Medical Policy Update: October 2018

October 2018 In This Issue

New Policy Established for Site of Care for Certain Injectable Drugs...... 2 Revised Coverage Guidelines for Thermography (Thermogram) ...... 3 REMINDER: Radiology and Cardiac Imaging Program...... 3

Contents...... 6

Policy

Coverage Criteria Established for Lanadelumab-flyo (TAKHZYRO)

Highmark Blue Cross Blue Shield has established coverage criteria for lanadelumab-flyo (TAKHZYRO™). Lanadelumab-flyo (TAKHZYRO) may be medically necessary for the prophylactic therapy of hereditary angioedema (HAE) types I and II in individuals 12 years of age and older.

This Medical Policy will apply to both professional provider and facility claims. The effective date is October 1, 2018.

Please refer to Medical Policy I-122, Treatment of Hereditary Angioedema (HAE) for additional information.

Highmark Blue Cross 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 2018

New Policy Established for Site of Care for Certain Injectable Drugs

Highmark Blue Cross Blue Shield has established coverage criteria for the site of care of the following injectable drugs; Remicade, Gammagard, Gamunex-C, Privigen, Octagam, Gammaplex, Bivigam, Flebogamma, Carimune NF and Gammargard S/D, Orencia, Fabrazyme, Lumizyme, Aralast, Zemaria, Prolastin, Glassia, Benlysta, Berinert, Soliris, Vimizim, Simponi, Elaprase, Cerezyme, Actemra, Entyvio, Vpriv, Renflexis and Inflectra. This will apply to both professional provider and facility claims. The effective date is January 1, 2019.

The medications identified above may be considered medically necessary when applicable clinical criteria for individual medication policies are met and when administered in a physician’s office not affiliated with a hospital, specialized infusion center not affiliated with a hospital or in the home.

Outpatient facility (Outpatient Hospital IV Infusion Department or Hospital-based Outpatient Clinical Level of Care) administration may be considered medically necessary if ANY of the following criteria are present to indicate the member is medically unstable for infusions in settings other than an outpatient facility setting:

• Pediatric individuals up to and including two (2) years of age; or • Member’s home is considered unsuitable for care by the home infusion provider; or • Individual’s medical status requires enhanced monitoring beyond that which would routinely be needed for infusion therapy; or • Previous severe adverse reaction (including but not limited to anaphylaxis, seizure, thromboembolism, myocardial infarction, renal failure) during or following administration of prescribed medication despite standard pre-medication; or • Individual is receiving other medications that require close monitoring with a higher level of care (e.g., cytotoxic chemotherapy or blood products); or • Individual is at high risk for complications due to medication administration (e.g., at risk for post-transplant complications, increased risk of infusion reactions due to presence of circulating antibodies, unstable vascular access, cardiopulmonary condition at risk for severe adverse reactions, unstable renal function with inability to safely tolerate IV volume loads, etc.); or • Individual is initiating therapy or re-initiating therapy after a period of at least 6 months with no therapy; or • Physically and/or cognitively impaired AND a home caregiver is not available to comply with the required treatment regimen and schedule.

Please refer to Medical Policy I-151 Site of Care, I-28 Infliximab, I-14 Immune Globulin Therapy, I-90 Abatacept (Orencia) IV and SC, I-55 Agalsidase beta (Fabrazyme), I-58 Alglucosidase alfa (Lumizyme), I-126 Alpha1-Proteinase Inhibitor Infusions, I-33 Belimumab (Benlysta), I-122 Treatment of Hereditary Angioedema (HAE), I-130 Eculizumab (Soliris), I- 138 Elosulfase alfa (Vimizim), I-35 Golimumab (Simponi, Simponi Aria), I-93 Idursulfase (Elaprase), I-9 Treatment of Gaucher Disease, I-31 Tocilizumab (Actemra), and I-129 Vedolizumab (Entyvio) for additional information.

2 Medical Policy Update October 2018

Revised Coverage Guidelines for Thermography (Thermogram)

Highmark Blue Cross Blue Shield has revised the coverage guideline from not medically necessary to experimental/investigational for Thermography (Thermogram). This new coverage guideline will apply to both professional provider and facility claims. The effective date is January 1, 2019.

Please refer to Medical Policy M-4, Thermography (Thermogram), for additional information.

Place of Service: Inpatient/Outpatient

REMINDER: Radiology and Cardiac Imaging Program

Highmark Blue Cross Blue Shield is providing a reminder to all providers.

As previously announced in the Special Bulletin, the new eviCore radiology and cardiac imaging medical policies and requirements will take effect January 1, 2019. This applies to both professional provider and facility claims.

At that time, policies can be accessed from the medical policy homepage.

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Medicare Advantage Policy

Coverage Criteria Established for Lanadelumab-flyo (TAKHZYRO)

Highmark’s Medicare Advantage products have established coverage criteria for lanadelumab-flyo (TAKHZYRO™). Lanadelumab-flyo (TAKHZYRO) may be medically necessary for the prophylactic therapy of hereditary angioedema (HAE) types I and II in individuals 12 years of age and older.

This Medicare Advantage Medical Policy will apply to both professional provider and facility claims. The effective date is October 1, 2018.

Please refer to Medical Policy I-122, Treatment of Hereditary Angioedema (HAE) for additional information.

Coverage Guidelines for Talimogene Laherparepvec (Imlygic) - Retracted

Highmark’s Medicare Advantage products will retract the established coverage criteria for talimogene laherparepvec (ImlygicTM). Centers for Medicare and Medicaid Services (CMS) do not provide coverage for this service. Therefore, the established coverage guidelines will be retracted on January 1, 2019.

Please refer to Medicare Advantage Medical Policy I-147, Talimogene Laherparepvec (Imlygic) for additional information.

4 Medical Policy Update October 2018

Coverage Guidelines for Chimeric Antigen Receptor T-Cell Therapy - Retracted Highmark’s Medicare Advantage products will retract the established coverage criteria for tisagenlecleucel (Kymriah®) and axicabtagene ciloleucel (Yescarta™). Centers for Medicare and Medicaid Services (CMS) do not provide coverage for this service. Therefore, the established coverage guidelines will be retracted on January 1, 2019.

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

Coverage Guidelines for Voretigene Neparvovec-rzyl (Luxturna) - Retracted

Highmark’s Medicare Advantage products will retract the established coverage criteria for Voretigene Neparvovec-rzyl (LuxturnaTM). Centers for Medicare and Medicaid Services (CMS) do not provide coverage for this service. Therefore, the established coverage guidelines will be retracted on January 1, 2019.

Please refer to Medicare Advantage Medical Policy I-183, Voretigene Neparvovec-rzyl (Luxturna) for additional information.

5 Medical Policy Update October 2018

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 Criteria Established for Lanadelumab-flyo (TAKHZYRO) ...... 1 New Policy Established for Site of Care for Certain Injectable Drugs...... 2 Revised Coverage Guidelines for Thermography (Thermogram) ...... 3 REMINDER: Radiology and Cardiac Imaging Program...... 3 Coverage Criteria Established for Lanadelumab-flyo (TAKHZYRO) ...... 4 Coverage Guidelines for Talimogene Laherparepvec (Imlygic) - Retracted...... 4 Coverage Guidelines for Chimeric Antigen Receptor T-Cell Therapy - Retracted...... 5 Coverage Guidelines for Voretigene Neparvovec-rzyl (Luxturna) - Retracted...... 5 Comments on these new medical policies?...... 6 Contents...... 6

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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.highmarkbcbs.com.

Inquiries about Eligibility, Benefits, Claims Status or Authorizations For inquiries about eligibility, benefits, claim status or authorizations, Highmark Blue Cross 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 1-800-242-0514.

Acknowledgement

The five-digit numeric codes that appear in Medical Policy Update were obtained from the Current Procedural Terminology (CPT), as contained in CPT- 2018, Copyright 2016, 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.