other than rheumatoid arthritis and psoriatic arthritis);
sacroiliitis (not associated with ankylosing spondylitis or spondyloarthritis;
intra-articular injections;

rheumatic joint disease refractory to tumor necrosis factor α inhibitors.

Infliximab off-label use indications

Immune Checkpoint Inhibitor-Related Toxicities

Consider adding for the management of immunotherapy-related

myocarditis as a further intervention if no improvement within 24-48 hours of starting pulse-dose methylprednisolone
moderate (G2) and strongly consider for severe (G3-4) diarrhea or colitis
severe inflammatory arthritis as additional disease modifying anti-rheumatic therapy if symptoms do not improve within 1 week after starting high-dosecorticosteroids or if unable to taper corticosteroids by week 2
moderate or severe steroid-refractory myalgias or myositis (muscleweakness), or life-threatening steroid-refractory myositis
G1 -4 uveitis that is refractory to high-dose systemic corticosteroids (treatmentguided by ophthalmology)
moderate (G2) pneumonitis if no improvement after 48-72 hours ofcorticosteroids or severe (G3-4) pneumonitis if no improvement after 48 hoursof methylprednisolone
severe (G3) or life-threatening (G4) elevated serum creatinine/acute kidneyinjury if toxicity remains >G2 after 4-6 weeks of corticosteroids

Hematopoietic Cell Transplantation

For acute* graft-versus-host disease (GVHD) as additional therapy in conjunction with systemic corticosteroids following no response (steroid-refractory disease) to first-line therapy options *therapy for steroid-refractory acute GVHD is often used in conjunction with the original immunosuppressive agent.»

Monthly administration of immune prophylaxis for respiratory syncytial virus (RSV) with palivizumab during the RSV season may be considered medically necessary in the following infants and children in accordance with guidelines-based recommendations; reaffirmed in 2019 (see Supplemental Information section):

In the first year of life, ie, younger than 12 months at the start of the RSV season or born during the RSV season:

Infants born before 29 weeks, 0 days of gestation;

Preterm infants with chronic lung disease (CLD) of prematurity, defined as birth at less than 32 weeks, 0 days of gestation and a requirement for more than 21% oxygen for at least the first 28 days after birth;

Certain infants with hemodynamically significant heart disease (eg, infants with acyanotic heart disease who are receiving medication to control congestive heart failure and will require cardiac surgical procedures; infants with moderate-to-severe pulmonary hypertension; infants with lesions adequately corrected by surgery who continue to require medication for heart failure);

Decisions regarding palivizumab prophylaxis for infants with cyanotic heart defects in the first year of life may be made in consultation with a pediatric cardiologist.

Children with pulmonary abnormality or neuromuscular disease that impairs the ability to clear secretions from the upper airways (eg, ineffective cough, recurrent gastroesophageal tract reflux, pulmonary malformations, tracheoesophageal fistula, upper airway conditions, or conditions requiring tracheostomy);

Children with cystic fibrosis who have at least one of the following conditions:

Clinical evidence of CLD; and/or

Nutritional compromise.

In the second year of life, ie, younger than 24 months at the start of the RSV season:

Children who were born at less than 32 weeks, 0 days of gestation and required at least 28 days of supplemental oxygen after birth and who continue to require medical intervention (supplemental oxygen, chronic corticosteroid, or diuretic therapy) during the 6-month period before the start of the second RSV season.

Children with cystic fibrosis who have either:

Manifestations of severe lung disease (previous hospitalization for pulmonary exacerbation in the first year of life or abnormalities on chest radiography or chest computed tomography that persists when stable); or

Weight for length less than the 10th percentile.

In the first or second year of life:

Children who will be profoundly immunocompromised (eg, will undergo solid organ or hematopoietic cell transplantation or receive chemotherapy) during the RSV season.

After surgical procedures that use cardiopulmonary bypass, for children who still require prophylaxis, a postoperative dose of palivizumab may be considered medically necessary after cardiac bypass or at the conclusion of extracorporeal membrane oxygenation for infants and children younger than 24 months.

Immunoprophylaxis for respiratory syncytial virus is considered not medically necessary in:

Infants and children with hemodynamically insignificant heart disease (eg, secundum atrial septal defect, small ventricular septal defect, pulmonic stenosis, uncomplicated aortic stenosis, mild coarctation of the aorta, and patent ductus arteriosus);

Infants with lesions adequately corrected by surgery, unless they continue to require medication for heart failure;

Infants with mild cardiomyopathy who are not receiving medical therapy for the condition; or

Children with congenital heart disease in the second year of life.

Other indications for immune prophylaxis for RSV are considered investigational including, but not limited to, controlling outbreaks of healthcare-associated disease; or use in children with cystic fibrosis or Down syndrome without other risk factors; or in children over 2 years of age, unless criteria for medical necessity (outlined above) are satisfied.

**For the Commonwealth of Puerto Rico, adminstrative order No. 340 Ammendment B of November 10, 2015states specific criteria for the propohylactic use of Palvizumab.

Acute tocolytic therapy with calcium channel blockers, magnesium sulfate, prostaglandin inhibitors, and parenteral terbutaline may be considered medically necessary to induce tocolysis in patients with preterm (<37 weeks of gestational age) labor. Maintenance (beyond 48-72 hours) tocolytic therapy with any medication is considered investigational.

Trastuzumab may be considered medically necessary for the treatment of patients with breast cancer whose tumors overexpress the human epidermal growth factor receptor 2 (HER2) protein (HER2-positive breast cancer). The use of trastuzumab includes use as adjuvant therapy, neoadjuvant therapy, and treatment of metastatic disease.

Trastuzumab may be considered medically necessary, when used in combination with systemic chemotherapy, for the treatment of patients with advanced (locally advanced or metastatic) gastric cancer or gastroesophageal junction adenocarcinoma whose tumors overexpress the HER2 protein (HER2-positive cancer).

Trastuzumab is considered investigational for the treatment of all other conditions including, but not limited to, HER2-negative breast cancer and the following types of cancer, which may be HER2-positive: osteosarcoma, non-small-cell lung, ovarian, prostate, head and neck, esophageal (except as noted above), gastric (except as noted above), pancreatic, colorectal, endometrial, and urothelial.

Triple-S cubrirá los medicamentos para el manejo de Hepatitis B Crónica (interferon alfa-2b [Intron A®], pegylated interferon alfa-2a [Pegasys®], lamivudine [Epivir HBV®], adefovir [Hepsera®], entecavir [Baraclude®]) para sus asegurados, si la cubierta de farmacia de los mismos incluye medicamentos de mantenimiento.