Billing chart
Blues highlight medical, benefit policy changes

Various, 81479

Basic benefit and medical policy

The safety and effectiveness of focused carrier testing for genetic diseases have been established. It may be considered a useful diagnostic option when indicated.

Expanded carrier screening panels are generally considered investigational or experimental. There is insufficient evidence that such tests impact clinical outcomes incrementally greater than traditional genetic testing. This policy is effective Nov. 1, 2015.

Inclusions:
Carrier testing for genetic diseases is established when one of the following criteria is met:

• The individuals have a previously affected child with the genetic disease
• One or both individuals have a first- or second-degree relative who is affected
• One or both individuals have a first-degree relative with an affected offspring
• One individual is known to be a carrier
• One or both individuals are members of a population known to have a carrier rate that exceeds a threshold considered appropriate for testing for a particular condition

And all of the following criteria are met:

• The natural history of the disease is well understood and there is a reasonable likelihood the disease is one with high morbidity in the homozygous or compound heterozygous state.
• Alternative biochemical or other clinical tests to definitively diagnose carrier status are not available or, if available, provide an indeterminate result or are individually less efficacious than genetic testing.
• The genetic test has adequate sensitivity and specificity to guide clinical decision making and residual risk is understood.
• An association of the marker with the disorder has been established.

Exclusions:
Expanded carrier screening panels are generally considered investigational or experimental. There is insufficient evidence that such tests impact clinical outcomes incrementally greater than traditional genetic testing.

Expanded carrier testing is excluded except when each individual genetic mutation included in the panel meets criteria listed above under “Inclusions” (for example, “Panel for Ashkenazi Jewish Ethnicity”).

Reimbursement for expanded carrier testing may receive individual consideration depending on comparative fees and charges.

Established: 22856, 22861, 22864
Non-established: 0095T, 0098T, 0375T, 22858

Basic benefit and medical policy
 
Artificial intervertebral discs-cervical spine

The criteria for artificial intervertebral discs-cervical spine have been updated. The safety and effectiveness of the insertion of cervical artificial intervertebral discs have been established. It is a useful therapeutic option for patients meeting patient selection criteria.
This policy is effective Nov. 1, 2015.

Inclusions: 
(Must meet all)

• The device is approved by FDA
• Patient is skeletally mature
• The patient has intractable cervical radicular pain or myelopathy
• Which has failed at least six weeks of conservative nonoperative treatment, including active pain management program or protocol, under the direction of a physician with pharmacotherapy that addresses neuropathic pain and other pain sources and physical therapy, or
• If the patient has severe or rapidly progressive symptoms of nerve root or spinal cord compression requiring hospitalization or immediate surgical treatment 

• Degeneration is documented by MRI, CT or myelography
• Cervical degenerative disc disease is limited to a single level from C3 to C7

Exclusions:

• Disc implantation at more than one level
• Combined use of an artificial cervical disc and fusion
• Prior surgery at the treated level
• Previous fusion at another cervical level
• Multilevel disc disease
• Translational (segmental) instability
• Anatomical deformity (for example, ankylosing spondylitis)
• Rheumatoid arthritis or other autoimmune disease
• Presence of facet arthritis
• Active infection
• Metabolic bone disease (for example, osteoporosis, osteopenia or osteomalacia)
• Malignancy affecting cervical spine

81235, 81275, 81404, 81405, 81406, 81479

Basic benefit and medical policy

Genetic testing-molecular analysis for targeted therapy of non-small cell lung cancer

Criteria for genetic testing-molecular analysis for targeted therapy of non-small cell lung cancer policy have been updated. This policy is effective Nov. 1, 2015.

• EGFR gene
• The safety and effectiveness of analysis of two types of somatic mutation within the EGFR gene — small deletions in exon 19 and a point mutation in exon 21 (L858R) — have been established. It is an effective diagnostic option for predicting treatment response to erlotinib or afatinib in patients with advanced non-squamous, non-small cell lung cancer.
• The analysis of two types of somatic mutation within the EGFR gene — small deletions in exon 19 and a point mutation in exon 21 (L858R) — is considered experimental or investigational for patients with advanced squamous cell-type advanced non-squamous, non-small cell lung cancer. The peer reviewed medical literature has not yet demonstrated the clinical utility of EGFR gene analysis for squamous cell non-squamous, non-small cell lung cancer.
• The analysis for other EGFR mutations within exons 18-24, or other applications related to non-squamous, non-small cell lung cancer, is considered experimental or investigational. The peer reviewed medical literature has not yet demonstrated the clinical utility of this testing for this indication.
• ALK gene
• The safety and effectiveness of analysis of somatic rearrangement mutations of the ALK gene have been established. It is an effective diagnostic option for predicting treatment response to crizotinib in patients with advanced lung adenocarcinoma and large cell carcinoma or for patients in whom an adenocarcinoma component cannot be excluded.
• Analysis of somatic rearrangement mutations of the ALK gene is considered experimental or investigational in all other situations.
• KRAS gene
• Analysis of somatic mutations of the KRAS gene is considered experimental or investigational as a technique to predict treatment nonresponse to anti-EGFR therapy with tyrosine kinase inhibitors and for the use of the anti-EGFR monoclonal antibody cetuximab in non-squamous, non-small cell lung cancer. The peer reviewed medical literature has not yet demonstrated the clinical utility of this testing for this indication.
• Other genes
• Analysis for genetic alterations in the genes ROS, RET, MET, BRAF and HER2 for targeted therapy in patients with non-squamous, non-small cell lung cancer is considered experimental or investigational. The peer reviewed medical literature hasn’t yet demonstrated the clinical utility of this testing for this indication.

81404**
No changes: 81275, 81403***, 88363, 81210****

Basic benefit and medical policy

The safety and effectiveness of v-Ki-ras2 Kirsten rat sarcoma viral oncogene and neuroblastoma RAS viral oncogene homolog mutation analyses have been established and may be considered a useful diagnostic option to predict non-response to anti-EGFR monoclonal antibodies cetuximab and panitumumab in the treatment of all patients with metastatic colorectal cancer. It is a useful therapeutic option when indicated.

BRAF mutation analysis is considered experimental or investigational for predicting treatment non-response to anti-EGFR monoclonal antibodies cetuximab and panitumumab in the treatment of metastatic colorectal cancer. The use of this testing hasn’t been scientifically demonstrated to improve patient clinical outcomes.

The policy and criteria have been updated to include NRAS testing, effective Nov. 1, 2015.

** Requires manual review — Includes neuroblastoma RAS viral oncogene homolog (for example, colorectal carcinoma), exon 1 and exon 2 sequences

*** Requires manual review — Includes v-Ki-ras2 Kirsten rat sarcoma viral oncogene (for example, carcinoma), gene analysis, variant(s) in exon 3 (for example, codon 61)

****Non-covered for policy indication

Inclusions:

• KRAS and NRASmutation analysis in patients with metastatic colorectal cancer in order to determine their nonresponse to EGFR inhibitor drugs such as Vectibix^® (cetuximab) and Erbitux^® (panitumumab).

Exclusions:

• BRAF mutation analysis in patients with metastatic colorectal cancer in order to determine their nonresponse to EGFR inhibitor drugs such as Vectibix^® (panitumumab) and Erbitux^® (cetuximab).

Code* only, no description
G0166

Basic benefit and medical policy

Enhanced external counterpulsation

The criteria for the enhanced external counterpulsation policy have been updated. The safety and effectiveness of enhanced external counterpulsation in the treatment of chronic stable angina have been established. It may be considered an alternative treatment for chronic stable angina in those patients who are refractory to maximal medical management and who are not suitable for invasive treatment techniques.

The use of EECP in patients with a diagnosis of any medical condition other than stable, chronic angina is experimental or investigational. EECP hasn’t been scientifically demonstrated to improve patient clinical outcomes for other conditions, such as erectile dysfunction, heart failure, ischemic stroke or unstable angina.

This policy is effective Nov. 1, 2015.

Inclusions:

EECP treatment should be limited to one or two times per day with a maximum of 35 one-hour treatments. Maximum treatment hours don’t have to be consecutive.

Patients selected for EECP for the treatment of chronic stable angina should meet the following criteria:

• Angina levels II, III or IV (Canadian Cardiovascular Society Classification) for patients not readily amenable to surgical intervention
• Documented evidence of coronary artery disease evidenced by one of the following criteria:
• > 70 percent stenosis of at least one or more major coronary arteries, proven angiographically
• History of myocardial infarct documented by electrocardiogram  (presence of Q wave) and elevation of cardiac enzymes
• Positive (for myocardial infarct or ischemia) nuclear exercise stress test
• Positive exercise treadmill test

Relative contraindications:

• Atrial fibrillation or frequent PVC’s that interfere with EECP triggering
• Baseline EKG abnormalities that will interfere with the
  interpretation of the exercise EKG
• Blood pressure > 180/110 mm Hg
• Cardiac catheterization in the preceding two weeks
• History of varicosities, deep vein thrombosis, phlebitis or stasis ulcer, bleeding diathesis, warfarin use
• Left ventricular ejection fraction < 30 percent
• Myocardial Infarction or coronary artery bypass in the preceding three months
• Non-bypassed left main artery stenosis > 50 percent
• Overt congestive heart failure
• Patients unable to undergo treadmill testing or who are in a cardiac rehabilitation program
• Permanent pacemaker or implantable defibrillator
• Severe symptomatic peripheral vascular disease
• Significant valvular heart disease
• Unstable angina
• Women with childbearing potential or who are pregnant

20979, E0760

Basic benefit and medical policy

The safety and effectiveness of low-intensity ultrasound
 treatment for the treatment of specified fractures have
 been established. It is useful therapeutic option for
 patients at high risk for delayed fracture healing or
 nonunion. Inclusionary and exclusionary criteria have
 been updated, effective Nov. 1, 2015.

Inclusions:

• Low-intensity ultrasound treatment may be considered established when used as an adjunct to conventional management (for example, closed reduction and cast immobilization) for the treatment of fresh, closed fractures in skeletally mature individuals. A fracture is most commonly defined as “fresh” for seven days after the fracture occurs. Candidates for ultrasound treatment are those at high risk for delayed fracture healing or nonunion. These risk factors may include either locations of fractures or patient comorbidities and include the following:
  
  Patient co-morbidities:
• Diabetes
• Steroid therapy
• Osteoporosis
• History of alcoholism
• History of smoking
Fracture locations:
• Jones fracture (fracture in the metadiaphyseal junction of the fifth metatarsal of the foot)
• Fracture of navicular bone in the wrist (also called the scaphoid)
• Fracture of metatarsal
• Fractures associated with extensive soft tissue or vascular damage
• Low-intensity ultrasound treatment may be considered established when used as a treatment of delayed union of bones, excluding the skull and vertebra.  Delayed union is defined as a decelerating healing process as determined by serial x-rays, together with a lack of clinical and radiologic evidence of union, bony continuity or bone reaction at the fracture site for no less than three months from the index injury or the most recent intervention.
  
  
• Low-intensity ultrasound treatment may be considered established as a treatment of fracture nonunions of bones, excluding the skull and vertebra. The definition of nonunion in the FDA labeling suggests nonunion is considered established when the fracture site shows no visibly progressive signs of healing as evidenced by each of the following:
• At least three months have passed since the date of the fracture
• Serial radiographs have confirmed that no progressive signs of healing have occurred
• The fracture gap is 1 centimeter or less
• The patient can be adequately immobilized and is of an age when he or she is likely to comply with non-weight bearing

Exclusions:
Other applications of low-intensity ultrasound treatment are experimental, including, but not limited to, treatment of:

• Congenital pseudarthrosis
• Open fractures
• Fresh surgically treated closed fractures in patients who are not at high risk for delayed fracture healing or nonunion stress fractures
• Arthrodesis
• Failed arthrodesis

81401, 81405, 81406, 82172, 86141, 84999
Experimental or noncovered:
82610, 83695, 83701, 83704, 83880, 85384

Basic benefit and medical policy

The safety and effectiveness of measuring apolipoprotein B concentrations have been established. It may be a useful diagnostic option when indicated for individuals at intermediate or high risk for a cardiovascular event.

The safety and effectiveness of high sensitivity C-reactive protein measurement have been established. It may be a useful diagnostic option when indicated for individuals at intermediate risk for a cardiovascular event.

The safety and effectiveness of genetic testing of LDLR, APOB, PCSK9 and ARHadaptor protein (LDLRAP1) have been established. It may be a useful diagnostic option for individuals with suspected homozygous familial hypercholesterolemia, in whom the diagnosis is uncertain.

The peer-reviewed medical literature hasn’t demonstrated the clinical utility of laboratory testing of other novel biomarkers to assess cardiovascular risk, including but not limited to apolipoprotein A-I, apolipoprotein E or APOE genotypes, LDL subclass, HDL subclass, lipoprotein (a), cystatin C, brain natriuretic peptide, fibrinogen and leptin. Therefore, these services are experimental or investigational.

The medical policy statement and inclusionary and exclusionary criteria have been updated, effective Nov. 1, 2015.

 Inclusions:
Apolipoprotein B
Apolipoprotein B measurement is established for individuals at intermediate or high risk for a cardiovascular event who meet one of the following criteria:

• For individuals at intermediate risk** of cardiovascular disease, those with recurrent events or a family history of premature cardiovascular disease
• High-risk*** individuals with hypercholesterolemia to assess whether additional interventions are necessary when LDL-C or non-HDL-C goals are reached

High-sensitivity C-reactive protein
High-sensitivity C-reactive protein testing is established for individuals who meet any of the following criteria:

• Individuals at intermediate risk** (5-7.5 percent risk of cardiovascular disease over 10 years), in whom the physician may need additional information to guide further evaluation or therapy.
• For the selection of patients for statin therapy:
• Men ≥ 50 years of age or women ≥ 60 years of age, and
• With low-density lipoprotein cholesterol (LDL-C) < 130 mg/dL, and
• Not on lipid-lowering, hormone replacement, or immunosuppressant therapy, and
• Without clinical cardiovascular disease, diabetes, chronic kidney disease, severe inflammatory conditions, or contraindications to statins
• In asymptomatic, intermediate-risk** men ≤ 50 years of age or women ≤ 60 years of age, measurement of high-sensitivity C-reactive protein  may be reasonable for cardiovascular disease risk assessment.

** Intermediate-risk people are defined as those with 5-7.5 percent 10-year atherosclerotic cardiovascular disease event risk. Refer to any of these web-based calculators:

• my.americanheart.org/cvriskcalculator
• cardiosource.org/science-and-quality/practice-guidelines-and-quality-standards/2013-prevention-guideline-tools.aspx
• clincalc.com/Cardiology/ASCVD/PooledCohort.aspx

*** High-risk people are those with one or more of the following criteria:

• Clinically established coronary heart disease
• Cerebrovascular disease
• Peripheral arterial disease
• Abdominal aortic aneurysm
• Diabetes mellitus
• Chronic kidney disease
• 10-year predicted ASCVD risk ≥ 7.5 percent

Familial hypercholesterolemia
Genetic testing of LDLR, APOB, PCSK9 and ARH adaptor protein (LDLRAP1) to aid in the diagnosis of homozygous FH is established when other laboratory tests have not definitively established the diagnosis.

Exclusions:

• The routine measurement of apolipoprotein B in low-risk individuals (< 5% 10 year cardiovascular event risk) is not recommended.
• Measurement of apolipoprotein B is excluded for all other indications
• High-sensitivity C-reactive protein testing is excluded for all other indications, including use as a routine screening test for the general population and for monitoring response to therapy.
• In asymptomatic, high-risk adults, measurement of C-reactive protein is not recommended for cardiovascular disease risk assessment

Laboratory testing of other novel biomarkers to assess cardiovascular risk, including but not limited to apolipoprotein A-I, apolipoprotein E or APOE genotypes, LDL subclass, HDL subclass, lipoprotein[a]), cystatin C, brain natriuretic peptide, fibrinogen and leptin.

A4575, E0446, G0277, 99183

Basic benefit and medical policy

Hyperbaric oxygen therapy, systemic and topical

The criteria have been updated for hyperbaric oxygen therapy, systemic and topical. The safety and effectiveness of systemic hyperbaric oxygen therapy have been established for some conditions. It may be considered a useful therapeutic option when indicated for specified conditions.

Topical hyperbaric oxygen therapy is experimental or investigational. It hasn’t been scientifically demonstrated to improve patient clinical outcomes.  This policy is effective Nov. 1, 2015.

Inclusions:

The following conditions are effectively treated by systemic hyperbaric oxygen therapy (this list may not be all-inclusive):

• Acute peripheral arterial insufficiency
• Acute traumatic peripheral ischemia: Hyperbaric oxygen therapy is a valuable adjunctive treatment to be used in combination with accepted standard therapeutic measures when loss of function, limb or life is threatened
• Carbon monoxide poisoning, acute
• Cerebral edema, acute
• Chronic refractory osteomyelitis, unresponsive to conventional medical and surgical management
• Crush injuries and suturing of severed limbs 
• Cyanide poisoning, acute
• Decompression sickness
• Gas embolism, acute
• Gas gangrene (for example, clostridial myonecrosis)
• Profound anemia with exceptional blood loss: Only when blood transfusion is impossible or must be delayed
• Osteoradionecrosis and soft tissue radiation necrosis as an adjunct to conventional treatment
• Pre- and post-treatment for patients undergoing dental surgery of an irradiated jaw
• Preparation and preservation of compromised skin grafts (not for primary management of wounds)
• Progressive necrotizing infections
• Refractory mycoses: Mucormycosis, actinomycosis, Conidiobolus coronata only as an adjunct to conventional therapy when the disease process is refractory to antibiotics and surgical treatment

Treatment of wounds using hyperbaric oxygen therapy may be appropriate when there have been no measurable signs of healing for at least 30 consecutive days or when there is failure to respond to standard wound care. Wounds must be evaluated at least every 30 days during administration of hyperbaric oxygen therapy for measurable signs of improvement.  Continued treatment with hyperbaric oxygen therapy should be discontinued when there are no measurable signs of healing within any 30-day period of treatment. 

Wounds, including diabetic wounds, being treated with hyperbaric oxygen therapy must be reviewed using clinical documentation that identifies measurable signs of healing, for example width, depth and length of the wound.

Additional criteria for diabetic wounds:

• Diabetic wounds of the lower extremities in patients who meet the following three criteria:
• A diagnosis of type 1 or type 2 diabetes with a lower extremity wound that is due to diabetes
• A wound classified as Wagner Grade 3 or higher. (The Wagner classification system of wounds is defined as follows: Grade 0 —  no open lesion; Grade 1 —  superficial ulcer without penetration to deeper layers; Grade 2 — ulcer penetrates to tendon, bone or joint; Grade 3 —  lesion has penetrated deeper than Grade 2 and there is abscess, osteomyelitis, pyarthrosis, plantar space abscess or infection of the tendon and tendon sheaths; Grade 4 — wet or dry gangrene in the toes or forefoot; Grade 5 —  gangrene involves the whole foot or such a percentage that no local procedures are possible and amputation, at least at the below the knee level, is indicated.)
• The patient has failed an adequate course of standard wound therapy. Standard wound care in patients with diabetic wounds includes all of the following:
• The assessment of a patient’s vascular status and correction of any vascular problems in the affected limb, if possible
• The optimization of nutritional status
• Optimization of glucose control
• Debridement by any means to remove devitalized tissue
• Maintenance of a clean, moist bed of granulation tissue with appropriate moist dressings
• Appropriate off-loading
• Necessary treatment to resolve any infection that might be present

Exclusions:
Hyperbaric oxygen pressurization is considered investigational in the treatment of the following conditions, (this list may not be all-inclusive):

• Acute coronary syndromes and as an adjunct to coronary interventions, including but not limited to percutaneous coronary interventions and cardiopulmonary bypass
• Acute or chronic cerebral vascular insufficiency
• Acute ischemic stroke
• Acute thermal and pulmonary damage, namely smoke inhalation with pulmonary insufficiency
• Acute thermal burns
• Acute surgical and traumatic wounds
• Aerobic septicemia
• Anaerobic septicemia and infection other than clostridial
• Arthritic diseases
• Autism spectrum disorders
• Bell’s palsy
• Bisphosphonate-related osteonecrosis of the jaw
• Bone grafts
• Brown recluse spider bites
• Carbon tetrachloride poisoning, acute
• Cardiogenic shock
• Cerebral palsy
• Cerebrovascular accident, acute (thrombotic or embolic)
• Chronic arm lymphedema following radiotherapy for cancer
• Chronic peripheral vascular insufficiency
• Chronic aerobic refractory osteomyelitis and acute osteomyelitis, refractory to standard medical management
• Cosmetic use
• Cutaneous, decubitus and stasis ulcers
• Delayed onset muscle soreness
• Demyelinating diseases, for example, multiple sclerosis, amyotrophic lateral sclerosis
• Early treatment (beginning at completion of radiation therapy) to reduce side effects of radiation therapy
• Fracture healing
• Hepatic necrosis
• Herpes Zoster
• Hydrogen sulfide poisoning
• Idiopathic femoral neck necrosis
• Idiopathic sudden sensorineural hearing loss
• Intra-abdominal and intracranial abscesses
• In vitro fertilization
• Lepromatous leprosy
• Meningitis
• Migraine
• Motor dysfunction associated with stroke
• Multiple sclerosis
• Myocardial Infarction
• Nonvascular causes of chronic brain syndrome (Pick’s disease, Alzheimer’s disease, Korsakoff’s syndrome)
• Organ storage
• Organ transplantation
• Pseudomembranous colitis (antimicrobial agent-induced colitis)
• Pulmonary emphysema
• Pyoderma gangrenosum
• Radiation myelitis, cystitis, enteritis or proctitis
• Radiation-induced injury in the head and neck
• Retinal artery insufficiency, acute
• Retinopathy, adjunct to scleral buckling procedures in patients with sickle cell peripheral retinopathy and retinal detachment
• Senility
• Severe or refractory Crohn’s disease
• Sickle cell crisis or hematuria
• Spinal cord injury
• Systemic aerobic infection
• Tetanus
• Traumatic brain injury
• Tumor sensitization for cancer treatments, including, but not limited to, radiotherapy or chemotherapy
• Vascular dementia

S3870, 81228, 81229
Experimental: 81470, 81471

Basic benefit and medical policy

The safety and effectiveness of chromosomal microarray analysis have been established. It may be considered a useful diagnostic option when indicated for patients meeting specific patient selection criteria. Criteria have been updated, effective Nov. 1, 2015.

Inclusions:
Chromosomal microarray analysis may be considered established as first line testing in the initial postnatal evaluation of individual with any of the following:

• Apparently nonsyndromic developmental delay or intellectual disability
• Autism spectrum disorder
• Multiple congenital anomalies not specific to a well-delineated genetic syndrome

Exclusions:

• Panel testing using next-generation sequencing is considered experimental or investigational in all cases of suspected genetic abnormality in children with developmental delay or intellectual disability, autism spectrum disorder, or congenital anomalies.