Blues highlight medical, benefit policy changes

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Basic Benefit and Medical Policy

The safety and effectiveness of isolated limb perfusion or infusion chemotherapy, with or without hyperthermia, have been established. It may be considered a useful therapeutic option when indicated. This policy is effective March 1, 2015.

Inclusionary Guidelines

• Isolated limb perfusion or isolated limb infusion with melphalan alone or in combination with cytostatic drugs, with or without hyperthermia, when used as a therapeutic treatment of local recurrence of nonresectable melanoma (that is, satellite lesions or “in transit” melanoma)

Exclusionary Guidelines

• Isolated limb perfusion or infusion used as an adjuvant treatment of surgically treated locally recurrent melanoma with no other evidence of disease
• Isolated limb perfusion or infusion in conjunction with tumor necrosis factor or interferon gamma
• Isolated limb perfusion or infusion as a primary or adjuvant treatment for any other malignant diagnosis (for example, soft tissue or bone sarcoma)

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Basic Benefit and Medical Policy

Intensity-modulated radiation therapy of the prostate may be considered established in the treatment of localized prostate cancer at radiation doses of 75 to 80 Gy. This policy is effective Jan. 1, 2015.

IMRT is considered investigational for the treatment of prostate cancer when the above criteria are not met. 

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Experimental:
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Basic Benefit and Medical Policy
The safety and effectiveness of genetic testing to confirm the diagnosis of a specific mitochondrial disorder, or for at-risk female relatives to determine carrier status prior to conception, have been established. It is an effective diagnostic option for patients meeting patient selection criteria.

Genetic testing for mitochondrial disorders using expanded panel testing is considered experimental.

This policy is effective Jan. 1, 2015.

Inclusionary Guidelines
For confirming a diagnosis of a mitochondrial disorder, both conditions must be met:

• The patient has clinical signs and symptoms consistent with a specific mitochondrial disorder, but the diagnosis cannot be made with certainty by clinical or biochemical evaluation.
• Genetic testing is restricted to the specific mutations that have been documented to be pathogenic for the particular mitochondrial disorder being considered.

Genetic testing of at-risk female relatives may be considered established as part of a preconception evaluation under the following conditions:

• There is a defined mitochondrial disorder in the family of sufficient severity to cause impairment of quality of life or functional status.
• A mutation that is known to be pathogenic for that specific mitochondrial disorder has been identified in the index case.

Exclusionary Guidelines
Genetic testing for mitochondrial disorders using expanded panel testing is considered experimental.

Genetic testing for mitochondrial disorders is considered experimental in all other situations when the criteria for medical necessity are not met.

Informational Guidelines
To maximize the positive and the negative predictive value of testing, it should be restricted to patients with a clinical picture consistent with a specific disorder and to a small number of mutations that are known to be pathogenic for that disorder. Table 2 on Page 5 of the medical policy is a guide to clinical symptoms and particular genetic mutations that are associated with particular mitochondrial syndromes. You can find the policy by using the Medical Pollcy & Pre-Cert/Pre-Auth Router.

Panels of mutations that are disease-specific, that is, contain only mutations associated with a specific type of mitochondrial disorder, can be used in place of testing individual genes in sequence. Disease-specific panels should include a list of mutations that approximates (but may not be identical to) those listed in Table 2 for each specific disorder.

“Expanded” panels refer to panels of many genes that are associated with numerous different types of mitochondrial disorders, typically including both mitochondrial and nuclear genes. These expanded panels are contrasted with the smaller number of genes associated with any particular disorder (see Table 2).

Examples of commercially available expanded panel testing are provided in Table 1 of the medical policy document.

Coding
There are several mitochondrial tests listed in the CPT Tier 2 molecular pathology codes.

Code *81401 includes:

• MT-ATP6 (mitochondrially encoded ATP synthase 6) (for example, neuropathy with ataxia and retinitis pigmentosa [NARP], Leigh syndrome), common variants (eg, m.8993T>G, m.8993T>C)
• MT-ND4, MT-ND6 (mitochondrially encoded NADH dehydrogenase 4, mitochondrially encoded NADH dehydrogenase 6) (for example, Leber hereditary optic neuropathy [LHON]), common variants (for example, m.11778G>A, m.3460G>A, m.14484T>C)
• MT-TK (mitochondrially encoded tRNA lysine) (for example, myoclonic epilepsy with ragged-red fibers [MERRF]), common variants (for example, m.8344A>G, m.8356T>C)
• MT-ND5 (mitochondrially encoded tRNA leucine 1 [UUA/G], mitochondrially encoded NADH dehydrogenase 5) (for example, mitochondrial encephalopathy with lactic acidosis and stroke-like episodes [MELAS]), common variants (for example, m.3243A>G, m.3271T>C, m.3252A>G, m.13513G>A)
• MT-TL1 (mitochondrially encoded tRNA leucine 1 [UUA/G]) (for example, diabetes and hearing loss), common variants (for example, m.3243A>G, m.14709 T>C)
• MT-TS1, MT-RNR1 (mitochondrially encoded tRNA serine 1 [UCN], mitochondrially encoded 12S RNA) (for example, nonsyndromic sensorineural deafness [including aminoglycoside-induced nonsyndromic deafness]), common variants (for example, m.7445A>G, m.1555A>G)

Code *81403 includes:

• MT-RNR1 (mitochondrially encoded 12S RNA) (for example, nonsyndromic hearing loss), full gene sequence
• MT-TS1 (mitochondrially encoded tRNA serine 1) (for example, nonsyndromic hearing loss), full gene sequence

If there is no specific listing in the CPT molecular pathology code list for the mitochondrial DNA test that is performed, the unlisted molecular pathology code *81479 may be reported. If multiple unlisted mitochondrial DNA tests are performed, the unlisted code is only reported once for all of the unlisted tests.

Group Variations
MESSA, MPSERS, State of Michigan, Chrysler and the UAW Retirees Medical Benefits Trust are excluded from this coverage decision.

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Basic Benefit and Medical Policy
Blepharoplasty procedures of the upper eyelid and repair of brow ptosis are safe and effective restorative procedures when performed to correct:

• Visual impairment due to dermatochalasis, blepharochalasis or blepharoptosis
• Symptomatic redundant skin weighing down on upper lashes
• Prosthetic difficulties in an anophthalmic socket
• Blepharospasm unresponsive to conservative treatment

Blepharoplasties of the lower lid are considered primarily cosmetic in nature. This service is usually performed to improve appearance or self-esteem, not to treat a specific disease state or improve function.  This policy is effective March 1, 2015.

Inclusionary Guidelines
Blepharoplasty is considered reconstructive and not cosmetic if all of the following criteria are met:

• There is a difference of 12 degrees or more or at least 30 percent superior visual field difference is demonstrated between visual field testing before and after manual elevation of the upper eyelids.
• The medical record should include visual field testing reports in both taped and untaped positions. Photographs should be maintained as part of the medical record, including photographs demonstrating the head held in an erect position with eyes open and focused straight ahead. Views should reveal the full-face anterior position, as well as the right and left lateral views with straightforward gaze.
• Surgical intervention may be indicated for infants and children whose blepharoptosis is severe enough to cause a functional visual impairment. While it may not be possible to obtain visual field measurements in young children, photographs documenting the lid obstruction should be maintained as part of the medical record.
• Blepharoplasty may be indicated to relieve eye symptoms associated with blepharospasm when other treatments (such as, an injection of Botulinum Toxin A) have failed or are contraindicated 

Repair of brow ptosis (browplasty) and blepharoptosis is considered reconstructive and not cosmetic if all of the criteria are met:

• There is a difference of 12 degrees or more or at least 30 percent superior visual field difference is demonstrated between visual field testing before and after manual elevation of the upper eyelids.

• The medical record should include visual field testing reports in both taped and untaped positions. Photographs should be maintained as part of the medical record. Views should reveal the full-face anterior position, as well as the right and left lateral views with straightforward gaze.

Clinical review of these procedures is usually required. Providers should consult the plan to determine whether photographs should be forwarded with the request. Photos should be maintained in the record in the event they are requested for later review.

Exclusionary Guidelines

• Lower lid blepharoplasty is considered cosmetic.
• Blepharoplasty or ptosis repair or brow lift surgery to improve the appearance when no functional impairment exists is considered cosmetic.

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Basic Benefit and Medical Policy

The safety and effectiveness of unilateral deep brain stimulation of the thalamus is established. It may be considered a useful therapeutic option in patients with disabling, medically unresponsive tremor due to essential tremor or Parkinson’s disease.

The safety and effectiveness of bilateral deep brain stimulation of the thalamus have been established. It may be considered a useful therapeutic option in patients with disabling, medically unresponsive tremor in both limbs due to essential tremor or Parkinson disease.

The safety and effectiveness of unilateral or bilateral deep brain stimulation of the globus pallidus and subthalamic nucleus have been established. It may be considered a useful therapeutic option in patients with medically refractory Parkinson’s disease, essential tremor or primary dystonia.

Deep brain stimulation for other movement disorders, including but not limited to tremors associated with multiple sclerosis, post-traumatic dyskinesia and tardive dyskinesia, is considered experimental. The safety and effectiveness of this treatment for these conditions have not been established.

Deep brain stimulation for the treatment of other psychiatric or neurologic disorders, including but not limited to Tourette syndrome, depression, obsessive-compulsive disorder, Alzheimer disease, anorexia nervosa, alcohol addiction, chronic pain, epilepsy and chronic cluster headaches, is considered experimental. The safety and effectiveness of this treatment for these conditions have not been established.

This policy is effective March 1, 2015.

Inclusionary Guidelines

• Unilateral deep brain stimulation of the thalamus may be indicated in patients with disabling, medically unresponsive tremor due to essential tremor or Parkinson’s disease.
• Bilateral deep brain stimulation of the thalamus may be indicated in patients with disabling, medically unresponsive tremor in both limbs due to essential tremor or Parkinson disease.
• Unilateral or bilateral deep brain stimulation of the globus pallidus or subthalamic nucleus may be indicated in those with Parkinson’s disease with all of the following:
• A good response to levodopa
• A minimal score of 30 points on the motor portion of the Unified Parkinson Disease Rating Scale when the patient has been without medication for approximately 12 hours
• Motor complications not controlled by pharmacologic therapy
• Patients  older than 7 years with chronic, intractable (drug refractory) primary dystonia, including generalized or segmental dystonia, hemidystonia and cervical dystonia (torticollis)

Exclusionary Guidelines

• Deep brain stimulation for other movement disorders, including but not limited to multiple sclerosis, post-traumatic dyskinesia, and tardive dyskinesia
• Deep brain stimulation for the treatment of chronic cluster headaches
• Deep brain stimulation for the treatment of other psychiatric or neurologic disorders, including but not limited to Tourette syndrome, depression, obsessive-compulsive disorder, Alzheimer disease, anorexia nervosa, alcohol addiction, chronic pain and epilepsy
• Movement disorders from other causes not noted above
• Patients who have cognitive impairments
• Inability to comply and participate with the treatment plan

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Experimental:
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Basic Benefit and Medical Policy
The safety and effectiveness of the insertion of U.S. Food and Drug Administration-approved aqueous shunts have been established. They are useful therapeutic options for reducing intraocular pressure in patients with glaucoma when medical therapy has failed to adequately control intraocular pressure.

Use of an aqueous shunt for all other conditions, including in patients with glaucoma when intraocular pressure is adequately controlled by medications, is considered experimental.

Implantation of a single FDA-approved microstent in conjunction with cataract surgery may be considered established in patients with mild to moderate open-angle glaucoma currently treated with ocular hypotensive medication. Inclusionary criteria have been updated. 

This policy is effective Jan. 1, 2015.

Inclusionary Guidelines
Insertion of FDA-approved aqueous shunts is considered established as a method to reduce intraocular pressure in patients with mild to moderate open-angle glaucoma when conventional pharmacologic treatments have failed to control intraocular pressure adequately. 

Currently available FDA-approved shunts include:

• Ahmed glaucoma implant
• Baerveldt seton
• Ex-PRESS™ mini glaucoma shunt
• Glaucoma pressure regulator
• Krupin-Denver valve implant
• Molteno implant
• Schocket shunt

Implantation of a single FDA-approved microstent in conjunction with cataract surgery may be considered established in patients with mild to moderate open-angle glaucoma currently treated with ocular hypotensive medication. The only FDA-approved stent system is the iStent Trabecular Micro-Bypass Stent System.

Exclusionary Guidelines

• The use of an aqueous shunt for all other conditions, including patients with glaucoma when intraocular pressure is controlled by medications.
• Insertion of aqueous shunts that are not FDA-approved.
• For the iStent Micro Bypass Stent, patients with the following conditions are not appropriate candidates and the insertion of this stent would be considered experimental:
• In children
• In eyes with significant prior trauma
• In eyes with abnormal anterior segment
• In eyes with chronic inflammation
• In glaucoma associated with vascular disorders
• In pseudophakic patients with glaucoma
• In uveitic glaucoma
• In patients with prior glaucoma surgery of any type including argon laser trabeculoplasty
• In patients with medicated intraocular pressure greater than 24 mm Hg
• In patients with unmedicated IOP less than 22 mm Hg nor greater than 36 mm Hg after "washout" of medications
• For implantation of more than a single stent
• After complications during cataract surgery, including but not limited to, severe corneal burn, vitreous removal or vitrectomy required, corneal injuries or complications requiring the placement of an anterior chamber IOL [intraocular lens]
• When implantation has been without concomitant cataract surgery with IOL implantation for visually significant cataract
• The implantation of more than one iStent per eye; further clinical trials are needed to validate the effectiveness of multiple stents.

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Basic Benefit and Medical Policy
Scintimammography, breast-specific gamma imaging and molecular breast imaging are considered experimental for all applications, including but not limited to their use as adjuncts to mammography or in staging the axillary lymph nodes. They have not been scientifically demonstrated to improve patient clinical outcomes.

Preoperative or intraoperative sentinel lymph node detection using handheld or mounted mobile gamma cameras is considered experimental. It has not been scientifically demonstrated to improve patient clinical outcomes.

This policy was updated, effective March 1, 2015.

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Basic Benefit and Medical Policy
The safety and effectiveness of hyperthermic intraperitoneal chemotherapy when used in combination with cytoreductive surgery have been established. It may be considered a useful therapeutic option for patients meeting patient selection criteria.

Inclusionary and exclusionary criteria have been updated, effective March 1, 2015.

Inclusionary Guidelines
The patient must meet all of the following criteria:

• A diagnosis of either pseudomyxoma peritonei or diffuse malignant peritoneal mesothelioma confirmed by the treating physician.
• The patient must be able to tolerate the extensive cytoreductive surgery and hyperthermic intraperitoneal chemotherapy.
• Peritoneal disease must be potentially completely resectable or significantly reduced.
• There must be no metastases to other organs or to the retroperitoneal space.

Exclusionary Guidelines

• A diagnosis of peritoneal carcinomatosis from other forms of gastrointestinal cancer, including colorectal or gastric cancer
• Metastatic spread to distant organs outside the peritoneal cavity
• Pulmonary, cardiac, renal, hepatic, central nervous system, metabolic or bone marrow dysfunction
• Active viral, bacterial or fungal infections

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Basic Benefit and Medical Policy

Blue Cross Medical Policy staff reviewed the Sacral Nerve Neuromodulation/Stimulation policy and updated the inclusionary and exclusionary guidelines. This policy is effective March 1, 2015.

The safety and effectiveness of sacral nerve stimulation for specific types of urinary or fecal incontinence have been established. It may be considered a useful therapeutic option for patients meeting specified criteria.

Urinary Incontinence and Nonobstructive Retention
Inclusionary Guidelines

• A trial period of sacral nerve neuromodulation with either percutaneous nerve stimulation or a temporarily implanted lead is established in patients who meet all of the following criteria:

1. There is a diagnosis of at least one of the following:
a. Urge incontinence
b. Urgency-frequency syndrome
c. Nonobstructive urinary retention
d. Overactive bladder

• There is documented failure or intolerance to at least two conventional therapies (for example, behavioral training such as bladder training, prompted voiding or pelvic muscle exercise training, pharmacologic treatment for at least a sufficient duration to fully assess its efficacy or surgical corrective therapy).
• The patient is an appropriate surgical candidate.
• Incontinence is not related to a neurologic condition.
• Permanent implantation of a sacral nerve neuromodulation device is established in patients who meet all of the following criteria:

1. All of the criteria in A (1-4) above are met.
2. A trial stimulation period demonstrates at least 50% improvement in symptoms over a period of at least one week.

Exclusionary Guidelines
Other urinary or voiding applications of sacral nerve neuromodulation are considered experimental, including but not limited to treatment of:

• Stress incontinence
• Urge incontinence due to a neurologic condition, (for example, detrusor hyperreflexia, multiple sclerosis, spinal cord injury or other types of chronic voiding dysfunction).

Fecal incontinence
Inclusionary Guidelines
Sacral nerve neuromodulation is established for the treatment of fecal incontinence when all of the following criteria are met:

1. A trial period of sacral nerve neuromodulation with either percutaneous nerve stimulation or a temporarily implanted lead may be considered established in patients who meet all of the following criteria:
1. There is a diagnosis of chronic fecal incontinence of greater than two incontinent episodes on average per week with duration greater than six months, or for more than 12 months after vaginal childbirth.
2. There is documented failure or intolerance to conventional conservative therapy (for example, dietary modification or the addition of bulking and pharmacologic treatment for at least a sufficient duration to fully assess its efficacy).
3. The patient is an appropriate surgical candidate.
4. The condition is not related to an anorectal malformation (for example, congenital anorectal malformation, defects of the external anal sphincter over 60 degrees, visible sequelae of pelvic radiation, active anal abscesses and fistulae) or chronic inflammatory bowel disease.
5. Incontinence is not related to a neurologic condition.
6. The patient has not had rectal surgery in the previous 12 months, or in the case of cancer, the patient has not had rectal surgery in the past 24 months.
• Permanent implantation of a sacral nerve neuromodulation device may be considered established in patients who meet all of the following criteria:
1. All of the criteria in A (1-6) above are met.
2. A trial stimulation period demonstrates at least 50% improvement in symptoms over a period of at least one week.

Exclusionary Guidelines
Sacral nerve neuromodulation is experimental for the treatment of chronic constipation or chronic pelvic pain.

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Basic Benefit and Medical Policy
Quantitative pupillometry or pupillography is experimental for all indications. The clinical utility of the use of this device has not been established in medical literature. This policy is effective March 1, 2015.

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Basic Benefit and Medical Policy
Whole exome sequencing and whole genome sequencing are experimental for diagnosing genetic disorders, effective March 1, 2015. The peer-reviewed medical literature has not yet demonstrated the clinical utility of whole exome or whole genome sequencing.

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Basic Benefit and Medical Policy
The use of a multi-biomarker disease activity score for rheumatoid arthritis (for example, Vectra DA score) is considered experimental in all situations.  There is insufficient documentation in medical literature to determine whether this testing is as good as or better than other measures of disease activity, and its clinical utility for improving patient clinical outcomes has not been proven.  This policy is effective Jan. 1, 2105.