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September Medical Policy Update 2019

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September Medical Policy Update 2019 September 2019 In This Issue Coverage Guidelines Revised for Daratumumab (Darzalex)..................................................................... 2 Facility Added to Dental Services.............................................................................................................. 4 Coverage Criteria Revised for Surgical Treatment of Varicose Veins........................................................ 4 Coverage Guidelines Revised for Olaratumab (Lartruvo).......................................................................... 6 Contents............................................................................................................................................................ 8 Policy Clinical Guidelines Revised for Ado-trastuzumab Emtansine (Kadcyla) Highmark Blue Shield has 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. 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 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 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 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 . 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. Place of Service: Outpatient 3 Medical Policy Update September 2019 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. 4 Medical Policy Update September 2019 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. 5 Medical Policy Update September 2019 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
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