February 2019
In This Issue
Reminder: Coverage Criteria for Alpha1-Proteinase Inhibitor Infusions...... 5 Coverage Guidelines Revised for Ocrelizumab (Ocrevus) ...... 5 Coverage Guidelines Reinstated for Donor Leukocyte Infusion for Hematologic Malignancies that Relapse after Allogeneic Cell Transplant ...... 5
Contents...... 10
Policy
Coverage Guidelines Revised for Rituximab (Rituxan) and Rituximab and Hyaluronidase Human (Rituxan Hycela) Highmark Blue Shield has revised the coverage criteria for rituximab (Rituxan®) and rituximab and hyaluronidase human (Rituxan HycelaTM) to include recent Food and Drug Administration (FDA) and National Comprehensive Cancer Network (NCCN) guidelines. The coverage criteria for rituximab (Rituxan) has been updated to include the following: • Relapsed or refractory, low grade or follicular, CD20-positive B-cell NHL as a single agent • Previously untreated follicular, CD20-positive, B-cell NHL in combination with first line chemotherapy and, in patients achieving a complete or partial response to rituximab (Rituxan) in combination with chemotherapy, as single-agent maintenance therapy • Non-progressing (including stable disease), low-grade, CD20-positive, B-cell NHL as a single agent after first-line cyclophosphamide, vincristine, and prednisone (CVP) chemotherapy • Previously untreated diffuse large B-cell, CD20-positive NHL in combination with (cyclophosphamide, doxorubicin, vincristine, and prednisone) (CHOP) or other anthracycline-based chemotherapy regimens
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 February 2019
• Previously untreated and previously treated CD20-positive CLL in combination with fludarabine and cyclophosphamide (FC) • Treatment of moderate to severe Pemphigus Vulgaris in adult individuals • Remove vincristine, procarbazine and cytarabine in combination with high-dose methotrexate and rituximab for primary central nervous system lymphoma • Include coverage for high-grade B-cell lymphomas per the NCCN guidelines • Allowing for DHAX (dexamethasone, cytarabine, and oxaliplatin) regimen where appropriate per NCCN guidelines The updated rituximab and hyaluronidase human (Rituxan Hycela) clinical criteria has been updated to include the following: • Require that the individual has required at least one full dose of rituximab (Rituxan) by intravenous infusion prior to starting treatment with rituximab and hyaluronidase human (Rituxan Hycela) • Require that individuals be adults aged 18 years or older • Individuals cannot receive a live vaccination at least four (4) weeks prior to or during treatment with rituximab and hyaluronidase human (Rituxan Hycela) • Cannot be given with ibritumomab tiuxetan for gastric MALT lymphoma, nongastric MALT lymphoma, nodal marginal zone lymphoma, splenic marginal zone lymphoma and diffuse large B-cell lymphoma • Allow for therapy for high-grade B-cell lymphomas
The effective date will be April 29, 2019.
Please refer to Medical Policy I-38, Rituximab (Rituxan) and Rituximab and Hyaluronidase Human (Rituxan Hycela), for additional information.
Place of Service: Outpatient
2 Medical Policy Update February 2019
Coverage Guidelines Revised for Programmed Death Receptor (PD-1)/ Programmed Death-Ligand (PD-L1) Blocking Antibodies Highmark Blue Shield has revised the coverage criteria for atezolizumab (Tecentriq®), durvalumab (Imfinzi™), nivolumab (Opdivo®), and pembrolizumab (Keytruda®) to include recent updates to FDA and NCCN guidelines. The coverage criteria for atezolizumab (Tecentriq) has been updated to include the following: • Administered to individuals 18 years of age and older • First line treatment of individuals with metastatic non-squamous non-small cell lung cancer (NSCLC) with no epidermal growth factor receptor (EGFR) or anaplastic lymphoma kinase (ALK) genomic tumor aberrations in combination with bevacizumab, paclitaxel and carboplatin • Preferred single agent as subsequent therapy for recurrent, advanced or metastatic Non-Small Cell Lung Cancer (NSCLC) – Squamous Cell Carcinoma, Adenocarcinoma (with mixed subtypes), Large Cell Carcinoma in individuals with PS 0-2 and no prior progression on a PD-1/PD-L1 inhibitor • Preferred initial treatment in combination with etoposide and carboplatin for extensive stage Small Cell Lung Cancer – Small Cell Carcinoma in individuals without localized symptomatic sites or brain metastases and good PS (0-2), without localized symptomatic sites or brain metastases and poor PS (3-4) due to small cell lung cancer, with localized symptomatic sites or with brain metastases The updated durvalumab (Imfinzi) coverage criteria has been updated to include the following: • Indicated as a single agent for recurrent or metastatic primary carcinoma of the urethra as subsequent systemic therapy post-platinum The updated nivolumab (Opdivo) coverage criteria has been updated to include the following: • May be given in combination with ipilimumab for colon and rectal cancer – adenocarcinoma • Treatment for relapsed/refractory Extranodal NK/T-Cell Lymphoma, Nasal Type following additional therapy with an alternate combination chemotherapy regimen (asparaginase-based) not previously used The updated pembrolizumab (Keytruda) coverage criteria has been updated to include the following: • As first-line treatment in combination with carboplatin and either paclitaxel or nab- paclitaxel for metastatic squamous NSCLC • Treatment of individuals with hepatocellular carcinoma who have been previously treated with sorafenib • Treatment of adult and pediatric individuals with recurrent locally advanced or metastatic merkel cell carcinoma • Single-agent treatment for limited brain metastases in individuals with melanoma or non-small cell lung cancer for newly diagnosed brain metastases in select patients (eg, patients with small asymptomatic brain metastases) with newly diagnosed or stable systemic disease or reasonable systemic treatment options or for recurrent brain metastases • Single-agent treatment for recurrent brain metastases in patients with melanoma or non-small cell lung cancer and stable systemic disease or reasonable systemic treatment options • Treatment of Adult individuals aged 18 years and older as subsequent systemic therapy as a single agent for refractory classic Hodgkin lymphoma or for those who
3 Medical Policy Update February 2019 have relapsed after three (3) or more prior lines of therapy • Subsequent treatment as a single agent for progressive Hepatocellular Carcinoma, Adenocarcinoma in individuals (Child-Pugh Class A only) who have unresectable disease and are not a transplant candidate, are inoperable by performance status or comorbidity, or have local disease or local disease with minimal extrahepatic disease only or have metastatic disease or extensive liver tumor burden • Adjuvant treatment for cutaneous melanoma as a single agent for stage III SLN positive disease during active nodal basin ultrasound surveillance or after CLND, for stage III disease with clinically positive node(s) following wide excision of primary tumor and a complete therapeutic lymph node dissection, for stage III disease with clinical or microscopic satellite/in-transit metastases if no evidence of disease post- surgery, for local satellite/in-transit recurrence if no evidence of disease post-surgery, following CLND and/or complete resection of nodal recurrence, or following complete resection of distant metastatic disease • Therapy for primary cutaneous anaplastic large cell lymphoma (ALCL) with multifocal lesions, or cutaneous ALCL with regional nodes (excludes systemic ALCL), as a single agent for relapsed/refractory disease • Expanded indications for non-small cell lung cancer • Subsequent systemic therapy for small cell lung cancer for individuals with PS 0-2 as a single agent for relapse within 6 months following complete or partial response or stable disease with initial treatment or primary progressive disease • Single-agent therapy of Alveolar Soft Part Sarcoma • Single agent for the treatment of metastatic undifferentiated pleomorphic sarcoma • Second line for treatment of certain advanced, recurrent or metastatic vulvar cancers
The effective date will be April 29, 2019.
Please refer to Medical Policy I-120, Programmed Death Receptor (PD-1)/ Programmed Death-Ligand (PD-L1) Blocking Antibodies, for additional information.
Place of Service: Outpatient
4 Medical Policy Update February 2019
Reminder: Coverage Criteria for Alpha1-Proteinase Inhibitor Infusions
Highmark Blue Shield has coverage criteria for alpha1-proteinase inhibitors (Prolastin C®, Prolastin-C Liquid®, Aralast NP™, Zemaira™, Glassia®) indicated for individuals with emphysema due to alpha-1 antitrypsin deficiency being treated with standard therapy for chronic obstructive pulmonary disease (i.e. inhaled bronchodilators, inhaled steroids) as defined by current coverage guidelines. This Medical Policy applies to both professional provider and facility claims.
The effective date was January 1, 2019.
Please refer to Medical Policy I-126, Ocrelizumab (Ocrevus), for additional information.
Place of Service: Outpatient
Coverage Guidelines Revised for Ocrelizumab (Ocrevus)
Highmark Blue Shield has revised the coverage criteria for ocrelizumab (Ocrevus®). The updates include removing the upper age limit and to indicate that individuals cannot receive a live vaccine for at least four (4) weeks prior to and during treatment with ocrelizumab (Ocrevus). This Medical Policy will apply to both professional provider and facility claims.
The effective date is April 29, 2019.
Please refer to Medical Policy I-171, Ocrelizumab (Ocrevus), for additional information.
Place of Service: Outpatient
Coverage Guidelines Reinstated for Donor Leukocyte Infusion for Hematologic Malignancies that Relapse after Allogeneic Cell Transplant
Highmark Blue Shield has reinstated coverage criteria for Donor Leukocyte Infusion for Hematologic Malignancies that Relapse after Allogeneic Cell Transplant. These criteria will apply to both professional provider and facility claims.
The effective date is April 29, 2019.
Place of Service: Outpatient/Inpatient
5 Medical Policy Update February 2019
Medicare Advantage Policy
Coverage Guidelines Established for Rituximab and Hyaluronidase (Rituxan Hycela)
Highmark’s Medicare Advantage products have established clinical criteria for rituximab and hyaluronidase human (Rituxan Hycela®). The clinical criteria include the requirements that the individual be 18 years of age and older, have received at least one full dose of rituximab (Rituxan®) and cannot receive live vaccines for four (4) weeks prior and during treatment. The clinical criteria establishes coverage for the Food and Drug Administration (FDA) and National Comprehensive Cancer Network (NCCN) guidelines for rituximab and hyaluronidase human (Rituxan Hycela) to include chronic lymphoid leukemia, diffuse large B-cell lymphoma, follicular lymphoma, primary cutaneous B-cell lymphomas, gastric and nongastric MALT lymphomas, nodal and splenic marginal zone lymphomas, mantle cell lymphoma, AIDS related B-cell lymphomas, Burkitt lymphoma, post-transplant lymphoproliferative disorders, castleman’s disease, chronic lymphocyticleukemia, small lymphocytic lymphoma and high-grade B-cell lymphomas. This Medical Policy will apply to both professional provider and facility claims.
The effective date is April 29, 2019.
Please refer to Medical Policy I-38, Rituximab (Rituxan) and Rituximab and Hyaluronidase Human (Rituxan Hycela), for additional information.
Place of Service: Outpatient
6 Medical Policy Update February 2019
Coverage Guidelines Revised for Programmed Death Receptor (PD-1)/ Programmed Death-Ligand (PD-L1) Blocking Antibodies Highmark’s Medicare Advantage products have revised the clinical criteria for atezolizumab (Tecentriq®), durvalumab (Imfinzi™), nivolumab (Opdivo®), and pembrolizumab (Keytruda®) to include recent updates to Food and Drug Administration (FDA) and National Comprehensive Cancer Network (NCCN) guidelines. The clinical criteria for atezolizumab (Tecentriq) has been updated to include the following: • Administered to individuals 18 years of age and older • First line treatment of individuals with metastatic non-squamous non-small cell lung cancer (NSCLC) with no epidermal growth factor receptor (EGFR) or anaplastic lymphoma kinase (ALK) genomic tumor aberrations in combination with bevacizumab, paclitaxel and carboplatin • Preferred single agent as subsequent therapy for recurrent, advanced or metastatic Non-Small Cell Lung Cancer (NSCLC) – Squamous Cell Carcinoma, Adenocarcinoma (with mixed subtypes), Large Cell Carcinoma in individuals with PS 0-2 and no prior progression on a PD-1/PD-L1 inhibitor • Preferred initial treatment in combination with etoposide and carboplatin for extensive stage Small Cell Lung Cancer – Small Cell Carcinoma in individuals without localized symptomatic sites or brain metastases and good PS (0-2), without localized symptomatic sites or brain metastases and poor PS (3-4) due to small cell lung cancer, with localized symptomatic sites or with brain metastases The updated durvalumab (Imfinzi) clinical criteria has been updated to include the following: • Indicated as a single agent for recurrent or metastatic primary carcinoma of the urethra as subsequent systemic therapy post-platinum The updated nivolumab (Opdivo) clinical criteria has been updated to include the following: • May be given in combination with ipilimumab for colon and rectal cancer – adenocarcinoma • Treatment for relapsed/refractory Extranodal NK/T-Cell Lymphoma, Nasal Type following additional therapy with an alternate combination chemotherapy regimen (asparaginase-based) not previously used The updated pembrolizumab (Keytruda) clinical criteria has been updated to include the following: • As first-line treatment in combination with carboplatin and either paclitaxel or nab- paclitaxel for metastatic squamous NSCLC • Treatment of individuals with hepatocellular carcinoma who have been previously treated with sorafenib • Treatment of adult and pediatric individuals with recurrent locally advanced or metastatic merkel cell carcinoma • Single-agent treatment for limited brain metastases in individuals with melanoma or non-small cell lung cancer for newly diagnosed brain metastases in select patients (eg, patients with small asymptomatic brain metastases) with newly diagnosed or stable systemic disease or reasonable systemic treatment options or for recurrent brain metastases • Single-agent treatment for recurrent brain metastases in patients with melanoma or non-small cell lung cancer and stable systemic disease or reasonable systemic treatment options • Treatment of Adult individuals aged 18 years and older as subsequent systemic therapy as a single agent for refractory classic Hodgkin lymphoma or for those who have relapsed after three (3) or more prior lines of therapy
7 Medical Policy Update February 2019
• Subsequent treatment as a single agent for progressive Hepatocellular Carcinoma, Adenocarcinoma in individuals (Child-Pugh Class A only) who have unresectable disease and are not a transplant candidate, are inoperable by performance status or comorbidity, or have local disease or local disease with minimal extrahepatic disease only or have metastatic disease or extensive liver tumor burden • Adjuvant treatment for cutaneous melanoma as a single agent for stage III SLN positive disease during active nodal basin ultrasound surveillance or after CLND, for stage III disease with clinically positive node(s) following wide excision of primary tumor and a complete therapeutic lymph node dissection, for stage III disease with clinical or microscopic satellite/in-transit metastases if no evidence of disease post- surgery, for local satellite/in-transit recurrence if no evidence of disease post-surgery, following CLND and/or complete resection of nodal recurrence, or following complete resection of distant metastatic disease • Therapy for primary cutaneous anaplastic large cell lymphoma (ALCL) with multifocal lesions, or cutaneous ALCL with regional nodes (excludes systemic ALCL), as a single agent for relapsed/refractory disease • Expanded indications for non-small cell lung cancer • Subsequent systemic therapy for small cell lung cancer for individuals with PS 0-2 as a single agent for relapse within 6 months following complete or partial response or stable disease with initial treatment or primary progressive disease • Single-agent therapy of Alveolar Soft Part Sarcoma • Single agent for the treatment of metastatic undifferentiated pleomorphic sarcoma
The effective date will be April 29, 2019.
Please refer to Medical Policy I-120, Programmed Death Receptor (PD-1)/ Programmed Death-Ligand (PD-L1) Blocking Antibodies, for additional information.
Place of Service: Outpatient
8 Medical Policy Update February 2019
Coverage Guidelines Revised for Ocrelizumab (Ocrevus)
Highmark’s Medicare Advantage products have revised the clinical criteria for ocrelizumab (Ocrevus®). The clinical criteria have been revised to include that the individual must be 18 years of age or older, does not have active Hepatitis B virus infection, cannot receive a live vaccine for at least four (4) weeks prior to and during treatment with ocrelizumab (Ocrevus), and has not had a life-threatening reaction to ocrelizumab (Ocrevus). The clinical criteria for relapsing forms of multiple sclerosis (MS) require an Expanded Disability Status Scale (EDSS) scpre of 0 to 5.5. The clinical criteria for primary progressive ms require an EDSS score of 3 to 6.5 and an EDSS pyramidal functional system score of 2 or greater. This Medical Policy will apply to both professional provider and facility claims.
The effective date is April 29, 2019.
Please refer to Medical Policy I-171, Ocrelizumab (Ocrevus), for additional information.
Place of Service: Outpatient
Coverage Guidelines Revised for Rituximab (Rituxan)
Highmark’s Medicare Advantage products have revised clinical criteria for rituximab (Rituxan®). The clinical criteria coverage has been revised to include recent Food and Drug Administration (FDA) and National Comprehensive Cancer Network (NCCN) guidelines for rituximab (Rituxan) to include expanded indications for chronic lymphocytic leukemia/small lymphocytic lymphoma, B-cell lymphomas, and mantle cell lymphoma. The criteria also includes new indications for acute lymphoblastic leukemia, immune checkpoint inhibitor- related toxicities, histologic transformation of marginal zone lymphoma to diffuse large B-cell lymphoma and nodal marginal zone lymphoma. This Medical Policy will apply to both professional provider and facility claims.
The effective date is April 29, 2019.
Please refer to Medical Policy I-38, Rituximab (Rituxan) and Rituximab and Hyaluronidase Human (Rituxan Hycela), for additional information.
Place of Service: Outpatient
9 Medical Policy Update February 2019
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 Rituximab (Rituxan) and Rituximab and Hyaluronidase Human (Rituxan Hycela) ...... 1 Coverage Coverage Guidelines Revised for Programmed Death Receptor (PD-1)/ Programmed Death-Ligand (PD- L1) Blocking Antibodies ...... 3 Reminder: Coverage Criteria for Alpha1-Proteinase Inhibitor Infusions ...... 5 Coverage Guidelines Revised for Ocrelizumab (Ocrevus) ...... 5 Coverage Guidelines Reinstated for Donor Leukocyte Infusion for Hematologic Malignancies that Relapse after Allogeneic Cell Transplant...... 5 Coverage Guidelines Established for Rituximab and Hyaluronidase (Rituxan Hycela)...... 6 Coverage Guidelines Revised for Programmed Death Receptor (PD-1)/ Programmed Death-Ligand (PD-L1) Blocking Antibodies ...... 7 Coverage Guidelines Revised for Ocrelizumab (Ocrevus) ...... 9 Coverage Guidelines Revised for Rituximab (Rituxan) ...... 9 Comments on these new medical policies?...... 10 Contents...... 10
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.
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 2017, 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.
10