September 2019

In This Issue

Coverage Guidelines Revised for (Darzalex)...... 2 Facility Added to Dental Services...... 4 Coverage Criteria Revised for Surgical Treatment of Varicose Veins...... 4 Coverage Guidelines Revised for (Lartruvo)...... 6

Contents...... 8

Policy

Clinical Guidelines Revised for Ado- Emtansine (Kadcyla) Highmark Blue Shield has added to the coverage criteria for ado- (Kadcyla®).

Ado-trastuzumab emtansine (Kadcyla) may be considered medically necessary for the adjuvant treatment of individuals with HER2-positive early who have residual invasive disease after neoadjuvant taxane and trastuzumab-based treatment.

This revised medical policy will apply to both professional provider and facility claims. The effective date was August 19, 2019.

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

Place of Service: Outpatient

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 September 2019

Coverage Guidelines Revised for Daratumumab (Darzalex) Highmark Blue Shield has revised coverage criteria for daratumumab (Darzalex™) to include the most recent Food and Drug Administration (FDA) and National Comprehensive Cancer Network (NCCN) Indications and limit coverage to individuals age 18 years or older.

The Medical Policy will apply to both professional provider and facility claims. The effective date will be November 25, 2019.

Please refer to Medical Policy I-150, Daratumumab (Darzalex), for additional information.

Place of Service: Outpatient

Coverage Guidelines Revised for Olaratumab (Lartruvo) Highmark Blue Shield has revised coverage criteria for Olaratumab (LartruvoTM) as follows: • Olaratumab (Lartruvo), for individuals initiating new therapy, is considered experimental and investigational. • Olaratumab (Lartruvo) will be considered medically necessary for individuals who meet ALL of the following: o Individual is 18 years of age or older; and o Individual has been receiving therapy with olaratumab (Lartruvo); and o There has been a proven clinical benefit with olaratumab (Lartruvo); and o Individual is enrolled in the Lartruvo Patient Access Program; and o Individual is being treated for ANY ONE of the following indications: • Soft Tissue Sarcoma (STS) – Angiosarcoma o In combination with in individuals with STS with a histologic subtype for which an -containing regimen is appropriate and which is not amenable to curative treatment with radiotherapy or surgery; or • Soft Tissue Sarcoma - Retroperitoneal/Intra-abdominal o In combination with doxorubicin for: . Preoperative for resectable disease; or . Primary chemotherapy or chemoradiation for attempted downstaging of unresectable, recurrent, or metastatic disease; or . Palliative therapy for unresectable or progressive disease; or • Soft Tissue Sarcoma – Rhabdomyosarcoma o Therapy for pleomorphic rhabdomyosarcoma in combination with doxorubicin; or • Soft Tissue Sarcoma of the Extremity/Superficial Trunk, Head/Neck o In combination with doxorubicin for: . Preoperative chemotherapy or chemoradiation for resectable stage III tumors (primary tumors or local recurrence) with acceptable functional outcomes; or . Primary treatment as chemotherapy or chemoradiation for stage II-III resectable disease with adverse functional outcomes or unresectable disease (primary tumors or local 2 Medical Policy Update September 2019 recurrence); or . Adjuvant chemotherapy for resectable stage III disease (primary tumors or local recurrence) with acceptable functional outcomes; or . Adjuvant chemotherapy for resectable stage II-III disease with acceptable functional outcomes following primary treatment for resectable stage II-III disease with adverse functional outcomes; or . Treatment before or after metastasectomy for single-organ confined, limited tumor bulk synchronous stage IV or recurrent disease that is amenable to local therapy or for recurrent isolated regional disease that is amenable to local therapy or for recurrent isolated regional disease or isolated regional lymph nodes; or . Treatment in addition to stereotactic body (SBRT) for single-organ confined, limited tumor bulk stage IV or recurrent disease that is amenable to local therapy or for recurrent isolated regional disease or isolated regional lymph nodes; or . Chemotherapy following regional node dissection for metastatic disease; or . Palliative chemotherapy for stage IV or recurrent disease with disseminated metastases for which an anthracycline- containing regimen is appropriate; or • Uterine – Uterine Sarcoma (New indication) o Preferred therapy in combination with doxorubicin: . For disease that is not suitable for primary surgery; or . May be considered following total hysterectomy with or without bilateral salpingo-oophorectomy (TH ± BSO) for stage I-III disease; or . Following TH ± BSO for stage IV disease; or . For a radiologically isolated vaginal/pelvic recurrence; or . For isolated metastases. Consider postoperative therapy for resectable isolated metastases; or . For disseminated metastases.

The Medical Policy will apply to both professional provider and facility claims. The effective date will be November 25, 2019.

Please refer to Medical Policy I-162, Olaratumab (Lartruvo), for additional information.

Place of Service: Outpatient

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Facility Added to Dental Services Highmark Blue Shield has established new clinical criteria for Dental Services.

The Medical Policy will apply to both professional provider and facility claims. The effective date is November 25, 2019.

Please refer to Commercial Medical Policy D-6, Dental Services for additional information.

Place of Service: Inpatient/Outpatient

REVISION: Drug Testing Medical Policy Highmark Blue Shield updated the clinical criteria for Drug Testing in Pain Management and Substance Abuse Treatment July 22, 2019. Drug testing limits were identified in the Medical Policy and July 2019 newsletter as being increased to reflect forty-eight (48) combined per year. The policy will be updated to indicate twenty-four (24) presumptive drug tests and twenty-four (24) definitive drug tests will be allowed per benefit period.

This specification will apply to both professional provider and facility claims. The effective date is November 25, 2019.

Place of Service: Outpatient/Inpatient

Coverage Criteria Revised for Surgical Treatment of Varicose Veins Highmark Blue Shield has revised clinical criteria for Surgical Treatment of Varicose Veins. Photographs of varicose veins are no longer required. The revised criteria will apply to both professional provider and facility claims. The effective date is September 30, 2019.

Place of Service: Inpatient/Outpatient

Please refer to medical Policy S-55, Surgical Treatment of Varicose Veins, for additional information.

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Medicare Advantage Policy

Clinical Guidelines Revised for Ado-trastuzumab Emtansine (Kadcyla) Highmark’s Medicare Advantage products have added to the coverage criteria for ado- trastuzumab emtansine (Kadcyla®).

Ado-trastuzumab emtansine (Kadcyla) may be considered medically necessary for the adjuvant treatment of individuals with HER2-positive early breast cancer who have residual invasive disease after neoadjuvant taxane and trastuzumab-based treatment.

This revised medical policy will apply to both professional provider and facility claims. The effective date was August 19, 2019.

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

Coverage Guidelines Revised for Daratumumab (Darzalex) Highmark’s Medicare Advantage products have revised coverage criteria for daratumumab (Darzalex™) to include the most recent Food and Drug Administration (FDA) and National Comprehensive Cancer Network (NCCN) Indications and limit coverage to individuals age 18 years or older.

The Medical Policy will apply to both professional provider and facility claims. The effective date will be November 25, 2019.

Please refer to Medical Policy I-150, Daratumumab (Darzalex), for additional information.

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Coverage Guidelines Revised for Olaratumab (Lartruvo) Highmark’s Medicare Advantage products have revised coverage criteria for Olaratumab (LartruvoTM) as follows: • Olaratumab (Lartruvo), for individuals initiating new therapy, is considered experimental and investigational. • Olaratumab (Lartruvo) will be considered medically necessary for individuals who meet ALL of the following: o Individual is 18 years of age or older; and o Individual has been receiving therapy with olaratumab (Lartruvo); and o There has been a proven clinical benefit with olaratumab (Lartruvo); and o Individual is enrolled in the Lartruvo Patient Access Program; and o Individual is being treated for ANY ONE of the following indications: • Soft Tissue Sarcoma (STS) – Angiosarcoma o In combination with doxorubicin in individuals with STS with a histologic subtype for which an anthracycline-containing regimen is appropriate and which is not amenable to curative treatment with radiotherapy or surgery; or • Soft Tissue Sarcoma - Retroperitoneal/Intra-abdominal o In combination with doxorubicin for: . Preoperative chemotherapy for resectable disease; or . Primary chemotherapy or chemoradiation for attempted downstaging of unresectable, recurrent, or metastatic disease; or . Palliative therapy for unresectable or progressive disease; or • Soft Tissue Sarcoma – Rhabdomyosarcoma o Therapy for pleomorphic rhabdomyosarcoma in combination with doxorubicin; or • Soft Tissue Sarcoma of the Extremity/Superficial Trunk, Head/Neck o In combination with doxorubicin for: . Preoperative chemotherapy or chemoradiation for resectable stage III tumors (primary tumors or local recurrence) with acceptable functional outcomes; or . Primary treatment as chemotherapy or chemoradiation for stage II- III resectable disease with adverse functional outcomes or unresectable disease (primary tumors or local recurrence); or . Adjuvant chemotherapy for resectable stage III disease (primary tumors or local recurrence) with acceptable functional outcomes; or . Adjuvant chemotherapy for resectable stage II-III disease with acceptable functional outcomes following primary treatment for resectable stage II-III disease with adverse functional outcomes; or . Treatment before or after metastasectomy for single-organ confined, limited tumor bulk synchronous stage IV or recurrent disease that is amenable to local therapy or for recurrent isolated regional disease that is amenable to local therapy or for recurrent isolated regional disease or isolated regional lymph nodes; or . Treatment in addition to stereotactic body radiation therapy (SBRT) for single-organ confined, limited tumor bulk stage IV or recurrent disease that is amenable to local therapy or for recurrent isolated regional disease or isolated regional lymph nodes; or

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. Chemotherapy following regional node dissection for metastatic disease; or . Palliative chemotherapy for stage IV or recurrent disease with disseminated metastases for which an anthracycline-containing regimen is appropriate; or • Uterine Neoplasms – Uterine Sarcoma (New indication) o Preferred therapy in combination with doxorubicin: . For disease that is not suitable for primary surgery; or . May be considered following total hysterectomy with or without bilateral salpingo-oophorectomy (TH ± BSO) for stage I-III disease; or . Following TH ± BSO for stage IV disease; or . For a radiologically isolated vaginal/pelvic recurrence; or . For isolated metastases. Consider postoperative therapy for resectable isolated metastases; or . For disseminated metastases The Medical Policy will apply to both professional provider and facility claims. The effective date will be November 25, 2019.

Please refer to Medical Policy I-162, Olaratumab (Lartruvo), for additional information.

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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 Clinical Guidelines Revised for Ado-trastuzumab Emtansine (Kadcyla)...... 1 Coverage Guidelines Revised for Daratumumab (Darzalex) ...... 2 Coverage Guidelines Revised for Olaratumab (Lartruvo) ...... 2 Facility Added to Dental Services ...... 4 REVISION: Drug Testing Medical Policy...... 4 Coverage Criteria Revised for Surgical Treatment of Varicose Veins ...... 4 Clinical Guidelines Revised for Ado-trastuzumab Emtansine (Kadcyla)...... 5 Coverage Guidelines Revised for Daratumumab (Darzalex) ...... 5 Coverage Guidelines Revised for Olaratumab (Lartruvo) ...... 6 Comments on these new medical policies?...... 8 Contents...... 8

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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 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.

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.

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