Contents Please refer to Medical Policy I-27, Certolizumab (Cimzia) for additional information.

Transcription

1 September 2017 In This Issue Coverage Criteria Revised for Golimumab (Simponi, Simponi Aria)... 2 Change in Policy Position for In Vitro Chemoresistance and Chemosensitivity Assays Revised Criteria for Electromyography (EMG) Contents Policy Coverage Criteria Revised for Certolizumab (Cimzia) Highmark West Virginia has revised the clinical criteria for certolizumab (Cimzia) to include two additional drug products; (tocilizumab (Actemra ) subcutaneous and tofacitinib (Xeljanz, Xeljanz XR), for step therapy for Rheumatoid Arthritis. Two additional drug products; ustekinumab (Stelara ) subcutaneous, and secukinumab (Cosentyx ), for step therapy for Psoriatic Arthritis. And one additional drug product; secukinumab (Cosentyx) for step therapy for Ankylosing Spondylitis before the use of certolizumab (Cimzia). The patient will still only be required to have had an adequate trial or experienced intolerance to at least two (2) of the preferred biologic products. This new criteria will apply to both professional provider and facility claims. The effective date is September 4, Please refer to Medical Policy I-27, Certolizumab (Cimzia) for additional information. Highmark Blue Cross Blue Shield West Virginia is an independent licensee of the Blue Cross and Blue Shield Association. NaviNet is a registered trademark of NaviNet, Inc., which is an independent company that provides a secure, web-based portal between providers and health care insurance companies.

2 Courtesy Update for Tocilizumab (Actemra) Highmark West Virginia has revised clinical criteria for Tocilizumab (Actemra ). The revised policy will apply to both professional provider and facility claims. The effective date was September 4, Tocilzumab subcutaneous (SQ) may be considered medically necessary when the individual meets the following: Inadequate response, intolerance, or contraindication to one (1) or more nonbiologic disease-modifying antirheumatic drugs (DMARDs) (i.e., methotrexate, leflunomide, sulfasalazine, hydroxychloroquine, or cyclosporine). Please refer to Medical Policy I-31, Tocilizumab (Actemra ) for additional information. Criteria Updated for Golimumab (Simponi, Simponi Aria) Highmark West Virginia has revised clinical criteria for Golimumab (Simponi, Simponi Aria ). The revised policy will apply to both professional provider and facility claims. The effective date is November 27, Golimumab (Simponi) subcutaneous injection (SQ): Rheumatoid Arthritis (RA) Golimumab SQ is used for the treatment of moderately to severely active RA in combination with methotrexate; and Has or had an adequate trial or experienced intolerance to at least two (2) of the preferred biologic products, which include adalimumab (Humira ), etanercept (Enbrel ), tocilizumab (Actemra ) subcutaneous, and tofacitinib (Xeljanz, Xeljanz XR). Psoriatic Arthritis Golimumab SQ is used for the treatment of active psoriatic arthritis alone or in combination with methotrexate; and Has or had an adequate trial or experienced intolerance to at least two (2) of the preferred biologic products, which include adalimumab (Humira), etanercept (Enbrel), ustekinumab (Stelara) subcutaneous, and secukinumab (Cosentyx ). Ankylosing Spondylitis Golimumab SQ is used for the treatment of active ankylosing spondylitis; and Has or had an adequate trial or experienced intolerance to at least two (2) of the preferred biologic products, which include adalimumab (Humira), etanercept (Enbrel), and secukinumab (Cosentyx). Please refer to Medical Policy I-35, Golimumab (Simponi, Simponi Aria ) for additional information. 2

3 Coverage Criteria Revised for Ustekinumab (Stelara) Highmark West Virginia has revised the clinical criteria for Ustekinumab (Stelara ) Ustekinumab (Stelara) subcutaneous (SQ) may be considered medically necessary to treat individuals with moderately to severely active Crohn s disease when ONE of the following are met: Treatment with at least two immunosuppressants (e.g. corticosteroids, azathioprine, 6-mercaptopurine, or methotrexate) was ineffective or not tolerated; or immunosuppressants are contraindicated; or The patient received a single induction dose of Stelara IV and achieved clinical response or remission; or Treatment with adalimumab (Humira) for the treatment of Crohn s disease was ineffective or not tolerated. Ustekinumab (Stelara) intravenous (IV) may be considered medically necessary to treat individuals with moderately to severely active Crohn s disease who have failed or were intolerant to the following treatment: Immunomodulators or corticosteroids, but never failed a tumor necrosis factor (TNF) blocker; or One or more TNF blocker. The use of ustekinumab (Stelara) for any other indication or in combination with any other biologic DMARD (e.g. Humira, Remicade, Cimzia, etc.) is considered experimental/ investigational, and therefore, not covered because its effectiveness for these indications has not been established. This new criteria will apply to both professional provider and facility claims. The effective date is November 27, Please refer to Medical Policy I-37, Ustekinumab (Stelara ) for additional information. Coverage Criteria Revised for Carfilzomib (Kyprolis) Highmark West Virginia has revised coverage criteria for carfilzomib (Kyprolis ) based on the FDA approved indications and National Comprehensive Cancer Network (NCCN) recommendations. This new criteria will apply to both professional provider and facility claims. The effective date is November 27, Please refer to Medical Policy I-41, Carfilzomib (Kyprolis ) for additional information. 3

4 Coverage Criteria Revised for Pemetrexed (Alimta) Highmark West Virginia has revised the clinical criteria for pemetrexed (Alimta ) based on the FDA approved indications and National Comprehensive Cancer Network (NCCN) recommendations. This new criteria will apply to both professional provider and facility claims. The effective date is November 27, Please refer to Medical Policy I-74, Pemetrexed (Alimta ) for additional information. Coverage Criteria Revised for Abatacept (Orencia) IV and SC Highmark West Virginia has revised the clinical criteria for abatacept (Orencia ) IV and SC. Abatacept SC may be considered medically necessary for the treatment of active psoriatic arthritis when the individual has a history of beneficial response to abatacept SC; or When ALL of the following indications are met: Abatacept (Orencia) SC is to be used in the treatment of adults with active psoriatic arthritis; and Treatment with at least one nonbiologic DMARD (e.g. methotrexate, leflunomide, sulfasalazine, hydroxychloroquine, or cyclosporine) was ineffective or not tolerated, or all nonbiologic DMARDs are contraindicated; and Treatment with at least TWO of the following preferred products was ineffective or not tolerated, or ALL of these preferred products are contraindicated: o adalimumab (Humira ) o etanercept (Enbrel ) o ustekinumab (Stelara ) o secukinumab (Cosentyx ) Juvenile Idiopathic Arthritis (JIA)/Juvenile Rheumatoid Arthritis (JRA) Abatacept (Orencia) SC may be considered medically necessary for the treatment of moderately to severely active JIA/JRA when the individual has a history of beneficial response to abatacept SC; or When ALL of the following indications are met: Abatacept (Orencia) SC is to be used for reducing the signs and symptoms of moderately to severely active JIA/JRA in patients greater than or equal to 2 years of age; and Treatment with adalimumab (Humira) and etanercept (Enbrel) has been ineffective or not tolerated, or both of these preferred products are contraindicated; and Treatment with at least TWO of the following preferred products was ineffective or not tolerated, or all of these preferred products are contraindicated: o adalimumab (Humira) o etanercept (Enbrel) o ustekinumab (Stelara) 4

5 o secukinumab (Cosentyx) This new criteria will apply to both professional provider and facility claims. The effective date is November 27, Please refer to Medical Policy I-90, Abatacept (Orencia ) IV and SC for additional information. Coverage Criteria Revised for Radium Ra 223 Dichloride for Treatment of Prostate Cancer Highmark West Virginia has revised coverage criteria for Radium Ra 223 Dichloride for treatment of prostate cancer. The following criteria requirements have been added to the policy in addition to the existing criteria. Prior to the initial dose, the individual must have an absolute neutrophil count greater than or equal to 1.5X10 9 /L, platelet count greater than or equal to 100X10 9 /L, and a hemoglobin greater than or equal to 10g/dL; and Prior to the subsequent doses, patients must have absolute neutrophil count greater than or equal to 1X10 9 /L and platelet count greater than or equal to 50X10 9 /L; and Radium RA 223 dichloride should be discontinued if a delay of 6-8 weeks does not result in return of blood counts to these levels. This new criteria will apply to both professional provider and facility claims. The effective date is November 27, Please refer to Medical Policy I-97, Radium Ra 223 Dichloride for Treatment of Prostate Cancer for additional information. 5

6 Coverage Criteria and Policy Title Revised for PD-1 and PD-L1 Blocking Antibodies Highmark West Virginia has established additional criteria for oncologic indications for PD-1 blocking antibodies. The revised criteria will apply to both professional provider and facility claims. The effective date is November 27, The following Oncologic PD-1 Blocking Antibodies have been added: Avelumab (Bavencio) Durvalumab (Imfinzi) New indications have been added for the following: Pembrolizumab (Keytruda) Nivolumab (Opdivo) Atezolizumab (Tecentriq) Please refer to Medical Policy I-120, Oncologic Indications for PD-1 Blocking Antibodies for additional information. Coverage Criteria Established for Octreotide acetate (Sandostatin, Sandostatin LAR) and Lanreotide (Somatuline Depot) Highmark West Virginia has established coverage criteria for octreotide acetate (Sandostatin, Sandostatin LAR) and Lanreotide (Somatuline Depot). Octreotide acetate (Sandostatin) may be considered medically necessary for ANY of the following indications: Acromegaly for patients who have had an inadequate response to or cannot be treated with: o Surgical resection; or o Pituitary irradiation; or o Bromocriptine mesylate at maximally tolerated doses; or Severe diarrhea and /or flushing episodes associated with metastatic carcinoid tumors; or Profuse watery diarrhea associated with Vasoactive Intestinal Peptide (VIP) secreting tumors; or Central Nervous System Cancers Meningiomas when used as: o Treatment for surgically inaccessible recurrent or progressive meningiomas when further radiation is not possible; or Neuroendocrine Tumors - Adrenal Gland Tumors: o For symptom control if somatostatin receptor scintigraphy is positive in patients with non-adrenocorticotropic hormone (ACTH)-dependent Cushing's syndrome with tumors less than 4 cm, benign imaging characteristics, and abnormal contralateral gland and symmetric cortisol production; or Neuroendocrine Tumors - Neuroendocrine Tumors of the GI Tract, Lung, and Thymus when used as: o Primary treatment for unresected primary gastrinoma; or 6

7 o Management of locoregional unresectable disease and/or distant metastases as a single agent or in combination with other systemic therapies; if disease progression, treatment with octreotide may be continued in combination with any of the subsequent treatment options; or o Treatment of underlying Zollinger-Ellison syndrome; or o Prophylactic treatment prior to surgery for gastrinoma; or Neuroendocrine Tumors - Neuroendocrine Tumors of the Pancreas when used as: o Treatment of symptoms related to hormone hypersecretion; if disease progression, treatment with octreotide may be continued in combination with any of the subsequent treatment options; or Thymomas and Thymic Carcinomas when used as second-line therapy with or without prednisone; or Poorly Differentiated (High Grade)/Large or Small Cell for symptom control if somatostatin scintigraphy positive; or Acquired immune deficiency syndrome (AIDS) - treatment of severe secretory diarrhea associated with AIDS when anti-microbial (e.g., ciprofloxacin or metronidazole) or anti-motility agents (e.g., loperamide or diphenoxylate and atropine) have become ineffective; or Bowel obstruction - management of gastrointestinal (GI) symptoms (e.g., nausea, pain, vomiting) of inoperable bowel obstruction in persons with terminal cancer; or Amelioration of volume depletion from enterocutaneous fistulae; or Prevention and treatment of pancreatic fistulas following pancreatic surgery; or Bleeding gastroesophageal (GE) varices when BOTH of the following are met: o GE varices are associated with liver disease; and o Octreotide acetate is used in combination with endoscopic therapy (that is, band ligation or sclerotherapy) or alone if endoscopic therapy is not immediately available; or Chemotherapy or radiation-induced diarrhea that is unresponsive to conventional antidiarrheal medications (e.g., diphenoxylate and atropine or loperamide). Octreotide acetate (Sandostatin LAR) may be considered medically necessary for ANY the following indications: Acromegaly for patients who have had an inadequate response to or cannot be treated with: o Surgical resection; or o Pituitary irradiation; or o Bromocriptine mesylate at maximally tolerated doses; or Severe diarrhea and/or flushing episodes associated with metastatic carcinoid tumors; or Profuse watery diarrhea associated with Vasoactive Intestinal Peptide (VIP) secreting tumors; or Central Nervous System Cancers - Meningiomas when used as: o Treatment for surgically inaccessible recurrent or progressive meningiomas when further radiation is not possible; or Neuroendocrine Tumors - Adrenal Gland Tumors: o For symptom control if somatostatin receptor scintigraphy is positive in patients with non-adrenocorticotropic hormone (ACTH)-dependent 7

8 Cushing's syndrome with tumors less than 4 cm, benign imaging characteristics, and abnormal contralateral gland and symmetric cortisol production; or Neuroendocrine Tumors - Neuroendocrine Tumors of the GI Tract, Lung, and Thymus when used as: o Primary treatment for unresected primary gastrinoma; or o Management of locoregional unresectable disease and/or distant metastases as a single agent or in combination with other systemic therapies; if disease progression, treatment with octreotide may be continued in combination with any of the subsequent treatment options; or o Treatment of underlying Zollinger-Ellison syndrome; or o Prophylactic treatment prior to surgery for gastrinoma; or o Treatment of carcinoid syndrome when used as: As a single agent; or In combination with telotristat for persistent diarrhea due to poorly controlled carcinoid syndrome; or In combination with subsequent treatment options for persistent symptoms such as flushing or diarrhea; or Neuroendocrine Tumors - Neuroendocrine Tumors of the Pancreas when used as: o Treatment of symptoms related to hormone hypersecretion; if disease progression, treatment with octreotide may be continued in combination with any of the subsequent treatment options; or o For tumor control in patients with unresectable locoregional disease and/or metastatic disease and clinically significant tumor burden or clinically significant progression if not already given; or Thymomas and Thymic Carcinomas when used as second-line therapy with or without prednisone; or Poorly Differentiated (High Grade)/Large or Small Cell for symptom control if somatostatin scintigraphy positive; or Acquired immune deficiency syndrome (AIDS) - treatment of severe secretory diarrhea associated with AIDS when anti-microbial (e.g., ciprofloxacin or metronidazole) or anti-motility agents (e.g., loperamide or diphenoxylate and atropine) have become ineffective; or Bowel obstruction - management of gastrointestinal (GI) symptoms (e.g., nausea, pain, vomiting) of inoperable bowel obstruction in persons with terminal cancer; or Amelioration of volume depletion from enterocutaneous fistulae; or Prevention and treatment of pancreatic fistulas following pancreatic surgery; or Bleeding gastroesophageal (GE) varices when BOTH of the following are met: o GE varices are associated with liver disease; and o Octreotide acetate is used in combination with endoscopic therapy (that is, band ligation or sclerotherapy) or alone if endoscopic therapy is not immediately available; or Chemotherapy or radiation-induced diarrhea that is unresponsive to conventional antidiarrheal medications (e.g., diphenoxylate and atropine or loperamide). Lanreotide (Somatuline Depot) may be considered medically necessary for ANY the following indications: Neuroendocrine Tumors - Adrenal Gland Tumors for: 8

9 o Symptom control if somatostatin receptor scintigraphy is positive in patients with non-adrenocorticotropic hormone (ACTH)-dependent Cushing's syndrome with tumors less than 4 cm, benign imaging characteristics, and abnormal contralateral gland and symmetric cortisol production; or Neuroendocrine Tumors - Neuroendocrine Tumors of the GI Tract, Lung, and Thymus as: o Primary treatment for unresected primary gastrinoma; or o Management of locoregional unresectable disease and/or distant metastases as a single agent or in combination with other systemic therapies; if disease progression, treatment with lanreotide may be continued in combination with any of the subsequent treatment options; or o Treatment of carcinoid syndrome: As a single agent; or In combination with telotristat for persistent diarrhea due to poorly controlled carcinoid syndrome; or In combination with subsequent treatment options for persistent symptoms such as flushing or diarrhea; or Neuroendocrine Tumors - Neuroendocrine Tumors of the Pancreas for: o Treatment of symptoms related to hormone hypersecretion; if disease progression, treatment with lanreotide may be continued in combination with any of the subsequent treatment options; or o For tumor control in patients with unresectable locoregional disease and/or metastatic disease and clinically significant tumor burden or clinically significant progression if not already given; or Treatment of patients with unresectable, well-or moderately-differentiated, locally advanced or metastatic gastroenteropancreatic neuroendocrine tumors (GEP-NETs) to improve progression-free survival; or For the long-term treatment of acromegaly in patients who have had an inadequate response to surgery and/or radiotherapy, or for whom surgery and/or radiotherapy is not an option. This new criteria will apply to both professional provider and facility claims. The effective date is November 27, Please refer to Medical Policy I-175, Octreotide acetate (Sandostatin, Sandostatin LAR) and Lanreotide (Somatuline Depot) for additional information. 9

10 Revised Coverage Criteria for Wireless Capsule Endoscopy as a Diagnostic Technique in Disorders of the Small Bowel, Esophagus, and Colon Highmark West Virginia has revised coverage criteria for Wireless Capsule Endoscopy as a Diagnostic Technique in Disorders of the Small Bowel, Esophagus, and Colon. These criteria will apply to both professional provider and facility claims. The effective date is November 27, Wireless capsule endoscopy (WCE) of the small intestine may be considered medically necessary for ages 2 years and older for the following indications when conventional endoscopic and diagnostic imaging evaluations (e.g., upper gastrointestinal endoscopy, colonoscopy, push enteroscopy, nuclear imaging, or radiological procedure) are inconclusive: To investigate anemia with concomitant iron deficiency, suspected to be of small bowel origin, after appropriate evaluation (at a minimum lower and upper endoscopy) has excluded a source of anemia from the upper GI tract and colon. WCE is considered experimental and investigational for all other indications including but not limited to the following because of insufficient evidence of efficacy and safety; therefore considered non-covered: Use of a patency capsule. Please refer to Medical Policy G-41, Wireless Capsule Endoscopy as a Diagnostic Technique in Disorders of the Small Bowel, Esophagus, and Colon for additional information. Change in Policy Position for In Vitro Chemoresistance and Chemosensitivity Assays Highmark West Virginia has changed its policy position for in vitro chemoresistance and chemosensitivity testing. These assays will be considered experimental/investigational. There is insufficient evidence that chemosensitivity or chemoresistance testing affects clinical decision-making and that health outcomes are improved as a result of the testing. This policy will apply to both professional provider and facility claims. The effective date is November 27, Please refer to Medical Policy L-58, In Vitro Chemoresistance and Chemosensitivity Assays, for additional information. 10

11 Revised Criteria for Electromyography (EMG) Effective November 27, 2017, clinical criteria for Electromyography (EMG) have been revised. Additionally, Highmark (HMK) Medical Policy M-51, Nerve Conduction Studies is combined with HMK Medical Policy M-28, Electromyography (EMG). The policy title will reflect this change by being revised to: Nerve Conduction Studies and Electromyography (EMG) and applies both to Professional and Facility Claims. The following clinical indication has been added under the EMG policy criteria: Recurrent laryngeal neuropathy (RLN), (unilateral or bilateral vocal cord fold paralysis) that is greater than 4 weeks, but less than 6 months in duration. Additionally, criteria have been added to reflect electrodiagnostic assessment that consists of EMG and NVC may be considered medically necessary as an adjunct to history, physical exam and imaging studies. A repeat electrodiagnostic assessment may be considered medically necessary when at least ONE of the following criteria have been met: Development of new symptoms or signs suggesting a second diagnosis in a patient who has received an initial diagnosis; or Interim progression of disease following an initial test that was inconclusive, such that a repeat test is likely to elicit additional findings; or Unexpected change(s) in the course of disease or response to treatment, suggesting that the initial diagnosis may be incorrect and that reexamination is indicated. The following tests are considered experimental/investigational: Automated non-invasive electro-diagnostic testing with a computerized handheld device (e.g., NC-stat ) to stimulate and measure neuromuscular signals; and Quantitative sensory testing (QST) which is the assessment of perceptual and/or physiological responses to pain. Criteria Updated for Upper Gastrointestinal Endoscopy/Esophagoscopy Highmark West Virginia has revised the clinical criteria for Upper Gastrointestinal Endoscopy/Esophagoscopy. The revisions will apply to both professional provider and facility claims. The effective date is November 27, High Risk Screening Esophagogastroduodenoscopy (EGD) EGD/upper endoscopy may be considered medically necessary for high risk screening in the following conditions: Individuals with a family history of esophageal or gastric cancer; or Individuals with familial adenomatous polyposis (FAP) syndrome; or Individuals being considered for bariatric surgery in which the presence of upper 11

12 gastrointestinal (GI) pathological conditions might modify planned management. Diagnostic EGD Diagnostic EGD may be considered medically necessary for the following criteria: Individuals with a positive tissue transglutaminase (TTG); or Individuals with symptomatic pernicious anemia (e.g., anemia, fatigue, pallor, red tongue, shortness of breath, as well as tingling and numbness in the hands and feet) to identify prevalent lesions (e.g., carcinoid tumors, gastric cancer). Therapeutic EGD Therapeutic EGD may be considered medically necessary for the following criteria: Endoscopic mucosal resection for suspicious lesions of the upper layer. Sequential or Periodic EGD Sequential or periodic EGD may be considered medically necessary in the following conditions: To assess for healing or Barrett s in patients with severe erosive esophagitis or ulcer after a two (2) month course of PPI therapy; or Follow-up of individuals with dysplastic Barrett s esophagus (BE) after ablative therapy every three (3) to six (6) months for one (1) year; or Follow-up of esophageal, gastric or stomal ulcers to demonstrate healing in patients with continued symptoms despite adequate medical therapy trial in two (2) to four (4) months; or Follow-up in individuals with prior adenomatous gastric polyps in one (1) year after resection six (6) months after resection of sessile and dysplastic polyps and in high risk patients every one (1) to three (3) years; or Follow-up of individuals after treatment of esophageal varices every one (1) to three (3) months till varices adequately treated; or Follow-up of individuals after endoscopic mucosal resection every three (3) to six (6) months until completion of resection; or Follow-up of gastric intestinal metaplasia every one (1) to three (3) years. Endoscopic retrograde cholangiopancreatography (ERCP) ERCP may be considered medically necessary for the following biliary and pancreatic conditions: Traumatic pancreatitis to accurately localize the injury and provide endoscopic drainage; or Pancreatic duct stricture evaluation; or The extraction of bile duct stones in severe gallstone induced pancreatitis; or Detecting pancreatic ductal changes in chronic pancreatitis and also the presence of calcified stones in the ductal system. A pancreatogram may be 12

13 performed and is likely to be abnormal in chronic alcoholic pancreatitis but less so in non-alcoholic induced types; or Individuals with radiologic imaging suggestive of common bile duct stones or other potential pathology. ERCP is considered not medically necessary for the following: The diagnosis of pancreatitis except for suspected gallstone pancreatitis; and Early stages of, or in acute pancreatitis and could possibly exacerbate it. Endoscopic ultrasound (EUS) EUS may be considered medically necessary for ANY of the following indications: Diagnosis of common bile duct stones; or Evaluate abnormalities of the biliary tree; or Evaluate abnormalities of the gastrointestinal tract wall or adjacent structures; or Evaluate abnormalities of the pancreas, including masses, pseudocysts and chronic pancreatitis; or Evaluate adenopathy and masses of the posterior mediastinum (endoscopic ultrasonography with fine-needle aspiration); or Gallbladder drainage for acute cholecystitis; or Pre-operative staging of gastric cancer; or Providing endoscopic therapy of the gastrointestinal tract under ultrasonographic guidance; or Tissue sampling of lesions within, or adjacent to, the wall of the gastrointestinal tract; or Staging of lung cancer (endoscopic ultrasonography with fine-needle aspiration); or Staging tumors of the gastrointestinal tract, pancreas and bile ducts; or Follow-up of certain gastric subepithelial masses (asymptomatic glomus tumors or small (less than 3 cm) gastrointestinal stromal tumors). Please refer to Medical Policy M-77, Upper Gastrointestinal Endoscopy/Esophagoscopy for additional information. 13

14 New Policy Established for Noninvasive Techniques for the Evaluation and Monitoring of Patients with Chronic Liver Disease Highmark West Virginia has established new coverage criteria for noninvasive techniques for the evaluation and monitoring of patients with chronic liver disease. The new criteria will apply to both professional provider and facility claims. The effective date is November 27, Place of Service: Inpatient/Outpatient Please refer to Medical Policy M-79, Noninvasive Techniques for the Evaluation and Monitoring of Patients With Chronic Liver Disease for additional information. Coverage Criteria Updated for Bio-Engineered Skin and Soft Tissue Substitutes Highmark West Virginia has revised the clinical criteria for Bio-Engineered Skin and Soft Tissue Substitutes. This new criteria will apply to both professional and facility claims. The effective date was September 18, AlloMend added for use in breast reconstructive surgery. AlloPatch added for the treatment of chronic, noninfected, full-thickness diabetic lower extremity ulcers. Please refer to Medical Policy S-33, Bio-Engineered Skin and Soft Tissue Substitutes for coverage criteria and additional information. New Policy Established for Total Hip and Total Knee Arthroplasty Highmark West Virginia has established new coverage criteria for total hip and total knee arthroplasty. The new criteria will apply to professional provider claims. The effective date is November 27, Place of Service: Inpatient Please refer to Medical Policy S-247, Total Hip and Total Knee Arthroplasty for additional information. 14

15 Revised Criteria for Eculizumab In the June 2017 Medical Policy Update, Highmark announced that beginning August 28, 2017, criteria was revised for Eculizumab. Highmark has postponed the publication of Medical Policy I-130 Eculizumab until November 27, Highmark West Virginia considers the following criteria medically necessary for the administration of Eculizumab: The following criteria have been added to the policy: Change in the perimeter for Flow Cytometry results have been changed from greater than or equal to 10% of glycosylphosphatidylinositol-anchored proteins (GPI-AP)-deficient polymorphonuclear cells (PMNs) to 50% of glycosylphosphatidylinositol-anchored proteins (GPI-AP)-deficient polymorphonuclear cells (PMNs). Qualifications for specific major adverse vascular events (MAVE) are now listed. Member clinical criteria for Hemoglobin that is less than or equal to 7 g/dl, or the individual has symptoms of anemia and the hemoglobin is less than equal to 9 g/dl; or evidence of clinically elevated hemolysis lactate dehydrogenase (LDH) greater than or equal to 1.5 times the upper limit of normal (ULN) has been added to the policy. Please refer to Medical Policy I-130, Eculizumab for additional information. 15

16 Medicare Advantage Policy Coverage Criteria Revised for Carfilzomib (Kyprolis) Highmark s Medicare Advantage product has revised coverage criteria carfilzomib (Kyprolis ) based on the FDA approved indications and National Comprehensive Cancer Network (NCCN) recommendations. This new criteria will apply to both professional provider and facility claims. The effective date is November 27, Please refer to Medical Policy I-57, Carfilzomib (Kyprolis ) for additional information. Coverage Criteria Revised for Pemetrexed (Alimta) Highmark s Medicare Advantage product has revised coverage criteria pemetrexed (Alimta ) based on the FDA approved indications and National Comprehensive Cancer Network (NCCN) recommendations. This new criteria will apply to both professional provider and facility claims. The effective date is November 27, Please refer to Medical Policy I-74, Pemetrexed (Alimta ) for additional information. Coverage Criteria Revised for Radium Ra 223 Dichloride for Treatment of Prostate Cancer Highmark s Medicare Advantage product has established coverage criteria for Radium Ra 223 Dichloride for treatment of prostate cancer. Radium Ra 223 Dichloride for Treatment of Prostate Cancer (Xofigo ) may be considered medically necessary when ALL of the following criteria are met: The individual has been diagnosed with metastatic castration-resistant prostate cancer (CRPC); and The individual has symptomatic skeletal (bone) metastases; and The individual has no known past or current lymph nodes or visceral metastatic disease on imaging within the past thirty (30) days; and The individual has received and exhausted all medical or surgical-ablative hormonal treatments. The individual may be kept on his ablative hormonal treatment to maintain a castrate level in accordance with National Comprehensive Cancer Network (NCCN) guidelines; and Prior to the initial dose, the individual must have an absolute neutrophil count greater 16

17 than or equal to 1.5X10 9 /L, platelet count greater than or equal to 100X10 9 /L, and a hemoglobin greater than or equal to 10g/dL; and Prior to the subsequent doses, patients must have absolute neutrophil count greater than or equal to 1X10 9 /L and platelet count greater than or equal to 50X10 9 /L; and Radium RA 223 dichloride should be discontinued if a delay of 6-8 weeks does not result in return of blood counts to these levels; and Medically or surgically-castration resistant prostate cancer, as defined by: o A serum testosterone level of less than less than or equal to 50 ng/dl and EITHER: Sequential rise of prostate specific antigen (PSA) levels (two consecutive increases over the previous reference value ); or Worsening of existing bone metastases or development of new bone metastases on a bone scan performed within the past 60 days despite androgen-deprivation treatment. Radium Ra 223 Dichloride for Treatment of Prostate Cancer (Xofigo) is considered not medically necessary for any other indications not stated above. Concurrent chemotherapy with Xofigo is considered experimental/investigational and therefore non-covered. Scientific evidence does not support its use with concurrent chemotherapy. This new criteria will apply to both professional provider and facility claims. The effective date is November 27, Please refer to Medical Policy I-97, Radium Ra 223 Dichloride for Treatment of Prostate Cancer for additional information. Coverage Criteria and Policy Title Revised for PD-1 and PD-L1 Blocking Antibodies Highmark s Medicare Advantage product has established additional criteria for oncologic indications for PD-1 blocking antibodies. The revised criteria will apply to both professional provider and facility claims. The effective date is November 27, The following Oncologic PD-1 Blocking Antibodies have been added: Avelumab (Bavencio) Durvalumab (Imfinzi) New indications have been added for the following: Pembrolizumab (Keytruda) Nivolumab (Opdivo) Atezolizumab (Tecentriq) 17

18 Please refer to Medical Policy I-120, Oncologic Indications for PD-1 Blocking Antibodies for additional information. Coverage Criteria Established for Octreotide acetate (Sandostatin, Sandostatin LAR) and Lanreotide (Somatuline Depot) Highmark s Medicare Advantage product has established coverage criteria for octreotide acetate (Sandostatin, Sandostatin LAR) and Lanreotide (Somatuline Depot). Octreotide acetate (Sandostatin) may be considered medically necessary for ANY of the following indications: Acromegaly for patients who have had an inadequate response to or cannot be treated with: o Surgical resection; or o Pituitary irradiation; or o Bromocriptine mesylate at maximally tolerated doses; or Severe diarrhea and /or flushing episodes associated with metastatic carcinoid tumors; or Profuse watery diarrhea associated with Vasoactive Intestinal Peptide (VIP) secreting tumors; or Central Nervous System Cancers - Meningiomas when used as: o Treatment for surgically inaccessible recurrent or progressive meningiomas when further radiation is not possible; or Neuroendocrine Tumors - Adrenal Gland Tumors: o For symptom control if somatostatin receptor scintigraphy is positive in patients with non-adrenocorticotropic hormone (ACTH)-dependent Cushing's syndrome with tumors less than 4 cm, benign imaging characteristics, and abnormal contralateral gland and symmetric cortisol production; or Neuroendocrine Tumors - Neuroendocrine Tumors of the GI Tract, Lung, and Thymus when used as: o Primary treatment for unresected primary gastrinoma: or o Management of locoregional unresectable disease and/or distant metastases as a single agent or in combination with other systemic therapies; if disease progression, treatment with octreotide may be continued in combination with any of the subsequent treatment options; or o Treatment of underlying Zollinger-Ellison syndrome; or o Prophylactic treatment prior to surgery for gastrinoma; or Neuroendocrine Tumors - Neuroendocrine Tumors of the Pancreas when used as: o Treatment of symptoms related to hormone hypersecretion; if disease progression, treatment with octreotide may be continued in combination with any of the subsequent treatment options; or Thymomas and Thymic Carcinomas when used as second-line therapy with or without prednisone; or Poorly Differentiated (High Grade)/Large or Small Cell for symptom control if somatostatin scintigraphy positive; or Acquired immune deficiency syndrome (AIDS) - treatment of severe secretory diarrhea associated with AIDS when anti-microbial (e.g., ciprofloxacin or metronidazole) or anti-motility agents (e.g. loperamide or diphenoxylate and atropine) have become ineffective; or Bowel obstruction - management of gastrointestinal (GI) symptoms (e.g., nausea, pain, vomiting) of inoperable bowel obstruction in persons with terminal cancer; or 18

19 Amelioration of volume depletion from enterocutaneous fistulae: or Prevention and treatment of pancreatic fistulas following pancreatic surgery; or Bleeding gastroesophageal (GE) varices when BOTH of the following are met: o GE varices are associated with liver disease; and o Octreotide acetate is used in combination with endoscopic therapy (that is, band ligation or sclerotherapy) or alone if endoscopic therapy is not immediately available; or Chemotherapy or radiation-induced diarrhea that is unresponsive to conventional antidiarrheal medications (e.g., diphenoxylate and atropine or loperamide). Octreotide acetate (Sandostatin LAR) may be considered medically necessary for ANY the following indications: Acromegaly for patients who have had an inadequate response to or cannot be treated with: o Surgical resection; or o Pituitary irradiation; or o Bromocriptine mesylate at maximally tolerated doses; or Severe diarrhea and /or flushing episodes associated with metastatic carcinoid tumors; or Profuse watery diarrhea associated with Vasoactive Intestinal Peptide (VIP) secreting tumors; or Central Nervous System Cancers - Meningiomas when used as: o Treatment for surgically inaccessible recurrent or progressive meningiomas when further radiation is not possible; or Neuroendocrine Tumors - Adrenal Gland Tumors: o For symptom control if somatostatin receptor scintigraphy is positive in patients with non-adrenocorticotropic hormone (ACTH)-dependent Cushing's syndrome with tumors less than 4 cm, benign imaging characteristics, and abnormal contralateral gland and symmetric cortisol production; or Neuroendocrine Tumors - Neuroendocrine Tumors of the GI Tract, Lung, and Thymus when used as: o Primary treatment for unresected primary gastrinoma: or o Management of locoregional unresectable disease and/or distant metastases as a single agent or in combination with other systemic therapies; if disease progression, treatment with octreotide may be continued in combination with any of the subsequent treatment options; or o Treatment of underlying Zollinger-Ellison syndrome; or o Prophylactic treatment prior to surgery for gastrinoma; or o Treatment of carcinoid syndrome when used as: As a single agent; or In combination with telotristat for persistent diarrhea due to poorly controlled carcinoid syndrome; or In combination with subsequent treatment options for persistent symptoms such as flushing or diarrhea; or Neuroendocrine Tumors - Neuroendocrine Tumors of the Pancreas when used as: o Treatment of symptoms related to hormone hypersecretion; if disease progression, treatment with octreotide may be continued in combination with any of the subsequent treatment options; or o For tumor control in patients with unresectable locoregional disease and/or metastatic disease and clinically significant tumor burden or clinically significant progression if not already given; or Thymomas and Thymic Carcinomas when used as second-line therapy with or 19

20 without prednisone; or Poorly Differentiated (High Grade)/Large or Small Cell for symptom control if somatostatin scintigraphy positive; or Acquired immune deficiency syndrome (AIDS) - treatment of severe secretory diarrhea associated with AIDS when anti-microbial (e.g., ciprofloxacin or metronidazole) or anti-motility agents (eg. loperamide or diphenoxylate and atropine) have become ineffective; or Bowel obstruction - management of gastrointestinal (GI) symptoms (e.g., nausea, pain, vomiting) of inoperable bowel obstruction in persons with terminal cancer; or Amelioration of volume depletion from enterocutaneous fistulae: or Prevention and treatment of pancreatic fistulas following pancreatic surgery; or Bleeding gastroesophageal (GE) varices when BOTH of the following are met: o GE varices are associated with liver disease; and o Octreotide acetate is used in combination with endoscopic therapy (that is, band ligation or sclerotherapy) or alone if endoscopic therapy is not immediately available; or Chemotherapy or radiation-induced diarrhea that is unresponsive to conventional antidiarrheal medications (e.g., diphenoxylate and atropine or loperamide). Lanreotide (Somatuline Depot) may be considered medically necessary for ANY the following indications: Neuroendocrine Tumors - Adrenal Gland Tumors for: o Symptom control if somatostatin receptor scintigraphy is positive in patients with non-adrenocorticotropic hormone (ACTH)-dependent Cushing's syndrome with tumors less than 4 cm, benign imaging characteristics, and abnormal contralateral gland and symmetric cortisol production; or Neuroendocrine Tumors - Neuroendocrine Tumors of the GI Tract, Lung, and Thymus as: o Primary treatment for unresected primary gastrinoma; or o Management of locoregional unresectable disease and/or distant metastases as a single agent or in combination with other systemic therapies; if disease progression, treatment with lanreotide may be continued in combination with any of the subsequent treatment options; or o Treatment of carcinoid syndrome: As a single agent; or In combination with telotristat for persistent diarrhea due to poorly controlled carcinoid syndrome; or In combination with subsequent treatment options for persistent symptoms such as flushing or diarrhea; or Neuroendocrine Tumors - Neuroendocrine Tumors of the Pancreas for: o Treatment of symptoms related to hormone hypersecretion; if disease progression, treatment with lanreotide may be continued in combination with any of the subsequent treatment options; or o For tumor control in patients with unresectable locoregional disease and/or metastatic disease and clinically significant tumor burden or clinically significant progression if not already given; or Treatment of patients with unresectable, well-or moderately-differentiated, locally advanced or metastatic gastroenteropancreatic neuroendocrine tumors (GEP-NETs) to improve progression-free survival; or For the long-term treatment of acromegaly in patients who have had an inadequate response to surgery and/or radiotherapy, or for whom surgery and/or radiotherapy is not an option. 20

21 This new criteria will apply to both professional provider and facility claims. The effective date is November 27, Please refer to Medical Policy I-175, Octreotide acetate (Sandostatin, Sandostatin LAR) and Lanreotide (Somatuline Depot) for additional information. Coverage Criteria Revised for Alpha 1 Proteinase Inhibitor Infusions Highmark s Medicare Advantage product has revised clinical criteria for Alpha 1 Proteinase Inhibitor infusions. Based on the FDA approved indications, this new criteria will apply to both professional provider and facility claims. The effective date is November 27, The following criteria has been changed in the policy: There is a documented high risk phenotype** resulting in a low serum concentration of Alpha 1 antitrypsin (AAT), as evidenced by less than 80 mg per deciliter (mg/dl) (0.8 g/l) by radial immundiffusion (or less than 50 mg/dl (0.5 g/l) if measured by nephelometry) or less than 11 um/l (35 % of normal). ** PiZZ, PiZ, or Pi phenotype (homozygous) or other phenotypes, (PiSZ or PiMS) associated with serum AAT concentrations of less than 80 mg/dl. Please refer to Medical Policy I-126, Alpha 1 Proteinase Inhibitor Infusions for additional information. Coverage Criteria Revised for Decitabine (Dacogen) Highmark s Medicare Advantage product has revised clinical criteria for Decitabine (Dacogen ) based on the FDA approved indications and the National Comprehensive Cancer Network (NCCN). This new criteria will apply to both professional provider and facility claims. The following criteria were added to Medical Policy I-128: Treatment of lower risk disease associated with symptomatic anemia and serum erythropoietin levels less than or equal to 500 mu/ml with no response to erythropoietins alone and in combination with lenalidomide and no response or intolerance to immunosuppressive therapy. Used as a single agent for patients age greater than or equal to 60 years as: o Lower intensity induction therapy: For intensive remission induction therapy in patients with unfavorable cytogenetic or molecular markers/antecedent hematologic disorder/therapy-related AML; or When the patient is not a candidate for intensive remission induction 21

22 therapy; or Declines intensive therapy; or Post-remission therapy: Following a response to prior lower intensive therapy; or Maintenance therapy following complete response to prior intensive therapy if the patient received hypomethylating agents (e.g. azacitidine, decitabine) during induction; or In therapy for relapse or refractory disease in patients who cannot tolerate more aggressive regimens: As a single agent; or In combination with sorafenib (FLT3-ITD mutation positive). Myeloproliferative Neoplasms - Primary Myelofibrosis and Post PV Myelofibrosis or Post ET MF: For treatment of myelofibrosis (MF) accelerated phase; or MF blast phase acute myeloid leukemia. The effective date is November 27, Please refer to Medical Policy I-128, Decitabine (Dacogen ) for additional information. Revised Criteria for Eculizumab Highmark s Medicare Advantage product has revised clinical criteria for Eculizumab. Based on the FDA approved indications, this new criteria will apply to both professional provider and facility claims. The effective date is November 27, The following criteria have been added to the policy: Change in the perimeter for Flow Cytometry results have been changed from greater than or equal to 10% of glycosylphosphatidylinositol-anchored proteins (GPI-AP)-deficient polymorphonuclear cells (PMNs) to 50% of glycosylphosphatidylinositol-anchored proteins (GPI-AP)-deficient polymorphonuclear cells (PMNs). Qualifications for specific major adverse vascular events (MAVE) are now listed. Member clinical criteria for Hemoglobin that is less than or equal to 7 g/dl, or the individual has symptoms of anemia and the hemoglobin is less than equal to 9 g/dl; or evidence of clinically elevated hemolysis lactate dehydrogenase (LDH) greater than or equal to 1.5 times the upper limit of normal (ULN) has been added to the policy. Please refer to Medical Policy I-130, Eculizumab for additional information. 22

23 New Policy Established for MolDx: Prolaris Prostate Cancer Genomic Assay Highmark s Medicare Advantage product has established new coverage criteria for MolDx: Prolaris Prostate Cancer Genomic Assay. This new criteria will apply to both professional provider and facility claims. The effective date is July 13, Prolaris prostate cancer assay may be considered medically necessary to help determine which patients with favorable intermediate risk, needle biopsy proven prostate cancer, can be conservatively managed rather than treated with definitive surgery or radiation therapy. Please refer to Medical Policy L-174, MolDX: Prolaris Prostate Cancer Genomic Assay for Men with Favorable Intermediate Risk Disease for additional information. New Policy Established for MolDX: Fragile X Highmark s Medicare Advantage product has established new coverage criteria for MolDX: Fragile X testing. Fragile X testing is not covered. This new criteria will apply to professional provider claims. The effective date is April 27, Please refer to Medical Policy L-175, MolDX: Fragile X Coding and Billing Guidelines Update for additional information. New Policy Established for MolDX: FANCC Genetic Testing Highmark s Medicare Advantage product has established new coverage criteria for MolDX: FANCC Genetic Testing. FANCC genetic testing is not covered. This new criteria will apply to professional provider claims. The effective date is April 27, Please refer to Medical Policy L-176, MolDX: FANCC Genetic Testing Coding and Billing Guidelines for additional information. 23

24 New Policy Established for MolDX: GBA Genetic Testing Highmark s Medicare Advantage product has established new coverage criteria for MolDX: GBA Genetic Testing. GBA genetic testing is not covered. This new criteria will apply to professional provider claims. The effective date is April 27, Please refer to Medical Policy L-177, MolDX: GBA Genetic Testing Coding and Billing Guidelines for additional information. New Policy Established for MolDX: MCOLN1 Genetic Testing Highmark s Medicare Advantage product has established new coverage criteria for MolDX: MCOLN1 Genetic Testing. MCOLN1 genetic testing is not covered. This new criteria will apply to professional provider claims. The effective date is March 16, Please refer to Medical Policy L-178, MolDX: MCOLN1 Genetic Testing Coding and Billing Guidelines for additional information. New Policy Established for MolDX: STAT3 Gene Testing Highmark s Medicare Advantage product has established new coverage criteria for MolDX: STAT3 Gene Testing. STAT3 gene testing is not covered. This new criteria will apply to professional provider claims. The effective date is August 28, Please refer to Medical Policy L-179, MolDX: STAT3 Gene Testing Coding and Billing Guidelines for additional information. New Policy Established for MolDX: IKBKAP Genetic Testing Highmark s Medicare Advantage product has established new coverage criteria for IKBKAP Genetic Testing. IKBKAP genetic testing is not covered. This new criteria will apply to professional provider claims. The effective date is August 28, Please refer to Medical Policy L-180, MolDX: IKBKAP Genetic Testing Coding and Billing Guidelines for additional information. 24