Medical Policy Update January 2015 Criteria Revised for Electrical Nerve Stimulation

January 2015

Policy

Coverage Criteria Established for Alemtuzumab (Lemtrada)

Highmark Delaware has established new clinical criteria for alemtuzumab (Lemtrada™). This new medical policy will apply to both professional provider and facility claims. The effective date is March 30, 2015.

Place of Service: Outpatient

Alemtuzumab (Lemtrada) may be considered medically necessary for relapsing-remitting forms of multiple sclerosis in patients who have had an inadequate response to two or more drugs indicated for the treatment of multiple sclerosis.

The use of alemtuzumab for all other indications is considered experimental/investigational. Scientific evidence does not support the use of alemtuzumab for any other indication. A participating, preferred, or network provider can bill the member for the denied service.

For further information, refer to Medical Policy I-118, Alemtuzumab (Lemtrada).

Highmark Blue Cross Blue Shield Delaware is an independent licensee of the Blue Cross and Blue Shield Association. NaviNet is a registered trademark of NaviNet, Inc., which is an independent company that provides a secure, web-based portal between providers and health insurance companies. Medical Policy Update January 2015 Criteria Revised for Electrical Nerve Stimulation

Highmark Delaware has revised the criteria for electrical nerve stimulation. The effective date is March 30, 2015.

Place of Service: Outpatient

The following information has either been revised or added to the electrical nerve stimulation medical policy:

Chronic intractable pain is defined as chronic pain that has no significant chance of being altered by usual treatment modalities or natural healing. Examples of Chronic Intractable Pain are as follows:

 An episode of low back pain that has persisted for three months or longer; and  Is not a manifestation of a clearly defined and generally recognizable primary disease entity. For example, there are cancers that, through metastatic spread to the spine or pelvis, may elicit pain in the lower back as a symptom; and certain systemic diseases such as rheumatoid arthritis and multiple sclerosis manifest many debilitating symptoms

Transcutaneous electrical nerve stimulation (TENS) is considered medically necessary when the chronic intractable pain causes significant disruption of function when all of the following have been met:

 The patient is unresponsive to at least three months of conservative medical therapy (i.e., non-steroidal anti-inflammatory medications, ice, rest and/or physical therapy);

AND

 the trial period is monitored by a physician

The physicians documentation should include:

 Initial assessment/evaluation of the nature, duration, and perceived intensity of pain  Treatment plan including ongoing medications and proposed use of TENS unit including the frequency and duration of treatment

A written order prior to delivery (WOPD) must be obtained before dispensing the TENS. There is to be a minimum trial period of two months (60 days) in which the unit is to be

2 Medical Policy Update January 2015 used in the physician or physical therapists office OR is to be rented by a DME supplier for a minimum of two months to determine whether the patient is likely to derive a significant therapeutic benefit from the continued use of electrical stimulation.

Supplies

Separate allowance will be made for replacement supplies when they are medically necessary and are used with a covered electrical stimulation device (i.e., TENS, NMES, etc.). Usual utilization is:

 2 TENS leads - a maximum of one unit of A4595 per month  4 TENS leads - a maximum of two units of A4595 per month

Replacement of lead wires (A4557) more often than every 12 months would rarely be medically necessary.

Electrodes

Separate allowance will be made for replacement supplies when they are medically necessary and are used with a covered electrical stimulation device (i.e., TENS, NMES, etc.). Usual utilization is:

 For 2 Lead device, 4 electrodes (A4556, 2 units) per month  For 4 lead device, 8 electrodes (A4556,4 units) per month

If additional electrodes are needed (due to skin condition, etc.), the referring physician is to clearly document the need in the patient’s medical record AND on the CMN/LMN. This documentation should clearly indicate how many additional units of A4556 are being requested for the patient. Additional units should never be requested in conjunction with an initial rental/purchase order as there is no demonstrated need for additional units, Additional units should be requested sparingly.

Please refer to Medical Policy Z-7, Electrical Nerve Stimulation, for a complete version.

3 Medical Policy Update January 2015 Coverage Criteria Established for Fulvestrant (Faslodex)

Highmark Delaware has established new clinical criteria for the use of Fulvestrant (Faslodex®). This new medical policy will apply to both professional provider and facility claims. The effective date is March 30, 2015.

Place of Service: Outpatient

Fulvestrant (Faslodex) may be considered medically necessary for first-line (no prior endocrine therapy within one year) or subsequent-line (following prior endocrine therapy within one year or progression on another endocrine agent) endocrine therapy for postmenopausal women or for premenopausal women treated with ovarian ablation/suppression who have recurrent or metastatic disease.

The use of fulvestrant for all other indications is considered not medically necessary.

Coverage Criteria Established for Nivolumab (Opdivo)

Highmark Delaware has established new clinical criteria for nivolumab (Opdivo®). This new medical policy will apply to both professional provider and facility claims. The effective date is March 30, 2015.

Place of Service: Outpatient

Nivolumab (Opdivo) may be considered medically necessary for the treatment of melanoma, unresectable or metastatic, as a single agent for disease progression after treatment with ipilimumab and, if BRAF V600 positive, a BRAF inhibitor.

The use of nivolumab for all other indications is considered experimental/investigational. Scientific evidence does not support the use of nivolumab for any other indication. A participating, preferred, or network provider can bill the member for the denied service.

4 Medical Policy Update January 2015 For further information, refer to Medical Policy I-120, Oncologic Indications for PD-1 Blocking Antibodies.

Coverage Criteria Established for Pembrolizumab (Keytruda)

Highmark Delaware has established new clinical criteria for pembrolizumab (Keytruda®). This new medical policy will apply to both professional provider and facility claims. The effective date is March 30, 2015.

Place of Service: Outpatient

Pembrolizumab (Keytruda) may be considered medically necessary for the treatment of melanoma, unresectable or metastatic, as a single agent for disease progression after treatment with ipilimumab and, if BRAF V600 positive, a BRAF inhibitor.

The use of pembrolizumab for all other indications is considered experimental/investigational. Scientific evidence does not support the use of pembrolizumab for any other indication. A participating, preferred, or network provider can bill the member for the denied service.

For further information, refer to Medical Policy I-120, Oncologic Indications for PD-1 Blocking Antibodies.

Criteria Revised for Lumbar Decompression

Highmark Delaware has revised the criteria for Lumbar Decompression. This revised medical policy will apply to both professional provider and facility claims. The effective date is March 30, 2015.

Place of Service: Inpatient/Outpatient

The following criteria for lumber decompression has been revised for herniated disc:

5 Medical Policy Update January 2015

Lumbar decompression for herniated disc may be considered medically necessary when ALL of the following criteria are met:

 Neurological deficits (e.g., reflex change in the legs, dermatomal sensory loss, motor weakness) or alternative signs of lumbar nerve root tension (e.g. positive leg raising test) are present on physical examination; and  Persistent, debilitating pain radiating from the low back down to the lower extremity is present on a daily basis that limits activities of daily living (ADLs); and  Unresponsive to 6 weeks of conservative medical management such as:  Activity/lifestyle modification; and  Nonsteroidal and/or steroidal medication (unless contraindicated); and  Physical therapy, including passive and active treatment modalities; and  Epidural steroid injections

Lumbar decompression for spinal stenosis may be considered medically necessary when ALL of the following criteria are met:

 All other sources of low back pain have been ruled out; and

 Persistent, progressive, debilitating symptoms of neurogenic claudication (with or without back pain) are present on a daily basis that limits activities of daily living (ADLs); and

 A lumbar spine imaging studies (e.g., CT or MRI) done within the past 6 months shows lumbar spine stenosis that corresponds to the clinical findings on physical examination; and

 Unresponsive to 3 months of conservative medical management such as:

 Activity/lifestyle modification; and

 Nonsteroidal and/or steroidal medication (unless contraindicated); and

 Physical therapy, including passive and active treatment modalities; and

 Epidural steroid injections

The following lumbar decompression criteria has been revised:

6 Medical Policy Update January 2015  The rapid progression of neurologic impairment (e.g., cauda equina syndrome, foot drop, extremity weakness, saddle anesthesia, sudden onset of bowel or bladder dysfunction)

For further information, refer to Medical Policy S-229, Lumbar Decompression (Discectomy, Laminectomy, Facetectomy and Foraminotomy).

Criteria Updated for Wearable Cardioverter-Defibrillator

Highmark Delaware has revised the criteria for Wearable Cardioverter-Defibrillators. This revised medical policy will apply to professional providers only. The effective date is March 30, 2015.

Place of Service: Outpatient

A wearable cardioverter-defibrillator (WCD) (K0606) may be considered medically necessary for a period of up to *3 months AND when the following criteria are met:

 At least 18 years of age or older; and

 At high risk for sudden cardiac death (SCD); and

 Requires the WCD as interim treatment for those who meet the criteria for an implantable cardioverter-defibrillator; and  Device must be worn for at least 22 hours per day (greater than 90% wear time); and

ANY ONE of the following criteria:

 A documented episode of ventricular fibrillation or a sustained (lasting 30 seconds or longer) ventricular tachyarrhythmia; or

 A previously implanted defibrillator now requires explantation; or

 As a bridge to LV improvement for ANY ONE of the following indications:

 LVEF less than or equal to 35% after cardiac events; or  Heart transplantation; or

 As an alternative to an implantable cardioverter-defibrillator (ICD) in an individual who has a documented contraindication to an ICD (e.g., systemic

7 Medical Policy Update January 2015 infection, lack of vascular access); or

 Inherited or familial conditions with a high risk for life-threatening ventricular tachyarrhythmias; or

 Cardiomyopathy with NYHA functional class II or class III symptoms, AND a history of myocardial infarction, AND measured left ventricular ejection fraction of ≤35%.

*All documentation include daily wear time must be maintained in the medical record and be available upon request. Beginning with the initial date the device was worn for continuous monitoring; the Cardiologist must reevaluate the need for continued use of the WCD at 3 months and then again at 90 day intervals until the device is discontinued. Documentation requirements including but not limited to the following must be maintained in the medical record: the date the device was first worn for continuous monitoring, the initial indication establishing medical necessity, member tolerance and compliance throughout the use of the WCD as documented by Cardiologist evaluations. The Cardiologist may access the Zoll LifeVest Network on-line patient management system allowing for monitoring of the patients data reports downloaded from a the LifeVest wearable defibrillator.

For further information, refer to Medical Policy E-58, Wearable Cardioverter- Defibrillators.

Criteria Revised for Dental Services

Highmark Delaware has revised the criteria for dental services. The effective date is March 30, 2015.

Place of Service: Outpatient

In most circumstances dental extractions (i.e., wisdom teeth) can be safely performed in an office setting. However, there may be rare circumstances where the procedure needs to be performed in an ambulatory surgery center or a hospital outpatient setting. In those instances when there are oral surgery benefits under the member's benefit plan, dental extractions may be medically necessary when they are performed in those settings.

In order for dental extractions to be considered medically necessary in a hospital outpatient or an ambulatory surgery center, the requesting physician or the patient's primary care physician must have documentation in the patient's medical record that

8 Medical Policy Update January 2015 supports the necessity of performing such extractions in these settings. The physician must provide substantiating documentation of such necessity as follows:

 Individuals with significant cognitive impairment or significant emotional conditions who have difficulty understanding what is expected in a dental treatment situation and have difficulty cooperating or following instructions. These individuals may require sedation and a higher level of monitoring.

 Individuals with complex medical problems under current medical management which increases the probability of complications (such as, but not limited to,

severe hypertension and cardiac or respiratory disease) who require intra- and peri-operative monitoring.

The following information has either been revised or added to the dental services medical policy:

Allowable Coverage for Dental Services in Hospital Outpatient Facility or Ambulatory Surgery Center Facility settings:

 Individuals with functional or behavioral impairment due to medical/behavioral conditions (e.g., autism, developmental delay) manifesting as severe oppositional and uncooperative behavior:  There must be supportive documentation to support the functional or behavioral impairment, and one of the following:  The member has rampant decay or dental needs of high complexity; or  The PCP or attending practitioner clearly describes why the member’s functional or behavioral impairment inhibits the safe delivery of care in an office setting considering the level of dental needs  Individuals with a co-existing medical condition, co-morbidity, or physical disability that might inhibit the safe delivery of care in an office setting;  The individuals dental needs are well documented, and there is evidence that the procedure cannot be safely delayed in order to try to stabilize the member’s medical condition; and  There is documentation of any of the following medical conditions, and an explanation from PCP or appropriate consultant as to why the procedure cannot be safely and effectively performed in an office setting:

Medical condition(s) resulting in American Society of Anesthesiology physical status

9 Medical Policy Update January 2015 classification Class 3 or higher;

 Pulmonary disease with pulmonary function measurement of FEV1 < 60% of predicted;  Moderate to severe asthma that is poorly controlled;  Acute cardiac disease, current angina, or class III or IV CHF;  Moderate to severe aortic stenosis, or symptomatic mitral stenosis;  Myocardial Infarction (MI) within past 6 months;  Poorly controlled hypertension;  Poorly controlled diabetes, or diabetes with vascular complications;  Morbid Obesity (BMI > 40);  Bleeding disorder that cannot be improved sufficiently to safely perform the procedure in an office setting:  Uncontrolled seizures;  Potential for difficult airway management (i.e. history of difficult intubation, neuromuscular disease, significant cervical spinal disease, deformities of the mouth or jaw impeding airway);  History of adverse reaction to anesthesia or sedation;  Other medical conditions felt to inhibit the safe delivery of care in an office setting

Complex dental procedures with a high probability of complications due to the nature of the surgery or a greater than average incidence of life threatening complications such as excessive bleeding or airway obstruction.

When anesthesia is required for the safe and effective administration of dental procedures for young children (below the age of 9 years), persons with serious mental or physical conditions or persons with significant behavioral problems.

Non Allowable Coverage for Dental Services in Hospital Outpatient Facility or Ambulatory Surgery Center Facility settings :

 In the absence of the medical criteria shown above.

Please refer to Medical Policy D-6, Dental Extractions, for a complete version.

10 Medical Policy Update January 2015 Facility and Place of Service Now Apply to Clinical Trials Effective March 30, 2015, Highmark Delaware’s Medical Policy Bulletin on Clinical Trials, will apply to both professional and facility claims. Additionally, place of service is designated as outpatient.

For additional information regarding Clinical Trials, please see Medical Policy G-27.

Immunoglobulin Criteria Revised

Highmark Delaware has revised the criteria for Immune Globulin Therapy. This revised Medical Policy will apply to facility and professional providers. The effective date is March 2, 2015.

Place of Service: Outpatient Home Infusion or Office Infusion Preferred

The revised criteria for immune globulin is as follows:

Subcutaneous Immune Globulin (SCIG) Therapy

Subcutaneous Immune Globulin (SCIG) may be considered medically necessary for the treatment of primary immunodeficiencies, only if standard therapies have failed, become intolerable, or are contraindicated. Primary immunodeficiencies also include:

 Congenital agammaglobulinemia,

 Hypogammaglobulinemia,

 Common variable immunodeficiency (CVID),

 Severe combined immunodeficiency,

 Wiskott-Aldrich syndrome,

 X-linked agammaglobulinemia (XLA),

 As an alternative to intravenous immunoglobulin therapy (IVIG) only if standard therapies have failed, become intolerable, or are contraindicated.

Intravenous immune globulin may be considered medically necessary for treatment of ANY ONE of the following conditions below:

11 Medical Policy Update January 2015 Autoimmune and inflammatory disorders

 Anti-phospholipid syndrome

 Hemophagocytic lymphohistiocytosis/hemophagocytic syndrome

 Kawasaki disease (mucocutaneous lymph node syndrome)

 Refractory dermatomyositis

 Refractory polymyositis

Hematologic

 Idiopathic thrombocytopenia purpura (ITP)

 treatment of acute, severe ITP defined by ANY ONE of the following parameters:

. acute ITP with major bleeding, e.g., life-threatening bleeding and/or

clinically important mucocutaneous bleeding; or

. acute ITP with severe thrombocytopenia and at high risk for bleeding complications; or

. acute ITP with severe thrombocytopenia and a slow or inadequate response to corticosteroids; or

. acute ITP with severe thrombocytopenia and a predictable risk of bleeding in the future, e.g., a procedure or surgery with a high bleeding risk

 treatment of chronic ITP; in patients with ALL of the following:

. duration of disease has been at least six (6) months; and

. individual has persistent thrombocytopenia despite treatment with corticosteroids and splenectomy

 Fetal alloimmune thrombocytopenia

 Allogeneic hematopoietic stem cell transplant or bone marrow transplant as prophylaxis in allogeneic transplant recipients within the first 100 days post

 Transplant; after 100 days post-transplant IVIG is indicated for recipients who are 12 Medical Policy Update January 2015 markedly hypogammaglobulinemic (TgG level less than 400 mg/dL)

 Individuals with hypogammaglobulinemia and/or recurrent bacterial infections associated with B-cell chronic lymphocytic leukemia, multiple myeloma or post- transplant lymphoproliferative disorder (PLD)

 Warm antibody autoimmune hemolytic anemia, refractory to corticosteroids and immunosuppressive agents

 Severe anemia due to parvovirus B19

Neuroimmunological

 Myasthenia gravis -chronic, severe, refractory to standard therapy (i.e., interferons, steroids/myasthenia crisis)

 Guillain Barre syndrome (acute infective polyneuritis)

 Chronic inflammatory demyelinating polyneuropathy (CIDP in individuals with progressive symptoms for at least two (2) months, when criteria 1, 2 and 3 are met:

1. Progressive or relapsing motor and sensory, rarely only motor or sensory,

dysfunction of more than 1 limb or a peripheral nerve nature, developing over at least 2 months, and

2. Hypo- or areflexia. This will usually involve all 4 limbs, and

3. Nerve conduction studies including studies of proximal nerve segments in which the predominant process is demyelination. (Must have 3 of the following A-D):

A. Reduction in conduction velocity (CV) in 2 or more motor nerves:

 <80% of lower limit of normal (LLN) is amplitude >80% of LLN

 <70% of LLN is amplitude <80% of LLN

B. Partial conduction block or abnormal temporal dispersion and possible conduction block 1 or more motor nerves:

Partial conduction block:

 <15% change in duration between proximal and distal sites, and

 >20% drop in negative peak (p) area or peak to peak (p-p)

13 Medical Policy Update January 2015 amplitude between proximal and distal sites.

Abnormal temporal dispersion and possible conduction block:

 >15% change in duration between proximal and distal sites, and

 >20% drop in p area or p-p amplitude between proximal and distal sites, and

 >20% drop in p or p-p amplitude between proximal and distal sites.

C. Prolonged distal latencies in 2 or more nerves:

 >125% of upper limit of normal (LEN) is amplitude >80% of LLN

 >150% of LEN if amplitude <80% of LLN.

D. Absent F waves or prolonged minimum

 >120% of ULN if amplitude >80% of LLN

 >150% of ULN if amplitude <80% of LLN.

 Multifocal motor neuropathy in patients with anti GM1 antibodies and conduction block

 Lambert-Eaton myasthenic syndrome when there is failure, contraindication, or intolerance to other therapies (i.e. anticholinesterase and diaminopyridine)

Transplantation

 Prior to solid organ transplant, for treatment of patients at high risk of antibody- mediated rejection (AMR) after steroid or other immunosuppressant failure, including highly sensitized patients, and those receiving an ABO incompatible organ.

 Following solid organ transplant, for treatment of antibody-mediated rejection (AMR).

Intravenous (IVIG) and subcutaneous (SCIG) immune globulin administered for conditions other than those referenced above should be denied as not medically.

14 Medical Policy Update January 2015 Immune Globulin Therapy for Post Exposure Prophylaxis

Botulism

Immune globulins for post-exposure prophylaxis may be considered medically necessary for ANY of the following indications:

 For the treatment of foodborne and wound botulism

 For the treatment of infantile botulism (human-derived botulinum immune globulin (BabyBIG or BIG-IV) in infants below 1 year of age, caused by toxin types A or B.

Experimental and Investigational

Immune Globulin therapy is considered experimental/investigational for the following conditions (not inclusive). A participating preferred, or network provider can bill the member for the denied experimental/investigational item or service.

 Acquired factor VIII inhibitors

 Acute lymphoblastic leukemia

 Adrenoleukodystrophy; stiff person syndrome

 Alzheimer disease

 Aplastic anemia

 Asthma

 Autism

 Behçet syndrome

 Birdshot retinopathy

 Chronic fatigue syndrome

 Chronic progressive multiple sclerosis

 Chronic sinusitis;

 Complex regional pain syndrome (CRPS)

 Crohn disease

 Cystic fibrosis

 Demyelinating optic neuritis

15 Medical Policy Update January 2015  Demyelinating polyneuropathy associated with IgM paraproteinemia

 Diabetes mellitus

 Diamond-Blackfan anemia

 Epidermolysis bullosa acquisita

 Epilepsy

 Fisher syndrome

 Hemolytic uremic syndrome

 Hemophagocytic syndrome, ie, hemophagocytic lymphohistiocytosis

 IGG subclass deficiency

 Immune-mediated neutropenia

 Inclusion-body myositis; polymyositis, including refractory polymyositis

 Multiple myeloma

 Myasthenia gravis in patients responsive to immunosuppressive treatment;

 Necrotizing fasciitis

 Non-immune thrombocytopenia

 Opsoclonus-myoclonus

 Organ transplant rejection for acute cellular-mediated rejection (CMR)

 Paraneoplastic syndromes, other than Eaton-Lambert myasthenic syndrome

 Pediatric autoimmune neuropsychiatric disorders associated with streptococcal infections (PANDAS)

 Polyradiculoneuropathy (other than CIDP)

 Recent-onset dilated cardiomyopathy

 Recurrent otitis media

 Recurrent spontaneous abortion

 Red cell aplasia

 Refractory rheumatoid arthritis and other connective tissue diseases, including systemic lupus erythematosus;

 Thrombotic thrombocytopenic purpura

16 Medical Policy Update January 2015  Treatment of sepsis including neonatal sepsis

 Uveitis

 Vasculitides (other than Kawasaki disease), including vasculitis associated with antineutrophil cytoplasmic antibodies (ANCA; eg, Wegener granulomatosis, polyarteritis nodosa), Goodpasture syndrome, and vasculitis associated with other connective tissue diseases.

Please refer to Medical Policy I-14 Immune Globulin Therapy for more information.

Minimally Invasive Microdiscectomy for Cervical and Thoracic Considered Experimental/Investigational

Effective March 30 2015, Highmark Delaware considers minimally invasive microdiscectomy of the cervical and thoracic regions experimental/investigational. This new medical policy will apply to both professional provider and facility claims.

Place of Service: Outpatient

Cervical and thoracic microdiscectomy, also known as microdecompression is considered experimental/investigational as a technique for intervertebral disc decompression due to symptomatic disc or asymptomatic herniation(s) in the thoracic or cervical spine. The published data regarding microdiscectomy for treatment of herniated intervertebral discs are inadequate to permit scientific conclusions regarding the advantages of this procedure over standard surgical or non-surgical options

Please see Medical Policy S-239 for additional information

Hot and Cold Packs No Longer Covered

Highmark Delaware has revised the criteria for Physical Medicine and will apply to both professional provider and facility claims. The effective date is March 30, 2015.

Place of Service: Inpatient/Outpatient

Hot or cold packs are considered an inherent part of physical medicine services. Hot or cold packs are included in the global allowance for physical medicine services and will not be reimbursed separately. Additionally, Athletic Training Evaluation will no longer be covered under Physical Medicine.

For additional information, refer to Medical Policy Y-1, Physical Medicine.

17 Medical Policy Update January 2015 Allergy Immunotherapy Criteria Revised

Highmark Delaware has established new clinical criteria for Allergy Immunotherapy. Medical Policy I-3 that will apply to both professional provider and facility claims. The effective date is March 30, 2015.

Allergy Immunotherapy may be considered medically necessary for:

 Allergic asthma; or

 Allergic rhinitis; or

 Allergic conjunctivitis; or

 Stinging insect allergy; or

 Clinical evidence of an inhalant sensitivity

AND

 Documented skin test and/or serologic evidence of IgE-mediated antibody to a potent extract of the allergen (IgE) test; and

 Avoidance or pharmacologic therapy cannot control allergic symptoms or member has unacceptable side effects with pharmacologic therapy; and

 The individual's medical record documents the antigens to be administered, the treatment plan, and the dosage regimen. The regimen must include the starting immunotherapy schedule, target maintenance dose, and immunotherapy schedule.

Supervision of preparation and provision of single or multiple antigens for allergen immunotherapy (95165) may be considered medically necessary for ANY ONE of the following:

 Up to 120 doses or units during the escalation phase for the first 12 month period of allergy immunotherapy; or

 Up to 90 doses or units every 12 months of allergy immunotherapy during the maintenance phase. A maximum of 10 doses per vial will be allowed, even if more than ten preparations are obtained from the vial.

Allergy immunotherapy is considered experimental/investigational and, therefore, not covered for ANY ONE of the following:

18 Medical Policy Update January 2015  Food Allergy; or  Chronic Urticaria; or  Angioedema

 Home administration of allergy immunotherapy. The safety and/or effectiveness of this service cannot be established by review of the available published peer- reviewed literature. A participating, preferred, or network provider can bill the member for the denied service.

Place of Service: Outpatient

Allergy Immunotherapy is typically an outpatient procedure which is only eligible for coverage as an inpatient procedure in special circumstances including, but not limited to the presence of a co-morbid condition that would require monitoring in a more controlled environment such as the inpatient setting.

For further information, refer to Medical Policy I-3, Allergy Immunotherapy.

Coverage Criteria Established for Paclitaxel, Albumin-Bound (Abraxane) Highmark Delaware has established new clinical criteria for paclitaxel, albumin-bound (Abraxane®). The effective date is March 30, 2015.

Paclitaxel, albumin-bound (Abraxane) may be considered medically necessary for the following indications:  Breast cancer (recurrent or metastatic); or  Melanoma (recurrent or metastatic); or  Non-small cell lung cancer (NSCLC) (recurrent or metastatic); or  Ovarian cancer-Epithelial ovarian cancer/Fallopian tube cancer/Primary peritoneal cancer; or  Pancreatic cancer

The use of paclitaxel, albumin-bound (Abraxane) for all other indications is considered experimental/investigational, and therefore, non-covered. Peer reviewed literature does not support the use of paclitaxel, albumin-bound (Abraxane) for any indications other than those listed on this medical policy. A participating, preferred, or network provider can bill the member for the non-covered service.

19 Medical Policy Update January 2015 Place of Service: Outpatient

The use of paclitaxel, albumin-bound (Abraxane) is typically an outpatient procedure which is only eligible for coverage as an inpatient procedure in special circumstances including, but not limited to the presence of a co-morbid condition that would require monitoring in a more controlled environment such as the inpatient setting.

For further information, refer to Medical Policy I-65, Paclitaxel, albumin-bound (Abraxane).

Criteria Established for Eribulin Mesylate (Halaven) Highmark Delaware has established new clinical criteria for eribulin mesylate (Halaven®). The effective date is March 30, 2015.

Place of Service: Outpatient

Eribulin mesylate (Halaven) is the preferred single agent for recurrent or metastatic breast disease. Intravenous therapy with eribulin mesylate may be considered medically necessary for the following indications:  patients with recurrent or  metastatic breast cancer, AND

One of the following criteria:  hormone receptor-positive, human epidermal growth factor receptor 2 (HER2)- negative with visceral crisis, OR  HER2-negative and either hormone receptor-negative or hormone receptor- positive and endocrine therapy refractory, OR  progressive with no clinical benefit after three consecutive endocrine therapy regimens or with symptomatic visceral disease.

The use of eribulin mesylate (Halaven) for any other indication not listed above is considered experimental/investigational, and therefore, not covered. A participating, preferred, or network provider can bill the member for the denied service.

For further information, refer to Medical Policy I-119.

20 Medical Policy Update January 2015 Criteria Revised for Urine Drug Testing (UDT)

Highmark Delaware has revised the criteria for Urine Drug Testing. This revised medical policy will apply to both facility and professional claims. The effective date is March 30, 2015.

Place of Service: Outpatient

The following revisions have been made for outpatient pain management setting:

 Subsequent monitoring of treatment at a frequency appropriate for the risk-level of the patient.

Frequency of urine drug screening to monitor patients on opioid therapy for chronic pain is a risk-based approach, as recommended by the Washington State Inter-Agency Guideline:

 Low risk by Opioid Risk Tool (ORT): Up to 1 per year, or  Moderate risk by ORT: Up to 2 per year, or  High risk or opioid dose >120 MED/d: Up to 3 to 4 per year, or  Recent history of *aberrant behavior, each visit.

*Aberrant behavior is defined by one or more of the following:

 Multiple lost prescriptions, or  Multiple requests for early refill, or  Obtained opioids from multiple provider, or  Unauthorized dose escalation, or  Apparent intoxication during previous visits.

Following revisions have been made for outpatient substance abuse treatment setting:

 Induction phase (1 time per program entry) - baseline screening at the time of initiating treatment.

*Stabilization phase: Some complicated patients may need frequent urine drug testing longer than 4 weeks. (i.e., those patients on an opioid abuse therapy [Suboxone] that could require additional urine drug testing more frequently and longer than 4 weeks; based on the patient's compliance and urine drug testing results.)

21 Medical Policy Update January 2015 *Maintenance phase: More frequent testing may be appropriate for more complicated patients.

The following revisions have been made for Limitations:

 The following calendar year limitations are recommendations:

The following statement has been added to the policy:

Note: Documentation in patient’s medical record must contain a history and physical pertinent to the indications of this policy, and be available upon request.

For a more comprehensive view of coverage please refer to Medical Policy L-102.

Facility Now Applicable to Electromyography (EMG)

Effective March 30, 2015, Highmark Delaware’s policy on electromyography (EMG) will apply to both professional provider and facility claims.

Place of Service: Outpatient

Please see Medical Policy M-28 for additional information.

Fecal Calprotectin Considered Experimental/Investigational

Effective March 30, 2015, Highmark Delaware considers fecal calprotectin (83993) experimental/investigational. This policy applies to both professional provider and facility claims.

Place of Service: Outpatient

Fecal calprotectin, a serologic fecal biomarker has been in evaluated in the diagnosis and management of inflammatory bowel disease. Scientific evidence does not support the use of this testing for inflammatory bowel management.

22 Medical Policy Update January 2015 Removal of Skin Lesions

Highmark Delaware Medical Policy S-36, Removal of Skin Lesions will apply to both professional providers and facility claims, effective March 30, 2015.

Place of Service: Outpatient

Facility Applies to Suction Assisted Lipectomy Highmark Delaware Medical Policy Bulletin S-74, Suction Assisted Lipectomy (SAL) will apply to both professional provider and facility claims effective Oct. 27, 2014.

Place of Service: Outpatient

Please see Medical Policy S-74 for additional information.

Guidelines Regarding HAART Therapy for AIDS Revised

Effective March 30, 2015, Highmark Delaware will revise the contraindications for isolated small bowel transplant for any patient with AIDS as follows:

 HIV-1 RNA undetectable (<50 HIV-1RNA copies/mL) for at least six (6) months); and

 On stable anti-retroviral therapy (HAART) greater than six (6) months; and

 Meeting all other criteria for isolated small bowel transplant.

Please refer to Medical Policy S-117 for more information.

Criteria Revised for Ocular Photodynamic Therapy and Transpupillary Thermotherapy Highmark Delaware has revised the clinical criteria for ocular photodynamic therapy and transpupillary thermotherapy. The effective date is March 30, 2015.

Place of Service: Outpatient

As a treatment of choroidal neovascularization (CNV), all stages of ocular photodynamic therapy (PDT) (codes 67221, 67225, J3396) are eligible only for the following conditions:  treatment of age-related wet macular degeneration in patients who have classic 23 Medical Policy Update January 2015 or predominately classic subfoveal choroidal neovascularization, or  chronic central serous chorioretinopathy,  choroidal hemangioma, or  occult neovascularization, or  pathologic myopia, or  ocular histoplasmosis.

Verteporfin (Visudyne) (J3396) is the only photosensitizing agent eligible for the treatment of age-related wet macular degeneration in patients with classic or predominately classic subfoveal choroidal neovascularization, occult neovascularization, pathologic myopia, and ocular histoplasmosis.

All other applications of ocular photodynamic therapy are considered experimental/investigational and are not covered. Scientific evidence does not demonstrate the effectiveness of ocular photodynamic therapy for other applications. A participating, preferred, or network provider can bill the member for the non-covered service.

Photodynamic therapy is considered experimental/investigational when used in combination with 1 or more of the antivascular endothelial growth factor therapies (anti- VEGF), ie, pegaptanib (Macugen®), ranibizumab (Lucentis®), bevacizumab (Avastin®), aflibercept (Eylea™) as a treatment of CNV associated with age related macular degeneration, chronic central serous chorioretinopathy, choroidal hemangioma, pathologic myopia, presumed ocular histoplasmosis, or for other ophthalmologic disorders. Transpupillary thermotherapy may be considered medically necessary for either of the following indications:  Retinoblastoma involving less than half (50%) of the retina, and without associated vitreal or subretinal seeds at the time of thermotherapy; or  Small (2 to 3 mm) choroidal melanomas located posterior in the globe.

Transpupillary thermotherapy is considered experimental/investigational for the following indications and any other indications other than those listed above because of the lack of prospective, controlled clinical supporting its effectiveness for these indications:  Central serous chorioretinopathy;

24 Medical Policy Update January 2015  Choroidal neovascularization associated with age-related macular degeneration;  Circumscribed choroidal hemangioma;  Polypoidal choroidal vasculopathy;  Retinopathy of prematurity. For further information, refer to Medical Policy S-140, Ocular Photodynamic Therapy.

Artificial Intervertebral Discs Criteria Revised Highmark Delaware has revised clinical criteria for Artificial Intervertebral Disc Replacement. This revised medical policy will apply to both professional provider and facility claims. The effective date for the revised criteria is March 30, 2015.

Place of Service: Inpatient/Outpatient

The following criteria has been added to the medical policy in addition to the current established criteria:

 Herniated nucleus pulposus, spondylosis defined by presence of osteophytes, and/or visible loss of disc height as compared to adjacent levels that are confirmed by radiographic studies (e.g., CT, MRI, x-rays); and  The individual does not have a previously implanted cervical artificial intervertebral disc device at another cervical level; and  The individual has not had a prior spinal fusion at an adjacent cervical level.

CONTRAINDICATIONS

A Cervical Disc should not be implanted in patients with the following conditions:  Active systemic infection or localized infection at the surgical site  Osteoporosis defined as a DEXA bone mineral density T-score equal to or worse than -3.5 or a T-score equal to or worse than -2.5 with vertebral compression fracture, or osteopenia defined as a DEXA bone mineral density T-score ≤ -1.0  Allergy or sensitivity to titanium, aluminum or vanadium  Marked cervical instability on neutral resting lateral or flexion/extension radiographs; translation >3.5mm and/or >11° rotational difference from that of either adjacent level  Severe spondylosis at the level to be treated, characterized by bridging osteophytes, loss of disc height >50%, an absence of motion (<2°) as this may lead to a limited range of motion and may encourage bone formation (e.g.

25 Medical Policy Update January 2015 heterotopic ossification, fusion)  Severe facet joint arthropathy  Significant cervical anatomical deformity or clinically compromised vertebral bodies at the affected level due to current or past trauma (e.g., by radiographic

appearance of fracture callus, malunion or nonunion) or disease (e.g., ankylosing spondylitis, rheumatoid arthritis)  Significant kyphotic deformity or significant reversal of lordosis; or  Symptoms attributed to more than one cervical level

Artificial intervertebral disc replacement for the thoracic spine is considered experimental/investigational due to insufficient evidence in the peer reviewed published literature regarding its effectiveness and safety. There are currently no FDA approved thoracic artificial disc devices to support thoracic artificial disc replacement. Artificial intervertebral disc thoracic spine replacement is not covered and is not eligible for payment. A participating preferred, or network provider can bill the member for this service.

Please refer to Medical Policy S-187 for complete policy review.

New Policy Created for Discography

Highmark Delaware has added a new policy, “S-237 Discography.” This new medical policy will apply to both professional provider and facility claims. The effective date is March 30, 2015.

Place of Service: Outpatient

Discography of the lumbar vertebrae is considered medically necessary for the evaluation of low back pain with or without lower extremity pain when ALL of the following are present:

 Pain is unrelenting and has persisted for an extended period of time (at least three (3) months);

 Pain has not responded to conservative treatment measures (i.e., NSAIDs,

26 Medical Policy Update January 2015 physical therapy, etc.);

 Noninvasive diagnostic studies have failed to provide sufficient diagnostic information regarding the origin of pain;

 There is no evidence of contraindications such as severe spinal stenosis resulting in intraspinal obstruction, infection, or predominantly psychogenic pain.

In addition to those listed above, at least ONE of the following indications must be present:

 A high index of suspicion for discogenic pain and the pain is severe enough to consider surgical intervention, or

 For failed back surgery individuals, to distinguish between painful pseudoarthrosis or a symptomatic disc in a posteriorly fused segment.

Cervical and thoracic discography, are each considered experimental/investigational and not medically necessary. A participating preferred, or network provider can bill the member for the denied experimental/investigational item or service.

Criteria Established for Transcatheter Mitral Valve Repair (TMVR) Highmark Delaware has established new clinical criteria for Transcatheter Mitral Valve Repair (TMVR). The effective date is March 30, 2015

Place of Service: Inpatient

Transcatheter Mitral Valve Repair (TMVR) may be considered medically necessary when ALL of the following are met:  Symptomatic degenerative mitral valve regurgitation, and  NYHA Class III to IV with severe primary mitral regurgitation (stage D)  Patient is considered prohibitive high risk for surgery, and  Has failed optimal guideline-directed medical therapy for heart failure, and  Has favorable anatomy for the procedure as well as a reasonable life expectancy.

The Professional Team must meet ALL of the following requirements:  Both a cardiothoracic surgeon experienced in mitral valve surgery and a

27 Medical Policy Update January 2015 cardiologist experienced in mitral valve disease, and  Each interventional cardiologist performs ≥ 50 structural procedures per year including atrial septal defects (ASD), patent foramen ovale (PFO) and trans-septal punctures, and  Interventional cardiologist(s) must receive prior suitable training on the devices to be used, and  The interventional cardiologist(s) must be board-certified in interventional cardiology or board-certified/eligible in pediatric cardiology or similar boards from outside the United States, and  The cardiothoracic surgeon(s) must be board-certified in thoracic surgery or similar foreign equivalent.

TMVR must be performed by an interventional cardiologist or a cardiothoracic surgeon. Interventional cardiologist(s) and cardiothoracic surgeon(s) may jointly participate in the intra-operative technical aspects of TMVR as appropriate.

The Facility must meet all of the following requirements:  On-site active valvular heart disease surgical program with ≥ 2 hospital-based cardiothoracic surgeons experienced in valvular surgery, and  A surgical program that performs ≥ 25 total mitral valve surgical procedures for severe mitral regurgitation (MR) per year of which at least 10 must be mitral valve repairs, and  An interventional cardiology program that performs ≥1000 catheterizations per year, including ≥ 400 percutaneous coronary interventions (PCIs) per year, with acceptable outcomes for conventional procedures compared to National Cardiovascular Data Registry (NCDR) benchmarks, and  Cardiac catheterization laboratory or hybrid operating room/catheterization laboratory equipped with a fixed radiographic imaging system with flat-panel fluoroscopy offering catheterization laboratory-quality imaging, and  Post-procedure intensive care facility with personnel experienced in managing patients who have undergone open-heart valve procedures.

For a more comprehensive view refer to Medical Policy S-238.

28 Medical Policy Update January 2015 Place of Service Added to Concurrent Care Policy Highmark Delaware has added inpatient place of service to Medical Policy V-2, Concurrent Care, effective Jan. 19, 2015.

Place of Service: Inpatient

For further information, refer to Medical Policy V-2, Concurrent Care.

Comments on these new medical policies? We want to know what you think about our new medical policy changes. Send us an email with any questions or comments that you may have on the new medical policies in this edition of Medical Policy Update.

Write to us at [email protected].

29 Medical Policy Update January 2015 Contents Coverage Criteria Established for Alemtuzumab (Lemtrada)...... 1 Criteria Revised for Electrical Nerve Stimulation ...... 2 Coverage Criteria Established for Fulvestrant (Faslodex) ...... 4 Coverage Criteria Established for Nivolumab (Opdivo)...... 4 Coverage Criteria Established for Pembrolizumab (Keytruda) ...... 5 Criteria Revised for Lumbar Decompression...... 5 Criteria Updated for Wearable Cardioverter-Defibrillator ...... 7 Criteria Revised for Dental Services ...... 8 Facility and Place of Service Now Apply to Clinical Trials ...... 11 Immunoglobulin Criteria Revised...... 11 Minimally Invasive Microdiscectomy for Cervical and Thoracic Considered Experimental/Investigational ...... 17 Hot and Cold Packs No Longer Covered...... 17 Allergy Immunotherapy Criteria Revised ...... 18 Coverage Criteria Established for Paclitaxel, Albumin-Bound (Abraxane) ...... 19 Criteria Established for Eribulin Mesylate (Halaven) ...... 20 Criteria Revised for Urine Drug Testing (UDT)...... 21 Facility Now Applicable to Electromyography (EMG) ...... 22 Fecal Calprotectin Considered Experimental/Investigational ...... 22 Removal of Skin Lesions...... 23 Facility Applies to Suction Assisted Lipectomy...... 23 Guidelines Regarding HAART Therapy for AIDS Revised...... 23 Criteria Revised for Ocular Photodynamic Therapy and Transpupillary Thermotherapy...... 23 Artificial Intervertebral Discs Criteria Revised...... 25 New Policy Created for Discography ...... 26 Criteria Established for Transcatheter Mitral Valve Repair (TMVR)...... 27 Place of Service Added to Concurrent Care Policy...... 29 Comments on these new medical policies?...... 29

30 Medical Policy Update January 2015

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About this newsletter

Medical Policy Update is the monthly newsletter for most health care professionals (and office staff) and facilities who participate in our networks and submit claims to Highmark Delaware using the 837P HIPAA transaction or the CMS 1500 form, or the 837I HIPAA transaction. Medical Policy Update focuses only on medical policy and claims administration updates, including coding guidelines and procedure code revisions, and is the sole source for this information. For all other news, information and updates, be sure to read Provider News, available on the Provider Resource Center at www.highmarkbcbsde.com.

Inquiries about Eligibility, Benefits, Claims Status or Authorizations For inquiries about eligibility, benefits, claim status or authorizations, Highmark Blue Cross Blue Shield Delaware encourages providers to use the electronic resources available to them - Navinet® and the applicable HIPAA transactions – prior to placing a telephone call to the Provider Service Center at 1-800-346-6262.

Acknowledgement

The five-digit numeric codes that appear in Medical Policy Update were obtained from the Current Procedural Terminology (CPT), as contained in CPT- 2015, Copyright 2014, by the American Medical Association. Medical Policy Update includes CPT descriptive terms and numeric procedure codes and modifiers that are copyrighted by the American Medical Association. These procedure codes and modifiers are used for reporting medical services and procedures.