Lumbar Spine/Sacroiliac Fusion Surgery and Axial ... · Lumbar Spine/Sacroiliac Fusion Surgery and Axial-Lumbosacral Interbody Fusion. Highmark announced an August 31, 2015 effective

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Quantity Level Limits for Diabetic Test Strips and Lancets are Increased ................................................. 2Electrical Nerve Stimulation Updated........................................................................................................ 3Emergency Room, Emergency Medical Care/Urgent Care, and Emergency Accident Care PolicyDelayed .................................................................................................................................................... 9Change in Policy Position for In Vitro Chemoresistance and Chemosensitivity Assays........................... 11

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In This Issue

Highmark Blue Cross Blue Shield is an independent licensee of the Blue Cross and Blue Shield Association.te: This publication may contain certain administrative requirements, policies, procedures, or other similar requirements of Highmark Inc. (or changesereto) which are binding upon Highmark Inc. and its contracted providers. Pursuant to their contract, Highmark Inc. and such providers must comply

with any requirements included herein unless and until such item(s) are subsequently modified in whole or in part.

umbar Spine/Sacroiliac Fusion Surgery and Axial-Lumbosacral Interbodyusion Medical Policy Delayed until November 2015

ugust 31, 2015 EFFECTIVE DATE POSTPONED

ighmark Blue Cross Blue Shield is delaying the effective date of its revised Commercial Policy S-230,umbar Spine/Sacroiliac Fusion Surgery and Axial-Lumbosacral Interbody Fusion.

ighmark announced an August 31, 2015 effective date for Medical Policy S-230, Lumbar Spine/Sacroiliacusion Surgery and Axial-Lumbosacral Interbody Fusion in the June 2015 issue of Medical Policy Update;owever, this date has been postponed.

lease watch future editions of Medical Policy Update for more details about Highmark's Medical Policy S-30, Lumbar Spine/Sacroiliac Fusion Surgery and Axial-Lumbosacral Interbody Fusion

Policy

Medical Policy Update July 2015

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Additional Tests Added to Medical Policy L-34, Genetic Testing Delayed

July 27, 2015 EFFECTIVE DATE POSTPONED

Highmark Blue Cross Blue Shield is delaying the effective date of its revised CommercialPolicy, L-34 Genetic Testing.

Highmark announced a July 27, 2015 effective date for Medical Policy L-34, Genetic Testingin the May 2015 issue of Medical Policy Update; however, this date has been postponed.

Please watch future editions of Medical Policy Update for more details about Highmark'sMedical Policy L-34, Genetic Testing.

Quantity Level Limits for Diabetic Test Strips and Lancets are Increased

Highmark Blue Cross Blue Shield has increased the quantity level limits (QLL) for diabetictest strips. Quantity limits for test strips will apply to the professional provider. The effectivedate is Aug. 3, 2015.

Pediatric

Ages 12 years old and under:

Test strips - 300 per month and 900 every 90 days; and

Lancets - 300 per month and 900 every 90 days; or

Lens shield cartridge- one (1) every 1 month.

Adolescent/Adult

Ages 13 years and older:

Test strips - 204 up to 34 days and 612 every 35-90 days; and

Lancets - 204 up to 34 days and 612 every 35-90 days; or

Lens shield cartridge- one (1) every 1 month.

When ALL of the following criteria are met:

The equipment and supplies are prescribed by a physician;

The glucose monitor is covered;

The supplier of the test strips and lancets or lens shield cartridge maintains in itsrecords the order from the treating physician;

The member has nearly exhausted the supply of test strips and lancets or usefullife of one lens shield cartridge previously dispensed.

Refer to Medical Policy E-15, Diabetic Services and Supplies, for additional information.


3

Electrical Nerve Stimulation Updated

Highmark Blue Cross Blue Shield has updated clinical criteria for Electrical NerveStimulation. This updated criterion will apply to both professional provider and facility claims.The effective date is Nov. 30, 2015.

Replacement batteries are considered non-covered, and are not eligible for payment.

Place of Service: Outpatient

Criteria Revised for Devices Used in the Treatment of Obstructive SleepApnea in Adults

Highmark Blue Cross Blue Shield has established new clinical criteria for devices used inthe treatment of obstructive sleep apnea in adults. This new criteria will apply to bothprofessional provider and facility claims. The effective date isSept. 28, 2015.

Pre-fabricated over-the-counter (OTC) intra-oral appliances to treat OSA are not consideredto be appropriate therapy for OSA in any clinical situation and therefore are not covered. Anetwork provider can bill the member for the denied service.

Please refer to Medical Policy E-20 for further information.

Facility Applied to Acupuncture

Highmark Blue Cross Blue Shield Medical Policy Z-14, Acupuncture, will apply to bothprofessional provider and facility claims. The effective date is Sept. 28, 2015


For further information, refer to Medical Policy Z-14, Acupuncture.


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Criteria Revised for Interferon Alpha

Effective July 20, 2015, Highmark Blue Cross Blue Shield has revised the clinical criterionfor interferon alpha to reflect additional coverage for other medically accepted non-FDAapproved indications class 2b or higher, per the National Comprehensive Cancer Network(NCCN).

Additionally, the Hepatitis C recommendations have also been revised as follows:

Initial therapy with interferon alpha may be considered medically necessary inpatients with a diagnosis of chronic hepatitis C infection. The prescribing clinicianmust be a gastroenterologist, hepatologist, infectious diseases physician or a livertransplant physician.

For patients with Genotype 1:

Interferon alpha may be considered medically necessary if one of the following criteria ismet:

1. Interferon alpha is being used in combination with sofosbuvir (Sovaldi) and ribavirin.OR

2. Interferon alpha is being used in combination with telaprevir (Incivek) and ribavirin.OR

3. Interferon alpha is being used in combination with boceprevir (Victrelis) and ribavirin.OR

4. Interferon alpha is being used in combination with simeprevir (Olysio) and ribavirin. Ifthe patient is genotype 1a, coverage will be limited to members without Q80Kpolymorphism

Genotypes 2, 3, 4, 5

Interferon alpha may be considered medically necessary if one of the following criteria ismet:

1. Interferon alpha is being used in combination with sofosbuvir (Sovaldi) and ribavirinin treatment naïve patients or patients who have previously failed a regimencontaining interferon alpha and ribavirin.

Note:

Interferon alpha is not to be used with ledipasvir/sofosbuvir (Harvoni) orparitaprevir/ritonavir/ombitasvir + dasabuvir (Viekira Pak).

Interferon alpha is not to be used in members with Genotype 1 infection and previousfailure of an interferon alpha-containing regimen.


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Trastuzumab Coverage Criteria Revised

Highmark Blue Cross Blue Shield has revised the clinical criteria for trastuzumab(Herceptin®). These revised criteria will apply to both professional provider and facilityclaims. The effective date is Sept. 28, 2015.

Revisions include:

Human epidermal growth factor receptor 2 (HER-2)/neu protein overexpression verified by:

Positive FISH test ratio greater than 2.0; or Single-probe ISH test with average HER2 copy number 6.0 signals/cell or

greater; or Dual-probe ISH test HER2/CEP17 ratio 2.0 or greater; HER2/CEP17 ratio less than 2.0 AND average HER2 copy number 6.0

signals/cell or greater Trastuzumab (Herceptin®) may be considered medically necessary based on:

FDA approved indications National Comprehensive Care Network (NCCN). Breast Cancer Clinical

Practice Guidelines in Oncology; version 12.2015; NCCN Drugs & Biologics Compendium™ Guidelines; 2015.

Please see Medical Policy I-21, Trastuzumab (Herceptin) for more information.

Place of Service Added to Varicella Zoster Immune Globulin

Highmark Blue Cross Shield has established place of service for Varicella Zoster ImmuneGlobulin. The effective date is Sept. 28, 2015.


For further information, refer to Medical Policy G-42, Varicella Zoster Immune Globulin.


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Coverage Criteria Established for GAZYVA (obinutuzumab)

Highmark Blue Cross Blue Shield has established new clinical criteria for obinutuzumab(GAZYVA). This new criteria will apply to both professional provider and facility claims. Theeffective date is Sept. 28, 2015.

Obinutuzumab is a CD20-directed cytolytic antibody and is indicated, in combination withchlorambucil, for the treatment of patients with previously untreated chronic lymphocyticleukemia.

Obinutuzumab is considered experimental/investigational when the above criteria are notmet and for all other indications.


For further information refer to Medical Policy I-137, GAZYVA (obinutuzumab)

Alglucosidase Alfa (Lumizyme, Myozyme) Coverage Guidelines Updated

Effective Sept. 28, 2015, Highmark Blue Cross Blue Shield has updated the clinical criteriafor algucosidase alfa as follows:

Alglucosidase alfa (Myozyme® and Lumizyme®) are considered medically necessary inpatients with infant-onset Pompe disease (GAA deficiency) when all of the following are met:

Diagnosis of infantile-onset Pompe disease confirmed with acid alpha-glucosidasedeficiency (GAA) activity in skin fibroblasts of less than 1% of the normal mean; and

Evidence of hypertropic cardiomyopathy

Alglucosidase alfa (Lumizyme) is also considered medically necessary for patients with late-onset Pompe disease (GAA deficiency) when all of the following are met:

Diagnosis of Pompe disease based on:

GAA enzyme assay which shows reduced enzyme activity less than 1%(generally infants) to 2- 40%(partial deficiency of GAA non-infantile forms orlate onset forms) of the lab specific normal mean value; and

Confirmed by a second GAA enzyme activity assay in a separate sample(from purified lymphocytes or fibroblast [minimally invasive test] or muscle, [invasive testing]) or by a GAA gene sequencing; and

One or more clinical symptoms of Pompe disease are present such as:muscle weakness, respiratory insufficiency. (not an all-inclusive list) AND

Does not have evidence of cardiac hypertrophy


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Revised Criteria for Gemcitabine HCl (Gemzar)

Highmark Blue Cross Blue Shield has established new clinical criteria for Gemcitabine HCl(Gemzar®). This new criteria will apply to both professional provider and facility claims. Theeffective date is Sept. 28, 2015.

The revised policy contains medical necessity criteria, preferred agents, and chemotherapycombinations for the following conditions:

Bladder cancer Bone Cancer Breast Cancer Cervical Cancer Head and Neck Cancers (Nasopharyngeal) Hepatobiliary Cancers Hodgkin Lymphoma Kidney Cancer Malignant Pleural Mesothelioma Non-Hodgkin Lymphoma Non-Melanoma Skin Cancers Non-Small Cell Lung Cancer (NSCLC) Occult Primary Ovarian Cancer Pancreatic Adenocarcinoma Small Cell Lung Cancer (SCLC) Soft Tissue Sarcoma Testicular Cancer Thymomas and Thymic Carcinomas Uterine Neoplasms - Uterine Sarcoma

For further information refer to Medical Policy I-59, Gemcitabine HCl (Gemzar).


Facility Applies to KRAS and GNAS Mutation Analysis for Pancreatic Cyst

Highmark Blue Cross Blue Shield will apply both professional provider and facility claims toMedical Policy L-103, KRAS and GNAS Mutation Analysis for Pancreatic Cyst. The effectivedate is Sept. 28, 2015.



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New Policy Created for Brentuximab Vedotin (Adcetris)

Highmark Blue Cross Blue Shield has established new clinical criteria for brentuximabvedotin (Adcetris®). This new policy will apply to both professional provider and facilityclaims. The effective date is Sept. 28, 2015.

The following indications may be considered medically necessary for receiving brentuximabvedotin (Adcetris®) intravenous therapy:

Classical Hodgkin Lymphoma

Maintenance therapy following high-dose therapy and autologous stem cellrescue for primary refractory disease or relapse <12 months following primarytherapy in patients who have not received prior brentuximab vedotin, OR

Therapy as a single agent for patients who have failed high-dose therapy withautologous stem cell rescue or at least 2 prior multi-agent chemotherapyregimens

Non-Hodgkin Lymphoma

AIDS-Related B-Cell Lymphoma as second-line or subsequent therapy forrelapse of CD30+ AIDS-related diffuse large B-cell lymphoma, primary effusionlymphoma, and lymphoma associated with Castleman's disease in non-candidates for high-dose therapy, OR

Diffuse Large B-Cell Lymphoma as second-line or subsequent therapy forCD30+ relapsed or refractory disease in non-candidates for high-dose therapy,OR

Mycosis Fungoides (MF)/Sezary Syndrome (SS) as first-line chemotherapy for

Stage IA-IIA MF with histologic evidence of folliculotropic or large celltransformation or stage IIB with generalized extent tumor, transformed, and/orfolliculotropic disease with or without skin-directed therapy, or

Stage IV non-Sezary or visceral disease, or

Refractory or progressive stage III MF or SS, OR

Peripheral T-Cell Lymphoma as second-line or subsequent therapy for relapsedor refractory systemic anaplastic large cell lymphoma (ALCL) (excludingcutaneous ALCL) and for CD30+ peripheral T-cell lymphoma, OR

Primary Cutaneous B-Cell Lymphoma as second-line or subsequent therapy forCD30+ relapsed or refractory primary cutaneous diffuse large B-cell lymphoma,leg type in non-candidates for high-dose therapy, OR

Primary Cutaneous CD30+ T-Cell Lymphoproliferative Disorders for thefollowing:

Single-agent therapy for primary cutaneous anaplastic large cell lymphoma(ALCL) with multifocal lesions or cutaneous ALCL with regional nodes(excludes systemic ALCL) as

a. primary treatment, or

b. therapy for relapsed or refractory disease, OR


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Single-agent therapy for symptomatic lymphomatoid papulosis (LyP) or LyPwith extensive lesions if refractory to all primary treatment options.

The use of brentuximab vedotin (Adcetris) for any other indication not listed above isconsidered not medically necessary, and therefore, not covered.


For more information on brentuximab vedotin (Adcetris), please see Medical Policy I-136.

Coverage Criteria Established for Vimizim

Effective Sept. 28, 2015, Highmark Blue Cross Blue Shield has established clinical criteriafor VimizimTM (elosulfase alfa) and will apply it to professional provider and facility claims.

Vimizim (elosulfase alfa) may be considered medically necessary for patients with adocumented diagnosis of mucopolysaccharidosis type IVA (MPS IVA; Morquio A syndrome).


Emergency Room, Emergency Medical Care/Urgent Care, and EmergencyAccident Care Policy Delayed

The implementation date for Highmark Blue Cross Blue Shield Medical Policy Z-13,

Emergency Room, Emergency Medical Care/Urgent Care, and Emergency Accident Care,

has been delayed. Please look for updates in future issues of the MPU.

Facility Notification: Irinotecan (Camptosar)

Highmark Blue Cross Blue Shield Medical Policy I-109, Irinotecan (Camptosar®), will applyto both professional provider and facility claims effectiveSept. 28, 2015.


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New Policy Created for Ixabepilone (Ixempra)

Highmark Blue Cross Blue Shield has established new clinical criteria for Ixabepilone(Ixempra®). This new policy will apply to both professional provider and facility claims.The effective date is Sept. 28, 2015.

Ixabepilone may be considered medically necessary for ANY of the following:

As a single agent for recurrent or metastatic breast cancer human epidermal growthfactor receptor 2 (HER2)-negative disease:

with symptomatic visceral disease or visceral crisis, OR is hormone receptor-negative or hormone receptor-positive and endocrine

therapy refractory, OR As monotherapy for locally advanced or metastatic breast cancer, in patients whose

tumors are resistant or refractory to anthracyclines, taxanes, and capecitabine, OR In combination with capecitabine for locally advanced or metastatic breast cancer, in

patients who are taxane- or anthracycline-resistant, or taxane-resistant with acontraindication to anthracyclines.


Please refer to Medical Policy I-133 for more information.

Clinical Criteria Revised for the Treatment of Gaucher Disease

Effective July 20, 2015,Highmark Blue Cross Blue Shield has revised the clinical criteria toMedical Policy I-9, Treatment of Gaucher Disease.

Previously Taliglucerase alfa (Elelyso) was only used in adult patients but due to new FDAindications, it is now used with pediatric patients as well.


Facility Notification: Proton Beam Radiation Therapy Treatment Delivery

Highmark Blue Cross Blue Shield Medical Policy R-18, Proton Beam Radiation TherapyTreatment Delivery, will apply to both professional provider and facility claims. The effectivedate is Sept. 28, 2015.


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Change in Policy Position for In Vitro Chemoresistance and ChemosensitivityAssays

Highmark Blue Cross Blue Shield has changed their policy position for in vitro

chemoresistance and chemosensitivity assays. These types of assays will be considered

experimental/investigational.

This policy will apply to both professional provider and facility claims. The effective date is

Sept. 28, 2015.

In vitro chemosensitivity assays, including, but not limited to, the Histoculture Drug

Response Assay (HDRA), a fluorescent cytoprint assay, the ChemoFx assay, or the

CorrectChemo assay, are considered experimental/investigational and therefore non-

covered.

Evidence from available studies is insufficient to conclude that in vitro chemosensitivity

testing leads to improved health management or outcomes. The majority of studies reported

no survival benefit associated with chemotherapy based on chemosensitivity assays when

compared to chemotherapy based on standard regimens

In vitro chemoresistance assays, including, but not limited to, Extreme Drug Resistance

(EDR) assays, are considered experimental/investigational and therefore non-covered.

Few clinical studies have investigated the value of chemoresistance assays for the selection

of chemotherapy. The literature contains only a limited number of randomized controlled

trials evaluating the survival rate of individuals treated with assay-directed regimens

compared with that of a control group treated with standard regimens.

For further information, refer to Medical Policy L-58, In Vitro Chemoresistance and

Chemosensitivity Assays.

New Policy for Galsulfase (Naglazyme)

Highmark Blue Cross Blue Shield has established new clinical criteria for galsulfase(Naglazyme®) for the treatment of mucopolysaccharidosis VI (MPS VI, Maroteaux-Lamysyndrome). This new criteria will apply to both professional provider and facility claims. Theeffective date is Sept. 28, 2015.


A galsulfase (Naglazyme) injection is typically an outpatient service which is only eligible forcoverage as an inpatient service in special circumstances including, but not limited to thepresence of a co-morbid condition that would require monitoring in a more controlledenvironment such as the inpatient setting.

Please see Medical Policy I-140, galsulfase (Naglazyme) for more information.


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Criteria Revised for Auditory Brainstem Implants and Magnetic Bone-Conduction Hearing Systems

Highmark Blue Cross Blue Shield has established new clinical criteria for partiallyimplantable magnetic bone-conduction hearing systems and auditory brainstem implants.The effective date is Sept. 28, 2015.

Partially implantable magnetic bone-conduction hearing systems using magnetic coupling foracoustic transmission (e.g., Otomag Alpha 1 and BAHA Attract) are consideredexperimental/investigational and therefore, not covered.

Auditory brainstem implants (ABI) (L8699, S2235, and 92640) are devices that replace thefunction of the auditory nerve (cranial nerve VIII).

Unilateral use of an auditory brainstem implant (using surface electrodes on the cochlearnuclei) may be considered medically necessary in patients with neurofibromatosis type II,12 years of age or older, who are rendered deaf due to bilateral resection of neurofibromasof the auditory nerve.

An auditory brainstem implant is considered experimental/investigational and therefore, notcovered for any other condition than listed above, including non-neurofibromatosis type 2indications.

Bilateral use of an auditory brainstem implant is considered experimental/investigational,and therefore, not covered as there are inadequate data to permit scientific conclusionsregarding its efficacy.

Table: Usual medically necessary frequency of replacement parts for BAHA and ABI

Replacement Parts # Considered Medically Necessary

Headband 1 per year

Processor replacement (L8691) 1 per 5 years

Quantities of supplies that exceed the frequency guidelines listed on the policy will be deniedas non-covered.

For more information, please refer to Medical Policy S-9, Hearing Aids and AudiologicalTesting.


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Additional Coverage Criteria for Biventricular Pacemakers for Treating HeartFailure

Highmark Blue Cross Blue Shield has established additional clinical criteria for biventricularpacemakers. The effective date is Sept. 28, 2015.

For patients who do not meet the existing criteria of the policy, but who have an indicationfor a biventricular pacemakers with or without an accompanying implantable cardiacdefibrillator (i.e., a combined biventricular pacemaker/ICD) may be considered medicallynecessary as an alternative to a right ventricular pacemaker in patients who meet ALL of thefollowing criteria:

NYHA class I, II, III, or IV heart failure; Left ventricular ejection fraction ≤50%; The presence of atrioventricular (AV) block with requirement for a high percentage of

ventricular pacing**; AND Patients treated with guideline-directed medical therapy

**AV block with a requirement for a high percentage of ventricular pacing is considered tobe present when there is either:

3rd degree AV block; or 2nd degree AV block or a PR interval of 300 ms or more when paced at 100 beats

per minute.

Biventricular pacemakers, with or without an accompanying implantable cardiac defibrillator(i.e., a combined biventricular pacemaker/ICD), are considered experimental/investigationalas a treatment for heart failure in patients with atrial fibrillation who do not meet the abovecriteria.

Triple-site (triventricular) CRT, using an additional pacing lead, is considered experimental/investigational.

For more information, please see Medical Policy S-153.

Facility Now Applicable to Hematopoietic Stem-Cell Transplantation for SolidTumors of Childhood

Highmark Blue Cross Blue Shield Medical Policy S-221, Hematopoietic Stem-CellTransplantation for Solid Tumors of Childhood, will apply to both professional provider andfacility claims effective Sept. 28, 2015.


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New Criteria Established for Carotid Artery Angioplasty With or WithoutStenting

Highmark Blue Cross Blue Shield has established new clinical criteria for intracranial andextracranial angioplasty with or without stenting. The effective date is Sept. 28, 2015.

Medical Policy S-182, Carotid Angioplasty with Stenting, is being archived and its criteriamoved to Medical Policy S-200. Some of the new or revised criteria is as follows:

Intracranial stent placement may be considered medically necessary as part of theendovascular treatment of intracranial aneurysms for patients when surgical treatment is notappropriate and standard endovascular techniques do not allow for complete isolation of theaneurysm, e.g., wide-neck aneurysm (≥4 mm) or sack-to-neck ratio less than 2:1.

Intracranial flow diverting stents with FDA approval for the treatment of intracranialaneurysms may be considered medically necessary as part of the endovascular treatmentof intracranial aneurysms that meet anatomic criteria and are not amenable to surgicaltreatment or standard endovascular therapy.

Anatomic criteria: Flow-diverting stents are indicated for the treatment of large or giant wide-necked intracranial aneurysms, with a size of 10 mm or more and a neck diameter of 4 mmor more, in the internal carotid artery from the petrous to the superior hypophysealsegments.

Intracranial stent placement is considered experimental/investigational in the treatment ofintracranial aneurysms except as noted above.

Intracranial percutaneous transluminal angioplasty with or without stenting is consideredexperimental/investigational in the treatment of atherosclerotic cerebrovascular disease.

Endovascular interventions (mechanical embolectomy, angioplasty, stenting) are consideredexperimental/investigational in the treatment of acute stroke.

Endovascular therapy, including percutaneous transluminal angioplasty with or withoutstenting, is considered experimental/investigational for the management of extracranialvertebral artery disease.

For more information, please refer to Medical Policy S-200, Intracranial and ExtracranialAngioplasty With or Without Stenting.


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Compounded Medications are Considered Experimental/Investigational

Highmark Blue Cross Blue Shield has developed a new medical policy to addresscompounded medications This new medical policy will apply to both professional providerand facility claims. The effective date is Sept. 28, 2015.

Compounded medications are considered experimental/investigational. Compoundedbioidentical hormone replacement therapy (BHRT) is consideredexperimental/investigational. Compounded drugs are not FDA-approved. Therefore, theFDA does not verify their safety, or effectiveness.

Note: This medical policy does not apply to intravitreal injections of Bevacizumab(Avastin®). For more information, refer to Medical Policy I-94.

Place of Service: Inpatient/Outpatient

Refer to Medical Policy I-141 for more information on compounded medications.

Criteria Revised for Electroencephalogram (EEG) Technologies

Highmark Blue Cross Blue Shield has revised clinical criteria for Electroencephalogram

(EEG) Technologies. The revised criteria will apply to both professional provider and facility

claims. The effective date for the revised criteria is

Sept. 28, 2015.

Digital analysis of electroencephalogram (DEEG) is considered not medically necessary as

there is no evidence that such additional processing and interpretation has been shown to

improve outcomes in patient management.

Telephone transmission of the EEG to determine electrocerebral silence, i.e., brain death, is

considered experimental/investigational.

Quantitative electroencephalographic-based assessment (QEEG) is considered

experimental/investigational when used as a diagnostic aid for attention deficit/hyperactivity

disorder.

Place of Service: Inpatient/Outpatient

For further information, refer to Medical Policy M-34, Electroencephalogram (EEG)Technologies.


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Ultrasound Guidance Limitation

Effective Sept. 28, 2015, Highmark Blue Cross Blue Shield has limited ultrasound guidanceto 1 per date of service, per provider and will apply it to professional provider and facilityclaims.


Please refer Medical Policy Z-52, Pain Management of Peripheral Nerves by Injection formore information.

New Policy for Velcade (bortezomib)

Highmark Blue Cross Blue Shield has established new clinical criteria for Velcade(bortezomib). This new criteria will apply to both professional provider and facility claims.The effective date is Sept. 28, 2015.

Bortezomib (Velcade®) is a proteasome inhibitor, which is used for targeted antineoplastictherapy.

For further information refer to Medical Policy I-83, Velcade (bortezomib)



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overage Criteria Established for Ustekinumab (Stelara)

Highmark Senior Health Company’s Medicare Advantage products have established criteriafor Ustekinumab (Stelara®). This new policy applies to both professional provider andfacility claims and became effective: Sept. 28, 2015.

Ustekinumab (Stelara) is a human interleukin-12 and -23 antagonist, may be consideredmedically necessary in adult patients (18 years or older) for the following indications:

Treatment of moderate to severe plaque psoriasis (PsO) in a member who is acandidate for phototherapy or systemic therapy

Treatment of active psoriatic arthritis (PsA), alone or in combination withmethotrexate.

Treatment of moderate to severe Crohn's disease in patients who are, resistant totumor necrosis factor (TNF) antagonists.

The use of Ustekinumab (Stelara) is considered not medically necessary for all otherindications.

For further information, please refer to Medicare Advantage Medical Policy I-139,

Ustekinumab (Stelara).

overage Criteria Established for Idursulfase (Elaprase)

Highmark Senior Health Company's Medicare Advantage products have established newclinical criteria for Idursulfase (Elaprase®). This new Medicare Advantage Medical Policywill apply to both professional provider and facility claims. The effective date isSept. 28, 2015.

Idursulfase (Elaprase) may be considered medically necessary in patients with Huntersyndrome (Mucopolysaccharidosis II, MPS II).

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

For further information, refer to Medicare Advantage Medical Policy I-93, Idursulfase(Elaprase).

Medicare Advantage Policy


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New Policy for Agalsidase beta (Fabrazyme)

Highmark Senior Health Company's Medicare Advantage products have established newclinical criteria for Agalsidase beta (Fabrazyme®).This new criteria will apply to bothprofessional provider and facility claims. The effective date is Sept. 28, 2015.

Agalsidase beta (Fabrazyme) reduces globotriaosylceramide (GL-3) deposition in thecapillary endothelium of the kidney and certain other cell types in individuals with adiagnosis of Fabry Disease.

The use of agalsidase beta for any indication other than Fabry disease, will be denied asnot medically necessary.

For further information, refer to Medicare Advantage Medical Policy I-132, Agalsidase beta(Fabrazyme).

Coverage Criteria Established for Ixabepilone (Ixempra)

Highmark Senior Health Company’s Medicare Advantage products have established newclinical criteria for Ixabepilone (Ixempra®). This new policy will apply to both professionalprovider and facility claims. The effective date is Sept. 28, 2015.

Ixabepilone may be considered medically necessary for ANY of the following:

As a single agent for recurrent or metastatic breast cancer human epidermal growthfactor receptor 2 (HER2)-negative disease:

with symptomatic visceral disease or visceral crisis, OR is hormone receptor-negative or hormone receptor-positive and endocrine

therapy refractory, OR As monotherapy for locally advanced or metastatic breast cancer, in patients whose

tumors are resistant or refractory to anthracyclines, taxanes, and capecitabine, OR In combination with capecitabine for locally advanced or metastatic breast cancer, in

patients who are taxane- or anthracycline-resistant, or taxane-resistant with acontraindication to anthracyclines.

Ixabepilone and other medically accepted non-FDA approved indications, Class IIb or highergrade recommendation:

Hormone refractory metastatic prostate cancer.

Ixabepilone is considered not medically necessary for all other indications.

Please refer to Medicare Advantage Medical Policy I-133, for more information.


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New Policy Created for Brentuximab Vedotin (Adcetris)

Highmark Senior Health Company's Medicare Advantage products have established newclinical criteria for brentuximab vedotin (Adcetris®). This new policy will apply to bothprofessional provider and facility claims. The effective date is Sept. 28, 2015.

The following indications may be considered medically necessary for receiving brentuximabvedotin (Adcetris) intravenous therapy:

Classical Hodgkin Lymphoma

Maintenance therapy following high-dose therapy and autologous stem cellrescue for primary refractory disease or relapse <12 months following primarytherapy in patients who have not received prior brentuximab vedotin, OR

Therapy as a single agent for patients who have failed high-dose therapy withautologous stem cell rescue or at least 2 prior multi-agent chemotherapyregimens

Non-Hodgkin Lymphoma

AIDS-Related B-Cell Lymphoma as second-line or subsequent therapy forrelapse of CD30+ AIDS-related diffuse large B-cell lymphoma, primaryeffusion lymphoma, and lymphoma associated with Castleman's disease innon-candidates for high-dose therapy, OR

Diffuse Large B-Cell Lymphoma as second-line or subsequent therapy forCD30+ relapsed or refractory disease in non-candidates for high-dosetherapy, OR

Mycosis Fungoides (MF)/Sezary Syndrome (SS) as first-line chemotherapyfor

Stage IA-IIA MF with histologic evidence of folliculotropic or large celltransformation or stage IIB with generalized extent tumor,transformed, and/or folliculotropic disease with or without skin-directedtherapy, or

Stage IV non-Sezary or visceral disease, or

Refractory or progressive stage III MF or SS, OR

Peripheral T-Cell Lymphoma as second-line or subsequent therapy forrelapsed or refractory systemic anaplastic large cell lymphoma (ALCL)(excluding cutaneous ALCL) and for CD30+ peripheral T-cell lymphoma, OR

Primary Cutaneous B-Cell Lymphoma as second-line or subsequent therapyfor CD30+ relapsed or refractory primary cutaneous diffuse large B-celllymphoma, leg type in non-candidates for high-dose therapy, OR

Primary Cutaneous CD30+ T-Cell Lymphoproliferative Disorders for thefollowing:

Single-agent therapy for primary cutaneous anaplastic large celllymphoma (ALCL) with multifocal lesions or cutaneous ALCL withregional nodes (excludes systemic ALCL) as

c. primary treatment, or


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d. therapy for relapsed or refractory disease, OR

Single-agent therapy for symptomatic lymphomatoid papulosis (LyP)or LyP with extensive lesions if refractory to all primary treatmentoptions.

The use of brentuximab vedotin (Adcetris) for any other indication not listed above isconsidered not medically necessary, and therefore, not covered.

For further information, refer to Medicare Advantage Medical Policy I-136, BrentuximabVedotin (Adcetris).

New Policy for Galsulfase (Naglazyme)

Highmark Senior Health Company's Medicare Advantage products have established newclinical criteria for galsulfase (Naglazyme®) for the treatment of mucopolysaccharidosis VI(MPS VI, Maroteaux-Lamy syndrome). This new criteria will apply to both professionalprovider and facility claims. The effective date is Sept. 28, 2015. \

Please see Medical Policy I-140, galsulfase (Naglazyme) for more information.

New Policy for GAZYVA (obinutuzumab)

Highmark Senior Health Company's Medicare Advantage products have established newclinical criteria for obinutuzumab (GAZYVA). This new criteria will apply to both professionalprovider and facility claims. The effective date is Sept. 28, 2015.

Obinutuzumab is a CD20-directed cytolytic antibody and is indicated, in combination withchlorambucil, for the treatment of patients with previously untreated chronic lymphocyticleukemia.

Obinutuzumab is considered not medically necessary when the above criteria are not metand for all other indications.

For further information, refer to Medicare Advantage Medical Policy I-137, GAZYVA(obinutuzumab).


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New Policy for Plerixafor (Mozobil)

Highmark Senior Health Company's Medicare Advantage products have established newclinical criteria for Plerixafor (Mozobil™). This new policy will apply to both professionalprovider and facility claims. The effective date is Sept. 28, 2015.

Plerixafor (Mozobil) may be considered medically necessary when ALL the following aremet:

Used in combination with granulocyte-colony stimulating factor (G-CSF) to mobilizehematopoietic stem cells to the peripheral blood for collection and subsequentautologous transplantation; and

Diagnosed with multiple myeloma or non-Hodgkin's lymphoma

Please refer to Medicare Advantage Medical Policy I-79, for more information on Plerixafor(Mozobil).

New Policy for Vimizim (elosulfase alfa)

Highmark Senior Health Company's Medicare Advantage products have established newclinical criteria for VimizimTM (elosulfase alfa). This new policy will apply to both professionalprovider and facility claims. The effective date is Sept. 28, 2015.

Vimizim (elosulfase alfa) may be considered medically necessary for the treatment ofMucopolysaccharidosis type IVA (MPS IVA; Morquio A syndrome).

Please refer to Medicare Advantage Medical Policy I-138, for more information on Vimizim(elosulfase alfa).

New Policy for Velcade (bortezomib)

Highmark Senior Health Company's Medicare Advantage products have established newclinical criteria for Velcade (bortezomib). This new criteria will apply to both professionalprovider and facility claims. The effective date is Sept. 28, 2015.

Bortezomib (Velcade®) is a proteasome inhibitor, which is used for targeted antineoplastictherapy.

For further information, refer to Medicare Advantage Medical Policy I-83,

Velcade (bortezomib).


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Clinical Criteria Established for Alglucosidase alfa (Lumizyme, Myozyme)

Highmark Senior Health Company's Medicare Advantage products have established clinicalcriteria for the use of Alglucosidase alfa (Lumizyme®, Myozyme®). This new MedicareAdvantage Medical Policy will apply to both professional and facility claims. The effectivedate is Sept. 28, 2015.

Alglucosidase alfa (Lumizyme and Myozyme) for intravenous infusion may be medicallynecessary (GAA deficiency) when:

Patient has a diagnosis of infant-onset Pompe disease AND

Evidence of cardiac hypertrophy

Alglucosidase alfa (Lumizyme) for intravenous infusion for patients with late-onset Pompedisease (GAA deficiency) may also be medically necessary when all of the following aremet:

Does not have evidence of cardiac hypertrophy.

Per the Food and Drug Administration (FDA), Myozyme has been shown to improveventilator-free survival in patients with infantile-onset Pompe disease as compared tountreated historical control, whereas use of Myozyme in patients with other forms of Pompedisease has not been adequately studied to assure safety and efficacy.

The following Medicare Advantage medical policies have now been applied tofacility processing:

PolicyNumber

Medicare AdvantageMedical Policy Title

EffectiveDate

N-6 Nesiritide for Treatment of Heart Failure Patients July 6, 2015N-7 Home Prothrombin Time INR Monitoring for

Anticoagulation ManagementJune 22, 2015.

N-15 Diabetes Self-Management Training (DSMT) June 29, 2015N-18 Vertebral Artery Surgery and Extracranial-Intracranial

Arterial Bypass SurgeryJuly 6, 2015

N-25 Displacement Cardiokymography (CKG) June 29, 2015N-35 Gamma Glutamyl Transferase July 13, 2015N-38 Partial Thromboplastin Time July 13, 2015N-44 Glycated Hemoglobin/Glycated ProteiN July 6, 2015N-48 Carcinoembryonic Antigen June 29, 2015N-55 Implanted Peripheral Nerve Stimulator July 6, 2015N-56 Blood Counts June 22, 2015N-70 Alpha-Fetoprotein June 22, 2015N-71 Fecal Blood Occult July 6, 2015N-72 Collagen Crosslinks, Any Method June 29, 2015N-73 Human Chorionic Gonadotropin July 6, 2015N-74 Hepatitis Panel July 6, 2015N-75 Human Immunodeficiency Virus Testing (Diagnosis) July 20, 2015


23

N-76 Human Immunodeficiency Virus Testing (PrognosisIncluding Monitoring)

July 6, 2015

N-81 Lymphocyte Mitogen Response Assays July 6, 2015N-83 Diagnostic Ultrasound Procedure June 29, 2015N-86 Percutaneous Electrical Nerve Stimulation (PENS) July 13, 2015N-90 Cardiac Pacemakers June 22, 2015N-94 CT Scans June 29, 2015N-97 Outpatient Intravenous Insulin Treatment (Therapy)

ProgramsJuly 13, 2015

N-102 Aprepitant for Chemotherapy-Induced Emesis June 22, 2015N-104 Anti-Cancer Chemotherapy for Colorectal Cancer June 22, 2015N-107 Levocarnitine for Use in the Treatment of Carnitine

Deficiency in ESRD PatientsJuly 6, 2015

N-110 Endothelial Cell Photography June 29, 2015N-111 Diagnostic Pap Smears June 29, 2015N-136 Porcine Skin and Gradient Pressure Dressings July 13, 2015N-137 Electroencephalographic Monitoring During Surgical

Procedures Involving the Cerebral VasculatureJune 29, 2015

N-146 Histocompatibility Testing July 6, 2015N-148 Induced Lesions of Nerve Tracts July 6, 2015N-152 Artificial Hearts and Related Devices June 22, 2015N-153 Deep Brain Stimulation for Essential Tremor and

Parkinson’s DiseaseJune 29, 2015

N-155 Home Health Nurses’ Visits to Patients RequiringHeparin Injection

July 6, 2015

N-158 Intensive Behavioral Therapy for CardiovascularDisease

July 6, 2015

N-160 Chemical Aversion Therapy for Treatment of Alcoholism July 27, 2015N-162 Laboratory Tests for Chronic Renal Disease (CRD)

PatientsJuly 6, 2015

N-174 Outpatient Physical Medicine and RehabilitationServices, PT and OT

July 13, 2015

N-193 Pharmacogenomic Testing for Warfarin Response July 13, 2015N-197 Coverage of Kidney Disease Patient Education Services June 29, 2015N-198 Dimethyl Sulfoxide (DMSO) June 29, 2015N-199 Outpatient Hospital Pain Rehabilitation Programs July 13, 2015N-201 Challenge Ingestion Food Testing June 29, 2015N-207 Blood Platelet Transfusions June 22, 2015N-209 Carotid Body Resection/Carotid Body Denervation June 29, 2015N-213 Injection Sclerotherapy for Esophageal Bleeding July 6, 2015N-214 Implantation of Gastroesophageal Reflux Device July 6, 2015N-61 Noncontact Normothermic Wound Therapy (NNWT) July 13, 2015O-19 Ostomy Supplies June 22, 2015O-26 Refractive Lenses June 29, 2015S-40 Implantable Infusion Pump June 29, 2015


24

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].

mailto:[email protected]


25

Contents

Quantity Level Limits for Diabetic Test Strips and Lancets are Increased..................................................................... 2

Criteria Revised for Devices Used in the Treatment of Obstructive Sleep Apnea in Adults ........................................ 3

Facility Applied to Acupuncture .......................................................................................................................................... 3

Criteria Revised for Interferon Alpha .................................................................................................................................. 4

Trastuzumab Coverage Criteria Revised............................................................................................................................ 5

Place of Service Added to Varicella Zoster Immune Globulin ......................................................................................... 5

Coverage Criteria Established for GAZYVA (obinutuzumab)........................................................................................... 6

Alglucosidase Alfa (Lumizyme, Myozyme) Coverage Guidelines, Updated .................................................................. 6

Revised Criteria for Gemcitabine HCl (Gemzar) ................................................................................................................ 7

Facility Applies to KRAS and GNAS Mutation Analysis for Pancreatic Cyst ................................................................. 7

New Policy Created for Brentuximab Vedotin (Adcetris).................................................................................................. 8

Coverage Criteria Established for Vimizim ........................................................................................................................ 9

Emergency Room, Emergency Medical Care/Urgent Care, and Emergency Accident Care Policy Delayed .............. 9

Facility Notification: Irinotecan (Camptosar) ..................................................................................................................... 9

Clinical Criteria Revised for the Treatment of Gaucher Disease ................................................................................... 10

Facility Notification: Proton Beam Radiation Therapy Treatment Delivery .................................................................. 10

Criteria Revised for Auditory Brainstem Implants and Magnetic Bone-Conduction Hearing Systems..................... 12

Additional Coverage Criteria for Biventricular Pacemakers for Treating Heart Failure .............................................. 13

Facility Now Applicable to Hematopoietic Stem-Cell Transplantation for Solid Tumors of Childhood .................... 13

New Criteria Established for Carotid Artery Angioplasty With or Without Stenting.................................................... 14

Coverage Criteria Established for Ustekinumab (Stelara).............................................................................................. 17

Coverage Criteria Established for Idursulfase (Elaprase) .............................................................................................. 17

New Policy for Agalsidase beta (Fabrazyme)................................................................................................................... 18

Coverage Criteria Established for Ixabepilone (Ixempra)............................................................................................... 18

New Policy Created for Brentuximab Vedotin (Adcetris)................................................................................................ 19

New Policy for GAZYVA (obinutuzumab) ......................................................................................................................... 20

New Policy for Plerixafor (Mozobil)................................................................................................................................... 21

New Policy for Vimizim (elosulfase alfa) .......................................................................................................................... 21

Clinical Criteria Established for Alglucosidase alfa (Lumizyme, Myozyme) ................................................................ 22

The following Medicare Advantage Medical Policies have now been applied to facility processing:....................... 22

Comments on these new medical policies?..................................................................................................................... 24


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edical Policy Update is the monthly newsletter for most health care professionals (and office staff) and facilities who participate in our networks and

bmit claims to Highmark using the 837P HIPAA transaction or the CMS 1500 form, or the 837I HIPAA transaction.

edical Policy Update focuses only on medical policy and claims administration updates, including coding guidelines and procedure code revisions, andthe sole source for this information. For all other news, information and updates, be sure to read Provider News, available on the Provider Resource

enter at www.highmarkbcbs.com.

quiries about Eligibility, Benefits, Claims Status or Authorizations

r inquiries about eligibility, benefits, claim status or authorizations, Highmark Blue Cross Blue Shield encourages providers to use the electronic

sources available to them - Navinet® and the applicable HIPAA transactions – prior to placing a telephone call to the Provider Service Center at

800-242-0514.

cknowledgement

e five-digit numeric codes that appear in Medical Policy Update were obtained from the Current Procedural Terminology (CPT), as contained in CPT-

15, Copyright 2014, by the American Medical Association. Medical Policy Update includes CPT descriptive terms and numeric procedure codes and

odifiers that are copyrighted by the American Medical Association. These procedure codes and modifiers are used for reporting medical services and

ocedures.

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