Contents The following Hemophilia treatment products are being added to the medical policy:

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1 August 2017 In This Issue New Policy - Coverage Criteria Established for Confocal Laser Endomicroscopy... 6 New Policy Established for Lower Limb Prostheses... 7 New Policy Coverage Criteria Established for Radiofrequency Ablation of Peripheral Nerves to Treat Chronic Knee Pain... 8 Contents Policy Expanded Criteria for Hemophilia Treatments Highmark Blue Shield has revised clinical criteria for hemophilia treatment. The revised policy will apply to both professional provider and facility claims. The effective date is October 30, The following Hemophilia treatment products are being added to the medical policy: Vonvend Kovaltry Adynovate Afstyla Idelvion Coagadex Cyklokapron In addition to Hemophilia products, the following sections of the policy criteria have been updated: Congenital Factor VII Deficiency Congenital Factor XIII Deficiency (i.e., Fibrin Stabilizing Factor Deficiency) Fibrinogen Deficiency (i.e., Factor I deficiency) Hereditary Factory X Deficiency Hemophilia A (i.e., Congenital Factor VIII Deficiency, Factor VIII Deficiency, 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.

2 Classical Hemophilia) Hemophilia B (i.e., Congenital Factor IX Deficiency, Factor IX Deficiency, Christmas disease) Immune Tolerance Induction von Willebrand Disease (vwd) Please refer to Medical Policy I-4, Hemophilia Treatment for additional information. Coverage Criteria Revised for Human Growth Hormone Highmark Blue Shield has revised the clinical criteria for Human Growth Hormone. Human Growth Hormone may be considered medically necessary for the treatment for adults with proven congenital or acquired GH deficiency when all of the following criteria are met: Documentation of multiple pituitary growth hormone deficiencies; or Documentation of Central nervous system (CNS) irradiation; or The member has reconfirmation of growth hormone deficiency in adulthood defined as ALL of the following: o Documentation that epiphyseal fusion has occurred (for females bone age greater than 14 years of age; for males bone age greater than 16 years of age); and o Clinical documentation (i.e. growth charts) indicating a growth velocity of less than 2 cm/year; and o The member has not used growth hormone for at least 1 month; and o The member has a negative response to BOTH of the following standard growth hormone stimulation tests: Insulin induced hypoglycemia (serum growth hormone concentration less than or equal to 5 ng/ml) Arginine (serum growth hormone concentration less than or equal to 4.1 ng/ml). Please refer to Medical Policy I-12, Human Growth Hormone for additional information. Coverage Criteria Revised for Palonosetron Hydrochloride (Aloxi) Highmark Blue Shield has revised the clinical criteria for palonosetron hydrochloride (Aloxi) based on the FDA approved indications and National Comprehensive Cancer Network (NCCN) recommendations. Please refer to Medical Policy I-36, Palonosetron Hydrochloride (Aloxi) for additional information. 2

3 Coverage Criteria Revised for Oxaliplatin (Eloxatin) Highmark Blue Shield has revised the clinical criteria for oxaliplatin (Eloxatin) based on the FDA approved indications and National Comprehensive Cancer Network (NCCN) recommendations. Please refer to Medical Policy I-87, Oxaliplatin (Eloxatin) for additional information. Revised Criteria for Granulocyte Colony Stimulating Factors Highmark Blue Shield considers the following criteria medically necessary for the administration of Granulocyte Colony Stimulating Factors: In accordance with evidence based literature, market level analysis, NCCN Compendia, FDA guidelines, Professional Societies and Pharmacy Review, it is recommended to revise the criteria for this policy. This policy has been updated with NCCN recommendations and FDA indications. It is further recommended to add and cover the drug; Sargramostim (GM-CSF) (Leukine ) and Pegfilgrastim (Neulasta Onpro ) to this policy. The effective date is October 30, 2017 Please refer to Medical Policy I-88, Granulocyte Colony Stimulating Factors for additional information. Coverage Criteria Revised for Irinotecan (Camptosar) Highmark Blue Shield has revised the clinical criteria for irinotecan (Camptosar) based on the FDA approved indications and National Comprehensive Cancer Network (NCCN) recommendations. Please refer to Medical Policy I-109, Irinotecan (Camptosar) for additional information. 3

4 Coverage Criteria Revised for Ofatumumab (Arzerra) Highmark Blue Shield has revised the clinical criteria for ofatumumab (Arzerra) based on the FDA approved indications and National Comprehensive Cancer Network (NCCN) recommendations. Please refer to Medical Policy I-116, Ofatumumab (Arzerra) for additional information. Revised Criteria for Blinatumomab, (Blincyto) Highmark Blue Shield considers the following criteria medically necessary for the administration of Blinatumomab: Consolidation therapy for Philadelphia chromosome-negative B-ALL in adolescent and young adult patients with persistent or late clearance minimal residual disease positive (MRD+) following a complete response to induction therapy; or Consolidation therapy for Philadelphia chromosome-negative B-ALL in adult patients < 65 years of age without substantial comorbidities with persistent or late clearance MRD+ (Minimal Residual Disease) following a complete response to induction therapy; or Relapsed/refractory Philadelphia chromosome-positive B-ALL after failure of 2 TKIs (Tysodine Kinase Inhibitor); which may include; boutinib, crizotinib, dasatinib, erlontinib or others in this drug class; or Relapsed/refractory Philadelphia chromosome-negative B-ALL. It is further recommended to add the following language for continuance therapy: For all subsequent cycle starts and re-initiation (i.e., if treatment is interrupted for 4 or more hours), supervision by a healthcare professional or hospitalization is recommended. The effective Please refer to Medical Policy I-127, Blinatumomab for additional information. 4

5 Coverage Criteria Revised for Elosulfase alfa (Vimizim) Highmark Blue Shield has revised the clinical criteria for Elosulfase alfa (Vimizim) to include clinical requirements that individuals must be 5 years of age or older, and have documented clinical signs and symptoms of the disease (e.g., kyphoscoliosis, corneal opacity, genu valgum, pectus carinatum, gait disturbance, growth deficiency, etc.); and documented deficiency of GALNS in cultured fibroblasts or leukocytes or molecular genetic testing of GALNS. Please refer to Medical Policy I-138, Elosulfase alfa (Vimizim) for additional information. Coverage Criteria Established for Cerliponase Alfa (Brineura) Highmark Blue Shield has established new coverage criteria for cerliponase alfa (Brineura). Cerliponase alfa (Brineura) may be considered medically necessary for symptomatic pediatric patients 3 years of age and older with late infantile neuronal ceroid lipofuscinosis type 2 (CLN2) when: Individual is symptomatic (e.g. motor or language symptoms); and Has a confirmed diagnosis of CLN2,defined as: o Deficient TPP1 activity in leukocytes; and o Pathogenic variants/mutations in each allele of TPP1/CLN2 gene; and Cerliponase Alfa (Brineura) is prescribed by or in consultation with a neurologist with experience and expertise in the treatment and ongoing management of patients with CLN2; and Documented current rating on the CLN2 Clinical Rating Scale; and Intent of treatment is to slow the loss of ambulation. Continuation of treatment with cerliponase alfa (Brineura) beyond 12 months after initiation of therapy, and every 6 months thereafter, may be considered medically necessary for the treatment of late infantile CLN2 when individuals meet the following: Individual demonstrates no decline in the Motor domain of the CLN2 Clinical Rating Scale, defined as having an unreversed (sustained) 2-category decline or an unreversed score of 0 in the Motor domain of the CLN2 Clinical Rating Scale. Please refer to Medical Policy I-172, Cerliponase Alfa (Brineura) for additional information. 5

6 Coverage Criteria Established for Edaravone (Radicava) Highmark Blue Shield has established clinical criteria for Edaravone (Radicava). Edaravone (Radicava) may be considered medically necessary for the treatment of patients with a diagnosis of amyotrophic lateral sclerosis (ALS) when all of the following criteria are met: Submission of the most recent, complete medical records (e.g. medical history, diagnostic testing) to substantiate ALL of the following: o Diagnosis of definite or probable ALS, as noted in the revised EL Escorial and Airlie House diagnostic criteria, as determined by, or in consultation with, a neurologist with expertise in the diagnosis of ALS; and o The Patient is capable of conducting most activities of daily living independently defined by an ALS Functional Rating Scale-Revised (ALSFRS-R) score of greater than or equal to 2 in all items of the ALSFRS-R criteria at the initiation of treatment; and o A percentage forced vital capacity (%FVC) equal to, or, greater than 80% at the initiation of treatment; and o The Patient diagnosed with ALS is not dependent on invasive ventilation or tracheostomy. Policy criteria must be met upon annual review and renewal request. Edaravone (Radicava) is considered experimental/investigational for any other indication and therefore non-covered. Scientific evidence does not support its use for any other indications. Please refer to Medical Policy I-173, Edaravone (Radicava) for additional information. New Policy - Coverage Criteria Established for Confocal Laser Endomicroscopy Highmark Blue Shield has established coverage criteria for confocal laser endomicroscopy as experimental/investigational and therefore, non-covered. This applies to both professional provider and facility claims. The effective date of the new policy is October 30, Please refer to Medical Policy M-78, Confocal Laser Endomicroscopy for coverage criteria and additional information. 6

7 New Policy Established for Lower Limb Prostheses Highmark Blue Shield has established new coverage criteria for lower limb prostheses, including microprocessor-controlled lower limb prostheses. The new criteria will apply to both professional provider and facility claims. The effective /Inpatient Please refer to Medical Policy O-32, Lower Limb Prostheses for additional information. Clinical Criteria Revised for Transplantation for Chondral Defects Highmark Blue Shield has revised clinical criteria for Transplantation for Chondral Defects. The revised criteria will apply to both professional provider and facility claims. The effective Revised coverage criteria is listed below: Autologous chondrocyte implantation (ACI): Persistent symptoms of disabling localized knee pain for at least six (6) months, which have failed to respond to conservative treatment (i.e., rest, antiinflammatory medication or physical therapy); and Focal, full-thickness (grade III or IV) unipolar lesions of the patella or weightbearing surface of the femoral condyles or trochlea region caused by acute or repetitive trauma; and Cartilage defect is greater than or equal to 1.5 cm² in size; and Documented minimal to absent degenerative changes in the surrounding articular cartilage (Outerbridge grade II or less), and normal-appearing hyaline cartilage surrounding the border of the defect; and No history of cancer in the bones, cartilage, fat or muscle of the affected limb; and The individual has a body mass index (BMI) less than or equal to 35. ACI may be considered medically necessary for treatment of focal articular cartilage lesions in combination (concurrently or sequentially) with meniscal allografts. Osteochondral allograft (OCA) Adolescent must be skeletally mature with documented closure of growth plates (e.g., greater than or equal to15 years of age). Adult too young to be considered an appropriate candidate for total knee arthroplasty or other reconstructive knee surgery (e.g., less than or equal to 55 years); Autologous osteochondral transplantation (OATS/Mosaicplasty), using one (1) or more cores of osteochondral tissue, of the knee may be considered medically necessary for the treatment of symptomatic full-thickness cartilage defects caused by acute or repetitive trauma in individuals who had an inadequate response to a prior surgical procedure when ALL of the following have been met: Adolescent must be skeletally mature with documented closure of growth plates (e.g., greater than or equal to 15 years of age). Adult too young to be considered 7

8 an appropriate candidate for total knee arthroplasty or other reconstructive knee surgery (e.g., less than or equal to 55 years of age); and Focal, full-thickness (grade III or IV) unipolar lesions on the weight-bearing surface of the femoral condyles, trochlea(medial, lateral, or trochlear), or patella that are between 1 and 2.5 cm² in size; and Documented minimal to absent degenerative changes in the surrounding articular cartilage (Outerbridge grade II or less), and normal-appearing hyaline cartilage surrounding the border of the defect; and Normal knee biomechanics or alignment and stability achieved concurrently with autologous chondrocyte implantation; Osteochondral autografts or allografts may be considered medically necessary for treatment of focal articular cartilage lesions in combination (concurrently or sequentially) with meniscal allografts. Treatment of focal articular cartilage lesions with allogeneic minced cartilage is considered experimental/investigational and therefore non-covered. Subchondroplasty (SCP) is considered experimental/investigational and therefore noncovered because the safety and/or effectiveness of the treatment cannot be established by published peer-reviewed literature. Place of Service: Inpatient/Outpatient Please refer to Medical Policy S-185, Transplantation for Chondral Defects for additional information. New Policy - Coverage Criteria Established for Radiofrequency Ablation of Peripheral Nerves to Treat Chronic Knee Pain Highmark Blue Shield has established coverage criteria for radiofrequency ablation of peripheral nerves to treat chronic knee pain as experimental/investigational and therefore, non-covered. This applies to both professional provider and facility claims. The effective date of the new policy is October 30, Please refer to Medical Policy S-248, Radiofrequency Ablation of Peripheral Nerves to Treat Chronic Knee Pain for coverage criteria and additional information. Revised Frequency Guidelines for Bone Mineral Density Studies Highmark Blue Shield has revised the frequency guideline for bone mineral density studies. This new guideline will apply to both professional and facility claims. The effective Coverage for eligible bone density studies is limited to one test every two (2) years from the date of the previous bone density study. Please refer to Medical Policy X-24, Bone Mineral Density Studies for coverage criteria and additional information. 8

9 Revised Criteria for Posterior Tibial Nerve Stimulation Highmark Blue Shield considers the following criteria medically necessary for the administration of Posterior Tibial Nerve Stimulation. Based on current evidenced based literature, market level analysis, Specialty Societies and the policy positions of other carriers, it is recommended that Highmark medical policy Z-75 be converted from Experimental/Investigational to a covered service. The effective date is October 30, 2017 Please refer to Medical Policy Z-75, Posterior Tibial Nerve Stimulation for additional information. 9

10 Medicare Advantage Policy Coverage Criteria Revised for Granulocyte Colony Stimulating Factors Highmark s Medicare Advantage products have revised clinical criteria for Granulocyte Colony Stimulating Factors 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. In accordance with evidence based literature, market level analysis, NCCN Compendia, FDA guidelines, Professional Societies and Pharmacy Review, it is recommended to revise the criteria for this policy. This policy has been updated with NCCN recommendations and FDA indications. It is further recommended to add and cover the drug; Sargramostim(GM-CSF) (Leukine ) and Pegfilgrastim (Neulasta Onpro ) to this policy. The effective Please refer to Medical Policy I-88, Granulocyte Colony Stimulating Factors for additional information. Coverage Criteria Revised for Irinotecan (Camptosar) Highmark s Medicare Advantage products have revised coverage criteria irinotecan (Camptosar) based on the FDA approved indications and National Comprehensive Cancer Network (NCCN) recommendations. Please refer to Medical Policy I-109, Irinotecan (Camptosar) for additional information. Coverage Criteria Revised for Ofatumumab (Arzerra) Highmark s Medicare Advantage products have revised coverage criteria ofatumumab (Arzerra) based on the FDA approved indications and National Comprehensive Cancer Network (NCCN) recommendations. Please refer to Medical Policy I-116, Ofatumumab (Arzerra) for additional information. 10

11 Coverage Criteria Revised for Blinatumomab, (Blincyto) Highmark s Medicare Advantage products have revised clinical criteria for Blinatumomab, (Blincyto ) 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. Consolidation therapy for Philadelphia chromosome-negative B-ALL in adolescent and young adult patients with persistent or late clearance minimal residual disease positive (MRD+) following a complete response to induction therapy; or Consolidation therapy for Philadelphia chromosome-negative B-ALL in adult patients < 65 years of age without substantial comorbidities with persistent or late clearance MRD+ (Minimal Residual Disease) following a complete response to induction therapy; or Relapsed/refractory Philadelphia chromosome-positive B-ALL after failure of 2 TKIs (Tysodine Kinase Inhibitor); which may include; boutinib, crizotinib, dasatinib, erlontinib or others in this drug class; or Relapsed/refractory Philadelphia chromosome-negative B-ALL. It is further recommended to add the following language for continuance therapy: For all subsequent cycle starts and re-initiation (i.e., if treatment is interrupted for 4 or more hours), supervision by a healthcare professional or hospitalization is recommended. The effective Please refer to Medical Policy I-127, Blinatumomab for additional information. Coverage Criteria Established for Cerliponase Alfa (Brineura) Highmark s Medicare Advantage products have established coverage criteria for cerliponase alfa (Brineura). Cerliponase alfa (Brineura) may be considered medically necessary when used to slow the loss of ambulation in symptomatic pediatric patients 3 years of age and older with late infantile neuronal ceroid lipofuscinosis type 2 (CLN2), also known as tripeptidyl peptidase 1 (TPP1) deficiency. Please refer to Medical Policy I-172, Cerliponase Alfa (Brineura) for additional information. 11

12 Coverage Criteria Established for Edaravone (Radicava) Highmark s Medicare Advantage products have established clinical criteria for Edaravone (Radicava). Edaravone (Radicava) may be considered medically necessary for the treatment of patients with a diagnosis of amyotrophic lateral sclerosis (ALS). Edaravone (Radicava) is considered not medically necessary for any other indication and therefore non-covered. Please refer to Medical Policy I-173, Edaravone (Radicava) for additional information. 12

13 Comments on these new medical policies? We want to know what you think about our new medical policy changes. Send us an 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 Expanded Criteria for Hemophilia Treatments... 1 Coverage Criteria Revised for Human Growth Hormone... 2 Coverage Criteria Revised for Palonosetron Hydrochloride (Aloxi)... 2 Coverage Criteria Revised for Oxaliplatin (Eloxatin)... 3 Revised Criteria for Granulocyte Colony Stimulating Factors... 3 Coverage Criteria Revised for Irinotecan (Camptosar)... 3 Coverage Criteria Revised for Ofatumumab (Arzerra)... 4 Revised Criteria for Blinatumomab, (Blincyto)... 4 Coverage Criteria Revised for Elosulfase alfa (Vimizim)... 5 Coverage Criteria Established for Cerliponase Alfa (Brineura)... 5 Coverage Criteria Established for Edaravone (Radicava)... 6 New Policy - Coverage Criteria Established for Confocal Laser Endomicroscopy... 6 New Policy Established for Lower Limb Prostheses... 7 Clinical Criteria Revised for Transplantation for Chondral Defects... 7 New Policy - Coverage Criteria Established for Radiofrequency Ablation of Peripheral Nerves to Treat Chronic Knee Pain... 8 Revised Frequency Guidelines for Bone Mineral Density Studies... 8 Revised Criteria for Posterior Tibial Nerve Stimulation... 9 Coverage Criteria Revised for Granulocyte Colony Stimulating Factors...10 Coverage Criteria Revised for Irinotecan (Camptosar)...10 Coverage Criteria Revised for Ofatumumab (Arzerra)...10 Coverage Criteria Revised for Blinatumomab, (Blincyto)...11 Coverage Criteria Established for Cerliponase Alfa (Brineura)...11 Coverage Criteria Established for Edaravone (Radicava)...12 Comments on these new medical policies?...13 Contents...13 Save yourself valuable time with e-subscribe! Sign up today and you ll begin receiving notifications with a direct link to the latest issue of Medical Policy Update. 13

14 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 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 Acknowledgement The five-digit numeric codes that appear in Medical Policy Update were obtained from the Current Procedural Terminology (CPT), as contained in CPT- 2017, Copyright 2016, by the American Medical Association. Medical Policy Update includes CPT descriptive terms and numeric procedure codes and modifiers that are copyrighted by the American Medical Association. These procedure codes and modifiers are used for reporting medical services and procedures. 14