October MPU CENTRAL FINAL 2020.Docx

October 2020

In This Issue

Coverage Guidelines Revised for Bendamustine (Treanda, Bendeka, Belrapzo)...... 2 Coverage Guidelines Developed for Brexucabtagene Autoleucel (Tecartus) ...... 5 Updated Criteria for Tumor Treatment Fields...... 7

Contents...... 17

Policy

Coverage Guidelines Revised for Cetuximab (Erbitux)

Highmark Blue Shield has revised criteria for cetuximab (Erbitux®).

The coverage position for basal cell skin cancer has been removed due to updates to the National Comprehensive Cancer Network (NCCN) recommendations.

This revised Medical Policy will apply to professional providers and facility claims. The effective date is December 28, 2020

Place of Service: Outpatient

Please refer to Medical Policy I-100, Cetuximab (Erbitux), for additional information.

Highmark Blue Shield is an independent licensee of the Blue Cross and Blue Shield Association. Note: This publication may contain certain administrative requirements, policies, procedures, or other similar requirements of Highmark Inc. (or changes thereto) 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. Medical Policy Update October 2020

Coverage Guidelines Revised for Bendamustine (Treanda, Bendeka, Belrapzo)

Highmark Blue Shield has revised the criteria for bendamustine (Treanda®, Bendeka®, Belrapzo™).The following revisions are being made based upon updates to the NCCN recommendations:

o Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma (CLL/SLL): . Removal of treatment in frail individuals with significant comorbidities; . Removal of with or without statement around del(17p)/TP53 mutation; o Non-Gastric MALT Lymphoma: . Removal of therapy as a single agent for second-line and subsequent therapy for refractory or progressive disease.

This revised Medical Policy will apply to professional providers and facility claims. The effective date is December 28, 2020.

Place of Service: Outpatient

Please refer to Medical Policy I-98 Bendamustine (Treanda, Bendeka, Belrapzo), for additional information.

Coverage Guidelines Revised for Ado-Trastuzumab Emtansine (Kadcyla)

Highmark Blue Shield has revised the criteria for ado-trastuzumab emtansine (Kadcyla®).

• Ado-trastuzumab emtansine (Kadcyla) may be considered medically necessary as adjuvant systemic therapy for individuals with HER2-positive invasive breast cancer and locally advanced clinical stage T2 or greater, M0 or N1 or greater, M0 disease following completion of planned chemotherapy and following mastectomy or lumpectomy with surgical axillary staging if EITHER of the following: o ypT1-4N0 or residual disease; or o ypN is 1 or greater or node positive.

This revised Medical Policy will apply to professional providers and facility claims. The effective date is December 28, 2020.

Place of Service: Outpatient

Please refer to Medical Policy I-113, Ado-trastuzumab emtansine (Kadcyla), for additional information.

2 Medical Policy Update October 2020

Coverage Guidelines Revised for Erbulin Mesylate (Halaven)

Highmark Blue Shield has revised criteria for Erbulin Mesylate (Halaven®) to align with current NCCN Recommendations for soft tissue sarcoma to include the following: Treatment as: • Single agent palliative therapy as subsequent lines of therapy for advanced/metastatic soft tissue sarcoma of the extremity/superficial trunk, head/neck with disseminated metastases; or • Subsequent lines of therapy for advanced/metastatic pleomorphic rhabdomyosarcoma as a single agent; or • Single-agent palliative treatment as subsequent lines of therapy for recurrent unresectable or stage IV retroperitoneal/intra-abdominal soft tissue sarcoma; or • Single agent palliative therapy for soft tissue angiosarcoma; or • Single agent therapy for the treatment of solitary fibrous tumor; or • Single agent therapy for the treatment of undifferentiated pleomorphic sarcoma (UPS).

This revised Medical Policy will apply to professional providers and facility claims. The effective date is December 28, 2020.

Place of Service:

Please refer to Medical Policy I-119, Erbulin Mesylate (Halaven), for additional information.

3 Medical Policy Update October 2020

Reauthorization Criteria Added to Eculizumab (Soliris) and Ravulizumab-cwvz (Ultomiris) for Paroxysmal Nocturnal Hemoglobinuria (PNH)

Highmark Blue Shield has developed reauthorization criteria for eculizumab (Soliris®) and ravulizumab-cwvz (UltomirisTM) for paroxysmal nocturnal hemoglobinuria (PNH).The reauthorization criteria requires individual to be previously treated with eculizumab (Soliris) or ravulizumab (Ultomiris) and ONE of the following: • LDH level less than 1.5 times the upper limit of normal; or • Normalization of PNH type III red blood cells (granulocyte or monocyte clone size); or • Stabilization of hemoglobin levels: or • Improvement in previously reported signs and symptoms of PNH (e.g., decreased fatigue, improvement in shortness of breath, etc.). This revised Medical Policy will apply to professional providers and facility claims. The effective date will be December 28, 2020.

Place of Service:

Please refer to Medical Policy I-130, Eculizumab (Soliris) and Ravulizumab (Ultomiris), for additional information.

4 Medical Policy Update October 2020

Coverage Guidelines Developed for Brexucabtagene Autoleucel (Tecartus) Highmark Blue Shield has developed coverage criteria for Brexucabtagene Autoleucel (TecartusTM) to include the following: Brexucabtagene autoleucel (Tecartus) may be considered medically necessary when the following is met: Mantle Cell Lymphoma (MCL) • Individual 18 years of age or older; and • Individual diagnosed with MCL; and • Individual diagnosed with relapsed or refractory disease; and • Disease progression following last regimen or refractory to most recent therapy [previous therapy must include a Bruton’s tyrosine kinase (BTK) inhibitor (e.g., ibrutinib, zanubrutinib, acalabrutinib) unless contraindicated]; and • Individual has not previously received prior allogeneic hematopoietic stem cell transplant (HSCT); and • No detectable cerebrospinal fluid malignant cells or brain metastases; and • No history of central nervous system (CNS) lymphoma or CNS disorders. Out of specification product administration is considered experimental/investigational and, therefore, non-covered for ANY indication. There is insufficient scientific evidence to support its effectiveness and safety for ANY indication. Additional infusions of brexucabtagene autoleucel (Tecartus) or infusion of alternative CAR- T products after an initial infusion of one product are considered experimental/investigational and therefore, non-covered. Scientific evidence does not support more than one (1) dose of a single CAR-T product per lifetime. This revised Medical Policy will apply to professional providers and facility claims. The effective date was September 7, 2020.

Place of Service:

Please refer to Medical Policy I-180, Chimeric Antigen Receptor T-Cell Therapy, for additional information.

5 Medical Policy Update October 2020

Coverage Guidelines Established for Tafasitamab-cxix (Monjuvi)

Highmark Blue Shield has established new guidelines for Tafasitamab-cxix (Monjuvi®) to align with Food and Drug Administration (FDA) indications and NCCN recommendations.

This new Medical Policy will apply to professional providers and facility claims. The effective date was September 21, 2020.

Please refer to Medical Policy I-226, Tafasitamab-cxix (Monjuvi), for additional information.

Place of Service: Outpatient

Coverage Guidelines Revised for Medical Policy, M-34, Electroencephalogram (EEG) Technologies Highmark Blue Shield has established new clinical criteria for M-34, Electroencephalogram (EEG) Technologies. These new criteria will apply to both professional provider and facility claims. The effective date is December 28, 2020.

Place of Service: Inpatient/Outpatient

Please refer to Medical Policy M-34, Electroencephalogram (EEG) Technologies, for additional information.

6 Medical Policy Update October 2020

Updated Criteria for Tumor Treatment Fields Highmark Blue Shield has revised criteria for E-5 Tumor Treatment Fields (TTF). TTF therapy to treat glioblastoma multiforme (GBM) may be considered medically necessary as an adjunct to standard maintenance therapy with temozolomide in individuals with newly diagnosed GBM following initial treatment with surgery, radiotherapy, and/or chemotherapy when ALL of the following criteria are met:

• Adult patients twenty two (22) years or older; and • Supratentorial tumor; and • Karnofsky Performance Status(KPS) score greater than or equal to 60 and • Individual understands device use, including the requirement for a shaved head and is willing to comply with use criteria according to the Food and Drug Administration, including wearing the device at least eighteen (18 hours daily). TTF may be considered medically necessary for recurrent GBM when it is used as an alternative to standard medical therapy, as a monotherapy, following treatment with surgery, radiotherapy, and/or chemotherapy when ALL of the following criteria are met:

• Adult patients twenty two (22) years or older; and • Supratentorial tumor; and • KPS score greater than or equal to 60 and • Individual understands device use, including the requirement for a shaved head and is willing to comply with use criteria according to the FDA, including wearing the device at least eighteen (18 hours daily). TTF is considered experimental/investigational for all other conditions and therefore, non- covered because the safety and/or effectiveness of this service cannot be established by the available published peer-reviewed literature. Examples of conditions include but are not limited to the following.

• Brain metastases • Cancer in areas other than the brain • As an adjunct to standard medical therapy (pemetrexed and platinum based chemotherapy) for individual with malignancy pleural mesothelioma. This revised Medical Policy will apply to professional providers and/or facility claims. The effective date is December 28, 2020.

Place of Service: Inpatient/Outpatient

Please refer to Medical Policy E-5 Tumor Treatment Fields, for additional information.

7 Medical Policy Update October 2020

Cleaning Systems for Devices for the Treatment of Sleep Apnea in Adults

Highmark Blue Shield has established new criteria for E-20 Devices Used for the Treatment of Obstructive Sleep Apnea in Adults. Positive airway pressure (PAP) devices have directions from the manufacturing company included for cleaning. Continuous positive airway pressure (CPAP) sanitizer cleaning systems are considered convenience items and therefore non-covered.

This revised Medical Policy will apply to professional providers. The effective date is December 28, 2020.

Place of Service: Outpatient

Please refer to Medical Policy E-20 Devices Used for the Treatment of Obstructive Sleep Apnea in Adults, for additional information.

REMINDER: Laboratory Management Clinical Guidelines Highmark Blue Shield is providing a reminder to all providers.

The molecular and genomic clinical guidelines will be updated and take effect January 1, 2021. This applies to both professional provider and facility claims.

At that time, a link can be accessed from the medical policy homepage to access eviCore clinical guidelines.

8 Medical Policy Update October 2020

Facility Application added for Small Bowel, Small Bowel/Liver and Multivisceral Transplantation Facility has been added and this revised policy will apply to both professional provider and facility claims. The effective date is December 28, 2020.

Please refer to Medical Policy S-118, Small Bowel, Small Bowel/Liver and Multivisceral Transplantation, for additional information.

Place of Service: Inpatient

Facility Application added for Liver Transplantation Facility has been added and this revised policy will apply to both professional provider and facility claims. The effective date is December 28, 2020.

Please refer to Medical Policy S-121, Liver Transplantation, for additional information.

Place of Service: Inpatient

9 Medical Policy Update October 2020

Coverage Guidelines Revised for Medical Policy S-237, Discography

Highmark Blue Shield has revised criteria for S-237, Discography as follows.

• Pain is unrelenting and has persisted for an extended period of time (may be least three (3) , revising to six (6) months)

Diagnosis codes have been updated.

This revised Medical Policy will apply to professional providers and/or facility claims. The effective date is December 28, 2020.

Place of Service: Inpatient/Outpatient

Please refer to Medical Policy S-237, Discography, for additional information.

Coverage Guidelines Established for Percutaneous Nerve Field Stimulator and Percutaneous Neuromodulation Therapy, Coverage Criteria Revised on Medical Policy Z-7 Highmark Blue Shield has established new guidelines/criteria for Percutaneous nerve field stimulator and Percutaneous neuromodulation therapy. The use of both stimulators has been added to the list of experimental/investigational treatments.

Coverage criteria on the policy has been updated.

This revised Medical Policy will apply to professional providers and/or facility claims. The effective date is December 28, 2020.

Place of Service: Inpatient/Outpatient

Please refer to Medical Policy Z-7, Electrical Nerve Stimulation, for additional information.

10 Medical Policy Update October 2020

Medical Necessity Definition Revised

Highmark Blue Shield has revised criteria related to the definition of medical necessity.

This revised Medical Policy will apply to professional providers and facility claims. The effective date is January 1, 2021.

Please refer to Medical Policy Z-11, Definition of Medical Necessity, for additional information.

Updated Diagnosis Codes for Ultrasound Osteogenesis Stimulator

Highmark Blue Shield has revised the diagnosis codes for Medical Policy E-35 Ultrasound Osteogenesis Stimulator.

This revised Medical Policy will apply to professional providers. The effective date is December 28, 2020.

Place of Service: Outpatient

Please refer to Medical Policy E-35, Ultrasound Osteogenesis Stimulator, for additional information.

11 Medical Policy Update October 2020

REMINDER: Cardiology & Radiology Imaging Clinical Guidelines Highmark Blue Shield is providing a reminder to all providers.

The Cardiology & Radiology Imaging clinical guidelines will be updated and take effect January 1, 2021. This applies to both professional provider and facility claims.

At that time, clinical guidelines can be accessed utilizing the live link from the medical policy website.

Coverage Guidelines Revised for Biometric Bone Filler

Highmark Blue Shield has revised coverage guidelines for Medical Policy S-231, Biometric Bone Void Filler. The place of service has been revised to inpatient/outpatient.

This revised Medical Policy will apply to professional providers and facility claims. The effective date is December 28, 2020.

Place of Service: Inpatient/Outpatient

Please refer to Medical Policy S-231, Biometric Bone Void Filler, for additional information.

12 Medical Policy Update October 2020

Medicare Advantage Policy

Coverage Guidelines Revised for Erbulin Mesylate (Halaven)

Highmark’s Medicare Advantage products have revised criteria for Erbulin Mesylate (Halaven®) to align with current National Comprehensive Cancer Network Recommendations for soft tissue sarcoma to include the following: Treatment as: • Single agent palliative therapy as subsequent lines of therapy for advanced/metastatic soft tissue sarcoma of the extremity/superficial trunk, head/neck with disseminated metastases; or • Subsequent lines of therapy for advanced/metastatic pleomorphic rhabdomyosarcoma as a single agent; or • Single-agent palliative treatment as subsequent lines of therapy for recurrent unresectable or stage IV retroperitoneal/intra-abdominal soft tissue sarcoma; or • Single agent palliative therapy for soft tissue angiosarcoma; or • Single agent therapy for the treatment of solitary fibrous tumor; or • Single agent therapy for the treatment of undifferentiated pleomorphic sarcoma (UPS).

This revised Medical Policy will apply to professional providers and facility claims. The effective date is December 28, 2020.

Place of Service:

Please refer to Medical Policy I-119, Erbulin Mesylate (Halaven), for additional information.

13 Medical Policy Update October 2020

Coverage Guidelines Established for Tafasitamab-cxix (Monjuvi)

Highmark’s Medicare Advantage products have established new guidelines for Tafasitamab-cxix (Monjuvi®) to align with Food and Drug Administration (FDA) indications and National Comprehensive Cancer Network recommendations.

This new Medical Policy will apply to professional providers and facility claims. The effective date was September 21, 2020.

Please refer to Medical Policy I-233, Tafasitamab-cxix (Monjuvi), for additional information.

Clinical Guidelines Revised for Bendamustine (Treanda, Bendeka, Belrapzo)

Highmark’s Medicare Advantage products have revised criteria for bendamustine (Treanda®, Bendeka®, Belrapzo™). The following revisions are being made based upon updates to the National Comprehensive Cancer Network (NCCN) recommendations:

This revised Medical Policy will apply to professional providers and facility claims. The effective date is December 28, 2020.

Please refer to Medical Policy I-55 Bendamustine (Treanda, Bendeka, Belrapzo), for additional information.

14 Medical Policy Update October 2020

Clinical Guidelines Revised for Cetuximab (Erbitux)

Highmark’s Medicare Advantage products have revised criteria for cetuximab (Erbitux®).

The coverage position for basal cell skin cancer has been removed due to updates to the National Comprehensive Cancer Network (NCCN) recommendations.

This revised Medical Policy will apply to professional providers and facility claims. The effective date is December 28, 2020

Please refer to Medical Policy I-69, Cetuximab (Erbitux) for additional information.

Clinical Guidelines Revised for Ado-Trastuzumab Emtansine (Kadcyla)

Highmark’s Medicare Advantage products have revised criteria for ado-trastuzumab emtansine (Kadcyla®).

This revised Medical Policy will apply to professional providers and facility claims. The effective date is December 28, 2020.

Please refer to Medical Policy I-113, Ado-trastuzumab emtansine (Kadcyla), for additional information.

15 Medical Policy Update October 2020

Coverage Guidelines Established for Nusinersen (Spinraza)

Highmark’s Medicare Advantage products has established new guidelines for Nusinersen (SpinrazaTM) to require the following criteria: Nusinersen (Spinraza) may be considered medically necessary for individuals with spinal muscular atrophy (SMA) caused by mutations in chromosome 5q when the following criteria are met: • Individual has had SMA diagnostic test results confirming 0 copies of SMN1; or • Molecular genetic testing of 5q SMA for any of the following: o homozygous gene deletion; or o homozygous conversion mutation; or o compound heterozygote; and • Individual is symptomatic; and o Individual has 2, 3, or 4 copies of SMN2; and o Individual is not reliant on ventilator support (may use non-invasive ventilator support for naps and nighttime sleep); and o Individual is not dependent on a tracheostomy; and • Individual is asymptomatic; and o Individual has 2 or 3 copies of SMN2; and o Individual is 1 year of age or younger at initiation of treatment; and • Nusinersen (Spinraza) is prescribed by or in consultation with a neuromuscular specialist or neurologist with experience and expertise in the treatment and ongoing management individuals with SMA; and • Baseline documentation of individual’s functional abilities by ANY ONE of the following: o For individuals 2-24 months old - Hammersmith Infant Neurologic Exam (HINE) Section 1 and Section 2; or o For individuals four (4) months to four (4) years of age - Children’s Hospital of Philadelphia Infant Test of Neuromuscular Disorders (CHOP-INTEND); or o Hammersmith Functional Motor Scale-Expanded (HFMSE), or 6-Minute Walk Test (6MWT); or o For individuals who are non-ambulatory: Upper Limb Module (ULM), Revised Upper Limb Module (RULM).

This new Medical Policy will apply to professional providers and facility claims. The effective date is December 28, 2020.

Please refer to Medical Policy I-239, Nusinersen (Spinraza), for additional information.

16 Medical Policy Update October 2020

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].

Contents Coverage Guidelines Revised for Cetuximab (Erbitux) ...... 1 Coverage Guidelines Revised for Bendamustine (Treanda, Bendeka, Belrapzo)...... 17 Coverage Guidelines Revised for Ado-Trastuzumab Emtansine (Kadcyla) ...... 17 Coverage Guidelines Revised for Erbulin Mesylate (Halaven)...... 3

Coverage Guidelines Revised for Cetuximab (Erbitux) ...... 1 Coverage Guidelines Revised for Bendamustine (Treanda, Bendeka, Belrapzo)...... 2 Coverage Guidelines Revised for Ado-Trastuzumab Emtansine (Kadcyla) ...... 2 Coverage Guidelines Revised for Erbulin Mesylate (Halaven)...... 3 Updated Criteria for Tumor Treatment Fields ...... 7 Cleaning Systems for Devices for the Treatment of Sleep Apnea in Adults ...... 8 Updated Diagnosis Codes for Ultrasound Osteogenesis Stimulator...... 11 Coverage Guidelines Revised for Biometric Bone Filler ...... 12 Coverage Guidelines Revised for Erbulin Mesylate (Halaven)...... 13 Coverage Guidelines Established for Tafasitamab-cxix (Monjuvi)...... 14 Clinical Guidelines Revised for Bendamustine (Treanda, Bendeka, Belrapzo) ...... 14 Clinical Guidelines Revised for Cetuximab (Erbitux)...... 15 Clinical Guidelines Revised for Ado-Trastuzumab Emtansine (Kadcyla)...... 15 Coverage Guidelines Established for Nusinersen (Spinraza) ...... 16 Comments on these new medical policies?...... 17 Contents...... 17

17 Medical Policy Update October 2020

Coverage Guidelines Revised for Erbulin Mesylate (Halaven)...... 13 Coverage Guidelines Established for Tafasitamab-cxix (Monjuvi)...... 14 Clinical Guidelines Revised for Bendamustine (Treanda, Bendeka, Belrapzo) ...... 14 Clinical Guidelines Revised for Cetuximab (Erbitux)...... 15 Clinical Guidelines Revised for Ado-Trastuzumab Emtansine (Kadcyla)...... 15 Coverage Guidelines Established for Nusinersen (Spinraza) ...... 16 Comments on these new medical policies?...... 17 Contents...... 17

18 Medical Policy Update October 2020

Coverage Guidelines Established for Nusinersen (Spinraza) ...... 16 Comments on these new medical policies?...... 17 Contents...... 17

Coverage Guidelines Revised for Cetuximab (Erbitux) ...... 1

19 Medical Policy Update October 2020

Coverage Guidelines Revised for Bendamustine (Treanda, Bendeka, Belrapzo)...... 2 Coverage Guidelines Revised for Ado-Trastuzumab Emtansine (Kadcyla) ...... 2 Coverage Guidelines Revised for Erbulin Mesylate (Halaven)...... 3 Updated Criteria for Tumor Treatment Fields ...... 7 Cleaning Systems for Devices for the Treatment of Sleep Apnea in Adults ...... 8 Updated Diagnosis Codes for Ultrasound Osteogenesis Stimulator...... 11 Coverage Guidelines Revised for Biometric Bone Filler ...... 12 Coverage Guidelines Revised for Erbulin Mesylate (Halaven)...... 13 Coverage Guidelines Established for Tafasitamab-cxix (Monjuvi)...... 14 Clinical Guidelines Revised for Bendamustine (Treanda, Bendeka, Belrapzo) ...... 14 Clinical Guidelines Revised for Cetuximab (Erbitux)...... 15 Clinical Guidelines Revised for Ado-Trastuzumab Emtansine (Kadcyla)...... 15 Coverage Guidelines Established for Nusinersen (Spinraza) ...... 16 Comments on these new medical policies?...... 17 Contents...... 17

20 Medical Policy Update October 2020

Updated Diagnosis Codes for Ultrasound Osteogenesis Stimulator...... 11 Coverage Guidelines Revised for Biometric Bone Filler ...... 12 Coverage Guidelines Revised for Erbulin Mesylate (Halaven)...... 13 Coverage Guidelines Established for Tafasitamab-cxix (Monjuvi)...... 14 Clinical Guidelines Revised for Bendamustine (Treanda, Bendeka, Belrapzo) ...... 14 Clinical Guidelines Revised for Cetuximab (Erbitux)...... 15 Clinical Guidelines Revised for Ado-Trastuzumab Emtansine (Kadcyla)...... 15 Coverage Guidelines Established for Nusinersen (Spinraza) ...... 16 Comments on these new medical policies?...... 17 Contents...... 17

Save yourself valuable time with e-Subscribe! Sign up today and you’ll begin receiving email notifications with a direct link to the latest issue of Medical Policy Update.

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 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.highmarkblueshield.com.

Inquiries about Eligibility, Benefits, Claims Status or Authorizations For inquiries about eligibility, benefits, claim status or authorizations, Highmark Blue Shield 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 1-866-803-3708. 21 Medical Policy Update October 2020

Acknowledgement The five-digit numeric codes that appear in Medical Policy Update were obtained from the Current Procedural Terminology (CPT), as contained in CPT- 2019, Copyright 2018, 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.